{ "schema_version": "chamgap-public-criteria-1.0", "title": "Xylitol five-times-daily prophylaxis × acute otitis media", "language": "en", "translation_date": "2026-10-16", "criteria_version": "1.0", "criteria_date": "2026-10-06", "condition_origin": "Chamgap's own application conditions", "method_sources": [ { "id": "M03", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03", "section": "§3.1, §3.2.1–3.2.3, MECIR C5/C7/C13", "official_principle": "Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.", "review_level": "Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed." }, { "id": "M04", "version": "Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04", "section": "§4.5, §4.6.1–4.6.3, MECIR C42", "official_principle": "Distinguish studies from reports and link them; do not omit a study solely because results are unreported.", "review_level": "Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed." }, { "id": "M08", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08", "section": "§8.1–8.2.3, Table 8.2.a", "official_principle": "Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.", "review_level": "Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed." }, { "id": "M15", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15", "section": "§15.2.4, §15.3.1–15.3.3", "official_principle": "Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.", "review_level": "Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed." }, { "id": "M19", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19", "section": "§19.1.2, §19.2.1–19.2.4", "official_principle": "Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.", "review_level": "Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed." } ], "status_dictionary": { "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." }, "requirements": [ { "item_id": "N01", "question_type": "Evidence condition", "question": "What is the selected original prevention question?", "needed": "Original subclaim, exposure, parent and other question", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_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." }, { "item_id": "N02", "question_type": "Evidence condition", "question": "Are subclaim C and parent C54 distinguished?", "needed": "Original subclaim grade/note and absent score/status", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Separate subclaim score, status and assessment axes are absent from the source. This records needed materials; no new research was executed." }, { "item_id": "N03", "question_type": "Evidence condition", "question": "Are early children's ages the same as recent ages 1–5?", "needed": "Report-specific ages, eligibility and formulation-use conditions", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_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." }, { "item_id": "N04", "question_type": "Evidence condition", "question": "How do daycare, high-risk and later populations differ?", "needed": "Recruitment, country, baseline risk and infection status", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_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." }, { "item_id": "N05", "question_type": "Evidence condition", "question": "Are gum, syrup and lozenges the same exposure?", "needed": "Formulation, product, composition, contents and comparator", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_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." }, { "item_id": "N06", "question_type": "Evidence condition", "question": "Are original five-times-daily frequency and actual adherence distinguished?", "needed": "Planned frequency, provision, consumption, missed uses and burden", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_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." }, { "item_id": "N07", "question_type": "Evidence condition", "question": "Are regular prophylaxis and use after infection onset the same?", "needed": "Timing, baseline infection and report identity", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_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." }, { "item_id": "N08", "question_type": "Evidence condition", "question": "What does approximately 2–3 months across trials describe?", "needed": "Original duration, prevention/follow-up and post-intervention outcomes", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Individual exposure periods, observation windows, discontinuation and post-intervention outcomes are unverified. This records needed materials; no new research was executed." }, { "item_id": "N09", "question_type": "Evidence condition", "question": "How much is known about placebo, contact and concomitant care?", "needed": "Formulation-specific placebo, equivalent management and healthcare use", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_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." }, { "item_id": "N10", "question_type": "Evidence condition", "question": "How, and in what units, was acute otitis media identified?", "needed": "Diagnosis, assessors, children, repeated events and collection", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_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." }, { "item_id": "N11", "question_type": "Evidence condition", "question": "Which report provides 19/157 versus 31/149?", "needed": "1996 gum comparison values, group correspondence and denominators", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_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." }, { "item_id": "N12", "question_type": "Evidence condition", "question": "Are 306 analyzed the same as allocated/completed denominators?", "needed": "Original analysis n, allocation, completion, exclusions and missingness", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_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." }, { "item_id": "N13", "question_type": "Evidence condition", "question": "What estimand do 8.7 percentage points, CI and P describe?", "needed": "Original absolute difference, direction, interval and model", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_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." }, { "item_id": "N14", "question_type": "Evidence condition", "question": "What is the level of formulation-specific favorable directions in 1998?", "needed": "Separate bibliography, five times daily and formulation-specific outcomes", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_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." }, { "item_id": "N15", "question_type": "Evidence condition", "question": "Are uncertain lozenges combined with favorable gum/syrup?", "needed": "1998 lozenges, effects, denominators and actual exposure", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_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." }, { "item_id": "N16", "question_type": "Evidence condition", "question": "How are the two reports from the same research program linked?", "needed": "1996/1998 bibliography, cohorts, recruitment and independence", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_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." }, { "item_id": "N17", "question_type": "Evidence condition", "question": "Are the later conditions for HR 0.88 the same as original five-times-daily use?", "needed": "2014 lower-frequency syrup, high-risk children and original HR", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_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." }, { "item_id": "N18", "question_type": "Evidence condition", "question": "Which report provides 6 versus 3 events and OR 2.04?", "needed": "2024, 250 participants, target frequency, events, OR and interval", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_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." }, { "item_id": "N19", "question_type": "Evidence condition", "question": "What precision boundary does the original 9-event wording describe?", "needed": "Sparse 2024 events, wide interval and null interpretation", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_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." }, { "item_id": "N20", "question_type": "Evidence condition", "question": "Are a twice-daily target and approximately two actual daily uses the same record?", "needed": "2024 target, actual exposure, adherence and discontinuation", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_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." }, { "item_id": "N21", "question_type": "Evidence condition", "question": "Can frequency alone establish administration amounts or doses?", "needed": "Formulation contents, per-use/daily doses, weight and age", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_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." }, { "item_id": "N22", "question_type": "Evidence condition", "question": "Are randomized labels distinguished from actual allocation?", "needed": "Design, sequence generation, concealment, formulation and cluster allocation", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_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." }, { "item_id": "N23", "question_type": "Evidence condition", "question": "Are event assessment and parent/assessor awareness known?", "needed": "Masking, diagnosis, reporting, healthcare use and recurrent-event collection", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_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." }, { "item_id": "N24", "question_type": "Evidence condition", "question": "What were baseline infection, clinical care and concurrent management?", "needed": "Baseline risk, prevention, diet, antibiotics and group changes", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_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." }, { "item_id": "N25", "question_type": "Evidence condition", "question": "What estimand is defined by denominators, attrition, repeated events and adjustment?", "needed": "ITT/PP, loss to follow-up, clusters, models and missingness", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_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." }, { "item_id": "N26", "question_type": "Evidence condition", "question": "Are historical registration wording and later registration/plans distinguished?", "needed": "Early pre-registration-era wording, unverified 2014 registration and 2024 identifier", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_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." }, { "item_id": "N27", "question_type": "Evidence condition", "question": "Do otitis-prevention outcomes answer caries, treatment or long-term questions?", "needed": "Original acute events, separate caries, treatment and post-intervention prevention", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_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." }, { "item_id": "N28", "question_type": "Evidence condition", "question": "Can formulation/frequency-only effects be isolated from later differences?", "needed": "Joint changes in formulation, frequency, timing, population and duration", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_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." }, { "item_id": "N29", "question_type": "Evidence condition", "question": "How are three evidence rows linked to four citations?", "needed": "Combined evidence, separate bibliography, reports, cohorts and outcome mapping", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_research": "Material needed: Report, cohort and recruitment relationships, overlap, independence and unique totals are unverified. This records needed materials; no new research was executed." }, { "item_id": "N30", "question_type": "Evidence condition", "question": "How far are public support and product involvement known?", "needed": "Report-specific funding, product support, roles and COI", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_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." }, { "item_id": "N31", "question_type": "Evidence condition", "question": "What material was actually read here?", "needed": "Complete stored summary and unread external material", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_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." }, { "item_id": "N32", "question_type": "Evidence condition", "question": "Are historical verification and current production/review separated?", "needed": "Original date, empty corrections/deliberation and historical decision", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_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." }, { "item_id": "N33", "question_type": "Evidence condition", "question": "Are original languages and event/frequency/formulation scope preserved?", "needed": "Original wording, note and language-specific event expressions", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_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." }, { "item_id": "N34", "question_type": "Evidence condition", "question": "Are parent axes distinguished from absent subclaim fields?", "needed": "Parent axes, null precision and absent subclaim score/status/axes", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_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." }, { "item_id": "N35", "question_type": "Evidence condition", "question": "Are diarrhea, abdominal discomfort, refusal and choking cautions actual event data?", "needed": "Formulation/age-specific harm definitions, collection, denominators and discontinuation", "role": "Supplementary; required for extending safety conclusions", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_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." }, { "item_id": "N36", "question_type": "Evidence condition", "question": "What are harm exposure, discontinuation, recovery and later observation times?", "needed": "Actual exposure, symptoms, refusal, recovery and observation windows", "role": "Supplementary; required for extending safety conclusions", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_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." }, { "item_id": "N37", "question_type": "Evidence condition", "question": "Were harms compared under equivalent observation/comparator conditions?", "needed": "Placebo, formulation-specific harm collection, windows and discontinuation comparisons", "role": "Supplementary; required for extending safety conclusions", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_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." }, { "item_id": "N38", "question_type": "Evidence condition", "question": "Are harm-event counts and actual-exposure denominators available?", "needed": "Formulation/age-specific harms, exposure, observation and discontinuation", "role": "Supplementary; required for extending safety conclusions", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_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." }, { "item_id": "N39", "question_type": "Evidence condition", "question": "Are infection, concomitant care, formulation, refusal and causation distinguished?", "needed": "Concurrent factors, actual events, exposure and discontinuation timing", "role": "Supplementary; required for extending safety conclusions", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_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." }, { "item_id": "N40", "question_type": "Evidence condition", "question": "Are refusal, discontinuation, loss to follow-up and harm reporting known?", "needed": "Group-specific refusal, attrition, harm missingness and selective reporting", "role": "Supplementary; required for extending safety conclusions", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_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." }, { "item_id": "N41", "question_type": "Evidence condition", "question": "How far are harms in other ages/formulations, independent evidence and long-term follow-up known?", "needed": "Same exposure, vulnerable populations, independent harms and post-intervention follow-up", "role": "Supplementary; required for extending safety conclusions", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_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." }, { "item_id": "N42", "question_type": "Evidence condition", "question": "Are originals, conditions, methods, observations and update records distinguished?", "needed": "Original texts, condition versions, separate application and change history", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.", "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.", "proposed_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." } ] }