# Xylitol five-times-daily prophylaxis × acute otitis media

Verdict 2994 · Evidence Check

Stored-material review date: Not recorded  
Original evidence cut-off: 2026-09-07  
Review-criteria version: 1.0  
Public page/material preparation date: 2026-10-16

Clinical papers were not read directly; existing review summaries were checked. No new clinical-literature search was performed. Unverified does not mean that research is absent or that there is no effect.

## Assessment scope

- 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

## Checklist items

### N01 · What is the selected original prevention question?

Verification status: Partly verified  
Reading scope: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread

- 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.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread

- 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.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread

- 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.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread

- 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.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread

- 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.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread

- 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.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread

- 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.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread

- 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.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread

- 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.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread

- 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.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread

- 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.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread

- 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.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread

- 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.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread

- 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.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread

- 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.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread

- 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.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread

- 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.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread

- 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.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread

- 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.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread

- 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.
- 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.
- 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.
- 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.
- 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?

Verification status: Unverified  
Reading scope: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread

- 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.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread

- 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.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread

- 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.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread

- 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.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread

- 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.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread

- 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.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread

- 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.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread

- 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.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread

- 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.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread

- 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.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread

- 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.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread

- 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.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread

- 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.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread

- 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.
- 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.
- 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.
- 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.
- Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.
- Related sources: 

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

Verification status: Partly verified  
Reading scope: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread

- 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.
- 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.
- 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.
- 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.
- 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?

Verification status: Unverified  
Reading scope: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread

- 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.
- 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.
- 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.
- 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.
- 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?

Verification status: Unverified  
Reading scope: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread

- 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.
- 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.
- 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.
- 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.
- 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?

Verification status: Unverified  
Reading scope: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread

- 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.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread

- 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.
- 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.
- 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.
- 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.
- 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?

Verification status: Unverified  
Reading scope: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread

- 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.
- 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.
- 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.
- 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.
- 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?

Verification status: Unverified  
Reading scope: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread

- 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.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread

- 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.
- 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.
- 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.
- 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.
- Referenced methods: Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.
- Related sources: 

## Evidence and sources

### 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](https://pubmed.ncbi.nlm.nih.gov/8916749/)

Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread  
Findings recorded in the 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.  
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.

| 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](https://pubmed.ncbi.nlm.nih.gov/9755259/)

Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread  
Findings recorded in the 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.  
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.

| 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](https://pubmed.ncbi.nlm.nih.gov/24394686/)

Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread  
Findings recorded in the 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.  
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.

| 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](https://pubmed.ncbi.nlm.nih.gov/37890960/)

Materials actually read: Stored summary read; external abstracts, full texts, registration, protocols, SAPs and support disclosures unread  
Findings recorded in the 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.  
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.

| 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. |

## Review criteria and methods

These are Chamgap's own application conditions, informed by the relevant sections of official methodological guidance. They do not constitute official assessment-tool certification or a new efficacy score.

- M03 [Cochrane Handbook 6.5 (2024), chapter updated 2023-08](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03) · §3.1, §3.2.1–3.2.3, MECIR C5/C7/C13 · Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions. · 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](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04) · §4.5, §4.6.1–4.6.3, MECIR C42 · Distinguish studies from reports and link them; do not omit a study solely because results are unreported. · 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](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08) · §8.1–8.2.3, Table 8.2.a · Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting. · 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](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15) · §15.2.4, §15.3.1–15.3.3 · Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision. · 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](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19) · §19.1.2, §19.2.1–19.2.4 · Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates. · 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/materials 1.0. Public pages and materials were created from the existing 42 items. No new clinical search, verification-status change, or scoring was performed.