# Ginger dry extract × Migraine prevention—no added benefit over placebo in the 50% responder rate Verdict 3009 · 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 stored account concerns a trial of 107 adults with episodic migraine. Overall size is not used as an arm-specific responder, completion or analysis denominator. Diagnosis, baseline frequency, age, concurrent care, exclusions and detailed eligibility are unverified. - Ingredient, formulation and route: The original intervention is ginger dry extract standardized to 5% active constituents. It is distinguished from culinary ginger, other formulations, feverfew combinations and acute treatment. Product, active-constituent definitions, batch and placebo-composition details are unverified; no new manufacturing or treatment instructions are created. - Dose: The original study schedule of dry extract 200 mg, 3 times daily for 3 months is preserved. Total daily or active-constituent amounts are not calculated or converted into personal dosing or an optimal dose. Actual exposure, adherence and product-specific quantitative details are unverified. - Comparator: The direct control is placebo. Improvement over time in both arms is not converted into an added ginger effect. Sensory matching and concurrent or changed preventive and acute medication details are unverified; sumatriptan active-control studies are not combined as the same prevention comparison. - Measured outcome: The selection concerns the proportion achieving at least a 50% reduction in migraine attacks. Original subclaim D and no significant difference from placebo are retained. This is not converted into a 50% reduction in the group mean, improvement in everyone, an exact zero effect or equivalence. Arm-specific responders, denominators, exact effects and CIs are unverified. - Duration: The trial concerns 3-month prevention, distinguished from acute-attack treatment. Exact baseline and measurement windows, post-treatment response maintenance, recurrence and long-term or rare harms are unverified. Study duration is not extended into verification of prevention or persistence over all longer periods. - Questions outside this scope: Do not convert the individual 50% reduction threshold or between-arm responder comparison into a 50% reduction in the group mean.; Do not convert nonsignificance against placebo into verification of exact zero effects, equivalence or noninferiority.; Do not combine acute feverfew combinations, sumatriptan controls or nausea-related materials as replication of the same single-ingredient prevention question.; Do not use reports shared across parent and subclaims or overall trial size as new independent totals or arm-specific outcome denominators.; Do not create new total daily or active-constituent amounts, dosing instructions, changes to preventive medication or treatment guidance. ## Checklist items ### N01 · What is the original conclusion for the selected 50% responder question? Verification status: Partly verified Reading scope: Stored summary read; external abstracts, full texts, registration, protocols and analysis plans unread - Current findings: The selection is at least a 50% reduction in migraine attacks, with original subclaim D. The relevant effect concerns the proportion reaching that threshold; the original conclusion of no significant difference from placebo 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: Responder definitions, baseline periods, measurement windows, arm-specific responders, denominators, effects and CIs are needed. No new grade or independence claim is created. - Required materials and conditions: Comparison of responder proportions against placebo - Materials to obtain first: Responder definitions, baseline periods, measurement windows, arm-specific responders, denominators, effects and CIs are needed. No new grade or independence claim is created. - Further research: Material needed: Responder definitions, baseline periods, measurement windows, arm-specific responders, denominators, effects and CIs are needed. No new grade or independence claim is created. This records needed materials; no new research was executed. - Conditions for verification: Original material for Comparison of responder proportions against placebo must be linked to individual responder definitions, between-arm comparisons, denominators and measurement windows, distinguishing stored summaries, unread external material, within-arm changes and other acute-treatment questions. - Why this condition is needed: This condition links Comparison of responder proportions against placebo with populations, formulations, controls, denominators, measurement windows, prespecified criteria, analyses, support and harms for the selected prevention responder outcome. - Application exceptions: Retain original subclaim D and absent individual score, status and axes without inheriting parent D30. Distinguish responder proportions, mean changes, other pain outcomes, single-ingredient prevention, acute combinations and active controls. No new effects, CIs, denominators, independent totals, grades, dosing or treatment instructions are created. - Remaining uncertainty: The original nonsignificance against placebo and precision gaps are retained. Exact responders, denominators, effects, CIs, missingness, concurrent care, prespecified plans, support and harm details are unverified. Historical full-text checking, the single-independent-trial statement or other symptom signals are not converted into completed current review, 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: R01 ### N02 · Is the 50% threshold a reduction in average attacks across the group? Verification status: Partly verified Reading scope: Stored summary read; external abstracts, full texts, registration, protocols and analysis plans unread - Current findings: The account says the proportion with at least a 50% reduction in attacks did not differ from placebo. This is not converted into a 50% reduction in the ginger group's mean or a 50% improvement in every person. - 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 baseline and treatment-period measurements, response classification, arm-specific events, denominators and original comparisons are needed. Responder rates and mean changes are not newly calculated. - Required materials and conditions: Distinction between an individual responder threshold and group mean change - Materials to obtain first: Individual baseline and treatment-period measurements, response classification, arm-specific events, denominators and original comparisons are needed. Responder rates and mean changes are not newly calculated. - Further research: Material needed: Individual baseline and treatment-period measurements, response classification, arm-specific events, denominators and original comparisons are needed. Responder rates and mean changes are not newly calculated. This records needed materials; no new research was executed. - Conditions for verification: Original material for Distinction between an individual responder threshold and group mean change must be linked to individual responder definitions, between-arm comparisons, denominators and measurement windows, distinguishing stored summaries, unread external material, within-arm changes and other acute-treatment questions. - Why this condition is needed: This condition links Distinction between an individual responder threshold and group mean change with populations, formulations, controls, denominators, measurement windows, prespecified criteria, analyses, support and harms for the selected prevention responder outcome. - Application exceptions: Retain original subclaim D and absent individual score, status and axes without inheriting parent D30. Distinguish responder proportions, mean changes, other pain outcomes, single-ingredient prevention, acute combinations and active controls. No new effects, CIs, denominators, independent totals, grades, dosing or treatment instructions are created. - Remaining uncertainty: The original nonsignificance against placebo and precision gaps are retained. Exact responders, denominators, effects, CIs, missingness, concurrent care, prespecified plans, support and harm details are unverified. Historical full-text checking, the single-independent-trial statement or other symptom signals are not converted into completed current review, 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: R01 ### N03 · Are exact arm-specific responders, effects and intervals known? Verification status: Unverified Reading scope: Stored summary read; external abstracts, full texts, registration, protocols and analysis plans unread - Current findings: The original account of no significant between-arm differences in core outcomes and insufficient point estimates or exact CIs in the public abstract is preserved. Arm-specific responders, proportions, direct P, RR, RD and CIs are absent from the stored 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 outcome tables, responders, denominators, effects, CIs, statistical models and missing-data handling are needed. Numbers, CIs and P are not invented. - Required materials and conditions: Original material for direct between-arm estimates and precision - Materials to obtain first: Original outcome tables, responders, denominators, effects, CIs, statistical models and missing-data handling are needed. Numbers, CIs and P are not invented. - Further research: Material needed: Original outcome tables, responders, denominators, effects, CIs, statistical models and missing-data handling are needed. Numbers, CIs and P are not invented. This records needed materials; no new research was executed. - Conditions for verification: Original material for Original material for direct between-arm estimates and precision must be linked to individual responder definitions, between-arm comparisons, denominators and measurement windows, distinguishing stored summaries, unread external material, within-arm changes and other acute-treatment questions. - Why this condition is needed: This condition links Original material for direct between-arm estimates and precision with populations, formulations, controls, denominators, measurement windows, prespecified criteria, analyses, support and harms for the selected prevention responder outcome. - Application exceptions: Retain original subclaim D and absent individual score, status and axes without inheriting parent D30. Distinguish responder proportions, mean changes, other pain outcomes, single-ingredient prevention, acute combinations and active controls. No new effects, CIs, denominators, independent totals, grades, dosing or treatment instructions are created. - Remaining uncertainty: The original nonsignificance against placebo and precision gaps are retained. Exact responders, denominators, effects, CIs, missingness, concurrent care, prespecified plans, support and harm details are unverified. Historical full-text checking, the single-independent-trial statement or other symptom signals are not converted into completed current review, 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: R01 ### N04 · Does nonsignificance prove the absence of even a small benefit? Verification status: Partly verified Reading scope: Stored summary read; external abstracts, full texts, registration, protocols and analysis plans unread - Current findings: The parent account says the direct placebo comparison does not support prevention efficacy, but insufficient CIs and importance boundaries prevent fully excluding a small benefit and assigning F. Parent D30 is not converted into proof of an absolute null effect. - 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 effects, CIs, external clinical importance boundaries, denominators, design and power information are needed. No new F or equivalence judgment or boundary calculation is made. - Required materials and conditions: Distinction between null findings, precision gaps and exact zero effects - Materials to obtain first: Direct effects, CIs, external clinical importance boundaries, denominators, design and power information are needed. No new F or equivalence judgment or boundary calculation is made. - Further research: Material needed: Direct effects, CIs, external clinical importance boundaries, denominators, design and power information are needed. No new F or equivalence judgment or boundary calculation is made. This records needed materials; no new research was executed. - Conditions for verification: Original material for Distinction between null findings, precision gaps and exact zero effects must be linked to individual responder definitions, between-arm comparisons, denominators and measurement windows, distinguishing stored summaries, unread external material, within-arm changes and other acute-treatment questions. - Why this condition is needed: This condition links Distinction between null findings, precision gaps and exact zero effects with populations, formulations, controls, denominators, measurement windows, prespecified criteria, analyses, support and harms for the selected prevention responder outcome. - Application exceptions: Retain original subclaim D and absent individual score, status and axes without inheriting parent D30. Distinguish responder proportions, mean changes, other pain outcomes, single-ingredient prevention, acute combinations and active controls. No new effects, CIs, denominators, independent totals, grades, dosing or treatment instructions are created. - Remaining uncertainty: The original nonsignificance against placebo and precision gaps are retained. Exact responders, denominators, effects, CIs, missingness, concurrent care, prespecified plans, support and harm details are unverified. Historical full-text checking, the single-independent-trial statement or other symptom signals are not converted into completed current review, 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: R01 ### N05 · Is improvement over time in both arms an added ginger effect? Verification status: Partly verified Reading scope: Stored summary read; external abstracts, full texts, registration, protocols and analysis plans unread - Current findings: The original explanation that improvement in both arms does not mean ginger outperformed placebo is retained. Within-arm changes in another subclaim do not replace the between-arm effect for the selected responder outcome. - 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: Baseline and follow-up data, time and arm comparisons, changes, models, denominators, original estimates and CIs are needed. Within-arm changes are not subtracted to create a new effect. - Required materials and conditions: Within-arm change versus the between-arm effect against placebo - Materials to obtain first: Baseline and follow-up data, time and arm comparisons, changes, models, denominators, original estimates and CIs are needed. Within-arm changes are not subtracted to create a new effect. - Further research: Material needed: Baseline and follow-up data, time and arm comparisons, changes, models, denominators, original estimates and CIs are needed. Within-arm changes are not subtracted to create a new effect. This records needed materials; no new research was executed. - Conditions for verification: Original material for Within-arm change versus the between-arm effect against placebo must be linked to individual responder definitions, between-arm comparisons, denominators and measurement windows, distinguishing stored summaries, unread external material, within-arm changes and other acute-treatment questions. - Why this condition is needed: This condition links Within-arm change versus the between-arm effect against placebo with populations, formulations, controls, denominators, measurement windows, prespecified criteria, analyses, support and harms for the selected prevention responder outcome. - Application exceptions: Retain original subclaim D and absent individual score, status and axes without inheriting parent D30. Distinguish responder proportions, mean changes, other pain outcomes, single-ingredient prevention, acute combinations and active controls. No new effects, CIs, denominators, independent totals, grades, dosing or treatment instructions are created. - Remaining uncertainty: The original nonsignificance against placebo and precision gaps are retained. Exact responders, denominators, effects, CIs, missingness, concurrent care, prespecified plans, support and harm details are unverified. Historical full-text checking, the single-independent-trial statement or other symptom signals are not converted into completed current review, 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: R01 ### N06 · Is detailed eligibility for adults with episodic migraine known? Verification status: Partly verified Reading scope: Stored summary read; external abstracts, full texts, registration, protocols and analysis plans unread - Current findings: The parent scope of 107 adults with episodic migraine is retained. Overall size does not substitute for arm-specific responder denominators or detailed diagnostic and eligibility criteria. - 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: Diagnostic criteria, baseline frequency, age, concurrent and prior care, exclusions and acute-medication information are needed. Findings are not extended to chronic migraine or other populations. - Required materials and conditions: Diagnosis, baseline attack frequency, preventive care and population scope - Materials to obtain first: Diagnostic criteria, baseline frequency, age, concurrent and prior care, exclusions and acute-medication information are needed. Findings are not extended to chronic migraine or other populations. - Further research: Material needed: Diagnostic criteria, baseline frequency, age, concurrent and prior care, exclusions and acute-medication information are needed. Findings are not extended to chronic migraine or other populations. This records needed materials; no new research was executed. - Conditions for verification: Original material for Diagnosis, baseline attack frequency, preventive care and population scope must be linked to individual responder definitions, between-arm comparisons, denominators and measurement windows, distinguishing stored summaries, unread external material, within-arm changes and other acute-treatment questions. - Why this condition is needed: This condition links Diagnosis, baseline attack frequency, preventive care and population scope with populations, formulations, controls, denominators, measurement windows, prespecified criteria, analyses, support and harms for the selected prevention responder outcome. - Application exceptions: Retain original subclaim D and absent individual score, status and axes without inheriting parent D30. Distinguish responder proportions, mean changes, other pain outcomes, single-ingredient prevention, acute combinations and active controls. No new effects, CIs, denominators, independent totals, grades, dosing or treatment instructions are created. - Remaining uncertainty: The original nonsignificance against placebo and precision gaps are retained. Exact responders, denominators, effects, CIs, missingness, concurrent care, prespecified plans, support and harm details are unverified. Historical full-text checking, the single-independent-trial statement or other symptom signals are not converted into completed current review, 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: R01 ### N07 · Which standardized ginger formulation was compared? Verification status: Partly verified Reading scope: Stored summary read; external abstracts, full texts, registration, protocols and analysis plans unread - Current findings: The original comparison of a 200 mg dry extract standardized to 5% active constituents, used 3 times daily for 3 months against placebo, is retained. Total daily or active amounts are not calculated, and culinary ginger is not treated as interchangeable. - 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: Products, active-constituent definitions, quantification, batches, quality, placebo composition, adherence and original exposure records are needed. New dosing or treatment instructions are not written. - Required materials and conditions: Dry extract 200 mg, 5% active constituents and the original schedule - Materials to obtain first: Products, active-constituent definitions, quantification, batches, quality, placebo composition, adherence and original exposure records are needed. New dosing or treatment instructions are not written. - Further research: Material needed: Products, active-constituent definitions, quantification, batches, quality, placebo composition, adherence and original exposure records are needed. New dosing or treatment instructions are not written. This records needed materials; no new research was executed. - Conditions for verification: Original material for Dry extract 200 mg, 5% active constituents and the original schedule must be linked to individual responder definitions, between-arm comparisons, denominators and measurement windows, distinguishing stored summaries, unread external material, within-arm changes and other acute-treatment questions. - Why this condition is needed: This condition links Dry extract 200 mg, 5% active constituents and the original schedule with populations, formulations, controls, denominators, measurement windows, prespecified criteria, analyses, support and harms for the selected prevention responder outcome. - Application exceptions: Retain original subclaim D and absent individual score, status and axes without inheriting parent D30. Distinguish responder proportions, mean changes, other pain outcomes, single-ingredient prevention, acute combinations and active controls. No new effects, CIs, denominators, independent totals, grades, dosing or treatment instructions are created. - Remaining uncertainty: The original nonsignificance against placebo and precision gaps are retained. Exact responders, denominators, effects, CIs, missingness, concurrent care, prespecified plans, support and harm details are unverified. Historical full-text checking, the single-independent-trial statement or other symptom signals are not converted into completed current review, 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: R01 ### N08 · Are 3-month prevention and acute-attack treatment the same question? Verification status: Partly verified Reading scope: Stored summary read; external abstracts, full texts, registration, protocols and analysis plans unread - Current findings: The original trial concerns 3-month prevention with ginger alone. Acute-attack treatment or nausea improvement is not transferred into the same 50% prevention responder outcome. - 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: Baseline observation, treatment and measurement windows, prevention eligibility, concurrent care and direct findings are needed. Acute studies are not added as replication of the same prevention question. - Required materials and conditions: Distinction between prevention intent, measurement periods and acute treatment - Materials to obtain first: Baseline observation, treatment and measurement windows, prevention eligibility, concurrent care and direct findings are needed. Acute studies are not added as replication of the same prevention question. - Further research: Material needed: Baseline observation, treatment and measurement windows, prevention eligibility, concurrent care and direct findings are needed. Acute studies are not added as replication of the same prevention question. This records needed materials; no new research was executed. - Conditions for verification: Original material for Distinction between prevention intent, measurement periods and acute treatment must be linked to individual responder definitions, between-arm comparisons, denominators and measurement windows, distinguishing stored summaries, unread external material, within-arm changes and other acute-treatment questions. - Why this condition is needed: This condition links Distinction between prevention intent, measurement periods and acute treatment with populations, formulations, controls, denominators, measurement windows, prespecified criteria, analyses, support and harms for the selected prevention responder outcome. - Application exceptions: Retain original subclaim D and absent individual score, status and axes without inheriting parent D30. Distinguish responder proportions, mean changes, other pain outcomes, single-ingredient prevention, acute combinations and active controls. No new effects, CIs, denominators, independent totals, grades, dosing or treatment instructions are created. - Remaining uncertainty: The original nonsignificance against placebo and precision gaps are retained. Exact responders, denominators, effects, CIs, missingness, concurrent care, prespecified plans, support and harm details are unverified. Historical full-text checking, the single-independent-trial statement or other symptom signals are not converted into completed current review, 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: R01 ### N09 · Are feverfew-plus-ginger combinations distinguished from ginger extract alone? Verification status: Partly verified Reading scope: Stored summary read; external abstracts, full texts, registration, protocols and analysis plans unread - Current findings: The parent account did not count acute feverfew-plus-ginger combinations as replication of 3-month prevention with ginger alone. Combination findings are not copied as direct efficacy for the selected question. - 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 materials on the same standardized single ingredient, population, control and prevention outcome are needed. Combination findings or trial counts absent from the stored account are not created. - Required materials and conditions: Distinction between acute combinations and single-ingredient prevention - Materials to obtain first: Direct materials on the same standardized single ingredient, population, control and prevention outcome are needed. Combination findings or trial counts absent from the stored account are not created. - Further research: Material needed: Direct materials on the same standardized single ingredient, population, control and prevention outcome are needed. Combination findings or trial counts absent from the stored account are not created. This records needed materials; no new research was executed. - Conditions for verification: Original material for Distinction between acute combinations and single-ingredient prevention must be linked to individual responder definitions, between-arm comparisons, denominators and measurement windows, distinguishing stored summaries, unread external material, within-arm changes and other acute-treatment questions. - Why this condition is needed: This condition links Distinction between acute combinations and single-ingredient prevention with populations, formulations, controls, denominators, measurement windows, prespecified criteria, analyses, support and harms for the selected prevention responder outcome. - Application exceptions: Retain original subclaim D and absent individual score, status and axes without inheriting parent D30. Distinguish responder proportions, mean changes, other pain outcomes, single-ingredient prevention, acute combinations and active controls. No new effects, CIs, denominators, independent totals, grades, dosing or treatment instructions are created. - Remaining uncertainty: The original nonsignificance against placebo and precision gaps are retained. Exact responders, denominators, effects, CIs, missingness, concurrent care, prespecified plans, support and harm details are unverified. Historical full-text checking, the single-independent-trial statement or other symptom signals are not converted into completed current review, 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: R01 ### N10 · Is a sumatriptan active-control study replication of placebo-controlled prevention? Verification status: Partly verified Reading scope: Stored summary read; external abstracts, full texts, registration, protocols and analysis plans unread - Current findings: The account did not count sumatriptan active-control studies as replication of 3-month prevention with ginger alone. Findings with other controls or durations are not converted into certification of the selected prevention effect or equivalence. - 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: Prespecified responder comparisons for the selected formulation, preventive population, duration and placebo control are needed. Active-control values or clinical guidance outside the account are not created. - Required materials and conditions: Directness of other controls and acute questions for the selected prevention outcome - Materials to obtain first: Prespecified responder comparisons for the selected formulation, preventive population, duration and placebo control are needed. Active-control values or clinical guidance outside the account are not created. - Further research: Material needed: Prespecified responder comparisons for the selected formulation, preventive population, duration and placebo control are needed. Active-control values or clinical guidance outside the account are not created. This records needed materials; no new research was executed. - Conditions for verification: Original material for Directness of other controls and acute questions for the selected prevention outcome must be linked to individual responder definitions, between-arm comparisons, denominators and measurement windows, distinguishing stored summaries, unread external material, within-arm changes and other acute-treatment questions. - Why this condition is needed: This condition links Directness of other controls and acute questions for the selected prevention outcome with populations, formulations, controls, denominators, measurement windows, prespecified criteria, analyses, support and harms for the selected prevention responder outcome. - Application exceptions: Retain original subclaim D and absent individual score, status and axes without inheriting parent D30. Distinguish responder proportions, mean changes, other pain outcomes, single-ingredient prevention, acute combinations and active controls. No new effects, CIs, denominators, independent totals, grades, dosing or treatment instructions are created. - Remaining uncertainty: The original nonsignificance against placebo and precision gaps are retained. Exact responders, denominators, effects, CIs, missingness, concurrent care, prespecified plans, support and harm details are unverified. Historical full-text checking, the single-independent-trial statement or other symptom signals are not converted into completed current review, 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: R01 ### N11 · Does a nausea-related signal establish migraine prevention? Verification status: Partly verified Reading scope: Stored summary read; external abstracts, full texts, registration, protocols and analysis plans unread - Current findings: The original boundary against transferring nausea, other symptoms, combination products or acute-treatment evidence to long-term single-ingredient prevention is retained. Mechanisms or nausea materials are not used as direct evidence for the 50% responder outcome. - 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 patient outcomes, between-arm estimates and CIs for the same prevention question are needed. No new mechanistic or efficacy judgment is made. - Required materials and conditions: Distinction between other symptoms or mechanisms and direct attack prevention - Materials to obtain first: Direct patient outcomes, between-arm estimates and CIs for the same prevention question are needed. No new mechanistic or efficacy judgment is made. - Further research: Material needed: Direct patient outcomes, between-arm estimates and CIs for the same prevention question are needed. No new mechanistic or efficacy judgment is made. This records needed materials; no new research was executed. - Conditions for verification: Original material for Distinction between other symptoms or mechanisms and direct attack prevention must be linked to individual responder definitions, between-arm comparisons, denominators and measurement windows, distinguishing stored summaries, unread external material, within-arm changes and other acute-treatment questions. - Why this condition is needed: This condition links Distinction between other symptoms or mechanisms and direct attack prevention with populations, formulations, controls, denominators, measurement windows, prespecified criteria, analyses, support and harms for the selected prevention responder outcome. - Application exceptions: Retain original subclaim D and absent individual score, status and axes without inheriting parent D30. Distinguish responder proportions, mean changes, other pain outcomes, single-ingredient prevention, acute combinations and active controls. No new effects, CIs, denominators, independent totals, grades, dosing or treatment instructions are created. - Remaining uncertainty: The original nonsignificance against placebo and precision gaps are retained. Exact responders, denominators, effects, CIs, missingness, concurrent care, prespecified plans, support and harm details are unverified. Historical full-text checking, the single-independent-trial statement or other symptom signals are not converted into completed current review, 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: R01 ### N12 · Are overall trial size and outcome-specific analysis denominators the same? Verification status: Unverified Reading scope: Stored summary read; external abstracts, full texts, registration, protocols and analysis plans unread - Current findings: The original wording of 107 randomized in NCT02570633 and 107 adults is preserved. Arm-specific allocation, completion, responder-analysis counts, missingness and ITT details are absent from the summary and are not treated as complete data for every outcome. - 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 analysis populations, missingness and withdrawal reasons, diary completeness, missing-responder handling and sensitivity materials are needed. New differences or ratios are not calculated. - Required materials and conditions: Allocation, completion, responder analysis and missingness handling - Materials to obtain first: Original flow diagrams, arm-specific analysis populations, missingness and withdrawal reasons, diary completeness, missing-responder handling and sensitivity materials are needed. New differences or ratios are not calculated. - Further research: Material needed: Original flow diagrams, arm-specific analysis populations, missingness and withdrawal reasons, diary completeness, missing-responder handling and sensitivity materials are needed. New differences or ratios are not calculated. This records needed materials; no new research was executed. - Conditions for verification: Original material for Allocation, completion, responder analysis and missingness handling must be linked to individual responder definitions, between-arm comparisons, denominators and measurement windows, distinguishing stored summaries, unread external material, within-arm changes and other acute-treatment questions. - Why this condition is needed: This condition links Allocation, completion, responder analysis and missingness handling with populations, formulations, controls, denominators, measurement windows, prespecified criteria, analyses, support and harms for the selected prevention responder outcome. - Application exceptions: Retain original subclaim D and absent individual score, status and axes without inheriting parent D30. Distinguish responder proportions, mean changes, other pain outcomes, single-ingredient prevention, acute combinations and active controls. No new effects, CIs, denominators, independent totals, grades, dosing or treatment instructions are created. - Remaining uncertainty: The original nonsignificance against placebo and precision gaps are retained. Exact responders, denominators, effects, CIs, missingness, concurrent care, prespecified plans, support and harm details are unverified. Historical full-text checking, the single-independent-trial statement or other symptom signals are not converted into completed current review, 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: R01 ### N13 · Are detailed randomization and double-blinding procedures known? Verification status: Partly verified Reading scope: Stored summary read; external abstracts, full texts, registration, protocols and analysis plans unread - Current findings: The original double-blind placebo-controlled randomized design is preserved. Its label does not verify allocation, concealment, sensory matching, masking success, attack-diary collection or analyst details. - 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 methods, withdrawals, missingness, diaries, analysis, outcome selection, registration and plans are needed. No new official risk-of-bias assessment is performed. - Required materials and conditions: Details of allocation, concealment, placebo, measurement and selective reporting - Materials to obtain first: Original methods, withdrawals, missingness, diaries, analysis, outcome selection, registration and plans are needed. No new official risk-of-bias assessment is performed. - Further research: Material needed: Original methods, withdrawals, missingness, diaries, analysis, outcome selection, registration and plans are needed. No new official risk-of-bias assessment is performed. This records needed materials; no new research was executed. - Conditions for verification: Original material for Details of allocation, concealment, placebo, measurement and selective reporting must be linked to individual responder definitions, between-arm comparisons, denominators and measurement windows, distinguishing stored summaries, unread external material, within-arm changes and other acute-treatment questions. - Why this condition is needed: This condition links Details of allocation, concealment, placebo, measurement and selective reporting with populations, formulations, controls, denominators, measurement windows, prespecified criteria, analyses, support and harms for the selected prevention responder outcome. - Application exceptions: Retain original subclaim D and absent individual score, status and axes without inheriting parent D30. Distinguish responder proportions, mean changes, other pain outcomes, single-ingredient prevention, acute combinations and active controls. No new effects, CIs, denominators, independent totals, grades, dosing or treatment instructions are created. - Remaining uncertainty: The original nonsignificance against placebo and precision gaps are retained. Exact responders, denominators, effects, CIs, missingness, concurrent care, prespecified plans, support and harm details are unverified. Historical full-text checking, the single-independent-trial statement or other symptom signals are not converted into completed current review, 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: R01 ### N14 · Is the registration identifier distinguished from actual reading of the original plan? Verification status: Partly verified Reading scope: Stored summary read; external abstracts, full texts, registration, protocols and analysis plans unread - Current findings: NCT02570633 is preserved in the existing evidence, citation and bilingual explanation. Registration, protocols, SAPs and amendment histories are unread in this work; the identifier alone does not establish prespecified agreement on responder criteria, denominators or analyses. - 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, amendments, protocols, SAPs, the 50% definition, timing, analyses and outcome hierarchy are needed. A registration URL is not newly inferred. - Required materials and conditions: Registration identifier versus prespecified outcomes and analysis hierarchy - Materials to obtain first: Original registration, amendments, protocols, SAPs, the 50% definition, timing, analyses and outcome hierarchy are needed. A registration URL is not newly inferred. - Further research: Material needed: Original registration, amendments, protocols, SAPs, the 50% definition, timing, analyses and outcome hierarchy are needed. A registration URL is not newly inferred. This records needed materials; no new research was executed. - Conditions for verification: Original material for Registration identifier versus prespecified outcomes and analysis hierarchy must be linked to individual responder definitions, between-arm comparisons, denominators and measurement windows, distinguishing stored summaries, unread external material, within-arm changes and other acute-treatment questions. - Why this condition is needed: This condition links Registration identifier versus prespecified outcomes and analysis hierarchy with populations, formulations, controls, denominators, measurement windows, prespecified criteria, analyses, support and harms for the selected prevention responder outcome. - Application exceptions: Retain original subclaim D and absent individual score, status and axes without inheriting parent D30. Distinguish responder proportions, mean changes, other pain outcomes, single-ingredient prevention, acute combinations and active controls. No new effects, CIs, denominators, independent totals, grades, dosing or treatment instructions are created. - Remaining uncertainty: The original nonsignificance against placebo and precision gaps are retained. Exact responders, denominators, effects, CIs, missingness, concurrent care, prespecified plans, support and harm details are unverified. Historical full-text checking, the single-independent-trial statement or other symptom signals are not converted into completed current review, 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: R01 ### N15 · Are severe-pain days, acute medication and duration the same responder outcome? Verification status: Partly verified Reading scope: Stored summary read; external abstracts, full texts, registration, protocols and analysis plans unread - Current findings: The account preserves no between-arm difference for severe-pain days, acute analgesic use and attack duration as well. These differ from the 50% responder outcome; original values, timing and CIs are not transferred between them. - 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: Outcome-specific definitions, measurement windows, denominators, between-arm effects, CIs, prespecified hierarchies and multiplicity materials are needed. The original null account is retained. - Required materials and conditions: Distinction between other outcomes or subclaims and the key responder outcome - Materials to obtain first: Outcome-specific definitions, measurement windows, denominators, between-arm effects, CIs, prespecified hierarchies and multiplicity materials are needed. The original null account is retained. - Further research: Material needed: Outcome-specific definitions, measurement windows, denominators, between-arm effects, CIs, prespecified hierarchies and multiplicity materials are needed. The original null account is retained. This records needed materials; no new research was executed. - Conditions for verification: Original material for Distinction between other outcomes or subclaims and the key responder outcome must be linked to individual responder definitions, between-arm comparisons, denominators and measurement windows, distinguishing stored summaries, unread external material, within-arm changes and other acute-treatment questions. - Why this condition is needed: This condition links Distinction between other outcomes or subclaims and the key responder outcome with populations, formulations, controls, denominators, measurement windows, prespecified criteria, analyses, support and harms for the selected prevention responder outcome. - Application exceptions: Retain original subclaim D and absent individual score, status and axes without inheriting parent D30. Distinguish responder proportions, mean changes, other pain outcomes, single-ingredient prevention, acute combinations and active controls. No new effects, CIs, denominators, independent totals, grades, dosing or treatment instructions are created. - Remaining uncertainty: The original nonsignificance against placebo and precision gaps are retained. Exact responders, denominators, effects, CIs, missingness, concurrent care, prespecified plans, support and harm details are unverified. Historical full-text checking, the single-independent-trial statement or other symptom signals are not converted into completed current review, 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: R01 ### N16 · Are concurrent medication, adherence and withdrawal details known? Verification status: Unverified Reading scope: Stored summary read; external abstracts, full texts, registration, protocols and analysis plans unread - Current findings: Acute analgesic use is an original outcome. Medication types, concurrent preventive drugs, changes, extract adherence, rescue care and arm-specific withdrawal details are absent from the stored 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: Arm-specific concurrent and acute medication, medication changes, actual exposure, adherence, withdrawals and missingness materials are needed. Unverified information is not converted into equality or absence. - Required materials and conditions: Preventive and acute medication, actual exposure and missingness - Materials to obtain first: Arm-specific concurrent and acute medication, medication changes, actual exposure, adherence, withdrawals and missingness materials are needed. Unverified information is not converted into equality or absence. - Further research: Material needed: Arm-specific concurrent and acute medication, medication changes, actual exposure, adherence, withdrawals and missingness materials are needed. Unverified information is not converted into equality or absence. This records needed materials; no new research was executed. - Conditions for verification: Original material for Preventive and acute medication, actual exposure and missingness must be linked to individual responder definitions, between-arm comparisons, denominators and measurement windows, distinguishing stored summaries, unread external material, within-arm changes and other acute-treatment questions. - Why this condition is needed: This condition links Preventive and acute medication, actual exposure and missingness with populations, formulations, controls, denominators, measurement windows, prespecified criteria, analyses, support and harms for the selected prevention responder outcome. - Application exceptions: Retain original subclaim D and absent individual score, status and axes without inheriting parent D30. Distinguish responder proportions, mean changes, other pain outcomes, single-ingredient prevention, acute combinations and active controls. No new effects, CIs, denominators, independent totals, grades, dosing or treatment instructions are created. - Remaining uncertainty: The original nonsignificance against placebo and precision gaps are retained. Exact responders, denominators, effects, CIs, missingness, concurrent care, prespecified plans, support and harm details are unverified. Historical full-text checking, the single-independent-trial statement or other symptom signals are not converted into completed current review, 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: R01 ### N17 · Do 3-month findings establish post-treatment persistence or long-term harms? Verification status: Partly verified Reading scope: Stored summary read; external abstracts, full texts, registration, protocols and analysis plans unread - Current findings: The trial's 3-month prevention condition is retained. Post-treatment attacks, maintained responses, recurrence and long-term or rare harms are unestablished in the account and are not extended into proof of prevention over all longer periods. - 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: Post-treatment follow-up, continuing or changed care, recurrence, adherence, harms, denominators and direct longer-duration materials are needed. - Required materials and conditions: Distinction between prevention during treatment and post-treatment follow-up - Materials to obtain first: Post-treatment follow-up, continuing or changed care, recurrence, adherence, harms, denominators and direct longer-duration materials are needed. - Further research: Material needed: Post-treatment follow-up, continuing or changed care, recurrence, adherence, harms, denominators and direct longer-duration materials are needed. This records needed materials; no new research was executed. - Conditions for verification: Original material for Distinction between prevention during treatment and post-treatment follow-up must be linked to individual responder definitions, between-arm comparisons, denominators and measurement windows, distinguishing stored summaries, unread external material, within-arm changes and other acute-treatment questions. - Why this condition is needed: This condition links Distinction between prevention during treatment and post-treatment follow-up with populations, formulations, controls, denominators, measurement windows, prespecified criteria, analyses, support and harms for the selected prevention responder outcome. - Application exceptions: Retain original subclaim D and absent individual score, status and axes without inheriting parent D30. Distinguish responder proportions, mean changes, other pain outcomes, single-ingredient prevention, acute combinations and active controls. No new effects, CIs, denominators, independent totals, grades, dosing or treatment instructions are created. - Remaining uncertainty: The original nonsignificance against placebo and precision gaps are retained. Exact responders, denominators, effects, CIs, missingness, concurrent care, prespecified plans, support and harm details are unverified. Historical full-text checking, the single-independent-trial statement or other symptom signals are not converted into completed current review, 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: R01 ### N18 · Is the original sole-direct-trial statement a new certification of independence? Verification status: Partly verified Reading scope: Stored summary read; external abstracts, full texts, registration, protocols and analysis plans unread - Current findings: The parent describes a single independent and sole direct prevention trial. The same paper is shared across the parent and subclaims; this is not newly certified as independent replication or an established unique-trial total. - 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: Registration, institutions, recruitment, participants, report relationships, overlap and support materials are needed. Unique trial and participant totals remain unverified. - Required materials and conditions: Distinction between shared original reports or cohorts and independent replication - Materials to obtain first: Registration, institutions, recruitment, participants, report relationships, overlap and support materials are needed. Unique trial and participant totals remain unverified. - Further research: Material needed: Registration, institutions, recruitment, participants, report relationships, overlap and support materials are needed. Unique trial and participant totals remain unverified. This records needed materials; no new research was executed. - Conditions for verification: Original material for Distinction between shared original reports or cohorts and independent replication must be linked to individual responder definitions, between-arm comparisons, denominators and measurement windows, distinguishing stored summaries, unread external material, within-arm changes and other acute-treatment questions. - Why this condition is needed: This condition links Distinction between shared original reports or cohorts and independent replication with populations, formulations, controls, denominators, measurement windows, prespecified criteria, analyses, support and harms for the selected prevention responder outcome. - Application exceptions: Retain original subclaim D and absent individual score, status and axes without inheriting parent D30. Distinguish responder proportions, mean changes, other pain outcomes, single-ingredient prevention, acute combinations and active controls. No new effects, CIs, denominators, independent totals, grades, dosing or treatment instructions are created. - Remaining uncertainty: The original nonsignificance against placebo and precision gaps are retained. Exact responders, denominators, effects, CIs, missingness, concurrent care, prespecified plans, support and harm details are unverified. Historical full-text checking, the single-independent-trial statement or other symptom signals are not converted into completed current review, 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: R01 ### N19 · Is historical full-text support checking distinguished from current reading? Verification status: Partly verified Reading scope: Stored summary read; external abstracts, full texts, registration, protocols and analysis plans unread - Current findings: Original manufacturer-independence and full-text support-checking wording is preserved in both Korean and English. This historical record is not promoted into completed full-text reading or independence verification 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 material linking financial and product support, author or company affiliations and design, analysis and publication roles is needed. Historical checking wording is not relabeled as a current check. - Required materials and conditions: Historical funding wording and original company-involvement materials - Materials to obtain first: Original material linking financial and product support, author or company affiliations and design, analysis and publication roles is needed. Historical checking wording is not relabeled as a current check. - Further research: Material needed: Original material linking financial and product support, author or company affiliations and design, analysis and publication roles is needed. Historical checking wording is not relabeled as a current check. This records needed materials; no new research was executed. - Conditions for verification: Original material for Historical funding wording and original company-involvement materials must be linked to individual responder definitions, between-arm comparisons, denominators and measurement windows, distinguishing stored summaries, unread external material, within-arm changes and other acute-treatment questions. - Why this condition is needed: This condition links Historical funding wording and original company-involvement materials with populations, formulations, controls, denominators, measurement windows, prespecified criteria, analyses, support and harms for the selected prevention responder outcome. - Application exceptions: Retain original subclaim D and absent individual score, status and axes without inheriting parent D30. Distinguish responder proportions, mean changes, other pain outcomes, single-ingredient prevention, acute combinations and active controls. No new effects, CIs, denominators, independent totals, grades, dosing or treatment instructions are created. - Remaining uncertainty: The original nonsignificance against placebo and precision gaps are retained. Exact responders, denominators, effects, CIs, missingness, concurrent care, prespecified plans, support and harm details are unverified. Historical full-text checking, the single-independent-trial statement or other symptom signals are not converted into completed current review, 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: R01 ### N20 · Are actual harm-event counts and denominators known? Verification status: Partly verified Reading scope: Stored summary read; external abstracts, full texts, registration, protocols and analysis plans unread - Current findings: The parent's cautions on heartburn, abdominal discomfort, anticoagulants, antiplatelet drugs, bleeding risks and surgery are preserved. Arm-specific harm counts, exposure, collection, withdrawal reasons and denominators are absent from the stored 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: Harm definitions, collection, events, affected participants, severity, timing, exposure, denominators, concurrent medication, vulnerable groups and long-term materials are needed. No new treatment or dosing guidance is written. - Required materials and conditions: Harm collection, exposure, withdrawal and bleeding-related concurrent-medication context - Materials to obtain first: Harm definitions, collection, events, affected participants, severity, timing, exposure, denominators, concurrent medication, vulnerable groups and long-term materials are needed. No new treatment or dosing guidance is written. - Further research: Material needed: Harm definitions, collection, events, affected participants, severity, timing, exposure, denominators, concurrent medication, vulnerable groups and long-term materials are needed. No new treatment or dosing guidance is written. This records needed materials; no new research was executed. - Conditions for verification: Original material for Harm collection, exposure, withdrawal and bleeding-related concurrent-medication context must be linked to individual responder definitions, between-arm comparisons, denominators and measurement windows, distinguishing stored summaries, unread external material, within-arm changes and other acute-treatment questions. - Why this condition is needed: This condition links Harm collection, exposure, withdrawal and bleeding-related concurrent-medication context with populations, formulations, controls, denominators, measurement windows, prespecified criteria, analyses, support and harms for the selected prevention responder outcome. - Application exceptions: Retain original subclaim D and absent individual score, status and axes without inheriting parent D30. Distinguish responder proportions, mean changes, other pain outcomes, single-ingredient prevention, acute combinations and active controls. No new effects, CIs, denominators, independent totals, grades, dosing or treatment instructions are created. - Remaining uncertainty: The original nonsignificance against placebo and precision gaps are retained. Exact responders, denominators, effects, CIs, missingness, concurrent care, prespecified plans, support and harm details are unverified. Historical full-text checking, the single-independent-trial statement or other symptom signals are not converted into completed current review, 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: R01 ### N21 · Is the 50% threshold the same as between-arm clinical importance? Verification status: Partly verified Reading scope: Stored summary read; external abstracts, full texts, registration, protocols and analysis plans unread - Current findings: The original 50% threshold classifies responders. Gaps in exact CIs and clinical importance boundaries are retained; the threshold alone does not certify an important between-arm benefit or external validation. - 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: Threshold sources, prespecified definitions, patient-importance boundaries, direct effects, CIs and arm-specific denominators are needed. Absolute benefits, NNTs, intervals and boundaries are not newly calculated. - Required materials and conditions: Responder classification, prespecification and external benefit boundaries - Materials to obtain first: Threshold sources, prespecified definitions, patient-importance boundaries, direct effects, CIs and arm-specific denominators are needed. Absolute benefits, NNTs, intervals and boundaries are not newly calculated. - Further research: Material needed: Threshold sources, prespecified definitions, patient-importance boundaries, direct effects, CIs and arm-specific denominators are needed. Absolute benefits, NNTs, intervals and boundaries are not newly calculated. This records needed materials; no new research was executed. - Conditions for verification: Original material for Responder classification, prespecification and external benefit boundaries must be linked to individual responder definitions, between-arm comparisons, denominators and measurement windows, distinguishing stored summaries, unread external material, within-arm changes and other acute-treatment questions. - Why this condition is needed: This condition links Responder classification, prespecification and external benefit boundaries with populations, formulations, controls, denominators, measurement windows, prespecified criteria, analyses, support and harms for the selected prevention responder outcome. - Application exceptions: Retain original subclaim D and absent individual score, status and axes without inheriting parent D30. Distinguish responder proportions, mean changes, other pain outcomes, single-ingredient prevention, acute combinations and active controls. No new effects, CIs, denominators, independent totals, grades, dosing or treatment instructions are created. - Remaining uncertainty: The original nonsignificance against placebo and precision gaps are retained. Exact responders, denominators, effects, CIs, missingness, concurrent care, prespecified plans, support and harm details are unverified. Historical full-text checking, the single-independent-trial statement or other symptom signals are not converted into completed current review, 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: R01 ### N22 · Are null core between-arm findings replaced by other results? Verification status: Partly verified Reading scope: Stored summary read; external abstracts, full texts, registration, protocols and analysis plans unread - Current findings: The parent centers the 50% responder outcome and core between-arm comparisons while distinguishing within-arm changes, acute combinations and active controls. Original null findings are not replaced with signals from other symptoms or studies. - 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 findings, denominators, prespecified hierarchies, analyses, missingness and timing materials are needed. Unread original tables are not described as fully reviewed. - Required materials and conditions: Distinction between core comparisons, within-arm changes and outcome hierarchy - Materials to obtain first: Complete original findings, denominators, prespecified hierarchies, analyses, missingness and timing materials are needed. Unread original tables are not described as fully reviewed. - Further research: Material needed: Complete original findings, denominators, prespecified hierarchies, analyses, missingness and timing materials are needed. Unread original tables are not described as fully reviewed. This records needed materials; no new research was executed. - Conditions for verification: Original material for Distinction between core comparisons, within-arm changes and outcome hierarchy must be linked to individual responder definitions, between-arm comparisons, denominators and measurement windows, distinguishing stored summaries, unread external material, within-arm changes and other acute-treatment questions. - Why this condition is needed: This condition links Distinction between core comparisons, within-arm changes and outcome hierarchy with populations, formulations, controls, denominators, measurement windows, prespecified criteria, analyses, support and harms for the selected prevention responder outcome. - Application exceptions: Retain original subclaim D and absent individual score, status and axes without inheriting parent D30. Distinguish responder proportions, mean changes, other pain outcomes, single-ingredient prevention, acute combinations and active controls. No new effects, CIs, denominators, independent totals, grades, dosing or treatment instructions are created. - Remaining uncertainty: The original nonsignificance against placebo and precision gaps are retained. Exact responders, denominators, effects, CIs, missingness, concurrent care, prespecified plans, support and harm details are unverified. Historical full-text checking, the single-independent-trial statement or other symptom signals are not converted into completed current review, 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: R01 ### N23 · Are the original subclaim grade and parent score or axes distinguished? Verification status: Partly verified Reading scope: Stored summary read; external abstracts, full texts, registration, protocols and analysis plans unread - Current findings: The original subclaim grade is D, with no individual score, status or axes. Parent D30, Caution and judgment axes remain separate contexts and do not fill absent subclaim values. - 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: Parent and subclaim questions and application scope need review. No new grades, scores, clinical statuses or independent certification are created. - Required materials and conditions: Subclaim D and absent individual score, status and axes - Materials to obtain first: Parent and subclaim questions and application scope need review. No new grades, scores, clinical statuses or independent certification are created. - Further research: Material needed: Parent and subclaim questions and application scope need review. No new grades, scores, clinical statuses or independent certification are created. This records needed materials; no new research was executed. - Conditions for verification: Original material for Subclaim D and absent individual score, status and axes must be linked to individual responder definitions, between-arm comparisons, denominators and measurement windows, distinguishing stored summaries, unread external material, within-arm changes and other acute-treatment questions. - Why this condition is needed: This condition links Subclaim D and absent individual score, status and axes with populations, formulations, controls, denominators, measurement windows, prespecified criteria, analyses, support and harms for the selected prevention responder outcome. - Application exceptions: Retain original subclaim D and absent individual score, status and axes without inheriting parent D30. Distinguish responder proportions, mean changes, other pain outcomes, single-ingredient prevention, acute combinations and active controls. No new effects, CIs, denominators, independent totals, grades, dosing or treatment instructions are created. - Remaining uncertainty: The original nonsignificance against placebo and precision gaps are retained. Exact responders, denominators, effects, CIs, missingness, concurrent care, prespecified plans, support and harm details are unverified. Historical full-text checking, the single-independent-trial statement or other symptom signals are not converted into completed current review, 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: R01 ### N24 · Are stored summaries distinguished from actual external-material reading? Verification status: Partly verified Reading scope: Stored summary read; external abstracts, full texts, registration, protocols and analysis plans unread - Current findings: The complete stored parent summary was read for production. Historical checking, cross-checking, full-text and calculation wording remains historical; external abstracts, full texts, registration, protocols and SAPs are unread 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: External acquisition, actual reading and content review are separate events. A link alone does not establish original reading, accessibility or completed review. - Required materials and conditions: Reading states for summaries, abstracts, full texts, registration and plans - Materials to obtain first: External acquisition, actual reading and content review are separate events. A link alone does not establish original reading, accessibility or completed review. - Further research: Material needed: External acquisition, actual reading and content review are separate events. A link alone does not establish original reading, accessibility or completed review. This records needed materials; no new research was executed. - Conditions for verification: Original material for Reading states for summaries, abstracts, full texts, registration and plans must be linked to individual responder definitions, between-arm comparisons, denominators and measurement windows, distinguishing stored summaries, unread external material, within-arm changes and other acute-treatment questions. - Why this condition is needed: This condition links Reading states for summaries, abstracts, full texts, registration and plans with populations, formulations, controls, denominators, measurement windows, prespecified criteria, analyses, support and harms for the selected prevention responder outcome. - Application exceptions: Retain original subclaim D and absent individual score, status and axes without inheriting parent D30. Distinguish responder proportions, mean changes, other pain outcomes, single-ingredient prevention, acute combinations and active controls. No new effects, CIs, denominators, independent totals, grades, dosing or treatment instructions are created. - Remaining uncertainty: The original nonsignificance against placebo and precision gaps are retained. Exact responders, denominators, effects, CIs, missingness, concurrent care, prespecified plans, support and harm details are unverified. Historical full-text checking, the single-independent-trial statement or other symptom signals are not converted into completed current review, 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: R01 ### N25 · Are bilingual representative descriptions applied to every report and outcome? Verification status: Partly verified Reading scope: Stored summary read; external abstracts, full texts, registration, protocols and analysis plans unread - Current findings: The complete parent Korean and English accounts and representative classifications are preserved. Representative doses, populations and outcomes are not automatically applied as quantitative exposure, denominators or identical findings across all arms and 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: Report-specific populations, formulations, controls, outcomes, timing and denominators need comparison materials. No new external English-original comparison or correction review was performed. - Required materials and conditions: Scope of original language, formulations, populations and representative outcomes - Materials to obtain first: Report-specific populations, formulations, controls, outcomes, timing and denominators need comparison materials. No new external English-original comparison or correction review was performed. - Further research: Material needed: Report-specific populations, formulations, controls, outcomes, timing and denominators need comparison materials. No new external English-original comparison or correction review was performed. This records needed materials; no new research was executed. - Conditions for verification: Original material for Scope of original language, formulations, populations and representative outcomes must be linked to individual responder definitions, between-arm comparisons, denominators and measurement windows, distinguishing stored summaries, unread external material, within-arm changes and other acute-treatment questions. - Why this condition is needed: This condition links Scope of original language, formulations, populations and representative outcomes with populations, formulations, controls, denominators, measurement windows, prespecified criteria, analyses, support and harms for the selected prevention responder outcome. - Application exceptions: Retain original subclaim D and absent individual score, status and axes without inheriting parent D30. Distinguish responder proportions, mean changes, other pain outcomes, single-ingredient prevention, acute combinations and active controls. No new effects, CIs, denominators, independent totals, grades, dosing or treatment instructions are created. - Remaining uncertainty: The original nonsignificance against placebo and precision gaps are retained. Exact responders, denominators, effects, CIs, missingness, concurrent care, prespecified plans, support and harm details are unverified. Historical full-text checking, the single-independent-trial statement or other symptom signals are not converted into completed current review, 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: R01 ### N26 · Are the original evidence date, corrections and production records distinguished? Verification status: Partly verified Reading scope: Stored summary read; external abstracts, full texts, registration, protocols and analysis plans unread - Current findings: The original evidence date of 2026-09-07 and empty correction and deliberation records are retained. Production time is not converted into a new evidence-verification date, and nonexistent corrections are not created. - 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: Additional materials, revised conditions, applied observations and judgment changes are separate events. Complete originals and reasons for changes must be preserved and linked to the required review. - Required materials and conditions: Original evidence date and empty correction or deliberation records - Materials to obtain first: Additional materials, revised conditions, applied observations and judgment changes are separate events. Complete originals and reasons for changes must be preserved and linked to the required review. - Further research: Material needed: Additional materials, revised conditions, applied observations and judgment changes are separate events. Complete originals and reasons for changes must be preserved and linked to the required review. This records needed materials; no new research was executed. - Conditions for verification: Original material for Original evidence date and empty correction or deliberation records must be linked to individual responder definitions, between-arm comparisons, denominators and measurement windows, distinguishing stored summaries, unread external material, within-arm changes and other acute-treatment questions. - Why this condition is needed: This condition links Original evidence date and empty correction or deliberation records with populations, formulations, controls, denominators, measurement windows, prespecified criteria, analyses, support and harms for the selected prevention responder outcome. - Application exceptions: Retain original subclaim D and absent individual score, status and axes without inheriting parent D30. Distinguish responder proportions, mean changes, other pain outcomes, single-ingredient prevention, acute combinations and active controls. No new effects, CIs, denominators, independent totals, grades, dosing or treatment instructions are created. - Remaining uncertainty: The original nonsignificance against placebo and precision gaps are retained. Exact responders, denominators, effects, CIs, missingness, concurrent care, prespecified plans, support and harm details are unverified. Historical full-text checking, the single-independent-trial statement or other symptom signals are not converted into completed current review, 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: R01 ### N27 · Are report and material counts used as unique trials or quality scores? Verification status: Partly verified Reading scope: Stored summary read; external abstracts, full texts, registration, protocols and analysis plans unread - Current findings: Report links, stored summaries and needed external-material entries form the table's structure. They are not acquired external papers, unique participants, trials, independent replications or quality scores; shared original reports are not double counted. - 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 trial, report and cohort links and actual material-reading records are needed. Unique trial and participant totals remain unverified. - Required materials and conditions: Distinction between preservation structure, unique clinical units and reading - Materials to obtain first: Original trial, report and cohort links and actual material-reading records are needed. Unique trial and participant totals remain unverified. - Further research: Material needed: Original trial, report and cohort links and actual material-reading records are needed. Unique trial and participant totals remain unverified. This records needed materials; no new research was executed. - Conditions for verification: Original material for Distinction between preservation structure, unique clinical units and reading must be linked to individual responder definitions, between-arm comparisons, denominators and measurement windows, distinguishing stored summaries, unread external material, within-arm changes and other acute-treatment questions. - Why this condition is needed: This condition links Distinction between preservation structure, unique clinical units and reading with populations, formulations, controls, denominators, measurement windows, prespecified criteria, analyses, support and harms for the selected prevention responder outcome. - Application exceptions: Retain original subclaim D and absent individual score, status and axes without inheriting parent D30. Distinguish responder proportions, mean changes, other pain outcomes, single-ingredient prevention, acute combinations and active controls. No new effects, CIs, denominators, independent totals, grades, dosing or treatment instructions are created. - Remaining uncertainty: The original nonsignificance against placebo and precision gaps are retained. Exact responders, denominators, effects, CIs, missingness, concurrent care, prespecified plans, support and harm details are unverified. Historical full-text checking, the single-independent-trial statement or other symptom signals are not converted into completed current review, 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: R01 ### N28 · How are new materials or corrections linked? Verification status: Partly verified Reading scope: Stored summary read; external abstracts, full texts, registration, protocols and analysis plans unread - Current findings: Originals and current conditions and observations are preserved. New materials need linking to the relevant comparisons, denominators, outcomes, reports and subclaims; this production is not a new clinical search or revised 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 prior originals, events, versions, reasons for changes and the required review must be recorded. New procedural or treatment instructions or clinical calculations are not created. - Required materials and conditions: Distinction between condition revisions, material updates and judgment changes - Materials to obtain first: Complete prior originals, events, versions, reasons for changes and the required review must be recorded. New procedural or treatment instructions or clinical calculations are not created. - Further research: Material needed: Complete prior originals, events, versions, reasons for changes and the required review must be recorded. New procedural or treatment instructions or clinical calculations are not created. This records needed materials; no new research was executed. - Conditions for verification: Original material for Distinction between condition revisions, material updates and judgment changes must be linked to individual responder definitions, between-arm comparisons, denominators and measurement windows, distinguishing stored summaries, unread external material, within-arm changes and other acute-treatment questions. - Why this condition is needed: This condition links Distinction between condition revisions, material updates and judgment changes with populations, formulations, controls, denominators, measurement windows, prespecified criteria, analyses, support and harms for the selected prevention responder outcome. - Application exceptions: Retain original subclaim D and absent individual score, status and axes without inheriting parent D30. Distinguish responder proportions, mean changes, other pain outcomes, single-ingredient prevention, acute combinations and active controls. No new effects, CIs, denominators, independent totals, grades, dosing or treatment instructions are created. - Remaining uncertainty: The original nonsignificance against placebo and precision gaps are retained. Exact responders, denominators, effects, CIs, missingness, concurrent care, prespecified plans, support and harm details are unverified. Historical full-text checking, the single-independent-trial statement or other symptom signals are not converted into completed current review, 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: R01 ## Evidence and sources ### R01 Martins LB et al. 2020 [PubMed](https://pubmed.ncbi.nlm.nih.gov/31398997/) Materials actually read: Complete stored parent summary read; external papers, registration and plans unread Findings recorded in the summary: No significant between-group difference in the core outcomes Record level: No significant between-arm difference in the 50% responder outcome and other core findings from the 3-month trial of 107 adults is preserved. Exact arm-specific responders, denominators, effects, CIs and concurrent-care details are unverified. Parent D30 and historical full-text or support-checking statements are separate historical contexts, not new clinical verification in this work. Independent replication: The original Martins report is shared across the parent and existing subclaims. The 107 adults and original sole-direct-prevention-trial statement retain their original contexts and are not used as new independent replication, additional participants or a unique-trial total. Unique trial, participant and independent-replication totals are 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 PMID31398997, DOI10.1177/0333102419869319 and NCT02570633. Manufacturer independence and full-text support checking are historical statements in the original account and do not establish completed current comparison of full text, registration or company involvement. Summary dates belong to the original evidence. Blank external-material dates remain blank; no new external-reading or completed-content-review date is created. | | External abstract | Original bibliographic link or needed material; external public availability/access status unverified | Unread; access not attempted | Not read | Preserve original PMID31398997, DOI10.1177/0333102419869319 and NCT02570633. Manufacturer independence and full-text support checking are historical statements in the original account and do not establish completed current comparison of full text, registration or company involvement. Summary dates belong to the original evidence. Blank external-material dates remain blank; no new external-reading or completed-content-review date is created. | | External full text | Original bibliographic link or needed material; external public availability/access status unverified | Unread; access not attempted | Not read | Preserve original PMID31398997, DOI10.1177/0333102419869319 and NCT02570633. Manufacturer independence and full-text support checking are historical statements in the original account and do not establish completed current comparison of full text, registration or company involvement. Summary dates belong to the original evidence. Blank external-material dates remain blank; no new external-reading or completed-content-review date is created. | | Registration material | Original bibliographic link or needed material; external public availability/access status unverified | Unread; access not attempted | Not read | Preserve original PMID31398997, DOI10.1177/0333102419869319 and NCT02570633. Manufacturer independence and full-text support checking are historical statements in the original account and do not establish completed current comparison of full text, registration or company involvement. Summary dates belong to the original evidence. Blank external-material dates remain blank; no new external-reading or completed-content-review date is created. | | Protocol and analysis plan | Original bibliographic link or needed material; external public availability/access status unverified | Unread; access not attempted | Not read | Preserve original PMID31398997, DOI10.1177/0333102419869319 and NCT02570633. Manufacturer independence and full-text support checking are historical statements in the original account and do not establish completed current comparison of full text, registration or company involvement. Summary dates belong to the original evidence. Blank external-material dates remain blank; no new external-reading or completed-content-review date is created. | ## Review criteria and methods These are Chamgap's own application conditions, informed by the relevant sections of official methodological guidance. They do not constitute official assessment-tool certification or a new efficacy score. - M03 [Cochrane Handbook 6.5 (2024), chapter updated 2023-08](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03) · §3.1, §3.2.1–3.2.3, MECIR C5/C7/C13 · Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions. · Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed. - M04 [Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04) · §4.5, §4.6.1–4.6.3, MECIR C42 · Distinguish studies from reports and link them; do not omit a study solely because results are unreported. · Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed. - M08 [Cochrane Handbook 6.5 (2024), chapter updated 2019-10](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08) · §8.1–8.2.3, Table 8.2.a · Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting. · Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed. - M15 [Cochrane Handbook 6.5 (2024), chapter updated 2023-08](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15) · §15.2.4, §15.3.1–15.3.3 · Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision. · Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed. - M19 [Cochrane Handbook 6.5 (2024), chapter updated 2019-10](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19) · §19.1.2, §19.2.1–19.2.4 · Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates. · Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed. ## What the statuses mean - Partly verified: Partial information from the stored summary is linked; detailed originals and content review remain incomplete. - Unverified: Required details cannot be established within the preserved scope. This does not establish absence of effects or studies, or safety. - Review incomplete: Review of existing content remains incomplete. - Met: This state is used only within the relevant conditions after material verification and content review. It was not automatically assigned in this work. - Not reported: Unreported within material actually read. Unread external material is not relabeled as unreported. - Inaccessible: This means actual access failure. External access was not attempted in this work, so this state was not assigned. - Not applicable: Used only with an application exception and reason based on the question scope. - Conflicting data: This requires actual comparison of materials; no new conflict judgment was made in this work. - Insufficient evidence for the conditions: This indicates gaps in additional material for the selected conditions. Unread material as a whole is not converted into an efficacy grade. ## Change history 2026-10-20 · Public page/materials 1.0. Public-facing views and materials were prepared from the existing 28 items. No new clinical search, verification-status change or scoring was performed.