# Topical 10% peppermint oil × Response at 120 minutes in acute tension-type headache Verdict 3010 · Evidence Check Stored-material review date: Not recorded Original evidence cut-off: 2026-09-07 Review-criteria version: 1.0 Public page/material preparation date: 2026-10-20 Clinical papers were not read directly; existing review summaries were checked. No new clinical-literature search was performed. Unverified does not mean that research is absent or that there is no effect. ## Assessment scope - Population: The selected outcome concerns the S02 registered phase 4 trial in episodic tension-type headache, preserving 209 starters, 189 in FAS and 94 versus 95. Diagnosis, age, eligibility and analysis-exclusion details are unverified. S01's 41 participants and 164 attacks belong to a different report context and are not added or used as the same denominator. - Ingredient, formulation and route: The account concerns topical 10% peppermint oil in ethanol repeatedly applied to the forehead and temples. S02's exact vehicle, ethanol concentration, manufacturing and quality are not linked. Findings are not extended to inhaled aroma, oral capsules or migraine. - Dose: S01's 10% oil, 90% ethanol and 0, 15 and 30-minute schedule are preserved early-crossover conditions. They are not automatically assigned as S02's application amount, repeat schedule or identical formulation. No new dose calculations, preparation or personal-use instructions are created. - Comparator: The direct selected outcome is S02's comparison with placebo. Exact vehicle, sensory matching, blinding, concurrent care and rescue-medication details are unverified. S01's vehicle or acetaminophen comparison and the equivalence question are separate contexts. - Measured outcome: The first primary endpoint is 120-minute VPRS response, 37/94 versus 28/95, preserving failure to meet the prespecified one-sided Fisher .025 threshold. The hierarchically second VAS-SPID endpoint is exploratory. Two-sided P≈.101 is a historical Codex calculation, not the trial's prespecified one-sided P or a new calculation in this work. - Duration: The selection is acute response at 120 minutes, distinct from S01's pain findings from 15 minutes. Other follow-up measurement windows, repeated use, long-term outcomes and harms in vulnerable groups are unverified. An early-time signal is not converted into persistent follow-up effects. - Questions outside this scope: Do not convert the early 41 participants and 164 attacks into the same participant count or follow-up analysis denominator.; Do not transfer early 90% ethanol or the 0, 15 and 30-minute schedule as the follow-up trial's identical formulation or application schedule.; Distinguish the values and attribution of the prespecified one-sided .025 threshold and historical two-sided P≈.101 without a new calculation.; Do not convert exploratory VAS-SPID or no difference from acetaminophen into selected-response success or equivalence.; Do not add registration identifiers, reports or sharing across parent and subclaims as new independent trial, participant or replication totals, or create new application guidance. ## Checklist items ### N01 · How does the selected 120-minute response differ from the parent verdict? Verification status: Partly verified Reading scope: Stored parent summary and bibliography read; external papers, registered results, registration, plans and support documents unread - Current findings: The selection is response at 120 minutes in acute tension-type headache, with original subclaim D. The explanation that the larger registered trial's first primary endpoint missed its prespecified threshold is retained, with parent D28 kept as separate context. - Why unverified: This information was transferred from the stored summary with the selected question distinguished from parent materials. Detailed originals and review of existing content remain incomplete; it does not establish clinical certification or review approval. - Reason for missing information: Individual score, status and axes are absent from the selection. Original selected and parent records must be linked without automatically assigning parent values to the subclaim. - Required materials and conditions: Distinction between the selected question, grade, original explanation and parent context - Materials to obtain first: Individual score, status and axes are absent from the selection. Original selected and parent records must be linked without automatically assigning parent values to the subclaim. - Further research: Material needed: Individual score, status and axes are absent from the selection. Original selected and parent records must be linked without automatically assigning parent values to the subclaim. This records needed materials; no new research was executed. - Conditions for verification: Original material for Distinction between the selected question, grade, original explanation and parent context must be linked to the relevant report's formulation, timing, outcome, arm-specific denominators and analysis plan, distinguishing direct findings, parent context, historical calculations and unread external material. - Why this condition is needed: This condition links Distinction between the selected question, grade, original explanation and parent context with population, formulation, control, timing, measures, denominators, prespecified analysis and harms for the selected acute response, distinguishing the early-report context. - Application exceptions: Retain selected D and absent individual score, status and axes without inheriting parent D28. Distinguish early crossover and follow-up registered trials, participants and attacks, prespecified one-sided testing, historical two-sided calculations and the separate equivalence question. No new effects, CIs, denominators, replication totals, grades, application or treatment instructions are created. - Remaining uncertainty: The missed prespecified threshold, early positive finding, precision gaps and historical calculation attribution are retained together. Exact one-sided P, effects, CIs, response definitions, arm labels, missingness, formulation, blinding, support roles and harms details are unverified. Linking stored summaries is not converted into original-material reading, new formal assessment, equivalence, exact zero effects or safety certification. - Referenced methods: Preserved application criteria were used to distinguish questions, comparisons, reports and trials, outcomes, denominators and harms. - Related sources: S01, S02 ### N02 · Which population with acute tension-type headache was studied? Verification status: Partly verified Reading scope: Stored parent summary and bibliography read; external papers, registered results, registration, plans and support documents unread - Current findings: The S02 bibliography records a placebo-controlled phase 4 trial in episodic tension-type headache. Migraine is excluded from the parent account's research scope and is not treated as the same population. - Why unverified: This information was transferred from the stored summary with the selected question distinguished from parent materials. Detailed originals and review of existing content remain incomplete; it does not establish clinical certification or review approval. - Reason for missing information: Original diagnostic, inclusion and exclusion, age, baseline pain, comorbidity and attack-selection rules are needed. Detailed eligibility absent from the stored summary is not filled in. - Required materials and conditions: Diagnosis, eligibility, age and attack selection in the follow-up trial - Materials to obtain first: Original diagnostic, inclusion and exclusion, age, baseline pain, comorbidity and attack-selection rules are needed. Detailed eligibility absent from the stored summary is not filled in. - Further research: Material needed: Original diagnostic, inclusion and exclusion, age, baseline pain, comorbidity and attack-selection rules are needed. Detailed eligibility absent from the stored summary is not filled in. This records needed materials; no new research was executed. - Conditions for verification: Original material for Diagnosis, eligibility, age and attack selection in the follow-up trial must be linked to the relevant report's formulation, timing, outcome, arm-specific denominators and analysis plan, distinguishing direct findings, parent context, historical calculations and unread external material. - Why this condition is needed: This condition links Diagnosis, eligibility, age and attack selection in the follow-up trial with population, formulation, control, timing, measures, denominators, prespecified analysis and harms for the selected acute response, distinguishing the early-report context. - Application exceptions: Retain selected D and absent individual score, status and axes without inheriting parent D28. Distinguish early crossover and follow-up registered trials, participants and attacks, prespecified one-sided testing, historical two-sided calculations and the separate equivalence question. No new effects, CIs, denominators, replication totals, grades, application or treatment instructions are created. - Remaining uncertainty: The missed prespecified threshold, early positive finding, precision gaps and historical calculation attribution are retained together. Exact one-sided P, effects, CIs, response definitions, arm labels, missingness, formulation, blinding, support roles and harms details are unverified. Linking stored summaries is not converted into original-material reading, new formal assessment, equivalence, exact zero effects or safety certification. - Referenced methods: Preserved application criteria were used to distinguish questions, comparisons, reports and trials, outcomes, denominators and harms. - Related sources: S02 ### N03 · Which 10% topical peppermint-oil formulation was studied? Verification status: Partly verified Reading scope: Stored parent summary and bibliography read; external papers, registered results, registration, plans and support documents unread - Current findings: The parent account concerns repeated application of a 10% peppermint-oil ethanol solution to the forehead and temples. Inhaled aroma and oral enteric capsules are different interventions. - Why unverified: This information was transferred from the stored summary with the selected question distinguished from parent materials. Detailed originals and review of existing content remain incomplete; it does not establish clinical certification or review approval. - Reason for missing information: S02 product, manufacturing, quality, vehicle, ethanol concentration and application specifications are needed. The early formulation is not automatically treated as identical to the follow-up formulation. - Required materials and conditions: Topical formulation, concentration, vehicle, quality and application sites - Materials to obtain first: S02 product, manufacturing, quality, vehicle, ethanol concentration and application specifications are needed. The early formulation is not automatically treated as identical to the follow-up formulation. - Further research: Material needed: S02 product, manufacturing, quality, vehicle, ethanol concentration and application specifications are needed. The early formulation is not automatically treated as identical to the follow-up formulation. This records needed materials; no new research was executed. - Conditions for verification: Original material for Topical formulation, concentration, vehicle, quality and application sites must be linked to the relevant report's formulation, timing, outcome, arm-specific denominators and analysis plan, distinguishing direct findings, parent context, historical calculations and unread external material. - Why this condition is needed: This condition links Topical formulation, concentration, vehicle, quality and application sites with population, formulation, control, timing, measures, denominators, prespecified analysis and harms for the selected acute response, distinguishing the early-report context. - Application exceptions: Retain selected D and absent individual score, status and axes without inheriting parent D28. Distinguish early crossover and follow-up registered trials, participants and attacks, prespecified one-sided testing, historical two-sided calculations and the separate equivalence question. No new effects, CIs, denominators, replication totals, grades, application or treatment instructions are created. - Remaining uncertainty: The missed prespecified threshold, early positive finding, precision gaps and historical calculation attribution are retained together. Exact one-sided P, effects, CIs, response definitions, arm labels, missingness, formulation, blinding, support roles and harms details are unverified. Linking stored summaries is not converted into original-material reading, new formal assessment, equivalence, exact zero effects or safety certification. - Referenced methods: Preserved application criteria were used to distinguish questions, comparisons, reports and trials, outcomes, denominators and harms. - Related sources: S02 ### N04 · Which trial used 90% ethanol and the 0/15/30-minute schedule? Verification status: Partly verified Reading scope: Stored parent summary and bibliography read; external papers, registered results, registration, plans and support documents unread - Current findings: S01's 10% oil, 90% ethanol and application at 0, 15 and 30 minutes are early-trial conditions in the preserved account. They are not transferred as S02's exact formulation or schedule. - Why unverified: This information was transferred from the stored summary with the selected question distinguished from parent materials. Detailed originals and review of existing content remain incomplete; it does not establish clinical certification or review approval. - Reason for missing information: Follow-up application amount, volume, frequency, timing, vehicle and adherence records are needed. No new undiluted preparation or personal-use instructions are created. - Required materials and conditions: Distinction between concentrations, application amounts and repeat schedules in the early and follow-up trials - Materials to obtain first: Follow-up application amount, volume, frequency, timing, vehicle and adherence records are needed. No new undiluted preparation or personal-use instructions are created. - Further research: Material needed: Follow-up application amount, volume, frequency, timing, vehicle and adherence records are needed. No new undiluted preparation or personal-use instructions are created. This records needed materials; no new research was executed. - Conditions for verification: Original material for Distinction between concentrations, application amounts and repeat schedules in the early and follow-up trials must be linked to the relevant report's formulation, timing, outcome, arm-specific denominators and analysis plan, distinguishing direct findings, parent context, historical calculations and unread external material. - Why this condition is needed: This condition links Distinction between concentrations, application amounts and repeat schedules in the early and follow-up trials with population, formulation, control, timing, measures, denominators, prespecified analysis and harms for the selected acute response, distinguishing the early-report context. - Application exceptions: Retain selected D and absent individual score, status and axes without inheriting parent D28. Distinguish early crossover and follow-up registered trials, participants and attacks, prespecified one-sided testing, historical two-sided calculations and the separate equivalence question. No new effects, CIs, denominators, replication totals, grades, application or treatment instructions are created. - Remaining uncertainty: The missed prespecified threshold, early positive finding, precision gaps and historical calculation attribution are retained together. Exact one-sided P, effects, CIs, response definitions, arm labels, missingness, formulation, blinding, support roles and harms details are unverified. Linking stored summaries is not converted into original-material reading, new formal assessment, equivalence, exact zero effects or safety certification. - Referenced methods: Preserved application criteria were used to distinguish questions, comparisons, reports and trials, outcomes, denominators and harms. - Related sources: S01, S02 ### N05 · Are the placebo vehicle and blinding procedures verified? Verification status: Unverified Reading scope: Stored parent summary and bibliography read; external papers, registered results, registration, plans and support documents unread - Current findings: S02 is described as placebo-controlled and S01 as a double-blind crossover trial. Design labels alone do not verify odor, cooling, irritation matching or successful blinding in the follow-up trial. - Why unverified: This information was transferred from the stored summary with the selected question distinguished from parent materials. Detailed originals and review of existing content remain incomplete; it does not establish clinical certification or review approval. - Reason for missing information: S02 control formulation, vehicle, sensory differences, blinding procedures and assessment records are needed. Unread external material is not converted into procedure verification or blinding failure. - Required materials and conditions: Sensory matching and participant and assessor blinding in the follow-up trial - Materials to obtain first: S02 control formulation, vehicle, sensory differences, blinding procedures and assessment records are needed. Unread external material is not converted into procedure verification or blinding failure. - Further research: Material needed: S02 control formulation, vehicle, sensory differences, blinding procedures and assessment records are needed. Unread external material is not converted into procedure verification or blinding failure. This records needed materials; no new research was executed. - Conditions for verification: Original material for Sensory matching and participant and assessor blinding in the follow-up trial must be linked to the relevant report's formulation, timing, outcome, arm-specific denominators and analysis plan, distinguishing direct findings, parent context, historical calculations and unread external material. - Why this condition is needed: This condition links Sensory matching and participant and assessor blinding in the follow-up trial with population, formulation, control, timing, measures, denominators, prespecified analysis and harms for the selected acute response, distinguishing the early-report context. - Application exceptions: Retain selected D and absent individual score, status and axes without inheriting parent D28. Distinguish early crossover and follow-up registered trials, participants and attacks, prespecified one-sided testing, historical two-sided calculations and the separate equivalence question. No new effects, CIs, denominators, replication totals, grades, application or treatment instructions are created. - Remaining uncertainty: The missed prespecified threshold, early positive finding, precision gaps and historical calculation attribution are retained together. Exact one-sided P, effects, CIs, response definitions, arm labels, missingness, formulation, blinding, support roles and harms details are unverified. Linking stored summaries is not converted into original-material reading, new formal assessment, equivalence, exact zero effects or safety certification. - Referenced methods: Preserved application criteria were used to distinguish questions, comparisons, reports and trials, outcomes, denominators and harms. - Related sources: S02 ### N06 · How are 209 starters and 189 in FAS distinguished? Verification status: Partly verified Reading scope: Stored parent summary and bibliography read; external papers, registered results, registration, plans and support documents unread - Current findings: S02 preserves 209 starters, 189 in FAS and 94 versus 95. Starting size and analysis population are not treated as identical, and their difference is not calculated into a new dropout count. - Why unverified: This information was transferred from the stored summary with the selected question distinguished from parent materials. Detailed originals and review of existing content remain incomplete; it does not establish clinical certification or review approval. - Reason for missing information: Original flow diagrams, arm-specific allocation, FAS definitions, exclusion reasons and other analysis populations are needed. Preserved counts are not arbitrarily relabeled as recruitment, allocation or completion counts. - Required materials and conditions: Participant flow across starting, allocation, analysis populations and individual outcomes - Materials to obtain first: Original flow diagrams, arm-specific allocation, FAS definitions, exclusion reasons and other analysis populations are needed. Preserved counts are not arbitrarily relabeled as recruitment, allocation or completion counts. - Further research: Material needed: Original flow diagrams, arm-specific allocation, FAS definitions, exclusion reasons and other analysis populations are needed. Preserved counts are not arbitrarily relabeled as recruitment, allocation or completion counts. This records needed materials; no new research was executed. - Conditions for verification: Original material for Participant flow across starting, allocation, analysis populations and individual outcomes must be linked to the relevant report's formulation, timing, outcome, arm-specific denominators and analysis plan, distinguishing direct findings, parent context, historical calculations and unread external material. - Why this condition is needed: This condition links Participant flow across starting, allocation, analysis populations and individual outcomes with population, formulation, control, timing, measures, denominators, prespecified analysis and harms for the selected acute response, distinguishing the early-report context. - Application exceptions: Retain selected D and absent individual score, status and axes without inheriting parent D28. Distinguish early crossover and follow-up registered trials, participants and attacks, prespecified one-sided testing, historical two-sided calculations and the separate equivalence question. No new effects, CIs, denominators, replication totals, grades, application or treatment instructions are created. - Remaining uncertainty: The missed prespecified threshold, early positive finding, precision gaps and historical calculation attribution are retained together. Exact one-sided P, effects, CIs, response definitions, arm labels, missingness, formulation, blinding, support roles and harms details are unverified. Linking stored summaries is not converted into original-material reading, new formal assessment, equivalence, exact zero effects or safety certification. - Referenced methods: Preserved application criteria were used to distinguish questions, comparisons, reports and trials, outcomes, denominators and harms. - Related sources: S02 ### N07 · How are 120-minute responders and denominators linked? Verification status: Partly verified Reading scope: Stored parent summary and bibliography read; external papers, registered results, registration, plans and support documents unread - Current findings: The preserved S02 comparison is 37/94 versus 28/95. These counts are retained without inventing original arm labels or handling of missing assessments that are not linked in the summary. - Why unverified: This information was transferred from the stored summary with the selected question distinguished from parent materials. Detailed originals and review of existing content remain incomplete; it does not establish clinical certification or review approval. - Reason for missing information: Original arm-specific VPRS tables, denominator definitions, arm labels and missing-data handling are needed. New response rates, effects or CIs are not calculated. - Required materials and conditions: Correspondence between original arm labels, responders, denominators and analysis populations - Materials to obtain first: Original arm-specific VPRS tables, denominator definitions, arm labels and missing-data handling are needed. New response rates, effects or CIs are not calculated. - Further research: Material needed: Original arm-specific VPRS tables, denominator definitions, arm labels and missing-data handling are needed. New response rates, effects or CIs are not calculated. This records needed materials; no new research was executed. - Conditions for verification: Original material for Correspondence between original arm labels, responders, denominators and analysis populations must be linked to the relevant report's formulation, timing, outcome, arm-specific denominators and analysis plan, distinguishing direct findings, parent context, historical calculations and unread external material. - Why this condition is needed: This condition links Correspondence between original arm labels, responders, denominators and analysis populations with population, formulation, control, timing, measures, denominators, prespecified analysis and harms for the selected acute response, distinguishing the early-report context. - Application exceptions: Retain selected D and absent individual score, status and axes without inheriting parent D28. Distinguish early crossover and follow-up registered trials, participants and attacks, prespecified one-sided testing, historical two-sided calculations and the separate equivalence question. No new effects, CIs, denominators, replication totals, grades, application or treatment instructions are created. - Remaining uncertainty: The missed prespecified threshold, early positive finding, precision gaps and historical calculation attribution are retained together. Exact one-sided P, effects, CIs, response definitions, arm labels, missingness, formulation, blinding, support roles and harms details are unverified. Linking stored summaries is not converted into original-material reading, new formal assessment, equivalence, exact zero effects or safety certification. - Referenced methods: Preserved application criteria were used to distinguish questions, comparisons, reports and trials, outcomes, denominators and harms. - Related sources: S02 ### N08 · How were FAS exclusions and missing outcomes handled? Verification status: Unverified Reading scope: Stored parent summary and bibliography read; external papers, registered results, registration, plans and support documents unread - Current findings: The account gives 189 in FAS and 120-minute response counts. This is not converted into complete outcome data for every participant or verification of all analysis rules. - Why unverified: This information was transferred from the stored summary with the selected question distinguished from parent materials. Detailed originals and review of existing content remain incomplete; it does not establish clinical certification or review approval. - Reason for missing information: FAS, ITT and PP definitions, handling of exclusions, missingness, rescue medication and protocol deviations, and sensitivity analyses are needed. Unverified missing-data policies are not invented. - Required materials and conditions: Analysis populations, missing assessments, rescue medication and sensitivity analyses - Materials to obtain first: FAS, ITT and PP definitions, handling of exclusions, missingness, rescue medication and protocol deviations, and sensitivity analyses are needed. Unverified missing-data policies are not invented. - Further research: Material needed: FAS, ITT and PP definitions, handling of exclusions, missingness, rescue medication and protocol deviations, and sensitivity analyses are needed. Unverified missing-data policies are not invented. This records needed materials; no new research was executed. - Conditions for verification: Original material for Analysis populations, missing assessments, rescue medication and sensitivity analyses must be linked to the relevant report's formulation, timing, outcome, arm-specific denominators and analysis plan, distinguishing direct findings, parent context, historical calculations and unread external material. - Why this condition is needed: This condition links Analysis populations, missing assessments, rescue medication and sensitivity analyses with population, formulation, control, timing, measures, denominators, prespecified analysis and harms for the selected acute response, distinguishing the early-report context. - Application exceptions: Retain selected D and absent individual score, status and axes without inheriting parent D28. Distinguish early crossover and follow-up registered trials, participants and attacks, prespecified one-sided testing, historical two-sided calculations and the separate equivalence question. No new effects, CIs, denominators, replication totals, grades, application or treatment instructions are created. - Remaining uncertainty: The missed prespecified threshold, early positive finding, precision gaps and historical calculation attribution are retained together. Exact one-sided P, effects, CIs, response definitions, arm labels, missingness, formulation, blinding, support roles and harms details are unverified. Linking stored summaries is not converted into original-material reading, new formal assessment, equivalence, exact zero effects or safety certification. - Referenced methods: Preserved application criteria were used to distinguish questions, comparisons, reports and trials, outcomes, denominators and harms. - Related sources: S02 ### N09 · What is the exact definition of a VPRS response? Verification status: Partly verified Reading scope: Stored parent summary and bibliography read; external papers, registered results, registration, plans and support documents unread - Current findings: S02's first primary endpoint is VPRS response at 120 minutes. Its name alone does not establish the scale range, response threshold, baseline conditions or exact assessment window. - Why unverified: This information was transferred from the stored summary with the selected question distinguished from parent materials. Detailed originals and review of existing content remain incomplete; it does not establish clinical certification or review approval. - Reason for missing information: Original VPRS items, response criteria, baseline pain, assessment manuals and timing are needed. Definitions absent from the stored summary are not added. - Required materials and conditions: Scale, response threshold, baseline conditions, assessors and measurement window - Materials to obtain first: Original VPRS items, response criteria, baseline pain, assessment manuals and timing are needed. Definitions absent from the stored summary are not added. - Further research: Material needed: Original VPRS items, response criteria, baseline pain, assessment manuals and timing are needed. Definitions absent from the stored summary are not added. This records needed materials; no new research was executed. - Conditions for verification: Original material for Scale, response threshold, baseline conditions, assessors and measurement window must be linked to the relevant report's formulation, timing, outcome, arm-specific denominators and analysis plan, distinguishing direct findings, parent context, historical calculations and unread external material. - Why this condition is needed: This condition links Scale, response threshold, baseline conditions, assessors and measurement window with population, formulation, control, timing, measures, denominators, prespecified analysis and harms for the selected acute response, distinguishing the early-report context. - Application exceptions: Retain selected D and absent individual score, status and axes without inheriting parent D28. Distinguish early crossover and follow-up registered trials, participants and attacks, prespecified one-sided testing, historical two-sided calculations and the separate equivalence question. No new effects, CIs, denominators, replication totals, grades, application or treatment instructions are created. - Remaining uncertainty: The missed prespecified threshold, early positive finding, precision gaps and historical calculation attribution are retained together. Exact one-sided P, effects, CIs, response definitions, arm labels, missingness, formulation, blinding, support roles and harms details are unverified. Linking stored summaries is not converted into original-material reading, new formal assessment, equivalence, exact zero effects or safety certification. - Referenced methods: Preserved application criteria were used to distinguish questions, comparisons, reports and trials, outcomes, denominators and harms. - Related sources: S02 ### N10 · Is the 120-minute response the same as early pain findings from 15 minutes? Verification status: Partly verified Reading scope: Stored parent summary and bibliography read; external papers, registered results, registration, plans and support documents unread - Current findings: S01 concerns pain intensity from 15 minutes, while S02 concerns VPRS response at 120 minutes. Different time points and measures are not combined as one result, and the early signal is not converted into confirmation of the later response. - Why unverified: This information was transferred from the stored summary with the selected question distinguished from parent materials. Detailed originals and review of existing content remain incomplete; it does not establish clinical certification or review approval. - Reason for missing information: Time-specific results, scales, prespecified outcomes and analysis units from both reports are needed. Persistence or the same target effect is not inferred without direct linking information. - Required materials and conditions: Distinction between trial-specific time points, scales and assessment units - Materials to obtain first: Time-specific results, scales, prespecified outcomes and analysis units from both reports are needed. Persistence or the same target effect is not inferred without direct linking information. - Further research: Material needed: Time-specific results, scales, prespecified outcomes and analysis units from both reports are needed. Persistence or the same target effect is not inferred without direct linking information. This records needed materials; no new research was executed. - Conditions for verification: Original material for Distinction between trial-specific time points, scales and assessment units must be linked to the relevant report's formulation, timing, outcome, arm-specific denominators and analysis plan, distinguishing direct findings, parent context, historical calculations and unread external material. - Why this condition is needed: This condition links Distinction between trial-specific time points, scales and assessment units with population, formulation, control, timing, measures, denominators, prespecified analysis and harms for the selected acute response, distinguishing the early-report context. - Application exceptions: Retain selected D and absent individual score, status and axes without inheriting parent D28. Distinguish early crossover and follow-up registered trials, participants and attacks, prespecified one-sided testing, historical two-sided calculations and the separate equivalence question. No new effects, CIs, denominators, replication totals, grades, application or treatment instructions are created. - Remaining uncertainty: The missed prespecified threshold, early positive finding, precision gaps and historical calculation attribution are retained together. Exact one-sided P, effects, CIs, response definitions, arm labels, missingness, formulation, blinding, support roles and harms details are unverified. Linking stored summaries is not converted into original-material reading, new formal assessment, equivalence, exact zero effects or safety certification. - Referenced methods: Preserved application criteria were used to distinguish questions, comparisons, reports and trials, outcomes, denominators and harms. - Related sources: S01, S02 ### N11 · What was the prespecified order of the first primary endpoint and VAS-SPID? Verification status: Partly verified Reading scope: Stored parent summary and bibliography read; external papers, registered results, registration, plans and support documents unread - Current findings: The account distinguishes 120-minute VPRS as the first primary endpoint and VAS-SPID as hierarchically second. The original interpretation of the latter as exploratory after the first threshold was missed is retained. - Why unverified: This information was transferred from the stored summary with the selected question distinguished from parent materials. Detailed originals and review of existing content remain incomplete; it does not establish clinical certification or review approval. - Reason for missing information: Complete initial registration, protocols, analysis plans, amendment history and hierarchy rules are needed. Preserved statements about prespecification are not converted into current reading of original plans. - Required materials and conditions: Hierarchy and testing rules for VPRS and VAS-SPID - Materials to obtain first: Complete initial registration, protocols, analysis plans, amendment history and hierarchy rules are needed. Preserved statements about prespecification are not converted into current reading of original plans. - Further research: Material needed: Complete initial registration, protocols, analysis plans, amendment history and hierarchy rules are needed. Preserved statements about prespecification are not converted into current reading of original plans. This records needed materials; no new research was executed. - Conditions for verification: Original material for Hierarchy and testing rules for VPRS and VAS-SPID must be linked to the relevant report's formulation, timing, outcome, arm-specific denominators and analysis plan, distinguishing direct findings, parent context, historical calculations and unread external material. - Why this condition is needed: This condition links Hierarchy and testing rules for VPRS and VAS-SPID with population, formulation, control, timing, measures, denominators, prespecified analysis and harms for the selected acute response, distinguishing the early-report context. - Application exceptions: Retain selected D and absent individual score, status and axes without inheriting parent D28. Distinguish early crossover and follow-up registered trials, participants and attacks, prespecified one-sided testing, historical two-sided calculations and the separate equivalence question. No new effects, CIs, denominators, replication totals, grades, application or treatment instructions are created. - Remaining uncertainty: The missed prespecified threshold, early positive finding, precision gaps and historical calculation attribution are retained together. Exact one-sided P, effects, CIs, response definitions, arm labels, missingness, formulation, blinding, support roles and harms details are unverified. Linking stored summaries is not converted into original-material reading, new formal assessment, equivalence, exact zero effects or safety certification. - Referenced methods: Preserved application criteria were used to distinguish questions, comparisons, reports and trials, outcomes, denominators and harms. - Related sources: S02 ### N12 · What is the prespecified one-sided Fisher .025 threshold? Verification status: Partly verified Reading scope: Stored parent summary and bibliography read; external papers, registered results, registration, plans and support documents unread - Current findings: S02 is preserved as having missed its prespecified one-sided Fisher .025 threshold. The original trial's exact one-sided P value and analysis output are not linked in the summary. - Why unverified: This information was transferred from the stored summary with the selected question distinguished from parent materials. Detailed originals and review of existing content remain incomplete; it does not establish clinical certification or review approval. - Reason for missing information: Original prespecified testing plans, direction, significance level, exact P value and analysis output are needed. A two-sided calculation is not substituted for the prespecified one-sided result. - Required materials and conditions: Prespecified test direction, significance level, exact P value and decision rule - Materials to obtain first: Original prespecified testing plans, direction, significance level, exact P value and analysis output are needed. A two-sided calculation is not substituted for the prespecified one-sided result. - Further research: Material needed: Original prespecified testing plans, direction, significance level, exact P value and analysis output are needed. A two-sided calculation is not substituted for the prespecified one-sided result. This records needed materials; no new research was executed. - Conditions for verification: Original material for Prespecified test direction, significance level, exact P value and decision rule must be linked to the relevant report's formulation, timing, outcome, arm-specific denominators and analysis plan, distinguishing direct findings, parent context, historical calculations and unread external material. - Why this condition is needed: This condition links Prespecified test direction, significance level, exact P value and decision rule with population, formulation, control, timing, measures, denominators, prespecified analysis and harms for the selected acute response, distinguishing the early-report context. - Application exceptions: Retain selected D and absent individual score, status and axes without inheriting parent D28. Distinguish early crossover and follow-up registered trials, participants and attacks, prespecified one-sided testing, historical two-sided calculations and the separate equivalence question. No new effects, CIs, denominators, replication totals, grades, application or treatment instructions are created. - Remaining uncertainty: The missed prespecified threshold, early positive finding, precision gaps and historical calculation attribution are retained together. Exact one-sided P, effects, CIs, response definitions, arm labels, missingness, formulation, blinding, support roles and harms details are unverified. Linking stored summaries is not converted into original-material reading, new formal assessment, equivalence, exact zero effects or safety certification. - Referenced methods: Preserved application criteria were used to distinguish questions, comparisons, reports and trials, outcomes, denominators and harms. - Related sources: S02 ### N13 · Whose calculation is the two-sided Fisher P≈.101? Verification status: Partly verified Reading scope: Stored parent summary and bibliography read; external papers, registered results, registration, plans and support documents unread - Current findings: The preserved evidence explicitly attributes the count-based two-sided Fisher P≈.101 to a historical Codex recalculation. Its value and attribution are retained without a new calculation or reproduction in this work. - Why unverified: This information was transferred from the stored summary with the selected question distinguished from parent materials. Detailed originals and review of existing content remain incomplete; it does not establish clinical certification or review approval. - Reason for missing information: Original prespecified analysis output and historical calculation records are separately needed. The historical value is not relabeled as a one-sided P value prespecified and reported by the trial. - Required materials and conditions: Distinction between the original prespecified analysis and the historical Codex calculation - Materials to obtain first: Original prespecified analysis output and historical calculation records are separately needed. The historical value is not relabeled as a one-sided P value prespecified and reported by the trial. - Further research: Material needed: Original prespecified analysis output and historical calculation records are separately needed. The historical value is not relabeled as a one-sided P value prespecified and reported by the trial. This records needed materials; no new research was executed. - Conditions for verification: Original material for Distinction between the original prespecified analysis and the historical Codex calculation must be linked to the relevant report's formulation, timing, outcome, arm-specific denominators and analysis plan, distinguishing direct findings, parent context, historical calculations and unread external material. - Why this condition is needed: This condition links Distinction between the original prespecified analysis and the historical Codex calculation with population, formulation, control, timing, measures, denominators, prespecified analysis and harms for the selected acute response, distinguishing the early-report context. - Application exceptions: Retain selected D and absent individual score, status and axes without inheriting parent D28. Distinguish early crossover and follow-up registered trials, participants and attacks, prespecified one-sided testing, historical two-sided calculations and the separate equivalence question. No new effects, CIs, denominators, replication totals, grades, application or treatment instructions are created. - Remaining uncertainty: The missed prespecified threshold, early positive finding, precision gaps and historical calculation attribution are retained together. Exact one-sided P, effects, CIs, response definitions, arm labels, missingness, formulation, blinding, support roles and harms details are unverified. Linking stored summaries is not converted into original-material reading, new formal assessment, equivalence, exact zero effects or safety certification. - Referenced methods: Preserved application criteria were used to distinguish questions, comparisons, reports and trials, outcomes, denominators and harms. - Related sources: S02 ### N14 · Are precision and importance of the 120-minute effect established? Verification status: Unverified Reading scope: Stored parent summary and bibliography read; external papers, registered results, registration, plans and support documents unread - Current findings: Response counts, failure to meet the prespecified threshold and the parent explanation of a direction favoring benefit are preserved together. These alone do not establish an exact effect range or absence of clinically important benefit. - Why unverified: This information was transferred from the stored summary with the selected question distinguished from parent materials. Detailed originals and review of existing content remain incomplete; it does not establish clinical certification or review approval. - Reason for missing information: Original between-arm estimates, CIs, effect measures, clinical importance thresholds and sample-size plans are needed. New RDs, RRs, CIs or importance thresholds are not calculated. - Required materials and conditions: Original between-arm effect measure, CI, clinical importance threshold and sample-size plan - Materials to obtain first: Original between-arm estimates, CIs, effect measures, clinical importance thresholds and sample-size plans are needed. New RDs, RRs, CIs or importance thresholds are not calculated. - Further research: Material needed: Original between-arm estimates, CIs, effect measures, clinical importance thresholds and sample-size plans are needed. New RDs, RRs, CIs or importance thresholds are not calculated. This records needed materials; no new research was executed. - Conditions for verification: Original material for Original between-arm effect measure, CI, clinical importance threshold and sample-size plan must be linked to the relevant report's formulation, timing, outcome, arm-specific denominators and analysis plan, distinguishing direct findings, parent context, historical calculations and unread external material. - Why this condition is needed: This condition links Original between-arm effect measure, CI, clinical importance threshold and sample-size plan with population, formulation, control, timing, measures, denominators, prespecified analysis and harms for the selected acute response, distinguishing the early-report context. - Application exceptions: Retain selected D and absent individual score, status and axes without inheriting parent D28. Distinguish early crossover and follow-up registered trials, participants and attacks, prespecified one-sided testing, historical two-sided calculations and the separate equivalence question. No new effects, CIs, denominators, replication totals, grades, application or treatment instructions are created. - Remaining uncertainty: The missed prespecified threshold, early positive finding, precision gaps and historical calculation attribution are retained together. Exact one-sided P, effects, CIs, response definitions, arm labels, missingness, formulation, blinding, support roles and harms details are unverified. Linking stored summaries is not converted into original-material reading, new formal assessment, equivalence, exact zero effects or safety certification. - Referenced methods: Preserved application criteria were used to distinguish questions, comparisons, reports and trials, outcomes, denominators and harms. - Related sources: S02 ### N15 · Does missing the prespecified threshold establish an exact zero effect? Verification status: Partly verified Reading scope: Stored parent summary and bibliography read; external papers, registered results, registration, plans and support documents unread - Current findings: The parent account explains that 37/94 versus 28/95 favors benefit in direction but does not prove an exact zero effect and missed the prespecified threshold. This distinction is retained. - Why unverified: This information was transferred from the stored summary with the selected question distinguished from parent materials. Detailed originals and review of existing content remain incomplete; it does not establish clinical certification or review approval. - Reason for missing information: Original estimates, CIs and testing plans are needed. This is not converted into exact zero effects, equivalence, established efficacy or a new grade. - Required materials and conditions: Separate preservation of the failed threshold, effect direction and uncertainty - Materials to obtain first: Original estimates, CIs and testing plans are needed. This is not converted into exact zero effects, equivalence, established efficacy or a new grade. - Further research: Material needed: Original estimates, CIs and testing plans are needed. This is not converted into exact zero effects, equivalence, established efficacy or a new grade. This records needed materials; no new research was executed. - Conditions for verification: Original material for Separate preservation of the failed threshold, effect direction and uncertainty must be linked to the relevant report's formulation, timing, outcome, arm-specific denominators and analysis plan, distinguishing direct findings, parent context, historical calculations and unread external material. - Why this condition is needed: This condition links Separate preservation of the failed threshold, effect direction and uncertainty with population, formulation, control, timing, measures, denominators, prespecified analysis and harms for the selected acute response, distinguishing the early-report context. - Application exceptions: Retain selected D and absent individual score, status and axes without inheriting parent D28. Distinguish early crossover and follow-up registered trials, participants and attacks, prespecified one-sided testing, historical two-sided calculations and the separate equivalence question. No new effects, CIs, denominators, replication totals, grades, application or treatment instructions are created. - Remaining uncertainty: The missed prespecified threshold, early positive finding, precision gaps and historical calculation attribution are retained together. Exact one-sided P, effects, CIs, response definitions, arm labels, missingness, formulation, blinding, support roles and harms details are unverified. Linking stored summaries is not converted into original-material reading, new formal assessment, equivalence, exact zero effects or safety certification. - Referenced methods: Preserved application criteria were used to distinguish questions, comparisons, reports and trials, outcomes, denominators and harms. - Related sources: S02 ### N16 · How far can the second VAS-SPID endpoint be interpreted? Verification status: Partly verified Reading scope: Stored parent summary and bibliography read; external papers, registered results, registration, plans and support documents unread - Current findings: The account treats the second VAS-SPID endpoint as exploratory after the first primary endpoint failed. It is not substituted as success for the selected 120-minute VPRS response. - Why unverified: This information was transferred from the stored summary with the selected question distinguished from parent materials. Detailed originals and review of existing content remain incomplete; it does not establish clinical certification or review approval. - Reason for missing information: Original VAS-SPID definitions, result tables, estimates, CIs, P values and prespecified hierarchy are needed. Exact findings absent from the summary are not invented. - Required materials and conditions: VAS-SPID definition, time window, estimation and interpretation after hierarchical testing - Materials to obtain first: Original VAS-SPID definitions, result tables, estimates, CIs, P values and prespecified hierarchy are needed. Exact findings absent from the summary are not invented. - Further research: Material needed: Original VAS-SPID definitions, result tables, estimates, CIs, P values and prespecified hierarchy are needed. Exact findings absent from the summary are not invented. This records needed materials; no new research was executed. - Conditions for verification: Original material for VAS-SPID definition, time window, estimation and interpretation after hierarchical testing must be linked to the relevant report's formulation, timing, outcome, arm-specific denominators and analysis plan, distinguishing direct findings, parent context, historical calculations and unread external material. - Why this condition is needed: This condition links VAS-SPID definition, time window, estimation and interpretation after hierarchical testing with population, formulation, control, timing, measures, denominators, prespecified analysis and harms for the selected acute response, distinguishing the early-report context. - Application exceptions: Retain selected D and absent individual score, status and axes without inheriting parent D28. Distinguish early crossover and follow-up registered trials, participants and attacks, prespecified one-sided testing, historical two-sided calculations and the separate equivalence question. No new effects, CIs, denominators, replication totals, grades, application or treatment instructions are created. - Remaining uncertainty: The missed prespecified threshold, early positive finding, precision gaps and historical calculation attribution are retained together. Exact one-sided P, effects, CIs, response definitions, arm labels, missingness, formulation, blinding, support roles and harms details are unverified. Linking stored summaries is not converted into original-material reading, new formal assessment, equivalence, exact zero effects or safety certification. - Referenced methods: Preserved application criteria were used to distinguish questions, comparisons, reports and trials, outcomes, denominators and harms. - Related sources: S02 ### N17 · Do the early 41 participants and 164 attacks represent the same denominator? Verification status: Partly verified Reading scope: Stored parent summary and bibliography read; external papers, registered results, registration, plans and support documents unread - Current findings: S01 is a repeated-attack crossover trial with 41 participants and 164 headache attacks. The 164 attacks are not relabeled as participants or used as the follow-up trial's analysis denominator. - Why unverified: This information was transferred from the stored summary with the selected question distinguished from parent materials. Detailed originals and review of existing content remain incomplete; it does not establish clinical certification or review approval. - Reason for missing information: Attacks per patient, patient and attack flow, correlation structure, completion denominators and analysis models are needed. New participant or event totals are not created. - Required materials and conditions: Distinction between patients, repeated attacks, treatment order and analysis units - Materials to obtain first: Attacks per patient, patient and attack flow, correlation structure, completion denominators and analysis models are needed. New participant or event totals are not created. - Further research: Material needed: Attacks per patient, patient and attack flow, correlation structure, completion denominators and analysis models are needed. New participant or event totals are not created. This records needed materials; no new research was executed. - Conditions for verification: Original material for Distinction between patients, repeated attacks, treatment order and analysis units must be linked to the relevant report's formulation, timing, outcome, arm-specific denominators and analysis plan, distinguishing direct findings, parent context, historical calculations and unread external material. - Why this condition is needed: This condition links Distinction between patients, repeated attacks, treatment order and analysis units with population, formulation, control, timing, measures, denominators, prespecified analysis and harms for the selected acute response, distinguishing the early-report context. - Application exceptions: Retain selected D and absent individual score, status and axes without inheriting parent D28. Distinguish early crossover and follow-up registered trials, participants and attacks, prespecified one-sided testing, historical two-sided calculations and the separate equivalence question. No new effects, CIs, denominators, replication totals, grades, application or treatment instructions are created. - Remaining uncertainty: The missed prespecified threshold, early positive finding, precision gaps and historical calculation attribution are retained together. Exact one-sided P, effects, CIs, response definitions, arm labels, missingness, formulation, blinding, support roles and harms details are unverified. Linking stored summaries is not converted into original-material reading, new formal assessment, equivalence, exact zero effects or safety certification. - Referenced methods: Preserved application criteria were used to distinguish questions, comparisons, reports and trials, outcomes, denominators and harms. - Related sources: S01 ### N18 · Are sequence, period and carryover effects in the crossover trial verified? Verification status: Unverified Reading scope: Stored parent summary and bibliography read; external papers, registered results, registration, plans and support documents unread - Current findings: S01's randomized, double-blind, repeated-attack crossover design labels are retained. They are not converted into verification of all sequence allocation, washout, carryover and analysis procedures. - Why unverified: This information was transferred from the stored summary with the selected question distinguished from parent materials. Detailed originals and review of existing content remain incomplete; it does not establish clinical certification or review approval. - Reason for missing information: Original crossover protocols, analysis plans, period-specific results and handling of repeated observations are needed. Unread originals are not labeled as verified procedures. - Required materials and conditions: Treatment sequence, washout, carryover, period effects and repeated-data handling - Materials to obtain first: Original crossover protocols, analysis plans, period-specific results and handling of repeated observations are needed. Unread originals are not labeled as verified procedures. - Further research: Material needed: Original crossover protocols, analysis plans, period-specific results and handling of repeated observations are needed. Unread originals are not labeled as verified procedures. This records needed materials; no new research was executed. - Conditions for verification: Original material for Treatment sequence, washout, carryover, period effects and repeated-data handling must be linked to the relevant report's formulation, timing, outcome, arm-specific denominators and analysis plan, distinguishing direct findings, parent context, historical calculations and unread external material. - Why this condition is needed: This condition links Treatment sequence, washout, carryover, period effects and repeated-data handling with population, formulation, control, timing, measures, denominators, prespecified analysis and harms for the selected acute response, distinguishing the early-report context. - Application exceptions: Retain selected D and absent individual score, status and axes without inheriting parent D28. Distinguish early crossover and follow-up registered trials, participants and attacks, prespecified one-sided testing, historical two-sided calculations and the separate equivalence question. No new effects, CIs, denominators, replication totals, grades, application or treatment instructions are created. - Remaining uncertainty: The missed prespecified threshold, early positive finding, precision gaps and historical calculation attribution are retained together. Exact one-sided P, effects, CIs, response definitions, arm labels, missingness, formulation, blinding, support roles and harms details are unverified. Linking stored summaries is not converted into original-material reading, new formal assessment, equivalence, exact zero effects or safety certification. - Referenced methods: Preserved application criteria were used to distinguish questions, comparisons, reports and trials, outcomes, denominators and harms. - Related sources: S01 ### N19 · Are the small early positive finding and larger follow-up failure both preserved? Verification status: Partly verified Reading scope: Stored parent summary and bibliography read; external papers, registered results, registration, plans and support documents unread - Current findings: S01's lower pain versus placebo at P<.01 and S02's failed first 120-minute primary endpoint are retained together. The early signal is not erased or the follow-up relabeled as successful. - Why unverified: This information was transferred from the stored summary with the selected question distinguished from parent materials. Detailed originals and review of existing content remain incomplete; it does not establish clinical certification or review approval. - Reason for missing information: Populations, formulations, outcomes, timing, protocols and analyses from both reports are needed. New confirmation of matched independent replication for the same target effect is not created. - Required materials and conditions: Findings and directness across different trials, outcomes and designs - Materials to obtain first: Populations, formulations, outcomes, timing, protocols and analyses from both reports are needed. New confirmation of matched independent replication for the same target effect is not created. - Further research: Material needed: Populations, formulations, outcomes, timing, protocols and analyses from both reports are needed. New confirmation of matched independent replication for the same target effect is not created. This records needed materials; no new research was executed. - Conditions for verification: Original material for Findings and directness across different trials, outcomes and designs must be linked to the relevant report's formulation, timing, outcome, arm-specific denominators and analysis plan, distinguishing direct findings, parent context, historical calculations and unread external material. - Why this condition is needed: This condition links Findings and directness across different trials, outcomes and designs with population, formulation, control, timing, measures, denominators, prespecified analysis and harms for the selected acute response, distinguishing the early-report context. - Application exceptions: Retain selected D and absent individual score, status and axes without inheriting parent D28. Distinguish early crossover and follow-up registered trials, participants and attacks, prespecified one-sided testing, historical two-sided calculations and the separate equivalence question. No new effects, CIs, denominators, replication totals, grades, application or treatment instructions are created. - Remaining uncertainty: The missed prespecified threshold, early positive finding, precision gaps and historical calculation attribution are retained together. Exact one-sided P, effects, CIs, response definitions, arm labels, missingness, formulation, blinding, support roles and harms details are unverified. Linking stored summaries is not converted into original-material reading, new formal assessment, equivalence, exact zero effects or safety certification. - Referenced methods: Preserved application criteria were used to distinguish questions, comparisons, reports and trials, outcomes, denominators and harms. - Related sources: S01, S02 ### N20 · Is equivalence to acetaminophen the same question? Verification status: Partly verified Reading scope: Stored parent summary and bibliography read; external papers, registered results, registration, plans and support documents unread - Current findings: The original explanation that no difference from acetaminophen in S01 does not establish equivalence is retained. This separate subclaim is not combined with the current 120-minute VPRS finding. - Why unverified: This information was transferred from the stored summary with the selected question distinguished from parent materials. Detailed originals and review of existing content remain incomplete; it does not establish clinical certification or review approval. - Reason for missing information: Original comparison designs, results, equivalence margins, tests and CIs are needed. No new judgment establishing equivalence or noninferiority is made. - Required materials and conditions: Distinction between placebo comparisons and separate equivalence or noninferiority designs - Materials to obtain first: Original comparison designs, results, equivalence margins, tests and CIs are needed. No new judgment establishing equivalence or noninferiority is made. - Further research: Material needed: Original comparison designs, results, equivalence margins, tests and CIs are needed. No new judgment establishing equivalence or noninferiority is made. This records needed materials; no new research was executed. - Conditions for verification: Original material for Distinction between placebo comparisons and separate equivalence or noninferiority designs must be linked to the relevant report's formulation, timing, outcome, arm-specific denominators and analysis plan, distinguishing direct findings, parent context, historical calculations and unread external material. - Why this condition is needed: This condition links Distinction between placebo comparisons and separate equivalence or noninferiority designs with population, formulation, control, timing, measures, denominators, prespecified analysis and harms for the selected acute response, distinguishing the early-report context. - Application exceptions: Retain selected D and absent individual score, status and axes without inheriting parent D28. Distinguish early crossover and follow-up registered trials, participants and attacks, prespecified one-sided testing, historical two-sided calculations and the separate equivalence question. No new effects, CIs, denominators, replication totals, grades, application or treatment instructions are created. - Remaining uncertainty: The missed prespecified threshold, early positive finding, precision gaps and historical calculation attribution are retained together. Exact one-sided P, effects, CIs, response definitions, arm labels, missingness, formulation, blinding, support roles and harms details are unverified. Linking stored summaries is not converted into original-material reading, new formal assessment, equivalence, exact zero effects or safety certification. - Referenced methods: Preserved application criteria were used to distinguish questions, comparisons, reports and trials, outcomes, denominators and harms. - Related sources: S01 ### N21 · Do EudraCT and NCT identifiers count as separate trials? Verification status: Partly verified Reading scope: Stored parent summary and bibliography read; external papers, registered results, registration, plans and support documents unread - Current findings: The S02 bibliography records EudraCT 2011-004777-89 and NCT01770080 together. Their preserved connection to the same follow-up trial is not added as independent trials. - Why unverified: This information was transferred from the stored summary with the selected question distinguished from parent materials. Detailed originals and review of existing content remain incomplete; it does not establish clinical certification or review approval. - Reason for missing information: Original registration versions, cross-references, result documents and cohort links are needed. Current external identity verification or unique participant and replication totals are not established. - Required materials and conditions: Links between registration identifiers, result reports and the same trial family - Materials to obtain first: Original registration versions, cross-references, result documents and cohort links are needed. Current external identity verification or unique participant and replication totals are not established. - Further research: Material needed: Original registration versions, cross-references, result documents and cohort links are needed. Current external identity verification or unique participant and replication totals are not established. This records needed materials; no new research was executed. - Conditions for verification: Original material for Links between registration identifiers, result reports and the same trial family must be linked to the relevant report's formulation, timing, outcome, arm-specific denominators and analysis plan, distinguishing direct findings, parent context, historical calculations and unread external material. - Why this condition is needed: This condition links Links between registration identifiers, result reports and the same trial family with population, formulation, control, timing, measures, denominators, prespecified analysis and harms for the selected acute response, distinguishing the early-report context. - Application exceptions: Retain selected D and absent individual score, status and axes without inheriting parent D28. Distinguish early crossover and follow-up registered trials, participants and attacks, prespecified one-sided testing, historical two-sided calculations and the separate equivalence question. No new effects, CIs, denominators, replication totals, grades, application or treatment instructions are created. - Remaining uncertainty: The missed prespecified threshold, early positive finding, precision gaps and historical calculation attribution are retained together. Exact one-sided P, effects, CIs, response definitions, arm labels, missingness, formulation, blinding, support roles and harms details are unverified. Linking stored summaries is not converted into original-material reading, new formal assessment, equivalence, exact zero effects or safety certification. - Referenced methods: Preserved application criteria were used to distinguish questions, comparisons, reports and trials, outcomes, denominators and harms. - Related sources: S02 ### N22 · How do the registered-results version, posting date and original evidence date differ? Verification status: Partly verified Reading scope: Stored parent summary and bibliography read; external papers, registered results, registration, plans and support documents unread - Current findings: The bibliography records results version 1 posted on 2025-05-22, while the original evidence date is 2026-09-07. Registered-trial results are not relabeled as an external paper or completed current reading. - Why unverified: This information was transferred from the stored summary with the selected question distinguished from parent materials. Detailed originals and review of existing content remain incomplete; it does not establish clinical certification or review approval. - Reason for missing information: Original results versions, subsequent amendments and registration history are needed. Current public availability and the latest linked version are unverified; condition and view production dates are distinct from completed content review. - Required materials and conditions: Distinction between result posting, version, preserved evidence and production dates - Materials to obtain first: Original results versions, subsequent amendments and registration history are needed. Current public availability and the latest linked version are unverified; condition and view production dates are distinct from completed content review. - Further research: Material needed: Original results versions, subsequent amendments and registration history are needed. Current public availability and the latest linked version are unverified; condition and view production dates are distinct from completed content review. This records needed materials; no new research was executed. - Conditions for verification: Original material for Distinction between result posting, version, preserved evidence and production dates must be linked to the relevant report's formulation, timing, outcome, arm-specific denominators and analysis plan, distinguishing direct findings, parent context, historical calculations and unread external material. - Why this condition is needed: This condition links Distinction between result posting, version, preserved evidence and production dates with population, formulation, control, timing, measures, denominators, prespecified analysis and harms for the selected acute response, distinguishing the early-report context. - Application exceptions: Retain selected D and absent individual score, status and axes without inheriting parent D28. Distinguish early crossover and follow-up registered trials, participants and attacks, prespecified one-sided testing, historical two-sided calculations and the separate equivalence question. No new effects, CIs, denominators, replication totals, grades, application or treatment instructions are created. - Remaining uncertainty: The missed prespecified threshold, early positive finding, precision gaps and historical calculation attribution are retained together. Exact one-sided P, effects, CIs, response definitions, arm labels, missingness, formulation, blinding, support roles and harms details are unverified. Linking stored summaries is not converted into original-material reading, new formal assessment, equivalence, exact zero effects or safety certification. - Referenced methods: Preserved application criteria were used to distinguish questions, comparisons, reports and trials, outcomes, denominators and harms. - Related sources: S02 ### N23 · Were original registration, protocols and analysis plans actually read? Verification status: Unverified Reading scope: Stored parent summary and bibliography read; external papers, registered results, registration, plans and support documents unread - Current findings: Original statements about registration and hierarchy are used as information from the stored summary. Presence of a results URL is not converted into acquisition or reading of original registration, protocols or analysis plans. - Why unverified: This information was transferred from the stored summary with the selected question distinguished from parent materials. Detailed originals and review of existing content remain incomplete; it does not establish clinical certification or review approval. - Reason for missing information: Original initial registration, amendment history, protocols, analysis plans and correspondence to results are needed. External materials remain unread with access unattempted. - Required materials and conditions: Links between prespecified plans, outcome changes and actual results - Materials to obtain first: Original initial registration, amendment history, protocols, analysis plans and correspondence to results are needed. External materials remain unread with access unattempted. - Further research: Material needed: Original initial registration, amendment history, protocols, analysis plans and correspondence to results are needed. External materials remain unread with access unattempted. This records needed materials; no new research was executed. - Conditions for verification: Original material for Links between prespecified plans, outcome changes and actual results must be linked to the relevant report's formulation, timing, outcome, arm-specific denominators and analysis plan, distinguishing direct findings, parent context, historical calculations and unread external material. - Why this condition is needed: This condition links Links between prespecified plans, outcome changes and actual results with population, formulation, control, timing, measures, denominators, prespecified analysis and harms for the selected acute response, distinguishing the early-report context. - Application exceptions: Retain selected D and absent individual score, status and axes without inheriting parent D28. Distinguish early crossover and follow-up registered trials, participants and attacks, prespecified one-sided testing, historical two-sided calculations and the separate equivalence question. No new effects, CIs, denominators, replication totals, grades, application or treatment instructions are created. - Remaining uncertainty: The missed prespecified threshold, early positive finding, precision gaps and historical calculation attribution are retained together. Exact one-sided P, effects, CIs, response definitions, arm labels, missingness, formulation, blinding, support roles and harms details are unverified. Linking stored summaries is not converted into original-material reading, new formal assessment, equivalence, exact zero effects or safety certification. - Referenced methods: Preserved application criteria were used to distinguish questions, comparisons, reports and trials, outcomes, denominators and harms. - Related sources: S02 ### N24 · Are rescue medication, concurrent care and actual application distinguished? Verification status: Unverified Reading scope: Stored parent summary and bibliography read; external papers, registered results, registration, plans and support documents unread - Current findings: The account describes repeated topical application and comparison with placebo. This is not converted into verification of S02 rescue medication, concurrent care, adherence or handling of outcomes after rescue medication. - Why unverified: This information was transferred from the stored summary with the selected question distinguished from parent materials. Detailed originals and review of existing content remain incomplete; it does not establish clinical certification or review approval. - Reason for missing information: Original concurrent-medication and rescue rules, application performance, adherence, assessment records and analysis policies are needed. Effects of concurrent care are not attributed solely to peppermint oil. - Required materials and conditions: Analgesic rescue medication, other care, application adherence and assessment timing - Materials to obtain first: Original concurrent-medication and rescue rules, application performance, adherence, assessment records and analysis policies are needed. Effects of concurrent care are not attributed solely to peppermint oil. - Further research: Material needed: Original concurrent-medication and rescue rules, application performance, adherence, assessment records and analysis policies are needed. Effects of concurrent care are not attributed solely to peppermint oil. This records needed materials; no new research was executed. - Conditions for verification: Original material for Analgesic rescue medication, other care, application adherence and assessment timing must be linked to the relevant report's formulation, timing, outcome, arm-specific denominators and analysis plan, distinguishing direct findings, parent context, historical calculations and unread external material. - Why this condition is needed: This condition links Analgesic rescue medication, other care, application adherence and assessment timing with population, formulation, control, timing, measures, denominators, prespecified analysis and harms for the selected acute response, distinguishing the early-report context. - Application exceptions: Retain selected D and absent individual score, status and axes without inheriting parent D28. Distinguish early crossover and follow-up registered trials, participants and attacks, prespecified one-sided testing, historical two-sided calculations and the separate equivalence question. No new effects, CIs, denominators, replication totals, grades, application or treatment instructions are created. - Remaining uncertainty: The missed prespecified threshold, early positive finding, precision gaps and historical calculation attribution are retained together. Exact one-sided P, effects, CIs, response definitions, arm labels, missingness, formulation, blinding, support roles and harms details are unverified. Linking stored summaries is not converted into original-material reading, new formal assessment, equivalence, exact zero effects or safety certification. - Referenced methods: Preserved application criteria were used to distinguish questions, comparisons, reports and trials, outcomes, denominators and harms. - Related sources: S02 ### N25 · Are funding and manufacturer involvement in the early trial verified? Verification status: Unverified Reading scope: Stored parent summary and bibliography read; external papers, registered results, registration, plans and support documents unread - Current findings: The original S01 record of unverified specific funding and manufacturer involvement is retained. Missing information is not converted into absence of support or interests, or independence. - Why unverified: This information was transferred from the stored summary with the selected question distinguished from parent materials. Detailed originals and review of existing content remain incomplete; it does not establish clinical certification or review approval. - Reason for missing information: Original funding, supplied-product, author-affiliation, employee-role and COI documents are needed. Unverified entries are not filled in as independent. - Required materials and conditions: Separate verification of funding, supplied products, employee authors and interests - Materials to obtain first: Original funding, supplied-product, author-affiliation, employee-role and COI documents are needed. Unverified entries are not filled in as independent. - Further research: Material needed: Original funding, supplied-product, author-affiliation, employee-role and COI documents are needed. Unverified entries are not filled in as independent. This records needed materials; no new research was executed. - Conditions for verification: Original material for Separate verification of funding, supplied products, employee authors and interests must be linked to the relevant report's formulation, timing, outcome, arm-specific denominators and analysis plan, distinguishing direct findings, parent context, historical calculations and unread external material. - Why this condition is needed: This condition links Separate verification of funding, supplied products, employee authors and interests with population, formulation, control, timing, measures, denominators, prespecified analysis and harms for the selected acute response, distinguishing the early-report context. - Application exceptions: Retain selected D and absent individual score, status and axes without inheriting parent D28. Distinguish early crossover and follow-up registered trials, participants and attacks, prespecified one-sided testing, historical two-sided calculations and the separate equivalence question. No new effects, CIs, denominators, replication totals, grades, application or treatment instructions are created. - Remaining uncertainty: The missed prespecified threshold, early positive finding, precision gaps and historical calculation attribution are retained together. Exact one-sided P, effects, CIs, response definitions, arm labels, missingness, formulation, blinding, support roles and harms details are unverified. Linking stored summaries is not converted into original-material reading, new formal assessment, equivalence, exact zero effects or safety certification. - Referenced methods: Preserved application criteria were used to distinguish questions, comparisons, reports and trials, outcomes, denominators and harms. - Related sources: S01 ### N26 · Which roles are known from Cassella-med sponsorship? Verification status: Partly verified Reading scope: Stored parent summary and bibliography read; external papers, registered results, registration, plans and support documents unread - Current findings: S02's sponsorship by Cassella-med GmbH is preserved without relabeling it as independent funding. Details of product support, employee authorship, design, analysis and publication roles remain separately unverified. - Why unverified: This information was transferred from the stored summary with the selected question distinguished from parent materials. Detailed originals and review of existing content remain incomplete; it does not establish clinical certification or review approval. - Reason for missing information: Original sponsorship, support, author affiliations, COI and analysis or publication-role documents are needed. Sponsorship alone does not establish other roles or a new independence grade. - Required materials and conditions: Sponsorship, product support, authorship, interests and analysis or publication control - Materials to obtain first: Original sponsorship, support, author affiliations, COI and analysis or publication-role documents are needed. Sponsorship alone does not establish other roles or a new independence grade. - Further research: Material needed: Original sponsorship, support, author affiliations, COI and analysis or publication-role documents are needed. Sponsorship alone does not establish other roles or a new independence grade. This records needed materials; no new research was executed. - Conditions for verification: Original material for Sponsorship, product support, authorship, interests and analysis or publication control must be linked to the relevant report's formulation, timing, outcome, arm-specific denominators and analysis plan, distinguishing direct findings, parent context, historical calculations and unread external material. - Why this condition is needed: This condition links Sponsorship, product support, authorship, interests and analysis or publication control with population, formulation, control, timing, measures, denominators, prespecified analysis and harms for the selected acute response, distinguishing the early-report context. - Application exceptions: Retain selected D and absent individual score, status and axes without inheriting parent D28. Distinguish early crossover and follow-up registered trials, participants and attacks, prespecified one-sided testing, historical two-sided calculations and the separate equivalence question. No new effects, CIs, denominators, replication totals, grades, application or treatment instructions are created. - Remaining uncertainty: The missed prespecified threshold, early positive finding, precision gaps and historical calculation attribution are retained together. Exact one-sided P, effects, CIs, response definitions, arm labels, missingness, formulation, blinding, support roles and harms details are unverified. Linking stored summaries is not converted into original-material reading, new formal assessment, equivalence, exact zero effects or safety certification. - Referenced methods: Preserved application criteria were used to distinguish questions, comparisons, reports and trials, outcomes, denominators and harms. - Related sources: S02 ### N27 · Are direct data on skin and eye harms available? Verification status: Unverified Reading scope: Stored parent summary and bibliography read; external papers, registered results, registration, plans and support documents unread - Current findings: Parent cautions about stinging, redness and eye injury with concentrated oil and ethanol are retained as historical information. These cautions are not converted into trial-specific event rates or established causality. - Why unverified: This information was transferred from the stored summary with the selected question distinguished from parent materials. Detailed originals and review of existing content remain incomplete; it does not establish clinical certification or review approval. - Reason for missing information: S02 original adverse-event tables, arm-specific events and denominators, collection, discontinuation, exposure and timing are needed. Evidence gaps are not labeled as safety or absence of harm. - Required materials and conditions: Adverse-event definitions, collection, severity, arm-specific events and denominators - Materials to obtain first: S02 original adverse-event tables, arm-specific events and denominators, collection, discontinuation, exposure and timing are needed. Evidence gaps are not labeled as safety or absence of harm. - Further research: Material needed: S02 original adverse-event tables, arm-specific events and denominators, collection, discontinuation, exposure and timing are needed. Evidence gaps are not labeled as safety or absence of harm. This records needed materials; no new research was executed. - Conditions for verification: Original material for Adverse-event definitions, collection, severity, arm-specific events and denominators must be linked to the relevant report's formulation, timing, outcome, arm-specific denominators and analysis plan, distinguishing direct findings, parent context, historical calculations and unread external material. - Why this condition is needed: This condition links Adverse-event definitions, collection, severity, arm-specific events and denominators with population, formulation, control, timing, measures, denominators, prespecified analysis and harms for the selected acute response, distinguishing the early-report context. - Application exceptions: Retain selected D and absent individual score, status and axes without inheriting parent D28. Distinguish early crossover and follow-up registered trials, participants and attacks, prespecified one-sided testing, historical two-sided calculations and the separate equivalence question. No new effects, CIs, denominators, replication totals, grades, application or treatment instructions are created. - Remaining uncertainty: The missed prespecified threshold, early positive finding, precision gaps and historical calculation attribution are retained together. Exact one-sided P, effects, CIs, response definitions, arm labels, missingness, formulation, blinding, support roles and harms details are unverified. Linking stored summaries is not converted into original-material reading, new formal assessment, equivalence, exact zero effects or safety certification. - Referenced methods: Preserved application criteria were used to distinguish questions, comparisons, reports and trials, outcomes, denominators and harms. - Related sources: S02 ### N28 · Are harms comparisons and missingness for oil, ethanol and vehicle verified? Verification status: Unverified Reading scope: Stored parent summary and bibliography read; external papers, registered results, registration, plans and support documents unread - Current findings: The preserved account concerns a specific topical formulation and caution scope. This is not converted into verification of active-versus-vehicle harm differences, exposure causes, concurrent exposures or missing safety data. - Why unverified: This information was transferred from the stored summary with the selected question distinguished from parent materials. Detailed originals and review of existing content remain incomplete; it does not establish clinical certification or review approval. - Reason for missing information: Original arm-specific harms, exposure, concurrent exposures, observation and missingness records are needed. Vehicle effects are not converted into causality attributed to oil itself or new risk numbers. - Required materials and conditions: Exposure-specific harms, active-versus-vehicle comparisons and concurrent exposures - Materials to obtain first: Original arm-specific harms, exposure, concurrent exposures, observation and missingness records are needed. Vehicle effects are not converted into causality attributed to oil itself or new risk numbers. - Further research: Material needed: Original arm-specific harms, exposure, concurrent exposures, observation and missingness records are needed. Vehicle effects are not converted into causality attributed to oil itself or new risk numbers. This records needed materials; no new research was executed. - Conditions for verification: Original material for Exposure-specific harms, active-versus-vehicle comparisons and concurrent exposures must be linked to the relevant report's formulation, timing, outcome, arm-specific denominators and analysis plan, distinguishing direct findings, parent context, historical calculations and unread external material. - Why this condition is needed: This condition links Exposure-specific harms, active-versus-vehicle comparisons and concurrent exposures with population, formulation, control, timing, measures, denominators, prespecified analysis and harms for the selected acute response, distinguishing the early-report context. - Application exceptions: Retain selected D and absent individual score, status and axes without inheriting parent D28. Distinguish early crossover and follow-up registered trials, participants and attacks, prespecified one-sided testing, historical two-sided calculations and the separate equivalence question. No new effects, CIs, denominators, replication totals, grades, application or treatment instructions are created. - Remaining uncertainty: The missed prespecified threshold, early positive finding, precision gaps and historical calculation attribution are retained together. Exact one-sided P, effects, CIs, response definitions, arm labels, missingness, formulation, blinding, support roles and harms details are unverified. Linking stored summaries is not converted into original-material reading, new formal assessment, equivalence, exact zero effects or safety certification. - Referenced methods: Preserved application criteria were used to distinguish questions, comparisons, reports and trials, outcomes, denominators and harms. - Related sources: S02 ### N29 · Is safety established for repeated or long-term use and vulnerable groups? Verification status: Unverified Reading scope: Stored parent summary and bibliography read; external papers, registered results, registration, plans and support documents unread - Current findings: Parent cautions concerning eyes, mucosa, broken skin and children's faces are retained as historical wording. Acute response findings or these cautions are not extended into safety certification for long-term use or vulnerable groups. - Why unverified: This information was transferred from the stored summary with the selected question distinguished from parent materials. Detailed originals and review of existing content remain incomplete; it does not establish clinical certification or review approval. - Reason for missing information: Direct safety information for repeated or long-term use, ages and vulnerable groups is needed. Unlinked materials are not used to create new application, discontinuation or treatment instructions. - Required materials and conditions: Distinction between acute trials and repeated-use, long-term and age-specific harms - Materials to obtain first: Direct safety information for repeated or long-term use, ages and vulnerable groups is needed. Unlinked materials are not used to create new application, discontinuation or treatment instructions. - Further research: Material needed: Direct safety information for repeated or long-term use, ages and vulnerable groups is needed. Unlinked materials are not used to create new application, discontinuation or treatment instructions. This records needed materials; no new research was executed. - Conditions for verification: Original material for Distinction between acute trials and repeated-use, long-term and age-specific harms must be linked to the relevant report's formulation, timing, outcome, arm-specific denominators and analysis plan, distinguishing direct findings, parent context, historical calculations and unread external material. - Why this condition is needed: This condition links Distinction between acute trials and repeated-use, long-term and age-specific harms with population, formulation, control, timing, measures, denominators, prespecified analysis and harms for the selected acute response, distinguishing the early-report context. - Application exceptions: Retain selected D and absent individual score, status and axes without inheriting parent D28. Distinguish early crossover and follow-up registered trials, participants and attacks, prespecified one-sided testing, historical two-sided calculations and the separate equivalence question. No new effects, CIs, denominators, replication totals, grades, application or treatment instructions are created. - Remaining uncertainty: The missed prespecified threshold, early positive finding, precision gaps and historical calculation attribution are retained together. Exact one-sided P, effects, CIs, response definitions, arm labels, missingness, formulation, blinding, support roles and harms details are unverified. Linking stored summaries is not converted into original-material reading, new formal assessment, equivalence, exact zero effects or safety certification. - Referenced methods: Preserved application criteria were used to distinguish questions, comparisons, reports and trials, outcomes, denominators and harms. - Related sources: S02 ### N30 · Can findings be extended to other formulations, headache types or long-term outcomes? Verification status: Partly verified Reading scope: Stored parent summary and bibliography read; external papers, registered results, registration, plans and support documents unread - Current findings: The original research scope excludes inhaled aroma, oral enteric capsules and migraine. The selected 120-minute response is not automatically generalized to other conditions, formulations, routes or long-term outcomes. - Why unverified: This information was transferred from the stored summary with the selected question distinguished from parent materials. Detailed originals and review of existing content remain incomplete; it does not establish clinical certification or review approval. - Reason for missing information: Separate information on the relevant formulation, condition, period and direct comparisons is needed. Effects of different exposures are not transferred merely because names are shared. - Required materials and conditions: Scope of topical formulation, tension-type headache and acute response - Materials to obtain first: Separate information on the relevant formulation, condition, period and direct comparisons is needed. Effects of different exposures are not transferred merely because names are shared. - Further research: Material needed: Separate information on the relevant formulation, condition, period and direct comparisons is needed. Effects of different exposures are not transferred merely because names are shared. This records needed materials; no new research was executed. - Conditions for verification: Original material for Scope of topical formulation, tension-type headache and acute response must be linked to the relevant report's formulation, timing, outcome, arm-specific denominators and analysis plan, distinguishing direct findings, parent context, historical calculations and unread external material. - Why this condition is needed: This condition links Scope of topical formulation, tension-type headache and acute response with population, formulation, control, timing, measures, denominators, prespecified analysis and harms for the selected acute response, distinguishing the early-report context. - Application exceptions: Retain selected D and absent individual score, status and axes without inheriting parent D28. Distinguish early crossover and follow-up registered trials, participants and attacks, prespecified one-sided testing, historical two-sided calculations and the separate equivalence question. No new effects, CIs, denominators, replication totals, grades, application or treatment instructions are created. - Remaining uncertainty: The missed prespecified threshold, early positive finding, precision gaps and historical calculation attribution are retained together. Exact one-sided P, effects, CIs, response definitions, arm labels, missingness, formulation, blinding, support roles and harms details are unverified. Linking stored summaries is not converted into original-material reading, new formal assessment, equivalence, exact zero effects or safety certification. - Referenced methods: Preserved application criteria were used to distinguish questions, comparisons, reports and trials, outcomes, denominators and harms. - Related sources: S02 ### N31 · Are the parent's representative details and assessment axes the same as the follow-up outcome? Verification status: Partly verified Reading scope: Stored parent summary and bibliography read; external papers, registered results, registration, plans and support documents unread - Current findings: The parent's representative details include 41 participants, 164 attacks, pain from 15 minutes and vehicle comparison. These are not transferred as denominators or outcomes for the selected 120-minute follow-up result, and parent assessment axes are not newly assigned to the subclaim. - Why unverified: This information was transferred from the stored summary with the selected question distinguished from parent materials. Detailed originals and review of existing content remain incomplete; it does not establish clinical certification or review approval. - Reason for missing information: Original formulation, population, timing and outcome records must be linked to the applicable scope of parent flags. Preserved assessment flags do not establish new content review or subclaim assessment. - Required materials and conditions: Distinction between parent early-trial details and the selected follow-up trial - Materials to obtain first: Original formulation, population, timing and outcome records must be linked to the applicable scope of parent flags. Preserved assessment flags do not establish new content review or subclaim assessment. - Further research: Material needed: Original formulation, population, timing and outcome records must be linked to the applicable scope of parent flags. Preserved assessment flags do not establish new content review or subclaim assessment. This records needed materials; no new research was executed. - Conditions for verification: Original material for Distinction between parent early-trial details and the selected follow-up trial must be linked to the relevant report's formulation, timing, outcome, arm-specific denominators and analysis plan, distinguishing direct findings, parent context, historical calculations and unread external material. - Why this condition is needed: This condition links Distinction between parent early-trial details and the selected follow-up trial with population, formulation, control, timing, measures, denominators, prespecified analysis and harms for the selected acute response, distinguishing the early-report context. - Application exceptions: Retain selected D and absent individual score, status and axes without inheriting parent D28. Distinguish early crossover and follow-up registered trials, participants and attacks, prespecified one-sided testing, historical two-sided calculations and the separate equivalence question. No new effects, CIs, denominators, replication totals, grades, application or treatment instructions are created. - Remaining uncertainty: The missed prespecified threshold, early positive finding, precision gaps and historical calculation attribution are retained together. Exact one-sided P, effects, CIs, response definitions, arm labels, missingness, formulation, blinding, support roles and harms details are unverified. Linking stored summaries is not converted into original-material reading, new formal assessment, equivalence, exact zero effects or safety certification. - Referenced methods: Preserved application criteria were used to distinguish questions, comparisons, reports and trials, outcomes, denominators and harms. - Related sources: S01, S02 ### N32 · Are original Korean and English wording, grades and correction history retained? Verification status: Partly verified Reading scope: Stored parent summary and bibliography read; external papers, registered results, registration, plans and support documents unread - Current findings: Parent Korean and English wording and D28, together with the explanation for selected D, are preserved. Original corrections and deliberation are empty, and historical cross-checking language is not inherited as completed current content review or a new clinical judgment. - Why unverified: This information was transferred from the stored summary with the selected question distinguished from parent materials. Detailed originals and review of existing content remain incomplete; it does not establish clinical certification or review approval. - Reason for missing information: Complete original materials, the selected explanation, authorized corrections and prior-version records are needed. Scores, status or axes absent from the selection, or new deliberation findings, are not created. - Required materials and conditions: Preservation of bilingual wording, grades, explanations and empty fields in parent and selected records - Materials to obtain first: Complete original materials, the selected explanation, authorized corrections and prior-version records are needed. Scores, status or axes absent from the selection, or new deliberation findings, are not created. - Further research: Material needed: Complete original materials, the selected explanation, authorized corrections and prior-version records are needed. Scores, status or axes absent from the selection, or new deliberation findings, are not created. This records needed materials; no new research was executed. - Conditions for verification: Original material for Preservation of bilingual wording, grades, explanations and empty fields in parent and selected records must be linked to the relevant report's formulation, timing, outcome, arm-specific denominators and analysis plan, distinguishing direct findings, parent context, historical calculations and unread external material. - Why this condition is needed: This condition links Preservation of bilingual wording, grades, explanations and empty fields in parent and selected records with population, formulation, control, timing, measures, denominators, prespecified analysis and harms for the selected acute response, distinguishing the early-report context. - Application exceptions: Retain selected D and absent individual score, status and axes without inheriting parent D28. Distinguish early crossover and follow-up registered trials, participants and attacks, prespecified one-sided testing, historical two-sided calculations and the separate equivalence question. No new effects, CIs, denominators, replication totals, grades, application or treatment instructions are created. - Remaining uncertainty: The missed prespecified threshold, early positive finding, precision gaps and historical calculation attribution are retained together. Exact one-sided P, effects, CIs, response definitions, arm labels, missingness, formulation, blinding, support roles and harms details are unverified. Linking stored summaries is not converted into original-material reading, new formal assessment, equivalence, exact zero effects or safety certification. - Referenced methods: Preserved application criteria were used to distinguish questions, comparisons, reports and trials, outcomes, denominators and harms. - Related sources: S01, S02 ### N33 · Are reading of stored summaries and external originals distinguished? Verification status: Partly verified Reading scope: Stored parent summary and bibliography read; external papers, registered results, registration, plans and support documents unread - Current findings: This production transfers information read from the complete stored parent summary and bibliography. S01 paper and S02 registered-results bibliographies are distinguished, while external materials remain unread with access unattempted. - Why unverified: This information was transferred from the stored summary with the selected question distinguished from parent materials. Detailed originals and review of existing content remain incomplete; it does not establish clinical certification or review approval. - Reason for missing information: Authorized external originals, registered results, original registration, protocols, analysis plans and support documents are needed. Links or needed-material entries are not converted into acquisition, full-text reading or completed clinical review. - Required materials and conditions: Actual reading, material type, links and access scope for each report - Materials to obtain first: Authorized external originals, registered results, original registration, protocols, analysis plans and support documents are needed. Links or needed-material entries are not converted into acquisition, full-text reading or completed clinical review. - Further research: Material needed: Authorized external originals, registered results, original registration, protocols, analysis plans and support documents are needed. Links or needed-material entries are not converted into acquisition, full-text reading or completed clinical review. This records needed materials; no new research was executed. - Conditions for verification: Original material for Actual reading, material type, links and access scope for each report must be linked to the relevant report's formulation, timing, outcome, arm-specific denominators and analysis plan, distinguishing direct findings, parent context, historical calculations and unread external material. - Why this condition is needed: This condition links Actual reading, material type, links and access scope for each report with population, formulation, control, timing, measures, denominators, prespecified analysis and harms for the selected acute response, distinguishing the early-report context. - Application exceptions: Retain selected D and absent individual score, status and axes without inheriting parent D28. Distinguish early crossover and follow-up registered trials, participants and attacks, prespecified one-sided testing, historical two-sided calculations and the separate equivalence question. No new effects, CIs, denominators, replication totals, grades, application or treatment instructions are created. - Remaining uncertainty: The missed prespecified threshold, early positive finding, precision gaps and historical calculation attribution are retained together. Exact one-sided P, effects, CIs, response definitions, arm labels, missingness, formulation, blinding, support roles and harms details are unverified. Linking stored summaries is not converted into original-material reading, new formal assessment, equivalence, exact zero effects or safety certification. - Referenced methods: Preserved application criteria were used to distinguish questions, comparisons, reports and trials, outcomes, denominators and harms. - Related sources: S01, S02 ## Evidence and sources ### S01 Göbel H et al. 1996 [PubMed](https://pubmed.ncbi.nlm.nih.gov/8805113/) Materials actually read: Complete stored parent summary and paper bibliography read; external paper, registration, plans and support materials unread Findings recorded in the summary: Less pain than placebo at P<.01; no difference from acetaminophen does not establish equivalence Record level: Pain findings from 15 minutes in 41 participants and 164 headache attacks are preserved. Repeated attacks are not participant counts and do not directly confirm S02's 120-minute response. Exact crossover analysis, support and independence details are unverified. Independent replication: The early Göbel report and later Euminz results retain distinct original design, timing and outcome contexts. EudraCT 2011-004777-89 and NCT01770080 are preserved links to the follow-up trial and are not added as separate independent trials. Reuse across parent and subclaims does not create new participants or independent replication; unique totals remain unverified. | Material | Public availability | Access status | Actually read | Notes | |---|---|---|---|---| | Stored existing review summary | Preserved copy of the complete parent-verdict stored summary | Stored summary | Summary read | Preserve original PMID8805113 and DOI10.1007/s001150050040. The account describes a pre-registration-era report with no separate registration identifier recorded. No current registry search, original reading, funding or manufacturer-independence verification was performed. Each material entry is dated to the stored original account, not external acquisition or reading. Condition and view production are distinguished from completed content review, and external materials remain unread. | | External paper | Original bibliographic link or needed material; external public availability/access status unverified | Unread; access not attempted | Not read | Preserve original PMID8805113 and DOI10.1007/s001150050040. The account describes a pre-registration-era report with no separate registration identifier recorded. No current registry search, original reading, funding or manufacturer-independence verification was performed. Each material entry is dated to the stored original account, not external acquisition or reading. Condition and view production are distinguished from completed content review, and external materials remain unread. | | Registration material | Original bibliographic link or needed material; external public availability/access status unverified | Unread; access not attempted | Not read | Preserve original PMID8805113 and DOI10.1007/s001150050040. The account describes a pre-registration-era report with no separate registration identifier recorded. No current registry search, original reading, funding or manufacturer-independence verification was performed. Each material entry is dated to the stored original account, not external acquisition or reading. Condition and view production are distinguished from completed content review, and external materials remain unread. | | Protocol | Original bibliographic link or needed material; external public availability/access status unverified | Unread; access not attempted | Not read | Preserve original PMID8805113 and DOI10.1007/s001150050040. The account describes a pre-registration-era report with no separate registration identifier recorded. No current registry search, original reading, funding or manufacturer-independence verification was performed. Each material entry is dated to the stored original account, not external acquisition or reading. Condition and view production are distinguished from completed content review, and external materials remain unread. | | Statistical analysis plan | Original bibliographic link or needed material; external public availability/access status unverified | Unread; access not attempted | Not read | Preserve original PMID8805113 and DOI10.1007/s001150050040. The account describes a pre-registration-era report with no separate registration identifier recorded. No current registry search, original reading, funding or manufacturer-independence verification was performed. Each material entry is dated to the stored original account, not external acquisition or reading. Condition and view production are distinguished from completed content review, and external materials remain unread. | | Funding, product support and COI material | Original bibliographic link or needed material; external public availability/access status unverified | Unread; access not attempted | Not read | Preserve original PMID8805113 and DOI10.1007/s001150050040. The account describes a pre-registration-era report with no separate registration identifier recorded. No current registry search, original reading, funding or manufacturer-independence verification was performed. Each material entry is dated to the stored original account, not external acquisition or reading. Condition and view production are distinguished from completed content review, and external materials remain unread. | ### S02 Euminz tension-type headache phase 4 study [Official source](https://www.clinicaltrialsregister.eu/ctr-search/trial/2011-004777-89/results) Materials actually read: Complete stored parent summary and results bibliography read; external registered results, original registration, plans and support materials unread Findings recorded in the summary: 37/94 versus 28/95; missed prespecified one-sided .025 threshold. Two-sided P≈.101 is a historical Codex calculation Record level: The original distinction between 209 starters, 189 in FAS and 94 versus 95, and the missed first 120-minute VPRS threshold are retained. The second VAS-SPID endpoint is exploratory; exact response definitions, arm labels, one-sided P, CIs and analysis plans are unverified. Historical calculation is not relabeled as the original prespecified result or a new calculation. Independent replication: The early Göbel report and later Euminz results retain distinct original design, timing and outcome contexts. EudraCT 2011-004777-89 and NCT01770080 are preserved links to the follow-up trial and are not added as separate independent trials. Reuse across parent and subclaims does not create new participants or independent replication; unique totals remain unverified. | Material | Public availability | Access status | Actually read | Notes | |---|---|---|---|---| | Stored existing review summary | Preserved copy of the complete parent-verdict stored summary | Stored summary | Summary read | Retain the preserved bibliographic link between EudraCT2011-004777-89 and NCT01770080 and sponsorship by Cassella-med GmbH. Empty original registration fields and bibliographic strings remain distinguished in internal originals. No current external verification of registration, support, employee authorship, analysis or publication roles was performed. Each material entry is dated to the stored original account, not external acquisition or reading. Condition and view production are distinguished from completed content review, and external materials remain unread. | | External registered-trial results | Original bibliographic link or needed material; external public availability/access status unverified | Unread; access not attempted | Not read | Retain the preserved bibliographic link between EudraCT2011-004777-89 and NCT01770080 and sponsorship by Cassella-med GmbH. Empty original registration fields and bibliographic strings remain distinguished in internal originals. No current external verification of registration, support, employee authorship, analysis or publication roles was performed. Each material entry is dated to the stored original account, not external acquisition or reading. Condition and view production are distinguished from completed content review, and external materials remain unread. | | Registration material | Original bibliographic link or needed material; external public availability/access status unverified | Unread; access not attempted | Not read | Retain the preserved bibliographic link between EudraCT2011-004777-89 and NCT01770080 and sponsorship by Cassella-med GmbH. Empty original registration fields and bibliographic strings remain distinguished in internal originals. No current external verification of registration, support, employee authorship, analysis or publication roles was performed. Each material entry is dated to the stored original account, not external acquisition or reading. Condition and view production are distinguished from completed content review, and external materials remain unread. | | Protocol | Original bibliographic link or needed material; external public availability/access status unverified | Unread; access not attempted | Not read | Retain the preserved bibliographic link between EudraCT2011-004777-89 and NCT01770080 and sponsorship by Cassella-med GmbH. Empty original registration fields and bibliographic strings remain distinguished in internal originals. No current external verification of registration, support, employee authorship, analysis or publication roles was performed. Each material entry is dated to the stored original account, not external acquisition or reading. Condition and view production are distinguished from completed content review, and external materials remain unread. | | Statistical analysis plan | Original bibliographic link or needed material; external public availability/access status unverified | Unread; access not attempted | Not read | Retain the preserved bibliographic link between EudraCT2011-004777-89 and NCT01770080 and sponsorship by Cassella-med GmbH. Empty original registration fields and bibliographic strings remain distinguished in internal originals. No current external verification of registration, support, employee authorship, analysis or publication roles was performed. Each material entry is dated to the stored original account, not external acquisition or reading. Condition and view production are distinguished from completed content review, and external materials remain unread. | | Funding, product support and COI material | Original bibliographic link or needed material; external public availability/access status unverified | Unread; access not attempted | Not read | Retain the preserved bibliographic link between EudraCT2011-004777-89 and NCT01770080 and sponsorship by Cassella-med GmbH. Empty original registration fields and bibliographic strings remain distinguished in internal originals. No current external verification of registration, support, employee authorship, analysis or publication roles was performed. Each material entry is dated to the stored original account, not external acquisition or reading. Condition and view production are distinguished from completed content review, and external materials remain unread. | ## Review criteria and methods These are Chamgap's own application conditions, informed by the relevant sections of official methodological guidance. They do not constitute official assessment-tool certification or a new efficacy score. - M03 [Cochrane Handbook 6.5 (2024), chapter updated 2023-08](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03) · §3.1, §3.2.1–3.2.3, MECIR C5/C7/C13 · Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions. · Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed. - M04 [Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04) · §4.5, §4.6.1–4.6.3, MECIR C42 · Distinguish studies from reports and link them; do not omit a study solely because results are unreported. · Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed. - M08 [Cochrane Handbook 6.5 (2024), chapter updated 2019-10](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08) · §8.1–8.2.3, Table 8.2.a · Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting. · Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed. - M15 [Cochrane Handbook 6.5 (2024), chapter updated 2023-08](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15) · §15.2.4, §15.3.1–15.3.3 · Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision. · Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed. - M19 [Cochrane Handbook 6.5 (2024), chapter updated 2019-10](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19) · §19.1.2, §19.2.1–19.2.4 · Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates. · Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed. ## What the statuses mean - Partly verified: Partial information from the stored summary is linked; detailed originals and content review remain incomplete. - Unverified: Required details cannot be established within the preserved scope. This does not establish absence of effects or studies, or safety. - Review incomplete: Review of existing content remains incomplete. - Met: This state is used only within the relevant conditions after material verification and content review. It was not automatically assigned in this work. - Not reported: Unreported within material actually read. Unread external material is not relabeled as unreported. - Inaccessible: This means actual access failure. External access was not attempted in this work, so this state was not assigned. - Not applicable: Used only with an application exception and reason based on the question scope. - Conflicting data: This requires actual comparison of materials; no new conflict judgment was made in this work. - Insufficient evidence for the conditions: This indicates gaps in additional material for the selected conditions. Unread material as a whole is not converted into an efficacy grade. ## Change history 2026-10-20 · Public page/materials 1.0. Public-facing views and materials were prepared from the existing 33 items. No new clinical search, verification-status change or scoring was performed.