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

Required evidence, verification status and materials actually read
Item	AVerification status	BReading scope	CReview item	DCurrent findings	EWhy unverified	FRequired materials and conditions	GFurther research
1	Partly verified	Full text not readStored summary read	N01 · Comparative efficacy · Pediatric drug responseSelected drug: original question and subclaim verdictRequired	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. R01	Display information, scope and gaps from the stored summary; this does not mean completed content review or a new efficacy/harm verdict.	Each drug’s 50% headache-day response question, grade and note	Distinguish the original subclaim verdict from this preparation and content review.
2	Partly verified	Full text not readStored summary read	N02 · Comparative efficacy · Pediatric drug responseSelected placebo comparisonRequired	This table concerns amitriptyline versus placebo. CHAMP also had a topiramate arm; distinguish that active-drug comparison from the selected placebo comparison. R01	Display information, scope and gaps from the stored summary; this does not mean completed content review or a new efficacy/harm verdict.	Distinguish the selected drug, placebo and other active-drug comparisons	Separate the selected placebo comparison from other active-drug and natural-history questions.
3	Partly verified	Full text not readStored summary read	N03 · Comparative efficacy · Pediatric drug responseActual pediatric population and application scopeRequired	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. R01	Display information, scope and gaps from the stored summary; this does not mean completed content review or a new efficacy/harm verdict.	Age, diagnosis, baseline headaches, eligibility, exclusions and centers	Distinguish the original age, diagnosis and period from application to other populations.
4	Partly verified	Full text not readStored summary read	N04 · Comparative efficacy · Pediatric drug responseActual drug exposure and dose informationRequired	The selected intervention is amitriptyline. The preserved summary says generic drugs were purchased with grant funds and overencapsulated to match placebo. R01	Display information, scope and gaps from the stored summary; this does not mean completed content review or a new efficacy/harm verdict.	Product, study exposure, dose, titration and duration specifications	Separate study identity from unverified exposure details.
5	Partly verified	Full text not readStored summary read	N05 · Comparative efficacy · Pediatric drug responsePlacebo identity and masking scopeRequired	CHAMP is recorded as a multicenter double-blind placebo-controlled trial, with purchased generic drugs overencapsulated to match placebo. R01	Display information, scope and gaps from the stored summary; this does not mean completed content review or a new efficacy/harm verdict.	Capsules, placebo composition, allocation and role-specific masking	Distinguish the masking label from actual implementation material.
6	Partly verified	Full text not readStored summary read	N06 · Comparative efficacy · Pediatric drug responseRandomization and three-arm denominatorsRequired	361 participants were randomized 2:2:1: amitriptyline 144, topiramate 145 and placebo 72. The selected drug’s original randomized denominator is 144. R01	Display information, scope and gaps from the stored summary; this does not mean completed content review or a new efficacy/harm verdict.	Allocation ratio, each arm, analysis and follow-up denominators	Display total and arm-specific randomization separately from response-analysis denominators.
7	Partly verified	Full text not readStored summary read	N07 · Comparative efficacy · Pediatric drug responseAllocation concealment, baseline balance and measurement methodsRequired	The preserved material describes a publicly funded double-blind randomized trial at 31 centers. Parent bias B2 is the original historical value. R01	Display information, scope and gaps from the stored summary; this does not mean completed content review or a new efficacy/harm verdict.	Random sequence, concealment, baseline and role-specific measurement	Distinguish design names from limitations in actual implementation material.
8	Unverified	Full text not readStored summary read	N08 · Comparative efficacy · Pediatric drug responseConcurrent care, rescue medication, drug changes and adherenceRequired	The current summary identifies the selected preventive drug, placebo and 24-week comparison. R01	Display information, scope and gaps from the stored summary; this does not mean completed content review or a new efficacy/harm verdict.	Arm-specific accompanying exposure, rescue, adherence and change handling	Distinguish assignment effects from actual-use and concurrent-care limitations.
9	Partly verified	Full text not readStored summary read	N09 · Comparative efficacy · Pediatric drug responseOriginal 50% headache-day response definition and periodRequired	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. R01	Display information, scope and gaps from the stored summary; this does not mean completed content review or a new efficacy/harm verdict.	Baseline/final periods, response threshold and headache-day definition	Distinguish threshold response from mean change and other symptom measures.
10	Unverified	Full text not readStored summary read	N10 · Comparative efficacy · Pediatric drug responseHeadache-day collection, recording and missing-data handlingRequired	The preserved material provides the proportional endpoint based on baseline and final 28-day headache records. R01	Display information, scope and gaps from the stored summary; this does not mean completed content review or a new efficacy/harm verdict.	Headache recording, measurement, omissions, assessment masking and response classification	Distinguish people from recording days, repeated measurements and adjudication denominators.
11	Partly verified	Full text not readStored summary read	N11 · Comparative efficacy · Pediatric drug responseSelected-arm and placebo responder percentagesRequired	The amitriptyline responder rate was 52% and placebo 61%. The original text says both active-drug responder percentages were numerically lower than placebo. R01	Display information, scope and gaps from the stored summary; this does not mean completed content review or a new efficacy/harm verdict.	Original selected/placebo response proportions, denominators and aggregation	Show original selected percentages together with gaps in analysis denominators and event counts.
12	Partly verified	Full text not readStored summary read	N12 · Comparative efficacy · Pediatric drug responseSelected drug’s OR, interval and P valueRequired	Amitriptyline versus placebo is preserved as OR 0.71, 98.3% CI 0.34–1.48 and P=0.26. R01	Display information, scope and gaps from the stored summary; this does not mean completed content review or a new efficacy/harm verdict.	Effect measure, original interval and test for the selected placebo comparison	Separate selected-drug estimates from other active-drug and review estimates.
13	Partly verified	Full text not readStored summary read	N13 · Comparative efficacy · Pediatric drug responseInterval level and multiplicity across three comparisonsRequired	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. R01	Display information, scope and gaps from the stored summary; this does not mean completed content review or a new efficacy/harm verdict.	Original interval levels, three pairwise tests and adjustment plan	Preserve interval labels and the multiple-comparison plan separately.
14	Partly verified	Full text not readStored summary read	N14 · Comparative efficacy · Pediatric drug responseNumerical percentages versus superiority or equivalenceRequired	The preserved original text says neither active drug exceeded placebo and their responder percentages were numerically lower. R01	Display information, scope and gaps from the stored summary; this does not mean completed content review or a new efficacy/harm verdict.	Original proportions, comparative effects, intervals and interpretation	Distinguish numerical ordering from comparative testing, equivalence and precision.
15	Partly verified	Full text not readStored summary read	N15 · Comparative efficacy · Pediatric drug responseResponse estimand and actual analysis populationRequired	The preserved evidence provides 361 randomized participants and arm-specific responder percentages and ORs. R01	Display information, scope and gaps from the stored summary; this does not mean completed content review or a new efficacy/harm verdict.	Assignment/actual-use effects, analysis populations, missing data and adjustment models	Distinguish randomized, actual-use and completer effects and analysis denominators.
16	Partly verified	Full text not readStored summary read	N16 · Comparative efficacy · Pediatric drug response24-week completion and incomplete-follow-up limitationsRequired	Selected amitriptyline’s 24-week completion is recorded as 80%. The parent rationale describes 20–22% incomplete follow-up across the two active drugs. R01	Display information, scope and gaps from the stored summary; this does not mean completed content review or a new efficacy/harm verdict.	Arm-specific completion, discontinuation, withdrawal reasons and handling	Present completion separately from response, observation and analysis denominators.
17	Partly verified	Full text not readStored summary read	N17 · Comparative efficacy · Pediatric drug responseSelected drug’s prespecified futility-interim valuesRequired	The original study records amitriptyline 16% and topiramate 14% conditional power below the prespecified 20% futility threshold. The selected amitriptyline value is 16%. R01	Display information, scope and gaps from the stored summary; this does not mean completed content review or a new efficacy/harm verdict.	Interim analysis, conditional power and prespecified futility threshold	Distinguish planned futility values from actual response effects.
18	Partly verified	Full text not readStored summary read	N18 · Comparative efficacy · Pediatric drug responseEarly stopping decision and statistical-boundary namesRequired	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. R01	Display information, scope and gaps from the stored summary; this does not mean completed content review or a new efficacy/harm verdict.	DSMB recommendation, NINDS approval, stopping time and original boundary	Connect prespecified stopping rules with actual stopping and incomplete-follow-up limitations.
19	Partly verified	Full text not readStored summary read	N19 · Comparative efficacy · Pediatric drug responsePrespecified clinical threshold and exclusion of meaningful benefitRequired	The original rationale says no prespecified clinical threshold allowed exclusion of meaningful benefit, and the counterpoint says wide intervals leave benefit possible. R01	Display information, scope and gaps from the stored summary; this does not mean completed content review or a new efficacy/harm verdict.	Prespecified response-benefit threshold, intervals and clinical importance	Distinguish null results from the range of benefit that can be excluded.
20	Partly verified	Full text not readStored summary read	N20 · Comparative efficacy · Pediatric drug responseRegistration, protocol, SAP and prespecified plans actually readRequired	CHAMP’s registration identifier is NCT01581281. The preserved summary describes the primary endpoint, multiple comparisons and planned interim analysis. R01	Display information, scope and gaps from the stored summary; this does not mean completed content review or a new efficacy/harm verdict.	Original registration, endpoints, interim analyses and amendment history	Distinguish preserved plan narratives from actual external-original reading.
21	Unverified	Full text not readStored summary read	N21 · Comparative efficacy · Pediatric drug responseDirect comparison between the two active drugsRequired	The original material records three pairwise comparisons, but presents each drug’s placebo comparison as the selected effect. R01	Display information, scope and gaps from the stored summary; this does not mean completed content review or a new efficacy/harm verdict.	Original active-drug comparative effects, intervals and question	Display placebo comparisons separately from direct active-drug comparisons.
22	Partly verified	Full text not readStored summary read	N22 · Comparative efficacy · Pediatric drug responseExtension to adults, other preventives or other clinical endpointsRequired	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. R01	Display information, scope and gaps from the stored summary; this does not mean completed content review or a new efficacy/harm verdict.	Direct evidence by age, indication, ingredient, function and clinical outcome	Distinguish the selected pediatric response from other populations and outcomes.
23	Partly verified	Full text not readStored summary read	N23 · Comparative efficacy · Pediatric drug responseOne CHAMP report, sibling tables and shared placeboRequired	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. R01	Display information, scope and gaps from the stored summary; this does not mean completed content review or a new efficacy/harm verdict.	Link the same trial, three arms, registration, bibliography and participants	Distinguish comparison questions from the same trial, shared control and participant units.
24	Partly verified	Full text not readStored summary read	N24 · Comparative efficacy · Pediatric drug responseScope of linking the topiramate review to the selected drugRequired	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. R01 R02	Display information, scope and gaps from the stored summary; this does not mean completed content review or a new efficacy/harm verdict.	Review populations, ingredient, endpoint, duration, included trials and selected applicability	Distinguish topiramate-review context from the selected direct placebo trial.
25	Partly verified	Full text not readStored summary read	N25 · Comparative efficacy · Pediatric drug responseRepeated null findings across the two drugsRequired	The original counterview says direct placebo evidence for amitriptyline is mainly the single CHAMP trial; topiramate meta-analyses concern that ingredient’s context. R01 R02	Display information, scope and gaps from the stored summary; this does not mean completed content review or a new efficacy/harm verdict.	Drug-specific direct evidence, independent replication and unique-trial linkage	Preserve drug-specific evidence scope and differences in replication.
26	Partly verified	Full text not readStored summary read	N26 · Comparative efficacy · Pediatric drug responsePublic grants, drug purchases and product supportRequired	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. R01	Display information, scope and gaps from the stored summary; this does not mean completed content review or a new efficacy/harm verdict.	Funding, generic purchases, pharmaceutical support and contracts	Distinguish publicly funded purchases from pharmaceutical support and unverified roles.
27	Unverified	Full text not readStored summary read	N27 · Comparative efficacy · Pediatric drug responseAuthors, analysis, medical writing, publication costs and data rightsRequired	The preserved summary provides public funding and some pharmaceutical-support items. R01	Display information, scope and gaps from the stored summary; this does not mean completed content review or a new efficacy/harm verdict.	Author affiliations, company relationships and analysis/writing/publication roles	Display known funding separately from unverified roles.
28	Partly verified	Full text not readStored summary read	N28 · Supplementary harm evidenceSelected drug’s common harmsSupplementary	The safety summary says fatigue and dry mouth were more common with amitriptyline. R01	Display information, scope and gaps from the stored summary; this does not mean completed content review or a new efficacy/harm verdict.	Selected/placebo event definitions, collection, frequency and denominators	Separate drug-specific common events from placebo comparisons and collection gaps.
29	Partly verified	Full text not readStored summary read	N29 · Supplementary harm evidenceSelected drug’s treatment-related serious eventsSupplementary	The original safety sentence records 3 mood-change events and 1 syncope event in the amitriptyline arm as adjudicated treatment-related serious events. R01	Display information, scope and gaps from the stored summary; this does not mean completed content review or a new efficacy/harm verdict.	Serious events, relatedness adjudication, people/events and exposure denominators	Distinguish original reported relatedness from limits in direct causality and person counts.
30	Unverified	Full text not readStored summary read	N30 · Supplementary harm evidence24-week harms versus long-term and rare-event safetySupplementary	The current pediatric comparison is 24 weeks with early stopping and incomplete follow-up. The parent safety warning is original verdict context. R01	Display information, scope and gaps from the stored summary; this does not mean completed content review or a new efficacy/harm verdict.	Long-term exposure, follow-up, withdrawal, rare events and population-specific material	Separate efficacy comparisons from long-term/rare-harm gaps.
31	Partly verified	Full text not readStored summary read	N31 · Comparative efficacy · Pediatric drug responseActual summary reading and unread external materialsRequired	The entire 2959 preserved summary was read. CHAMP and Le-review PubMed URLs are linked as in the original bibliography. R01 R02	Display information, scope and gaps from the stored summary; this does not mean completed content review or a new efficacy/harm verdict.	Status of two bibliographic records, stored summary, abstracts, full texts, registration and plans	Display summary reading separately from unread external materials.
32	Partly verified	Full text not readStored summary read	N32 · Comparative efficacy · Pediatric drug responseOriginal history, verdict linkage, preparation and content reviewRequired	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. R01 R02	Display information, scope and gaps from the stored summary; this does not mean completed content review or a new efficacy/harm verdict.	Subclaim/parent Korean-English text, axes, dates, corrections, existing selection and condition preservation/application	Record original verdicts/corrections separately from preparation and content review.

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32 itemsWhat the statuses mean

Assessment scope

Stored-material review date: Not recorded
Original evidence cut-off: 2026-08-26
Scope actually checked: Existing review summaries and stored records of methodological application. Full papers, supplements, registrations, plans and original data were not read.
What the dates mean: This is the date the stored materials were checked, not the date of a new search of the clinical literature.
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.

Evidence and sources

The links below lead to the sources. A link alone does not mean the original source was read or its latest publication status verified.

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

Material type: Stored bibliographic summary of a multicenter three-arm trial
Materials actually read: Summary read; external abstracts, full texts, registration and plans unread
Findings recorded in the stored 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.
Study overlap and 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.

Public availability, access and reading status by material
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

Material type: Stored bibliographic summary of a systematic review and meta-analysis
Materials actually read: Summary read; external abstracts, full texts, registration and plans unread
Findings recorded in the stored 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
Study overlap and 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.

Public availability, access and reading status by material
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.

Report counts versus independent study counts

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.

Review criteria

Version 1.0 · Criteria record date 2026-10-06. These are Chamgap's own application conditions, informed by the referenced methods. They do not constitute official assessment-tool certification or a new efficacy score.

N01 · Selected drug: original question and subclaim verdict

Required materials and conditions: Each drug’s 50% headache-day response question, grade and note
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.
Requirement and applicability: Required
Application exceptions: Do not fill gaps in the selected question using the other active drug, adults, reviews, measurement windows or denominators.
Why this condition is needed: A production condition distinguishing the selected ingredient’s direct placebo response from required original material and unverified information.
Referenced methods: Retain existing application conditions and preserved methodological links for production; full-definition content review and official certification are incomplete.

N02 · Selected placebo comparison

Required materials and conditions: Distinguish the selected drug, placebo and other active-drug comparisons
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.
Requirement and applicability: Required
Application exceptions: Do not fill gaps in the selected question using the other active drug, adults, reviews, measurement windows or denominators.
Why this condition is needed: A production condition distinguishing the selected ingredient’s direct placebo response from required original material and unverified information.
Referenced methods: Retain existing application conditions and preserved methodological links for production; full-definition content review and official certification are incomplete.

N03 · Actual pediatric population and application scope

Required materials and conditions: Age, diagnosis, baseline headaches, eligibility, exclusions and centers
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.
Requirement and applicability: Required
Application exceptions: Do not fill gaps in the selected question using the other active drug, adults, reviews, measurement windows or denominators.
Why this condition is needed: A production condition distinguishing the selected ingredient’s direct placebo response from required original material and unverified information.
Referenced methods: Retain existing application conditions and preserved methodological links for production; full-definition content review and official certification are incomplete.

N04 · Actual drug exposure and dose information

Required materials and conditions: Product, study exposure, dose, titration and duration specifications
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.
Requirement and applicability: Required
Application exceptions: Do not fill gaps in the selected question using the other active drug, adults, reviews, measurement windows or denominators.
Why this condition is needed: A production condition distinguishing the selected ingredient’s direct placebo response from required original material and unverified information.
Referenced methods: Retain existing application conditions and preserved methodological links for production; full-definition content review and official certification are incomplete.

N05 · Placebo identity and masking scope

Required materials and conditions: Capsules, placebo composition, allocation and role-specific masking
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.
Requirement and applicability: Required
Application exceptions: Do not fill gaps in the selected question using the other active drug, adults, reviews, measurement windows or denominators.
Why this condition is needed: A production condition distinguishing the selected ingredient’s direct placebo response from required original material and unverified information.
Referenced methods: Retain existing application conditions and preserved methodological links for production; full-definition content review and official certification are incomplete.

N06 · Randomization and three-arm denominators

Required materials and conditions: Allocation ratio, each arm, analysis and follow-up 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.
Requirement and applicability: Required
Application exceptions: Do not fill gaps in the selected question using the other active drug, adults, reviews, measurement windows or denominators.
Why this condition is needed: A production condition distinguishing the selected ingredient’s direct placebo response from required original material and unverified information.
Referenced methods: Retain existing application conditions and preserved methodological links for production; full-definition content review and official certification are incomplete.

N07 · Allocation concealment, baseline balance and measurement methods

Required materials and conditions: Random sequence, concealment, baseline and role-specific measurement
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.
Requirement and applicability: Required
Application exceptions: Do not fill gaps in the selected question using the other active drug, adults, reviews, measurement windows or denominators.
Why this condition is needed: A production condition distinguishing the selected ingredient’s direct placebo response from required original material and unverified information.
Referenced methods: Retain existing application conditions and preserved methodological links for production; full-definition content review and official certification are incomplete.

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

Required materials and conditions: Arm-specific accompanying exposure, rescue, adherence and change handling
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.
Requirement and applicability: Required
Application exceptions: Do not fill gaps in the selected question using the other active drug, adults, reviews, measurement windows or denominators.
Why this condition is needed: A production condition distinguishing the selected ingredient’s direct placebo response from required original material and unverified information.
Referenced methods: Retain existing application conditions and preserved methodological links for production; full-definition content review and official certification are incomplete.

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

Required materials and conditions: Baseline/final periods, response threshold and headache-day definition
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.
Requirement and applicability: Required
Application exceptions: Do not fill gaps in the selected question using the other active drug, adults, reviews, measurement windows or denominators.
Why this condition is needed: A production condition distinguishing the selected ingredient’s direct placebo response from required original material and unverified information.
Referenced methods: Retain existing application conditions and preserved methodological links for production; full-definition content review and official certification are incomplete.

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

Required materials and conditions: Headache recording, measurement, omissions, assessment masking and response classification
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.
Requirement and applicability: Required
Application exceptions: Do not fill gaps in the selected question using the other active drug, adults, reviews, measurement windows or denominators.
Why this condition is needed: A production condition distinguishing the selected ingredient’s direct placebo response from required original material and unverified information.
Referenced methods: Retain existing application conditions and preserved methodological links for production; full-definition content review and official certification are incomplete.

N11 · Selected-arm and placebo responder percentages

Required materials and conditions: Original selected/placebo response proportions, denominators and aggregation
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.
Requirement and applicability: Required
Application exceptions: Do not fill gaps in the selected question using the other active drug, adults, reviews, measurement windows or denominators.
Why this condition is needed: A production condition distinguishing the selected ingredient’s direct placebo response from required original material and unverified information.
Referenced methods: Retain existing application conditions and preserved methodological links for production; full-definition content review and official certification are incomplete.

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

Required materials and conditions: Effect measure, original interval and test for the selected placebo comparison
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.
Requirement and applicability: Required
Application exceptions: Do not fill gaps in the selected question using the other active drug, adults, reviews, measurement windows or denominators.
Why this condition is needed: A production condition distinguishing the selected ingredient’s direct placebo response from required original material and unverified information.
Referenced methods: Retain existing application conditions and preserved methodological links for production; full-definition content review and official certification are incomplete.

N13 · Interval level and multiplicity across three comparisons

Required materials and conditions: Original interval levels, three pairwise tests and adjustment plan
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.
Requirement and applicability: Required
Application exceptions: Do not fill gaps in the selected question using the other active drug, adults, reviews, measurement windows or denominators.
Why this condition is needed: A production condition distinguishing the selected ingredient’s direct placebo response from required original material and unverified information.
Referenced methods: Retain existing application conditions and preserved methodological links for production; full-definition content review and official certification are incomplete.

N14 · Numerical percentages versus superiority or equivalence

Required materials and conditions: Original proportions, comparative effects, intervals and interpretation
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.
Requirement and applicability: Required
Application exceptions: Do not fill gaps in the selected question using the other active drug, adults, reviews, measurement windows or denominators.
Why this condition is needed: A production condition distinguishing the selected ingredient’s direct placebo response from required original material and unverified information.
Referenced methods: Retain existing application conditions and preserved methodological links for production; full-definition content review and official certification are incomplete.

N15 · Response estimand and actual analysis population

Required materials and conditions: Assignment/actual-use effects, analysis populations, missing data and adjustment models
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.
Requirement and applicability: Required
Application exceptions: Do not fill gaps in the selected question using the other active drug, adults, reviews, measurement windows or denominators.
Why this condition is needed: A production condition distinguishing the selected ingredient’s direct placebo response from required original material and unverified information.
Referenced methods: Retain existing application conditions and preserved methodological links for production; full-definition content review and official certification are incomplete.

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

Required materials and conditions: Arm-specific completion, discontinuation, withdrawal reasons and handling
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.
Requirement and applicability: Required
Application exceptions: Do not fill gaps in the selected question using the other active drug, adults, reviews, measurement windows or denominators.
Why this condition is needed: A production condition distinguishing the selected ingredient’s direct placebo response from required original material and unverified information.
Referenced methods: Retain existing application conditions and preserved methodological links for production; full-definition content review and official certification are incomplete.

N17 · Selected drug’s prespecified futility-interim values

Required materials and conditions: Interim analysis, conditional power and prespecified futility threshold
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.
Requirement and applicability: Required
Application exceptions: Do not fill gaps in the selected question using the other active drug, adults, reviews, measurement windows or denominators.
Why this condition is needed: A production condition distinguishing the selected ingredient’s direct placebo response from required original material and unverified information.
Referenced methods: Retain existing application conditions and preserved methodological links for production; full-definition content review and official certification are incomplete.

N18 · Early stopping decision and statistical-boundary names

Required materials and conditions: DSMB recommendation, NINDS approval, stopping time and original boundary
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.
Requirement and applicability: Required
Application exceptions: Do not fill gaps in the selected question using the other active drug, adults, reviews, measurement windows or denominators.
Why this condition is needed: A production condition distinguishing the selected ingredient’s direct placebo response from required original material and unverified information.
Referenced methods: Retain existing application conditions and preserved methodological links for production; full-definition content review and official certification are incomplete.

N19 · Prespecified clinical threshold and exclusion of meaningful benefit

Required materials and conditions: Prespecified response-benefit threshold, intervals and clinical importance
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.
Requirement and applicability: Required
Application exceptions: Do not fill gaps in the selected question using the other active drug, adults, reviews, measurement windows or denominators.
Why this condition is needed: A production condition distinguishing the selected ingredient’s direct placebo response from required original material and unverified information.
Referenced methods: Retain existing application conditions and preserved methodological links for production; full-definition content review and official certification are incomplete.

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

Required materials and conditions: Original registration, endpoints, interim analyses and amendment history
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.
Requirement and applicability: Required
Application exceptions: Do not fill gaps in the selected question using the other active drug, adults, reviews, measurement windows or denominators.
Why this condition is needed: A production condition distinguishing the selected ingredient’s direct placebo response from required original material and unverified information.
Referenced methods: Retain existing application conditions and preserved methodological links for production; full-definition content review and official certification are incomplete.

N21 · Direct comparison between the two active drugs

Required materials and conditions: Original active-drug comparative effects, intervals and question
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.
Requirement and applicability: Required
Application exceptions: Do not fill gaps in the selected question using the other active drug, adults, reviews, measurement windows or denominators.
Why this condition is needed: A production condition distinguishing the selected ingredient’s direct placebo response from required original material and unverified information.
Referenced methods: Retain existing application conditions and preserved methodological links for production; full-definition content review and official certification are incomplete.

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

Required materials and conditions: Direct evidence by age, indication, ingredient, function and clinical outcome
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.
Requirement and applicability: Required
Application exceptions: Do not fill gaps in the selected question using the other active drug, adults, reviews, measurement windows or denominators.
Why this condition is needed: A production condition distinguishing the selected ingredient’s direct placebo response from required original material and unverified information.
Referenced methods: Retain existing application conditions and preserved methodological links for production; full-definition content review and official certification are incomplete.

N23 · One CHAMP report, sibling tables and shared placebo

Required materials and conditions: Link the same trial, three arms, registration, bibliography and participants
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.
Requirement and applicability: Required
Application exceptions: Do not fill gaps in the selected question using the other active drug, adults, reviews, measurement windows or denominators.
Why this condition is needed: A production condition distinguishing the selected ingredient’s direct placebo response from required original material and unverified information.
Referenced methods: Retain existing application conditions and preserved methodological links for production; full-definition content review and official certification are incomplete.

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

Required materials and conditions: Review populations, ingredient, endpoint, duration, included trials and selected applicability
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.
Requirement and applicability: Required
Application exceptions: Do not fill gaps in the selected question using the other active drug, adults, reviews, measurement windows or denominators.
Why this condition is needed: A production condition distinguishing the selected ingredient’s direct placebo response from required original material and unverified information.
Referenced methods: Retain existing application conditions and preserved methodological links for production; full-definition content review and official certification are incomplete.

N25 · Repeated null findings across the two drugs

Required materials and conditions: Drug-specific direct evidence, independent replication and unique-trial linkage
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.
Requirement and applicability: Required
Application exceptions: Do not fill gaps in the selected question using the other active drug, adults, reviews, measurement windows or denominators.
Why this condition is needed: A production condition distinguishing the selected ingredient’s direct placebo response from required original material and unverified information.
Referenced methods: Retain existing application conditions and preserved methodological links for production; full-definition content review and official certification are incomplete.

N26 · Public grants, drug purchases and product support

Required materials and conditions: Funding, generic purchases, pharmaceutical support and contracts
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.
Requirement and applicability: Required
Application exceptions: Do not fill gaps in the selected question using the other active drug, adults, reviews, measurement windows or denominators.
Why this condition is needed: A production condition distinguishing the selected ingredient’s direct placebo response from required original material and unverified information.
Referenced methods: Retain existing application conditions and preserved methodological links for production; full-definition content review and official certification are incomplete.

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

Required materials and conditions: Author affiliations, company relationships and analysis/writing/publication 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.
Requirement and applicability: Required
Application exceptions: Do not fill gaps in the selected question using the other active drug, adults, reviews, measurement windows or denominators.
Why this condition is needed: A production condition distinguishing the selected ingredient’s direct placebo response from required original material and unverified information.
Referenced methods: Retain existing application conditions and preserved methodological links for production; full-definition content review and official certification are incomplete.

N28 · Selected drug’s common harms

Required materials and conditions: Selected/placebo event definitions, collection, frequency and denominators
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.
Requirement and applicability: Supplementary
Application exceptions: Do not fill gaps in the selected question using the other active drug, adults, reviews, measurement windows or denominators.
Why this condition is needed: A supplementary condition recording the selected ingredient’s harm/safety observation scope separately from efficacy.
Referenced methods: Retain existing application conditions and preserved methodological links for production; full-definition content review and official certification are incomplete.

N29 · Selected drug’s treatment-related serious events

Required materials and conditions: Serious events, relatedness adjudication, people/events and exposure denominators
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.
Requirement and applicability: Supplementary
Application exceptions: Do not fill gaps in the selected question using the other active drug, adults, reviews, measurement windows or denominators.
Why this condition is needed: A supplementary condition recording the selected ingredient’s harm/safety observation scope separately from efficacy.
Referenced methods: Retain existing application conditions and preserved methodological links for production; full-definition content review and official certification are incomplete.

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

Required materials and conditions: Long-term exposure, follow-up, withdrawal, rare events and population-specific material
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.
Requirement and applicability: Supplementary
Application exceptions: Do not fill gaps in the selected question using the other active drug, adults, reviews, measurement windows or denominators.
Why this condition is needed: A supplementary condition recording the selected ingredient’s harm/safety observation scope separately from efficacy.
Referenced methods: Retain existing application conditions and preserved methodological links for production; full-definition content review and official certification are incomplete.

N31 · Actual summary reading and unread external materials

Required materials and conditions: Status of two bibliographic records, stored summary, abstracts, full texts, registration and plans
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.
Requirement and applicability: Required
Application exceptions: Do not fill gaps in the selected question using the other active drug, adults, reviews, measurement windows or denominators.
Why this condition is needed: A production condition distinguishing the selected ingredient’s direct placebo response from required original material and unverified information.
Referenced methods: Retain existing application conditions and preserved methodological links for production; full-definition content review and official certification are incomplete.

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

Required materials and conditions: Subclaim/parent Korean-English text, axes, dates, corrections, existing selection and condition preservation/application
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.
Requirement and applicability: Required
Application exceptions: Do not fill gaps in the selected question using the other active drug, adults, reviews, measurement windows or denominators.
Why this condition is needed: A production condition distinguishing the selected ingredient’s direct placebo response from required original material and unverified information.
Referenced methods: Retain existing application conditions and preserved methodological links for production; full-definition content review and official certification are incomplete.

Referenced methods and the sections actually reviewed

M03 · Cochrane Handbook 6.5 (2024), chapter updated 2023-08

Official methodology · §3.1, §3.2.1–3.2.3, MECIR C5/C7/C13

Referenced principle: Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.
Extent of review: 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

Official methodology · §4.5, §4.6.1–4.6.3, MECIR C42

Referenced principle: Distinguish studies from reports and link them; do not omit a study solely because results are unreported.
Extent of review: 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

Official methodology · §8.1–8.2.3, Table 8.2.a

Referenced principle: Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.
Extent of review: 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

Official methodology · §15.2.4, §15.3.1–15.3.3

Referenced principle: Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.
Extent of review: 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

Official methodology · §19.1.2, §19.2.1–19.2.4

Referenced principle: Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.
Extent of review: 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/material version 1.0

Public pages and materials were prepared from the existing 32 items. No new clinical search, verification-status change or scoring was performed.

The stored-material review date (Not recorded) and original evidence cut-off (2026-08-26) were retained unchanged.

Researcher downloads

These materials provide the same evidence, scope and verification status as this page.

View all item details

N01 · Selected drug: original question and subclaim verdict

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.
Verification status: Partly verified
Materials actually read: Summary read; related external material unread
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.
Remaining uncertainty: External abstracts, full texts, registration, protocol and SAP were unread; no new calculations or clinical-content review were performed.
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.
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

Current findings: This table concerns amitriptyline versus placebo. CHAMP also had a topiramate arm; distinguish that active-drug comparison from the selected placebo comparison.
Verification status: Partly verified
Materials actually read: Summary read; related external material unread
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.
Remaining uncertainty: External abstracts, full texts, registration, protocol and SAP were unread; no new calculations or clinical-content review were performed.
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.
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

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.
Verification status: Partly verified
Materials actually read: Summary read; related external material unread
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.
Remaining uncertainty: External abstracts, full texts, registration, protocol and SAP were unread; no new calculations or clinical-content review were performed.
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.
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

Current findings: The selected intervention is amitriptyline. The preserved summary says generic drugs were purchased with grant funds and overencapsulated to match placebo.
Verification status: Partly verified
Materials actually read: Summary read; related external material unread
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.
Remaining uncertainty: External abstracts, full texts, registration, protocol and SAP were unread; no new calculations or clinical-content review were performed.
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.
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

Current findings: CHAMP is recorded as a multicenter double-blind placebo-controlled trial, with purchased generic drugs overencapsulated to match placebo.
Verification status: Partly verified
Materials actually read: Summary read; related external material unread
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.
Remaining uncertainty: External abstracts, full texts, registration, protocol and SAP were unread; no new calculations or clinical-content review were performed.
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.
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

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.
Verification status: Partly verified
Materials actually read: Summary read; related external material unread
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.
Remaining uncertainty: External abstracts, full texts, registration, protocol and SAP were unread; no new calculations or clinical-content review were performed.
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.
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

Current findings: The preserved material describes a publicly funded double-blind randomized trial at 31 centers. Parent bias B2 is the original historical value.
Verification status: Partly verified
Materials actually read: Summary read; related external material unread
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.
Remaining uncertainty: External abstracts, full texts, registration, protocol and SAP were unread; no new calculations or clinical-content review were performed.
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.
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

Current findings: The current summary identifies the selected preventive drug, placebo and 24-week comparison.
Verification status: Unverified
Materials actually read: Summary read; related external material unread
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.
Remaining uncertainty: External abstracts, full texts, registration, protocol and SAP were unread; no new calculations or clinical-content review were performed.
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.
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

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.
Verification status: Partly verified
Materials actually read: Summary read; related external material unread
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.
Remaining uncertainty: External abstracts, full texts, registration, protocol and SAP were unread; no new calculations or clinical-content review were performed.
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.
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

Current findings: The preserved material provides the proportional endpoint based on baseline and final 28-day headache records.
Verification status: Unverified
Materials actually read: Summary read; related external material unread
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.
Remaining uncertainty: External abstracts, full texts, registration, protocol and SAP were unread; no new calculations or clinical-content review were performed.
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.
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

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.
Verification status: Partly verified
Materials actually read: Summary read; related external material unread
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.
Remaining uncertainty: External abstracts, full texts, registration, protocol and SAP were unread; no new calculations or clinical-content review were performed.
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.
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

Current findings: Amitriptyline versus placebo is preserved as OR 0.71, 98.3% CI 0.34–1.48 and P=0.26.
Verification status: Partly verified
Materials actually read: Summary read; related external material unread
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.
Remaining uncertainty: External abstracts, full texts, registration, protocol and SAP were unread; no new calculations or clinical-content review were performed.
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.
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

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.
Verification status: Partly verified
Materials actually read: Summary read; related external material unread
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.
Remaining uncertainty: External abstracts, full texts, registration, protocol and SAP were unread; no new calculations or clinical-content review were performed.
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.
Referenced methods: Retain existing application conditions and preserved methodological links for production; full-definition content review and official certification are incomplete.

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N14 · Numerical percentages versus superiority or equivalence

Current findings: The preserved original text says neither active drug exceeded placebo and their responder percentages were numerically lower.
Verification status: Partly verified
Materials actually read: Summary read; related external material unread
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.
Remaining uncertainty: External abstracts, full texts, registration, protocol and SAP were unread; no new calculations or clinical-content review were performed.
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.
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

Current findings: The preserved evidence provides 361 randomized participants and arm-specific responder percentages and ORs.
Verification status: Partly verified
Materials actually read: Summary read; related external material unread
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.
Remaining uncertainty: External abstracts, full texts, registration, protocol and SAP were unread; no new calculations or clinical-content review were performed.
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.
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

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.
Verification status: Partly verified
Materials actually read: Summary read; related external material unread
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.
Remaining uncertainty: External abstracts, full texts, registration, protocol and SAP were unread; no new calculations or clinical-content review were performed.
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.
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

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%.
Verification status: Partly verified
Materials actually read: Summary read; related external material unread
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.
Remaining uncertainty: External abstracts, full texts, registration, protocol and SAP were unread; no new calculations or clinical-content review were performed.
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.
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

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.
Verification status: Partly verified
Materials actually read: Summary read; related external material unread
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.
Remaining uncertainty: External abstracts, full texts, registration, protocol and SAP were unread; no new calculations or clinical-content review were performed.
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.
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

Current findings: The original rationale says no prespecified clinical threshold allowed exclusion of meaningful benefit, and the counterpoint says wide intervals leave benefit possible.
Verification status: Partly verified
Materials actually read: Summary read; related external material unread
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.
Remaining uncertainty: External abstracts, full texts, registration, protocol and SAP were unread; no new calculations or clinical-content review were performed.
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.
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

Current findings: CHAMP’s registration identifier is NCT01581281. The preserved summary describes the primary endpoint, multiple comparisons and planned interim analysis.
Verification status: Partly verified
Materials actually read: Summary read; related external material unread
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.
Remaining uncertainty: External abstracts, full texts, registration, protocol and SAP were unread; no new calculations or clinical-content review were performed.
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.
Referenced methods: Retain existing application conditions and preserved methodological links for production; full-definition content review and official certification are incomplete.

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N21 · Direct comparison between the two active drugs

Current findings: The original material records three pairwise comparisons, but presents each drug’s placebo comparison as the selected effect.
Verification status: Unverified
Materials actually read: Summary read; related external material unread
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.
Remaining uncertainty: External abstracts, full texts, registration, protocol and SAP were unread; no new calculations or clinical-content review were performed.
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.
Referenced methods: Retain existing application conditions and preserved methodological links for production; full-definition content review and official certification are incomplete.

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

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.
Verification status: Partly verified
Materials actually read: Summary read; related external material unread
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.
Remaining uncertainty: External abstracts, full texts, registration, protocol and SAP were unread; no new calculations or clinical-content review were performed.
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.
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

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.
Verification status: Partly verified
Materials actually read: Summary read; related external material unread
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.
Remaining uncertainty: External abstracts, full texts, registration, protocol and SAP were unread; no new calculations or clinical-content review were performed.
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.
Referenced methods: Retain existing application conditions and preserved methodological links for production; full-definition content review and official certification are incomplete.

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

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.
Verification status: Partly verified
Materials actually read: Summary read; related external material unread
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.
Remaining uncertainty: External abstracts, full texts, registration, protocol and SAP were unread; no new calculations or clinical-content review were performed.
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.
Referenced methods: Retain existing application conditions and preserved methodological links for production; full-definition content review and official certification are incomplete.

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N25 · Repeated null findings across the two drugs

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.
Verification status: Partly verified
Materials actually read: Summary read; related external material unread
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.
Remaining uncertainty: External abstracts, full texts, registration, protocol and SAP were unread; no new calculations or clinical-content review were performed.
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.
Referenced methods: Retain existing application conditions and preserved methodological links for production; full-definition content review and official certification are incomplete.

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N26 · Public grants, drug purchases and product support

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.
Verification status: Partly verified
Materials actually read: Summary read; related external material unread
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.
Remaining uncertainty: External abstracts, full texts, registration, protocol and SAP were unread; no new calculations or clinical-content review were performed.
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.
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

Current findings: The preserved summary provides public funding and some pharmaceutical-support items.
Verification status: Unverified
Materials actually read: Summary read; related external material unread
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.
Remaining uncertainty: External abstracts, full texts, registration, protocol and SAP were unread; no new calculations or clinical-content review were performed.
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.
Referenced methods: Retain existing application conditions and preserved methodological links for production; full-definition content review and official certification are incomplete.

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N28 · Selected drug’s common harms

Current findings: The safety summary says fatigue and dry mouth were more common with amitriptyline.
Verification status: Partly verified
Materials actually read: Summary read; related external material unread
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.
Remaining uncertainty: External abstracts, full texts, registration, protocol and SAP were unread; no new calculations or clinical-content review were performed.
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.
Referenced methods: Retain existing application conditions and preserved methodological links for production; full-definition content review and official certification are incomplete.

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N29 · Selected drug’s treatment-related serious events

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.
Verification status: Partly verified
Materials actually read: Summary read; related external material unread
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.
Remaining uncertainty: External abstracts, full texts, registration, protocol and SAP were unread; no new calculations or clinical-content review were performed.
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.
Referenced methods: Retain existing application conditions and preserved methodological links for production; full-definition content review and official certification are incomplete.

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

Current findings: The current pediatric comparison is 24 weeks with early stopping and incomplete follow-up. The parent safety warning is original verdict context.
Verification status: Unverified
Materials actually read: Summary read; related external material unread
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.
Remaining uncertainty: External abstracts, full texts, registration, protocol and SAP were unread; no new calculations or clinical-content review were performed.
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.
Referenced methods: Retain existing application conditions and preserved methodological links for production; full-definition content review and official certification are incomplete.

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N31 · Actual summary reading and unread external materials

Current findings: The entire 2959 preserved summary was read. CHAMP and Le-review PubMed URLs are linked as in the original bibliography.
Verification status: Partly verified
Materials actually read: Summary read; related external material unread
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.
Remaining uncertainty: External abstracts, full texts, registration, protocol and SAP were unread; no new calculations or clinical-content review were performed.
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.
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

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.
Verification status: Partly verified
Materials actually read: Summary read; related external material unread
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.
Remaining uncertainty: External abstracts, full texts, registration, protocol and SAP were unread; no new calculations or clinical-content review were performed.
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.
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