{ "schema_version": "chamgap-public-criteria-1.0", "title": "Xylitol × lower-frequency or infection-triggered use", "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": "A state used when required evidence is confirmed after user review. This production does not declare that review complete.", "Partly verified": "Some information in the stored summary is linked into the table. External comparison/content review is not complete.", "Unverified": "The article leaves this unverified, or required material is absent from the current stored summary. This is distinct from zero, absence or safety.", "Review incomplete": "User review pending.", "Not reported": "Not reported within the stored material actually read; not extended to the entire primary paper.", "Inaccessible": "Means an actual access failure. Access not attempted here is not assigned this state.", "Not applicable": "Not used as a substitute for an evidence gap.", "Conflicting data": "Requires an observed disagreement under the same comparison criteria; not automatically judged in this production.", "Insufficient evidence for the conditions": "Marks a gap in additional material required by the selected conditions; not a new efficacy grade." }, "requirements": [ { "item_id": "N01", "question_type": "Evidence condition", "question": "What are the selected use conditions and original subclaim grade?", "needed": "Original wording, note, grade and parent context", "role": "Required", "role_reason": "This condition connects Original wording, note, grade and parent context with lower-frequency or infection-triggered use, report-specific actual exposure, populations, comparators, HR/OR, event units, denominators, early high-frequency background, 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, grade and parent context 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": "N02", "question_type": "Evidence condition", "question": "Did formulation, frequency and timing change together?", "needed": "Report-specific formulation, actual exposure and infection timing", "role": "Required", "role_reason": "This condition connects Report-specific formulation, actual exposure and infection timing with lower-frequency or infection-triggered use, report-specific actual exposure, populations, comparators, HR/OR, event units, denominators, early high-frequency background, 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 formulation, actual exposure and infection 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. 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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 S03 eligibility, ages, risk and allocated/analyzed n 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: The high-risk definition, exact ages, eligibility and group-specific allocated, completed and analyzed n are unverified. This records needed materials; no new research was executed." }, { "item_id": "N04", "question_type": "Evidence condition", "question": "What are the 2024 population, ages and analysis denominators?", "needed": "S04 original count, ages, eligibility and denominator flow", "role": "Required", "role_reason": "This condition connects S04 original count, ages, eligibility and denominator flow with lower-frequency or infection-triggered use, report-specific actual exposure, populations, comparators, HR/OR, event units, denominators, early high-frequency background, 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 S04 original count, ages, eligibility and denominator flow 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. 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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 S03 formulation, target/actual frequency, timing 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: Exact contents, amounts, target/actual frequency, initiation relative to infection and duration are unverified. This records needed materials; no new research was executed." }, { "item_id": "N06", "question_type": "Evidence condition", "question": "Are the 2024 target and actual use distinguished?", "needed": "S04 planned frequency, actual use and adherence distribution", "role": "Required", "role_reason": "This condition connects S04 planned frequency, actual use and adherence distribution with lower-frequency or infection-triggered use, report-specific actual exposure, populations, comparators, HR/OR, event units, denominators, early high-frequency background, 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 S04 planned frequency, actual use and adherence distribution 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 actual use, contents, duration, refusal, discontinuation and exposure-specific outcomes are unverified. This records needed materials; no new research was executed." }, { "item_id": "N07", "question_type": "Evidence condition", "question": "Is a direct report for use only after infection onset linked?", "needed": "Infection definition, timing, specific report and denominators", "role": "Required", "role_reason": "This condition connects Infection definition, timing, specific report and denominators with lower-frequency or infection-triggered use, report-specific actual exposure, populations, comparators, HR/OR, event units, denominators, early high-frequency background, 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 Infection definition, timing, specific report 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: Infection type, onset assessment, delay, specific direct report, effects and denominators are unlinked. This records needed materials; no new research was executed." }, { "item_id": "N08", "question_type": "Evidence condition", "question": "Are prevention before infection and treatment of existing otitis the same outcome?", "needed": "Timing, prevention, infection course and treatment endpoints", "role": "Required", "role_reason": "This condition connects Timing, prevention, infection course and treatment endpoints with lower-frequency or infection-triggered use, report-specific actual exposure, populations, comparators, HR/OR, event units, denominators, early high-frequency background, 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, prevention, infection course and treatment endpoints 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: Prospective definitions of prevention relative to infection timing and direct treatment-outcome evidence are unlinked. This records needed materials; no new research was executed." }, { "item_id": "N09", "question_type": "Evidence condition", "question": "What were the actual comparators in lower-frequency reports?", "needed": "Report-specific comparator products, ingredients, frequency and contact", "role": "Required", "role_reason": "This condition connects Report-specific comparator products, ingredients, frequency and contact with lower-frequency or infection-triggered use, report-specific actual exposure, populations, comparators, HR/OR, event units, denominators, early high-frequency background, 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 comparator products, ingredients, frequency and contact 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: Correspondence of comparator formulations, ingredients, exposure, infection care, contact and concomitant care is unverified. This records needed materials; no new research was executed." }, { "item_id": "N10", "question_type": "Evidence condition", "question": "How were acute-otitis-media events defined?", "needed": "Diagnosis, units, observation windows and ascertainment", "role": "Required", "role_reason": "This condition connects Diagnosis, units, observation windows and ascertainment with lower-frequency or infection-triggered use, report-specific actual exposure, populations, comparators, HR/OR, event units, denominators, early high-frequency background, 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, units, observation windows and ascertainment 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: Diagnostic criteria, assessors, first/repeated events, observation windows and event-specific denominators are unverified. This records needed materials; no new research was executed." }, { "item_id": "N11", "question_type": "Evidence condition", "question": "What original values do the 2014 HR and confidence interval represent?", "needed": "S03 time-to-event estimate, comparison and model", "role": "Required", "role_reason": "This condition connects S03 time-to-event estimate, comparison and model with lower-frequency or infection-triggered use, report-specific actual exposure, populations, comparators, HR/OR, event units, denominators, early high-frequency background, 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 S03 time-to-event estimate, comparison 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: Exact events, observation time, adjusted model and analysis denominators are unverified. This records needed materials; no new research was executed." }, { "item_id": "N12", "question_type": "Evidence condition", "question": "What are the original 2024 events, OR, interval and P value?", "needed": "S04 group correspondence, event units, denominators and analysis", "role": "Required", "role_reason": "This condition connects S04 group correspondence, event units, denominators and analysis with lower-frequency or infection-triggered use, report-specific actual exposure, populations, comparators, HR/OR, event units, denominators, early high-frequency background, 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 S04 group correspondence, event units, denominators and analysis 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 group correspondence, event/person units, group-specific denominators, model and adjustment are unverified. This records needed materials; no new research was executed." }, { "item_id": "N13", "question_type": "Evidence condition", "question": "What do sparse events and the null result mean?", "needed": "Precision, uncertainty, equivalence and noninferiority", "role": "Required", "role_reason": "This condition connects Precision, uncertainty, equivalence and noninferiority with lower-frequency or infection-triggered use, report-specific actual exposure, populations, comparators, HR/OR, event units, denominators, early high-frequency background, 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 Precision, uncertainty, equivalence and noninferiority 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: Prospective equivalence/noninferiority plans, sufficient events and precise estimates are unverified. This records needed materials; no new research was executed." }, { "item_id": "N14", "question_type": "Evidence condition", "question": "How far are randomization, concealment and masking known?", "needed": "S03/S04 allocation, product distinguishability, assessment and analysis", "role": "Required", "role_reason": "This condition connects S03/S04 allocation, product distinguishability, assessment and analysis with lower-frequency or infection-triggered use, report-specific actual exposure, populations, comparators, HR/OR, event units, denominators, early high-frequency background, 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 S03/S04 allocation, product distinguishability, assessment and analysis 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 processes, concealment, product distinguishability and diagnostic-assessor/analyst masking are unverified. This records needed materials; no new research was executed." }, { "item_id": "N15", "question_type": "Evidence condition", "question": "What were completion, missingness and analysis populations?", "needed": "Group completion, missing events, follow-up after discontinuation and ITT/PP", "role": "Required", "role_reason": "This condition connects Group completion, missing events, follow-up after discontinuation and ITT/PP with lower-frequency or infection-triggered use, report-specific actual exposure, populations, comparators, HR/OR, event units, denominators, early high-frequency background, 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 completion, missing events, follow-up after discontinuation and ITT/PP 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 attrition, missing events, follow-up after discontinuation, ITT/PP and missing-data handling/reasons are unverified. This records needed materials; no new research was executed." }, { "item_id": "N16", "question_type": "Evidence condition", "question": "Were concurrent prevention, infection care and exposure equivalent?", "needed": "Group-specific care, risk, daycare and diagnostic access", "role": "Required", "role_reason": "This condition connects Group-specific care, risk, daycare and diagnostic access with lower-frequency or infection-triggered use, report-specific actual exposure, populations, comparators, HR/OR, event units, denominators, early high-frequency background, 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 care, risk, daycare and diagnostic access 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: Cointerventions, baseline infection risk, daycare exposure and differences in diagnostic access are unverified. This records needed materials; no new research was executed." }, { "item_id": "N17", "question_type": "Evidence condition", "question": "Are registration identifiers distinguished from actual reading?", "needed": "Historical registration wording, report-specific identities and access", "role": "Required", "role_reason": "This condition connects Historical registration wording, report-specific identities and access with lower-frequency or infection-triggered use, report-specific actual exposure, populations, comparators, HR/OR, event units, denominators, early high-frequency background, 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 Historical registration wording, report-specific identities and access 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: Registration originals, change history, exact endpoint plans and details supporting historical absence wording are unverified. This records needed materials; no new research was executed." }, { "item_id": "N18", "question_type": "Evidence condition", "question": "Are prospective hierarchy, SAP and multiple analyses known?", "needed": "Plans, primary endpoints, models, subgroups and changes", "role": "Required", "role_reason": "This condition connects Plans, primary endpoints, models, subgroups and changes with lower-frequency or infection-triggered use, report-specific actual exposure, populations, comparators, HR/OR, event units, denominators, early high-frequency background, 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 Plans, primary endpoints, models, subgroups and 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: Prospective first endpoints, event analyses, frequency/formulation subgroups, multiplicity and change history are unverified. This records needed materials; no new research was executed." }, { "item_id": "N19", "question_type": "Evidence condition", "question": "Where do the favorable high-frequency values from 1996 belong?", "needed": "S01 frequency, formulation, denominators and original-effect background", "role": "Required", "role_reason": "This condition connects S01 frequency, formulation, denominators and original-effect background with lower-frequency or infection-triggered use, report-specific actual exposure, populations, comparators, HR/OR, event units, denominators, early high-frequency background, 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 S01 frequency, formulation, denominators and original-effect background 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: A direct comparison varying only frequency in the same population/formulation is unlinked. No new differences, ratios or totals are calculated. This records needed materials; no new research was executed." }, { "item_id": "N20", "question_type": "Evidence condition", "question": "Are 1998 formulation-specific directions distinguished from the combined evidence row?", "needed": "S02 bibliography/directions and precise 1996 values", "role": "Required", "role_reason": "This condition connects S02 bibliography/directions and precise 1996 values with lower-frequency or infection-triggered use, report-specific actual exposure, populations, comparators, HR/OR, event units, denominators, early high-frequency background, 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 S02 bibliography/directions and precise 1996 values 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 1998 denominators, exact effects/CIs and links to infection-triggered use are unverified. This records needed materials; no new research was executed." }, { "item_id": "N21", "question_type": "Evidence condition", "question": "Are research program, shared reports and independent replication distinguished?", "needed": "Reports, trial families, populations, use conditions and unique counts", "role": "Required", "role_reason": "This condition connects Reports, trial families, populations, use conditions and unique counts with lower-frequency or infection-triggered use, report-specific actual exposure, populations, comparators, HR/OR, event units, denominators, early high-frequency background, 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 Reports, trial families, populations, use conditions and unique counts 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 cohort overlap, independence, replication under the same conditions and unique trial/participant totals are unverified. This records needed materials; no new research was executed." }, { "item_id": "N22", "question_type": "Evidence condition", "question": "Can this generalize across duration, long-term persistence and populations?", "needed": "Report-specific observation, ages, risk groups and effect persistence", "role": "Required", "role_reason": "This condition connects Report-specific observation, ages, risk groups and effect persistence with lower-frequency or infection-triggered use, report-specific actual exposure, populations, comparators, HR/OR, event units, denominators, early high-frequency background, 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 observation, ages, risk groups and effect persistence 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 follow-up, long-term events, population heterogeneity, persistence after stopping and generalization are unverified. This records needed materials; no new research was executed." }, { "item_id": "N23", "question_type": "Evidence condition", "question": "Are funding, support and COI in later reports distinguished?", "needed": "S03/S04 funding, products, employees, roles and interests", "role": "Required", "role_reason": "This condition connects S03/S04 funding, products, employees, roles and interests with lower-frequency or infection-triggered use, report-specific actual exposure, populations, comparators, HR/OR, event units, denominators, early high-frequency background, 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 S03/S04 funding, products, employees, roles and interests 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 product/free support, employee authors, COI, funding roles and design/analysis involvement are unverified. This records needed materials; no new research was executed." }, { "item_id": "N24", "question_type": "Evidence condition", "question": "Are early support statements inherited by later reports?", "needed": "Government/product-involvement scope of the early combined evidence", "role": "Required", "role_reason": "This condition connects Government/product-involvement scope of the early combined evidence with lower-frequency or infection-triggered use, report-specific actual exposure, populations, comparators, HR/OR, event units, denominators, early high-frequency background, 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 Government/product-involvement scope of the early combined evidence 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: Product involvement, employee authors, COI and funding/research roles in each of 1996/1998 are unverified. This records needed materials; no new research was executed." }, { "item_id": "N25", "question_type": "Evidence condition", "question": "How far are pediatric safety, refusal and discontinuation known?", "needed": "Report-specific harms, exposure, denominators, discontinuation and vulnerable ages", "role": "Supplementary", "role_reason": "This condition connects Report-specific harms, exposure, denominators, discontinuation and vulnerable ages with lower-frequency or infection-triggered use, report-specific actual exposure, populations, comparators, HR/OR, event units, denominators, early high-frequency background, 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 harms, exposure, denominators, discontinuation and vulnerable ages 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 event definitions, collection, actual group exposure, denominators, discontinuation, vulnerable ages and long-term/rare harms are unverified. This records needed materials; no new research was executed." }, { "item_id": "N26", "question_type": "Evidence condition", "question": "Are parent axes, subclaim D, original languages, dates and corrections distinguished?", "needed": "Original parent C54, axes, absent subclaim values and historical verdict", "role": "Required", "role_reason": "This condition connects Original parent C54, axes, absent subclaim values and historical verdict with lower-frequency or infection-triggered use, report-specific actual exposure, populations, comparators, HR/OR, event units, denominators, early high-frequency background, 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 parent C54, axes, absent subclaim values and historical verdict 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 assessment axes are absent from the source; external details of historical checks and current content review are unverified. This records needed materials; no new research was executed." }, { "item_id": "N27", "question_type": "Evidence condition", "question": "What was actually read, and what follow-up material is needed?", "needed": "Stored summary, original URLs, unread external material and updates", "role": "Required", "role_reason": "This condition connects Stored summary, original URLs, unread external material and updates with lower-frequency or infection-triggered use, report-specific actual exposure, populations, comparators, HR/OR, event units, denominators, early high-frequency background, 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 Stored summary, original URLs, unread external material and updates 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 acquisition, actual reading, content review and needed original materials remain outstanding. Updates must preserve complete prior texts, condition versions, separate application records and change history. This records needed materials; no new research was executed." } ] }