# Topical 10% peppermint oil × Tension-type headache—equivalence to acetaminophen not established Verdict 3010 · Evidence Check Stored-material review date: Not recorded Original evidence cut-off: 2026-09-07 Review-criteria version: 1.0 Public page/material preparation date: 2026-10-20 Clinical papers were not read directly; existing review summaries were checked. No new clinical-literature search was performed. Unverified does not mean that research is absent or that there is no effect. ## Assessment scope - Population: The population has acute tension-type headache. Detailed diagnosis and eligibility in the early repeated-attack trial remain unverified; findings are not extended to migraine. - Ingredient, formulation and route: Topical application of 10% peppermint oil in ethanol to the forehead and temples. This is distinguished from inhalation and oral enteric capsules. - Dose: The early report's 10% oil and 90% ethanol conditions are retained. Exact acetaminophen dose, formulation, timing and concurrent-care conditions are absent from the summary. - Comparator: The selected question concerns the early active comparison with acetaminophen. The placebo signal and later placebo-controlled trial remain separate context. - Measured outcome: The question concerns active-comparator pain intensity and equivalence. No difference did not establish equivalence or noninferiority; direct effects, CIs and prespecified margins are unverified. - Duration: The early comparison concerns pain from 15 minutes. Later VPRS response at 120 minutes and VAS-SPID are not merged as the same scale or time. - Questions outside this scope: Converting nonsignificance into equivalence, noninferiority, an exactly zero effect or substitutability; Adding participants, repeated attacks, reports or shared subquestion sheets as independent participants or replications; Treating different formulations, populations, comparators, times, scales or acute and long-term questions as the same direct effect; Promoting historical verification, full-text reading or calculation narratives to current completion; Creating new effects, CIs, margins, sample sizes, grades, independence conclusions or use or treatment guidance ## Checklist items ### N01 · Which acetaminophen comparison is being considered? Verification status: Partly verified Reading scope: Stored parent summary and bibliography read; external abstracts, full text, registered results, registration, protocols and SAPs unread - Current findings: The selected original claim is analgesic efficacy equivalent to acetaminophen. The existing explanation records that the early trial was not designed to establish equivalence or noninferiority, separately from analgesia versus placebo. - Why unverified: Information was transferred from the stored summary with the selected question distinguished from parent context. Detailed originals and content review remain incomplete; this does not establish clinical certification or review approval. - Reason for missing information: The original active-comparator design, denominators, effect, CI and prespecified margin are needed. This sheet is not counted as a new independent study. - Required materials and conditions: Distinction between the existing equivalence question and analgesia versus placebo - Materials to obtain first: The original active-comparator design, denominators, effect, CI and prespecified margin are needed. This sheet is not counted as a new independent study. - Further 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. - Conditions for verification: 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. - Why this condition is needed: 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 exceptions: 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. - Remaining uncertainty: Exact active-comparator effects, CIs, testing, denominators, prespecified margins, power, dose, formulation, concurrent care, missingness and harms remain unverified. Placebo signals, later first-primary-endpoint failure and historical calculation are distinguished; no difference is not converted into equivalence, noninferiority, an exactly zero effect or substitutability. - Referenced methods: Preserved principles distinguishing questions, comparators, reports and trials, endpoints, denominators and harms informed production. - Related sources: R01 ### N02 · Does no difference establish equivalence or noninferiority? Verification status: Partly verified Reading scope: Stored parent summary and bibliography read; external abstracts, full text, registered results, registration, protocols and SAPs unread - Current findings: The preserved account explains that no difference from acetaminophen did not establish equivalence. No new conclusion of equal or interchangeable treatments is made. - Why unverified: Information was transferred from the stored summary with the selected question distinguished from parent context. Detailed originals and content review remain incomplete; this does not establish clinical certification or review approval. - Reason for missing information: The prespecified clinical margin, effect of interest, test direction, relevant CI and analysis plan are needed. Nonsignificance is not converted into proof of equivalence. - Required materials and conditions: Nonsignificance in a superiority test versus prespecified equivalence or noninferiority criteria - Materials to obtain first: The prespecified clinical margin, effect of interest, test direction, relevant CI and analysis plan are needed. Nonsignificance is not converted into proof of equivalence. - Further 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. - Conditions for verification: 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. - Why this condition is needed: 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 exceptions: 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. - Remaining uncertainty: Exact active-comparator effects, CIs, testing, denominators, prespecified margins, power, dose, formulation, concurrent care, missingness and harms remain unverified. Placebo signals, later first-primary-endpoint failure and historical calculation are distinguished; no difference is not converted into equivalence, noninferiority, an exactly zero effect or substitutability. - Referenced methods: Preserved principles distinguishing questions, comparators, reports and trials, endpoints, denominators and harms informed production. - Related sources: R01 ### N03 · Are the exact active-comparator effect, CI and P known? Verification status: Partly verified Reading scope: Stored parent summary and bibliography read; external abstracts, full text, registered results, registration, protocols and SAPs unread - Current findings: The early result is a narrative of no difference from acetaminophen. Its exact effect, CI, P and test are absent from the summary; P<.01 concerns pain reduction versus placebo. - Why unverified: Information was transferred from the stored summary with the selected question distinguished from parent context. Detailed originals and content review remain incomplete; this does not establish clinical certification or review approval. - Reason for missing information: 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. - Required materials and conditions: Estimate and precision of the direct comparison with acetaminophen - Materials to obtain first: 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. - Further 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. - Conditions for verification: 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. - Why this condition is needed: 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 exceptions: 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. - Remaining uncertainty: Exact active-comparator effects, CIs, testing, denominators, prespecified margins, power, dose, formulation, concurrent care, missingness and harms remain unverified. Placebo signals, later first-primary-endpoint failure and historical calculation are distinguished; no difference is not converted into equivalence, noninferiority, an exactly zero effect or substitutability. - Referenced methods: Preserved principles distinguishing questions, comparators, reports and trials, endpoints, denominators and harms informed production. - Related sources: R01 ### N04 · Is a signal versus placebo direct evidence of equivalence? Verification status: Partly verified Reading scope: Stored parent summary and bibliography read; external abstracts, full text, registered results, registration, protocols and SAPs unread - Current findings: The early trial's pain reduction versus placebo, P<.01, is retained. This signal is not converted into a direct estimate of equivalence to acetaminophen or a prespecified equivalence trial. - Why unverified: Information was transferred from the stored summary with the selected question distinguished from parent context. Detailed originals and content review remain incomplete; this does not establish clinical certification or review approval. - Reason for missing information: The active-comparator effect, CI, original design and prespecified margin at the same time and analysis are needed. - Required materials and conditions: Distinction between effects versus placebo and versus an active comparator - Materials to obtain first: The active-comparator effect, CI, original design and prespecified margin at the same time and analysis are needed. - Further 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. - Conditions for verification: 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. - Why this condition is needed: 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 exceptions: 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. - Remaining uncertainty: Exact active-comparator effects, CIs, testing, denominators, prespecified margins, power, dose, formulation, concurrent care, missingness and harms remain unverified. Placebo signals, later first-primary-endpoint failure and historical calculation are distinguished; no difference is not converted into equivalence, noninferiority, an exactly zero effect or substitutability. - Referenced methods: Preserved principles distinguishing questions, comparators, reports and trials, endpoints, denominators and harms informed production. - Related sources: R01 ### N05 · Are 41 participants and 164 attacks the same denominator? Verification status: Partly verified Reading scope: Stored parent summary and bibliography read; external abstracts, full text, registered results, registration, protocols and SAPs unread - Current findings: R01 is a repeated-attack crossover trial with 41 participants and 164 headache attacks. The 164 attacks are not labeled as participants or added as independent participants. - Why unverified: Information was transferred from the stored summary with the selected question distinguished from parent context. Detailed originals and content review remain incomplete; this does not establish clinical certification or review approval. - Reason for missing information: 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. - Required materials and conditions: Participants, attacks, treatment periods and units of analysis - Materials to obtain first: 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. - Further 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. - Conditions for verification: 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. - Why this condition is needed: 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 exceptions: 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. - Remaining uncertainty: Exact active-comparator effects, CIs, testing, denominators, prespecified margins, power, dose, formulation, concurrent care, missingness and harms remain unverified. Placebo signals, later first-primary-endpoint failure and historical calculation are distinguished; no difference is not converted into equivalence, noninferiority, an exactly zero effect or substitutability. - Referenced methods: Preserved principles distinguishing questions, comparators, reports and trials, endpoints, denominators and harms informed production. - Related sources: R01 ### N06 · Are crossover correlation, carryover and period effects verified? Verification status: Partly verified Reading scope: Stored parent summary and bibliography read; external abstracts, full text, registered results, registration, protocols and SAPs unread - Current findings: The original design is a randomized double-blind repeated-attack crossover trial. Its label alone does not verify independence of attacks, washout, or handling of period and sequence effects. - Why unverified: Information was transferred from the stored summary with the selected question distinguished from parent context. Detailed originals and content review remain incomplete; this does not establish clinical certification or review approval. - Reason for missing information: 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. - Required materials and conditions: Treatment sequence, washout, carryover and within-participant correlation - Materials to obtain first: 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. - Further 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. - Conditions for verification: 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. - Why this condition is needed: 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 exceptions: 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. - Remaining uncertainty: Exact active-comparator effects, CIs, testing, denominators, prespecified margins, power, dose, formulation, concurrent care, missingness and harms remain unverified. Placebo signals, later first-primary-endpoint failure and historical calculation are distinguished; no difference is not converted into equivalence, noninferiority, an exactly zero effect or substitutability. - Referenced methods: Preserved principles distinguishing questions, comparators, reports and trials, endpoints, denominators and harms informed production. - Related sources: R01 ### N07 · Are acetaminophen dose, formulation and concurrent-care conditions known? Verification status: Unverified Reading scope: Stored parent summary and bibliography read; external abstracts, full text, registered results, registration, protocols and SAPs unread - Current findings: The preserved account records comparison with placebo or acetaminophen. The summary lacks exact acetaminophen dose, formulation, timing, concurrent care and rescue-medication conditions. - Why unverified: Information was transferred from the stored summary with the selected question distinguished from parent context. Detailed originals and content review remain incomplete; this does not establish clinical certification or review approval. - Reason for missing information: Original arm-specific drugs, formulations, concurrent care, rescue medication, exposure and comparator conditions are needed. No new dose, use or administration guidance is created. - Required materials and conditions: Arm-specific exposure conditions for active, topical and placebo comparisons - Materials to obtain first: Original arm-specific drugs, formulations, concurrent care, rescue medication, exposure and comparator conditions are needed. No new dose, use or administration guidance is created. - Further 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. - Conditions for verification: 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. - Why this condition is needed: 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 exceptions: 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. - Remaining uncertainty: Exact active-comparator effects, CIs, testing, denominators, prespecified margins, power, dose, formulation, concurrent care, missingness and harms remain unverified. Placebo signals, later first-primary-endpoint failure and historical calculation are distinguished; no difference is not converted into equivalence, noninferiority, an exactly zero effect or substitutability. - Referenced methods: Preserved principles distinguishing questions, comparators, reports and trials, endpoints, denominators and harms informed production. - Related sources: R01 ### N08 · Which 10% topical formulation was compared? Verification status: Partly verified Reading scope: Stored parent summary and bibliography read; external abstracts, full text, registered results, registration, protocols and SAPs unread - Current findings: The parent account's topical 10% peppermint-oil and 90% ethanol solution is retained. Inhalation, oral enteric capsules and migraine involve different routes or populations; concentration is not converted into absorbed dose. - Why unverified: Information was transferred from the stored summary with the selected question distinguished from parent context. Detailed originals and content review remain incomplete; this does not establish clinical certification or review approval. - Reason for missing information: Original product, manufacture, composition, exposure, use records and comparator-vehicle details are needed. Formulations are distinguished by report, without new procedures or treatment guidance. - Required materials and conditions: The specific topical solution of 10% peppermint oil and 90% ethanol - Materials to obtain first: Original product, manufacture, composition, exposure, use records and comparator-vehicle details are needed. Formulations are distinguished by report, without new procedures or treatment guidance. - Further 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. - Conditions for verification: 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. - Why this condition is needed: 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 exceptions: 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. - Remaining uncertainty: Exact active-comparator effects, CIs, testing, denominators, prespecified margins, power, dose, formulation, concurrent care, missingness and harms remain unverified. Placebo signals, later first-primary-endpoint failure and historical calculation are distinguished; no difference is not converted into equivalence, noninferiority, an exactly zero effect or substitutability. - Referenced methods: Preserved principles distinguishing questions, comparators, reports and trials, endpoints, denominators and harms informed production. - Related sources: R01, R02 ### N09 · Are tension-type headache and migraine populations distinguished? Verification status: Partly verified Reading scope: Stored parent summary and bibliography read; external abstracts, full text, registered results, registration, protocols and SAPs unread - Current findings: The original population has acute tension-type headache. The early 41 participants and 164 attacks do not replace detailed diagnosis or eligibility; the context excluding inhalation, enteric capsules and migraine is retained. - Why unverified: Information was transferred from the stored summary with the selected question distinguished from parent context. Detailed originals and content review remain incomplete; this does not establish clinical certification or review approval. - Reason for missing information: Original diagnostic criteria, frequency, severity, baseline pain, exclusions, comorbidity and recruitment information are needed. Findings are not extended to other headaches or populations. - Required materials and conditions: Eligibility and attack characteristics in acute tension-type headache - Materials to obtain first: Original diagnostic criteria, frequency, severity, baseline pain, exclusions, comorbidity and recruitment information are needed. Findings are not extended to other headaches or populations. - Further 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. - Conditions for verification: 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. - Why this condition is needed: 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 exceptions: 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. - Remaining uncertainty: Exact active-comparator effects, CIs, testing, denominators, prespecified margins, power, dose, formulation, concurrent care, missingness and harms remain unverified. Placebo signals, later first-primary-endpoint failure and historical calculation are distinguished; no difference is not converted into equivalence, noninferiority, an exactly zero effect or substitutability. - Referenced methods: Preserved principles distinguishing questions, comparators, reports and trials, endpoints, denominators and harms informed production. - Related sources: R01, R02 ### N10 · Are pain after 15 minutes and response at 120 minutes the same endpoint? Verification status: Partly verified Reading scope: Stored parent summary and bibliography read; external abstracts, full text, registered results, registration, protocols and SAPs unread - Current findings: The early comparison concerns pain intensity from 15 minutes and an active comparator. The later first primary endpoint is VPRS response at 120 minutes, followed by VAS-SPID; these are not treated as the same scale, time or responder definition. - Why unverified: Information was transferred from the stored summary with the selected question distinguished from parent context. Detailed originals and content review remain incomplete; this does not establish clinical certification or review approval. - Reason for missing information: 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. - Required materials and conditions: Timing and scales of early pain intensity and later VPRS response - Materials to obtain first: 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. - Further 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. - Conditions for verification: 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. - Why this condition is needed: 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 exceptions: 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. - Remaining uncertainty: Exact active-comparator effects, CIs, testing, denominators, prespecified margins, power, dose, formulation, concurrent care, missingness and harms remain unverified. Placebo signals, later first-primary-endpoint failure and historical calculation are distinguished; no difference is not converted into equivalence, noninferiority, an exactly zero effect or substitutability. - Referenced methods: Preserved principles distinguishing questions, comparators, reports and trials, endpoints, denominators and harms informed production. - Related sources: R01, R02 ### N11 · What are the later trial's starting size and analysis denominators? Verification status: Partly verified Reading scope: Stored parent summary and bibliography read; external abstracts, full text, registered results, registration, protocols and SAPs unread - Current findings: The later trial records 209 started, 189 in FAS and 94 versus 95. The 37/94 versus 28/95 comparison concerns response at 120 minutes; the starting count does not replace FAS denominators or event totals. - Why unverified: Information was transferred from the stored summary with the selected question distinguished from parent context. Detailed originals and content review remain incomplete; this does not establish clinical certification or review approval. - Reason for missing information: 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. - Required materials and conditions: Distinction between 209 started, 189 in FAS and 94 versus 95 - Materials to obtain first: 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. - Further 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. - Conditions for verification: 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. - Why this condition is needed: 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 exceptions: 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. - Remaining uncertainty: Exact active-comparator effects, CIs, testing, denominators, prespecified margins, power, dose, formulation, concurrent care, missingness and harms remain unverified. Placebo signals, later first-primary-endpoint failure and historical calculation are distinguished; no difference is not converted into equivalence, noninferiority, an exactly zero effect or substitutability. - Referenced methods: Preserved principles distinguishing questions, comparators, reports and trials, endpoints, denominators and harms informed production. - Related sources: R02 ### N12 · Is failure of the later first primary endpoint's threshold retained? Verification status: Partly verified Reading scope: Stored parent summary and bibliography read; external abstracts, full text, registered results, registration, protocols and SAPs unread - Current findings: The later response at 120 minutes, 37/94 versus 28/95, retains failure of the prespecified one-sided .025 threshold. A benefit direction is not converted into passing the threshold or an exactly 0 effect. - Why unverified: Information was transferred from the stored summary with the selected question distinguished from parent context. Detailed originals and content review remain incomplete; this does not establish clinical certification or review approval. - Reason for missing information: 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. - Required materials and conditions: Prespecified one-sided Fisher .025 threshold and hierarchical gate - Materials to obtain first: 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. - Further 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. - Conditions for verification: 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. - Why this condition is needed: 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 exceptions: 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. - Remaining uncertainty: Exact active-comparator effects, CIs, testing, denominators, prespecified margins, power, dose, formulation, concurrent care, missingness and harms remain unverified. Placebo signals, later first-primary-endpoint failure and historical calculation are distinguished; no difference is not converted into equivalence, noninferiority, an exactly zero effect or substitutability. - Referenced methods: Preserved principles distinguishing questions, comparators, reports and trials, endpoints, denominators and harms informed production. - Related sources: R02 ### N13 · Was two-sided Fisher P≈.101 calculated in this work? Verification status: Partly verified Reading scope: Stored parent summary and bibliography read; external abstracts, full text, registered results, registration, protocols and SAPs unread - Current findings: The preserved result explicitly attributes two-sided Fisher P≈.101 to a historical Codex recalculation. The value and attribution are retained without presenting it as a current calculation or the original prespecified one-sided result. - Why unverified: Information was transferred from the stored summary with the selected question distinguished from parent context. Detailed originals and content review remain incomplete; this does not establish clinical certification or review approval. - Reason for missing information: 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. - Required materials and conditions: Distinction between the historical Codex calculation from counts and original trial results - Materials to obtain first: 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. - Further 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. - Conditions for verification: 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. - Why this condition is needed: 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 exceptions: 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. - Remaining uncertainty: Exact active-comparator effects, CIs, testing, denominators, prespecified margins, power, dose, formulation, concurrent care, missingness and harms remain unverified. Placebo signals, later first-primary-endpoint failure and historical calculation are distinguished; no difference is not converted into equivalence, noninferiority, an exactly zero effect or substitutability. - Referenced methods: Preserved principles distinguishing questions, comparators, reports and trials, endpoints, denominators and harms informed production. - Related sources: R02 ### N14 · Is VAS-SPID treated as confirmatory after the first primary endpoint failed? Verification status: Partly verified Reading scope: Stored parent summary and bibliography read; external abstracts, full text, registered results, registration, protocols and SAPs unread - Current findings: The parent account treats the second VAS-SPID endpoint as exploratory after the first primary endpoint failed. The parent's secondary-result indicator is not converted into current confirmatory analgesia or successful equivalence. - Why unverified: Information was transferred from the stored summary with the selected question distinguished from parent context. Detailed originals and content review remain incomplete; this does not establish clinical certification or review approval. - Reason for missing information: The prespecified hierarchy, original second-endpoint result, CI, denominators, adjustment and testing procedures are needed. Unread values are not filled in. - Required materials and conditions: Exploratory context of the hierarchically second endpoint - Materials to obtain first: The prespecified hierarchy, original second-endpoint result, CI, denominators, adjustment and testing procedures are needed. Unread values are not filled in. - Further 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. - Conditions for verification: 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. - Why this condition is needed: 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 exceptions: 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. - Remaining uncertainty: Exact active-comparator effects, CIs, testing, denominators, prespecified margins, power, dose, formulation, concurrent care, missingness and harms remain unverified. Placebo signals, later first-primary-endpoint failure and historical calculation are distinguished; no difference is not converted into equivalence, noninferiority, an exactly zero effect or substitutability. - Referenced methods: Preserved principles distinguishing questions, comparators, reports and trials, endpoints, denominators and harms informed production. - Related sources: R02 ### N15 · Is the later placebo-controlled trial an active-comparator equivalence trial? Verification status: Partly verified Reading scope: Stored parent summary and bibliography read; external abstracts, full text, registered results, registration, protocols and SAPs unread - Current findings: The later report is a registered placebo-controlled phase 4 trial. Its context as follow-up of a topical product is retained without turning it into a direct trial of equivalence to acetaminophen. - Why unverified: Information was transferred from the stored summary with the selected question distinguished from parent context. Detailed originals and content review remain incomplete; this does not establish clinical certification or review approval. - Reason for missing information: Prespecified active-comparator design, margin and CI directly addressing the selected question are needed. Results against a different comparator do not replace them. - Required materials and conditions: Distinction between the later placebo comparison and early acetaminophen comparison - Materials to obtain first: Prespecified active-comparator design, margin and CI directly addressing the selected question are needed. Results against a different comparator do not replace them. - Further 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. - Conditions for verification: 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. - Why this condition is needed: 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 exceptions: 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. - Remaining uncertainty: Exact active-comparator effects, CIs, testing, denominators, prespecified margins, power, dose, formulation, concurrent care, missingness and harms remain unverified. Placebo signals, later first-primary-endpoint failure and historical calculation are distinguished; no difference is not converted into equivalence, noninferiority, an exactly zero effect or substitutability. - Referenced methods: Preserved principles distinguishing questions, comparators, reports and trials, endpoints, denominators and harms informed production. - Related sources: R01, R02 ### N16 · Are the prespecified equivalence margin and power known? Verification status: Unverified Reading scope: Stored parent summary and bibliography read; external abstracts, full text, registered results, registration, protocols and SAPs unread - Current findings: The existing explanation says that the early trial was not designed to establish equivalence or noninferiority. Original clinical margins, power and relevant analysis populations are absent; no difference alone does not certify substitutability. - Why unverified: Information was transferred from the stored summary with the selected question distinguished from parent context. Detailed originals and content review remain incomplete; this does not establish clinical certification or review approval. - Reason for missing information: 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. - Required materials and conditions: Patient-important margin, sample-size plan, ITT and PP - Materials to obtain first: 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. - Further 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. - Conditions for verification: 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. - Why this condition is needed: 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 exceptions: 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. - Remaining uncertainty: Exact active-comparator effects, CIs, testing, denominators, prespecified margins, power, dose, formulation, concurrent care, missingness and harms remain unverified. Placebo signals, later first-primary-endpoint failure and historical calculation are distinguished; no difference is not converted into equivalence, noninferiority, an exactly zero effect or substitutability. - Referenced methods: Preserved principles distinguishing questions, comparators, reports and trials, endpoints, denominators and harms informed production. - Related sources: R01 ### N17 · Does rapid pain relief establish sustained recovery or recurrence prevention? Verification status: Partly verified Reading scope: Stored parent summary and bibliography read; external abstracts, full text, registered results, registration, protocols and SAPs unread - Current findings: The parent's scope is pain relief in acute tension-type headache. An early rapid signal is not converted into direct confirmation of sustained recovery, causal treatment, long-term prevention or replacement of acetaminophen. - Why unverified: Information was transferred from the stored summary with the selected question distinguished from parent context. Detailed originals and content review remain incomplete; this does not establish clinical certification or review approval. - Reason for missing information: Original definitions, denominators, effects and CIs for complete pain freedom, persistence, recurrence, rescue medication and patient-important outcomes are needed. - Required materials and conditions: Acute pain and response versus persistence, recurrence and rescue-medication outcomes - Materials to obtain first: Original definitions, denominators, effects and CIs for complete pain freedom, persistence, recurrence, rescue medication and patient-important outcomes are needed. - Further 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. - Conditions for verification: 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. - Why this condition is needed: 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 exceptions: 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. - Remaining uncertainty: Exact active-comparator effects, CIs, testing, denominators, prespecified margins, power, dose, formulation, concurrent care, missingness and harms remain unverified. Placebo signals, later first-primary-endpoint failure and historical calculation are distinguished; no difference is not converted into equivalence, noninferiority, an exactly zero effect or substitutability. - Referenced methods: Preserved principles distinguishing questions, comparators, reports and trials, endpoints, denominators and harms informed production. - Related sources: R01, R02 ### N18 · Are early positive findings and later failure both retained? Verification status: Partly verified Reading scope: Stored parent summary and bibliography read; external abstracts, full text, registered results, registration, protocols and SAPs unread - Current findings: The parent account addresses both a small early signal and failure of the larger registered trial's first primary endpoint, prioritizing the later failure. Both results are retained and distinguished from directness for equivalence. - Why unverified: Information was transferred from the stored summary with the selected question distinguished from parent context. Detailed originals and content review remain incomplete; this does not establish clinical certification or review approval. - Reason for missing information: Original material distinguishing products, populations, times, comparators, denominators, prespecified endpoints, effects and CIs in the two reports is needed. - Required materials and conditions: Early and later reports, and directness for the equivalence question - Materials to obtain first: Original material distinguishing products, populations, times, comparators, denominators, prespecified endpoints, effects and CIs in the two reports is needed. - Further 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. - Conditions for verification: 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. - Why this condition is needed: 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 exceptions: 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. - Remaining uncertainty: Exact active-comparator effects, CIs, testing, denominators, prespecified margins, power, dose, formulation, concurrent care, missingness and harms remain unverified. Placebo signals, later first-primary-endpoint failure and historical calculation are distinguished; no difference is not converted into equivalence, noninferiority, an exactly zero effect or substitutability. - Referenced methods: Preserved principles distinguishing questions, comparators, reports and trials, endpoints, denominators and harms informed production. - Related sources: R01, R02 ### N19 · Are funding, products, authorship and design or analysis involvement separated? Verification status: Partly verified Reading scope: Stored parent summary and bibliography read; external abstracts, full text, registered results, registration, protocols and SAPs unread - Current findings: Specific early funding and manufacturer involvement are unverified; the later trial was sponsored by Cassella-med GmbH. The parent's I0 and weak-independence explanation are not converted into new category-specific conclusions of absence or causation. - Why unverified: Information was transferred from the stored summary with the selected question distinguished from parent context. Detailed originals and content review remain incomplete; this does not establish clinical certification or review approval. - Reason for missing information: 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. - Required materials and conditions: Independence assessed by specific support and involvement categories - Materials to obtain first: 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. - Further 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. - Conditions for verification: 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. - Why this condition is needed: 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 exceptions: 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. - Remaining uncertainty: Exact active-comparator effects, CIs, testing, denominators, prespecified margins, power, dose, formulation, concurrent care, missingness and harms remain unverified. Placebo signals, later first-primary-endpoint failure and historical calculation are distinguished; no difference is not converted into equivalence, noninferiority, an exactly zero effect or substitutability. - Referenced methods: Preserved principles distinguishing questions, comparators, reports and trials, endpoints, denominators and harms informed production. - Related sources: R01, R02 ### N20 · Are denominators and collection methods for skin and eye harms known? Verification status: Partly verified Reading scope: Stored parent summary and bibliography read; external abstracts, full text, registered results, registration, protocols and SAPs unread - Current findings: The parent's safety wording concerns skin stinging, redness, eye injury and application boundaries for concentrated peppermint oil and ethanol. The summary lacks actual arm-specific harm counts, collection methods, denominators and exposure. - Why unverified: Information was transferred from the stored summary with the selected question distinguished from parent context. Detailed originals and content review remain incomplete; this does not establish clinical certification or review approval. - Reason for missing information: 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. - Required materials and conditions: Topical harm events, exposure, routes and vulnerable groups - Materials to obtain first: 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. - Further 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. - Conditions for verification: 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. - Why this condition is needed: 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 exceptions: 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. - Remaining uncertainty: Exact active-comparator effects, CIs, testing, denominators, prespecified margins, power, dose, formulation, concurrent care, missingness and harms remain unverified. Placebo signals, later first-primary-endpoint failure and historical calculation are distinguished; no difference is not converted into equivalence, noninferiority, an exactly zero effect or substitutability. - Referenced methods: Preserved principles distinguishing questions, comparators, reports and trials, endpoints, denominators and harms informed production. - Related sources: R01, R02 ### N21 · Are shared reports and repeated attacks added as independent studies? Verification status: Partly verified Reading scope: Stored parent summary and bibliography read; external abstracts, full text, registered results, registration, protocols and SAPs unread - Current findings: The early paper and later registered results are shared by the parent's two subquestions. The 41 participants, 164 attacks and 209/189 are not calculated as independent participant totals, and registered results are not certified as a separate paper. - Why unverified: Information was transferred from the stored summary with the selected question distinguished from parent context. Detailed originals and content review remain incomplete; this does not establish clinical certification or review approval. - Reason for missing information: Links among original trials, reports, sites, recruitment, participants and registration versions are needed. Unique trial, participant and independent-replication counts remain unverified. - Required materials and conditions: Two reports, shared subquestions and registered-result versions - Materials to obtain first: Links among original trials, reports, sites, recruitment, participants and registration versions are needed. Unique trial, participant and independent-replication counts remain unverified. - Further 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. - Conditions for verification: 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. - Why this condition is needed: 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 exceptions: 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. - Remaining uncertainty: Exact active-comparator effects, CIs, testing, denominators, prespecified margins, power, dose, formulation, concurrent care, missingness and harms remain unverified. Placebo signals, later first-primary-endpoint failure and historical calculation are distinguished; no difference is not converted into equivalence, noninferiority, an exactly zero effect or substitutability. - Referenced methods: Preserved principles distinguishing questions, comparators, reports and trials, endpoints, denominators and harms informed production. - Related sources: R01, R02 ### N22 · Are registration IDs and posting dates distinguished from current reading? Verification status: Partly verified Reading scope: Stored parent summary and bibliography read; external abstracts, full text, registered results, registration, protocols and SAPs unread - Current findings: The later NCT01770080, EudraCT 2011-004777-89 and results version 1 posting date 2025-05-22 are retained from the bibliography. The early pre-registration-era absence narrative is historical and does not represent current registration comparison. - Why unverified: Information was transferred from the stored summary with the selected question distinguished from parent context. Detailed originals and content review remain incomplete; this does not establish clinical certification or review approval. - Reason for missing information: 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. - Required materials and conditions: NCT01770080, EudraCT and posting of results version 1 - Materials to obtain first: 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. - Further 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. - Conditions for verification: 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. - Why this condition is needed: 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 exceptions: 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. - Remaining uncertainty: Exact active-comparator effects, CIs, testing, denominators, prespecified margins, power, dose, formulation, concurrent care, missingness and harms remain unverified. Placebo signals, later first-primary-endpoint failure and historical calculation are distinguished; no difference is not converted into equivalence, noninferiority, an exactly zero effect or substitutability. - Referenced methods: Preserved principles distinguishing questions, comparators, reports and trials, endpoints, denominators and harms informed production. - Related sources: R01, R02 ### N23 · Are selected D and parent D28, Caution and axes distinguished? Verification status: Partly verified Reading scope: Stored parent summary and bibliography read; external abstracts, full text, registered results, registration, protocols and SAPs unread - Current findings: The selected subquestion has D and lacks individual score, status and axes. Parent D28, Caution and axes remain parent context without filling a subclaim score. - Why unverified: Information was transferred from the stored summary with the selected question distinguished from parent context. Detailed originals and content review remain incomplete; this does not establish clinical certification or review approval. - Reason for missing information: Content review of the subquestion and parent boundary remains incomplete. No new grade, score, clinical status or certification of independence is created. - Required materials and conditions: Selected subclaim grade and absence of individual score, status and axes - Materials to obtain first: Content review of the subquestion and parent boundary remains incomplete. No new grade, score, clinical status or certification of independence is created. - Further 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. - Conditions for verification: 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. - Why this condition is needed: 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 exceptions: 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. - Remaining uncertainty: Exact active-comparator effects, CIs, testing, denominators, prespecified margins, power, dose, formulation, concurrent care, missingness and harms remain unverified. Placebo signals, later first-primary-endpoint failure and historical calculation are distinguished; no difference is not converted into equivalence, noninferiority, an exactly zero effect or substitutability. - Referenced methods: Preserved principles distinguishing questions, comparators, reports and trials, endpoints, denominators and harms informed production. - Related sources: R01, R02 ### N24 · Are stored-summary reading and external-original reading distinguished? Verification status: Partly verified Reading scope: Stored parent summary and bibliography read; external abstracts, full text, registered results, registration, protocols and SAPs unread - Current findings: The preserved parent summary was read for production. Historical bibliographic claims of verification, cross-checking, full-text reading and calculation remain historical; external abstracts, full text, registration, protocols and SAPs are unread. - Why unverified: Information was transferred from the stored summary with the selected question distinguished from parent context. Detailed originals and content review remain incomplete; this does not establish clinical certification or review approval. - Reason for missing information: External acquisition, reading and content review are separate events. A link does not establish original reading, accessibility or completed review. - Required materials and conditions: Materials actually read, separated by type - Materials to obtain first: External acquisition, reading and content review are separate events. A link does not establish original reading, accessibility or completed review. - Further 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. - Conditions for verification: 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. - Why this condition is needed: 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 exceptions: 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. - Remaining uncertainty: Exact active-comparator effects, CIs, testing, denominators, prespecified margins, power, dose, formulation, concurrent care, missingness and harms remain unverified. Placebo signals, later first-primary-endpoint failure and historical calculation are distinguished; no difference is not converted into equivalence, noninferiority, an exactly zero effect or substitutability. - Referenced methods: Preserved principles distinguishing questions, comparators, reports and trials, endpoints, denominators and harms informed production. - Related sources: R01, R02 ### N25 · How far do representative values in the Korean and English accounts apply? Verification status: Partly verified Reading scope: Stored parent summary and bibliography read; external abstracts, full text, registered results, registration, protocols and SAPs unread - Current findings: The parent's Korean and English accounts and representative values are preserved. Representative dose, population and endpoint summaries are not automatically applied as quantities, denominators or identical outcomes across every report, arm and endpoint. - Why unverified: Information was transferred from the stored summary with the selected question distinguished from parent context. Detailed originals and content review remain incomplete; this does not establish clinical certification or review approval. - Reason for missing information: 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. - Required materials and conditions: Scope of language-specific accounts and representative formulation, population and endpoint - Materials to obtain first: 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. - Further 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. - Conditions for verification: 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. - Why this condition is needed: 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 exceptions: 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. - Remaining uncertainty: Exact active-comparator effects, CIs, testing, denominators, prespecified margins, power, dose, formulation, concurrent care, missingness and harms remain unverified. Placebo signals, later first-primary-endpoint failure and historical calculation are distinguished; no difference is not converted into equivalence, noninferiority, an exactly zero effect or substitutability. - Referenced methods: Preserved principles distinguishing questions, comparators, reports and trials, endpoints, denominators and harms informed production. - Related sources: R01, R02 ### N26 · Are the evidence date, empty correction history and production time distinguished? Verification status: Partly verified Reading scope: Stored parent summary and bibliography read; external abstracts, full text, registered results, registration, protocols and SAPs unread - Current findings: The original evidence date is 2026-09-07, with an empty correction array and deliberation text. Production time does not become an evidence-verification date and no nonexistent correction is created. - Why unverified: Information was transferred from the stored summary with the selected question distinguished from parent context. Detailed originals and content review remain incomplete; this does not establish clinical certification or review approval. - Reason for missing information: Material additions, criterion revisions, observation application and verdict changes must preserve the complete prior account and distinguish events, versions and reasons. - Required materials and conditions: Original evidence date versus correction and change events - Materials to obtain first: Material additions, criterion revisions, observation application and verdict changes must preserve the complete prior account and distinguish events, versions and reasons. - Further 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. - Conditions for verification: 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. - Why this condition is needed: 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 exceptions: 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. - Remaining uncertainty: Exact active-comparator effects, CIs, testing, denominators, prespecified margins, power, dose, formulation, concurrent care, missingness and harms remain unverified. Placebo signals, later first-primary-endpoint failure and historical calculation are distinguished; no difference is not converted into equivalence, noninferiority, an exactly zero effect or substitutability. - Referenced methods: Preserved principles distinguishing questions, comparators, reports and trials, endpoints, denominators and harms informed production. - Related sources: R01, R02 ### N27 · Do report or material-slot counts represent unique trials or quality scores? Verification status: Partly verified Reading scope: Stored parent summary and bibliography read; external abstracts, full text, registered results, registration, protocols and SAPs unread - Current findings: Report links, stored summaries and external-material slots describe table structure. They are not acquired external papers, unique participants, original trials, independent replications or quality scores; shared material is not counted twice. - Why unverified: Information was transferred from the stored summary with the selected question distinguished from parent context. Detailed originals and content review remain incomplete; this does not establish clinical certification or review approval. - Reason for missing information: Original trial, report and cohort links, and actual acquisition and reading records, are needed. Unique trial and participant counts remain unverified. - Required materials and conditions: Table structure versus unique clinical units and actual reading - Materials to obtain first: Original trial, report and cohort links, and actual acquisition and reading records, are needed. Unique trial and participant counts remain unverified. - Further 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. - Conditions for verification: 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. - Why this condition is needed: 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 exceptions: 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. - Remaining uncertainty: Exact active-comparator effects, CIs, testing, denominators, prespecified margins, power, dose, formulation, concurrent care, missingness and harms remain unverified. Placebo signals, later first-primary-endpoint failure and historical calculation are distinguished; no difference is not converted into equivalence, noninferiority, an exactly zero effect or substitutability. - Referenced methods: Preserved principles distinguishing questions, comparators, reports and trials, endpoints, denominators and harms informed production. - Related sources: R01, R02 ### N28 · Where should new material and corrections be linked? Verification status: Partly verified Reading scope: Stored parent summary and bibliography read; external abstracts, full text, registered results, registration, protocols and SAPs unread - Current findings: Original material, existing conditions and observations are preserved. New material must link to relevant comparisons, denominators, endpoints, reports and subquestion boundaries; this production is not labeled as new retrieval or a revised verdict. - Why unverified: Information was transferred from the stored summary with the selected question distinguished from parent context. Detailed originals and content review remain incomplete; this does not establish clinical certification or review approval. - Reason for missing information: 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. - Required materials and conditions: Distinction between criterion revision, material updates and verdict changes - Materials to obtain first: 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. - Further 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. - Conditions for verification: 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. - Why this condition is needed: 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 exceptions: 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. - Remaining uncertainty: Exact active-comparator effects, CIs, testing, denominators, prespecified margins, power, dose, formulation, concurrent care, missingness and harms remain unverified. Placebo signals, later first-primary-endpoint failure and historical calculation are distinguished; no difference is not converted into equivalence, noninferiority, an exactly zero effect or substitutability. - Referenced methods: Preserved principles distinguishing questions, comparators, reports and trials, endpoints, denominators and harms informed production. - Related sources: R01, R02 ## Evidence and sources ### R01 Göbel H et al. 1996 [PubMed](https://pubmed.ncbi.nlm.nih.gov/8805113/) Materials actually read: Only the stored parent summary and bibliography were read. External abstracts, full text, registration, protocols and SAPs are unread. Findings recorded in the summary: There were 41 participants and 164 headache attacks, with less pain than placebo, P<.01. No difference from acetaminophen did not establish equivalence; exact direct-comparison effects, CIs, P and prespecified margins are absent from the summary. Record level: This is the stored summary of the early active comparison. No difference is distinguished from proof of equivalence or noninferiority; no current external paper reading, recalculation or reassessment was performed. Independent replication: The parent and its two subquestions share the early paper and later registered results. The preserved linkage is not counted as new independent trials or replications; unique trial and participant totals remain unverified. | Material | Public availability | Access status | Actually read | Notes | |---|---|---|---|---| | Stored existing review summary | Preserved copy of the complete parent-verdict stored summary | Stored summary | Summary read | The early active comparison is linked from the stored bibliography and summary. Historical verification or full-text narratives and unverified funding or manufacturer involvement remain in internal originals and are not labeled as current external reading. Only stored-summary dates retain the original evidence date. Empty external-material dates remain empty and are not filled as actual reading or completed-review dates. | | External abstract | Original bibliographic link or needed material; external public availability/access status unverified | Unread; access not attempted | Not read | The early active comparison is linked from the stored bibliography and summary. Historical verification or full-text narratives and unverified funding or manufacturer involvement remain in internal originals and are not labeled as current external reading. Only stored-summary dates retain the original evidence date. Empty external-material dates remain empty and are not filled as actual reading or completed-review dates. | | External full text | Original bibliographic link or needed material; external public availability/access status unverified | Unread; access not attempted | Not read | The early active comparison is linked from the stored bibliography and summary. Historical verification or full-text narratives and unverified funding or manufacturer involvement remain in internal originals and are not labeled as current external reading. Only stored-summary dates retain the original evidence date. Empty external-material dates remain empty and are not filled as actual reading or completed-review dates. | | Registration material | Original bibliographic link or needed material; external public availability/access status unverified | Unread; access not attempted | Not read | The early active comparison is linked from the stored bibliography and summary. Historical verification or full-text narratives and unverified funding or manufacturer involvement remain in internal originals and are not labeled as current external reading. Only stored-summary dates retain the original evidence date. Empty external-material dates remain empty and are not filled as actual reading or completed-review dates. | | Protocol and analysis plan | Original bibliographic link or needed material; external public availability/access status unverified | Unread; access not attempted | Not read | The early active comparison is linked from the stored bibliography and summary. Historical verification or full-text narratives and unverified funding or manufacturer involvement remain in internal originals and are not labeled as current external reading. Only stored-summary dates retain the original evidence date. Empty external-material dates remain empty and are not filled as actual reading or completed-review dates. | ### R02 Euminz tension-type headache phase 4 study · later registered results [Official source](https://www.clinicaltrialsregister.eu/ctr-search/trial/2011-004777-89/results) Materials actually read: Only the stored parent summary and bibliography were read. External abstracts, full text, registration, protocols and SAPs are unread. Findings recorded in the summary: There were 209 started, 189 in FAS and 94 versus 95. Response at 120 minutes, 37/94 versus 28/95, missed the prespecified one-sided .025 threshold; two-sided Fisher P≈.101 is a historical Codex recalculation. This is not a direct comparison of equivalence to acetaminophen. Record level: This provides the later placebo comparison's first-primary-endpoint failure and hierarchical context. The second VAS-SPID endpoint is exploratory and is not converted into a current calculation or confirmation of selected equivalence. Independent replication: The parent and its two subquestions share the early paper and later registered results. The preserved linkage is not counted as new independent trials or replications; unique trial and participant totals remain unverified. | Material | Public availability | Access status | Actually read | Notes | |---|---|---|---|---| | Stored existing review summary | Preserved copy of the complete parent-verdict stored summary | Stored summary | Summary read | The preserved bibliography's NCT01770080, EudraCT2011-004777-89 and Cassella-med GmbH sponsorship are retained. External verification of registered results, plans, amendments and company roles was not performed. Only stored-summary dates retain the original evidence date. Empty external-material dates remain empty and are not filled as actual reading or completed-review dates. | | External abstract | Original bibliographic link or needed material; external public availability/access status unverified | Unread; access not attempted | Not read | The preserved bibliography's NCT01770080, EudraCT2011-004777-89 and Cassella-med GmbH sponsorship are retained. External verification of registered results, plans, amendments and company roles was not performed. Only stored-summary dates retain the original evidence date. Empty external-material dates remain empty and are not filled as actual reading or completed-review dates. | | External full text | Original bibliographic link or needed material; external public availability/access status unverified | Unread; access not attempted | Not read | The preserved bibliography's NCT01770080, EudraCT2011-004777-89 and Cassella-med GmbH sponsorship are retained. External verification of registered results, plans, amendments and company roles was not performed. Only stored-summary dates retain the original evidence date. Empty external-material dates remain empty and are not filled as actual reading or completed-review dates. | | Registration material | Original bibliographic link or needed material; external public availability/access status unverified | Unread; access not attempted | Not read | The preserved bibliography's NCT01770080, EudraCT2011-004777-89 and Cassella-med GmbH sponsorship are retained. External verification of registered results, plans, amendments and company roles was not performed. Only stored-summary dates retain the original evidence date. Empty external-material dates remain empty and are not filled as actual reading or completed-review dates. | | Protocol and analysis plan | Original bibliographic link or needed material; external public availability/access status unverified | Unread; access not attempted | Not read | The preserved bibliography's NCT01770080, EudraCT2011-004777-89 and Cassella-med GmbH sponsorship are retained. External verification of registered results, plans, amendments and company roles was not performed. Only stored-summary dates retain the original evidence date. Empty external-material dates remain empty and are not filled as actual reading or completed-review dates. | ## Review criteria and methods These are Chamgap's own application conditions, informed by the relevant sections of official methodological guidance. They do not constitute official assessment-tool certification or a new efficacy score. - M03 [Cochrane Handbook 6.5 (2024), chapter updated 2023-08](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03) · §3.1, §3.2.1–3.2.3, MECIR C5/C7/C13 · Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions. · Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed. - M04 [Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04) · §4.5, §4.6.1–4.6.3, MECIR C42 · Distinguish studies from reports and link them; do not omit a study solely because results are unreported. · Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed. - M08 [Cochrane Handbook 6.5 (2024), chapter updated 2019-10](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08) · §8.1–8.2.3, Table 8.2.a · Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting. · Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed. - M15 [Cochrane Handbook 6.5 (2024), chapter updated 2023-08](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15) · §15.2.4, §15.3.1–15.3.3 · Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision. · Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed. - M19 [Cochrane Handbook 6.5 (2024), chapter updated 2019-10](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19) · §19.1.2, §19.2.1–19.2.4 · Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates. · Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed. ## What the statuses mean - 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. ## Change history 2026-10-20 · Public page/materials 1.0. Public-facing views and materials were prepared from the existing 28 items. No new clinical search, verification-status change or scoring was performed.