# Amitriptyline · Pediatric 24-week 50% headache-day response — Evidence Check

Verdict 2959 · Evidence Check

Stored-material review date: Not recorded  
Original evidence cut-off: 2026-08-26  
Review-criteria version: 1.0  
Public page/material preparation date: 2026-10-12

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: Migraine patients aged 8–17 at 31 US centers; detailed eligibility, baseline headaches and response-analysis denominators were unread.
- Ingredient, formulation and route: Amitriptyline study drug; preserve the original identity of purchased generic drugs overencapsulated to match placebo.
- Dose: Actual dose, titration, dose reduction and administration schedules are absent from the preserved summary; only study identity is retained and no treatment instructions are created.
- Comparator: Shared placebo arm; direct comparison with the other active drug is a separate question.
- Measured outcome: Proportion with at least a 50% reduction in headache days during the final 28 days of 24 weeks versus the baseline 28 days; distinguish this from mean headache days, attacks or intensity.
- Duration: 24-week pediatric prevention comparison; retain the scope of planned futility stopping and incomplete follow-up.
- Questions outside this scope: No new research, effects, CIs, calculations, verdicts, independence certification, participant totals or medication/administration/treatment/drug-switching instructions are created.

## Checklist items

### N01 · Selected drug: original question and subclaim verdict

Verification status: Partly verified  
Reading scope: Summary read; related external material unread

- Current findings: The selected original claim is increased 50% headache-day response with amitriptyline in children, graded D with the note of 52% versus 61% with placebo. The parent covers both drugs and is D with 30 points.
- Why unverified: Display information, scope and gaps from the stored summary; this does not mean completed content review or a new efficacy/harm verdict.
- Reason for missing information: Subclaim score, status and axes are absent. Do not fill them from parent values or create a new verdict.
- Required materials and conditions: Each drug’s 50% headache-day response question, grade and note
- Materials to obtain first: Selected subclaim and parent original verdict
- Further research: Distinguish the original subclaim verdict from this preparation and content review.
- Conditions for verification: Each drug’s 50% headache-day response question, grade and note: record only original values, scope and gaps; no new clinical evidence, calculations, verdicts or independence certification are created.
- Why this condition is needed: A production condition distinguishing the selected ingredient’s direct placebo response from required original material and unverified information.
- Application exceptions: Do not fill gaps in the selected question using the other active drug, adults, reviews, measurement windows or denominators.
- Remaining uncertainty: External abstracts, full texts, registration, protocol and SAP were unread; no new calculations or clinical-content review were performed.
- Referenced methods: Retain existing application conditions and preserved methodological links for production; full-definition content review and official certification are incomplete.
- Related sources: R01

### N02 · Selected placebo comparison

Verification status: Partly verified  
Reading scope: Summary read; related external material unread

- Current findings: This table concerns amitriptyline versus placebo. CHAMP also had a topiramate arm; distinguish that active-drug comparison from the selected placebo comparison.
- Why unverified: Display information, scope and gaps from the stored summary; this does not mean completed content review or a new efficacy/harm verdict.
- Reason for missing information: Do not combine the two active-drug effects or equate placebo response with untreated natural history.
- Required materials and conditions: Distinguish the selected drug, placebo and other active-drug comparisons
- Materials to obtain first: Original three-arm comparisons and control conditions
- Further research: Separate the selected placebo comparison from other active-drug and natural-history questions.
- Conditions for verification: Distinguish the selected drug, placebo and other active-drug comparisons: record only original values, scope and gaps; no new clinical evidence, calculations, verdicts or independence certification are created.
- Why this condition is needed: A production condition distinguishing the selected ingredient’s direct placebo response from required original material and unverified information.
- Application exceptions: Do not fill gaps in the selected question using the other active drug, adults, reviews, measurement windows or denominators.
- Remaining uncertainty: External abstracts, full texts, registration, protocol and SAP were unread; no new calculations or clinical-content review were performed.
- Referenced methods: Retain existing application conditions and preserved methodological links for production; full-definition content review and official certification are incomplete.
- Related sources: R01

### N03 · Actual pediatric population and application scope

Verification status: Partly verified  
Reading scope: Summary read; related external material unread

- Current findings: The parent outcome and advertising interpretation restrict the question to 24-week migraine prevention at ages 8–17. The trial was conducted at 31 US centers.
- Why unverified: Display information, scope and gaps from the stored summary; this does not mean completed content review or a new efficacy/harm verdict.
- Reason for missing information: Detailed baseline headache days, diagnostic criteria, comorbidities and exclusions are unverified. Do not establish applicability to every pediatric age or to adults.
- Required materials and conditions: Age, diagnosis, baseline headaches, eligibility, exclusions and centers
- Materials to obtain first: Pediatric eligibility, diagnosis and baseline-characteristic tables
- Further research: Distinguish the original age, diagnosis and period from application to other populations.
- Conditions for verification: Age, diagnosis, baseline headaches, eligibility, exclusions and centers: record only original values, scope and gaps; no new clinical evidence, calculations, verdicts or independence certification are created.
- Why this condition is needed: A production condition distinguishing the selected ingredient’s direct placebo response from required original material and unverified information.
- Application exceptions: Do not fill gaps in the selected question using the other active drug, adults, reviews, measurement windows or denominators.
- Remaining uncertainty: External abstracts, full texts, registration, protocol and SAP were unread; no new calculations or clinical-content review were performed.
- Referenced methods: Retain existing application conditions and preserved methodological links for production; full-definition content review and official certification are incomplete.
- Related sources: R01

### N04 · Actual drug exposure and dose information

Verification status: Partly verified  
Reading scope: Summary read; related external material unread

- Current findings: The selected intervention is amitriptyline. The preserved summary says generic drugs were purchased with grant funds and overencapsulated to match placebo.
- Why unverified: Display information, scope and gaps from the stored summary; this does not mean completed content review or a new efficacy/harm verdict.
- Reason for missing information: Actual study dose, titration, dose reduction and administration schedules are absent from the summary. Do not create regimens, product recommendations or treatment instructions.
- Required materials and conditions: Product, study exposure, dose, titration and duration specifications
- Materials to obtain first: Trial drug, formulation, exposure specifications and actual-use records
- Further research: Separate study identity from unverified exposure details.
- Conditions for verification: Product, study exposure, dose, titration and duration specifications: record only original values, scope and gaps; no new clinical evidence, calculations, verdicts or independence certification are created.
- Why this condition is needed: A production condition distinguishing the selected ingredient’s direct placebo response from required original material and unverified information.
- Application exceptions: Do not fill gaps in the selected question using the other active drug, adults, reviews, measurement windows or denominators.
- Remaining uncertainty: External abstracts, full texts, registration, protocol and SAP were unread; no new calculations or clinical-content review were performed.
- Referenced methods: Retain existing application conditions and preserved methodological links for production; full-definition content review and official certification are incomplete.
- Related sources: R01

### N05 · Placebo identity and masking scope

Verification status: Partly verified  
Reading scope: Summary read; related external material unread

- Current findings: CHAMP is recorded as a multicenter double-blind placebo-controlled trial, with purchased generic drugs overencapsulated to match placebo.
- Why unverified: Display information, scope and gaps from the stored summary; this does not mean completed content review or a new efficacy/harm verdict.
- Reason for missing information: External original material on placebo ingredients and masking implementation, success or unmasking was unread.
- Required materials and conditions: Capsules, placebo composition, allocation and role-specific masking
- Materials to obtain first: Active/placebo specifications and role-specific masking records
- Further research: Distinguish the masking label from actual implementation material.
- Conditions for verification: Capsules, placebo composition, allocation and role-specific masking: record only original values, scope and gaps; no new clinical evidence, calculations, verdicts or independence certification are created.
- Why this condition is needed: A production condition distinguishing the selected ingredient’s direct placebo response from required original material and unverified information.
- Application exceptions: Do not fill gaps in the selected question using the other active drug, adults, reviews, measurement windows or denominators.
- Remaining uncertainty: External abstracts, full texts, registration, protocol and SAP were unread; no new calculations or clinical-content review were performed.
- Referenced methods: Retain existing application conditions and preserved methodological links for production; full-definition content review and official certification are incomplete.
- Related sources: R01

### N06 · Randomization and three-arm denominators

Verification status: Partly verified  
Reading scope: Summary read; related external material unread

- Current findings: 361 participants were randomized 2:2:1: amitriptyline 144, topiramate 145 and placebo 72. The selected drug’s original randomized denominator is 144.
- Why unverified: Display information, scope and gaps from the stored summary; this does not mean completed content review or a new efficacy/harm verdict.
- Reason for missing information: Do not equate the total 361, other active arm or shared placebo arm with the selected response-analysis denominator. No new totals or participant counts are calculated.
- Required materials and conditions: Allocation ratio, each arm, analysis and follow-up denominators
- Materials to obtain first: Arm-specific randomized, analyzed and followed-up flow
- Further research: Display total and arm-specific randomization separately from response-analysis denominators.
- Conditions for verification: Allocation ratio, each arm, analysis and follow-up denominators: record only original values, scope and gaps; no new clinical evidence, calculations, verdicts or independence certification are created.
- Why this condition is needed: A production condition distinguishing the selected ingredient’s direct placebo response from required original material and unverified information.
- Application exceptions: Do not fill gaps in the selected question using the other active drug, adults, reviews, measurement windows or denominators.
- Remaining uncertainty: External abstracts, full texts, registration, protocol and SAP were unread; no new calculations or clinical-content review were performed.
- Referenced methods: Retain existing application conditions and preserved methodological links for production; full-definition content review and official certification are incomplete.
- Related sources: R01

### N07 · Allocation concealment, baseline balance and measurement methods

Verification status: Partly verified  
Reading scope: Summary read; related external material unread

- Current findings: The preserved material describes a publicly funded double-blind randomized trial at 31 centers. Parent bias B2 is the original historical value.
- Why unverified: Display information, scope and gaps from the stored summary; this does not mean completed content review or a new efficacy/harm verdict.
- Reason for missing information: Detailed external sequence, concealment, baseline-balance and assessor material was unread. A design name does not mean methods review is now complete.
- Required materials and conditions: Random sequence, concealment, baseline and role-specific measurement
- Materials to obtain first: Original allocation, concealment, baseline characteristics and assessment methods
- Further research: Distinguish design names from limitations in actual implementation material.
- Conditions for verification: Random sequence, concealment, baseline and role-specific measurement: record only original values, scope and gaps; no new clinical evidence, calculations, verdicts or independence certification are created.
- Why this condition is needed: A production condition distinguishing the selected ingredient’s direct placebo response from required original material and unverified information.
- Application exceptions: Do not fill gaps in the selected question using the other active drug, adults, reviews, measurement windows or denominators.
- Remaining uncertainty: External abstracts, full texts, registration, protocol and SAP were unread; no new calculations or clinical-content review were performed.
- Referenced methods: Retain existing application conditions and preserved methodological links for production; full-definition content review and official certification are incomplete.
- Related sources: R01

### N08 · Concurrent care, rescue medication, drug changes and adherence

Verification status: Unverified  
Reading scope: Summary read; related external material unread

- Current findings: The current summary identifies the selected preventive drug, placebo and 24-week comparison.
- Why unverified: Display information, scope and gaps from the stored summary; this does not mean completed content review or a new efficacy/harm verdict.
- Reason for missing information: Detailed concurrent treatment, rescue medication, adherence, departures and changes are absent. Do not certify separation of the selected drug’s contribution from other changes or create drug-switching instructions.
- Required materials and conditions: Arm-specific accompanying exposure, rescue, adherence and change handling
- Materials to obtain first: Arm-specific accompanying exposure, rescue, adherence and change tables
- Further research: Distinguish assignment effects from actual-use and concurrent-care limitations.
- Conditions for verification: Arm-specific accompanying exposure, rescue, adherence and change handling: record only original values, scope and gaps; no new clinical evidence, calculations, verdicts or independence certification are created.
- Why this condition is needed: A production condition distinguishing the selected ingredient’s direct placebo response from required original material and unverified information.
- Application exceptions: Do not fill gaps in the selected question using the other active drug, adults, reviews, measurement windows or denominators.
- Remaining uncertainty: External abstracts, full texts, registration, protocol and SAP were unread; no new calculations or clinical-content review were performed.
- Referenced methods: Retain existing application conditions and preserved methodological links for production; full-definition content review and official certification are incomplete.
- Related sources: R01

### N09 · Original 50% headache-day response definition and period

Verification status: Partly verified  
Reading scope: Summary read; related external material unread

- Current findings: The primary endpoint was the proportion with at least a 50% reduction in headache days during the final 28 days of 24 weeks compared with the baseline 28 days.
- Why unverified: Display information, scope and gaps from the stored summary; this does not mean completed content review or a new efficacy/harm verdict.
- Reason for missing information: Do not turn this into mean headache-day reduction, pain intensity, headache cure or a 50% reduction in attacks. Detailed response recording methods were unread.
- Required materials and conditions: Baseline/final periods, response threshold and headache-day definition
- Materials to obtain first: Original headache-day, response, baseline and assessment-window definitions
- Further research: Distinguish threshold response from mean change and other symptom measures.
- Conditions for verification: Baseline/final periods, response threshold and headache-day definition: record only original values, scope and gaps; no new clinical evidence, calculations, verdicts or independence certification are created.
- Why this condition is needed: A production condition distinguishing the selected ingredient’s direct placebo response from required original material and unverified information.
- Application exceptions: Do not fill gaps in the selected question using the other active drug, adults, reviews, measurement windows or denominators.
- Remaining uncertainty: External abstracts, full texts, registration, protocol and SAP were unread; no new calculations or clinical-content review were performed.
- Referenced methods: Retain existing application conditions and preserved methodological links for production; full-definition content review and official certification are incomplete.
- Related sources: R01

### N10 · Headache-day collection, recording and missing-data handling

Verification status: Unverified  
Reading scope: Summary read; related external material unread

- Current findings: The preserved material provides the proportional endpoint based on baseline and final 28-day headache records.
- Why unverified: Display information, scope and gaps from the stored summary; this does not mean completed content review or a new efficacy/harm verdict.
- Reason for missing information: Recording tools, recorded-day counts, omitted days, incomplete diaries and response adjudication procedures were unread. People, days and repeated measurements are not counted as new participants.
- Required materials and conditions: Headache recording, measurement, omissions, assessment masking and response classification
- Materials to obtain first: Original headache recording, omissions and response classification
- Further research: Distinguish people from recording days, repeated measurements and adjudication denominators.
- Conditions for verification: Headache recording, measurement, omissions, assessment masking and response classification: record only original values, scope and gaps; no new clinical evidence, calculations, verdicts or independence certification are created.
- Why this condition is needed: A production condition distinguishing the selected ingredient’s direct placebo response from required original material and unverified information.
- Application exceptions: Do not fill gaps in the selected question using the other active drug, adults, reviews, measurement windows or denominators.
- Remaining uncertainty: External abstracts, full texts, registration, protocol and SAP were unread; no new calculations or clinical-content review were performed.
- Referenced methods: Retain existing application conditions and preserved methodological links for production; full-definition content review and official certification are incomplete.
- Related sources: R01

### N11 · Selected-arm and placebo responder percentages

Verification status: Partly verified  
Reading scope: Summary read; related external material unread

- Current findings: The amitriptyline responder rate was 52% and placebo 61%. The original text says both active-drug responder percentages were numerically lower than placebo.
- Why unverified: Display information, scope and gaps from the stored summary; this does not mean completed content review or a new efficacy/harm verdict.
- Reason for missing information: Do not calculate responder event counts from rounded percentages and randomized denominators. Do not add the same 72 placebo participants as new people across two tables.
- Required materials and conditions: Original selected/placebo response proportions, denominators and aggregation
- Materials to obtain first: Arm-specific responder counts, denominators and original response tables
- Further research: Show original selected percentages together with gaps in analysis denominators and event counts.
- Conditions for verification: Original selected/placebo response proportions, denominators and aggregation: record only original values, scope and gaps; no new clinical evidence, calculations, verdicts or independence certification are created.
- Why this condition is needed: A production condition distinguishing the selected ingredient’s direct placebo response from required original material and unverified information.
- Application exceptions: Do not fill gaps in the selected question using the other active drug, adults, reviews, measurement windows or denominators.
- Remaining uncertainty: External abstracts, full texts, registration, protocol and SAP were unread; no new calculations or clinical-content review were performed.
- Referenced methods: Retain existing application conditions and preserved methodological links for production; full-definition content review and official certification are incomplete.
- Related sources: R01

### N12 · Selected drug’s OR, interval and P value

Verification status: Partly verified  
Reading scope: Summary read; related external material unread

- Current findings: Amitriptyline versus placebo is preserved as OR 0.71, 98.3% CI 0.34–1.48 and P=0.26.
- Why unverified: Display information, scope and gaps from the stored summary; this does not mean completed content review or a new efficacy/harm verdict.
- Reason for missing information: Do not copy the other drug’s OR, interval or P value or calculate new absolute differences, RR, NNT or CIs.
- Required materials and conditions: Effect measure, original interval and test for the selected placebo comparison
- Materials to obtain first: Original effect, interval and P-value tables for each comparison
- Further research: Separate selected-drug estimates from other active-drug and review estimates.
- Conditions for verification: Effect measure, original interval and test for the selected placebo comparison: record only original values, scope and gaps; no new clinical evidence, calculations, verdicts or independence certification are created.
- Why this condition is needed: A production condition distinguishing the selected ingredient’s direct placebo response from required original material and unverified information.
- Application exceptions: Do not fill gaps in the selected question using the other active drug, adults, reviews, measurement windows or denominators.
- Remaining uncertainty: External abstracts, full texts, registration, protocol and SAP were unread; no new calculations or clinical-content review were performed.
- Referenced methods: Retain existing application conditions and preserved methodological links for production; full-definition content review and official certification are incomplete.
- Related sources: R01

### N13 · Interval level and multiplicity across three comparisons

Verification status: Partly verified  
Reading scope: Summary read; related external material unread

- Current findings: The three pairwise comparisons used Bonferroni-adjusted two-sided alpha 0.017. The original summary explicitly labels the amitriptyline interval as 98.3% CI and records the topiramate interval as 0.39–1.68.
- Why unverified: Display information, scope and gaps from the stored summary; this does not mean completed content review or a new efficacy/harm verdict.
- Reason for missing information: Do not arbitrarily relabel intervals as 95%. The individual original-table interval-level label for topiramate was unread, and no new adjustment calculations are performed.
- Required materials and conditions: Original interval levels, three pairwise tests and adjustment plan
- Materials to obtain first: Three pairwise analyses, original intervals and adjustment-plan material
- Further research: Preserve interval labels and the multiple-comparison plan separately.
- Conditions for verification: Original interval levels, three pairwise tests and adjustment plan: record only original values, scope and gaps; no new clinical evidence, calculations, verdicts or independence certification are created.
- Why this condition is needed: A production condition distinguishing the selected ingredient’s direct placebo response from required original material and unverified information.
- Application exceptions: Do not fill gaps in the selected question using the other active drug, adults, reviews, measurement windows or denominators.
- Remaining uncertainty: External abstracts, full texts, registration, protocol and SAP were unread; no new calculations or clinical-content review were performed.
- Referenced methods: Retain existing application conditions and preserved methodological links for production; full-definition content review and official certification are incomplete.
- Related sources: R01

### N14 · Numerical percentages versus superiority or equivalence

Verification status: Partly verified  
Reading scope: Summary read; related external material unread

- Current findings: The preserved original text says neither active drug exceeded placebo and their responder percentages were numerically lower.
- Why unverified: Display information, scope and gaps from the stored summary; this does not mean completed content review or a new efficacy/harm verdict.
- Reason for missing information: Original percentages alone do not certify statistically significant placebo superiority, zero drug effect, equivalence or exclusion of every meaningful benefit.
- Required materials and conditions: Original proportions, comparative effects, intervals and interpretation
- Materials to obtain first: Original comparisons, clinical importance and interpretation criteria
- Further research: Distinguish numerical ordering from comparative testing, equivalence and precision.
- Conditions for verification: Original proportions, comparative effects, intervals and interpretation: record only original values, scope and gaps; no new clinical evidence, calculations, verdicts or independence certification are created.
- Why this condition is needed: A production condition distinguishing the selected ingredient’s direct placebo response from required original material and unverified information.
- Application exceptions: Do not fill gaps in the selected question using the other active drug, adults, reviews, measurement windows or denominators.
- Remaining uncertainty: External abstracts, full texts, registration, protocol and SAP were unread; no new calculations or clinical-content review were performed.
- Referenced methods: Retain existing application conditions and preserved methodological links for production; full-definition content review and official certification are incomplete.
- Related sources: R01

### N15 · Response estimand and actual analysis population

Verification status: Partly verified  
Reading scope: Summary read; related external material unread

- Current findings: The preserved evidence provides 361 randomized participants and arm-specific responder percentages and ORs.
- Why unverified: Display information, scope and gaps from the stored summary; this does not mean completed content review or a new efficacy/harm verdict.
- Reason for missing information: Exact arm-specific response-analysis denominators, ITT/PP, missing-data handling and covariates are absent. Do not substitute randomized counts for completed-response denominators.
- Required materials and conditions: Assignment/actual-use effects, analysis populations, missing data and adjustment models
- Materials to obtain first: Original response-analysis populations, models and missing-data handling
- Further research: Distinguish randomized, actual-use and completer effects and analysis denominators.
- Conditions for verification: Assignment/actual-use effects, analysis populations, missing data and adjustment models: record only original values, scope and gaps; no new clinical evidence, calculations, verdicts or independence certification are created.
- Why this condition is needed: A production condition distinguishing the selected ingredient’s direct placebo response from required original material and unverified information.
- Application exceptions: Do not fill gaps in the selected question using the other active drug, adults, reviews, measurement windows or denominators.
- Remaining uncertainty: External abstracts, full texts, registration, protocol and SAP were unread; no new calculations or clinical-content review were performed.
- Referenced methods: Retain existing application conditions and preserved methodological links for production; full-definition content review and official certification are incomplete.
- Related sources: R01

### N16 · 24-week completion and incomplete-follow-up limitations

Verification status: Partly verified  
Reading scope: Summary read; related external material unread

- Current findings: Selected amitriptyline’s 24-week completion is recorded as 80%. The parent rationale describes 20–22% incomplete follow-up across the two active drugs.
- Why unverified: Display information, scope and gaps from the stored summary; this does not mean completed content review or a new efficacy/harm verdict.
- Reason for missing information: Do not turn completion into response rate or a response-analysis denominator. Placebo completion, arm-specific withdrawal reasons and missing-data sensitivity are absent.
- Required materials and conditions: Arm-specific completion, discontinuation, withdrawal reasons and handling
- Materials to obtain first: Arm-specific completion, withdrawals, reasons and sensitivity analyses
- Further research: Present completion separately from response, observation and analysis denominators.
- Conditions for verification: Arm-specific completion, discontinuation, withdrawal reasons and handling: record only original values, scope and gaps; no new clinical evidence, calculations, verdicts or independence certification are created.
- Why this condition is needed: A production condition distinguishing the selected ingredient’s direct placebo response from required original material and unverified information.
- Application exceptions: Do not fill gaps in the selected question using the other active drug, adults, reviews, measurement windows or denominators.
- Remaining uncertainty: External abstracts, full texts, registration, protocol and SAP were unread; no new calculations or clinical-content review were performed.
- Referenced methods: Retain existing application conditions and preserved methodological links for production; full-definition content review and official certification are incomplete.
- Related sources: R01

### N17 · Selected drug’s prespecified futility-interim values

Verification status: Partly verified  
Reading scope: Summary read; related external material unread

- Current findings: The original study records amitriptyline 16% and topiramate 14% conditional power below the prespecified 20% futility threshold. The selected amitriptyline value is 16%.
- Why unverified: Display information, scope and gaps from the stored summary; this does not mean completed content review or a new efficacy/harm verdict.
- Reason for missing information: Do not turn conditional power into current efficacy probability, responder percentage, confidence or participant proportion. No new power calculations are performed.
- Required materials and conditions: Interim analysis, conditional power and prespecified futility threshold
- Materials to obtain first: Interim-analysis plan, conditional power and stopping records
- Further research: Distinguish planned futility values from actual response effects.
- Conditions for verification: Interim analysis, conditional power and prespecified futility threshold: record only original values, scope and gaps; no new clinical evidence, calculations, verdicts or independence certification are created.
- Why this condition is needed: A production condition distinguishing the selected ingredient’s direct placebo response from required original material and unverified information.
- Application exceptions: Do not fill gaps in the selected question using the other active drug, adults, reviews, measurement windows or denominators.
- Remaining uncertainty: External abstracts, full texts, registration, protocol and SAP were unread; no new calculations or clinical-content review were performed.
- Referenced methods: Retain existing application conditions and preserved methodological links for production; full-definition content review and official certification are incomplete.
- Related sources: R01

### N18 · Early stopping decision and statistical-boundary names

Verification status: Partly verified  
Reading scope: Summary read; related external material unread

- Current findings: The trial stopped at the prespecified futility threshold after DSMB recommendation and NINDS approval. The original text says no separate name was given to the stopping boundary.
- Why unverified: Display information, scope and gaps from the stored summary; this does not mean completed content review or a new efficacy/harm verdict.
- Reason for missing information: Do not invent a statistical-boundary name, exact stopping date or full follow-up impact. Early stopping is not counted as independent repeated null evidence.
- Required materials and conditions: DSMB recommendation, NINDS approval, stopping time and original boundary
- Materials to obtain first: Stopping decisions, interim-analysis plan and follow-up records
- Further research: Connect prespecified stopping rules with actual stopping and incomplete-follow-up limitations.
- Conditions for verification: DSMB recommendation, NINDS approval, stopping time and original boundary: record only original values, scope and gaps; no new clinical evidence, calculations, verdicts or independence certification are created.
- Why this condition is needed: A production condition distinguishing the selected ingredient’s direct placebo response from required original material and unverified information.
- Application exceptions: Do not fill gaps in the selected question using the other active drug, adults, reviews, measurement windows or denominators.
- Remaining uncertainty: External abstracts, full texts, registration, protocol and SAP were unread; no new calculations or clinical-content review were performed.
- Referenced methods: Retain existing application conditions and preserved methodological links for production; full-definition content review and official certification are incomplete.
- Related sources: R01

### N19 · Prespecified clinical threshold and exclusion of meaningful benefit

Verification status: Partly verified  
Reading scope: Summary read; related external material unread

- Current findings: The original rationale says no prespecified clinical threshold allowed exclusion of meaningful benefit, and the counterpoint says wide intervals leave benefit possible.
- Why unverified: Display information, scope and gaps from the stored summary; this does not mean completed content review or a new efficacy/harm verdict.
- Reason for missing information: Do not invent an MCID, passing threshold, noninferiority or exclusion of all benefit to enlarge the null finding.
- Required materials and conditions: Prespecified response-benefit threshold, intervals and clinical importance
- Materials to obtain first: Prespecified importance, interval interpretation and comparison criteria
- Further research: Distinguish null results from the range of benefit that can be excluded.
- Conditions for verification: Prespecified response-benefit threshold, intervals and clinical importance: record only original values, scope and gaps; no new clinical evidence, calculations, verdicts or independence certification are created.
- Why this condition is needed: A production condition distinguishing the selected ingredient’s direct placebo response from required original material and unverified information.
- Application exceptions: Do not fill gaps in the selected question using the other active drug, adults, reviews, measurement windows or denominators.
- Remaining uncertainty: External abstracts, full texts, registration, protocol and SAP were unread; no new calculations or clinical-content review were performed.
- Referenced methods: Retain existing application conditions and preserved methodological links for production; full-definition content review and official certification are incomplete.
- Related sources: R01

### N20 · Registration, protocol, SAP and prespecified plans actually read

Verification status: Partly verified  
Reading scope: Summary read; related external material unread

- Current findings: CHAMP’s registration identifier is NCT01581281. The preserved summary describes the primary endpoint, multiple comparisons and planned interim analysis.
- Why unverified: Display information, scope and gaps from the stored summary; this does not mean completed content review or a new efficacy/harm verdict.
- Reason for missing information: Original registration, exact dates, protocol, SAP and amendment history were unread in this conversion. An identifier or citation does not mean prospective-planning review is complete.
- Required materials and conditions: Original registration, endpoints, interim analyses and amendment history
- Materials to obtain first: NCT01581281 registration, protocol, SAP and amendments
- Further research: Distinguish preserved plan narratives from actual external-original reading.
- Conditions for verification: Original registration, endpoints, interim analyses and amendment history: record only original values, scope and gaps; no new clinical evidence, calculations, verdicts or independence certification are created.
- Why this condition is needed: A production condition distinguishing the selected ingredient’s direct placebo response from required original material and unverified information.
- Application exceptions: Do not fill gaps in the selected question using the other active drug, adults, reviews, measurement windows or denominators.
- Remaining uncertainty: External abstracts, full texts, registration, protocol and SAP were unread; no new calculations or clinical-content review were performed.
- Referenced methods: Retain existing application conditions and preserved methodological links for production; full-definition content review and official certification are incomplete.
- Related sources: R01

### N21 · Direct comparison between the two active drugs

Verification status: Unverified  
Reading scope: Summary read; related external material unread

- Current findings: The original material records three pairwise comparisons, but presents each drug’s placebo comparison as the selected effect.
- Why unverified: Display information, scope and gaps from the stored summary; this does not mean completed content review or a new efficacy/harm verdict.
- Reason for missing information: Do not derive direct superiority or equivalence between the drugs from 52% and 55% or separate placebo ORs. Do not create drug-switching guidance.
- Required materials and conditions: Original active-drug comparative effects, intervals and question
- Materials to obtain first: Original active-drug comparison and interval tables
- Further research: Display placebo comparisons separately from direct active-drug comparisons.
- Conditions for verification: Original active-drug comparative effects, intervals and question: record only original values, scope and gaps; no new clinical evidence, calculations, verdicts or independence certification are created.
- Why this condition is needed: A production condition distinguishing the selected ingredient’s direct placebo response from required original material and unverified information.
- Application exceptions: Do not fill gaps in the selected question using the other active drug, adults, reviews, measurement windows or denominators.
- Remaining uncertainty: External abstracts, full texts, registration, protocol and SAP were unread; no new calculations or clinical-content review were performed.
- Referenced methods: Retain existing application conditions and preserved methodological links for production; full-definition content review and official certification are incomplete.
- Related sources: R01

### N22 · Extension to adults, other preventives or other clinical endpoints

Verification status: Partly verified  
Reading scope: Summary read; related external material unread

- Current findings: The original advertising interpretation says adult migraine evidence cannot be transferred to ages 8–17 and restricts the claim to these two drugs and 24-week prevention.
- Why unverified: Display information, scope and gaps from the stored summary; this does not mean completed content review or a new efficacy/harm verdict.
- Reason for missing information: Do not create conclusions of null efficacy for all pediatric preventives or adult indications, or new quality-of-life, function or treatment-replacement conclusions.
- Required materials and conditions: Direct evidence by age, indication, ingredient, function and clinical outcome
- Materials to obtain first: Actual direct material by population, ingredient and endpoint
- Further research: Distinguish the selected pediatric response from other populations and outcomes.
- Conditions for verification: Direct evidence by age, indication, ingredient, function and clinical outcome: record only original values, scope and gaps; no new clinical evidence, calculations, verdicts or independence certification are created.
- Why this condition is needed: A production condition distinguishing the selected ingredient’s direct placebo response from required original material and unverified information.
- Application exceptions: Do not fill gaps in the selected question using the other active drug, adults, reviews, measurement windows or denominators.
- Remaining uncertainty: External abstracts, full texts, registration, protocol and SAP were unread; no new calculations or clinical-content review were performed.
- Referenced methods: Retain existing application conditions and preserved methodological links for production; full-definition content review and official certification are incomplete.
- Related sources: R01

### N23 · One CHAMP report, sibling tables and shared placebo

Verification status: Partly verified  
Reading scope: Summary read; related external material unread

- Current findings: The two tables share the same CHAMP report, registration, 72 placebo participants and 2959 preserved summary. Separating the drug questions does not create a new trial.
- Why unverified: Display information, scope and gaps from the stored summary; this does not mean completed content review or a new efficacy/harm verdict.
- Reason for missing information: Do not newly sum papers, registration, three arms, two tables or 28-day windows as independent trials or participants. Confirmed trial/participant totals remain unrecorded.
- Required materials and conditions: Link the same trial, three arms, registration, bibliography and participants
- Materials to obtain first: CHAMP report, registration and arm-specific linkage material
- Further research: Distinguish comparison questions from the same trial, shared control and participant units.
- Conditions for verification: Link the same trial, three arms, registration, bibliography and participants: record only original values, scope and gaps; no new clinical evidence, calculations, verdicts or independence certification are created.
- Why this condition is needed: A production condition distinguishing the selected ingredient’s direct placebo response from required original material and unverified information.
- Application exceptions: Do not fill gaps in the selected question using the other active drug, adults, reviews, measurement windows or denominators.
- Remaining uncertainty: External abstracts, full texts, registration, protocol and SAP were unread; no new calculations or clinical-content review were performed.
- Referenced methods: Retain existing application conditions and preserved methodological links for production; full-definition content review and official certification are incomplete.
- Related sources: R01

### N24 · Scope of linking the topiramate review to the selected drug

Verification status: Partly verified  
Reading scope: Summary read; related external material unread

- Current findings: Le 2017 is recorded as a topiramate review of at least 50% reduction in headache frequency, with 4 RCTs and 465 participants. It is topiramate-only and is not applied as direct amitriptyline efficacy or independent replication.
- Why unverified: Display information, scope and gaps from the stored summary; this does not mean completed content review or a new efficacy/harm verdict.
- Reason for missing information: Do not certify the review’s 4 trials/465 participants as current unique totals or add them to CHAMP’s 361. Inclusion, overlap and exact measurement windows were externally unread.
- Required materials and conditions: Review populations, ingredient, endpoint, duration, included trials and selected applicability
- Materials to obtain first: Review included-trial, population, endpoint, duration and overlap tables
- Further research: Distinguish topiramate-review context from the selected direct placebo trial.
- Conditions for verification: Review populations, ingredient, endpoint, duration, included trials and selected applicability: record only original values, scope and gaps; no new clinical evidence, calculations, verdicts or independence certification are created.
- Why this condition is needed: A production condition distinguishing the selected ingredient’s direct placebo response from required original material and unverified information.
- Application exceptions: Do not fill gaps in the selected question using the other active drug, adults, reviews, measurement windows or denominators.
- Remaining uncertainty: External abstracts, full texts, registration, protocol and SAP were unread; no new calculations or clinical-content review were performed.
- Referenced methods: Retain existing application conditions and preserved methodological links for production; full-definition content review and official certification are incomplete.
- Related sources: R01, R02

### N25 · Repeated null findings across the two drugs

Verification status: Partly verified  
Reading scope: Summary read; related external material unread

- Current findings: The original counterview says direct placebo evidence for amitriptyline is mainly the single CHAMP trial; topiramate meta-analyses concern that ingredient’s context.
- Why unverified: Display information, scope and gaps from the stored summary; this does not mean completed content review or a new efficacy/harm verdict.
- Reason for missing information: Do not elevate the paired drugs to repeated refutation or expand to all pediatric preventives. Retain unverified same-cohort/review overlap and independence.
- Required materials and conditions: Drug-specific direct evidence, independent replication and unique-trial linkage
- Materials to obtain first: Drug-specific direct reports and included-trial linkage material
- Further research: Preserve drug-specific evidence scope and differences in replication.
- Conditions for verification: Drug-specific direct evidence, independent replication and unique-trial linkage: record only original values, scope and gaps; no new clinical evidence, calculations, verdicts or independence certification are created.
- Why this condition is needed: A production condition distinguishing the selected ingredient’s direct placebo response from required original material and unverified information.
- Application exceptions: Do not fill gaps in the selected question using the other active drug, adults, reviews, measurement windows or denominators.
- Remaining uncertainty: External abstracts, full texts, registration, protocol and SAP were unread; no new calculations or clinical-content review were performed.
- Referenced methods: Retain existing application conditions and preserved methodological links for production; full-definition content review and official certification are incomplete.
- Related sources: R01, R02

### N26 · Public grants, drug purchases and product support

Verification status: Partly verified  
Reading scope: Summary read; related external material unread

- Current findings: CHAMP had NIH/NINDS and NCATS public grants; generic drugs were purchased and capsules matched using grant funds. The Korean product record states no pharmaceutical donation, analysis service or cofunding, while the English record says these were not reported.
- Why unverified: Display information, scope and gaps from the stored summary; this does not mean completed content review or a new efficacy/harm verdict.
- Reason for missing information: Do not turn generic purchases into donated company products; preserve both original language versions. Full support/involvement disclosures were unread.
- Required materials and conditions: Funding, generic purchases, pharmaceutical support and contracts
- Materials to obtain first: Funding, purchases, products and company-relationship disclosures
- Further research: Distinguish publicly funded purchases from pharmaceutical support and unverified roles.
- Conditions for verification: Funding, generic purchases, pharmaceutical support and contracts: record only original values, scope and gaps; no new clinical evidence, calculations, verdicts or independence certification are created.
- Why this condition is needed: A production condition distinguishing the selected ingredient’s direct placebo response from required original material and unverified information.
- Application exceptions: Do not fill gaps in the selected question using the other active drug, adults, reviews, measurement windows or denominators.
- Remaining uncertainty: External abstracts, full texts, registration, protocol and SAP were unread; no new calculations or clinical-content review were performed.
- Referenced methods: Retain existing application conditions and preserved methodological links for production; full-definition content review and official certification are incomplete.
- Related sources: R01

### N27 · Authors, analysis, medical writing, publication costs and data rights

Verification status: Unverified  
Reading scope: Summary read; related external material unread

- Current findings: The preserved summary provides public funding and some pharmaceutical-support items.
- Why unverified: Display information, scope and gaps from the stored summary; this does not mean completed content review or a new efficacy/harm verdict.
- Reason for missing information: Full employee-author, consultancy, medical-writing, publication-cost and data-control disclosures are absent. Nonmention does not establish absence of all roles or independent clinical certification.
- Required materials and conditions: Author affiliations, company relationships and analysis/writing/publication roles
- Materials to obtain first: Author/supporter roles, COI and data/publication rights
- Further research: Display known funding separately from unverified roles.
- Conditions for verification: Author affiliations, company relationships and analysis/writing/publication roles: record only original values, scope and gaps; no new clinical evidence, calculations, verdicts or independence certification are created.
- Why this condition is needed: A production condition distinguishing the selected ingredient’s direct placebo response from required original material and unverified information.
- Application exceptions: Do not fill gaps in the selected question using the other active drug, adults, reviews, measurement windows or denominators.
- Remaining uncertainty: External abstracts, full texts, registration, protocol and SAP were unread; no new calculations or clinical-content review were performed.
- Referenced methods: Retain existing application conditions and preserved methodological links for production; full-definition content review and official certification are incomplete.
- Related sources: R01

### N28 · Selected drug’s common harms

Verification status: Partly verified  
Reading scope: Summary read; related external material unread

- Current findings: The safety summary says fatigue and dry mouth were more common with amitriptyline.
- Why unverified: Display information, scope and gaps from the stored summary; this does not mean completed content review or a new efficacy/harm verdict.
- Reason for missing information: Do not copy other active-drug harms to the selected drug. Original event counts, arm-specific rates, intervals and collection methods are absent and are not invented.
- Required materials and conditions: Selected/placebo event definitions, collection, frequency and denominators
- Materials to obtain first: Arm-specific full harm, denominator and event-definition tables
- Further research: Separate drug-specific common events from placebo comparisons and collection gaps.
- Conditions for verification: Selected/placebo event definitions, collection, frequency and denominators: record only original values, scope and gaps; no new clinical evidence, calculations, verdicts or independence certification are created.
- Why this condition is needed: A supplementary condition recording the selected ingredient’s harm/safety observation scope separately from efficacy.
- Application exceptions: Do not fill gaps in the selected question using the other active drug, adults, reviews, measurement windows or denominators.
- Remaining uncertainty: External abstracts, full texts, registration, protocol and SAP were unread; no new calculations or clinical-content review were performed.
- Referenced methods: Retain existing application conditions and preserved methodological links for production; full-definition content review and official certification are incomplete.
- Related sources: R01

### N29 · Selected drug’s treatment-related serious events

Verification status: Partly verified  
Reading scope: Summary read; related external material unread

- Current findings: The original safety sentence records 3 mood-change events and 1 syncope event in the amitriptyline arm as adjudicated treatment-related serious events.
- Why unverified: Display information, scope and gaps from the stored summary; this does not mean completed content review or a new efficacy/harm verdict.
- Reason for missing information: Do not sum events into unique people or incidence or certify causal risk at every age. Detailed adjudication, exposure and event course were unread; no medication/treatment instructions are created.
- Required materials and conditions: Serious events, relatedness adjudication, people/events and exposure denominators
- Materials to obtain first: Original serious-event tables, relatedness adjudication, exposure and event-course material
- Further research: Distinguish original reported relatedness from limits in direct causality and person counts.
- Conditions for verification: Serious events, relatedness adjudication, people/events and exposure denominators: record only original values, scope and gaps; no new clinical evidence, calculations, verdicts or independence certification are created.
- Why this condition is needed: A supplementary condition recording the selected ingredient’s harm/safety observation scope separately from efficacy.
- Application exceptions: Do not fill gaps in the selected question using the other active drug, adults, reviews, measurement windows or denominators.
- Remaining uncertainty: External abstracts, full texts, registration, protocol and SAP were unread; no new calculations or clinical-content review were performed.
- Referenced methods: Retain existing application conditions and preserved methodological links for production; full-definition content review and official certification are incomplete.
- Related sources: R01

### N30 · 24-week harms versus long-term and rare-event safety

Verification status: Unverified  
Reading scope: Summary read; related external material unread

- Current findings: The current pediatric comparison is 24 weeks with early stopping and incomplete follow-up. The parent safety warning is original verdict context.
- Why unverified: Display information, scope and gaps from the stored summary; this does not mean completed content review or a new efficacy/harm verdict.
- Reason for missing information: Do not fill in absence of long-term/rare harms, safety for all children or equivalent harms between drugs. Do not merge harms into null efficacy or treatment-replacement instructions.
- Required materials and conditions: Long-term exposure, follow-up, withdrawal, rare events and population-specific material
- Materials to obtain first: Long-term harms, exposure, discontinuation and follow-up material
- Further research: Separate efficacy comparisons from long-term/rare-harm gaps.
- Conditions for verification: Long-term exposure, follow-up, withdrawal, rare events and population-specific material: record only original values, scope and gaps; no new clinical evidence, calculations, verdicts or independence certification are created.
- Why this condition is needed: A supplementary condition recording the selected ingredient’s harm/safety observation scope separately from efficacy.
- Application exceptions: Do not fill gaps in the selected question using the other active drug, adults, reviews, measurement windows or denominators.
- Remaining uncertainty: External abstracts, full texts, registration, protocol and SAP were unread; no new calculations or clinical-content review were performed.
- Referenced methods: Retain existing application conditions and preserved methodological links for production; full-definition content review and official certification are incomplete.
- Related sources: R01

### N31 · Actual summary reading and unread external materials

Verification status: Partly verified  
Reading scope: Summary read; related external material unread

- Current findings: The entire 2959 preserved summary was read. CHAMP and Le-review PubMed URLs are linked as in the original bibliography.
- Why unverified: Display information, scope and gaps from the stored summary; this does not mean completed content review or a new efficacy/harm verdict.
- Reason for missing information: External abstracts, full texts, registration, protocol and SAP were unread; external link, click and screen checks were not performed. A URL does not mean external reading or completed content review.
- Required materials and conditions: Status of two bibliographic records, stored summary, abstracts, full texts, registration and plans
- Materials to obtain first: Original trial paper, review, registration, protocol and SAP
- Further research: Display summary reading separately from unread external materials.
- Conditions for verification: Status of two bibliographic records, stored summary, abstracts, full texts, registration and plans: record only original values, scope and gaps; no new clinical evidence, calculations, verdicts or independence certification are created.
- Why this condition is needed: A production condition distinguishing the selected ingredient’s direct placebo response from required original material and unverified information.
- Application exceptions: Do not fill gaps in the selected question using the other active drug, adults, reviews, measurement windows or denominators.
- Remaining uncertainty: External abstracts, full texts, registration, protocol and SAP were unread; no new calculations or clinical-content review were performed.
- Referenced methods: Retain existing application conditions and preserved methodological links for production; full-definition content review and official certification are incomplete.
- Related sources: R01, R02

### N32 · Original history, verdict linkage, preparation and content review

Verification status: Partly verified  
Reading scope: Summary read; related external material unread

- Current findings: Original Korean/English text, axes, 2026-08-26 cut-off, empty corrections/deliberation and selected subclaim are preserved as a complete copy. Original candidate pending/eligibility labels are selection history.
- Why unverified: Display information, scope and gaps from the stored summary; this does not mean completed content review or a new efficacy/harm verdict.
- Reason for missing information: Keep absent subclaim score, status and axes; do not use the evidence cut-off as the current review date. Existing content review is incomplete, completion is false, no new unit is created and final independent totals remain unrecorded.
- Required materials and conditions: Subclaim/parent Korean-English text, axes, dates, corrections, existing selection and condition preservation/application
- Materials to obtain first: Original summary, existing selection and condition-preservation/application production events
- Further research: Record original verdicts/corrections separately from preparation and content review.
- Conditions for verification: Subclaim/parent Korean-English text, axes, dates, corrections, existing selection and condition preservation/application: record only original values, scope and gaps; no new clinical evidence, calculations, verdicts or independence certification are created.
- Why this condition is needed: A production condition distinguishing the selected ingredient’s direct placebo response from required original material and unverified information.
- Application exceptions: Do not fill gaps in the selected question using the other active drug, adults, reviews, measurement windows or denominators.
- Remaining uncertainty: External abstracts, full texts, registration, protocol and SAP were unread; no new calculations or clinical-content review were performed.
- Referenced methods: Retain existing application conditions and preserved methodological links for production; full-definition content review and official certification are incomplete.
- Related sources: R01, R02

## Evidence and sources

### R01

Powers SW, et al. Trial of Amitriptyline, Topiramate, and Placebo for Pediatric Migraine. N Engl J Med. 2017;376:115-124. PMID: 27788026.

[PubMed](https://pubmed.ncbi.nlm.nih.gov/27788026/)

Materials actually read: Summary read; external abstracts, full texts, registration and plans unread  
Findings recorded in the summary: Amitriptyline 52% versus placebo 61%; OR 0.71 (98.3% CI 0.34–1.48), P=0.26. Original values for the other active drug have a separate scope.  
Record level: Selected-drug OR, interval, P value and responder percentages; preserve the complete original two-drug wording of the parent evidence entry.  
Independent replication: The same CHAMP trial’s three arms, two drugs, shared placebo, registration and sibling tables: distinguish selected comparisons without adding unique trials or participants. The topiramate-only review is not applied as direct amitriptyline efficacy or independent replication. CHAMP inclusion in the review, overlap among trials and actual independence are unverified.

| Material | Public availability | Access status | Actually read | Notes |
|---|---|---|---|---|
| Stored summary | Summary read | Stored summary read | Summary read | A material slot does not certify newly acquired documents, external reading, link checks or independent trial counts. |
| External abstract | Not read | External material unread | Not read | A material slot does not certify newly acquired documents, external reading, link checks or independent trial counts. |
| External full text | Not read | External material unread | Not read | A material slot does not certify newly acquired documents, external reading, link checks or independent trial counts. |
| Original registration | Not read | External material unread | Not read | A material slot does not certify newly acquired documents, external reading, link checks or independent trial counts. |
| Protocol/SAP | Not read | External material unread | Not read | A material slot does not certify newly acquired documents, external reading, link checks or independent trial counts. |

### R02

Le K, et al. Is topiramate effective for migraine prevention in patients less than 18 years of age? J Headache Pain. 2017;18:69. PMID: 28721545.

[PubMed](https://pubmed.ncbi.nlm.nih.gov/28721545/)

Materials actually read: Summary read; external abstracts, full texts, registration and plans unread  
Findings recorded in the summary: RR 1.26(95% CI 0.94~1.67), P=0.12  
Record level: Review RR and unverified scope of other definitions and periods  
Independent replication: The same CHAMP trial’s three arms, two drugs, shared placebo, registration and sibling tables: distinguish selected comparisons without adding unique trials or participants. The topiramate-only review is not applied as direct amitriptyline efficacy or independent replication. CHAMP inclusion in the review, overlap among trials and actual independence are unverified.

| Material | Public availability | Access status | Actually read | Notes |
|---|---|---|---|---|
| Stored summary | Summary read | Stored summary read | Summary read | A material slot does not certify newly acquired documents, external reading, link checks or independent trial counts. |
| External abstract | Not read | External material unread | Not read | A material slot does not certify newly acquired documents, external reading, link checks or independent trial counts. |
| External full text | Not read | External material unread | Not read | A material slot does not certify newly acquired documents, external reading, link checks or independent trial counts. |
| Original registration | Not read | External material unread | Not read | A material slot does not certify newly acquired documents, external reading, link checks or independent trial counts. |
| Protocol/SAP | Not read | External material unread | Not read | A material slot does not certify newly acquired documents, external reading, link checks or independent trial counts. |

## 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. · Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed.
- 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. · Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed.
- 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. · Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed.
- 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. · Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed.
- 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. · Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed.

## What the statuses mean

- Partly verified: Some information exists in the preserved review summary; detailed original materials remain unverified. This does not certify a passed review or clinical efficacy.
- Unverified: Detailed materials for the selected condition could not be established within the stored scope; this does not mean zero effect, zero studies or safety
- Review incomplete: Review of existing content incomplete
- Met: Use only within the relevant conditions after existing content review; no automatic designation in this preparation
- Not reported: Distinguish only within materials actually read; do not turn unread external materials into unreported findings
- Inaccessible: Not applied during this preparation because actual access was not tested
- Not applicable: Use with a reason for non-applicability based on an explicit question boundary
- Conflicting data: Judge after actual material comparison; review was not performed during this preparation
- Insufficient evidence for the conditions: Do not use as a clinical grade encompassing currently unread materials

## Change history

2026-10-12 · Public page/materials 1.0. Public pages and materials were prepared from the existing 32 items. No new clinical search, verification-status change or scoring was performed.