{ "schema_version": "chamgap-public-criteria-1.0", "title": "Topical 10% peppermint oil × Tension-type headache—equivalence to acetaminophen not established", "language": "en", "translation_date": "2026-10-20", "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": { "Partly verified": "Partial information from the stored summary is linked; detailed originals and content review remain incomplete.", "Unverified": "Required details cannot be established within the preserved scope. This does not establish absence of effects or studies, or safety.", "Review incomplete": "Review of existing content remains incomplete.", "Met": "This state is used only within the relevant conditions after material verification and content review. It was not automatically assigned in this work.", "Not reported": "Unreported within material actually read. Unread external material is not relabeled as unreported.", "Inaccessible": "This means actual access failure. External access was not attempted in this work, so this state was not assigned.", "Not applicable": "Used only with an application exception and reason based on the question scope.", "Conflicting data": "This requires actual comparison of materials; no new conflict judgment was made in this work.", "Insufficient evidence for the conditions": "This indicates gaps in additional material for the selected conditions. Unread material as a whole is not converted into an efficacy grade." }, "requirements": [ { "item_id": "N01", "question_type": "Evidence condition", "question": "Which acetaminophen comparison is being considered?", "needed": "Distinction between the existing equivalence question and analgesia versus placebo", "role": "Required", "role_reason": "Material on Distinction between the existing equivalence question and analgesia versus placebo is needed to connect the selected active-comparator question with formulation, population, comparator, timing, scales, denominators, precision and harms.", "application_exception": "Original details absent from the summary remain unverified. Selected D and the absence of individual score, status and axes are retained without inheriting parent D28. No new effect, CI, margin, sample size, grade, equivalence, safety or independence certification, or use or treatment guidance is created.", "criterion": "Original material on Distinction between the existing equivalence question and analgesia versus placebo must link to the report-specific population, formulation, comparator, time, endpoint, denominators and prespecified analysis, distinguishing direct comparison, parent context, historical calculation and unread external materials.", "basis": "Preserved principles distinguishing questions, comparators, reports and trials, endpoints, denominators and harms informed production.", "condition_origin": "These are evidence conditions for the existing selected question. They do not establish preregistration, use of an official assessment tool or completed content review.", "proposed_research": "Material needed: The original active-comparator design, denominators, effect, CI and prespecified margin are needed. This sheet is not counted as a new independent study. This records needed materials; no new research was executed." }, { "item_id": "N02", "question_type": "Evidence condition", "question": "Does no difference establish equivalence or noninferiority?", "needed": "Nonsignificance in a superiority test versus prespecified equivalence or noninferiority criteria", "role": "Required", "role_reason": "Material on Nonsignificance in a superiority test versus prespecified equivalence or noninferiority criteria is needed to connect the selected active-comparator question with formulation, population, comparator, timing, scales, denominators, precision and harms.", "application_exception": "Original details absent from the summary remain unverified. Selected D and the absence of individual score, status and axes are retained without inheriting parent D28. No new effect, CI, margin, sample size, grade, equivalence, safety or independence certification, or use or treatment guidance is created.", "criterion": "Original material on Nonsignificance in a superiority test versus prespecified equivalence or noninferiority criteria must link to the report-specific population, formulation, comparator, time, endpoint, denominators and prespecified analysis, distinguishing direct comparison, parent context, historical calculation and unread external materials.", "basis": "Preserved principles distinguishing questions, comparators, reports and trials, endpoints, denominators and harms informed production.", "condition_origin": "These are evidence conditions for the existing selected question. They do not establish preregistration, use of an official assessment tool or completed content review.", "proposed_research": "Material needed: The prespecified clinical margin, effect of interest, test direction, relevant CI and analysis plan are needed. Nonsignificance is not converted into proof of equivalence. This records needed materials; no new research was executed." }, { "item_id": "N03", "question_type": "Evidence condition", "question": "Are the exact active-comparator effect, CI and P known?", "needed": "Estimate and precision of the direct comparison with acetaminophen", "role": "Required", "role_reason": "Material on Estimate and precision of the direct comparison with acetaminophen is needed to connect the selected active-comparator question with formulation, population, comparator, timing, scales, denominators, precision and harms.", "application_exception": "Original details absent from the summary remain unverified. Selected D and the absence of individual score, status and axes are retained without inheriting parent D28. No new effect, CI, margin, sample size, grade, equivalence, safety or independence certification, or use or treatment guidance is created.", "criterion": "Original material on Estimate and precision of the direct comparison with acetaminophen must link to the report-specific population, formulation, comparator, time, endpoint, denominators and prespecified analysis, distinguishing direct comparison, parent context, historical calculation and unread external materials.", "basis": "Preserved principles distinguishing questions, comparators, reports and trials, endpoints, denominators and harms informed production.", "condition_origin": "These are evidence conditions for the existing selected question. They do not establish preregistration, use of an official assessment tool or completed content review.", "proposed_research": "Material needed: Original active-comparator effect, CI, scale, time, denominators, testing and multiplicity materials are needed. The placebo P is not copied as the active-comparator P. This records needed materials; no new research was executed." }, { "item_id": "N04", "question_type": "Evidence condition", "question": "Is a signal versus placebo direct evidence of equivalence?", "needed": "Distinction between effects versus placebo and versus an active comparator", "role": "Required", "role_reason": "Material on Distinction between effects versus placebo and versus an active comparator is needed to connect the selected active-comparator question with formulation, population, comparator, timing, scales, denominators, precision and harms.", "application_exception": "Original details absent from the summary remain unverified. Selected D and the absence of individual score, status and axes are retained without inheriting parent D28. No new effect, CI, margin, sample size, grade, equivalence, safety or independence certification, or use or treatment guidance is created.", "criterion": "Original material on Distinction between effects versus placebo and versus an active comparator must link to the report-specific population, formulation, comparator, time, endpoint, denominators and prespecified analysis, distinguishing direct comparison, parent context, historical calculation and unread external materials.", "basis": "Preserved principles distinguishing questions, comparators, reports and trials, endpoints, denominators and harms informed production.", "condition_origin": "These are evidence conditions for the existing selected question. They do not establish preregistration, use of an official assessment tool or completed content review.", "proposed_research": "Material needed: The active-comparator effect, CI, original design and prespecified margin at the same time and analysis are needed. This records needed materials; no new research was executed." }, { "item_id": "N05", "question_type": "Evidence condition", "question": "Are 41 participants and 164 attacks the same denominator?", "needed": "Participants, attacks, treatment periods and units of analysis", "role": "Required", "role_reason": "Material on Participants, attacks, treatment periods and units of analysis is needed to connect the selected active-comparator question with formulation, population, comparator, timing, scales, denominators, precision and harms.", "application_exception": "Original details absent from the summary remain unverified. Selected D and the absence of individual score, status and axes are retained without inheriting parent D28. No new effect, CI, margin, sample size, grade, equivalence, safety or independence certification, or use or treatment guidance is created.", "criterion": "Original material on Participants, attacks, treatment periods and units of analysis must link to the report-specific population, formulation, comparator, time, endpoint, denominators and prespecified analysis, distinguishing direct comparison, parent context, historical calculation and unread external materials.", "basis": "Preserved principles distinguishing questions, comparators, reports and trials, endpoints, denominators and harms informed production.", "condition_origin": "These are evidence conditions for the existing selected question. They do not establish preregistration, use of an official assessment tool or completed content review.", "proposed_research": "Material needed: Treatments and attacks per participant, allocation sequence, periods, endpoint-specific analysis denominators and repeated-data methods are needed. No new mean attack count is calculated. This records needed materials; no new research was executed." }, { "item_id": "N06", "question_type": "Evidence condition", "question": "Are crossover correlation, carryover and period effects verified?", "needed": "Treatment sequence, washout, carryover and within-participant correlation", "role": "Required", "role_reason": "Material on Treatment sequence, washout, carryover and within-participant correlation is needed to connect the selected active-comparator question with formulation, population, comparator, timing, scales, denominators, precision and harms.", "application_exception": "Original details absent from the summary remain unverified. Selected D and the absence of individual score, status and axes are retained without inheriting parent D28. No new effect, CI, margin, sample size, grade, equivalence, safety or independence certification, or use or treatment guidance is created.", "criterion": "Original material on Treatment sequence, washout, carryover and within-participant correlation must link to the report-specific population, formulation, comparator, time, endpoint, denominators and prespecified analysis, distinguishing direct comparison, parent context, historical calculation and unread external materials.", "basis": "Preserved principles distinguishing questions, comparators, reports and trials, endpoints, denominators and harms informed production.", "condition_origin": "These are evidence conditions for the existing selected question. They do not establish preregistration, use of an official assessment tool or completed content review.", "proposed_research": "Material needed: Original allocation sequence, periods, washout, carryover tests, paired data, within-participant correlation and missing-data methods are needed. No independent parallel-group calculation is performed. This records needed materials; no new research was executed." }, { "item_id": "N07", "question_type": "Evidence condition", "question": "Are acetaminophen dose, formulation and concurrent-care conditions known?", "needed": "Arm-specific exposure conditions for active, topical and placebo comparisons", "role": "Required", "role_reason": "Material on Arm-specific exposure conditions for active, topical and placebo comparisons is needed to connect the selected active-comparator question with formulation, population, comparator, timing, scales, denominators, precision and harms.", "application_exception": "Original details absent from the summary remain unverified. Selected D and the absence of individual score, status and axes are retained without inheriting parent D28. No new effect, CI, margin, sample size, grade, equivalence, safety or independence certification, or use or treatment guidance is created.", "criterion": "Original material on Arm-specific exposure conditions for active, topical and placebo comparisons must link to the report-specific population, formulation, comparator, time, endpoint, denominators and prespecified analysis, distinguishing direct comparison, parent context, historical calculation and unread external materials.", "basis": "Preserved principles distinguishing questions, comparators, reports and trials, endpoints, denominators and harms informed production.", "condition_origin": "These are evidence conditions for the existing selected question. They do not establish preregistration, use of an official assessment tool or completed content review.", "proposed_research": "Material needed: Original arm-specific drugs, formulations, concurrent care, rescue medication, exposure and comparator conditions are needed. No new dose, use or administration guidance is created. This records needed materials; no new research was executed." }, { "item_id": "N08", "question_type": "Evidence condition", "question": "Which 10% topical formulation was compared?", "needed": "The specific topical solution of 10% peppermint oil and 90% ethanol", "role": "Required", "role_reason": "Material on The specific topical solution of 10% peppermint oil and 90% ethanol is needed to connect the selected active-comparator question with formulation, population, comparator, timing, scales, denominators, precision and harms.", "application_exception": "Original details absent from the summary remain unverified. Selected D and the absence of individual score, status and axes are retained without inheriting parent D28. No new effect, CI, margin, sample size, grade, equivalence, safety or independence certification, or use or treatment guidance is created.", "criterion": "Original material on The specific topical solution of 10% peppermint oil and 90% ethanol must link to the report-specific population, formulation, comparator, time, endpoint, denominators and prespecified analysis, distinguishing direct comparison, parent context, historical calculation and unread external materials.", "basis": "Preserved principles distinguishing questions, comparators, reports and trials, endpoints, denominators and harms informed production.", "condition_origin": "These are evidence conditions for the existing selected question. They do not establish preregistration, use of an official assessment tool or completed content review.", "proposed_research": "Material needed: Original product, manufacture, composition, exposure, use records and comparator-vehicle details are needed. Formulations are distinguished by report, without new procedures or treatment guidance. This records needed materials; no new research was executed." }, { "item_id": "N09", "question_type": "Evidence condition", "question": "Are tension-type headache and migraine populations distinguished?", "needed": "Eligibility and attack characteristics in acute tension-type headache", "role": "Required", "role_reason": "Material on Eligibility and attack characteristics in acute tension-type headache is needed to connect the selected active-comparator question with formulation, population, comparator, timing, scales, denominators, precision and harms.", "application_exception": "Original details absent from the summary remain unverified. Selected D and the absence of individual score, status and axes are retained without inheriting parent D28. No new effect, CI, margin, sample size, grade, equivalence, safety or independence certification, or use or treatment guidance is created.", "criterion": "Original material on Eligibility and attack characteristics in acute tension-type headache must link to the report-specific population, formulation, comparator, time, endpoint, denominators and prespecified analysis, distinguishing direct comparison, parent context, historical calculation and unread external materials.", "basis": "Preserved principles distinguishing questions, comparators, reports and trials, endpoints, denominators and harms informed production.", "condition_origin": "These are evidence conditions for the existing selected question. They do not establish preregistration, use of an official assessment tool or completed content review.", "proposed_research": "Material needed: Original diagnostic criteria, frequency, severity, baseline pain, exclusions, comorbidity and recruitment information are needed. Findings are not extended to other headaches or populations. This records needed materials; no new research was executed." }, { "item_id": "N10", "question_type": "Evidence condition", "question": "Are pain after 15 minutes and response at 120 minutes the same endpoint?", "needed": "Timing and scales of early pain intensity and later VPRS response", "role": "Required", "role_reason": "Material on Timing and scales of early pain intensity and later VPRS response is needed to connect the selected active-comparator question with formulation, population, comparator, timing, scales, denominators, precision and harms.", "application_exception": "Original details absent from the summary remain unverified. Selected D and the absence of individual score, status and axes are retained without inheriting parent D28. No new effect, CI, margin, sample size, grade, equivalence, safety or independence certification, or use or treatment guidance is created.", "criterion": "Original material on Timing and scales of early pain intensity and later VPRS response must link to the report-specific population, formulation, comparator, time, endpoint, denominators and prespecified analysis, distinguishing direct comparison, parent context, historical calculation and unread external materials.", "basis": "Preserved principles distinguishing questions, comparators, reports and trials, endpoints, denominators and harms informed production.", "condition_origin": "These are evidence conditions for the existing selected question. They do not establish preregistration, use of an official assessment tool or completed content review.", "proposed_research": "Material needed: Each scale, response definition, baseline and follow-up, denominators, original analysis and prespecified hierarchy are needed. Times and scales are not converted or results merged. This records needed materials; no new research was executed." }, { "item_id": "N11", "question_type": "Evidence condition", "question": "What are the later trial's starting size and analysis denominators?", "needed": "Distinction between 209 started, 189 in FAS and 94 versus 95", "role": "Required", "role_reason": "Material on Distinction between 209 started, 189 in FAS and 94 versus 95 is needed to connect the selected active-comparator question with formulation, population, comparator, timing, scales, denominators, precision and harms.", "application_exception": "Original details absent from the summary remain unverified. Selected D and the absence of individual score, status and axes are retained without inheriting parent D28. No new effect, CI, margin, sample size, grade, equivalence, safety or independence certification, or use or treatment guidance is created.", "criterion": "Original material on Distinction between 209 started, 189 in FAS and 94 versus 95 must link to the report-specific population, formulation, comparator, time, endpoint, denominators and prespecified analysis, distinguishing direct comparison, parent context, historical calculation and unread external materials.", "basis": "Preserved principles distinguishing questions, comparators, reports and trials, endpoints, denominators and harms informed production.", "condition_origin": "These are evidence conditions for the existing selected question. They do not establish preregistration, use of an official assessment tool or completed content review.", "proposed_research": "Material needed: Allocation, treatment and completion flow, FAS definition, exclusion and missingness reasons, and original arm-specific analysis populations are needed. No new count difference, response rate or effect is calculated. This records needed materials; no new research was executed." }, { "item_id": "N12", "question_type": "Evidence condition", "question": "Is failure of the later first primary endpoint's threshold retained?", "needed": "Prespecified one-sided Fisher .025 threshold and hierarchical gate", "role": "Required", "role_reason": "Material on Prespecified one-sided Fisher .025 threshold and hierarchical gate is needed to connect the selected active-comparator question with formulation, population, comparator, timing, scales, denominators, precision and harms.", "application_exception": "Original details absent from the summary remain unverified. Selected D and the absence of individual score, status and axes are retained without inheriting parent D28. No new effect, CI, margin, sample size, grade, equivalence, safety or independence certification, or use or treatment guidance is created.", "criterion": "Original material on Prespecified one-sided Fisher .025 threshold and hierarchical gate must link to the report-specific population, formulation, comparator, time, endpoint, denominators and prespecified analysis, distinguishing direct comparison, parent context, historical calculation and unread external materials.", "basis": "Preserved principles distinguishing questions, comparators, reports and trials, endpoints, denominators and harms informed production.", "condition_origin": "These are evidence conditions for the existing selected question. They do not establish preregistration, use of an official assessment tool or completed content review.", "proposed_research": "Material needed: Original registered results, prespecified plan, testing, denominators, direct effect and CI are needed. The original criterion is not replaced by a different two-sided .05 criterion. This records needed materials; no new research was executed." }, { "item_id": "N13", "question_type": "Evidence condition", "question": "Was two-sided Fisher P≈.101 calculated in this work?", "needed": "Distinction between the historical Codex calculation from counts and original trial results", "role": "Required", "role_reason": "Material on Distinction between the historical Codex calculation from counts and original trial results is needed to connect the selected active-comparator question with formulation, population, comparator, timing, scales, denominators, precision and harms.", "application_exception": "Original details absent from the summary remain unverified. Selected D and the absence of individual score, status and axes are retained without inheriting parent D28. No new effect, CI, margin, sample size, grade, equivalence, safety or independence certification, or use or treatment guidance is created.", "criterion": "Original material on Distinction between the historical Codex calculation from counts and original trial results must link to the report-specific population, formulation, comparator, time, endpoint, denominators and prespecified analysis, distinguishing direct comparison, parent context, historical calculation and unread external materials.", "basis": "Preserved principles distinguishing questions, comparators, reports and trials, endpoints, denominators and harms informed production.", "condition_origin": "These are evidence conditions for the existing selected question. They do not establish preregistration, use of an official assessment tool or completed content review.", "proposed_research": "Material needed: Original results and analysis plan, and a separate record of the historical calculation, are needed. No statistical recalculation or new effect or CI is produced here. This records needed materials; no new research was executed." }, { "item_id": "N14", "question_type": "Evidence condition", "question": "Is VAS-SPID treated as confirmatory after the first primary endpoint failed?", "needed": "Exploratory context of the hierarchically second endpoint", "role": "Required", "role_reason": "Material on Exploratory context of the hierarchically second endpoint is needed to connect the selected active-comparator question with formulation, population, comparator, timing, scales, denominators, precision and harms.", "application_exception": "Original details absent from the summary remain unverified. Selected D and the absence of individual score, status and axes are retained without inheriting parent D28. No new effect, CI, margin, sample size, grade, equivalence, safety or independence certification, or use or treatment guidance is created.", "criterion": "Original material on Exploratory context of the hierarchically second endpoint must link to the report-specific population, formulation, comparator, time, endpoint, denominators and prespecified analysis, distinguishing direct comparison, parent context, historical calculation and unread external materials.", "basis": "Preserved principles distinguishing questions, comparators, reports and trials, endpoints, denominators and harms informed production.", "condition_origin": "These are evidence conditions for the existing selected question. They do not establish preregistration, use of an official assessment tool or completed content review.", "proposed_research": "Material needed: The prespecified hierarchy, original second-endpoint result, CI, denominators, adjustment and testing procedures are needed. Unread values are not filled in. This records needed materials; no new research was executed." }, { "item_id": "N15", "question_type": "Evidence condition", "question": "Is the later placebo-controlled trial an active-comparator equivalence trial?", "needed": "Distinction between the later placebo comparison and early acetaminophen comparison", "role": "Required", "role_reason": "Material on Distinction between the later placebo comparison and early acetaminophen comparison is needed to connect the selected active-comparator question with formulation, population, comparator, timing, scales, denominators, precision and harms.", "application_exception": "Original details absent from the summary remain unverified. Selected D and the absence of individual score, status and axes are retained without inheriting parent D28. No new effect, CI, margin, sample size, grade, equivalence, safety or independence certification, or use or treatment guidance is created.", "criterion": "Original material on Distinction between the later placebo comparison and early acetaminophen comparison must link to the report-specific population, formulation, comparator, time, endpoint, denominators and prespecified analysis, distinguishing direct comparison, parent context, historical calculation and unread external materials.", "basis": "Preserved principles distinguishing questions, comparators, reports and trials, endpoints, denominators and harms informed production.", "condition_origin": "These are evidence conditions for the existing selected question. They do not establish preregistration, use of an official assessment tool or completed content review.", "proposed_research": "Material needed: Prespecified active-comparator design, margin and CI directly addressing the selected question are needed. Results against a different comparator do not replace them. This records needed materials; no new research was executed." }, { "item_id": "N16", "question_type": "Evidence condition", "question": "Are the prespecified equivalence margin and power known?", "needed": "Patient-important margin, sample-size plan, ITT and PP", "role": "Required", "role_reason": "Material on Patient-important margin, sample-size plan, ITT and PP is needed to connect the selected active-comparator question with formulation, population, comparator, timing, scales, denominators, precision and harms.", "application_exception": "Original details absent from the summary remain unverified. Selected D and the absence of individual score, status and axes are retained without inheriting parent D28. No new effect, CI, margin, sample size, grade, equivalence, safety or independence certification, or use or treatment guidance is created.", "criterion": "Original material on Patient-important margin, sample-size plan, ITT and PP must link to the report-specific population, formulation, comparator, time, endpoint, denominators and prespecified analysis, distinguishing direct comparison, parent context, historical calculation and unread external materials.", "basis": "Preserved principles distinguishing questions, comparators, reports and trials, endpoints, denominators and harms informed production.", "condition_origin": "These are evidence conditions for the existing selected question. They do not establish preregistration, use of an official assessment tool or completed content review.", "proposed_research": "Material needed: The basis for a prespecified clinical margin, sample-size plan, direct CI, ITT and PP definitions and sensitivity analyses are needed. No new margin or sample size is calculated. This records needed materials; no new research was executed." }, { "item_id": "N17", "question_type": "Evidence condition", "question": "Does rapid pain relief establish sustained recovery or recurrence prevention?", "needed": "Acute pain and response versus persistence, recurrence and rescue-medication outcomes", "role": "Required", "role_reason": "Material on Acute pain and response versus persistence, recurrence and rescue-medication outcomes is needed to connect the selected active-comparator question with formulation, population, comparator, timing, scales, denominators, precision and harms.", "application_exception": "Original details absent from the summary remain unverified. Selected D and the absence of individual score, status and axes are retained without inheriting parent D28. No new effect, CI, margin, sample size, grade, equivalence, safety or independence certification, or use or treatment guidance is created.", "criterion": "Original material on Acute pain and response versus persistence, recurrence and rescue-medication outcomes must link to the report-specific population, formulation, comparator, time, endpoint, denominators and prespecified analysis, distinguishing direct comparison, parent context, historical calculation and unread external materials.", "basis": "Preserved principles distinguishing questions, comparators, reports and trials, endpoints, denominators and harms informed production.", "condition_origin": "These are evidence conditions for the existing selected question. They do not establish preregistration, use of an official assessment tool or completed content review.", "proposed_research": "Material needed: Original definitions, denominators, effects and CIs for complete pain freedom, persistence, recurrence, rescue medication and patient-important outcomes are needed. This records needed materials; no new research was executed." }, { "item_id": "N18", "question_type": "Evidence condition", "question": "Are early positive findings and later failure both retained?", "needed": "Early and later reports, and directness for the equivalence question", "role": "Required", "role_reason": "Material on Early and later reports, and directness for the equivalence question is needed to connect the selected active-comparator question with formulation, population, comparator, timing, scales, denominators, precision and harms.", "application_exception": "Original details absent from the summary remain unverified. Selected D and the absence of individual score, status and axes are retained without inheriting parent D28. No new effect, CI, margin, sample size, grade, equivalence, safety or independence certification, or use or treatment guidance is created.", "criterion": "Original material on Early and later reports, and directness for the equivalence question must link to the report-specific population, formulation, comparator, time, endpoint, denominators and prespecified analysis, distinguishing direct comparison, parent context, historical calculation and unread external materials.", "basis": "Preserved principles distinguishing questions, comparators, reports and trials, endpoints, denominators and harms informed production.", "condition_origin": "These are evidence conditions for the existing selected question. They do not establish preregistration, use of an official assessment tool or completed content review.", "proposed_research": "Material needed: Original material distinguishing products, populations, times, comparators, denominators, prespecified endpoints, effects and CIs in the two reports is needed. This records needed materials; no new research was executed." }, { "item_id": "N19", "question_type": "Evidence condition", "question": "Are funding, products, authorship and design or analysis involvement separated?", "needed": "Independence assessed by specific support and involvement categories", "role": "Required", "role_reason": "Material on Independence assessed by specific support and involvement categories is needed to connect the selected active-comparator question with formulation, population, comparator, timing, scales, denominators, precision and harms.", "application_exception": "Original details absent from the summary remain unverified. Selected D and the absence of individual score, status and axes are retained without inheriting parent D28. No new effect, CI, margin, sample size, grade, equivalence, safety or independence certification, or use or treatment guidance is created.", "criterion": "Original material on Independence assessed by specific support and involvement categories must link to the report-specific population, formulation, comparator, time, endpoint, denominators and prespecified analysis, distinguishing direct comparison, parent context, historical calculation and unread external materials.", "basis": "Preserved principles distinguishing questions, comparators, reports and trials, endpoints, denominators and harms informed production.", "condition_origin": "These are evidence conditions for the existing selected question. They do not establish preregistration, use of an official assessment tool or completed content review.", "proposed_research": "Material needed: Separate material on research funding, product provision, author affiliations and involvement in design, analysis and publication is needed. Sponsorship alone does not fill other categories. This records needed materials; no new research was executed." }, { "item_id": "N20", "question_type": "Evidence condition", "question": "Are denominators and collection methods for skin and eye harms known?", "needed": "Topical harm events, exposure, routes and vulnerable groups", "role": "Supplementary", "role_reason": "Material on Topical harm events, exposure, routes and vulnerable groups is needed to connect the selected active-comparator question with formulation, population, comparator, timing, scales, denominators, precision and harms.", "application_exception": "Original details absent from the summary remain unverified. Selected D and the absence of individual score, status and axes are retained without inheriting parent D28. No new effect, CI, margin, sample size, grade, equivalence, safety or independence certification, or use or treatment guidance is created.", "criterion": "Original material on Topical harm events, exposure, routes and vulnerable groups must link to the report-specific population, formulation, comparator, time, endpoint, denominators and prespecified analysis, distinguishing direct comparison, parent context, historical calculation and unread external materials.", "basis": "Preserved principles distinguishing questions, comparators, reports and trials, endpoints, denominators and harms informed production.", "condition_origin": "These are evidence conditions for the existing selected question. They do not establish preregistration, use of an official assessment tool or completed content review.", "proposed_research": "Material needed: Harm collection, events and affected people, severity, timing, exposure, arm-specific denominators and actual inclusion of children, eyes or mucosa are needed. No new use or treatment guidance is created. This records needed materials; no new research was executed." }, { "item_id": "N21", "question_type": "Evidence condition", "question": "Are shared reports and repeated attacks added as independent studies?", "needed": "Two reports, shared subquestions and registered-result versions", "role": "Required", "role_reason": "Material on Two reports, shared subquestions and registered-result versions is needed to connect the selected active-comparator question with formulation, population, comparator, timing, scales, denominators, precision and harms.", "application_exception": "Original details absent from the summary remain unverified. Selected D and the absence of individual score, status and axes are retained without inheriting parent D28. No new effect, CI, margin, sample size, grade, equivalence, safety or independence certification, or use or treatment guidance is created.", "criterion": "Original material on Two reports, shared subquestions and registered-result versions must link to the report-specific population, formulation, comparator, time, endpoint, denominators and prespecified analysis, distinguishing direct comparison, parent context, historical calculation and unread external materials.", "basis": "Preserved principles distinguishing questions, comparators, reports and trials, endpoints, denominators and harms informed production.", "condition_origin": "These are evidence conditions for the existing selected question. They do not establish preregistration, use of an official assessment tool or completed content review.", "proposed_research": "Material needed: Links among original trials, reports, sites, recruitment, participants and registration versions are needed. Unique trial, participant and independent-replication counts remain unverified. This records needed materials; no new research was executed." }, { "item_id": "N22", "question_type": "Evidence condition", "question": "Are registration IDs and posting dates distinguished from current reading?", "needed": "NCT01770080, EudraCT and posting of results version 1", "role": "Required", "role_reason": "Material on NCT01770080, EudraCT and posting of results version 1 is needed to connect the selected active-comparator question with formulation, population, comparator, timing, scales, denominators, precision and harms.", "application_exception": "Original details absent from the summary remain unverified. Selected D and the absence of individual score, status and axes are retained without inheriting parent D28. No new effect, CI, margin, sample size, grade, equivalence, safety or independence certification, or use or treatment guidance is created.", "criterion": "Original material on NCT01770080, EudraCT and posting of results version 1 must link to the report-specific population, formulation, comparator, time, endpoint, denominators and prespecified analysis, distinguishing direct comparison, parent context, historical calculation and unread external materials.", "basis": "Preserved principles distinguishing questions, comparators, reports and trials, endpoints, denominators and harms informed production.", "condition_origin": "These are evidence conditions for the existing selected question. They do not establish preregistration, use of an official assessment tool or completed content review.", "proposed_research": "Material needed: Actual original registration, plan, amendments and result-version materials are needed. The early record is not converted into a new registry-search conclusion, or a link into completed reading. This records needed materials; no new research was executed." }, { "item_id": "N23", "question_type": "Evidence condition", "question": "Are selected D and parent D28, Caution and axes distinguished?", "needed": "Selected subclaim grade and absence of individual score, status and axes", "role": "Required", "role_reason": "Material on Selected subclaim grade and absence of individual score, status and axes is needed to connect the selected active-comparator question with formulation, population, comparator, timing, scales, denominators, precision and harms.", "application_exception": "Original details absent from the summary remain unverified. Selected D and the absence of individual score, status and axes are retained without inheriting parent D28. No new effect, CI, margin, sample size, grade, equivalence, safety or independence certification, or use or treatment guidance is created.", "criterion": "Original material on Selected subclaim grade and absence of individual score, status and axes must link to the report-specific population, formulation, comparator, time, endpoint, denominators and prespecified analysis, distinguishing direct comparison, parent context, historical calculation and unread external materials.", "basis": "Preserved principles distinguishing questions, comparators, reports and trials, endpoints, denominators and harms informed production.", "condition_origin": "These are evidence conditions for the existing selected question. They do not establish preregistration, use of an official assessment tool or completed content review.", "proposed_research": "Material needed: Content review of the subquestion and parent boundary remains incomplete. No new grade, score, clinical status or certification of independence is created. This records needed materials; no new research was executed." }, { "item_id": "N24", "question_type": "Evidence condition", "question": "Are stored-summary reading and external-original reading distinguished?", "needed": "Materials actually read, separated by type", "role": "Required", "role_reason": "Material on Materials actually read, separated by type is needed to connect the selected active-comparator question with formulation, population, comparator, timing, scales, denominators, precision and harms.", "application_exception": "Original details absent from the summary remain unverified. Selected D and the absence of individual score, status and axes are retained without inheriting parent D28. No new effect, CI, margin, sample size, grade, equivalence, safety or independence certification, or use or treatment guidance is created.", "criterion": "Original material on Materials actually read, separated by type must link to the report-specific population, formulation, comparator, time, endpoint, denominators and prespecified analysis, distinguishing direct comparison, parent context, historical calculation and unread external materials.", "basis": "Preserved principles distinguishing questions, comparators, reports and trials, endpoints, denominators and harms informed production.", "condition_origin": "These are evidence conditions for the existing selected question. They do not establish preregistration, use of an official assessment tool or completed content review.", "proposed_research": "Material needed: External acquisition, reading and content review are separate events. A link does not establish original reading, accessibility or completed review. This records needed materials; no new research was executed." }, { "item_id": "N25", "question_type": "Evidence condition", "question": "How far do representative values in the Korean and English accounts apply?", "needed": "Scope of language-specific accounts and representative formulation, population and endpoint", "role": "Required", "role_reason": "Material on Scope of language-specific accounts and representative formulation, population and endpoint is needed to connect the selected active-comparator question with formulation, population, comparator, timing, scales, denominators, precision and harms.", "application_exception": "Original details absent from the summary remain unverified. Selected D and the absence of individual score, status and axes are retained without inheriting parent D28. No new effect, CI, margin, sample size, grade, equivalence, safety or independence certification, or use or treatment guidance is created.", "criterion": "Original material on Scope of language-specific accounts and representative formulation, population and endpoint must link to the report-specific population, formulation, comparator, time, endpoint, denominators and prespecified analysis, distinguishing direct comparison, parent context, historical calculation and unread external materials.", "basis": "Preserved principles distinguishing questions, comparators, reports and trials, endpoints, denominators and harms informed production.", "condition_origin": "These are evidence conditions for the existing selected question. They do not establish preregistration, use of an official assessment tool or completed content review.", "proposed_research": "Material needed: Original material comparing report-specific populations, formulations, comparators, endpoints, times and denominators is needed. No current comparison with external English originals or correction review was performed. This records needed materials; no new research was executed." }, { "item_id": "N26", "question_type": "Evidence condition", "question": "Are the evidence date, empty correction history and production time distinguished?", "needed": "Original evidence date versus correction and change events", "role": "Required", "role_reason": "Material on Original evidence date versus correction and change events is needed to connect the selected active-comparator question with formulation, population, comparator, timing, scales, denominators, precision and harms.", "application_exception": "Original details absent from the summary remain unverified. Selected D and the absence of individual score, status and axes are retained without inheriting parent D28. No new effect, CI, margin, sample size, grade, equivalence, safety or independence certification, or use or treatment guidance is created.", "criterion": "Original material on Original evidence date versus correction and change events must link to the report-specific population, formulation, comparator, time, endpoint, denominators and prespecified analysis, distinguishing direct comparison, parent context, historical calculation and unread external materials.", "basis": "Preserved principles distinguishing questions, comparators, reports and trials, endpoints, denominators and harms informed production.", "condition_origin": "These are evidence conditions for the existing selected question. They do not establish preregistration, use of an official assessment tool or completed content review.", "proposed_research": "Material needed: Material additions, criterion revisions, observation application and verdict changes must preserve the complete prior account and distinguish events, versions and reasons. This records needed materials; no new research was executed." }, { "item_id": "N27", "question_type": "Evidence condition", "question": "Do report or material-slot counts represent unique trials or quality scores?", "needed": "Table structure versus unique clinical units and actual reading", "role": "Required", "role_reason": "Material on Table structure versus unique clinical units and actual reading is needed to connect the selected active-comparator question with formulation, population, comparator, timing, scales, denominators, precision and harms.", "application_exception": "Original details absent from the summary remain unverified. Selected D and the absence of individual score, status and axes are retained without inheriting parent D28. No new effect, CI, margin, sample size, grade, equivalence, safety or independence certification, or use or treatment guidance is created.", "criterion": "Original material on Table structure versus unique clinical units and actual reading must link to the report-specific population, formulation, comparator, time, endpoint, denominators and prespecified analysis, distinguishing direct comparison, parent context, historical calculation and unread external materials.", "basis": "Preserved principles distinguishing questions, comparators, reports and trials, endpoints, denominators and harms informed production.", "condition_origin": "These are evidence conditions for the existing selected question. They do not establish preregistration, use of an official assessment tool or completed content review.", "proposed_research": "Material needed: Original trial, report and cohort links, and actual acquisition and reading records, are needed. Unique trial and participant counts remain unverified. This records needed materials; no new research was executed." }, { "item_id": "N28", "question_type": "Evidence condition", "question": "Where should new material and corrections be linked?", "needed": "Distinction between criterion revision, material updates and verdict changes", "role": "Required", "role_reason": "Material on Distinction between criterion revision, material updates and verdict changes is needed to connect the selected active-comparator question with formulation, population, comparator, timing, scales, denominators, precision and harms.", "application_exception": "Original details absent from the summary remain unverified. Selected D and the absence of individual score, status and axes are retained without inheriting parent D28. No new effect, CI, margin, sample size, grade, equivalence, safety or independence certification, or use or treatment guidance is created.", "criterion": "Original material on Distinction between criterion revision, material updates and verdict changes must link to the report-specific population, formulation, comparator, time, endpoint, denominators and prespecified analysis, distinguishing direct comparison, parent context, historical calculation and unread external materials.", "basis": "Preserved principles distinguishing questions, comparators, reports and trials, endpoints, denominators and harms informed production.", "condition_origin": "These are evidence conditions for the existing selected question. They do not establish preregistration, use of an official assessment tool or completed content review.", "proposed_research": "Material needed: After acquisition and content review, the complete prior account must be preserved and events, versions and reasons recorded. No new procedures, treatment guidance or calculations are created. This records needed materials; no new research was executed." } ] }