Xylitol five-times-daily prophylaxis × acute otitis media

Required evidence, verification status and materials actually read
Item	AVerification status	BReading scope	CReview item	DCurrent findings	EWhy unverified	FRequired materials and conditions	GFurther research
1	Partly verified	Full text not readStored summary read	N01 · Evidence conditionWhat is the selected original prevention question?Required	The selected original wording is five-times-daily prophylaxis. The parent's acute-otitis-media prevention claim is distinguished from the other subclaim of two- or three-times-daily or infection-triggered use. Original research exposure is identified without generating administration instructions. R01 R02	The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.	Original subclaim, exposure, parent and other question	Material needed: Exact plans, event definitions, denominators and the separate report identity for infection-triggered use are unverified. This records needed materials; no new research was executed.
2	Partly verified	Full text not readStored summary read	N02 · Evidence conditionAre subclaim C and parent C54 distinguished?Required	The original subclaim is C, with a note of positive directions in early gum/syrup trials. It has no separate score or status; parent C54, Caution and historical regimen-specific discussion do not supply a new subclaim score.	The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.	Original subclaim grade/note and absent score/status	Material needed: Separate subclaim score, status and assessment axes are absent from the source. This records needed materials; no new research was executed.
3	Partly verified	Full text not readStored summary read	N03 · Evidence conditionAre early children's ages the same as recent ages 1–5?Required	Early evidence concerns Finnish daycare children; exact ages and formulation-specific eligibility are unverified. Ages 1–5 in the R04 Persaud 2024 bibliography describe the recent lower-frequency population and do not fill early ages. R01 R02 R04	The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.	Report-specific ages, eligibility and formulation-use conditions	Material needed: Exact early/formulation-specific ages, eligibility, exclusions, development and use conditions are unverified. This records needed materials; no new research was executed.
4	Partly verified	Full text not readStored summary read	N04 · Evidence conditionHow do daycare, high-risk and later populations differ?Required	The stored account distinguishes early Finnish daycare from later US/Canadian contexts and records R03 Vernacchio 2014 as high-risk children. Baseline risk, recruitment and infection status are not established as identical across populations. R01 R02 R03 R04	The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.	Recruitment, country, baseline risk and infection status	Material needed: Report-specific recruitment, exclusions, baseline otitis/respiratory infection and environmental risks are unverified. This records needed materials; no new research was executed.
5	Partly verified	Full text not readStored summary read	N05 · Evidence conditionAre gum, syrup and lozenges the same exposure?Required	Original interventions were gum, syrup and lozenges. Favorable gum/syrup directions in 1998 are distinguished from uncertain lozenges; composition, contents, products, actual exposure and dose equivalence are unverified. R01 R02	The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.	Formulation, product, composition, contents and comparator	Material needed: Formulation-specific products, composition, contents, actual exposure, eligibility and comparator specifications are unverified. This records needed materials; no new research was executed.
6	Partly verified	Full text not readStored summary read	N06 · Evidence conditionAre original five-times-daily frequency and actual adherence distinguished?Required	The original frequency in 1996 gum and the same early research program in 1998 was five times daily. Planned frequency is not converted into actual provision, consumption or complete adherence; missed uses, refusal and burden remain separately unverified. R01 R02	The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.	Planned frequency, provision, consumption, missed uses and burden	Material needed: Actual provision, consumption, missed uses, refusal, discontinuation and adherence by formulation, child and period are unverified. This records needed materials; no new research was executed.
7	Partly verified	Full text not readStored summary read	N07 · Evidence conditionAre regular prophylaxis and use after infection onset the same?Required	The stored account distinguishes five-times-daily prevention from use after respiratory-infection onset. The separate report identity, start criteria, formulation, duration and exact effect of infection-triggered use are unlinked; no new report is created.	The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.	Timing, baseline infection and report identity	Material needed: Original infection-onset/eligibility criteria, separate bibliography, exact exposure and outcomes are needed. This records needed materials; no new research was executed.
8	Partly verified	Full text not readStored summary read	N08 · Evidence conditionWhat does approximately 2–3 months across trials describe?Required	The original classification is approximately 2–3 months across trials, with early evidence described as short-term. Exact report-specific start/end dates, event-observation windows and persistence after stopping are unverified. R01 R02 R03 R04	The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.	Original duration, prevention/follow-up and post-intervention outcomes	Material needed: Individual exposure periods, observation windows, discontinuation and post-intervention outcomes are unverified. This records needed materials; no new research was executed.
9	Partly verified	Full text not readStored summary read	N09 · Evidence conditionHow much is known about placebo, contact and concomitant care?Required	The original comparator classification is placebo. Report/formulation-specific composition, sweetness, calories, contact, antibiotics, concomitant care, clinical care and equivalent management are unverified. R01 R02 R03 R04	The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.	Formulation-specific placebo, equivalent management and healthcare use	Material needed: Comparator-product specifications, attention/contact, concomitant care, healthcare use and group-specific management are needed. This records needed materials; no new research was executed.
10	Partly verified	Full text not readStored summary read	N10 · Evidence conditionHow, and in what units, was acute otitis media identified?Required	Original endpoints concern acute-otitis-media events/occurrence. Exact diagnoses, adjudicators, children with at least one event versus repeated events, observation windows and collection are unverified. The original English word episodes is not converted into established child-level units. R01 R02 R03 R04	The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.	Diagnosis, assessors, children, repeated events and collection	Material needed: Diagnosis, assessment, reporting, event/child units, recurrence, collection and observation windows are unverified. This records needed materials; no new research was executed.
11	Partly verified	Full text not readStored summary read	N11 · Evidence conditionWhich report provides 19/157 versus 31/149?Required	19/157 versus 31/149 are original values from 1996 gum. They are not copied into 1998 gum, syrup, lozenges or later reports; exact event units, group correspondence and denominator flow remain separately unverified. R01	The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.	1996 gum comparison values, group correspondence and denominators	Material needed: Original-table event/child units, allocation, observation, denominator flow and group correspondence are needed. This records needed materials; no new research was executed.
12	Partly verified	Full text not readStored summary read	N12 · Evidence conditionAre 306 analyzed the same as allocated/completed denominators?Required	306 analyzed applies only to the 1996 gum trial. It is not the population count for 1998 or later reports; group-specific allocation, completion, follow-up, exclusions and endpoint denominators are unverified. R01	The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.	Original analysis n, allocation, completion, exclusions and missingness	Material needed: Allocation, completion, observation, analysis populations and group-specific attrition/exclusion flow are unverified. This records needed materials; no new research was executed.
13	Partly verified	Full text not readStored summary read	N13 · Evidence conditionWhat estimand do 8.7 percentage points, CI and P describe?Required	The original difference 8.7 percentage points (95% CI 0.4–17.0), P=.04 and original wording of an absolute 8.7-percentage-point reduction are preserved. Exact model, adjustment, estimand and event units are unverified; no new differences, ratios or NNTs are calculated. R01	The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.	Original absolute difference, direction, interval and model	Material needed: Details of original estimates, adjustment, analysis populations, event units and group correspondence are needed. This records needed materials; no new research was executed.
14	Partly verified	Full text not readStored summary read	N14 · Evidence conditionWhat is the level of formulation-specific favorable directions in 1998?Required	R02 is a separate 1998 citation; the stored account records favorable five-times-daily gum/syrup directions. The combined evidence row's 306 participants and precise events/effects from 1996 are not read as individual 1998 values. R02	The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.	Separate bibliography, five times daily and formulation-specific outcomes	Material needed: Formulation-specific n, events, effects, CIs, groups, duration and analyses in 1998 are unverified. This records needed materials; no new research was executed.
15	Partly verified	Full text not readStored summary read	N15 · Evidence conditionAre uncertain lozenges combined with favorable gum/syrup?Required	The stored account records uncertain lozenges in 1998, unlike favorable gum/syrup directions. Formulation names alone do not establish equal effects, contents, adherence or eligibility. R02	The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.	1998 lozenges, effects, denominators and actual exposure	Material needed: Exact lozenge effects, CIs, n, product specifications, actual exposure and adherence are unverified. This records needed materials; no new research was executed.
16	Partly verified	Full text not readStored summary read	N16 · Evidence conditionHow are the two reports from the same research program linked?Required	1996 and 1998 are separate citations, originally described as the same early research program. Cohort overlap, recruitment, report/registration relationships, exact independence and unique totals are unverified. R01 R02	The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.	1996/1998 bibliography, cohorts, recruitment and independence	Material needed: Cohort/participant overlap, recruitment, reporting relationships, independence and unique-trial status are needed. This records needed materials; no new research was executed.
17	Partly verified	Full text not readStored summary read	N17 · Evidence conditionAre the later conditions for HR 0.88 the same as original five-times-daily use?Required	R03 Vernacchio 2014 is preserved as a pragmatic lower-frequency syrup trial in high-risk children, HR 0.88 (95% CI 0.61–1.30), null. Exact report-specific frequency, contents, numerical n, observation and model are unverified; a frequency-only effect is not isolated. R03	The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.	2014 lower-frequency syrup, high-risk children and original HR	Material needed: Individual frequency, contents, n, timing, denominators, model, adjustment and comparison conditions are unverified. This records needed materials; no new research was executed.
18	Partly verified	Full text not readStored summary read	N18 · Evidence conditionWhich report provides 6 versus 3 events and OR 2.04?Required	R04 Persaud 2024 records 250 participants, twice-daily-target syrup, 6 versus 3 events, OR 2.04 (0.43–12.92), P=.50. Group-specific allocated/analyzed n, event units and model are unverified; these are not early five-times-daily results. R04	The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.	2024, 250 participants, target frequency, events, OR and interval	Material needed: Group-specific n, event units, model, adjustment, loss to follow-up and actual analysis populations are unverified. This records needed materials; no new research was executed.
19	Partly verified	Full text not readStored summary read	N19 · Evidence conditionWhat precision boundary does the original 9-event wording describe?Required	The original 2024 wording of 9 events and the wide interval are retained. A lower-frequency null result is not established as harm, an effect of 0 or complete equivalence; no new event totals, effects or CIs are calculated. R04	The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.	Sparse 2024 events, wide interval and null interpretation	Material needed: Exact denominators, model, loss to follow-up and additional original material for precision assessment are needed. This records needed materials; no new research was executed.
20	Partly verified	Full text not readStored summary read	N20 · Evidence conditionAre a twice-daily target and approximately two actual daily uses the same record?Required	R04 distinguishes a twice-daily target from the original record of approximately two actual uses daily. This is not converted into complete individual adherence or absence of discontinuation. R04	The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.	2024 target, actual exposure, adherence and discontinuation	Material needed: Actual exposure, missed uses, refusal, discontinuation, deviation from target and analytic handling by child/period are unverified. This records needed materials; no new research was executed.
21	Unverified	Full text not readStored summary read	N21 · Evidence conditionCan frequency alone establish administration amounts or doses?Required	The original summary describes five-times-daily or lower-frequency use and formulations but lacks formulation contents, per-use/daily doses and weight-specific ranges. No new amounts, dose conversions, administration schedules or pediatric prevention/treatment instructions are created. R01 R02	The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.	Formulation contents, per-use/daily doses, weight and age	Material needed: Contents, per-use/daily doses and actual weight/age-specific exposures are unverified. This records needed materials; no new research was executed.
22	Partly verified	Full text not readStored summary read	N22 · Evidence conditionAre randomized labels distinguished from actual allocation?Required	The stored account describes early/later randomized trials, and the 1996 citation includes double-blind randomized wording. Actual generation, concealment, formulation allocation, recruitment order and cluster units are unverified. R01 R02 R03 R04	The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.	Design, sequence generation, concealment, formulation and cluster allocation	Material needed: Original report-specific allocation, concealment, randomization units, recruitment and formulation distribution methods are needed. This records needed materials; no new research was executed.
23	Partly verified	Full text not readStored summary read	N23 · Evidence conditionAre event assessment and parent/assessor awareness known?Required	Double-blind wording in the 1996 citation is preserved. It is not expanded into verified masking of parents, children, clinicians or adjudicators, or equivalent event collection across every report. R01 R02 R03 R04	The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.	Masking, diagnosis, reporting, healthcare use and recurrent-event collection	Material needed: Report-specific masking procedures, diagnosis, assessment, reporting, healthcare use and recurrent-event collection are unverified. This records needed materials; no new research was executed.
24	Partly verified	Full text not readStored summary read	N24 · Evidence conditionWhat were baseline infection, clinical care and concurrent management?Required	Daycare, high-risk and regular-prevention contexts are recorded, but group-specific baseline infection, other prevention, diet, antibiotics, healthcare use, lifestyle changes and analytic handling are unverified. R01 R02 R03 R04	The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.	Baseline risk, prevention, diet, antibiotics and group changes	Material needed: Original material on baseline infection/risk, concomitant care, healthcare use, group changes and analyses remains needed. This records needed materials; no new research was executed.
25	Partly verified	Full text not readStored summary read	N25 · Evidence conditionWhat estimand is defined by denominators, attrition, repeated events and adjustment?Required	306 analyzed in 1996, 250 participants in 2024, events, HR and OR are preserved. Report-specific ITT/PP, discontinuation, loss to follow-up, cluster/repeated-event handling, adjustment and sensitivity analyses are unverified; individual 1998 n and numerical 2014 n are also unverified. R01 R02 R03 R04	The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.	ITT/PP, loss to follow-up, clusters, models and missingness	Material needed: Denominator stages, ITT/PP, recurrence/clustering, adjustment, missingness, sensitivity analyses and original plans are needed. This records needed materials; no new research was executed.
26	Partly verified	Full text not readStored summary read	N26 · Evidence conditionAre historical registration wording and later registration/plans distinguished?Required	The early combined row's registration-does-not-exist-because-it-predates-registration wording is historical.2014 is recorded as not confirmed and 2024 as NCT03055091; registration contents, timing relative to recruitment, hierarchy and changes were not read in this work. R01 R02 R03 R04	The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.	Early pre-registration-era wording, unverified 2014 registration and 2024 identifier	Material needed: Report-specific registration identity/content, recruitment timing, prospective endpoints/analyses and change history are unverified. This records needed materials; no new research was executed.
27	Partly verified	Full text not readStored summary read	N27 · Evidence conditionDo otitis-prevention outcomes answer caries, treatment or long-term questions?Required	The stored account identifies dental-caries verdict 748 as a different question. This sheet concerns original acute-otitis-media preventive events; direct evidence for treatment of existing otitis, long-term/post-intervention prevention or other clinical effects is unverified.	The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.	Original acute events, separate caries, treatment and post-intervention prevention	Material needed: Direct endpoints, comparators, denominators and duration for caries, treatment and long-term/repeated prevention are needed. This records needed materials; no new research was executed.
28	Partly verified	Full text not readStored summary read	N28 · Evidence conditionCan formulation/frequency-only effects be isolated from later differences?Required	The stored account says formulation and frequency changed together, preventing isolation of formulation-only effects. No new direct superiority or universal prevention effect is established from high-/lower-frequency, infection-timing or population differences. R01 R02 R03 R04	The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.	Joint changes in formulation, frequency, timing, population and duration	Material needed: Direct formulation/frequency comparisons under identical conditions, individual original tables and exact replication are unverified. This records needed materials; no new research was executed.
29	Partly verified	Full text not readStored summary read	N29 · Evidence conditionHow are three evidence rows linked to four citations?Required	There are 3 evidence rows and 4 citations. Original n and precise results from 1996 in the early combined row link only to R01; the separate 1998 citation/directions link to R02. R03/R04 are lower-frequency contexts; unique trial, participant and event totals are unrecorded. R01 R02 R03 R04	The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.	Combined evidence, separate bibliography, reports, cohorts and outcome mapping	Material needed: Report, cohort and recruitment relationships, overlap, independence and unique totals are unverified. This records needed materials; no new research was executed.
30	Partly verified	Full text not readStored summary read	N30 · Evidence conditionHow far are public support and product involvement known?Required	The early combined row records indexed non-US government support with complete product involvement incompletely verified;2014 records NIH/non-US government support and 2024 public research support. Individual 1998 support details, institutions, products, design/analysis involvement and COI are unverified. R01 R02 R03 R04	The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.	Report-specific funding, product support, roles and COI	Material needed: Report-specific funding, product provision, employees, design/analysis/publication roles, COI and detailed independence are unverified. This records needed materials; no new research was executed.
31	Partly verified	Full text not readStored summary read	N31 · Evidence conditionWhat material was actually read here?Required	The complete parent stored summary and corresponding summaries for the four citations were read and preserved in full internally. External papers, abstracts, registration, plans and support disclosures are unread/access unattempted; they are not classified as inaccessible or failed access. R01 R02 R03 R04	The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.	Complete stored summary and unread external material	Material needed: External originals, supplements, registration, plans, support, actual reading records and content review remain outstanding. This records needed materials; no new research was executed.
32	Partly verified	Full text not readStored summary read	N32 · Evidence conditionAre historical verification and current production/review separated?Required	Original evidence cut-off 2026-09-07, an empty correction array and an empty deliberation string are preserved. The parent's cross-check-applied wording is historical, not current external verification or completed content review.	The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.	Original date, empty corrections/deliberation and historical decision	Material needed: New clinical verification, corrections/follow-up materials and current content review remain outstanding; the unrecorded material-review date stays unrecorded. This records needed materials; no new research was executed.
33	Partly verified	Full text not readStored summary read	N33 · Evidence conditionAre original languages and event/frequency/formulation scope preserved?Required	The original English is Five-times-daily prophylaxis, with a note of favorable early gum/syrup trials. Parent Korean/English boundaries concerning frequency, timing, lower-frequency null results and sparse events are preserved; event units and detailed translation are not treated as newly checked against external papers.	The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.	Original wording, note and language-specific event expressions	Material needed: External-paper comparison of detailed Korean/English translation, corrections and event units remains incomplete. This records needed materials; no new research was executed.
34	Partly verified	Full text not readStored summary read	N34 · Evidence conditionAre parent axes distinguished from absent subclaim fields?Required	Parent values are B/H/R0/I1/E+/B2, null precision, four false flags, derived C and an empty override. The subclaim has no separate score, status or axes; parent C54/Caution do not fill subclaim values or provide new independence certification.	The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.	Parent axes, null precision and absent subclaim score/status/axes	Material needed: Subclaim score, status and axes are absent from the source and detailed precision remains unverified. Null is not filled with an invented grade. This records needed materials; no new research was executed.
35	Partly verified	Full text not readStored summary read	N35 · Evidence conditionAre diarrhea, abdominal discomfort, refusal and choking cautions actual event data?Supplementary; required for extending safety conclusions	Original safety is Caution, with syrup/lozenge diarrhea, abdominal discomfort/refusal and choking concern with gum in young children. This wording is not converted into actual event counts, rates or verified causation. R01 R02 R03 R04	The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.	Formulation/age-specific harm definitions, collection, denominators and discontinuation	Material needed: Harm definitions, collection, assessment, actual events and formulation/age-specific denominators are unverified. This records needed materials; no new research was executed.
36	Unverified	Full text not readStored summary read	N36 · Evidence conditionWhat are harm exposure, discontinuation, recovery and later observation times?Supplementary; required for extending safety conclusions	Original prevention duration/frequency are recorded, but harm onset, recovery, refusal, discontinuation, later follow-up and the timing relative to actual exposure by formulation/age are unverified. R01 R02 R03 R04	The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.	Actual exposure, symptoms, refusal, recovery and observation windows	Material needed: Original harm-onset, recovery, discontinuation, follow-up timing and actual-exposure material is needed. This records needed materials; no new research was executed.
37	Unverified	Full text not readStored summary read	N37 · Evidence conditionWere harms compared under equivalent observation/comparator conditions?Supplementary; required for extending safety conclusions	Original placebo/formulation contexts are recorded, but equal harm collection, observation windows and direct harm/discontinuation comparisons between groups are unverified. The preventive-outcome comparator is not inherited as equivalent harm collection. R01 R02 R03 R04	The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.	Placebo, formulation-specific harm collection, windows and discontinuation comparisons	Material needed: Original tables with equivalent harm collection, observation windows, comparator and formulation-specific direct comparisons are needed. This records needed materials; no new research was executed.
38	Unverified	Full text not readStored summary read	N38 · Evidence conditionAre harm-event counts and actual-exposure denominators available?Supplementary; required for extending safety conclusions	Original 306 analyzed, later 250 participants and preventive-event counts are recorded, but actual harm counts, formulation/age-specific exposure/observation denominators and discontinuation are unverified. Preventive-analysis n is not used as the harm denominator. R01 R02 R03 R04	The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.	Formulation/age-specific harms, exposure, observation and discontinuation	Material needed: Harm counts, actual exposure/follow-up denominators, formulation, age and duration are unverified. This records needed materials; no new research was executed.
39	Partly verified	Full text not readStored summary read	N39 · Evidence conditionAre infection, concomitant care, formulation, refusal and causation distinguished?Supplementary; required for extending safety conclusions	The stored account includes formulation-specific possibilities and refusal/discontinuation cautions, but actual events, contributions of concomitant care, infection, formulation/age and causal assessment are unverified. R01 R02 R03 R04	The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.	Concurrent factors, actual events, exposure and discontinuation timing	Material needed: Actual events, concurrent factors, formulation/age contributions, exposure timing and causal assessment are needed. This records needed materials; no new research was executed.
40	Unverified	Full text not readStored summary read	N40 · Evidence conditionAre refusal, discontinuation, loss to follow-up and harm reporting known?Supplementary; required for extending safety conclusions	Original safety wording concerns possible refusal/discontinuation; the 2024 citation records limited adherence. Report-specific group discontinuation/attrition reasons, missing harms, selective reporting and loss to follow-up are unverified. R01 R02 R03 R04	The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.	Group-specific refusal, attrition, harm missingness and selective reporting	Material needed: Group-specific refusal, discontinuation, attrition, harm missingness, selective reporting and later follow-up are needed. This records needed materials; no new research was executed.
41	Unverified	Full text not readStored summary read	N41 · Evidence conditionHow far are harms in other ages/formulations, independent evidence and long-term follow-up known?Supplementary; required for extending safety conclusions	The current preserved scope contains preventive findings and harm cautions. Independent harm evidence for the same formulation/frequency, vulnerable ages/diseases and post-intervention follow-up are unverified; no new external search was performed. R01 R02 R03 R04	The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.	Same exposure, vulnerable populations, independent harms and post-intervention follow-up	Material needed: Independent harms, vulnerable populations, other formulations/ages and long-term/post-intervention follow-up are unverified. This records needed materials; no new research was executed.
42	Partly verified	Full text not readStored summary read	N42 · Evidence conditionAre originals, conditions, methods, observations and update records distinguished?Required	Existing preserved methodology and application conditions are linked; conditions were saved/frozen before observations were recorded at a separate time. This is not upgraded into methodological certification or completed content review; no new research, calculations, grades or administration instructions are created.	The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.	Original texts, condition versions, separate application and change history	Material needed: Complete prior texts, condition versions, separate application records, current content review and change history must be preserved distinctly. This records needed materials; no new research was executed.

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42 itemsWhat the statuses mean

Assessment scope

Stored-material review date: Not recorded
Original evidence cut-off: 2026-09-07
Scope actually checked: Existing review summaries and stored records of methodological application. Full papers, supplements, registrations, plans and original data were not read.
What the dates mean: This is the date the stored materials were checked, not the date of a new search of the clinical literature.
Population: Early Finnish daycare children; exact ages, formulation-specific eligibility and baseline risk are unverified. The 306 analyzed in the 1996 gum trial are not transferred to 1998 or later reports. R03 concerns high-risk children; ages 1–5 and 250 participants in R04 belong only to the 2024 lower-frequency report.
Ingredient, formulation and route: The selected exposure is early regular five-times-daily prophylaxis with xylitol gum/syrup. Uncertain lozenges in 1998, two- or three-times-daily use and use after infection onset are separate contexts. Formulation, frequency and timing changed together, so formulation/frequency-only contributions or superiority are not established.
Dose: Five times daily identifies the original research frequency. Formulation contents, per-use/daily doses, weight/age-specific actual exposure and dose equivalence are unverified. No new doses, conversions, administration schedules or pediatric prevention/treatment instructions are created.
Comparator: The original classification is placebo. Report/formulation-specific placebo composition, sweetness, calories, contact, healthcare use, antibiotics, concomitant care and equivalent management are unverified. Different formulations, frequencies and populations are not converted into direct comparisons under identical conditions.
Measured outcome: The selected outcome is prevention of acute otitis media. Preserve 19/157 versus 31/149 in the 1996 gum trial, the original wording of an absolute 8.7-percentage-point reduction, 95% CI 0.4–17.0 and P=.04. Exact child/repeated-event units, denominator flow, models and adjustment are unverified. Positive gum/syrup directions and uncertain lozenges in 1998, null HR 0.88 (0.61–1.30) in 2014, and 6 versus 3 events, OR 2.04 (0.43–12.92), P=.50 and the original 9-event wording in 2024 are separate report contexts.
Duration: The original classification is approximately 2–3 months across trials, with early evidence described as short-term. Exact exposure, event-observation windows and persistence after stopping per report are unverified. Short-term preventive findings are not extended into long-term prevention, treatment of existing otitis media or dental-caries prevention.
Questions outside this scope: Copying 306 participants, 19/157, 31/149 or 8.7 percentage points from 1996 to other formulations in 1998; Combining five-times-daily, two- or three-times-daily and infection-triggered use into a single effect; Transferring ages 1–5, 250 participants or sparse events in 2024 to early populations or proven harm/equivalence; Certifying risk differences, HRs, ORs, children, repeated events and multiple reports as new totals, identical estimands or independent replication; Establishing formulation/frequency-only superiority from evidence differing jointly in formulation, frequency, timing and population; Inheriting parent C54, axes or historical checks as absent subclaim values/completed current review, or generating doses, conversions or pediatric prevention/treatment instructions

Evidence and sources

The links below lead to the sources. A link alone does not mean the original source was read or its latest publication status verified.

R01 · Uhari M, Kontiokari T, Koskela M, Niemelä M. Xylitol chewing gum in prevention of acute otitis media: double blind randomised trial. BMJ. 1996;313:1180-1184. PMID: 8916749. PMCID: PMC2352484. DOI: 10.1136/bmj.313.7066.1180.

PubMed

Material type: 1996 five-times-daily gum randomized trial
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Findings recorded in the stored summary: Gum 19/157 versus 31/149; original absolute difference 8.7 percentage points (95% CI 0.4–17.0), P=.04
Record level: Only the 306 analyzed and precise original values from the 1996 gum trial are linked. The combined 1996/1998 evidence row does not supply formulation-specific n, events, effects or CIs for 1998. Exact event units, denominator flow and adjustment are unverified.
Study overlap and independent replication: The 1996/1998 reports are separate bibliography within the same early research program. The combined evidence row's 306 participants and precise events/effects belong only to 1996 gum. The 2014/2024 reports concern different lower-frequency/population contexts; the separate infection-triggered-use identity is unlinked. Four citations, three evidence rows, formulations, children and repeated events are not summed into new unique trials, participants, events or independent-replication totals; confirmed totals are unrecorded.

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Stored existing review summary	Preserved copy of the complete parent-verdict stored summary	Stored summary	Summary read	Original PubMed URL, PMID 8916749, PMCID PMC2352484 and DOI 10.1136/bmj.313.7066.1180 are preserved. The combined evidence row's pre-registration-era wording is historical, not new verification of individual registration absence, prospective status or access. No new full-text/registration URLs are inferred.
External abstract	Original bibliographic link or needed material; external public availability/access status unverified	Unread; access not attempted	Not read	Original PubMed URL, PMID 8916749, PMCID PMC2352484 and DOI 10.1136/bmj.313.7066.1180 are preserved. The combined evidence row's pre-registration-era wording is historical, not new verification of individual registration absence, prospective status or access. No new full-text/registration URLs are inferred.
External full text	Original bibliographic link or needed material; external public availability/access status unverified	Unread; access not attempted	Not read	Original PubMed URL, PMID 8916749, PMCID PMC2352484 and DOI 10.1136/bmj.313.7066.1180 are preserved. The combined evidence row's pre-registration-era wording is historical, not new verification of individual registration absence, prospective status or access. No new full-text/registration URLs are inferred.
Registration material	Original bibliographic link or needed material; external public availability/access status unverified	Unread; access not attempted	Not read	Original PubMed URL, PMID 8916749, PMCID PMC2352484 and DOI 10.1136/bmj.313.7066.1180 are preserved. The combined evidence row's pre-registration-era wording is historical, not new verification of individual registration absence, prospective status or access. No new full-text/registration URLs are inferred.
Protocol	Original bibliographic link or needed material; external public availability/access status unverified	Unread; access not attempted	Not read	Original PubMed URL, PMID 8916749, PMCID PMC2352484 and DOI 10.1136/bmj.313.7066.1180 are preserved. The combined evidence row's pre-registration-era wording is historical, not new verification of individual registration absence, prospective status or access. No new full-text/registration URLs are inferred.
Analysis plan and original tables	Original bibliographic link or needed material; external public availability/access status unverified	Unread; access not attempted	Not read	Original PubMed URL, PMID 8916749, PMCID PMC2352484 and DOI 10.1136/bmj.313.7066.1180 are preserved. The combined evidence row's pre-registration-era wording is historical, not new verification of individual registration absence, prospective status or access. No new full-text/registration URLs are inferred.
Intervention and harms	Original bibliographic link or needed material; external public availability/access status unverified	Unread; access not attempted	Not read	Original PubMed URL, PMID 8916749, PMCID PMC2352484 and DOI 10.1136/bmj.313.7066.1180 are preserved. The combined evidence row's pre-registration-era wording is historical, not new verification of individual registration absence, prospective status or access. No new full-text/registration URLs are inferred.
Support and interests	Original bibliographic link or needed material; external public availability/access status unverified	Unread; access not attempted	Not read	Original PubMed URL, PMID 8916749, PMCID PMC2352484 and DOI 10.1136/bmj.313.7066.1180 are preserved. The combined evidence row's pre-registration-era wording is historical, not new verification of individual registration absence, prospective status or access. No new full-text/registration URLs are inferred.

R02 · Uhari M, Kontiokari T, Niemelä M. A novel use of xylitol sugar in preventing acute otitis media. Pediatrics. 1998;102:879-884. PMID: 9755259. DOI: 10.1542/peds.102.4.879.

PubMed

Material type: 1998 five-times-daily formulation-specific follow-up report
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Findings recorded in the stored summary: 1998 five-times-daily gum/syrup favorable directions; lozenges uncertain, individual effects/denominators/CIs unverified
Record level: Original citation and formulation-specific directions only. The 306 participants, precise events and absolute difference from 1996 are not inherited; individual design, formulation eligibility, denominators, effects, CIs and duration in 1998 are unverified.
Study overlap and independent replication: The 1996/1998 reports are separate bibliography within the same early research program. The combined evidence row's 306 participants and precise events/effects belong only to 1996 gum. The 2014/2024 reports concern different lower-frequency/population contexts; the separate infection-triggered-use identity is unlinked. Four citations, three evidence rows, formulations, children and repeated events are not summed into new unique trials, participants, events or independent-replication totals; confirmed totals are unrecorded.

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Stored existing review summary	Preserved copy of the complete parent-verdict stored summary	Stored summary	Summary read	Original PubMed URL, PMID 9755259, DOI 10.1542/peds.102.4.879 and unrecorded PMCID/registration identifiers are preserved. The n, precise results and support details from 1996 do not fill the separate 1998 report.
External abstract	Original bibliographic link or needed material; external public availability/access status unverified	Unread; access not attempted	Not read	Original PubMed URL, PMID 9755259, DOI 10.1542/peds.102.4.879 and unrecorded PMCID/registration identifiers are preserved. The n, precise results and support details from 1996 do not fill the separate 1998 report.
External full text	Original bibliographic link or needed material; external public availability/access status unverified	Unread; access not attempted	Not read	Original PubMed URL, PMID 9755259, DOI 10.1542/peds.102.4.879 and unrecorded PMCID/registration identifiers are preserved. The n, precise results and support details from 1996 do not fill the separate 1998 report.
Registration material	Original bibliographic link or needed material; external public availability/access status unverified	Unread; access not attempted	Not read	Original PubMed URL, PMID 9755259, DOI 10.1542/peds.102.4.879 and unrecorded PMCID/registration identifiers are preserved. The n, precise results and support details from 1996 do not fill the separate 1998 report.
Protocol	Original bibliographic link or needed material; external public availability/access status unverified	Unread; access not attempted	Not read	Original PubMed URL, PMID 9755259, DOI 10.1542/peds.102.4.879 and unrecorded PMCID/registration identifiers are preserved. The n, precise results and support details from 1996 do not fill the separate 1998 report.
Analysis plan and original tables	Original bibliographic link or needed material; external public availability/access status unverified	Unread; access not attempted	Not read	Original PubMed URL, PMID 9755259, DOI 10.1542/peds.102.4.879 and unrecorded PMCID/registration identifiers are preserved. The n, precise results and support details from 1996 do not fill the separate 1998 report.
Intervention and harms	Original bibliographic link or needed material; external public availability/access status unverified	Unread; access not attempted	Not read	Original PubMed URL, PMID 9755259, DOI 10.1542/peds.102.4.879 and unrecorded PMCID/registration identifiers are preserved. The n, precise results and support details from 1996 do not fill the separate 1998 report.
Support and interests	Original bibliographic link or needed material; external public availability/access status unverified	Unread; access not attempted	Not read	Original PubMed URL, PMID 9755259, DOI 10.1542/peds.102.4.879 and unrecorded PMCID/registration identifiers are preserved. The n, precise results and support details from 1996 do not fill the separate 1998 report.

R03 · Vernacchio L, Corwin MJ, Vezina RM, et al. Xylitol syrup for the prevention of acute otitis media. Pediatrics. 2014;133:289-295. PMID: 24394686. PMCID: PMC3904279. DOI: 10.1542/peds.2013-2373.

PubMed

Material type: 2014 pragmatic lower-frequency syrup randomized trial
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Findings recorded in the stored summary: HR 0.88 (95% CI 0.61–1.30), null
Record level: Original HR for lower-frequency syrup in high-risk children. Exact report-specific frequency, contents, numerical n, observation window, model and adjustment are unverified. The unidentified infection-triggered-use mention is not arbitrarily assigned to this report.
Study overlap and independent replication: The 1996/1998 reports are separate bibliography within the same early research program. The combined evidence row's 306 participants and precise events/effects belong only to 1996 gum. The 2014/2024 reports concern different lower-frequency/population contexts; the separate infection-triggered-use identity is unlinked. Four citations, three evidence rows, formulations, children and repeated events are not summed into new unique trials, participants, events or independent-replication totals; confirmed totals are unrecorded.

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Stored existing review summary	Preserved copy of the complete parent-verdict stored summary	Stored summary	Summary read	Original PubMed URL, PMID 24394686, PMCID PMC3904279, DOI 10.1542/peds.2013-2373 and registration-not-confirmed wording are preserved. Identifiers/URLs alone do not certify reading, prospective status or access.
External abstract	Original bibliographic link or needed material; external public availability/access status unverified	Unread; access not attempted	Not read	Original PubMed URL, PMID 24394686, PMCID PMC3904279, DOI 10.1542/peds.2013-2373 and registration-not-confirmed wording are preserved. Identifiers/URLs alone do not certify reading, prospective status or access.
External full text	Original bibliographic link or needed material; external public availability/access status unverified	Unread; access not attempted	Not read	Original PubMed URL, PMID 24394686, PMCID PMC3904279, DOI 10.1542/peds.2013-2373 and registration-not-confirmed wording are preserved. Identifiers/URLs alone do not certify reading, prospective status or access.
Registration material	Original bibliographic link or needed material; external public availability/access status unverified	Unread; access not attempted	Not read	Original PubMed URL, PMID 24394686, PMCID PMC3904279, DOI 10.1542/peds.2013-2373 and registration-not-confirmed wording are preserved. Identifiers/URLs alone do not certify reading, prospective status or access.
Protocol	Original bibliographic link or needed material; external public availability/access status unverified	Unread; access not attempted	Not read	Original PubMed URL, PMID 24394686, PMCID PMC3904279, DOI 10.1542/peds.2013-2373 and registration-not-confirmed wording are preserved. Identifiers/URLs alone do not certify reading, prospective status or access.
Analysis plan and original tables	Original bibliographic link or needed material; external public availability/access status unverified	Unread; access not attempted	Not read	Original PubMed URL, PMID 24394686, PMCID PMC3904279, DOI 10.1542/peds.2013-2373 and registration-not-confirmed wording are preserved. Identifiers/URLs alone do not certify reading, prospective status or access.
Intervention and harms	Original bibliographic link or needed material; external public availability/access status unverified	Unread; access not attempted	Not read	Original PubMed URL, PMID 24394686, PMCID PMC3904279, DOI 10.1542/peds.2013-2373 and registration-not-confirmed wording are preserved. Identifiers/URLs alone do not certify reading, prospective status or access.
Support and interests	Original bibliographic link or needed material; external public availability/access status unverified	Unread; access not attempted	Not read	Original PubMed URL, PMID 24394686, PMCID PMC3904279, DOI 10.1542/peds.2013-2373 and registration-not-confirmed wording are preserved. Identifiers/URLs alone do not certify reading, prospective status or access.

R04 · Persaud N, Azarpazhooh A, Keown-Stoneman C, et al. Xylitol for the prevention of acute otitis media episodes in children aged 1-5 years: a randomised controlled trial. Arch Dis Child. 2024. PMID: 37890960. PMCID: PMC10850643. DOI: 10.1136/archdischild-2023-325565.

PubMed

Material type: 2024 twice-daily-target syrup randomized trial
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Findings recorded in the stored summary: 6 versus 3 events; OR 2.04 (0.43–12.92), P=.50
Record level: Preserve the original 250 participants, bibliographic ages 1–5, twice-daily target/approximately two actual uses daily and original 9-event wording. Group-specific n, event units, model, adjustment and loss to follow-up are unverified; the wide interval/null result does not establish harm or equivalence.
Study overlap and independent replication: The 1996/1998 reports are separate bibliography within the same early research program. The combined evidence row's 306 participants and precise events/effects belong only to 1996 gum. The 2014/2024 reports concern different lower-frequency/population contexts; the separate infection-triggered-use identity is unlinked. Four citations, three evidence rows, formulations, children and repeated events are not summed into new unique trials, participants, events or independent-replication totals; confirmed totals are unrecorded.

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Stored existing review summary	Preserved copy of the complete parent-verdict stored summary	Stored summary	Summary read	Original PubMed URL, PMID 37890960, PMCID PMC10850643, DOI 10.1136/archdischild-2023-325565 and NCT03055091 are preserved. Registration contents, timing relative to recruitment, prospective hierarchy and changes are unread; no new full-text/registration URLs are inferred.
External abstract	Original bibliographic link or needed material; external public availability/access status unverified	Unread; access not attempted	Not read	Original PubMed URL, PMID 37890960, PMCID PMC10850643, DOI 10.1136/archdischild-2023-325565 and NCT03055091 are preserved. Registration contents, timing relative to recruitment, prospective hierarchy and changes are unread; no new full-text/registration URLs are inferred.
External full text	Original bibliographic link or needed material; external public availability/access status unverified	Unread; access not attempted	Not read	Original PubMed URL, PMID 37890960, PMCID PMC10850643, DOI 10.1136/archdischild-2023-325565 and NCT03055091 are preserved. Registration contents, timing relative to recruitment, prospective hierarchy and changes are unread; no new full-text/registration URLs are inferred.
Registration material	Original bibliographic link or needed material; external public availability/access status unverified	Unread; access not attempted	Not read	Original PubMed URL, PMID 37890960, PMCID PMC10850643, DOI 10.1136/archdischild-2023-325565 and NCT03055091 are preserved. Registration contents, timing relative to recruitment, prospective hierarchy and changes are unread; no new full-text/registration URLs are inferred.
Protocol	Original bibliographic link or needed material; external public availability/access status unverified	Unread; access not attempted	Not read	Original PubMed URL, PMID 37890960, PMCID PMC10850643, DOI 10.1136/archdischild-2023-325565 and NCT03055091 are preserved. Registration contents, timing relative to recruitment, prospective hierarchy and changes are unread; no new full-text/registration URLs are inferred.
Analysis plan and original tables	Original bibliographic link or needed material; external public availability/access status unverified	Unread; access not attempted	Not read	Original PubMed URL, PMID 37890960, PMCID PMC10850643, DOI 10.1136/archdischild-2023-325565 and NCT03055091 are preserved. Registration contents, timing relative to recruitment, prospective hierarchy and changes are unread; no new full-text/registration URLs are inferred.
Intervention and harms	Original bibliographic link or needed material; external public availability/access status unverified	Unread; access not attempted	Not read	Original PubMed URL, PMID 37890960, PMCID PMC10850643, DOI 10.1136/archdischild-2023-325565 and NCT03055091 are preserved. Registration contents, timing relative to recruitment, prospective hierarchy and changes are unread; no new full-text/registration URLs are inferred.
Support and interests	Original bibliographic link or needed material; external public availability/access status unverified	Unread; access not attempted	Not read	Original PubMed URL, PMID 37890960, PMCID PMC10850643, DOI 10.1136/archdischild-2023-325565 and NCT03055091 are preserved. Registration contents, timing relative to recruitment, prospective hierarchy and changes are unread; no new full-text/registration URLs are inferred.

Report counts versus independent study counts

The 1996/1998 reports are separate bibliography within the same early research program. The combined evidence row's 306 participants and precise events/effects belong only to 1996 gum. The 2014/2024 reports concern different lower-frequency/population contexts; the separate infection-triggered-use identity is unlinked. Four citations, three evidence rows, formulations, children and repeated events are not summed into new unique trials, participants, events or independent-replication totals; confirmed totals are unrecorded.

Review criteria

Version 1.0 · Criteria record date 2026-10-06. These are Chamgap's own application conditions, informed by the referenced methods. They do not constitute official assessment-tool certification or a new efficacy score.

N01 · What is the selected original prevention question?

Required materials and conditions: Original subclaim, exposure, parent and other question
Conditions for verification: Material for Original subclaim, exposure, parent and other question must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Requirement and applicability: Required
Application exceptions: Preserve original numbers, frequencies, formulations and research exposure only. Do not copy 306 participants or precise event/effect values from the 1996 gum trial to other formulations in 1998. Distinguish five-times-daily from two- or three-times-daily/infection-triggered use, target from actual frequency, children from repeated events, risk differences from HR/OR, and original cautions from actual harm rates. No new totals, effects, CIs, NNTs, dose conversions, grades, independence certification, formulation/frequency-only superiority or pediatric prevention/treatment instructions are created.
Why this condition is needed: This condition connects Original subclaim, exposure, parent and other question with the original five-times-daily prevention question, formulation/age, the 1996/1998 reports, later lower-frequency use, infection timing, event units, denominators, support and harms.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N02 · Are subclaim C and parent C54 distinguished?

Required materials and conditions: Original subclaim grade/note and absent score/status
Conditions for verification: Material for Original subclaim grade/note and absent score/status must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Requirement and applicability: Required
Application exceptions: Preserve original numbers, frequencies, formulations and research exposure only. Do not copy 306 participants or precise event/effect values from the 1996 gum trial to other formulations in 1998. Distinguish five-times-daily from two- or three-times-daily/infection-triggered use, target from actual frequency, children from repeated events, risk differences from HR/OR, and original cautions from actual harm rates. No new totals, effects, CIs, NNTs, dose conversions, grades, independence certification, formulation/frequency-only superiority or pediatric prevention/treatment instructions are created.
Why this condition is needed: This condition connects Original subclaim grade/note and absent score/status with the original five-times-daily prevention question, formulation/age, the 1996/1998 reports, later lower-frequency use, infection timing, event units, denominators, support and harms.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N03 · Are early children's ages the same as recent ages 1–5?

Required materials and conditions: Report-specific ages, eligibility and formulation-use conditions
Conditions for verification: Material for Report-specific ages, eligibility and formulation-use conditions must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Requirement and applicability: Required
Application exceptions: Preserve original numbers, frequencies, formulations and research exposure only. Do not copy 306 participants or precise event/effect values from the 1996 gum trial to other formulations in 1998. Distinguish five-times-daily from two- or three-times-daily/infection-triggered use, target from actual frequency, children from repeated events, risk differences from HR/OR, and original cautions from actual harm rates. No new totals, effects, CIs, NNTs, dose conversions, grades, independence certification, formulation/frequency-only superiority or pediatric prevention/treatment instructions are created.
Why this condition is needed: This condition connects Report-specific ages, eligibility and formulation-use conditions with the original five-times-daily prevention question, formulation/age, the 1996/1998 reports, later lower-frequency use, infection timing, event units, denominators, support and harms.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N04 · How do daycare, high-risk and later populations differ?

Required materials and conditions: Recruitment, country, baseline risk and infection status
Conditions for verification: Material for Recruitment, country, baseline risk and infection status must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Requirement and applicability: Required
Application exceptions: Preserve original numbers, frequencies, formulations and research exposure only. Do not copy 306 participants or precise event/effect values from the 1996 gum trial to other formulations in 1998. Distinguish five-times-daily from two- or three-times-daily/infection-triggered use, target from actual frequency, children from repeated events, risk differences from HR/OR, and original cautions from actual harm rates. No new totals, effects, CIs, NNTs, dose conversions, grades, independence certification, formulation/frequency-only superiority or pediatric prevention/treatment instructions are created.
Why this condition is needed: This condition connects Recruitment, country, baseline risk and infection status with the original five-times-daily prevention question, formulation/age, the 1996/1998 reports, later lower-frequency use, infection timing, event units, denominators, support and harms.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N05 · Are gum, syrup and lozenges the same exposure?

Required materials and conditions: Formulation, product, composition, contents and comparator
Conditions for verification: Material for Formulation, product, composition, contents and comparator must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Requirement and applicability: Required
Application exceptions: Preserve original numbers, frequencies, formulations and research exposure only. Do not copy 306 participants or precise event/effect values from the 1996 gum trial to other formulations in 1998. Distinguish five-times-daily from two- or three-times-daily/infection-triggered use, target from actual frequency, children from repeated events, risk differences from HR/OR, and original cautions from actual harm rates. No new totals, effects, CIs, NNTs, dose conversions, grades, independence certification, formulation/frequency-only superiority or pediatric prevention/treatment instructions are created.
Why this condition is needed: This condition connects Formulation, product, composition, contents and comparator with the original five-times-daily prevention question, formulation/age, the 1996/1998 reports, later lower-frequency use, infection timing, event units, denominators, support and harms.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N06 · Are original five-times-daily frequency and actual adherence distinguished?

Required materials and conditions: Planned frequency, provision, consumption, missed uses and burden
Conditions for verification: Material for Planned frequency, provision, consumption, missed uses and burden must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Requirement and applicability: Required
Application exceptions: Preserve original numbers, frequencies, formulations and research exposure only. Do not copy 306 participants or precise event/effect values from the 1996 gum trial to other formulations in 1998. Distinguish five-times-daily from two- or three-times-daily/infection-triggered use, target from actual frequency, children from repeated events, risk differences from HR/OR, and original cautions from actual harm rates. No new totals, effects, CIs, NNTs, dose conversions, grades, independence certification, formulation/frequency-only superiority or pediatric prevention/treatment instructions are created.
Why this condition is needed: This condition connects Planned frequency, provision, consumption, missed uses and burden with the original five-times-daily prevention question, formulation/age, the 1996/1998 reports, later lower-frequency use, infection timing, event units, denominators, support and harms.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N07 · Are regular prophylaxis and use after infection onset the same?

Required materials and conditions: Timing, baseline infection and report identity
Conditions for verification: Material for Timing, baseline infection and report identity must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Requirement and applicability: Required
Application exceptions: Preserve original numbers, frequencies, formulations and research exposure only. Do not copy 306 participants or precise event/effect values from the 1996 gum trial to other formulations in 1998. Distinguish five-times-daily from two- or three-times-daily/infection-triggered use, target from actual frequency, children from repeated events, risk differences from HR/OR, and original cautions from actual harm rates. No new totals, effects, CIs, NNTs, dose conversions, grades, independence certification, formulation/frequency-only superiority or pediatric prevention/treatment instructions are created.
Why this condition is needed: This condition connects Timing, baseline infection and report identity with the original five-times-daily prevention question, formulation/age, the 1996/1998 reports, later lower-frequency use, infection timing, event units, denominators, support and harms.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N08 · What does approximately 2–3 months across trials describe?

Required materials and conditions: Original duration, prevention/follow-up and post-intervention outcomes
Conditions for verification: Material for Original duration, prevention/follow-up and post-intervention outcomes must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Requirement and applicability: Required
Application exceptions: Preserve original numbers, frequencies, formulations and research exposure only. Do not copy 306 participants or precise event/effect values from the 1996 gum trial to other formulations in 1998. Distinguish five-times-daily from two- or three-times-daily/infection-triggered use, target from actual frequency, children from repeated events, risk differences from HR/OR, and original cautions from actual harm rates. No new totals, effects, CIs, NNTs, dose conversions, grades, independence certification, formulation/frequency-only superiority or pediatric prevention/treatment instructions are created.
Why this condition is needed: This condition connects Original duration, prevention/follow-up and post-intervention outcomes with the original five-times-daily prevention question, formulation/age, the 1996/1998 reports, later lower-frequency use, infection timing, event units, denominators, support and harms.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N09 · How much is known about placebo, contact and concomitant care?

Required materials and conditions: Formulation-specific placebo, equivalent management and healthcare use
Conditions for verification: Material for Formulation-specific placebo, equivalent management and healthcare use must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Requirement and applicability: Required
Application exceptions: Preserve original numbers, frequencies, formulations and research exposure only. Do not copy 306 participants or precise event/effect values from the 1996 gum trial to other formulations in 1998. Distinguish five-times-daily from two- or three-times-daily/infection-triggered use, target from actual frequency, children from repeated events, risk differences from HR/OR, and original cautions from actual harm rates. No new totals, effects, CIs, NNTs, dose conversions, grades, independence certification, formulation/frequency-only superiority or pediatric prevention/treatment instructions are created.
Why this condition is needed: This condition connects Formulation-specific placebo, equivalent management and healthcare use with the original five-times-daily prevention question, formulation/age, the 1996/1998 reports, later lower-frequency use, infection timing, event units, denominators, support and harms.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N10 · How, and in what units, was acute otitis media identified?

Required materials and conditions: Diagnosis, assessors, children, repeated events and collection
Conditions for verification: Material for Diagnosis, assessors, children, repeated events and collection must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Requirement and applicability: Required
Application exceptions: Preserve original numbers, frequencies, formulations and research exposure only. Do not copy 306 participants or precise event/effect values from the 1996 gum trial to other formulations in 1998. Distinguish five-times-daily from two- or three-times-daily/infection-triggered use, target from actual frequency, children from repeated events, risk differences from HR/OR, and original cautions from actual harm rates. No new totals, effects, CIs, NNTs, dose conversions, grades, independence certification, formulation/frequency-only superiority or pediatric prevention/treatment instructions are created.
Why this condition is needed: This condition connects Diagnosis, assessors, children, repeated events and collection with the original five-times-daily prevention question, formulation/age, the 1996/1998 reports, later lower-frequency use, infection timing, event units, denominators, support and harms.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N11 · Which report provides 19/157 versus 31/149?

Required materials and conditions: 1996 gum comparison values, group correspondence and denominators
Conditions for verification: Material for 1996 gum comparison values, group correspondence and denominators must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Requirement and applicability: Required
Application exceptions: Preserve original numbers, frequencies, formulations and research exposure only. Do not copy 306 participants or precise event/effect values from the 1996 gum trial to other formulations in 1998. Distinguish five-times-daily from two- or three-times-daily/infection-triggered use, target from actual frequency, children from repeated events, risk differences from HR/OR, and original cautions from actual harm rates. No new totals, effects, CIs, NNTs, dose conversions, grades, independence certification, formulation/frequency-only superiority or pediatric prevention/treatment instructions are created.
Why this condition is needed: This condition connects 1996 gum comparison values, group correspondence and denominators with the original five-times-daily prevention question, formulation/age, the 1996/1998 reports, later lower-frequency use, infection timing, event units, denominators, support and harms.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N12 · Are 306 analyzed the same as allocated/completed denominators?

Required materials and conditions: Original analysis n, allocation, completion, exclusions and missingness
Conditions for verification: Material for Original analysis n, allocation, completion, exclusions and missingness must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Requirement and applicability: Required
Application exceptions: Preserve original numbers, frequencies, formulations and research exposure only. Do not copy 306 participants or precise event/effect values from the 1996 gum trial to other formulations in 1998. Distinguish five-times-daily from two- or three-times-daily/infection-triggered use, target from actual frequency, children from repeated events, risk differences from HR/OR, and original cautions from actual harm rates. No new totals, effects, CIs, NNTs, dose conversions, grades, independence certification, formulation/frequency-only superiority or pediatric prevention/treatment instructions are created.
Why this condition is needed: This condition connects Original analysis n, allocation, completion, exclusions and missingness with the original five-times-daily prevention question, formulation/age, the 1996/1998 reports, later lower-frequency use, infection timing, event units, denominators, support and harms.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N13 · What estimand do 8.7 percentage points, CI and P describe?

Required materials and conditions: Original absolute difference, direction, interval and model
Conditions for verification: Material for Original absolute difference, direction, interval and model must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Requirement and applicability: Required
Application exceptions: Preserve original numbers, frequencies, formulations and research exposure only. Do not copy 306 participants or precise event/effect values from the 1996 gum trial to other formulations in 1998. Distinguish five-times-daily from two- or three-times-daily/infection-triggered use, target from actual frequency, children from repeated events, risk differences from HR/OR, and original cautions from actual harm rates. No new totals, effects, CIs, NNTs, dose conversions, grades, independence certification, formulation/frequency-only superiority or pediatric prevention/treatment instructions are created.
Why this condition is needed: This condition connects Original absolute difference, direction, interval and model with the original five-times-daily prevention question, formulation/age, the 1996/1998 reports, later lower-frequency use, infection timing, event units, denominators, support and harms.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N14 · What is the level of formulation-specific favorable directions in 1998?

Required materials and conditions: Separate bibliography, five times daily and formulation-specific outcomes
Conditions for verification: Material for Separate bibliography, five times daily and formulation-specific outcomes must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Requirement and applicability: Required
Application exceptions: Preserve original numbers, frequencies, formulations and research exposure only. Do not copy 306 participants or precise event/effect values from the 1996 gum trial to other formulations in 1998. Distinguish five-times-daily from two- or three-times-daily/infection-triggered use, target from actual frequency, children from repeated events, risk differences from HR/OR, and original cautions from actual harm rates. No new totals, effects, CIs, NNTs, dose conversions, grades, independence certification, formulation/frequency-only superiority or pediatric prevention/treatment instructions are created.
Why this condition is needed: This condition connects Separate bibliography, five times daily and formulation-specific outcomes with the original five-times-daily prevention question, formulation/age, the 1996/1998 reports, later lower-frequency use, infection timing, event units, denominators, support and harms.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N15 · Are uncertain lozenges combined with favorable gum/syrup?

Required materials and conditions: 1998 lozenges, effects, denominators and actual exposure
Conditions for verification: Material for 1998 lozenges, effects, denominators and actual exposure must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Requirement and applicability: Required
Application exceptions: Preserve original numbers, frequencies, formulations and research exposure only. Do not copy 306 participants or precise event/effect values from the 1996 gum trial to other formulations in 1998. Distinguish five-times-daily from two- or three-times-daily/infection-triggered use, target from actual frequency, children from repeated events, risk differences from HR/OR, and original cautions from actual harm rates. No new totals, effects, CIs, NNTs, dose conversions, grades, independence certification, formulation/frequency-only superiority or pediatric prevention/treatment instructions are created.
Why this condition is needed: This condition connects 1998 lozenges, effects, denominators and actual exposure with the original five-times-daily prevention question, formulation/age, the 1996/1998 reports, later lower-frequency use, infection timing, event units, denominators, support and harms.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N16 · How are the two reports from the same research program linked?

Required materials and conditions: 1996/1998 bibliography, cohorts, recruitment and independence
Conditions for verification: Material for 1996/1998 bibliography, cohorts, recruitment and independence must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Requirement and applicability: Required
Application exceptions: Preserve original numbers, frequencies, formulations and research exposure only. Do not copy 306 participants or precise event/effect values from the 1996 gum trial to other formulations in 1998. Distinguish five-times-daily from two- or three-times-daily/infection-triggered use, target from actual frequency, children from repeated events, risk differences from HR/OR, and original cautions from actual harm rates. No new totals, effects, CIs, NNTs, dose conversions, grades, independence certification, formulation/frequency-only superiority or pediatric prevention/treatment instructions are created.
Why this condition is needed: This condition connects 1996/1998 bibliography, cohorts, recruitment and independence with the original five-times-daily prevention question, formulation/age, the 1996/1998 reports, later lower-frequency use, infection timing, event units, denominators, support and harms.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N17 · Are the later conditions for HR 0.88 the same as original five-times-daily use?

Required materials and conditions: 2014 lower-frequency syrup, high-risk children and original HR
Conditions for verification: Material for 2014 lower-frequency syrup, high-risk children and original HR must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Requirement and applicability: Required
Application exceptions: Preserve original numbers, frequencies, formulations and research exposure only. Do not copy 306 participants or precise event/effect values from the 1996 gum trial to other formulations in 1998. Distinguish five-times-daily from two- or three-times-daily/infection-triggered use, target from actual frequency, children from repeated events, risk differences from HR/OR, and original cautions from actual harm rates. No new totals, effects, CIs, NNTs, dose conversions, grades, independence certification, formulation/frequency-only superiority or pediatric prevention/treatment instructions are created.
Why this condition is needed: This condition connects 2014 lower-frequency syrup, high-risk children and original HR with the original five-times-daily prevention question, formulation/age, the 1996/1998 reports, later lower-frequency use, infection timing, event units, denominators, support and harms.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N18 · Which report provides 6 versus 3 events and OR 2.04?

Required materials and conditions: 2024, 250 participants, target frequency, events, OR and interval
Conditions for verification: Material for 2024, 250 participants, target frequency, events, OR and interval must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Requirement and applicability: Required
Application exceptions: Preserve original numbers, frequencies, formulations and research exposure only. Do not copy 306 participants or precise event/effect values from the 1996 gum trial to other formulations in 1998. Distinguish five-times-daily from two- or three-times-daily/infection-triggered use, target from actual frequency, children from repeated events, risk differences from HR/OR, and original cautions from actual harm rates. No new totals, effects, CIs, NNTs, dose conversions, grades, independence certification, formulation/frequency-only superiority or pediatric prevention/treatment instructions are created.
Why this condition is needed: This condition connects 2024, 250 participants, target frequency, events, OR and interval with the original five-times-daily prevention question, formulation/age, the 1996/1998 reports, later lower-frequency use, infection timing, event units, denominators, support and harms.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N19 · What precision boundary does the original 9-event wording describe?

Required materials and conditions: Sparse 2024 events, wide interval and null interpretation
Conditions for verification: Material for Sparse 2024 events, wide interval and null interpretation must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Requirement and applicability: Required
Application exceptions: Preserve original numbers, frequencies, formulations and research exposure only. Do not copy 306 participants or precise event/effect values from the 1996 gum trial to other formulations in 1998. Distinguish five-times-daily from two- or three-times-daily/infection-triggered use, target from actual frequency, children from repeated events, risk differences from HR/OR, and original cautions from actual harm rates. No new totals, effects, CIs, NNTs, dose conversions, grades, independence certification, formulation/frequency-only superiority or pediatric prevention/treatment instructions are created.
Why this condition is needed: This condition connects Sparse 2024 events, wide interval and null interpretation with the original five-times-daily prevention question, formulation/age, the 1996/1998 reports, later lower-frequency use, infection timing, event units, denominators, support and harms.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N20 · Are a twice-daily target and approximately two actual daily uses the same record?

Required materials and conditions: 2024 target, actual exposure, adherence and discontinuation
Conditions for verification: Material for 2024 target, actual exposure, adherence and discontinuation must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Requirement and applicability: Required
Application exceptions: Preserve original numbers, frequencies, formulations and research exposure only. Do not copy 306 participants or precise event/effect values from the 1996 gum trial to other formulations in 1998. Distinguish five-times-daily from two- or three-times-daily/infection-triggered use, target from actual frequency, children from repeated events, risk differences from HR/OR, and original cautions from actual harm rates. No new totals, effects, CIs, NNTs, dose conversions, grades, independence certification, formulation/frequency-only superiority or pediatric prevention/treatment instructions are created.
Why this condition is needed: This condition connects 2024 target, actual exposure, adherence and discontinuation with the original five-times-daily prevention question, formulation/age, the 1996/1998 reports, later lower-frequency use, infection timing, event units, denominators, support and harms.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N21 · Can frequency alone establish administration amounts or doses?

Required materials and conditions: Formulation contents, per-use/daily doses, weight and age
Conditions for verification: Material for Formulation contents, per-use/daily doses, weight and age must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Requirement and applicability: Required
Application exceptions: Preserve original numbers, frequencies, formulations and research exposure only. Do not copy 306 participants or precise event/effect values from the 1996 gum trial to other formulations in 1998. Distinguish five-times-daily from two- or three-times-daily/infection-triggered use, target from actual frequency, children from repeated events, risk differences from HR/OR, and original cautions from actual harm rates. No new totals, effects, CIs, NNTs, dose conversions, grades, independence certification, formulation/frequency-only superiority or pediatric prevention/treatment instructions are created.
Why this condition is needed: This condition connects Formulation contents, per-use/daily doses, weight and age with the original five-times-daily prevention question, formulation/age, the 1996/1998 reports, later lower-frequency use, infection timing, event units, denominators, support and harms.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N22 · Are randomized labels distinguished from actual allocation?

Required materials and conditions: Design, sequence generation, concealment, formulation and cluster allocation
Conditions for verification: Material for Design, sequence generation, concealment, formulation and cluster allocation must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Requirement and applicability: Required
Application exceptions: Preserve original numbers, frequencies, formulations and research exposure only. Do not copy 306 participants or precise event/effect values from the 1996 gum trial to other formulations in 1998. Distinguish five-times-daily from two- or three-times-daily/infection-triggered use, target from actual frequency, children from repeated events, risk differences from HR/OR, and original cautions from actual harm rates. No new totals, effects, CIs, NNTs, dose conversions, grades, independence certification, formulation/frequency-only superiority or pediatric prevention/treatment instructions are created.
Why this condition is needed: This condition connects Design, sequence generation, concealment, formulation and cluster allocation with the original five-times-daily prevention question, formulation/age, the 1996/1998 reports, later lower-frequency use, infection timing, event units, denominators, support and harms.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N23 · Are event assessment and parent/assessor awareness known?

Required materials and conditions: Masking, diagnosis, reporting, healthcare use and recurrent-event collection
Conditions for verification: Material for Masking, diagnosis, reporting, healthcare use and recurrent-event collection must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Requirement and applicability: Required
Application exceptions: Preserve original numbers, frequencies, formulations and research exposure only. Do not copy 306 participants or precise event/effect values from the 1996 gum trial to other formulations in 1998. Distinguish five-times-daily from two- or three-times-daily/infection-triggered use, target from actual frequency, children from repeated events, risk differences from HR/OR, and original cautions from actual harm rates. No new totals, effects, CIs, NNTs, dose conversions, grades, independence certification, formulation/frequency-only superiority or pediatric prevention/treatment instructions are created.
Why this condition is needed: This condition connects Masking, diagnosis, reporting, healthcare use and recurrent-event collection with the original five-times-daily prevention question, formulation/age, the 1996/1998 reports, later lower-frequency use, infection timing, event units, denominators, support and harms.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N24 · What were baseline infection, clinical care and concurrent management?

Required materials and conditions: Baseline risk, prevention, diet, antibiotics and group changes
Conditions for verification: Material for Baseline risk, prevention, diet, antibiotics and group changes must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Requirement and applicability: Required
Application exceptions: Preserve original numbers, frequencies, formulations and research exposure only. Do not copy 306 participants or precise event/effect values from the 1996 gum trial to other formulations in 1998. Distinguish five-times-daily from two- or three-times-daily/infection-triggered use, target from actual frequency, children from repeated events, risk differences from HR/OR, and original cautions from actual harm rates. No new totals, effects, CIs, NNTs, dose conversions, grades, independence certification, formulation/frequency-only superiority or pediatric prevention/treatment instructions are created.
Why this condition is needed: This condition connects Baseline risk, prevention, diet, antibiotics and group changes with the original five-times-daily prevention question, formulation/age, the 1996/1998 reports, later lower-frequency use, infection timing, event units, denominators, support and harms.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N25 · What estimand is defined by denominators, attrition, repeated events and adjustment?

Required materials and conditions: ITT/PP, loss to follow-up, clusters, models and missingness
Conditions for verification: Material for ITT/PP, loss to follow-up, clusters, models and missingness must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Requirement and applicability: Required
Application exceptions: Preserve original numbers, frequencies, formulations and research exposure only. Do not copy 306 participants or precise event/effect values from the 1996 gum trial to other formulations in 1998. Distinguish five-times-daily from two- or three-times-daily/infection-triggered use, target from actual frequency, children from repeated events, risk differences from HR/OR, and original cautions from actual harm rates. No new totals, effects, CIs, NNTs, dose conversions, grades, independence certification, formulation/frequency-only superiority or pediatric prevention/treatment instructions are created.
Why this condition is needed: This condition connects ITT/PP, loss to follow-up, clusters, models and missingness with the original five-times-daily prevention question, formulation/age, the 1996/1998 reports, later lower-frequency use, infection timing, event units, denominators, support and harms.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N26 · Are historical registration wording and later registration/plans distinguished?

Required materials and conditions: Early pre-registration-era wording, unverified 2014 registration and 2024 identifier
Conditions for verification: Material for Early pre-registration-era wording, unverified 2014 registration and 2024 identifier must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Requirement and applicability: Required
Application exceptions: Preserve original numbers, frequencies, formulations and research exposure only. Do not copy 306 participants or precise event/effect values from the 1996 gum trial to other formulations in 1998. Distinguish five-times-daily from two- or three-times-daily/infection-triggered use, target from actual frequency, children from repeated events, risk differences from HR/OR, and original cautions from actual harm rates. No new totals, effects, CIs, NNTs, dose conversions, grades, independence certification, formulation/frequency-only superiority or pediatric prevention/treatment instructions are created.
Why this condition is needed: This condition connects Early pre-registration-era wording, unverified 2014 registration and 2024 identifier with the original five-times-daily prevention question, formulation/age, the 1996/1998 reports, later lower-frequency use, infection timing, event units, denominators, support and harms.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N27 · Do otitis-prevention outcomes answer caries, treatment or long-term questions?

Required materials and conditions: Original acute events, separate caries, treatment and post-intervention prevention
Conditions for verification: Material for Original acute events, separate caries, treatment and post-intervention prevention must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Requirement and applicability: Required
Application exceptions: Preserve original numbers, frequencies, formulations and research exposure only. Do not copy 306 participants or precise event/effect values from the 1996 gum trial to other formulations in 1998. Distinguish five-times-daily from two- or three-times-daily/infection-triggered use, target from actual frequency, children from repeated events, risk differences from HR/OR, and original cautions from actual harm rates. No new totals, effects, CIs, NNTs, dose conversions, grades, independence certification, formulation/frequency-only superiority or pediatric prevention/treatment instructions are created.
Why this condition is needed: This condition connects Original acute events, separate caries, treatment and post-intervention prevention with the original five-times-daily prevention question, formulation/age, the 1996/1998 reports, later lower-frequency use, infection timing, event units, denominators, support and harms.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N28 · Can formulation/frequency-only effects be isolated from later differences?

Required materials and conditions: Joint changes in formulation, frequency, timing, population and duration
Conditions for verification: Material for Joint changes in formulation, frequency, timing, population and duration must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Requirement and applicability: Required
Application exceptions: Preserve original numbers, frequencies, formulations and research exposure only. Do not copy 306 participants or precise event/effect values from the 1996 gum trial to other formulations in 1998. Distinguish five-times-daily from two- or three-times-daily/infection-triggered use, target from actual frequency, children from repeated events, risk differences from HR/OR, and original cautions from actual harm rates. No new totals, effects, CIs, NNTs, dose conversions, grades, independence certification, formulation/frequency-only superiority or pediatric prevention/treatment instructions are created.
Why this condition is needed: This condition connects Joint changes in formulation, frequency, timing, population and duration with the original five-times-daily prevention question, formulation/age, the 1996/1998 reports, later lower-frequency use, infection timing, event units, denominators, support and harms.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N29 · How are three evidence rows linked to four citations?

Required materials and conditions: Combined evidence, separate bibliography, reports, cohorts and outcome mapping
Conditions for verification: Material for Combined evidence, separate bibliography, reports, cohorts and outcome mapping must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Requirement and applicability: Required
Application exceptions: Preserve original numbers, frequencies, formulations and research exposure only. Do not copy 306 participants or precise event/effect values from the 1996 gum trial to other formulations in 1998. Distinguish five-times-daily from two- or three-times-daily/infection-triggered use, target from actual frequency, children from repeated events, risk differences from HR/OR, and original cautions from actual harm rates. No new totals, effects, CIs, NNTs, dose conversions, grades, independence certification, formulation/frequency-only superiority or pediatric prevention/treatment instructions are created.
Why this condition is needed: This condition connects Combined evidence, separate bibliography, reports, cohorts and outcome mapping with the original five-times-daily prevention question, formulation/age, the 1996/1998 reports, later lower-frequency use, infection timing, event units, denominators, support and harms.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N30 · How far are public support and product involvement known?

Required materials and conditions: Report-specific funding, product support, roles and COI
Conditions for verification: Material for Report-specific funding, product support, roles and COI must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Requirement and applicability: Required
Application exceptions: Preserve original numbers, frequencies, formulations and research exposure only. Do not copy 306 participants or precise event/effect values from the 1996 gum trial to other formulations in 1998. Distinguish five-times-daily from two- or three-times-daily/infection-triggered use, target from actual frequency, children from repeated events, risk differences from HR/OR, and original cautions from actual harm rates. No new totals, effects, CIs, NNTs, dose conversions, grades, independence certification, formulation/frequency-only superiority or pediatric prevention/treatment instructions are created.
Why this condition is needed: This condition connects Report-specific funding, product support, roles and COI with the original five-times-daily prevention question, formulation/age, the 1996/1998 reports, later lower-frequency use, infection timing, event units, denominators, support and harms.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N31 · What material was actually read here?

Required materials and conditions: Complete stored summary and unread external material
Conditions for verification: Material for Complete stored summary and unread external material must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Requirement and applicability: Required
Application exceptions: Preserve original numbers, frequencies, formulations and research exposure only. Do not copy 306 participants or precise event/effect values from the 1996 gum trial to other formulations in 1998. Distinguish five-times-daily from two- or three-times-daily/infection-triggered use, target from actual frequency, children from repeated events, risk differences from HR/OR, and original cautions from actual harm rates. No new totals, effects, CIs, NNTs, dose conversions, grades, independence certification, formulation/frequency-only superiority or pediatric prevention/treatment instructions are created.
Why this condition is needed: This condition connects Complete stored summary and unread external material with the original five-times-daily prevention question, formulation/age, the 1996/1998 reports, later lower-frequency use, infection timing, event units, denominators, support and harms.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N32 · Are historical verification and current production/review separated?

Required materials and conditions: Original date, empty corrections/deliberation and historical decision
Conditions for verification: Material for Original date, empty corrections/deliberation and historical decision must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Requirement and applicability: Required
Application exceptions: Preserve original numbers, frequencies, formulations and research exposure only. Do not copy 306 participants or precise event/effect values from the 1996 gum trial to other formulations in 1998. Distinguish five-times-daily from two- or three-times-daily/infection-triggered use, target from actual frequency, children from repeated events, risk differences from HR/OR, and original cautions from actual harm rates. No new totals, effects, CIs, NNTs, dose conversions, grades, independence certification, formulation/frequency-only superiority or pediatric prevention/treatment instructions are created.
Why this condition is needed: This condition connects Original date, empty corrections/deliberation and historical decision with the original five-times-daily prevention question, formulation/age, the 1996/1998 reports, later lower-frequency use, infection timing, event units, denominators, support and harms.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N33 · Are original languages and event/frequency/formulation scope preserved?

Required materials and conditions: Original wording, note and language-specific event expressions
Conditions for verification: Material for Original wording, note and language-specific event expressions must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Requirement and applicability: Required
Application exceptions: Preserve original numbers, frequencies, formulations and research exposure only. Do not copy 306 participants or precise event/effect values from the 1996 gum trial to other formulations in 1998. Distinguish five-times-daily from two- or three-times-daily/infection-triggered use, target from actual frequency, children from repeated events, risk differences from HR/OR, and original cautions from actual harm rates. No new totals, effects, CIs, NNTs, dose conversions, grades, independence certification, formulation/frequency-only superiority or pediatric prevention/treatment instructions are created.
Why this condition is needed: This condition connects Original wording, note and language-specific event expressions with the original five-times-daily prevention question, formulation/age, the 1996/1998 reports, later lower-frequency use, infection timing, event units, denominators, support and harms.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N34 · Are parent axes distinguished from absent subclaim fields?

Required materials and conditions: Parent axes, null precision and absent subclaim score/status/axes
Conditions for verification: Material for Parent axes, null precision and absent subclaim score/status/axes must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Requirement and applicability: Required
Application exceptions: Preserve original numbers, frequencies, formulations and research exposure only. Do not copy 306 participants or precise event/effect values from the 1996 gum trial to other formulations in 1998. Distinguish five-times-daily from two- or three-times-daily/infection-triggered use, target from actual frequency, children from repeated events, risk differences from HR/OR, and original cautions from actual harm rates. No new totals, effects, CIs, NNTs, dose conversions, grades, independence certification, formulation/frequency-only superiority or pediatric prevention/treatment instructions are created.
Why this condition is needed: This condition connects Parent axes, null precision and absent subclaim score/status/axes with the original five-times-daily prevention question, formulation/age, the 1996/1998 reports, later lower-frequency use, infection timing, event units, denominators, support and harms.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N35 · Are diarrhea, abdominal discomfort, refusal and choking cautions actual event data?

Required materials and conditions: Formulation/age-specific harm definitions, collection, denominators and discontinuation
Conditions for verification: Material for Formulation/age-specific harm definitions, collection, denominators and discontinuation must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Requirement and applicability: Supplementary; required for extending safety conclusions
Application exceptions: Preserve original numbers, frequencies, formulations and research exposure only. Do not copy 306 participants or precise event/effect values from the 1996 gum trial to other formulations in 1998. Distinguish five-times-daily from two- or three-times-daily/infection-triggered use, target from actual frequency, children from repeated events, risk differences from HR/OR, and original cautions from actual harm rates. No new totals, effects, CIs, NNTs, dose conversions, grades, independence certification, formulation/frequency-only superiority or pediatric prevention/treatment instructions are created.
Why this condition is needed: This condition connects Formulation/age-specific harm definitions, collection, denominators and discontinuation with the original five-times-daily prevention question, formulation/age, the 1996/1998 reports, later lower-frequency use, infection timing, event units, denominators, support and harms.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N36 · What are harm exposure, discontinuation, recovery and later observation times?

Required materials and conditions: Actual exposure, symptoms, refusal, recovery and observation windows
Conditions for verification: Material for Actual exposure, symptoms, refusal, recovery and observation windows must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Requirement and applicability: Supplementary; required for extending safety conclusions
Application exceptions: Preserve original numbers, frequencies, formulations and research exposure only. Do not copy 306 participants or precise event/effect values from the 1996 gum trial to other formulations in 1998. Distinguish five-times-daily from two- or three-times-daily/infection-triggered use, target from actual frequency, children from repeated events, risk differences from HR/OR, and original cautions from actual harm rates. No new totals, effects, CIs, NNTs, dose conversions, grades, independence certification, formulation/frequency-only superiority or pediatric prevention/treatment instructions are created.
Why this condition is needed: This condition connects Actual exposure, symptoms, refusal, recovery and observation windows with the original five-times-daily prevention question, formulation/age, the 1996/1998 reports, later lower-frequency use, infection timing, event units, denominators, support and harms.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N37 · Were harms compared under equivalent observation/comparator conditions?

Required materials and conditions: Placebo, formulation-specific harm collection, windows and discontinuation comparisons
Conditions for verification: Material for Placebo, formulation-specific harm collection, windows and discontinuation comparisons must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Requirement and applicability: Supplementary; required for extending safety conclusions
Application exceptions: Preserve original numbers, frequencies, formulations and research exposure only. Do not copy 306 participants or precise event/effect values from the 1996 gum trial to other formulations in 1998. Distinguish five-times-daily from two- or three-times-daily/infection-triggered use, target from actual frequency, children from repeated events, risk differences from HR/OR, and original cautions from actual harm rates. No new totals, effects, CIs, NNTs, dose conversions, grades, independence certification, formulation/frequency-only superiority or pediatric prevention/treatment instructions are created.
Why this condition is needed: This condition connects Placebo, formulation-specific harm collection, windows and discontinuation comparisons with the original five-times-daily prevention question, formulation/age, the 1996/1998 reports, later lower-frequency use, infection timing, event units, denominators, support and harms.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N38 · Are harm-event counts and actual-exposure denominators available?

Required materials and conditions: Formulation/age-specific harms, exposure, observation and discontinuation
Conditions for verification: Material for Formulation/age-specific harms, exposure, observation and discontinuation must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Requirement and applicability: Supplementary; required for extending safety conclusions
Application exceptions: Preserve original numbers, frequencies, formulations and research exposure only. Do not copy 306 participants or precise event/effect values from the 1996 gum trial to other formulations in 1998. Distinguish five-times-daily from two- or three-times-daily/infection-triggered use, target from actual frequency, children from repeated events, risk differences from HR/OR, and original cautions from actual harm rates. No new totals, effects, CIs, NNTs, dose conversions, grades, independence certification, formulation/frequency-only superiority or pediatric prevention/treatment instructions are created.
Why this condition is needed: This condition connects Formulation/age-specific harms, exposure, observation and discontinuation with the original five-times-daily prevention question, formulation/age, the 1996/1998 reports, later lower-frequency use, infection timing, event units, denominators, support and harms.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N39 · Are infection, concomitant care, formulation, refusal and causation distinguished?

Required materials and conditions: Concurrent factors, actual events, exposure and discontinuation timing
Conditions for verification: Material for Concurrent factors, actual events, exposure and discontinuation timing must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Requirement and applicability: Supplementary; required for extending safety conclusions
Application exceptions: Preserve original numbers, frequencies, formulations and research exposure only. Do not copy 306 participants or precise event/effect values from the 1996 gum trial to other formulations in 1998. Distinguish five-times-daily from two- or three-times-daily/infection-triggered use, target from actual frequency, children from repeated events, risk differences from HR/OR, and original cautions from actual harm rates. No new totals, effects, CIs, NNTs, dose conversions, grades, independence certification, formulation/frequency-only superiority or pediatric prevention/treatment instructions are created.
Why this condition is needed: This condition connects Concurrent factors, actual events, exposure and discontinuation timing with the original five-times-daily prevention question, formulation/age, the 1996/1998 reports, later lower-frequency use, infection timing, event units, denominators, support and harms.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N40 · Are refusal, discontinuation, loss to follow-up and harm reporting known?

Required materials and conditions: Group-specific refusal, attrition, harm missingness and selective reporting
Conditions for verification: Material for Group-specific refusal, attrition, harm missingness and selective reporting must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Requirement and applicability: Supplementary; required for extending safety conclusions
Application exceptions: Preserve original numbers, frequencies, formulations and research exposure only. Do not copy 306 participants or precise event/effect values from the 1996 gum trial to other formulations in 1998. Distinguish five-times-daily from two- or three-times-daily/infection-triggered use, target from actual frequency, children from repeated events, risk differences from HR/OR, and original cautions from actual harm rates. No new totals, effects, CIs, NNTs, dose conversions, grades, independence certification, formulation/frequency-only superiority or pediatric prevention/treatment instructions are created.
Why this condition is needed: This condition connects Group-specific refusal, attrition, harm missingness and selective reporting with the original five-times-daily prevention question, formulation/age, the 1996/1998 reports, later lower-frequency use, infection timing, event units, denominators, support and harms.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N41 · How far are harms in other ages/formulations, independent evidence and long-term follow-up known?

Required materials and conditions: Same exposure, vulnerable populations, independent harms and post-intervention follow-up
Conditions for verification: Material for Same exposure, vulnerable populations, independent harms and post-intervention follow-up must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Requirement and applicability: Supplementary; required for extending safety conclusions
Application exceptions: Preserve original numbers, frequencies, formulations and research exposure only. Do not copy 306 participants or precise event/effect values from the 1996 gum trial to other formulations in 1998. Distinguish five-times-daily from two- or three-times-daily/infection-triggered use, target from actual frequency, children from repeated events, risk differences from HR/OR, and original cautions from actual harm rates. No new totals, effects, CIs, NNTs, dose conversions, grades, independence certification, formulation/frequency-only superiority or pediatric prevention/treatment instructions are created.
Why this condition is needed: This condition connects Same exposure, vulnerable populations, independent harms and post-intervention follow-up with the original five-times-daily prevention question, formulation/age, the 1996/1998 reports, later lower-frequency use, infection timing, event units, denominators, support and harms.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

N42 · Are originals, conditions, methods, observations and update records distinguished?

Required materials and conditions: Original texts, condition versions, separate application and change history
Conditions for verification: Material for Original texts, condition versions, separate application and change history must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Requirement and applicability: Required
Application exceptions: Preserve original numbers, frequencies, formulations and research exposure only. Do not copy 306 participants or precise event/effect values from the 1996 gum trial to other formulations in 1998. Distinguish five-times-daily from two- or three-times-daily/infection-triggered use, target from actual frequency, children from repeated events, risk differences from HR/OR, and original cautions from actual harm rates. No new totals, effects, CIs, NNTs, dose conversions, grades, independence certification, formulation/frequency-only superiority or pediatric prevention/treatment instructions are created.
Why this condition is needed: This condition connects Original texts, condition versions, separate application and change history with the original five-times-daily prevention question, formulation/age, the 1996/1998 reports, later lower-frequency use, infection timing, event units, denominators, support and harms.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Referenced methods and the sections actually reviewed

M03 · Cochrane Handbook 6.5 (2024), chapter updated 2023-08

Official methodology · §3.1, §3.2.1–3.2.3, MECIR C5/C7/C13

Referenced principle: Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.
Extent of review: Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed.

M04 · Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03

Official methodology · §4.5, §4.6.1–4.6.3, MECIR C42

Referenced principle: Distinguish studies from reports and link them; do not omit a study solely because results are unreported.
Extent of review: Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed.

M08 · Cochrane Handbook 6.5 (2024), chapter updated 2019-10

Official methodology · §8.1–8.2.3, Table 8.2.a

Referenced principle: Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.
Extent of review: Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed.

M15 · Cochrane Handbook 6.5 (2024), chapter updated 2023-08

Official methodology · §15.2.4, §15.3.1–15.3.3

Referenced principle: Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.
Extent of review: Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed.

M19 · Cochrane Handbook 6.5 (2024), chapter updated 2019-10

Official methodology · §19.1.2, §19.2.1–19.2.4

Referenced principle: Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.
Extent of review: Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed.

What the statuses mean

Met: The original content has been reviewed as meeting the conditions. This status is not used in this preparation.
Partly verified: Some information in the stored summary was linked during preparation; clinical verification or review is not complete.
Unverified: Required direct values, definitions or materials have not been established within the current storage and reading scope. This does not mean zero effect, no papers or failed access.
Review incomplete: Awaiting user review, or actual review remains incomplete.
Not reported: Used only when original materials were actually read and the outcome was judged unreported. Not used for external materials unread in this work.
Inaccessible: Used only when an actual access attempt has a recorded failure. Not used for access that was not attempted in this work.
Insufficient evidence for the conditions: Indicates insufficient direct materials for the relevant scope or conditions; it is not a new grade.
Not applicable: Used when the reason it does not apply to the original question is stated.
Conflicting data: Retains the scope of conflicting statements in original materials; it is not an arbitrary reassessment.

Change history

2026-10-16 · Public page/material version 1.0

Public pages and materials were created from the existing 42 items. No new clinical search, verification-status change, or scoring was performed.

The stored-material review date (Not recorded) and original evidence cut-off (2026-09-07) were retained unchanged.

Researcher downloads

These materials provide the same evidence, scope and verification status as this page.

View all item details

N01 · What is the selected original prevention question?

Current findings: The selected original wording is five-times-daily prophylaxis. The parent's acute-otitis-media prevention claim is distinguished from the other subclaim of two- or three-times-daily or infection-triggered use. Original research exposure is identified without generating administration instructions.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
Reason for missing information: Exact plans, event definitions, denominators and the separate report identity for infection-triggered use are unverified.
Required materials and conditions: Original subclaim, exposure, parent and other question
Materials to obtain first: Exact plans, event definitions, denominators and the separate report identity for infection-triggered use are unverified.
Further research: Material needed: Exact plans, event definitions, denominators and the separate report identity for infection-triggered use are unverified. This records needed materials; no new research was executed.
Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
Conditions for verification: Material for Original subclaim, exposure, parent and other question must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Why this condition is needed: This condition connects Original subclaim, exposure, parent and other question with the original five-times-daily prevention question, formulation/age, the 1996/1998 reports, later lower-frequency use, infection timing, event units, denominators, support and harms.
Application exceptions: Preserve original numbers, frequencies, formulations and research exposure only. Do not copy 306 participants or precise event/effect values from the 1996 gum trial to other formulations in 1998. Distinguish five-times-daily from two- or three-times-daily/infection-triggered use, target from actual frequency, children from repeated events, risk differences from HR/OR, and original cautions from actual harm rates. No new totals, effects, CIs, NNTs, dose conversions, grades, independence certification, formulation/frequency-only superiority or pediatric prevention/treatment instructions are created.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R01 R02

N02 · Are subclaim C and parent C54 distinguished?

Current findings: The original subclaim is C, with a note of positive directions in early gum/syrup trials. It has no separate score or status; parent C54, Caution and historical regimen-specific discussion do not supply a new subclaim score.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
Reason for missing information: Separate subclaim score, status and assessment axes are absent from the source.
Required materials and conditions: Original subclaim grade/note and absent score/status
Materials to obtain first: Separate subclaim score, status and assessment axes are absent from the source.
Further research: Material needed: Separate subclaim score, status and assessment axes are absent from the source. This records needed materials; no new research was executed.
Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
Conditions for verification: Material for Original subclaim grade/note and absent score/status must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Why this condition is needed: This condition connects Original subclaim grade/note and absent score/status with the original five-times-daily prevention question, formulation/age, the 1996/1998 reports, later lower-frequency use, infection timing, event units, denominators, support and harms.
Application exceptions: Preserve original numbers, frequencies, formulations and research exposure only. Do not copy 306 participants or precise event/effect values from the 1996 gum trial to other formulations in 1998. Distinguish five-times-daily from two- or three-times-daily/infection-triggered use, target from actual frequency, children from repeated events, risk differences from HR/OR, and original cautions from actual harm rates. No new totals, effects, CIs, NNTs, dose conversions, grades, independence certification, formulation/frequency-only superiority or pediatric prevention/treatment instructions are created.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources

N03 · Are early children's ages the same as recent ages 1–5?

Current findings: Early evidence concerns Finnish daycare children; exact ages and formulation-specific eligibility are unverified. Ages 1–5 in the R04 Persaud 2024 bibliography describe the recent lower-frequency population and do not fill early ages.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
Reason for missing information: Exact early/formulation-specific ages, eligibility, exclusions, development and use conditions are unverified.
Required materials and conditions: Report-specific ages, eligibility and formulation-use conditions
Materials to obtain first: Exact early/formulation-specific ages, eligibility, exclusions, development and use conditions are unverified.
Further research: Material needed: Exact early/formulation-specific ages, eligibility, exclusions, development and use conditions are unverified. This records needed materials; no new research was executed.
Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
Conditions for verification: Material for Report-specific ages, eligibility and formulation-use conditions must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Why this condition is needed: This condition connects Report-specific ages, eligibility and formulation-use conditions with the original five-times-daily prevention question, formulation/age, the 1996/1998 reports, later lower-frequency use, infection timing, event units, denominators, support and harms.
Application exceptions: Preserve original numbers, frequencies, formulations and research exposure only. Do not copy 306 participants or precise event/effect values from the 1996 gum trial to other formulations in 1998. Distinguish five-times-daily from two- or three-times-daily/infection-triggered use, target from actual frequency, children from repeated events, risk differences from HR/OR, and original cautions from actual harm rates. No new totals, effects, CIs, NNTs, dose conversions, grades, independence certification, formulation/frequency-only superiority or pediatric prevention/treatment instructions are created.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R01 R02 R04

N04 · How do daycare, high-risk and later populations differ?

Current findings: The stored account distinguishes early Finnish daycare from later US/Canadian contexts and records R03 Vernacchio 2014 as high-risk children. Baseline risk, recruitment and infection status are not established as identical across populations.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
Reason for missing information: Report-specific recruitment, exclusions, baseline otitis/respiratory infection and environmental risks are unverified.
Required materials and conditions: Recruitment, country, baseline risk and infection status
Materials to obtain first: Report-specific recruitment, exclusions, baseline otitis/respiratory infection and environmental risks are unverified.
Further research: Material needed: Report-specific recruitment, exclusions, baseline otitis/respiratory infection and environmental risks are unverified. This records needed materials; no new research was executed.
Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
Conditions for verification: Material for Recruitment, country, baseline risk and infection status must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Why this condition is needed: This condition connects Recruitment, country, baseline risk and infection status with the original five-times-daily prevention question, formulation/age, the 1996/1998 reports, later lower-frequency use, infection timing, event units, denominators, support and harms.
Application exceptions: Preserve original numbers, frequencies, formulations and research exposure only. Do not copy 306 participants or precise event/effect values from the 1996 gum trial to other formulations in 1998. Distinguish five-times-daily from two- or three-times-daily/infection-triggered use, target from actual frequency, children from repeated events, risk differences from HR/OR, and original cautions from actual harm rates. No new totals, effects, CIs, NNTs, dose conversions, grades, independence certification, formulation/frequency-only superiority or pediatric prevention/treatment instructions are created.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R01 R02 R03 R04

N05 · Are gum, syrup and lozenges the same exposure?

Current findings: Original interventions were gum, syrup and lozenges. Favorable gum/syrup directions in 1998 are distinguished from uncertain lozenges; composition, contents, products, actual exposure and dose equivalence are unverified.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
Reason for missing information: Formulation-specific products, composition, contents, actual exposure, eligibility and comparator specifications are unverified.
Required materials and conditions: Formulation, product, composition, contents and comparator
Materials to obtain first: Formulation-specific products, composition, contents, actual exposure, eligibility and comparator specifications are unverified.
Further research: Material needed: Formulation-specific products, composition, contents, actual exposure, eligibility and comparator specifications are unverified. This records needed materials; no new research was executed.
Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
Conditions for verification: Material for Formulation, product, composition, contents and comparator must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Why this condition is needed: This condition connects Formulation, product, composition, contents and comparator with the original five-times-daily prevention question, formulation/age, the 1996/1998 reports, later lower-frequency use, infection timing, event units, denominators, support and harms.
Application exceptions: Preserve original numbers, frequencies, formulations and research exposure only. Do not copy 306 participants or precise event/effect values from the 1996 gum trial to other formulations in 1998. Distinguish five-times-daily from two- or three-times-daily/infection-triggered use, target from actual frequency, children from repeated events, risk differences from HR/OR, and original cautions from actual harm rates. No new totals, effects, CIs, NNTs, dose conversions, grades, independence certification, formulation/frequency-only superiority or pediatric prevention/treatment instructions are created.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R01 R02

N06 · Are original five-times-daily frequency and actual adherence distinguished?

Current findings: The original frequency in 1996 gum and the same early research program in 1998 was five times daily. Planned frequency is not converted into actual provision, consumption or complete adherence; missed uses, refusal and burden remain separately unverified.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
Reason for missing information: Actual provision, consumption, missed uses, refusal, discontinuation and adherence by formulation, child and period are unverified.
Required materials and conditions: Planned frequency, provision, consumption, missed uses and burden
Materials to obtain first: Actual provision, consumption, missed uses, refusal, discontinuation and adherence by formulation, child and period are unverified.
Further research: Material needed: Actual provision, consumption, missed uses, refusal, discontinuation and adherence by formulation, child and period are unverified. This records needed materials; no new research was executed.
Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
Conditions for verification: Material for Planned frequency, provision, consumption, missed uses and burden must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Why this condition is needed: This condition connects Planned frequency, provision, consumption, missed uses and burden with the original five-times-daily prevention question, formulation/age, the 1996/1998 reports, later lower-frequency use, infection timing, event units, denominators, support and harms.
Application exceptions: Preserve original numbers, frequencies, formulations and research exposure only. Do not copy 306 participants or precise event/effect values from the 1996 gum trial to other formulations in 1998. Distinguish five-times-daily from two- or three-times-daily/infection-triggered use, target from actual frequency, children from repeated events, risk differences from HR/OR, and original cautions from actual harm rates. No new totals, effects, CIs, NNTs, dose conversions, grades, independence certification, formulation/frequency-only superiority or pediatric prevention/treatment instructions are created.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R01 R02

N07 · Are regular prophylaxis and use after infection onset the same?

Current findings: The stored account distinguishes five-times-daily prevention from use after respiratory-infection onset. The separate report identity, start criteria, formulation, duration and exact effect of infection-triggered use are unlinked; no new report is created.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
Reason for missing information: Original infection-onset/eligibility criteria, separate bibliography, exact exposure and outcomes are needed.
Required materials and conditions: Timing, baseline infection and report identity
Materials to obtain first: Original infection-onset/eligibility criteria, separate bibliography, exact exposure and outcomes are needed.
Further research: Material needed: Original infection-onset/eligibility criteria, separate bibliography, exact exposure and outcomes are needed. This records needed materials; no new research was executed.
Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
Conditions for verification: Material for Timing, baseline infection and report identity must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Why this condition is needed: This condition connects Timing, baseline infection and report identity with the original five-times-daily prevention question, formulation/age, the 1996/1998 reports, later lower-frequency use, infection timing, event units, denominators, support and harms.
Application exceptions: Preserve original numbers, frequencies, formulations and research exposure only. Do not copy 306 participants or precise event/effect values from the 1996 gum trial to other formulations in 1998. Distinguish five-times-daily from two- or three-times-daily/infection-triggered use, target from actual frequency, children from repeated events, risk differences from HR/OR, and original cautions from actual harm rates. No new totals, effects, CIs, NNTs, dose conversions, grades, independence certification, formulation/frequency-only superiority or pediatric prevention/treatment instructions are created.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources

N08 · What does approximately 2–3 months across trials describe?

Current findings: The original classification is approximately 2–3 months across trials, with early evidence described as short-term. Exact report-specific start/end dates, event-observation windows and persistence after stopping are unverified.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
Reason for missing information: Individual exposure periods, observation windows, discontinuation and post-intervention outcomes are unverified.
Required materials and conditions: Original duration, prevention/follow-up and post-intervention outcomes
Materials to obtain first: Individual exposure periods, observation windows, discontinuation and post-intervention outcomes are unverified.
Further research: Material needed: Individual exposure periods, observation windows, discontinuation and post-intervention outcomes are unverified. This records needed materials; no new research was executed.
Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
Conditions for verification: Material for Original duration, prevention/follow-up and post-intervention outcomes must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Why this condition is needed: This condition connects Original duration, prevention/follow-up and post-intervention outcomes with the original five-times-daily prevention question, formulation/age, the 1996/1998 reports, later lower-frequency use, infection timing, event units, denominators, support and harms.
Application exceptions: Preserve original numbers, frequencies, formulations and research exposure only. Do not copy 306 participants or precise event/effect values from the 1996 gum trial to other formulations in 1998. Distinguish five-times-daily from two- or three-times-daily/infection-triggered use, target from actual frequency, children from repeated events, risk differences from HR/OR, and original cautions from actual harm rates. No new totals, effects, CIs, NNTs, dose conversions, grades, independence certification, formulation/frequency-only superiority or pediatric prevention/treatment instructions are created.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R01 R02 R03 R04

N09 · How much is known about placebo, contact and concomitant care?

Current findings: The original comparator classification is placebo. Report/formulation-specific composition, sweetness, calories, contact, antibiotics, concomitant care, clinical care and equivalent management are unverified.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
Reason for missing information: Comparator-product specifications, attention/contact, concomitant care, healthcare use and group-specific management are needed.
Required materials and conditions: Formulation-specific placebo, equivalent management and healthcare use
Materials to obtain first: Comparator-product specifications, attention/contact, concomitant care, healthcare use and group-specific management are needed.
Further research: Material needed: Comparator-product specifications, attention/contact, concomitant care, healthcare use and group-specific management are needed. This records needed materials; no new research was executed.
Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
Conditions for verification: Material for Formulation-specific placebo, equivalent management and healthcare use must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Why this condition is needed: This condition connects Formulation-specific placebo, equivalent management and healthcare use with the original five-times-daily prevention question, formulation/age, the 1996/1998 reports, later lower-frequency use, infection timing, event units, denominators, support and harms.
Application exceptions: Preserve original numbers, frequencies, formulations and research exposure only. Do not copy 306 participants or precise event/effect values from the 1996 gum trial to other formulations in 1998. Distinguish five-times-daily from two- or three-times-daily/infection-triggered use, target from actual frequency, children from repeated events, risk differences from HR/OR, and original cautions from actual harm rates. No new totals, effects, CIs, NNTs, dose conversions, grades, independence certification, formulation/frequency-only superiority or pediatric prevention/treatment instructions are created.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R01 R02 R03 R04

N10 · How, and in what units, was acute otitis media identified?

Current findings: Original endpoints concern acute-otitis-media events/occurrence. Exact diagnoses, adjudicators, children with at least one event versus repeated events, observation windows and collection are unverified. The original English word episodes is not converted into established child-level units.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
Reason for missing information: Diagnosis, assessment, reporting, event/child units, recurrence, collection and observation windows are unverified.
Required materials and conditions: Diagnosis, assessors, children, repeated events and collection
Materials to obtain first: Diagnosis, assessment, reporting, event/child units, recurrence, collection and observation windows are unverified.
Further research: Material needed: Diagnosis, assessment, reporting, event/child units, recurrence, collection and observation windows are unverified. This records needed materials; no new research was executed.
Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
Conditions for verification: Material for Diagnosis, assessors, children, repeated events and collection must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Why this condition is needed: This condition connects Diagnosis, assessors, children, repeated events and collection with the original five-times-daily prevention question, formulation/age, the 1996/1998 reports, later lower-frequency use, infection timing, event units, denominators, support and harms.
Application exceptions: Preserve original numbers, frequencies, formulations and research exposure only. Do not copy 306 participants or precise event/effect values from the 1996 gum trial to other formulations in 1998. Distinguish five-times-daily from two- or three-times-daily/infection-triggered use, target from actual frequency, children from repeated events, risk differences from HR/OR, and original cautions from actual harm rates. No new totals, effects, CIs, NNTs, dose conversions, grades, independence certification, formulation/frequency-only superiority or pediatric prevention/treatment instructions are created.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R01 R02 R03 R04

N11 · Which report provides 19/157 versus 31/149?

Current findings: 19/157 versus 31/149 are original values from 1996 gum. They are not copied into 1998 gum, syrup, lozenges or later reports; exact event units, group correspondence and denominator flow remain separately unverified.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
Reason for missing information: Original-table event/child units, allocation, observation, denominator flow and group correspondence are needed.
Required materials and conditions: 1996 gum comparison values, group correspondence and denominators
Materials to obtain first: Original-table event/child units, allocation, observation, denominator flow and group correspondence are needed.
Further research: Material needed: Original-table event/child units, allocation, observation, denominator flow and group correspondence are needed. This records needed materials; no new research was executed.
Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
Conditions for verification: Material for 1996 gum comparison values, group correspondence and denominators must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Why this condition is needed: This condition connects 1996 gum comparison values, group correspondence and denominators with the original five-times-daily prevention question, formulation/age, the 1996/1998 reports, later lower-frequency use, infection timing, event units, denominators, support and harms.
Application exceptions: Preserve original numbers, frequencies, formulations and research exposure only. Do not copy 306 participants or precise event/effect values from the 1996 gum trial to other formulations in 1998. Distinguish five-times-daily from two- or three-times-daily/infection-triggered use, target from actual frequency, children from repeated events, risk differences from HR/OR, and original cautions from actual harm rates. No new totals, effects, CIs, NNTs, dose conversions, grades, independence certification, formulation/frequency-only superiority or pediatric prevention/treatment instructions are created.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R01

N12 · Are 306 analyzed the same as allocated/completed denominators?

Current findings: 306 analyzed applies only to the 1996 gum trial. It is not the population count for 1998 or later reports; group-specific allocation, completion, follow-up, exclusions and endpoint denominators are unverified.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
Reason for missing information: Allocation, completion, observation, analysis populations and group-specific attrition/exclusion flow are unverified.
Required materials and conditions: Original analysis n, allocation, completion, exclusions and missingness
Materials to obtain first: Allocation, completion, observation, analysis populations and group-specific attrition/exclusion flow are unverified.
Further research: Material needed: Allocation, completion, observation, analysis populations and group-specific attrition/exclusion flow are unverified. This records needed materials; no new research was executed.
Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
Conditions for verification: Material for Original analysis n, allocation, completion, exclusions and missingness must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Why this condition is needed: This condition connects Original analysis n, allocation, completion, exclusions and missingness with the original five-times-daily prevention question, formulation/age, the 1996/1998 reports, later lower-frequency use, infection timing, event units, denominators, support and harms.
Application exceptions: Preserve original numbers, frequencies, formulations and research exposure only. Do not copy 306 participants or precise event/effect values from the 1996 gum trial to other formulations in 1998. Distinguish five-times-daily from two- or three-times-daily/infection-triggered use, target from actual frequency, children from repeated events, risk differences from HR/OR, and original cautions from actual harm rates. No new totals, effects, CIs, NNTs, dose conversions, grades, independence certification, formulation/frequency-only superiority or pediatric prevention/treatment instructions are created.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R01

N13 · What estimand do 8.7 percentage points, CI and P describe?

Current findings: The original difference 8.7 percentage points (95% CI 0.4–17.0), P=.04 and original wording of an absolute 8.7-percentage-point reduction are preserved. Exact model, adjustment, estimand and event units are unverified; no new differences, ratios or NNTs are calculated.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
Reason for missing information: Details of original estimates, adjustment, analysis populations, event units and group correspondence are needed.
Required materials and conditions: Original absolute difference, direction, interval and model
Materials to obtain first: Details of original estimates, adjustment, analysis populations, event units and group correspondence are needed.
Further research: Material needed: Details of original estimates, adjustment, analysis populations, event units and group correspondence are needed. This records needed materials; no new research was executed.
Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
Conditions for verification: Material for Original absolute difference, direction, interval and model must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Why this condition is needed: This condition connects Original absolute difference, direction, interval and model with the original five-times-daily prevention question, formulation/age, the 1996/1998 reports, later lower-frequency use, infection timing, event units, denominators, support and harms.
Application exceptions: Preserve original numbers, frequencies, formulations and research exposure only. Do not copy 306 participants or precise event/effect values from the 1996 gum trial to other formulations in 1998. Distinguish five-times-daily from two- or three-times-daily/infection-triggered use, target from actual frequency, children from repeated events, risk differences from HR/OR, and original cautions from actual harm rates. No new totals, effects, CIs, NNTs, dose conversions, grades, independence certification, formulation/frequency-only superiority or pediatric prevention/treatment instructions are created.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R01

N14 · What is the level of formulation-specific favorable directions in 1998?

Current findings: R02 is a separate 1998 citation; the stored account records favorable five-times-daily gum/syrup directions. The combined evidence row's 306 participants and precise events/effects from 1996 are not read as individual 1998 values.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
Reason for missing information: Formulation-specific n, events, effects, CIs, groups, duration and analyses in 1998 are unverified.
Required materials and conditions: Separate bibliography, five times daily and formulation-specific outcomes
Materials to obtain first: Formulation-specific n, events, effects, CIs, groups, duration and analyses in 1998 are unverified.
Further research: Material needed: Formulation-specific n, events, effects, CIs, groups, duration and analyses in 1998 are unverified. This records needed materials; no new research was executed.
Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
Conditions for verification: Material for Separate bibliography, five times daily and formulation-specific outcomes must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Why this condition is needed: This condition connects Separate bibliography, five times daily and formulation-specific outcomes with the original five-times-daily prevention question, formulation/age, the 1996/1998 reports, later lower-frequency use, infection timing, event units, denominators, support and harms.
Application exceptions: Preserve original numbers, frequencies, formulations and research exposure only. Do not copy 306 participants or precise event/effect values from the 1996 gum trial to other formulations in 1998. Distinguish five-times-daily from two- or three-times-daily/infection-triggered use, target from actual frequency, children from repeated events, risk differences from HR/OR, and original cautions from actual harm rates. No new totals, effects, CIs, NNTs, dose conversions, grades, independence certification, formulation/frequency-only superiority or pediatric prevention/treatment instructions are created.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R02

N15 · Are uncertain lozenges combined with favorable gum/syrup?

Current findings: The stored account records uncertain lozenges in 1998, unlike favorable gum/syrup directions. Formulation names alone do not establish equal effects, contents, adherence or eligibility.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
Reason for missing information: Exact lozenge effects, CIs, n, product specifications, actual exposure and adherence are unverified.
Required materials and conditions: 1998 lozenges, effects, denominators and actual exposure
Materials to obtain first: Exact lozenge effects, CIs, n, product specifications, actual exposure and adherence are unverified.
Further research: Material needed: Exact lozenge effects, CIs, n, product specifications, actual exposure and adherence are unverified. This records needed materials; no new research was executed.
Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
Conditions for verification: Material for 1998 lozenges, effects, denominators and actual exposure must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Why this condition is needed: This condition connects 1998 lozenges, effects, denominators and actual exposure with the original five-times-daily prevention question, formulation/age, the 1996/1998 reports, later lower-frequency use, infection timing, event units, denominators, support and harms.
Application exceptions: Preserve original numbers, frequencies, formulations and research exposure only. Do not copy 306 participants or precise event/effect values from the 1996 gum trial to other formulations in 1998. Distinguish five-times-daily from two- or three-times-daily/infection-triggered use, target from actual frequency, children from repeated events, risk differences from HR/OR, and original cautions from actual harm rates. No new totals, effects, CIs, NNTs, dose conversions, grades, independence certification, formulation/frequency-only superiority or pediatric prevention/treatment instructions are created.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R02

N16 · How are the two reports from the same research program linked?

Current findings: 1996 and 1998 are separate citations, originally described as the same early research program. Cohort overlap, recruitment, report/registration relationships, exact independence and unique totals are unverified.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
Reason for missing information: Cohort/participant overlap, recruitment, reporting relationships, independence and unique-trial status are needed.
Required materials and conditions: 1996/1998 bibliography, cohorts, recruitment and independence
Materials to obtain first: Cohort/participant overlap, recruitment, reporting relationships, independence and unique-trial status are needed.
Further research: Material needed: Cohort/participant overlap, recruitment, reporting relationships, independence and unique-trial status are needed. This records needed materials; no new research was executed.
Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
Conditions for verification: Material for 1996/1998 bibliography, cohorts, recruitment and independence must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Why this condition is needed: This condition connects 1996/1998 bibliography, cohorts, recruitment and independence with the original five-times-daily prevention question, formulation/age, the 1996/1998 reports, later lower-frequency use, infection timing, event units, denominators, support and harms.
Application exceptions: Preserve original numbers, frequencies, formulations and research exposure only. Do not copy 306 participants or precise event/effect values from the 1996 gum trial to other formulations in 1998. Distinguish five-times-daily from two- or three-times-daily/infection-triggered use, target from actual frequency, children from repeated events, risk differences from HR/OR, and original cautions from actual harm rates. No new totals, effects, CIs, NNTs, dose conversions, grades, independence certification, formulation/frequency-only superiority or pediatric prevention/treatment instructions are created.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R01 R02

N17 · Are the later conditions for HR 0.88 the same as original five-times-daily use?

Current findings: R03 Vernacchio 2014 is preserved as a pragmatic lower-frequency syrup trial in high-risk children, HR 0.88 (95% CI 0.61–1.30), null. Exact report-specific frequency, contents, numerical n, observation and model are unverified; a frequency-only effect is not isolated.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
Reason for missing information: Individual frequency, contents, n, timing, denominators, model, adjustment and comparison conditions are unverified.
Required materials and conditions: 2014 lower-frequency syrup, high-risk children and original HR
Materials to obtain first: Individual frequency, contents, n, timing, denominators, model, adjustment and comparison conditions are unverified.
Further research: Material needed: Individual frequency, contents, n, timing, denominators, model, adjustment and comparison conditions are unverified. This records needed materials; no new research was executed.
Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
Conditions for verification: Material for 2014 lower-frequency syrup, high-risk children and original HR must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Why this condition is needed: This condition connects 2014 lower-frequency syrup, high-risk children and original HR with the original five-times-daily prevention question, formulation/age, the 1996/1998 reports, later lower-frequency use, infection timing, event units, denominators, support and harms.
Application exceptions: Preserve original numbers, frequencies, formulations and research exposure only. Do not copy 306 participants or precise event/effect values from the 1996 gum trial to other formulations in 1998. Distinguish five-times-daily from two- or three-times-daily/infection-triggered use, target from actual frequency, children from repeated events, risk differences from HR/OR, and original cautions from actual harm rates. No new totals, effects, CIs, NNTs, dose conversions, grades, independence certification, formulation/frequency-only superiority or pediatric prevention/treatment instructions are created.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R03

N18 · Which report provides 6 versus 3 events and OR 2.04?

Current findings: R04 Persaud 2024 records 250 participants, twice-daily-target syrup, 6 versus 3 events, OR 2.04 (0.43–12.92), P=.50. Group-specific allocated/analyzed n, event units and model are unverified; these are not early five-times-daily results.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
Reason for missing information: Group-specific n, event units, model, adjustment, loss to follow-up and actual analysis populations are unverified.
Required materials and conditions: 2024, 250 participants, target frequency, events, OR and interval
Materials to obtain first: Group-specific n, event units, model, adjustment, loss to follow-up and actual analysis populations are unverified.
Further research: Material needed: Group-specific n, event units, model, adjustment, loss to follow-up and actual analysis populations are unverified. This records needed materials; no new research was executed.
Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
Conditions for verification: Material for 2024, 250 participants, target frequency, events, OR and interval must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Why this condition is needed: This condition connects 2024, 250 participants, target frequency, events, OR and interval with the original five-times-daily prevention question, formulation/age, the 1996/1998 reports, later lower-frequency use, infection timing, event units, denominators, support and harms.
Application exceptions: Preserve original numbers, frequencies, formulations and research exposure only. Do not copy 306 participants or precise event/effect values from the 1996 gum trial to other formulations in 1998. Distinguish five-times-daily from two- or three-times-daily/infection-triggered use, target from actual frequency, children from repeated events, risk differences from HR/OR, and original cautions from actual harm rates. No new totals, effects, CIs, NNTs, dose conversions, grades, independence certification, formulation/frequency-only superiority or pediatric prevention/treatment instructions are created.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R04

N19 · What precision boundary does the original 9-event wording describe?

Current findings: The original 2024 wording of 9 events and the wide interval are retained. A lower-frequency null result is not established as harm, an effect of 0 or complete equivalence; no new event totals, effects or CIs are calculated.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
Reason for missing information: Exact denominators, model, loss to follow-up and additional original material for precision assessment are needed.
Required materials and conditions: Sparse 2024 events, wide interval and null interpretation
Materials to obtain first: Exact denominators, model, loss to follow-up and additional original material for precision assessment are needed.
Further research: Material needed: Exact denominators, model, loss to follow-up and additional original material for precision assessment are needed. This records needed materials; no new research was executed.
Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
Conditions for verification: Material for Sparse 2024 events, wide interval and null interpretation must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Why this condition is needed: This condition connects Sparse 2024 events, wide interval and null interpretation with the original five-times-daily prevention question, formulation/age, the 1996/1998 reports, later lower-frequency use, infection timing, event units, denominators, support and harms.
Application exceptions: Preserve original numbers, frequencies, formulations and research exposure only. Do not copy 306 participants or precise event/effect values from the 1996 gum trial to other formulations in 1998. Distinguish five-times-daily from two- or three-times-daily/infection-triggered use, target from actual frequency, children from repeated events, risk differences from HR/OR, and original cautions from actual harm rates. No new totals, effects, CIs, NNTs, dose conversions, grades, independence certification, formulation/frequency-only superiority or pediatric prevention/treatment instructions are created.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R04

N20 · Are a twice-daily target and approximately two actual daily uses the same record?

Current findings: R04 distinguishes a twice-daily target from the original record of approximately two actual uses daily. This is not converted into complete individual adherence or absence of discontinuation.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
Reason for missing information: Actual exposure, missed uses, refusal, discontinuation, deviation from target and analytic handling by child/period are unverified.
Required materials and conditions: 2024 target, actual exposure, adherence and discontinuation
Materials to obtain first: Actual exposure, missed uses, refusal, discontinuation, deviation from target and analytic handling by child/period are unverified.
Further research: Material needed: Actual exposure, missed uses, refusal, discontinuation, deviation from target and analytic handling by child/period are unverified. This records needed materials; no new research was executed.
Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
Conditions for verification: Material for 2024 target, actual exposure, adherence and discontinuation must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Why this condition is needed: This condition connects 2024 target, actual exposure, adherence and discontinuation with the original five-times-daily prevention question, formulation/age, the 1996/1998 reports, later lower-frequency use, infection timing, event units, denominators, support and harms.
Application exceptions: Preserve original numbers, frequencies, formulations and research exposure only. Do not copy 306 participants or precise event/effect values from the 1996 gum trial to other formulations in 1998. Distinguish five-times-daily from two- or three-times-daily/infection-triggered use, target from actual frequency, children from repeated events, risk differences from HR/OR, and original cautions from actual harm rates. No new totals, effects, CIs, NNTs, dose conversions, grades, independence certification, formulation/frequency-only superiority or pediatric prevention/treatment instructions are created.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R04

N21 · Can frequency alone establish administration amounts or doses?

Current findings: The original summary describes five-times-daily or lower-frequency use and formulations but lacks formulation contents, per-use/daily doses and weight-specific ranges. No new amounts, dose conversions, administration schedules or pediatric prevention/treatment instructions are created.
Verification status: Unverified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
Reason for missing information: Contents, per-use/daily doses and actual weight/age-specific exposures are unverified.
Required materials and conditions: Formulation contents, per-use/daily doses, weight and age
Materials to obtain first: Contents, per-use/daily doses and actual weight/age-specific exposures are unverified.
Further research: Material needed: Contents, per-use/daily doses and actual weight/age-specific exposures are unverified. This records needed materials; no new research was executed.
Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
Conditions for verification: Material for Formulation contents, per-use/daily doses, weight and age must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Why this condition is needed: This condition connects Formulation contents, per-use/daily doses, weight and age with the original five-times-daily prevention question, formulation/age, the 1996/1998 reports, later lower-frequency use, infection timing, event units, denominators, support and harms.
Application exceptions: Preserve original numbers, frequencies, formulations and research exposure only. Do not copy 306 participants or precise event/effect values from the 1996 gum trial to other formulations in 1998. Distinguish five-times-daily from two- or three-times-daily/infection-triggered use, target from actual frequency, children from repeated events, risk differences from HR/OR, and original cautions from actual harm rates. No new totals, effects, CIs, NNTs, dose conversions, grades, independence certification, formulation/frequency-only superiority or pediatric prevention/treatment instructions are created.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R01 R02

N22 · Are randomized labels distinguished from actual allocation?

Current findings: The stored account describes early/later randomized trials, and the 1996 citation includes double-blind randomized wording. Actual generation, concealment, formulation allocation, recruitment order and cluster units are unverified.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
Reason for missing information: Original report-specific allocation, concealment, randomization units, recruitment and formulation distribution methods are needed.
Required materials and conditions: Design, sequence generation, concealment, formulation and cluster allocation
Materials to obtain first: Original report-specific allocation, concealment, randomization units, recruitment and formulation distribution methods are needed.
Further research: Material needed: Original report-specific allocation, concealment, randomization units, recruitment and formulation distribution methods are needed. This records needed materials; no new research was executed.
Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
Conditions for verification: Material for Design, sequence generation, concealment, formulation and cluster allocation must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Why this condition is needed: This condition connects Design, sequence generation, concealment, formulation and cluster allocation with the original five-times-daily prevention question, formulation/age, the 1996/1998 reports, later lower-frequency use, infection timing, event units, denominators, support and harms.
Application exceptions: Preserve original numbers, frequencies, formulations and research exposure only. Do not copy 306 participants or precise event/effect values from the 1996 gum trial to other formulations in 1998. Distinguish five-times-daily from two- or three-times-daily/infection-triggered use, target from actual frequency, children from repeated events, risk differences from HR/OR, and original cautions from actual harm rates. No new totals, effects, CIs, NNTs, dose conversions, grades, independence certification, formulation/frequency-only superiority or pediatric prevention/treatment instructions are created.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R01 R02 R03 R04

N23 · Are event assessment and parent/assessor awareness known?

Current findings: Double-blind wording in the 1996 citation is preserved. It is not expanded into verified masking of parents, children, clinicians or adjudicators, or equivalent event collection across every report.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
Reason for missing information: Report-specific masking procedures, diagnosis, assessment, reporting, healthcare use and recurrent-event collection are unverified.
Required materials and conditions: Masking, diagnosis, reporting, healthcare use and recurrent-event collection
Materials to obtain first: Report-specific masking procedures, diagnosis, assessment, reporting, healthcare use and recurrent-event collection are unverified.
Further research: Material needed: Report-specific masking procedures, diagnosis, assessment, reporting, healthcare use and recurrent-event collection are unverified. This records needed materials; no new research was executed.
Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
Conditions for verification: Material for Masking, diagnosis, reporting, healthcare use and recurrent-event collection must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Why this condition is needed: This condition connects Masking, diagnosis, reporting, healthcare use and recurrent-event collection with the original five-times-daily prevention question, formulation/age, the 1996/1998 reports, later lower-frequency use, infection timing, event units, denominators, support and harms.
Application exceptions: Preserve original numbers, frequencies, formulations and research exposure only. Do not copy 306 participants or precise event/effect values from the 1996 gum trial to other formulations in 1998. Distinguish five-times-daily from two- or three-times-daily/infection-triggered use, target from actual frequency, children from repeated events, risk differences from HR/OR, and original cautions from actual harm rates. No new totals, effects, CIs, NNTs, dose conversions, grades, independence certification, formulation/frequency-only superiority or pediatric prevention/treatment instructions are created.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R01 R02 R03 R04

N24 · What were baseline infection, clinical care and concurrent management?

Current findings: Daycare, high-risk and regular-prevention contexts are recorded, but group-specific baseline infection, other prevention, diet, antibiotics, healthcare use, lifestyle changes and analytic handling are unverified.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
Reason for missing information: Original material on baseline infection/risk, concomitant care, healthcare use, group changes and analyses remains needed.
Required materials and conditions: Baseline risk, prevention, diet, antibiotics and group changes
Materials to obtain first: Original material on baseline infection/risk, concomitant care, healthcare use, group changes and analyses remains needed.
Further research: Material needed: Original material on baseline infection/risk, concomitant care, healthcare use, group changes and analyses remains needed. This records needed materials; no new research was executed.
Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
Conditions for verification: Material for Baseline risk, prevention, diet, antibiotics and group changes must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Why this condition is needed: This condition connects Baseline risk, prevention, diet, antibiotics and group changes with the original five-times-daily prevention question, formulation/age, the 1996/1998 reports, later lower-frequency use, infection timing, event units, denominators, support and harms.
Application exceptions: Preserve original numbers, frequencies, formulations and research exposure only. Do not copy 306 participants or precise event/effect values from the 1996 gum trial to other formulations in 1998. Distinguish five-times-daily from two- or three-times-daily/infection-triggered use, target from actual frequency, children from repeated events, risk differences from HR/OR, and original cautions from actual harm rates. No new totals, effects, CIs, NNTs, dose conversions, grades, independence certification, formulation/frequency-only superiority or pediatric prevention/treatment instructions are created.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R01 R02 R03 R04

N25 · What estimand is defined by denominators, attrition, repeated events and adjustment?

Current findings: 306 analyzed in 1996, 250 participants in 2024, events, HR and OR are preserved. Report-specific ITT/PP, discontinuation, loss to follow-up, cluster/repeated-event handling, adjustment and sensitivity analyses are unverified; individual 1998 n and numerical 2014 n are also unverified.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
Reason for missing information: Denominator stages, ITT/PP, recurrence/clustering, adjustment, missingness, sensitivity analyses and original plans are needed.
Required materials and conditions: ITT/PP, loss to follow-up, clusters, models and missingness
Materials to obtain first: Denominator stages, ITT/PP, recurrence/clustering, adjustment, missingness, sensitivity analyses and original plans are needed.
Further research: Material needed: Denominator stages, ITT/PP, recurrence/clustering, adjustment, missingness, sensitivity analyses and original plans are needed. This records needed materials; no new research was executed.
Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
Conditions for verification: Material for ITT/PP, loss to follow-up, clusters, models and missingness must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Why this condition is needed: This condition connects ITT/PP, loss to follow-up, clusters, models and missingness with the original five-times-daily prevention question, formulation/age, the 1996/1998 reports, later lower-frequency use, infection timing, event units, denominators, support and harms.
Application exceptions: Preserve original numbers, frequencies, formulations and research exposure only. Do not copy 306 participants or precise event/effect values from the 1996 gum trial to other formulations in 1998. Distinguish five-times-daily from two- or three-times-daily/infection-triggered use, target from actual frequency, children from repeated events, risk differences from HR/OR, and original cautions from actual harm rates. No new totals, effects, CIs, NNTs, dose conversions, grades, independence certification, formulation/frequency-only superiority or pediatric prevention/treatment instructions are created.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R01 R02 R03 R04

N26 · Are historical registration wording and later registration/plans distinguished?

Current findings: The early combined row's registration-does-not-exist-because-it-predates-registration wording is historical.2014 is recorded as not confirmed and 2024 as NCT03055091; registration contents, timing relative to recruitment, hierarchy and changes were not read in this work.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
Reason for missing information: Report-specific registration identity/content, recruitment timing, prospective endpoints/analyses and change history are unverified.
Required materials and conditions: Early pre-registration-era wording, unverified 2014 registration and 2024 identifier
Materials to obtain first: Report-specific registration identity/content, recruitment timing, prospective endpoints/analyses and change history are unverified.
Further research: Material needed: Report-specific registration identity/content, recruitment timing, prospective endpoints/analyses and change history are unverified. This records needed materials; no new research was executed.
Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
Conditions for verification: Material for Early pre-registration-era wording, unverified 2014 registration and 2024 identifier must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Why this condition is needed: This condition connects Early pre-registration-era wording, unverified 2014 registration and 2024 identifier with the original five-times-daily prevention question, formulation/age, the 1996/1998 reports, later lower-frequency use, infection timing, event units, denominators, support and harms.
Application exceptions: Preserve original numbers, frequencies, formulations and research exposure only. Do not copy 306 participants or precise event/effect values from the 1996 gum trial to other formulations in 1998. Distinguish five-times-daily from two- or three-times-daily/infection-triggered use, target from actual frequency, children from repeated events, risk differences from HR/OR, and original cautions from actual harm rates. No new totals, effects, CIs, NNTs, dose conversions, grades, independence certification, formulation/frequency-only superiority or pediatric prevention/treatment instructions are created.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R01 R02 R03 R04

N27 · Do otitis-prevention outcomes answer caries, treatment or long-term questions?

Current findings: The stored account identifies dental-caries verdict 748 as a different question. This sheet concerns original acute-otitis-media preventive events; direct evidence for treatment of existing otitis, long-term/post-intervention prevention or other clinical effects is unverified.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
Reason for missing information: Direct endpoints, comparators, denominators and duration for caries, treatment and long-term/repeated prevention are needed.
Required materials and conditions: Original acute events, separate caries, treatment and post-intervention prevention
Materials to obtain first: Direct endpoints, comparators, denominators and duration for caries, treatment and long-term/repeated prevention are needed.
Further research: Material needed: Direct endpoints, comparators, denominators and duration for caries, treatment and long-term/repeated prevention are needed. This records needed materials; no new research was executed.
Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
Conditions for verification: Material for Original acute events, separate caries, treatment and post-intervention prevention must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Why this condition is needed: This condition connects Original acute events, separate caries, treatment and post-intervention prevention with the original five-times-daily prevention question, formulation/age, the 1996/1998 reports, later lower-frequency use, infection timing, event units, denominators, support and harms.
Application exceptions: Preserve original numbers, frequencies, formulations and research exposure only. Do not copy 306 participants or precise event/effect values from the 1996 gum trial to other formulations in 1998. Distinguish five-times-daily from two- or three-times-daily/infection-triggered use, target from actual frequency, children from repeated events, risk differences from HR/OR, and original cautions from actual harm rates. No new totals, effects, CIs, NNTs, dose conversions, grades, independence certification, formulation/frequency-only superiority or pediatric prevention/treatment instructions are created.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources

N28 · Can formulation/frequency-only effects be isolated from later differences?

Current findings: The stored account says formulation and frequency changed together, preventing isolation of formulation-only effects. No new direct superiority or universal prevention effect is established from high-/lower-frequency, infection-timing or population differences.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
Reason for missing information: Direct formulation/frequency comparisons under identical conditions, individual original tables and exact replication are unverified.
Required materials and conditions: Joint changes in formulation, frequency, timing, population and duration
Materials to obtain first: Direct formulation/frequency comparisons under identical conditions, individual original tables and exact replication are unverified.
Further research: Material needed: Direct formulation/frequency comparisons under identical conditions, individual original tables and exact replication are unverified. This records needed materials; no new research was executed.
Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
Conditions for verification: Material for Joint changes in formulation, frequency, timing, population and duration must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Why this condition is needed: This condition connects Joint changes in formulation, frequency, timing, population and duration with the original five-times-daily prevention question, formulation/age, the 1996/1998 reports, later lower-frequency use, infection timing, event units, denominators, support and harms.
Application exceptions: Preserve original numbers, frequencies, formulations and research exposure only. Do not copy 306 participants or precise event/effect values from the 1996 gum trial to other formulations in 1998. Distinguish five-times-daily from two- or three-times-daily/infection-triggered use, target from actual frequency, children from repeated events, risk differences from HR/OR, and original cautions from actual harm rates. No new totals, effects, CIs, NNTs, dose conversions, grades, independence certification, formulation/frequency-only superiority or pediatric prevention/treatment instructions are created.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R01 R02 R03 R04

N29 · How are three evidence rows linked to four citations?

Current findings: There are 3 evidence rows and 4 citations. Original n and precise results from 1996 in the early combined row link only to R01; the separate 1998 citation/directions link to R02. R03/R04 are lower-frequency contexts; unique trial, participant and event totals are unrecorded.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
Reason for missing information: Report, cohort and recruitment relationships, overlap, independence and unique totals are unverified.
Required materials and conditions: Combined evidence, separate bibliography, reports, cohorts and outcome mapping
Materials to obtain first: Report, cohort and recruitment relationships, overlap, independence and unique totals are unverified.
Further research: Material needed: Report, cohort and recruitment relationships, overlap, independence and unique totals are unverified. This records needed materials; no new research was executed.
Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
Conditions for verification: Material for Combined evidence, separate bibliography, reports, cohorts and outcome mapping must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Why this condition is needed: This condition connects Combined evidence, separate bibliography, reports, cohorts and outcome mapping with the original five-times-daily prevention question, formulation/age, the 1996/1998 reports, later lower-frequency use, infection timing, event units, denominators, support and harms.
Application exceptions: Preserve original numbers, frequencies, formulations and research exposure only. Do not copy 306 participants or precise event/effect values from the 1996 gum trial to other formulations in 1998. Distinguish five-times-daily from two- or three-times-daily/infection-triggered use, target from actual frequency, children from repeated events, risk differences from HR/OR, and original cautions from actual harm rates. No new totals, effects, CIs, NNTs, dose conversions, grades, independence certification, formulation/frequency-only superiority or pediatric prevention/treatment instructions are created.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R01 R02 R03 R04

N30 · How far are public support and product involvement known?

Current findings: The early combined row records indexed non-US government support with complete product involvement incompletely verified;2014 records NIH/non-US government support and 2024 public research support. Individual 1998 support details, institutions, products, design/analysis involvement and COI are unverified.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
Reason for missing information: Report-specific funding, product provision, employees, design/analysis/publication roles, COI and detailed independence are unverified.
Required materials and conditions: Report-specific funding, product support, roles and COI
Materials to obtain first: Report-specific funding, product provision, employees, design/analysis/publication roles, COI and detailed independence are unverified.
Further research: Material needed: Report-specific funding, product provision, employees, design/analysis/publication roles, COI and detailed independence are unverified. This records needed materials; no new research was executed.
Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
Conditions for verification: Material for Report-specific funding, product support, roles and COI must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Why this condition is needed: This condition connects Report-specific funding, product support, roles and COI with the original five-times-daily prevention question, formulation/age, the 1996/1998 reports, later lower-frequency use, infection timing, event units, denominators, support and harms.
Application exceptions: Preserve original numbers, frequencies, formulations and research exposure only. Do not copy 306 participants or precise event/effect values from the 1996 gum trial to other formulations in 1998. Distinguish five-times-daily from two- or three-times-daily/infection-triggered use, target from actual frequency, children from repeated events, risk differences from HR/OR, and original cautions from actual harm rates. No new totals, effects, CIs, NNTs, dose conversions, grades, independence certification, formulation/frequency-only superiority or pediatric prevention/treatment instructions are created.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R01 R02 R03 R04

N31 · What material was actually read here?

Current findings: The complete parent stored summary and corresponding summaries for the four citations were read and preserved in full internally. External papers, abstracts, registration, plans and support disclosures are unread/access unattempted; they are not classified as inaccessible or failed access.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
Reason for missing information: External originals, supplements, registration, plans, support, actual reading records and content review remain outstanding.
Required materials and conditions: Complete stored summary and unread external material
Materials to obtain first: External originals, supplements, registration, plans, support, actual reading records and content review remain outstanding.
Further research: Material needed: External originals, supplements, registration, plans, support, actual reading records and content review remain outstanding. This records needed materials; no new research was executed.
Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
Conditions for verification: Material for Complete stored summary and unread external material must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Why this condition is needed: This condition connects Complete stored summary and unread external material with the original five-times-daily prevention question, formulation/age, the 1996/1998 reports, later lower-frequency use, infection timing, event units, denominators, support and harms.
Application exceptions: Preserve original numbers, frequencies, formulations and research exposure only. Do not copy 306 participants or precise event/effect values from the 1996 gum trial to other formulations in 1998. Distinguish five-times-daily from two- or three-times-daily/infection-triggered use, target from actual frequency, children from repeated events, risk differences from HR/OR, and original cautions from actual harm rates. No new totals, effects, CIs, NNTs, dose conversions, grades, independence certification, formulation/frequency-only superiority or pediatric prevention/treatment instructions are created.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R01 R02 R03 R04

N32 · Are historical verification and current production/review separated?

Current findings: Original evidence cut-off 2026-09-07, an empty correction array and an empty deliberation string are preserved. The parent's cross-check-applied wording is historical, not current external verification or completed content review.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
Reason for missing information: New clinical verification, corrections/follow-up materials and current content review remain outstanding; the unrecorded material-review date stays unrecorded.
Required materials and conditions: Original date, empty corrections/deliberation and historical decision
Materials to obtain first: New clinical verification, corrections/follow-up materials and current content review remain outstanding; the unrecorded material-review date stays unrecorded.
Further research: Material needed: New clinical verification, corrections/follow-up materials and current content review remain outstanding; the unrecorded material-review date stays unrecorded. This records needed materials; no new research was executed.
Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
Conditions for verification: Material for Original date, empty corrections/deliberation and historical decision must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Why this condition is needed: This condition connects Original date, empty corrections/deliberation and historical decision with the original five-times-daily prevention question, formulation/age, the 1996/1998 reports, later lower-frequency use, infection timing, event units, denominators, support and harms.
Application exceptions: Preserve original numbers, frequencies, formulations and research exposure only. Do not copy 306 participants or precise event/effect values from the 1996 gum trial to other formulations in 1998. Distinguish five-times-daily from two- or three-times-daily/infection-triggered use, target from actual frequency, children from repeated events, risk differences from HR/OR, and original cautions from actual harm rates. No new totals, effects, CIs, NNTs, dose conversions, grades, independence certification, formulation/frequency-only superiority or pediatric prevention/treatment instructions are created.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources

N33 · Are original languages and event/frequency/formulation scope preserved?

Current findings: The original English is Five-times-daily prophylaxis, with a note of favorable early gum/syrup trials. Parent Korean/English boundaries concerning frequency, timing, lower-frequency null results and sparse events are preserved; event units and detailed translation are not treated as newly checked against external papers.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
Reason for missing information: External-paper comparison of detailed Korean/English translation, corrections and event units remains incomplete.
Required materials and conditions: Original wording, note and language-specific event expressions
Materials to obtain first: External-paper comparison of detailed Korean/English translation, corrections and event units remains incomplete.
Further research: Material needed: External-paper comparison of detailed Korean/English translation, corrections and event units remains incomplete. This records needed materials; no new research was executed.
Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
Conditions for verification: Material for Original wording, note and language-specific event expressions must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Why this condition is needed: This condition connects Original wording, note and language-specific event expressions with the original five-times-daily prevention question, formulation/age, the 1996/1998 reports, later lower-frequency use, infection timing, event units, denominators, support and harms.
Application exceptions: Preserve original numbers, frequencies, formulations and research exposure only. Do not copy 306 participants or precise event/effect values from the 1996 gum trial to other formulations in 1998. Distinguish five-times-daily from two- or three-times-daily/infection-triggered use, target from actual frequency, children from repeated events, risk differences from HR/OR, and original cautions from actual harm rates. No new totals, effects, CIs, NNTs, dose conversions, grades, independence certification, formulation/frequency-only superiority or pediatric prevention/treatment instructions are created.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources

N34 · Are parent axes distinguished from absent subclaim fields?

Current findings: Parent values are B/H/R0/I1/E+/B2, null precision, four false flags, derived C and an empty override. The subclaim has no separate score, status or axes; parent C54/Caution do not fill subclaim values or provide new independence certification.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
Reason for missing information: Subclaim score, status and axes are absent from the source and detailed precision remains unverified. Null is not filled with an invented grade.
Required materials and conditions: Parent axes, null precision and absent subclaim score/status/axes
Materials to obtain first: Subclaim score, status and axes are absent from the source and detailed precision remains unverified. Null is not filled with an invented grade.
Further research: Material needed: Subclaim score, status and axes are absent from the source and detailed precision remains unverified. Null is not filled with an invented grade. This records needed materials; no new research was executed.
Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
Conditions for verification: Material for Parent axes, null precision and absent subclaim score/status/axes must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Why this condition is needed: This condition connects Parent axes, null precision and absent subclaim score/status/axes with the original five-times-daily prevention question, formulation/age, the 1996/1998 reports, later lower-frequency use, infection timing, event units, denominators, support and harms.
Application exceptions: Preserve original numbers, frequencies, formulations and research exposure only. Do not copy 306 participants or precise event/effect values from the 1996 gum trial to other formulations in 1998. Distinguish five-times-daily from two- or three-times-daily/infection-triggered use, target from actual frequency, children from repeated events, risk differences from HR/OR, and original cautions from actual harm rates. No new totals, effects, CIs, NNTs, dose conversions, grades, independence certification, formulation/frequency-only superiority or pediatric prevention/treatment instructions are created.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

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N35 · Are diarrhea, abdominal discomfort, refusal and choking cautions actual event data?

Current findings: Original safety is Caution, with syrup/lozenge diarrhea, abdominal discomfort/refusal and choking concern with gum in young children. This wording is not converted into actual event counts, rates or verified causation.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
Reason for missing information: Harm definitions, collection, assessment, actual events and formulation/age-specific denominators are unverified.
Required materials and conditions: Formulation/age-specific harm definitions, collection, denominators and discontinuation
Materials to obtain first: Harm definitions, collection, assessment, actual events and formulation/age-specific denominators are unverified.
Further research: Material needed: Harm definitions, collection, assessment, actual events and formulation/age-specific denominators are unverified. This records needed materials; no new research was executed.
Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
Conditions for verification: Material for Formulation/age-specific harm definitions, collection, denominators and discontinuation must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Why this condition is needed: This condition connects Formulation/age-specific harm definitions, collection, denominators and discontinuation with the original five-times-daily prevention question, formulation/age, the 1996/1998 reports, later lower-frequency use, infection timing, event units, denominators, support and harms.
Application exceptions: Preserve original numbers, frequencies, formulations and research exposure only. Do not copy 306 participants or precise event/effect values from the 1996 gum trial to other formulations in 1998. Distinguish five-times-daily from two- or three-times-daily/infection-triggered use, target from actual frequency, children from repeated events, risk differences from HR/OR, and original cautions from actual harm rates. No new totals, effects, CIs, NNTs, dose conversions, grades, independence certification, formulation/frequency-only superiority or pediatric prevention/treatment instructions are created.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R01 R02 R03 R04

N36 · What are harm exposure, discontinuation, recovery and later observation times?

Current findings: Original prevention duration/frequency are recorded, but harm onset, recovery, refusal, discontinuation, later follow-up and the timing relative to actual exposure by formulation/age are unverified.
Verification status: Unverified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
Reason for missing information: Original harm-onset, recovery, discontinuation, follow-up timing and actual-exposure material is needed.
Required materials and conditions: Actual exposure, symptoms, refusal, recovery and observation windows
Materials to obtain first: Original harm-onset, recovery, discontinuation, follow-up timing and actual-exposure material is needed.
Further research: Material needed: Original harm-onset, recovery, discontinuation, follow-up timing and actual-exposure material is needed. This records needed materials; no new research was executed.
Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
Conditions for verification: Material for Actual exposure, symptoms, refusal, recovery and observation windows must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Why this condition is needed: This condition connects Actual exposure, symptoms, refusal, recovery and observation windows with the original five-times-daily prevention question, formulation/age, the 1996/1998 reports, later lower-frequency use, infection timing, event units, denominators, support and harms.
Application exceptions: Preserve original numbers, frequencies, formulations and research exposure only. Do not copy 306 participants or precise event/effect values from the 1996 gum trial to other formulations in 1998. Distinguish five-times-daily from two- or three-times-daily/infection-triggered use, target from actual frequency, children from repeated events, risk differences from HR/OR, and original cautions from actual harm rates. No new totals, effects, CIs, NNTs, dose conversions, grades, independence certification, formulation/frequency-only superiority or pediatric prevention/treatment instructions are created.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R01 R02 R03 R04

N37 · Were harms compared under equivalent observation/comparator conditions?

Current findings: Original placebo/formulation contexts are recorded, but equal harm collection, observation windows and direct harm/discontinuation comparisons between groups are unverified. The preventive-outcome comparator is not inherited as equivalent harm collection.
Verification status: Unverified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
Reason for missing information: Original tables with equivalent harm collection, observation windows, comparator and formulation-specific direct comparisons are needed.
Required materials and conditions: Placebo, formulation-specific harm collection, windows and discontinuation comparisons
Materials to obtain first: Original tables with equivalent harm collection, observation windows, comparator and formulation-specific direct comparisons are needed.
Further research: Material needed: Original tables with equivalent harm collection, observation windows, comparator and formulation-specific direct comparisons are needed. This records needed materials; no new research was executed.
Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
Conditions for verification: Material for Placebo, formulation-specific harm collection, windows and discontinuation comparisons must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Why this condition is needed: This condition connects Placebo, formulation-specific harm collection, windows and discontinuation comparisons with the original five-times-daily prevention question, formulation/age, the 1996/1998 reports, later lower-frequency use, infection timing, event units, denominators, support and harms.
Application exceptions: Preserve original numbers, frequencies, formulations and research exposure only. Do not copy 306 participants or precise event/effect values from the 1996 gum trial to other formulations in 1998. Distinguish five-times-daily from two- or three-times-daily/infection-triggered use, target from actual frequency, children from repeated events, risk differences from HR/OR, and original cautions from actual harm rates. No new totals, effects, CIs, NNTs, dose conversions, grades, independence certification, formulation/frequency-only superiority or pediatric prevention/treatment instructions are created.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R01 R02 R03 R04

N38 · Are harm-event counts and actual-exposure denominators available?

Current findings: Original 306 analyzed, later 250 participants and preventive-event counts are recorded, but actual harm counts, formulation/age-specific exposure/observation denominators and discontinuation are unverified. Preventive-analysis n is not used as the harm denominator.
Verification status: Unverified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
Reason for missing information: Harm counts, actual exposure/follow-up denominators, formulation, age and duration are unverified.
Required materials and conditions: Formulation/age-specific harms, exposure, observation and discontinuation
Materials to obtain first: Harm counts, actual exposure/follow-up denominators, formulation, age and duration are unverified.
Further research: Material needed: Harm counts, actual exposure/follow-up denominators, formulation, age and duration are unverified. This records needed materials; no new research was executed.
Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
Conditions for verification: Material for Formulation/age-specific harms, exposure, observation and discontinuation must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Why this condition is needed: This condition connects Formulation/age-specific harms, exposure, observation and discontinuation with the original five-times-daily prevention question, formulation/age, the 1996/1998 reports, later lower-frequency use, infection timing, event units, denominators, support and harms.
Application exceptions: Preserve original numbers, frequencies, formulations and research exposure only. Do not copy 306 participants or precise event/effect values from the 1996 gum trial to other formulations in 1998. Distinguish five-times-daily from two- or three-times-daily/infection-triggered use, target from actual frequency, children from repeated events, risk differences from HR/OR, and original cautions from actual harm rates. No new totals, effects, CIs, NNTs, dose conversions, grades, independence certification, formulation/frequency-only superiority or pediatric prevention/treatment instructions are created.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R01 R02 R03 R04

N39 · Are infection, concomitant care, formulation, refusal and causation distinguished?

Current findings: The stored account includes formulation-specific possibilities and refusal/discontinuation cautions, but actual events, contributions of concomitant care, infection, formulation/age and causal assessment are unverified.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
Reason for missing information: Actual events, concurrent factors, formulation/age contributions, exposure timing and causal assessment are needed.
Required materials and conditions: Concurrent factors, actual events, exposure and discontinuation timing
Materials to obtain first: Actual events, concurrent factors, formulation/age contributions, exposure timing and causal assessment are needed.
Further research: Material needed: Actual events, concurrent factors, formulation/age contributions, exposure timing and causal assessment are needed. This records needed materials; no new research was executed.
Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
Conditions for verification: Material for Concurrent factors, actual events, exposure and discontinuation timing must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Why this condition is needed: This condition connects Concurrent factors, actual events, exposure and discontinuation timing with the original five-times-daily prevention question, formulation/age, the 1996/1998 reports, later lower-frequency use, infection timing, event units, denominators, support and harms.
Application exceptions: Preserve original numbers, frequencies, formulations and research exposure only. Do not copy 306 participants or precise event/effect values from the 1996 gum trial to other formulations in 1998. Distinguish five-times-daily from two- or three-times-daily/infection-triggered use, target from actual frequency, children from repeated events, risk differences from HR/OR, and original cautions from actual harm rates. No new totals, effects, CIs, NNTs, dose conversions, grades, independence certification, formulation/frequency-only superiority or pediatric prevention/treatment instructions are created.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R01 R02 R03 R04

N40 · Are refusal, discontinuation, loss to follow-up and harm reporting known?

Current findings: Original safety wording concerns possible refusal/discontinuation; the 2024 citation records limited adherence. Report-specific group discontinuation/attrition reasons, missing harms, selective reporting and loss to follow-up are unverified.
Verification status: Unverified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
Reason for missing information: Group-specific refusal, discontinuation, attrition, harm missingness, selective reporting and later follow-up are needed.
Required materials and conditions: Group-specific refusal, attrition, harm missingness and selective reporting
Materials to obtain first: Group-specific refusal, discontinuation, attrition, harm missingness, selective reporting and later follow-up are needed.
Further research: Material needed: Group-specific refusal, discontinuation, attrition, harm missingness, selective reporting and later follow-up are needed. This records needed materials; no new research was executed.
Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
Conditions for verification: Material for Group-specific refusal, attrition, harm missingness and selective reporting must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Why this condition is needed: This condition connects Group-specific refusal, attrition, harm missingness and selective reporting with the original five-times-daily prevention question, formulation/age, the 1996/1998 reports, later lower-frequency use, infection timing, event units, denominators, support and harms.
Application exceptions: Preserve original numbers, frequencies, formulations and research exposure only. Do not copy 306 participants or precise event/effect values from the 1996 gum trial to other formulations in 1998. Distinguish five-times-daily from two- or three-times-daily/infection-triggered use, target from actual frequency, children from repeated events, risk differences from HR/OR, and original cautions from actual harm rates. No new totals, effects, CIs, NNTs, dose conversions, grades, independence certification, formulation/frequency-only superiority or pediatric prevention/treatment instructions are created.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R01 R02 R03 R04

N41 · How far are harms in other ages/formulations, independent evidence and long-term follow-up known?

Current findings: The current preserved scope contains preventive findings and harm cautions. Independent harm evidence for the same formulation/frequency, vulnerable ages/diseases and post-intervention follow-up are unverified; no new external search was performed.
Verification status: Unverified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
Reason for missing information: Independent harms, vulnerable populations, other formulations/ages and long-term/post-intervention follow-up are unverified.
Required materials and conditions: Same exposure, vulnerable populations, independent harms and post-intervention follow-up
Materials to obtain first: Independent harms, vulnerable populations, other formulations/ages and long-term/post-intervention follow-up are unverified.
Further research: Material needed: Independent harms, vulnerable populations, other formulations/ages and long-term/post-intervention follow-up are unverified. This records needed materials; no new research was executed.
Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
Conditions for verification: Material for Same exposure, vulnerable populations, independent harms and post-intervention follow-up must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Why this condition is needed: This condition connects Same exposure, vulnerable populations, independent harms and post-intervention follow-up with the original five-times-daily prevention question, formulation/age, the 1996/1998 reports, later lower-frequency use, infection timing, event units, denominators, support and harms.
Application exceptions: Preserve original numbers, frequencies, formulations and research exposure only. Do not copy 306 participants or precise event/effect values from the 1996 gum trial to other formulations in 1998. Distinguish five-times-daily from two- or three-times-daily/infection-triggered use, target from actual frequency, children from repeated events, risk differences from HR/OR, and original cautions from actual harm rates. No new totals, effects, CIs, NNTs, dose conversions, grades, independence certification, formulation/frequency-only superiority or pediatric prevention/treatment instructions are created.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources R01 R02 R03 R04

N42 · Are originals, conditions, methods, observations and update records distinguished?

Current findings: Existing preserved methodology and application conditions are linked; conditions were saved/frozen before observations were recorded at a separate time. This is not upgraded into methodological certification or completed content review; no new research, calculations, grades or administration instructions are created.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread
Why unverified: The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.
Reason for missing information: Complete prior texts, condition versions, separate application records, current content review and change history must be preserved distinctly.
Required materials and conditions: Original texts, condition versions, separate application and change history
Materials to obtain first: Complete prior texts, condition versions, separate application records, current content review and change history must be preserved distinctly.
Further research: Material needed: Complete prior texts, condition versions, separate application records, current content review and change history must be preserved distinctly. This records needed materials; no new research was executed.
Remaining uncertainty: External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.
Conditions for verification: Material for Original texts, condition versions, separate application and change history must be linked to the selected subclaim, parent context, same report/trial, outcome units, times, actual comparator and denominators, distinguishing unread external material.
Why this condition is needed: This condition connects Original texts, condition versions, separate application and change history with the original five-times-daily prevention question, formulation/age, the 1996/1998 reports, later lower-frequency use, infection timing, event units, denominators, support and harms.
Application exceptions: Preserve original numbers, frequencies, formulations and research exposure only. Do not copy 306 participants or precise event/effect values from the 1996 gum trial to other formulations in 1998. Distinguish five-times-daily from two- or three-times-daily/infection-triggered use, target from actual frequency, children from repeated events, risk differences from HR/OR, and original cautions from actual harm rates. No new totals, effects, CIs, NNTs, dose conversions, grades, independence certification, formulation/frequency-only superiority or pediatric prevention/treatment instructions are created.
Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources