{ "schema_version": "chamgap-public-evidence-check-1.0", "public_id": "v3010-s1", "verdict_number": "3010", "title": "Topical 10% peppermint oil × Tension-type headache—equivalence to acetaminophen not established", "view_version": "1.0", "view_created_date": "2026-10-20", "criteria_version": "1.0", "criteria_date": "2026-10-06", "review_date": null, "legacy_evidence_date": "2026-09-07", "review_scope": { "materials_read": "Existing review summaries and stored records of methodological application", "clinical_papers_directly_read": false, "new_clinical_search": false, "limitation": "Existing stored summary and preserved methodology application records. External papers, abstracts, registration, protocols, SAPs, original result tables and support disclosures are unread, and review of existing content remains incomplete.", "date_meaning": "This is the date the stored materials were checked, not the date of a new search of the clinical literature." }, "claim_context": { "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.", "intervention": "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.", "endpoint": "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.", "excluded_extensions": [ "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" ] }, "requirements": [ { "item_id": "N01", "question_type": "Evidence condition", "question": "Which acetaminophen comparison is being considered?", "needed": "Distinction between the existing equivalence question and analgesia versus placebo", "role": "Required", "role_reason": "Material on Distinction between the existing equivalence question and analgesia versus placebo is needed to connect the selected active-comparator question with formulation, population, comparator, timing, scales, denominators, precision and harms.", "application_exception": "Original details absent from the summary remain unverified. Selected D and the absence of individual score, status and axes are retained without inheriting parent D28. No new effect, CI, margin, sample size, grade, equivalence, safety or independence certification, or use or treatment guidance is created.", "criterion": "Original material on Distinction between the existing equivalence question and analgesia versus placebo must link to the report-specific population, formulation, comparator, time, endpoint, denominators and prespecified analysis, distinguishing direct comparison, parent context, historical calculation and unread external materials.", "basis": "Preserved principles distinguishing questions, comparators, reports and trials, endpoints, denominators and harms informed production.", "condition_origin": "These are evidence conditions for the existing selected question. They do not establish preregistration, use of an official assessment tool or completed content review.", "proposed_research": "Material needed: The original active-comparator design, denominators, effect, CI and prespecified margin are needed. This sheet is not counted as a new independent study. This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "The displayed records exist in the preserved parent summary. External availability, acquisition and reading of detailed materials remain separately unverified.", "acquired_read": "Stored parent summary and bibliography read; external abstracts, full text, registered results, registration, protocols and SAPs unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "The original active-comparator design, denominators, effect, CI and prespecified margin are needed. This sheet is not counted as a new independent study.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "The original active-comparator design, denominators, effect, CI and prespecified margin are needed. This sheet is not counted as a new independent study." }, { "item_id": "N02", "question_type": "Evidence condition", "question": "Does no difference establish equivalence or noninferiority?", "needed": "Nonsignificance in a superiority test versus prespecified equivalence or noninferiority criteria", "role": "Required", "role_reason": "Material on Nonsignificance in a superiority test versus prespecified equivalence or noninferiority criteria is needed to connect the selected active-comparator question with formulation, population, comparator, timing, scales, denominators, precision and harms.", "application_exception": "Original details absent from the summary remain unverified. Selected D and the absence of individual score, status and axes are retained without inheriting parent D28. No new effect, CI, margin, sample size, grade, equivalence, safety or independence certification, or use or treatment guidance is created.", "criterion": "Original material on Nonsignificance in a superiority test versus prespecified equivalence or noninferiority criteria must link to the report-specific population, formulation, comparator, time, endpoint, denominators and prespecified analysis, distinguishing direct comparison, parent context, historical calculation and unread external materials.", "basis": "Preserved principles distinguishing questions, comparators, reports and trials, endpoints, denominators and harms informed production.", "condition_origin": "These are evidence conditions for the existing selected question. They do not establish preregistration, use of an official assessment tool or completed content review.", "proposed_research": "Material needed: The prespecified clinical margin, effect of interest, test direction, relevant CI and analysis plan are needed. Nonsignificance is not converted into proof of equivalence. This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "The displayed records exist in the preserved parent summary. External availability, acquisition and reading of detailed materials remain separately unverified.", "acquired_read": "Stored parent summary and bibliography read; external abstracts, full text, registered results, registration, protocols and SAPs unread", "observation": "The preserved account explains that no difference from acetaminophen did not establish equivalence. No new conclusion of equal or interchangeable treatments is made.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "The prespecified clinical margin, effect of interest, test direction, relevant CI and analysis plan are needed. Nonsignificance is not converted into proof of equivalence.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "The prespecified clinical margin, effect of interest, test direction, relevant CI and analysis plan are needed. Nonsignificance is not converted into proof of equivalence." }, { "item_id": "N03", "question_type": "Evidence condition", "question": "Are the exact active-comparator effect, CI and P known?", "needed": "Estimate and precision of the direct comparison with acetaminophen", "role": "Required", "role_reason": "Material on Estimate and precision of the direct comparison with acetaminophen is needed to connect the selected active-comparator question with formulation, population, comparator, timing, scales, denominators, precision and harms.", "application_exception": "Original details absent from the summary remain unverified. Selected D and the absence of individual score, status and axes are retained without inheriting parent D28. No new effect, CI, margin, sample size, grade, equivalence, safety or independence certification, or use or treatment guidance is created.", "criterion": "Original material on Estimate and precision of the direct comparison with acetaminophen must link to the report-specific population, formulation, comparator, time, endpoint, denominators and prespecified analysis, distinguishing direct comparison, parent context, historical calculation and unread external materials.", "basis": "Preserved principles distinguishing questions, comparators, reports and trials, endpoints, denominators and harms informed production.", "condition_origin": "These are evidence conditions for the existing selected question. They do not establish preregistration, use of an official assessment tool or completed content review.", "proposed_research": "Material needed: Original active-comparator effect, CI, scale, time, denominators, testing and multiplicity materials are needed. The placebo P is not copied as the active-comparator P. This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "The displayed records exist in the preserved parent summary. External availability, acquisition and reading of detailed materials remain separately unverified.", "acquired_read": "Stored parent summary and bibliography read; external abstracts, full text, registered results, registration, protocols and SAPs unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "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.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "item_id": "N04", "question_type": "Evidence condition", "question": "Is a signal versus placebo direct evidence of equivalence?", "needed": "Distinction between effects versus placebo and versus an active comparator", "role": "Required", "role_reason": "Material on Distinction between effects versus placebo and versus an active comparator is needed to connect the selected active-comparator question with formulation, population, comparator, timing, scales, denominators, precision and harms.", "application_exception": "Original details absent from the summary remain unverified. Selected D and the absence of individual score, status and axes are retained without inheriting parent D28. No new effect, CI, margin, sample size, grade, equivalence, safety or independence certification, or use or treatment guidance is created.", "criterion": "Original material on Distinction between effects versus placebo and versus an active comparator must link to the report-specific population, formulation, comparator, time, endpoint, denominators and prespecified analysis, distinguishing direct comparison, parent context, historical calculation and unread external materials.", "basis": "Preserved principles distinguishing questions, comparators, reports and trials, endpoints, denominators and harms informed production.", "condition_origin": "These are evidence conditions for the existing selected question. They do not establish preregistration, use of an official assessment tool or completed content review.", "proposed_research": "Material needed: The active-comparator effect, CI, original design and prespecified margin at the same time and analysis are needed. This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "The displayed records exist in the preserved parent summary. External availability, acquisition and reading of detailed materials remain separately unverified.", "acquired_read": "Stored parent summary and bibliography read; external abstracts, full text, registered results, registration, protocols and SAPs unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "The active-comparator effect, CI, original design and prespecified margin at the same time and analysis are needed.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "The active-comparator effect, CI, original design and prespecified margin at the same time and analysis are needed." }, { "item_id": "N05", "question_type": "Evidence condition", "question": "Are 41 participants and 164 attacks the same denominator?", "needed": "Participants, attacks, treatment periods and units of analysis", "role": "Required", "role_reason": "Material on Participants, attacks, treatment periods and units of analysis is needed to connect the selected active-comparator question with formulation, population, comparator, timing, scales, denominators, precision and harms.", "application_exception": "Original details absent from the summary remain unverified. Selected D and the absence of individual score, status and axes are retained without inheriting parent D28. No new effect, CI, margin, sample size, grade, equivalence, safety or independence certification, or use or treatment guidance is created.", "criterion": "Original material on Participants, attacks, treatment periods and units of analysis must link to the report-specific population, formulation, comparator, time, endpoint, denominators and prespecified analysis, distinguishing direct comparison, parent context, historical calculation and unread external materials.", "basis": "Preserved principles distinguishing questions, comparators, reports and trials, endpoints, denominators and harms informed production.", "condition_origin": "These are evidence conditions for the existing selected question. They do not establish preregistration, use of an official assessment tool or completed content review.", "proposed_research": "Material needed: Treatments and attacks per participant, allocation sequence, periods, endpoint-specific analysis denominators and repeated-data methods are needed. No new mean attack count is calculated. This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "The displayed records exist in the preserved parent summary. External availability, acquisition and reading of detailed materials remain separately unverified.", "acquired_read": "Stored parent summary and bibliography read; external abstracts, full text, registered results, registration, protocols and SAPs unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "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.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "item_id": "N06", "question_type": "Evidence condition", "question": "Are crossover correlation, carryover and period effects verified?", "needed": "Treatment sequence, washout, carryover and within-participant correlation", "role": "Required", "role_reason": "Material on Treatment sequence, washout, carryover and within-participant correlation is needed to connect the selected active-comparator question with formulation, population, comparator, timing, scales, denominators, precision and harms.", "application_exception": "Original details absent from the summary remain unverified. Selected D and the absence of individual score, status and axes are retained without inheriting parent D28. No new effect, CI, margin, sample size, grade, equivalence, safety or independence certification, or use or treatment guidance is created.", "criterion": "Original material on Treatment sequence, washout, carryover and within-participant correlation must link to the report-specific population, formulation, comparator, time, endpoint, denominators and prespecified analysis, distinguishing direct comparison, parent context, historical calculation and unread external materials.", "basis": "Preserved principles distinguishing questions, comparators, reports and trials, endpoints, denominators and harms informed production.", "condition_origin": "These are evidence conditions for the existing selected question. They do not establish preregistration, use of an official assessment tool or completed content review.", "proposed_research": "Material needed: Original allocation sequence, periods, washout, carryover tests, paired data, within-participant correlation and missing-data methods are needed. No independent parallel-group calculation is performed. This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "The displayed records exist in the preserved parent summary. External availability, acquisition and reading of detailed materials remain separately unverified.", "acquired_read": "Stored parent summary and bibliography read; external abstracts, full text, registered results, registration, protocols and SAPs unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "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.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "item_id": "N07", "question_type": "Evidence condition", "question": "Are acetaminophen dose, formulation and concurrent-care conditions known?", "needed": "Arm-specific exposure conditions for active, topical and placebo comparisons", "role": "Required", "role_reason": "Material on Arm-specific exposure conditions for active, topical and placebo comparisons is needed to connect the selected active-comparator question with formulation, population, comparator, timing, scales, denominators, precision and harms.", "application_exception": "Original details absent from the summary remain unverified. Selected D and the absence of individual score, status and axes are retained without inheriting parent D28. No new effect, CI, margin, sample size, grade, equivalence, safety or independence certification, or use or treatment guidance is created.", "criterion": "Original material on Arm-specific exposure conditions for active, topical and placebo comparisons must link to the report-specific population, formulation, comparator, time, endpoint, denominators and prespecified analysis, distinguishing direct comparison, parent context, historical calculation and unread external materials.", "basis": "Preserved principles distinguishing questions, comparators, reports and trials, endpoints, denominators and harms informed production.", "condition_origin": "These are evidence conditions for the existing selected question. They do not establish preregistration, use of an official assessment tool or completed content review.", "proposed_research": "Material needed: Original arm-specific drugs, formulations, concurrent care, rescue medication, exposure and comparator conditions are needed. No new dose, use or administration guidance is created. This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "The displayed records exist in the preserved parent summary. External availability, acquisition and reading of detailed materials remain separately unverified.", "acquired_read": "Stored parent summary and bibliography read; external abstracts, full text, registered results, registration, protocols and SAPs unread", "observation": "The preserved account records comparison with placebo or acetaminophen. The summary lacks exact acetaminophen dose, formulation, timing, concurrent care and rescue-medication conditions.", "condition_status": "Unverified", "status_reason": "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.", "missingness": "Original arm-specific drugs, formulations, concurrent care, rescue medication, exposure and comparator conditions are needed. No new dose, use or administration guidance is created.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original arm-specific drugs, formulations, concurrent care, rescue medication, exposure and comparator conditions are needed. No new dose, use or administration guidance is created." }, { "item_id": "N08", "question_type": "Evidence condition", "question": "Which 10% topical formulation was compared?", "needed": "The specific topical solution of 10% peppermint oil and 90% ethanol", "role": "Required", "role_reason": "Material on The specific topical solution of 10% peppermint oil and 90% ethanol is needed to connect the selected active-comparator question with formulation, population, comparator, timing, scales, denominators, precision and harms.", "application_exception": "Original details absent from the summary remain unverified. Selected D and the absence of individual score, status and axes are retained without inheriting parent D28. No new effect, CI, margin, sample size, grade, equivalence, safety or independence certification, or use or treatment guidance is created.", "criterion": "Original material on The specific topical solution of 10% peppermint oil and 90% ethanol must link to the report-specific population, formulation, comparator, time, endpoint, denominators and prespecified analysis, distinguishing direct comparison, parent context, historical calculation and unread external materials.", "basis": "Preserved principles distinguishing questions, comparators, reports and trials, endpoints, denominators and harms informed production.", "condition_origin": "These are evidence conditions for the existing selected question. They do not establish preregistration, use of an official assessment tool or completed content review.", "proposed_research": "Material needed: Original product, manufacture, composition, exposure, use records and comparator-vehicle details are needed. Formulations are distinguished by report, without new procedures or treatment guidance. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "The displayed records exist in the preserved parent summary. External availability, acquisition and reading of detailed materials remain separately unverified.", "acquired_read": "Stored parent summary and bibliography read; external abstracts, full text, registered results, registration, protocols and SAPs unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Original product, manufacture, composition, exposure, use records and comparator-vehicle details are needed. Formulations are distinguished by report, without new procedures or treatment guidance.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original product, manufacture, composition, exposure, use records and comparator-vehicle details are needed. Formulations are distinguished by report, without new procedures or treatment guidance." }, { "item_id": "N09", "question_type": "Evidence condition", "question": "Are tension-type headache and migraine populations distinguished?", "needed": "Eligibility and attack characteristics in acute tension-type headache", "role": "Required", "role_reason": "Material on Eligibility and attack characteristics in acute tension-type headache is needed to connect the selected active-comparator question with formulation, population, comparator, timing, scales, denominators, precision and harms.", "application_exception": "Original details absent from the summary remain unverified. Selected D and the absence of individual score, status and axes are retained without inheriting parent D28. No new effect, CI, margin, sample size, grade, equivalence, safety or independence certification, or use or treatment guidance is created.", "criterion": "Original material on Eligibility and attack characteristics in acute tension-type headache must link to the report-specific population, formulation, comparator, time, endpoint, denominators and prespecified analysis, distinguishing direct comparison, parent context, historical calculation and unread external materials.", "basis": "Preserved principles distinguishing questions, comparators, reports and trials, endpoints, denominators and harms informed production.", "condition_origin": "These are evidence conditions for the existing selected question. They do not establish preregistration, use of an official assessment tool or completed content review.", "proposed_research": "Material needed: Original diagnostic criteria, frequency, severity, baseline pain, exclusions, comorbidity and recruitment information are needed. Findings are not extended to other headaches or populations. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "The displayed records exist in the preserved parent summary. External availability, acquisition and reading of detailed materials remain separately unverified.", "acquired_read": "Stored parent summary and bibliography read; external abstracts, full text, registered results, registration, protocols and SAPs unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Original diagnostic criteria, frequency, severity, baseline pain, exclusions, comorbidity and recruitment information are needed. Findings are not extended to other headaches or populations.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original diagnostic criteria, frequency, severity, baseline pain, exclusions, comorbidity and recruitment information are needed. Findings are not extended to other headaches or populations." }, { "item_id": "N10", "question_type": "Evidence condition", "question": "Are pain after 15 minutes and response at 120 minutes the same endpoint?", "needed": "Timing and scales of early pain intensity and later VPRS response", "role": "Required", "role_reason": "Material on Timing and scales of early pain intensity and later VPRS response is needed to connect the selected active-comparator question with formulation, population, comparator, timing, scales, denominators, precision and harms.", "application_exception": "Original details absent from the summary remain unverified. Selected D and the absence of individual score, status and axes are retained without inheriting parent D28. No new effect, CI, margin, sample size, grade, equivalence, safety or independence certification, or use or treatment guidance is created.", "criterion": "Original material on Timing and scales of early pain intensity and later VPRS response must link to the report-specific population, formulation, comparator, time, endpoint, denominators and prespecified analysis, distinguishing direct comparison, parent context, historical calculation and unread external materials.", "basis": "Preserved principles distinguishing questions, comparators, reports and trials, endpoints, denominators and harms informed production.", "condition_origin": "These are evidence conditions for the existing selected question. They do not establish preregistration, use of an official assessment tool or completed content review.", "proposed_research": "Material needed: Each scale, response definition, baseline and follow-up, denominators, original analysis and prespecified hierarchy are needed. Times and scales are not converted or results merged. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "The displayed records exist in the preserved parent summary. External availability, acquisition and reading of detailed materials remain separately unverified.", "acquired_read": "Stored parent summary and bibliography read; external abstracts, full text, registered results, registration, protocols and SAPs unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "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.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "item_id": "N11", "question_type": "Evidence condition", "question": "What are the later trial's starting size and analysis denominators?", "needed": "Distinction between 209 started, 189 in FAS and 94 versus 95", "role": "Required", "role_reason": "Material on Distinction between 209 started, 189 in FAS and 94 versus 95 is needed to connect the selected active-comparator question with formulation, population, comparator, timing, scales, denominators, precision and harms.", "application_exception": "Original details absent from the summary remain unverified. Selected D and the absence of individual score, status and axes are retained without inheriting parent D28. No new effect, CI, margin, sample size, grade, equivalence, safety or independence certification, or use or treatment guidance is created.", "criterion": "Original material on Distinction between 209 started, 189 in FAS and 94 versus 95 must link to the report-specific population, formulation, comparator, time, endpoint, denominators and prespecified analysis, distinguishing direct comparison, parent context, historical calculation and unread external materials.", "basis": "Preserved principles distinguishing questions, comparators, reports and trials, endpoints, denominators and harms informed production.", "condition_origin": "These are evidence conditions for the existing selected question. They do not establish preregistration, use of an official assessment tool or completed content review.", "proposed_research": "Material needed: Allocation, treatment and completion flow, FAS definition, exclusion and missingness reasons, and original arm-specific analysis populations are needed. No new count difference, response rate or effect is calculated. This records needed materials; no new research was executed.", "current_reports": [ "R02" ], "existence": "The displayed records exist in the preserved parent summary. External availability, acquisition and reading of detailed materials remain separately unverified.", "acquired_read": "Stored parent summary and bibliography read; external abstracts, full text, registered results, registration, protocols and SAPs unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "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.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "item_id": "N12", "question_type": "Evidence condition", "question": "Is failure of the later first primary endpoint's threshold retained?", "needed": "Prespecified one-sided Fisher .025 threshold and hierarchical gate", "role": "Required", "role_reason": "Material on Prespecified one-sided Fisher .025 threshold and hierarchical gate is needed to connect the selected active-comparator question with formulation, population, comparator, timing, scales, denominators, precision and harms.", "application_exception": "Original details absent from the summary remain unverified. Selected D and the absence of individual score, status and axes are retained without inheriting parent D28. No new effect, CI, margin, sample size, grade, equivalence, safety or independence certification, or use or treatment guidance is created.", "criterion": "Original material on Prespecified one-sided Fisher .025 threshold and hierarchical gate must link to the report-specific population, formulation, comparator, time, endpoint, denominators and prespecified analysis, distinguishing direct comparison, parent context, historical calculation and unread external materials.", "basis": "Preserved principles distinguishing questions, comparators, reports and trials, endpoints, denominators and harms informed production.", "condition_origin": "These are evidence conditions for the existing selected question. They do not establish preregistration, use of an official assessment tool or completed content review.", "proposed_research": "Material needed: Original registered results, prespecified plan, testing, denominators, direct effect and CI are needed. The original criterion is not replaced by a different two-sided .05 criterion. This records needed materials; no new research was executed.", "current_reports": [ "R02" ], "existence": "The displayed records exist in the preserved parent summary. External availability, acquisition and reading of detailed materials remain separately unverified.", "acquired_read": "Stored parent summary and bibliography read; external abstracts, full text, registered results, registration, protocols and SAPs unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "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.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "item_id": "N13", "question_type": "Evidence condition", "question": "Was two-sided Fisher P≈.101 calculated in this work?", "needed": "Distinction between the historical Codex calculation from counts and original trial results", "role": "Required", "role_reason": "Material on Distinction between the historical Codex calculation from counts and original trial results is needed to connect the selected active-comparator question with formulation, population, comparator, timing, scales, denominators, precision and harms.", "application_exception": "Original details absent from the summary remain unverified. Selected D and the absence of individual score, status and axes are retained without inheriting parent D28. No new effect, CI, margin, sample size, grade, equivalence, safety or independence certification, or use or treatment guidance is created.", "criterion": "Original material on Distinction between the historical Codex calculation from counts and original trial results must link to the report-specific population, formulation, comparator, time, endpoint, denominators and prespecified analysis, distinguishing direct comparison, parent context, historical calculation and unread external materials.", "basis": "Preserved principles distinguishing questions, comparators, reports and trials, endpoints, denominators and harms informed production.", "condition_origin": "These are evidence conditions for the existing selected question. They do not establish preregistration, use of an official assessment tool or completed content review.", "proposed_research": "Material needed: Original results and analysis plan, and a separate record of the historical calculation, are needed. No statistical recalculation or new effect or CI is produced here. This records needed materials; no new research was executed.", "current_reports": [ "R02" ], "existence": "The displayed records exist in the preserved parent summary. External availability, acquisition and reading of detailed materials remain separately unverified.", "acquired_read": "Stored parent summary and bibliography read; external abstracts, full text, registered results, registration, protocols and SAPs unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "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.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "item_id": "N14", "question_type": "Evidence condition", "question": "Is VAS-SPID treated as confirmatory after the first primary endpoint failed?", "needed": "Exploratory context of the hierarchically second endpoint", "role": "Required", "role_reason": "Material on Exploratory context of the hierarchically second endpoint is needed to connect the selected active-comparator question with formulation, population, comparator, timing, scales, denominators, precision and harms.", "application_exception": "Original details absent from the summary remain unverified. Selected D and the absence of individual score, status and axes are retained without inheriting parent D28. No new effect, CI, margin, sample size, grade, equivalence, safety or independence certification, or use or treatment guidance is created.", "criterion": "Original material on Exploratory context of the hierarchically second endpoint must link to the report-specific population, formulation, comparator, time, endpoint, denominators and prespecified analysis, distinguishing direct comparison, parent context, historical calculation and unread external materials.", "basis": "Preserved principles distinguishing questions, comparators, reports and trials, endpoints, denominators and harms informed production.", "condition_origin": "These are evidence conditions for the existing selected question. They do not establish preregistration, use of an official assessment tool or completed content review.", "proposed_research": "Material needed: The prespecified hierarchy, original second-endpoint result, CI, denominators, adjustment and testing procedures are needed. Unread values are not filled in. This records needed materials; no new research was executed.", "current_reports": [ "R02" ], "existence": "The displayed records exist in the preserved parent summary. External availability, acquisition and reading of detailed materials remain separately unverified.", "acquired_read": "Stored parent summary and bibliography read; external abstracts, full text, registered results, registration, protocols and SAPs unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "The prespecified hierarchy, original second-endpoint result, CI, denominators, adjustment and testing procedures are needed. Unread values are not filled in.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "The prespecified hierarchy, original second-endpoint result, CI, denominators, adjustment and testing procedures are needed. Unread values are not filled in." }, { "item_id": "N15", "question_type": "Evidence condition", "question": "Is the later placebo-controlled trial an active-comparator equivalence trial?", "needed": "Distinction between the later placebo comparison and early acetaminophen comparison", "role": "Required", "role_reason": "Material on Distinction between the later placebo comparison and early acetaminophen comparison is needed to connect the selected active-comparator question with formulation, population, comparator, timing, scales, denominators, precision and harms.", "application_exception": "Original details absent from the summary remain unverified. Selected D and the absence of individual score, status and axes are retained without inheriting parent D28. No new effect, CI, margin, sample size, grade, equivalence, safety or independence certification, or use or treatment guidance is created.", "criterion": "Original material on Distinction between the later placebo comparison and early acetaminophen comparison must link to the report-specific population, formulation, comparator, time, endpoint, denominators and prespecified analysis, distinguishing direct comparison, parent context, historical calculation and unread external materials.", "basis": "Preserved principles distinguishing questions, comparators, reports and trials, endpoints, denominators and harms informed production.", "condition_origin": "These are evidence conditions for the existing selected question. They do not establish preregistration, use of an official assessment tool or completed content review.", "proposed_research": "Material needed: Prespecified active-comparator design, margin and CI directly addressing the selected question are needed. Results against a different comparator do not replace them. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "The displayed records exist in the preserved parent summary. External availability, acquisition and reading of detailed materials remain separately unverified.", "acquired_read": "Stored parent summary and bibliography read; external abstracts, full text, registered results, registration, protocols and SAPs unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Prespecified active-comparator design, margin and CI directly addressing the selected question are needed. Results against a different comparator do not replace them.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Prespecified active-comparator design, margin and CI directly addressing the selected question are needed. Results against a different comparator do not replace them." }, { "item_id": "N16", "question_type": "Evidence condition", "question": "Are the prespecified equivalence margin and power known?", "needed": "Patient-important margin, sample-size plan, ITT and PP", "role": "Required", "role_reason": "Material on Patient-important margin, sample-size plan, ITT and PP is needed to connect the selected active-comparator question with formulation, population, comparator, timing, scales, denominators, precision and harms.", "application_exception": "Original details absent from the summary remain unverified. Selected D and the absence of individual score, status and axes are retained without inheriting parent D28. No new effect, CI, margin, sample size, grade, equivalence, safety or independence certification, or use or treatment guidance is created.", "criterion": "Original material on Patient-important margin, sample-size plan, ITT and PP must link to the report-specific population, formulation, comparator, time, endpoint, denominators and prespecified analysis, distinguishing direct comparison, parent context, historical calculation and unread external materials.", "basis": "Preserved principles distinguishing questions, comparators, reports and trials, endpoints, denominators and harms informed production.", "condition_origin": "These are evidence conditions for the existing selected question. They do not establish preregistration, use of an official assessment tool or completed content review.", "proposed_research": "Material needed: The basis for a prespecified clinical margin, sample-size plan, direct CI, ITT and PP definitions and sensitivity analyses are needed. No new margin or sample size is calculated. This records needed materials; no new research was executed.", "current_reports": [ "R01" ], "existence": "The displayed records exist in the preserved parent summary. External availability, acquisition and reading of detailed materials remain separately unverified.", "acquired_read": "Stored parent summary and bibliography read; external abstracts, full text, registered results, registration, protocols and SAPs unread", "observation": "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.", "condition_status": "Unverified", "status_reason": "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.", "missingness": "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.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "item_id": "N17", "question_type": "Evidence condition", "question": "Does rapid pain relief establish sustained recovery or recurrence prevention?", "needed": "Acute pain and response versus persistence, recurrence and rescue-medication outcomes", "role": "Required", "role_reason": "Material on Acute pain and response versus persistence, recurrence and rescue-medication outcomes is needed to connect the selected active-comparator question with formulation, population, comparator, timing, scales, denominators, precision and harms.", "application_exception": "Original details absent from the summary remain unverified. Selected D and the absence of individual score, status and axes are retained without inheriting parent D28. No new effect, CI, margin, sample size, grade, equivalence, safety or independence certification, or use or treatment guidance is created.", "criterion": "Original material on Acute pain and response versus persistence, recurrence and rescue-medication outcomes must link to the report-specific population, formulation, comparator, time, endpoint, denominators and prespecified analysis, distinguishing direct comparison, parent context, historical calculation and unread external materials.", "basis": "Preserved principles distinguishing questions, comparators, reports and trials, endpoints, denominators and harms informed production.", "condition_origin": "These are evidence conditions for the existing selected question. They do not establish preregistration, use of an official assessment tool or completed content review.", "proposed_research": "Material needed: Original definitions, denominators, effects and CIs for complete pain freedom, persistence, recurrence, rescue medication and patient-important outcomes are needed. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "The displayed records exist in the preserved parent summary. External availability, acquisition and reading of detailed materials remain separately unverified.", "acquired_read": "Stored parent summary and bibliography read; external abstracts, full text, registered results, registration, protocols and SAPs unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Original definitions, denominators, effects and CIs for complete pain freedom, persistence, recurrence, rescue medication and patient-important outcomes are needed.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original definitions, denominators, effects and CIs for complete pain freedom, persistence, recurrence, rescue medication and patient-important outcomes are needed." }, { "item_id": "N18", "question_type": "Evidence condition", "question": "Are early positive findings and later failure both retained?", "needed": "Early and later reports, and directness for the equivalence question", "role": "Required", "role_reason": "Material on Early and later reports, and directness for the equivalence question is needed to connect the selected active-comparator question with formulation, population, comparator, timing, scales, denominators, precision and harms.", "application_exception": "Original details absent from the summary remain unverified. Selected D and the absence of individual score, status and axes are retained without inheriting parent D28. No new effect, CI, margin, sample size, grade, equivalence, safety or independence certification, or use or treatment guidance is created.", "criterion": "Original material on Early and later reports, and directness for the equivalence question must link to the report-specific population, formulation, comparator, time, endpoint, denominators and prespecified analysis, distinguishing direct comparison, parent context, historical calculation and unread external materials.", "basis": "Preserved principles distinguishing questions, comparators, reports and trials, endpoints, denominators and harms informed production.", "condition_origin": "These are evidence conditions for the existing selected question. They do not establish preregistration, use of an official assessment tool or completed content review.", "proposed_research": "Material needed: Original material distinguishing products, populations, times, comparators, denominators, prespecified endpoints, effects and CIs in the two reports is needed. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "The displayed records exist in the preserved parent summary. External availability, acquisition and reading of detailed materials remain separately unverified.", "acquired_read": "Stored parent summary and bibliography read; external abstracts, full text, registered results, registration, protocols and SAPs unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Original material distinguishing products, populations, times, comparators, denominators, prespecified endpoints, effects and CIs in the two reports is needed.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original material distinguishing products, populations, times, comparators, denominators, prespecified endpoints, effects and CIs in the two reports is needed." }, { "item_id": "N19", "question_type": "Evidence condition", "question": "Are funding, products, authorship and design or analysis involvement separated?", "needed": "Independence assessed by specific support and involvement categories", "role": "Required", "role_reason": "Material on Independence assessed by specific support and involvement categories is needed to connect the selected active-comparator question with formulation, population, comparator, timing, scales, denominators, precision and harms.", "application_exception": "Original details absent from the summary remain unverified. Selected D and the absence of individual score, status and axes are retained without inheriting parent D28. No new effect, CI, margin, sample size, grade, equivalence, safety or independence certification, or use or treatment guidance is created.", "criterion": "Original material on Independence assessed by specific support and involvement categories must link to the report-specific population, formulation, comparator, time, endpoint, denominators and prespecified analysis, distinguishing direct comparison, parent context, historical calculation and unread external materials.", "basis": "Preserved principles distinguishing questions, comparators, reports and trials, endpoints, denominators and harms informed production.", "condition_origin": "These are evidence conditions for the existing selected question. They do not establish preregistration, use of an official assessment tool or completed content review.", "proposed_research": "Material needed: Separate material on research funding, product provision, author affiliations and involvement in design, analysis and publication is needed. Sponsorship alone does not fill other categories. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "The displayed records exist in the preserved parent summary. External availability, acquisition and reading of detailed materials remain separately unverified.", "acquired_read": "Stored parent summary and bibliography read; external abstracts, full text, registered results, registration, protocols and SAPs unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "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.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "item_id": "N20", "question_type": "Evidence condition", "question": "Are denominators and collection methods for skin and eye harms known?", "needed": "Topical harm events, exposure, routes and vulnerable groups", "role": "Supplementary", "role_reason": "Material on Topical harm events, exposure, routes and vulnerable groups is needed to connect the selected active-comparator question with formulation, population, comparator, timing, scales, denominators, precision and harms.", "application_exception": "Original details absent from the summary remain unverified. Selected D and the absence of individual score, status and axes are retained without inheriting parent D28. No new effect, CI, margin, sample size, grade, equivalence, safety or independence certification, or use or treatment guidance is created.", "criterion": "Original material on Topical harm events, exposure, routes and vulnerable groups must link to the report-specific population, formulation, comparator, time, endpoint, denominators and prespecified analysis, distinguishing direct comparison, parent context, historical calculation and unread external materials.", "basis": "Preserved principles distinguishing questions, comparators, reports and trials, endpoints, denominators and harms informed production.", "condition_origin": "These are evidence conditions for the existing selected question. They do not establish preregistration, use of an official assessment tool or completed content review.", "proposed_research": "Material needed: Harm collection, events and affected people, severity, timing, exposure, arm-specific denominators and actual inclusion of children, eyes or mucosa are needed. No new use or treatment guidance is created. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "The displayed records exist in the preserved parent summary. External availability, acquisition and reading of detailed materials remain separately unverified.", "acquired_read": "Stored parent summary and bibliography read; external abstracts, full text, registered results, registration, protocols and SAPs unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "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.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "item_id": "N21", "question_type": "Evidence condition", "question": "Are shared reports and repeated attacks added as independent studies?", "needed": "Two reports, shared subquestions and registered-result versions", "role": "Required", "role_reason": "Material on Two reports, shared subquestions and registered-result versions is needed to connect the selected active-comparator question with formulation, population, comparator, timing, scales, denominators, precision and harms.", "application_exception": "Original details absent from the summary remain unverified. Selected D and the absence of individual score, status and axes are retained without inheriting parent D28. No new effect, CI, margin, sample size, grade, equivalence, safety or independence certification, or use or treatment guidance is created.", "criterion": "Original material on Two reports, shared subquestions and registered-result versions must link to the report-specific population, formulation, comparator, time, endpoint, denominators and prespecified analysis, distinguishing direct comparison, parent context, historical calculation and unread external materials.", "basis": "Preserved principles distinguishing questions, comparators, reports and trials, endpoints, denominators and harms informed production.", "condition_origin": "These are evidence conditions for the existing selected question. They do not establish preregistration, use of an official assessment tool or completed content review.", "proposed_research": "Material needed: Links among original trials, reports, sites, recruitment, participants and registration versions are needed. Unique trial, participant and independent-replication counts remain unverified. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "The displayed records exist in the preserved parent summary. External availability, acquisition and reading of detailed materials remain separately unverified.", "acquired_read": "Stored parent summary and bibliography read; external abstracts, full text, registered results, registration, protocols and SAPs unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Links among original trials, reports, sites, recruitment, participants and registration versions are needed. Unique trial, participant and independent-replication counts remain unverified.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Links among original trials, reports, sites, recruitment, participants and registration versions are needed. Unique trial, participant and independent-replication counts remain unverified." }, { "item_id": "N22", "question_type": "Evidence condition", "question": "Are registration IDs and posting dates distinguished from current reading?", "needed": "NCT01770080, EudraCT and posting of results version 1", "role": "Required", "role_reason": "Material on NCT01770080, EudraCT and posting of results version 1 is needed to connect the selected active-comparator question with formulation, population, comparator, timing, scales, denominators, precision and harms.", "application_exception": "Original details absent from the summary remain unverified. Selected D and the absence of individual score, status and axes are retained without inheriting parent D28. No new effect, CI, margin, sample size, grade, equivalence, safety or independence certification, or use or treatment guidance is created.", "criterion": "Original material on NCT01770080, EudraCT and posting of results version 1 must link to the report-specific population, formulation, comparator, time, endpoint, denominators and prespecified analysis, distinguishing direct comparison, parent context, historical calculation and unread external materials.", "basis": "Preserved principles distinguishing questions, comparators, reports and trials, endpoints, denominators and harms informed production.", "condition_origin": "These are evidence conditions for the existing selected question. They do not establish preregistration, use of an official assessment tool or completed content review.", "proposed_research": "Material needed: Actual original registration, plan, amendments and result-version materials are needed. The early record is not converted into a new registry-search conclusion, or a link into completed reading. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "The displayed records exist in the preserved parent summary. External availability, acquisition and reading of detailed materials remain separately unverified.", "acquired_read": "Stored parent summary and bibliography read; external abstracts, full text, registered results, registration, protocols and SAPs unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "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.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "item_id": "N23", "question_type": "Evidence condition", "question": "Are selected D and parent D28, Caution and axes distinguished?", "needed": "Selected subclaim grade and absence of individual score, status and axes", "role": "Required", "role_reason": "Material on Selected subclaim grade and absence of individual score, status and axes is needed to connect the selected active-comparator question with formulation, population, comparator, timing, scales, denominators, precision and harms.", "application_exception": "Original details absent from the summary remain unverified. Selected D and the absence of individual score, status and axes are retained without inheriting parent D28. No new effect, CI, margin, sample size, grade, equivalence, safety or independence certification, or use or treatment guidance is created.", "criterion": "Original material on Selected subclaim grade and absence of individual score, status and axes must link to the report-specific population, formulation, comparator, time, endpoint, denominators and prespecified analysis, distinguishing direct comparison, parent context, historical calculation and unread external materials.", "basis": "Preserved principles distinguishing questions, comparators, reports and trials, endpoints, denominators and harms informed production.", "condition_origin": "These are evidence conditions for the existing selected question. They do not establish preregistration, use of an official assessment tool or completed content review.", "proposed_research": "Material needed: Content review of the subquestion and parent boundary remains incomplete. No new grade, score, clinical status or certification of independence is created. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "The displayed records exist in the preserved parent summary. External availability, acquisition and reading of detailed materials remain separately unverified.", "acquired_read": "Stored parent summary and bibliography read; external abstracts, full text, registered results, registration, protocols and SAPs unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Content review of the subquestion and parent boundary remains incomplete. No new grade, score, clinical status or certification of independence is created.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Content review of the subquestion and parent boundary remains incomplete. No new grade, score, clinical status or certification of independence is created." }, { "item_id": "N24", "question_type": "Evidence condition", "question": "Are stored-summary reading and external-original reading distinguished?", "needed": "Materials actually read, separated by type", "role": "Required", "role_reason": "Material on Materials actually read, separated by type is needed to connect the selected active-comparator question with formulation, population, comparator, timing, scales, denominators, precision and harms.", "application_exception": "Original details absent from the summary remain unverified. Selected D and the absence of individual score, status and axes are retained without inheriting parent D28. No new effect, CI, margin, sample size, grade, equivalence, safety or independence certification, or use or treatment guidance is created.", "criterion": "Original material on Materials actually read, separated by type must link to the report-specific population, formulation, comparator, time, endpoint, denominators and prespecified analysis, distinguishing direct comparison, parent context, historical calculation and unread external materials.", "basis": "Preserved principles distinguishing questions, comparators, reports and trials, endpoints, denominators and harms informed production.", "condition_origin": "These are evidence conditions for the existing selected question. They do not establish preregistration, use of an official assessment tool or completed content review.", "proposed_research": "Material needed: External acquisition, reading and content review are separate events. A link does not establish original reading, accessibility or completed review. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "The displayed records exist in the preserved parent summary. External availability, acquisition and reading of detailed materials remain separately unverified.", "acquired_read": "Stored parent summary and bibliography read; external abstracts, full text, registered results, registration, protocols and SAPs unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "External acquisition, reading and content review are separate events. A link does not establish original reading, accessibility or completed review.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "External acquisition, reading and content review are separate events. A link does not establish original reading, accessibility or completed review." }, { "item_id": "N25", "question_type": "Evidence condition", "question": "How far do representative values in the Korean and English accounts apply?", "needed": "Scope of language-specific accounts and representative formulation, population and endpoint", "role": "Required", "role_reason": "Material on Scope of language-specific accounts and representative formulation, population and endpoint is needed to connect the selected active-comparator question with formulation, population, comparator, timing, scales, denominators, precision and harms.", "application_exception": "Original details absent from the summary remain unverified. Selected D and the absence of individual score, status and axes are retained without inheriting parent D28. No new effect, CI, margin, sample size, grade, equivalence, safety or independence certification, or use or treatment guidance is created.", "criterion": "Original material on Scope of language-specific accounts and representative formulation, population and endpoint must link to the report-specific population, formulation, comparator, time, endpoint, denominators and prespecified analysis, distinguishing direct comparison, parent context, historical calculation and unread external materials.", "basis": "Preserved principles distinguishing questions, comparators, reports and trials, endpoints, denominators and harms informed production.", "condition_origin": "These are evidence conditions for the existing selected question. They do not establish preregistration, use of an official assessment tool or completed content review.", "proposed_research": "Material needed: Original material comparing report-specific populations, formulations, comparators, endpoints, times and denominators is needed. No current comparison with external English originals or correction review was performed. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "The displayed records exist in the preserved parent summary. External availability, acquisition and reading of detailed materials remain separately unverified.", "acquired_read": "Stored parent summary and bibliography read; external abstracts, full text, registered results, registration, protocols and SAPs unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "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.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "item_id": "N26", "question_type": "Evidence condition", "question": "Are the evidence date, empty correction history and production time distinguished?", "needed": "Original evidence date versus correction and change events", "role": "Required", "role_reason": "Material on Original evidence date versus correction and change events is needed to connect the selected active-comparator question with formulation, population, comparator, timing, scales, denominators, precision and harms.", "application_exception": "Original details absent from the summary remain unverified. Selected D and the absence of individual score, status and axes are retained without inheriting parent D28. No new effect, CI, margin, sample size, grade, equivalence, safety or independence certification, or use or treatment guidance is created.", "criterion": "Original material on Original evidence date versus correction and change events must link to the report-specific population, formulation, comparator, time, endpoint, denominators and prespecified analysis, distinguishing direct comparison, parent context, historical calculation and unread external materials.", "basis": "Preserved principles distinguishing questions, comparators, reports and trials, endpoints, denominators and harms informed production.", "condition_origin": "These are evidence conditions for the existing selected question. They do not establish preregistration, use of an official assessment tool or completed content review.", "proposed_research": "Material needed: Material additions, criterion revisions, observation application and verdict changes must preserve the complete prior account and distinguish events, versions and reasons. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "The displayed records exist in the preserved parent summary. External availability, acquisition and reading of detailed materials remain separately unverified.", "acquired_read": "Stored parent summary and bibliography read; external abstracts, full text, registered results, registration, protocols and SAPs unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Material additions, criterion revisions, observation application and verdict changes must preserve the complete prior account and distinguish events, versions and reasons.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Material additions, criterion revisions, observation application and verdict changes must preserve the complete prior account and distinguish events, versions and reasons." }, { "item_id": "N27", "question_type": "Evidence condition", "question": "Do report or material-slot counts represent unique trials or quality scores?", "needed": "Table structure versus unique clinical units and actual reading", "role": "Required", "role_reason": "Material on Table structure versus unique clinical units and actual reading is needed to connect the selected active-comparator question with formulation, population, comparator, timing, scales, denominators, precision and harms.", "application_exception": "Original details absent from the summary remain unverified. Selected D and the absence of individual score, status and axes are retained without inheriting parent D28. No new effect, CI, margin, sample size, grade, equivalence, safety or independence certification, or use or treatment guidance is created.", "criterion": "Original material on Table structure versus unique clinical units and actual reading must link to the report-specific population, formulation, comparator, time, endpoint, denominators and prespecified analysis, distinguishing direct comparison, parent context, historical calculation and unread external materials.", "basis": "Preserved principles distinguishing questions, comparators, reports and trials, endpoints, denominators and harms informed production.", "condition_origin": "These are evidence conditions for the existing selected question. They do not establish preregistration, use of an official assessment tool or completed content review.", "proposed_research": "Material needed: Original trial, report and cohort links, and actual acquisition and reading records, are needed. Unique trial and participant counts remain unverified. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "The displayed records exist in the preserved parent summary. External availability, acquisition and reading of detailed materials remain separately unverified.", "acquired_read": "Stored parent summary and bibliography read; external abstracts, full text, registered results, registration, protocols and SAPs unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Original trial, report and cohort links, and actual acquisition and reading records, are needed. Unique trial and participant counts remain unverified.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original trial, report and cohort links, and actual acquisition and reading records, are needed. Unique trial and participant counts remain unverified." }, { "item_id": "N28", "question_type": "Evidence condition", "question": "Where should new material and corrections be linked?", "needed": "Distinction between criterion revision, material updates and verdict changes", "role": "Required", "role_reason": "Material on Distinction between criterion revision, material updates and verdict changes is needed to connect the selected active-comparator question with formulation, population, comparator, timing, scales, denominators, precision and harms.", "application_exception": "Original details absent from the summary remain unverified. Selected D and the absence of individual score, status and axes are retained without inheriting parent D28. No new effect, CI, margin, sample size, grade, equivalence, safety or independence certification, or use or treatment guidance is created.", "criterion": "Original material on Distinction between criterion revision, material updates and verdict changes must link to the report-specific population, formulation, comparator, time, endpoint, denominators and prespecified analysis, distinguishing direct comparison, parent context, historical calculation and unread external materials.", "basis": "Preserved principles distinguishing questions, comparators, reports and trials, endpoints, denominators and harms informed production.", "condition_origin": "These are evidence conditions for the existing selected question. They do not establish preregistration, use of an official assessment tool or completed content review.", "proposed_research": "Material needed: After acquisition and content review, the complete prior account must be preserved and events, versions and reasons recorded. No new procedures, treatment guidance or calculations are created. This records needed materials; no new research was executed.", "current_reports": [ "R01", "R02" ], "existence": "The displayed records exist in the preserved parent summary. External availability, acquisition and reading of detailed materials remain separately unverified.", "acquired_read": "Stored parent summary and bibliography read; external abstracts, full text, registered results, registration, protocols and SAPs unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "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.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "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." } ], "reports": [ { "report_id": "R01", "title": "Göbel H et al. 1996", "url": "https://pubmed.ncbi.nlm.nih.gov/8805113/", "report_type": "Randomized double-blind repeated-attack crossover trial; early active comparison", "existence": "The stored parent summary contains the report and bibliographic link. Current acquisition, access and content verification of external originals were not performed.", "acquired_read": "Only the stored parent summary and bibliography were read. External abstracts, full text, registration, protocols and SAPs are unread.", "study_family": "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.", "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.", "observed_result": "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.", "result_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.", "source_evidence_date": "2026-09-07", "materials": [ { "material_type": "Stored existing review summary", "public_status": "Preserved copy of the complete parent-verdict stored summary", "access_status": "Stored summary", "acquired": true, "actually_read": "Summary read", "as_of": "2026-09-07", "qualification": "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." }, { "material_type": "External abstract", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "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." }, { "material_type": "External full text", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "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." }, { "material_type": "Registration material", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "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." }, { "material_type": "Protocol and analysis plan", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "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." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/8805113/" } ] }, { "report_id": "R02", "title": "Euminz tension-type headache phase 4 study · later registered results", "url": "https://www.clinicaltrialsregister.eu/ctr-search/trial/2011-004777-89/results", "report_type": "Registered placebo-controlled phase 4 trial; separate context for active-comparator equivalence", "existence": "The stored parent summary contains the report and bibliographic link. Current acquisition, access and content verification of external originals were not performed.", "acquired_read": "Only the stored parent summary and bibliography were read. External abstracts, full text, registration, protocols and SAPs are unread.", "study_family": "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.", "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.", "observed_result": "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.", "result_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.", "source_evidence_date": "2026-09-07", "materials": [ { "material_type": "Stored existing review summary", "public_status": "Preserved copy of the complete parent-verdict stored summary", "access_status": "Stored summary", "acquired": true, "actually_read": "Summary read", "as_of": "2026-09-07", "qualification": "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." }, { "material_type": "External abstract", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "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." }, { "material_type": "External full text", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "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." }, { "material_type": "Registration material", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "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." }, { "material_type": "Protocol and analysis plan", "public_status": "Original bibliographic link or needed material; external public availability/access status unverified", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "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." } ], "links": [ { "label": "Official source", "url": "https://www.clinicaltrialsregister.eu/ctr-search/trial/2011-004777-89/results" } ] } ], "method_sources": [ { "id": "M03", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03", "section": "§3.1, §3.2.1–3.2.3, MECIR C5/C7/C13", "official_principle": "Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.", "review_level": "Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed." }, { "id": "M04", "version": "Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04", "section": "§4.5, §4.6.1–4.6.3, MECIR C42", "official_principle": "Distinguish studies from reports and link them; do not omit a study solely because results are unreported.", "review_level": "Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed." }, { "id": "M08", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08", "section": "§8.1–8.2.3, Table 8.2.a", "official_principle": "Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.", "review_level": "Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed." }, { "id": "M15", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15", "section": "§15.2.4, §15.3.1–15.3.3", "official_principle": "Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.", "review_level": "Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed." }, { "id": "M19", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19", "section": "§19.1.2, §19.2.1–19.2.4", "official_principle": "Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.", "review_level": "Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed." } ], "status_dictionary": { "Partly verified": "Partial information from the stored summary is linked; detailed originals and content review remain incomplete.", "Unverified": "Required details cannot be established within the preserved scope. This does not establish absence of effects or studies, or safety.", "Review incomplete": "Review of existing content remains incomplete.", "Met": "This state is used only within the relevant conditions after material verification and content review. It was not automatically assigned in this work.", "Not reported": "Unreported within material actually read. Unread external material is not relabeled as unreported.", "Inaccessible": "This means actual access failure. External access was not attempted in this work, so this state was not assigned.", "Not applicable": "Used only with an application exception and reason based on the question scope.", "Conflicting data": "This requires actual comparison of materials; no new conflict judgment was made in this work.", "Insufficient evidence for the conditions": "This indicates gaps in additional material for the selected conditions. Unread material as a whole is not converted into an efficacy grade." }, "study_overlap": { "state": "Unverified", "unique_trial_count": null, "unique_participant_count": null, "reason": "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." }, "history": [ { "date": "2026-10-20", "kind": "Separation of public-facing pages and materials", "view_version": "1.0", "change": "Public-facing views and materials were prepared from the existing 28 items. No new clinical search, verification-status change or scoring was performed." } ], "language": "en", "translation_date": "2026-10-20" }