Antidepressant maintenance × reduced depression relapse within 52 weeks after remission: evidence checklist

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 · Efficacy comparison and presentation of stored materialHow do the selected 52-week relapse-reduction record and parent values differ?Required	The selected existing question is ‘Reduced depression relapse by 52 weeks’, with original grade B and note ‘39% versus 56%, absolute difference 17%p’. Score, status and axes are absent. Parent B70, Caution and original axes including R1/I2 and E+ are parent verdict context. S01 S02	Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Subclaim score, status and axes were originally absent; no new grade or score is written. Review of existing content remains incomplete.	Separate preservation of subclaim B/note and absent values, and parent B70, axes and verdict.	Proposal: Separate source records for the selected question and parent verdict; no new investigation, calculation or trial was conducted.
2	Partly verified	Full text not readStored summary read	N02 · Efficacy comparison and presentation of stored materialWho were the long-term antidepressant users in ANTLER?Required	Adults who felt well enough to consider stopping were recruited at 150 UK general practices. Original conditions included at least 2 previous depressive episodes or at least 2 years of treatment, and long-term use of four antidepressants. S01 S02	Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Exact remission and eligibility criteria, symptom thresholds, age and baseline characteristics, exclusions and representativeness are unverified. Review of existing content remains incomplete.	Remission, consideration of discontinuation, prior episodes, treatment duration and primary-care recruitment conditions.	Proposal: Linking actual eligibility conditions to relapse materials; no new investigation, calculation or trial was conducted.
3	Partly verified	Full text not readStored summary read	N03 · Efficacy comparison and presentation of stored materialWhat study exposure was compared between maintenance and tapering to placebo?Required	ANTLER assigned users of original specified doses of citalopram, fluoxetine, sertraline or mirtazapine to maintenance or matching placebo after a 1–2-month taper. Drugs and periods are historical trial conditions, not instructions for taking or tapering medication. S01 S02	Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Actual denominators by drug, adherent exposure, individual taper trajectories and concomitant treatment are unverified. Review of existing content remains incomplete.	Historical scope of the four drugs, maintenance, tapering to placebo and matching appearance.	Proposal: Distinguishing study allocation conditions from actual exposure; no new investigation, calculation or trial was conducted.
4	Partly verified	Full text not readStored summary read	N04 · Efficacy comparison and presentation of stored materialWhat were the actual randomization and masking procedures?Required	The multicenter double-blind placebo-controlled superiority RCT randomized 478 participants to maintenance, 238, or tapering to placebo, 240, using matching tablets. S01 S02	Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Allocation generation and concealment, assessor masking, and numbers, timing and procedures for allocation guesses are unverified. Review of existing content remains incomplete.	Allocation of 478 participants, 238 maintenance and 240 placebo, allocation concealment and masking.	Proposal: Documenting design, measurement and allocation awareness; no new investigation, calculation or trial was conducted.
5	Partly verified	Full text not readStored summary read	N05 · Efficacy comparison and presentation of stored materialWas the primary endpoint time to first relapse or an event proportion?Required	The primary endpoint was time to first depression relapse within 52 weeks. 92/238 and 135/240 are absolute relapse counts, not total repeated relapses or mean symptom-scale scores. S01 S02	Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Details of the first-relapse symptom instrument, diagnostic threshold, assessment schedule, repeated events and censoring rules are unverified. Review of existing content remains incomplete.	Time to first relapse within 52 weeks, original events and participants, and separation from repeated events.	Proposal: Separating first events from symptoms and repeated events; no new investigation, calculation or trial was conducted.
6	Partly verified	Full text not readStored summary read	N06 · Efficacy comparison and presentation of stored materialWhich arms do the absolute relapse counts, proportions and difference represent?Required	Original maintenance 92/238 (39%) versus discontinuation after tapering 135/240 (56%) and absolute difference 17%p are preserved. No new proportion, difference, NNT or individual risk is calculated. S01 S02	Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Original CI for the absolute difference, events and missingness by timepoint, and interval-estimation models are unverified. Review of existing content remains incomplete.	Arms and denominators for original 92/238 (39%), 135/240 (56%) and 17%p.	Proposal: Linking events, denominators and absolute-effect intervals; no new investigation, calculation or trial was conducted.
7	Partly verified	Full text not readStored summary read	N07 · Efficacy comparison and presentation of stored materialWhich comparison direction does HR 2.06 represent?Required	Discontinuation-versus-maintenance HR 2.06 (95% CI 1.56–2.70), P<.001 is the original time-to-event estimate. 39%/56% and 17%p are different measures. HR is not inverted to maintenance versus discontinuation or renamed a risk ratio or individual probability. S01 S02	Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Model covariates, proportional-hazards assumptions, censoring and the exact analysis specification are unverified. Review of existing content remains incomplete.	Discontinuation-versus-maintenance HR, CI and P, distinguished from absolute proportions.	Proposal: Distinguishing comparison direction and model; no new investigation, calculation or trial was conducted.
8	Partly verified	Full text not readStored summary read	N08 · Efficacy comparison and presentation of stored materialHow do the 478 randomized participants differ from the 468 in the time-to-event analysis?Required	Of 478 randomized participants, 10 without relapse timing, 6 maintenance and 4 discontinuation, were excluded from the primary time-to-event analysis, leaving 468. The original statement that they remained in absolute relapse counts is preserved. S01 S02	Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Actual timing and status of the 10 participants, missingness reasons, analysis denominators by arm and follow-up ending details are unverified. Review of existing content remains incomplete.	Roles of each denominator and preservation of 10 participants without timing, 6 and 4 by arm.	Proposal: Linking absolute-event and time-to-event denominators; no new investigation, calculation or trial was conducted.
9	Partly verified	Full text not readStored summary read	N09 · Efficacy comparison and presentation of stored materialWhat scope is supported by missing-data sensitivity analyses?Required	The original states that best- and worst-case missing-data sensitivity analyses remained directionally consistent. This statement is not substituted for absence of all missingness or censoring bias, or new numbers. S01 S02	Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Events, denominators, HR, CI, models and sensitivity values under each assumption are unverified. Review of existing content remains incomplete.	Original direction under best- and worst-case assumptions and specific estimates.	Proposal: Documenting results and precision under each missingness assumption; no new investigation, calculation or trial was conducted.
10	Partly verified	Full text not readStored summary read	N10 · Efficacy comparison and presentation of stored materialHow do adherence of 70%/52% and restarting of 39% relate to the allocation effect?Required	Original values are adherence of 70% in maintenance and 52% in discontinuation, and 39% of the discontinuation group restarting a clinician-prescribed antidepressant before trial end. The allocation comparison is not changed to a pure exposure effect of complete discontinuation versus complete maintenance. S01 S02	Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Adherence definition and measurement, restart timing and reasons, treatment–relapse timing and actual-exposure analyses are unverified. Review of existing content remains incomplete.	Definitions and timing of allocation, actual exposure, adherence and restarting.	Proposal: Linking allocation to actual exposure and rescue treatment; no new investigation, calculation or trial was conducted.
11	Partly verified	Full text not readStored summary read	N11 · Efficacy comparison and presentation of stored materialHow were withdrawal symptoms distinguished from depression relapse?Required	Withdrawal was greater at 12 weeks in the discontinuation group. Original modified DESS means 3.1 versus 1.3 and between-arm difference 1.9 (95% CI 1.5–2.3) are recorded. The original retains possible partial misclassification of withdrawal as relapse and allocation awareness, without establishing their magnitude. S01 S02	Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Relapse and withdrawal classification criteria, case assessment, misclassification magnitude and separate analyses are unverified. Review of existing content remains incomplete.	Instruments, symptom overlap, timing, classification and misclassification scope.	Proposal: Separating measurement and timing of withdrawal and relapse; no new investigation, calculation or trial was conducted.
12	Partly verified	Full text not readStored summary read	N12 · Efficacy comparison and presentation of stored materialCan DESS means and the between-arm difference be turned into the same arithmetic value?Required	Original modified DESS means 3.1/1.3 and between-arm difference 1.9 (1.5–2.3) are preserved unchanged. The difference is not recalculated from the means, and original values are not corrected. S01 S02	Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Adjustment, rounding, analysis populations and original-table details for the means and difference are unverified. Review of existing content remains incomplete.	Estimation specification for original means 3.1/1.3, difference 1.9 and CI.	Proposal: Linking estimation specifications for each reported value; no new investigation, calculation or trial was conducted.
13	Partly verified	Full text not readStored summary read	N13 · Efficacy comparison and presentation of stored materialHow does the difference in allocation awareness relate to relapse assessment?Required	The original statement that discontinuation participants guessed allocation more often is preserved. It is not newly established as the cause of every relapse difference, a bias magnitude or invalidation of the trial. S01 S02	Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Guess proportions, timing, assessor awareness and analyses involving withdrawal and relapse are unverified. Review of existing content remains incomplete.	Maintained masking, timing of awareness and unverified measurement-bias magnitude.	Proposal: Documenting allocation awareness and outcome measurement; no new investigation, calculation or trial was conducted.
14	Partly verified	Full text not readStored summary read	N14 · Efficacy comparison and presentation of stored materialDoes relapse defined by a symptom instrument also answer other clinical-outcome questions?Required	The parent describes relapse assessed through a depression symptom scale as a patient-important treatment target. This is not moved to all depressive symptoms, function, hospitalization or suicide-prevention outcomes. S01 S02	Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Scale details, clinical diagnosis, function, hospitalization and effects for other endpoints are unverified. Review of existing content remains incomplete.	Relapse definition separated from suicide, function, hospitalization and other outcomes.	Proposal: Linking selected relapse to separate clinical outcomes; no new investigation, calculation or trial was conducted.
15	Partly verified	Full text not readStored summary read	N15 · Efficacy comparison and presentation of stored materialDoes the 52-week benefit describe later persistence or lifetime risk?Required	The selected question is first relapse within 52 weeks. Original values are not used to fill in long-term remission, later relapse, drug- or episode-specific effects, or lifetime effects of continuing maintenance. S01 S02	Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Follow-up beyond 52 weeks, prespecified subgroups and results by drug, episodes or treatment duration are unverified. Review of existing content remains incomplete.	Actual observation period, outcomes outside observation and subgroups by drug.	Proposal: Separate follow-up materials by period and condition; no new investigation, calculation or trial was conducted.
16	Partly verified	Full text not readStored summary read	N16 · Efficacy comparison and presentation of stored materialHow does average relapse reduction differ from prevention for everyone or inevitable relapse?Required	Original statements are that 39% relapsed despite maintenance and 44% of discontinuation participants did not relapse within 52 weeks. An average between-arm difference is not changed to every individual's outcome or inevitable relapse after discontinuation. S01 S02	Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Validated individual predictions of who will or will not relapse under which conditions are unverified in these materials. Review of existing content remains incomplete.	Original 39% relapse during maintenance and 44% without relapse after discontinuation, with gaps in individual prediction.	Proposal: Distinguishing individual prediction from arm comparisons; no new investigation, calculation or trial was conducted.
17	Partly verified	Full text not readStored summary read	N17 · Efficacy comparison and presentation of stored materialWhich reports of the same trial are NEJM and NIHR HTA?Required	NEJM PMID 34587384 and NIHR HTA PMID 34842135 report the same ANTLER trial. The first evidence-list record groups them; HTA is an existing citation providing detailed design, missingness, withdrawal and adherence reporting. They are not counted as two separate trials of 478 participants. S01 S02	Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Direct mapping of report-specific tables and analyses to shared results remains externally unread. Review of existing content remains incomplete.	Shared relationships among reports, trial, population and the two bibliographic records and URLs.	Proposal: Linking main and detailed reports of the same trial; no new investigation, calculation or trial was conducted.
18	Partly verified	Full text not readStored summary read	N18 · Efficacy comparison and presentation of stored materialIs the Kato meta-analysis an independent replication of the same question?Required	Kato synthesizes 40 maintenance-versus-placebo-switch trials involving 8,890 participants. Maintenance 20.9% versus 39.7%, OR .38 (95% CI .33–.43), P<.00001 provide directionally consistent context. The original statement that heterogeneous post-acute maintenance trials were not counted as independent replication of the long-term primary-care discontinuation decision is preserved. S03	Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Included trial lists, populations, periods, drugs, overlap, timepoint-specific links to ANTLER and heterogeneity are unverified. Review of existing content remains incomplete.	Relationships among 40 studies, 8890 participants, other maintenance trials and ANTLER conditions.	Proposal: Linking different maintenance questions to synthesis materials; no new investigation, calculation or trial was conducted.
19	Partly verified	Full text not readStored summary read	N19 · Efficacy comparison and presentation of stored materialHow do the review's proportions and OR differ from ANTLER HR and difference?Required	Kato maintenance 20.9%/placebo 39.7%, OR .38 (.33–.43), and ANTLER discontinuation-versus-maintenance HR 2.06 and 17%p are each original estimates. They are not divided, inverted, combined into a new pooled effect or changed to incidence for the same period. S01 S02 S03	Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Actual denominators, periods, event definitions, models and weights for each analysis, and absolute-difference CI are unverified. Review of existing content remains incomplete.	Endpoints, denominators and directions for proportions, OR, HR and absolute difference.	Proposal: Separating measures, periods and estimands; no new investigation, calculation or trial was conducted.
20	Partly verified	Full text not readStored summary read	N20 · Efficacy comparison and presentation of stored materialAre the same participants, two sheets and review kept from being added together?Required	This sheet and the ‘Discontinuation inevitably causes relapse’ sheet share the same parent summary and ANTLER reports and population. NEJM/HTA are not counted as duplicate trials, and 478 and 8,890 participants are not added as a total. S01 S02 S03	Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Unique trial, participant and independent-replication totals are unconfirmed and unrecorded. Review of existing content remains incomplete.	Preservation of shared and overlapping relationships among the two subclaim sheets, NEJM/HTA and the review.	Proposal: Recording report families and overlap; no new investigation, calculation or trial was conducted.
21	Partly verified	Full text not readStored summary read	N21 · Efficacy comparison and presentation of stored materialWhat public support and sponsor did ANTLER have, and what remains unverified?Required	Original funding was NIHR HTA award 13/115/48 and NIHR core support for PRIMENT CTU; UCL was the sponsor. Public support is not changed to absence of all company involvement, employee authors or conflicts of interest, or current certification of independence. S01 S02	Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Specific research, analysis and manuscript roles, authors and conflicts of interest, and other support remain externally unread. Review of existing content remains incomplete.	NIHR, PRIMENT and UCL, separated from products, employees, conflicts of interest and roles.	Proposal: Separating funding from actual research roles; no new investigation, calculation or trial was conducted.
22	Partly verified	Full text not readStored summary read	N22 · Efficacy comparison and presentation of stored materialDoes unreported free trial-drug or placebo provision mean no provision occurred?Required	The original states that donated pharmaceutical-company trial drugs or placebo were not described in NEJM or NIHR HTA. Neither external report was read during this work, and non-reporting is not asserted to mean no actual support. S01 S02	Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Supply, purchase and manufacturing contracts, free support, companies, employee authors and conflicts of interest are unverified. Review of existing content remains incomplete.	Historical statements of unreported provision, separated from unverified actual product support.	Proposal: Separately documenting support types and actual roles; no new investigation, calculation or trial was conducted.
23	Partly verified	Full text not readStored summary read	N23 · Efficacy comparison and presentation of stored materialWhat scope of independence information does public funding of the review provide?Required	Kato's original Ministry of Health, Labour and Welfare of Japan grants H29-SEISHIN-ippan-001 and 19GC1012 are preserved. Review funding and included trials' funding, products, authors and conflicts of interest are different items. S03	Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Actual review roles and conflicts of interest, and company, product and employee relationships in each included trial are unverified. Review of existing content remains incomplete.	Japanese research grants for the review, separated from funding and conflicts of interest in included trials.	Proposal: Linking independence materials for synthesis and individual trials; no new investigation, calculation or trial was conducted.
24	Partly verified	Full text not readStored summary read	N24 · Efficacy comparison and presentation of stored materialAt what level are registry identifiers and actual prespecified endpoints and plans recorded?Required	Original ANTLER registry identifiers are ‘ISRCTN15969819 · EudraCT 2015-004210-26’. Preserving the two identifiers is separate from reading the actual registry, protocol or SAP; Kato's ‘Not applicable’ is original wording. S01 S02 S03	Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Registry source text, amendments, prespecified endpoints, analysis and missing-data plans remain unread; access was not attempted. Review of existing content remains incomplete.	Original ISRCTN and EudraCT identifiers, plans and amendment histories.	Proposal: Linking registry and plan versions by report; no new investigation, calculation or trial was conducted.
25	Partly verified	Full text not readStored summary read	N25 · Harm-information gaps supplementing the efficacy tableWhat outcomes do serious adverse events, deaths and suicide attempts represent?Supplementary	Original serious adverse events occurred in 9 maintenance participants (4%) versus 8 discontinuation participants (3%). Deaths and suicide attempts were 0 in both arms. Zero events are not changed to zero risk, long-term safety or treatment guidance. S01 S02	Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Safety denominators, collection and assessment, exposure, follow-up, censoring, CI, and rare and long-term harms are unverified. Review of existing content remains incomplete.	Definitions and scope of safety events, 9/8 participants, 4%/3% and 0 events in both arms.	Proposal: Linking event-specific safety materials and precision; no new investigation, calculation or trial was conducted.
26	Partly verified	Full text not readStored summary read	N26 · Harm-information gaps supplementing the efficacy tableAre safety, relapse and withdrawal different measurements?Supplementary	Withdrawal symptoms at 12 weeks, first relapse by 52 weeks, and serious adverse events, deaths and suicide attempts are different endpoints. Statements about increased withdrawal and reduced relapse are not newly combined into a single safety or efficacy score. S01 S02	Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Harm-collection definitions, periods, populations and adverse-effect materials by other drugs are unverified. Review of existing content remains incomplete.	Collection, timepoints and occurrence units for serious events, withdrawal and relapse.	Proposal: Separating event and symptom measurements by endpoint; no new investigation, calculation or trial was conducted.
27	Partly verified	Full text not readStored summary read	N27 · Efficacy comparison and presentation of stored materialTo whom can the result generalize, and what lies outside its scope?Required	Selected materials concern the original 52-week comparison in long-term users, adults in remission considering discontinuation. This trial does not establish effects for newly started acute treatment, other drugs or doses, abrupt stopping, lifetime maintenance or individually safe discontinuation. S01 S02	Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Direct materials for other populations, exposures, periods and individual prediction are unverified. Review of existing content remains incomplete.	Boundaries between long-term primary-care users in remission considering discontinuation and other situations.	Proposal: Recording evidence gaps by population, exposure and period; no new investigation, calculation or trial was conducted.
28	Partly verified	Full text not readStored summary read	N28 · Efficacy comparison and presentation of stored materialHow are actual summary reading and external-material access labeled?Required	The full preserved summary was read for production and labeled ‘Summary read’. External NEJM, HTA, Kato, registry, plan and conflicts-of-interest materials are labeled ‘Unread’. URLs, identifiers and historical statements of full-text review alone do not upgrade reading status. S01 S02 S03	Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. External abstracts, full texts, registries, protocols and SAP remain unread; external link and click tests were not conducted. Review of existing content remains incomplete.	Levels of the preserved summary, NEJM/HTA/Kato URLs, registries, plans and conflicts of interest.	Proposal: Recording acquisition, reading and versions by material; no new investigation, calculation or trial was conducted.
29	Partly verified	Full text not readStored summary read	N29 · Efficacy comparison and presentation of stored materialHow are original Korean and English texts, dates, corrections and empty values preserved?Required	The full summary's parent B70, original axes with unrecorded precision and false values, Caution, Korean and English texts, 2026-08-26, empty corrections and empty deliberation are preserved. Subclaim B/note and absent score, status and axes are distinguished and not filled from parent values. S01 S02 S03	Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. At original authoring, external updating, verdict-manuscript translation, clinical-original review and added corrections were not performed. Existing content review remains incomplete.	Parent B70, Korean and English texts, 2026-08-26, and empty correction, deliberation, unrecorded and false values.	Proposal: Linking original versions and dates to production content; no new investigation, calculation or trial was conducted.
30	Partly verified	Full text not readStored summary read	N30 · Efficacy comparison and presentation of stored materialHow are condition freezing, application and content review separate events?Required	Condition preservation, freezing, application, case production and content review are separate records. Existing content review remains incomplete; production-row, report and material counts are not unique trial or participant totals. S01 S02 S03	Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Existing content review remains incomplete. Additional content review, testing, screen checks and link tests were not conducted during the original production. Review of existing content remains incomplete.	Condition preservation, freezing, application, case production and incomplete content review	Proposal: Recording condition and production versions and user revision comments; no new investigation, calculation or trial was conducted.

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30 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: Adults in UK primary care with remission or improvement who were considering discontinuation and had at least 2 previous episodes or at least 2 years of treatment
Ingredient, formulation and route: Long-term maintenance of the original four drugs versus a study taper over 1–2 months followed by matching placebo; historical study exposure
Dose: Not recorded
Comparator: ANTLER: 238 participants in maintenance versus 240 in taper followed by placebo; actual exposure, adherence and restarting recorded separately
Measured outcome: Time to first depression relapse within 52 weeks; original absolute relapse counts, proportions and difference recorded separately
Duration: First relapse within 52 weeks; withdrawal at 12 weeks recorded separately
Questions outside this scope: Extending the original reduction in relapse within 52 weeks to complete prevention for every person or period, or inevitable relapse on discontinuation; Extending the original 44% without relapse to lifelong freedom from relapse, safe discontinuation for an individual, or complete discontinuation without restarting; Calculating correspondence or overlap by assuming the discontinuation group's 52% adherence, 39% restarting and 44% without relapse refer to the same people; Calculating new exclusion proportions, denominators, events or individual classifications from 478 randomized, 468 in the time-to-event analysis and 10 with missing timing (6/4); Recalculating or converting the original 92/238, 135/240, 39%/56%, 17%p, HR 2.06/CI/P or DESS means and difference into reciprocals, NNT or individual probabilities; Double-counting NEJM and HTA as independent trials, or adding participants across the two sheets, arms, time points or the 478/8890 participant figures; Using the 40-study meta-analysis as a new independent replication under ANTLER conditions, or certification of inevitability or individual prediction; Treating possible withdrawal misclassification or awareness of allocation as the cause of all results, a newly quantified bias, or invalidation of the trial; Extending 9/8 participants with serious events and 0 deaths or suicide attempts to zero risk, long-term safety or drug selection; Treating the absence of reported company donations in the original account as absence of support, employee authors or conflicts of interest, or certification of independence; Inheriting the parent's B70, axes, historical cross-checking, public funding or original-material review statements as subclaim values, review of content in this work or external reading; New searches or numerical calculations; hypothetical quantitative examples; new effects, CIs, grades or certification of independence; guidance on maintenance, discontinuation, tapering, dosing, drug changes or treatment

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.

S01 · Lewis G, Marston L, Duffy L, et al. Maintenance or Discontinuation of Antidepressants in Primary Care. N Engl J Med. 2021;385:1257-1267. PMID: 34587384. DOI: 10.1056/NEJMoa2106356.

Publisher · PubMed

Material type: Multicenter double-blind placebo-controlled superiority RCT
Materials actually read: Summary read; external material unread
Findings recorded in the stored summary: Relapse: 92/238 (39%) versus 135/240 (56%); discontinuation versus maintenance HR 2.06 (95% CI 1.56~2.70), P<0.001; absolute difference 17%p. The existing reader answer and subclaim state that 44% of the discontinuation group had no relapse within 52 weeks and that 39% of the maintenance group relapsed. The 10 participants with missing timing were excluded from the primary analysis but included in absolute counts. Adherence of 70%/52%, restarting in 39% of the discontinuation group, and 12-week DESS means of 3.1/1.3 with the original difference of 1.9 (CI 1.5~2.3) are preserved separately. No new proportions, differences, individual probabilities, reciprocals, effects, CIs or grades are calculated.
Record level: Outcome wording in the stored summary
Study overlap and independent replication: S01 NEJM/Lewis2021 PMID34587384 is the main ANTLER report. The first record in the existing evidence list describes both reports together. They share 478 randomized participants (238 maintenance/240 taper followed by placebo), 468 in the time-to-event analysis, 10 with missing timing (6/4), absolute relapse counts, withdrawal, adherence and restarting. Reports, related sheets, arms, time points and people are not added as new independent trials or participants. Counts of report or material slots are not totals of unique clinical trials, participants or independent replications. Unique clinical totals remain unrecorded. S02 NIHR HTA/Duffy2021 PMID34842135 is a detailed report of the same ANTLER trial. The first record in the existing evidence list describes both reports together. They share 478 randomized participants (238 maintenance/240 taper followed by placebo), 468 in the time-to-event analysis, 10 with missing timing (6/4), absolute relapse counts, withdrawal, adherence and restarting. Reports, related sheets, arms, time points and people are not added as new independent trials or participants. Counts of report or material slots are not totals of unique clinical trials, participants or independent replications. Unique clinical totals remain unrecorded. S03 Kato2021 PMID32704061 is a meta-analysis of 40 trials with 8,890 participants comparing maintenance with switching to placebo after various acute treatments. The original wording that does not count it as an independent replication of ANTLER's long-term primary-care discontinuation decision is preserved. Inclusion, overlap, timing and unique trial totals remain unverified; participants in the review, ANTLER and related sheets are not added together. Counts of report or material slots are not totals of unique clinical trials, participants or independent replications. Unique clinical totals remain unrecorded.

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Stored summary	Stored file	Stored summary	Summary read	Only the stored JSON summary and bibliography were used for production. This does not constitute external verification or completed content review.
External paper	Public availability unverified; only bibliography links preserved	Unread; access not attempted	Not read	No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.
Registration material	Public availability unverified; only bibliography links preserved	Unread; access not attempted	Not read	No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.
Protocol	Public availability unverified; only bibliography links preserved	Unread; access not attempted	Not read	No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.
Statistical analysis plan	Public availability unverified; only bibliography links preserved	Unread; access not attempted	Not read	No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.
Funding, product-support and COI material	Public availability unverified; only bibliography links preserved	Unread; access not attempted	Not read	No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.

S02 · Duffy L, Clarke CS, Lewis G, et al. Antidepressant medication to prevent depression relapse in primary care: the ANTLER RCT. Health Technol Assess. 2021;25(69):1-62. PMID: 34842135. DOI: 10.3310/hta25690.

Publisher · PubMed

Material type: Multicenter double-blind placebo-controlled superiority RCT
Materials actually read: Summary read; external material unread
Findings recorded in the stored summary: Relapse: 92/238 (39%) versus 135/240 (56%); discontinuation versus maintenance HR 2.06 (95% CI 1.56~2.70), P<0.001; absolute difference 17%p. The existing reader answer and subclaim state that 44% of the discontinuation group had no relapse within 52 weeks and that 39% of the maintenance group relapsed. The 10 participants with missing timing were excluded from the primary analysis but included in absolute counts. Adherence of 70%/52%, restarting in 39% of the discontinuation group, and 12-week DESS means of 3.1/1.3 with the original difference of 1.9 (CI 1.5~2.3) are preserved separately. No new proportions, differences, individual probabilities, reciprocals, effects, CIs or grades are calculated.
Record level: Outcome wording in the stored summary
Study overlap and independent replication: S01 NEJM/Lewis2021 PMID34587384 is the main ANTLER report. The first record in the existing evidence list describes both reports together. They share 478 randomized participants (238 maintenance/240 taper followed by placebo), 468 in the time-to-event analysis, 10 with missing timing (6/4), absolute relapse counts, withdrawal, adherence and restarting. Reports, related sheets, arms, time points and people are not added as new independent trials or participants. Counts of report or material slots are not totals of unique clinical trials, participants or independent replications. Unique clinical totals remain unrecorded. S02 NIHR HTA/Duffy2021 PMID34842135 is a detailed report of the same ANTLER trial. The first record in the existing evidence list describes both reports together. They share 478 randomized participants (238 maintenance/240 taper followed by placebo), 468 in the time-to-event analysis, 10 with missing timing (6/4), absolute relapse counts, withdrawal, adherence and restarting. Reports, related sheets, arms, time points and people are not added as new independent trials or participants. Counts of report or material slots are not totals of unique clinical trials, participants or independent replications. Unique clinical totals remain unrecorded. S03 Kato2021 PMID32704061 is a meta-analysis of 40 trials with 8,890 participants comparing maintenance with switching to placebo after various acute treatments. The original wording that does not count it as an independent replication of ANTLER's long-term primary-care discontinuation decision is preserved. Inclusion, overlap, timing and unique trial totals remain unverified; participants in the review, ANTLER and related sheets are not added together. Counts of report or material slots are not totals of unique clinical trials, participants or independent replications. Unique clinical totals remain unrecorded.

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Stored summary	Stored file	Stored summary	Summary read	Only the stored JSON summary and bibliography were used for production. This does not constitute external verification or completed content review.
External paper	Public availability unverified; only bibliography links preserved	Unread; access not attempted	Not read	No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.
Registration material	Public availability unverified; only bibliography links preserved	Unread; access not attempted	Not read	No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.
Protocol	Public availability unverified; only bibliography links preserved	Unread; access not attempted	Not read	No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.
Statistical analysis plan	Public availability unverified; only bibliography links preserved	Unread; access not attempted	Not read	No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.
Funding, product-support and COI material	Public availability unverified; only bibliography links preserved	Unread; access not attempted	Not read	No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.

S03 · Kato M, Hori H, Inoue T, et al. Discontinuation of antidepressants after remission with antidepressant medication in major depressive disorder: a systematic review and meta-analysis. Mol Psychiatry. 2021;26:118-133. PMID: 32704061. DOI: 10.1038/s41380-020-0843-0.

Publisher · PubMed

Material type: Meta-analysis of 40 trials of antidepressant maintenance versus switching to placebo
Materials actually read: Summary read; external material unread
Findings recorded in the stored summary: Maintenance 20.9% versus switching to placebo 39.7%, OR 0.38 (95% CI 0.33~0.43), P<0.00001. The original proportions, OR and direction are preserved within the scope of this synthesis. This estimand differs from the ANTLER HR and 17%p; no new reciprocal, pooled effect, period-specific incidence, total participant count or individual prediction is generated.
Record level: Outcome wording in the stored summary
Study overlap and independent replication: S01 NEJM/Lewis2021 PMID34587384 is the main ANTLER report. The first record in the existing evidence list describes both reports together. They share 478 randomized participants (238 maintenance/240 taper followed by placebo), 468 in the time-to-event analysis, 10 with missing timing (6/4), absolute relapse counts, withdrawal, adherence and restarting. Reports, related sheets, arms, time points and people are not added as new independent trials or participants. Counts of report or material slots are not totals of unique clinical trials, participants or independent replications. Unique clinical totals remain unrecorded. S02 NIHR HTA/Duffy2021 PMID34842135 is a detailed report of the same ANTLER trial. The first record in the existing evidence list describes both reports together. They share 478 randomized participants (238 maintenance/240 taper followed by placebo), 468 in the time-to-event analysis, 10 with missing timing (6/4), absolute relapse counts, withdrawal, adherence and restarting. Reports, related sheets, arms, time points and people are not added as new independent trials or participants. Counts of report or material slots are not totals of unique clinical trials, participants or independent replications. Unique clinical totals remain unrecorded. S03 Kato2021 PMID32704061 is a meta-analysis of 40 trials with 8,890 participants comparing maintenance with switching to placebo after various acute treatments. The original wording that does not count it as an independent replication of ANTLER's long-term primary-care discontinuation decision is preserved. Inclusion, overlap, timing and unique trial totals remain unverified; participants in the review, ANTLER and related sheets are not added together. Counts of report or material slots are not totals of unique clinical trials, participants or independent replications. Unique clinical totals remain unrecorded.

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Stored summary	Stored file	Stored summary	Summary read	Only the stored JSON summary and bibliography were used for production. This does not constitute external verification or completed content review.
External paper	Public availability unverified; only bibliography links preserved	Unread; access not attempted	Not read	No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.
Registration material	Public availability unverified; only bibliography links preserved	Unread; access not attempted	Not read	No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.
Protocol	Public availability unverified; only bibliography links preserved	Unread; access not attempted	Not read	No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.
Statistical analysis plan	Public availability unverified; only bibliography links preserved	Unread; access not attempted	Not read	No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.
Funding, product-support and COI material	Public availability unverified; only bibliography links preserved	Unread; access not attempted	Not read	No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.

Report counts versus independent study counts

S01 NEJM/Lewis2021 PMID34587384 is the main ANTLER report. The first record in the existing evidence list describes both reports together. They share 478 randomized participants (238 maintenance/240 taper followed by placebo), 468 in the time-to-event analysis, 10 with missing timing (6/4), absolute relapse counts, withdrawal, adherence and restarting. Reports, related sheets, arms, time points and people are not added as new independent trials or participants. Counts of report or material slots are not totals of unique clinical trials, participants or independent replications. Unique clinical totals remain unrecorded. S02 NIHR HTA/Duffy2021 PMID34842135 is a detailed report of the same ANTLER trial. The first record in the existing evidence list describes both reports together. They share 478 randomized participants (238 maintenance/240 taper followed by placebo), 468 in the time-to-event analysis, 10 with missing timing (6/4), absolute relapse counts, withdrawal, adherence and restarting. Reports, related sheets, arms, time points and people are not added as new independent trials or participants. Counts of report or material slots are not totals of unique clinical trials, participants or independent replications. Unique clinical totals remain unrecorded. S03 Kato2021 PMID32704061 is a meta-analysis of 40 trials with 8,890 participants comparing maintenance with switching to placebo after various acute treatments. The original wording that does not count it as an independent replication of ANTLER's long-term primary-care discontinuation decision is preserved. Inclusion, overlap, timing and unique trial totals remain unverified; participants in the review, ANTLER and related sheets are not added together. Counts of report or material slots are not totals of unique clinical trials, participants or independent replications. Unique clinical totals remain unrecorded.

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 · How do the selected 52-week relapse-reduction record and parent values differ?

Required materials and conditions: Separate preservation of subclaim B/note and absent values, and parent B70, axes and verdict.
Conditions for verification: Relevant original materials and analysis scope for Separate preservation of subclaim B/note and absent values, and parent B70, axes and verdict must be supplied and unverified matters distinguished. Preserved wording is linked during this work; review of existing content remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: Production item to distinguish Separate preservation of subclaim B/note and absent values, and parent B70, axes and verdict and link the materials required for the selected question to currently available materials.
Referenced methods: M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design

N02 · Who were the long-term antidepressant users in ANTLER?

Required materials and conditions: Remission, consideration of discontinuation, prior episodes, treatment duration and primary-care recruitment conditions.
Conditions for verification: Relevant original materials and analysis scope for Remission, consideration of discontinuation, prior episodes, treatment duration and primary-care recruitment conditions must be supplied and unverified matters distinguished. Preserved wording is linked during this work; review of existing content remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: Production item to distinguish Remission, consideration of discontinuation, prior episodes, treatment duration and primary-care recruitment conditions and link the materials required for the selected question to currently available materials.
Referenced methods: M03 §3.2.1; detailed population conditions are Chamgap's own design

N03 · What study exposure was compared between maintenance and tapering to placebo?

Required materials and conditions: Historical scope of the four drugs, maintenance, tapering to placebo and matching appearance.
Conditions for verification: Relevant original materials and analysis scope for Historical scope of the four drugs, maintenance, tapering to placebo and matching appearance must be supplied and unverified matters distinguished. Preserved wording is linked during this work; review of existing content remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: Production item to distinguish Historical scope of the four drugs, maintenance, tapering to placebo and matching appearance and link the materials required for the selected question to currently available materials.
Referenced methods: M03 §3.2.2–3.2.3; Reverse-direction labels and assessment adaptation are Chamgap design; M03 §3.2.3 and M08 §8.2.2–8.2.3; Chamgap application

N04 · What were the actual randomization and masking procedures?

Required materials and conditions: Allocation of 478 participants, 238 maintenance and 240 placebo, allocation concealment and masking.
Conditions for verification: Relevant original materials and analysis scope for Allocation of 478 participants, 238 maintenance and 240 placebo, allocation concealment and masking must be supplied and unverified matters distinguished. Preserved wording is linked during this work; review of existing content remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: Production item to distinguish Allocation of 478 participants, 238 maintenance and 240 placebo, allocation concealment and masking and link the materials required for the selected question to currently available materials.
Referenced methods: M08 §8.1–8.2.3; internal application; M08 Table 8.2.a, M03 §3.2.4; internal application

N05 · Was the primary endpoint time to first relapse or an event proportion?

Required materials and conditions: Time to first relapse within 52 weeks, original events and participants, and separation from repeated events.
Conditions for verification: Relevant original materials and analysis scope for Time to first relapse within 52 weeks, original events and participants, and separation from repeated events must be supplied and unverified matters distinguished. Preserved wording is linked during this work; review of existing content remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: Production item to distinguish Time to first relapse within 52 weeks, original events and participants, and separation from repeated events and link the materials required for the selected question to currently available materials.
Referenced methods: M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific result adaptation is our own design; M08 Table 8.2.a, M04 §4.6.3; own application

N06 · Which arms do the absolute relapse counts, proportions and difference represent?

Required materials and conditions: Arms and denominators for original 92/238 (39%), 135/240 (56%) and 17%p.
Conditions for verification: Relevant original materials and analysis scope for Arms and denominators for original 92/238 (39%), 135/240 (56%) and 17%p must be supplied and unverified matters distinguished. Preserved wording is linked during this work; review of existing content remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: Production item to distinguish Arms and denominators for original 92/238 (39%), 135/240 (56%) and 17%p and link the materials required for the selected question to currently available materials.
Referenced methods: M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is internally designed; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is internally designed; M15 §15.3.1–15.3.3; internal application

N07 · Which comparison direction does HR 2.06 represent?

Required materials and conditions: Discontinuation-versus-maintenance HR, CI and P, distinguished from absolute proportions.
Conditions for verification: Relevant original materials and analysis scope for Discontinuation-versus-maintenance HR, CI and P, distinguished from absolute proportions must be supplied and unverified matters distinguished. Preserved wording is linked during this work; review of existing content remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: Production item to distinguish Discontinuation-versus-maintenance HR, CI and P, distinguished from absolute proportions and link the materials required for the selected question to currently available materials.
Referenced methods: M08 §8.2.2, M15 §15.3.1; Chamgap's own application; M15 §15.3.1–15.3.3; Chamgap's own application; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are Chamgap's own design

N08 · How do the 478 randomized participants differ from the 468 in the time-to-event analysis?

Required materials and conditions: Roles of each denominator and preservation of 10 participants without timing, 6 and 4 by arm.
Conditions for verification: Relevant original materials and analysis scope for Roles of each denominator and preservation of 10 participants without timing, 6 and 4 by arm must be supplied and unverified matters distinguished. Preserved wording is linked during this work; review of existing content remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: Production item to distinguish Roles of each denominator and preservation of 10 participants without timing, 6 and 4 by arm and link the materials required for the selected question to currently available materials.
Referenced methods: M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; Design-specific adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap application

N09 · What scope is supported by missing-data sensitivity analyses?

Required materials and conditions: Original direction under best- and worst-case assumptions and specific estimates.
Conditions for verification: Relevant original materials and analysis scope for Original direction under best- and worst-case assumptions and specific estimates must be supplied and unverified matters distinguished. Preserved wording is linked during this work; review of existing content remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: Production item to distinguish Original direction under best- and worst-case assumptions and specific estimates and link the materials required for the selected question to currently available materials.
Referenced methods: M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; Design-specific adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap application; M15 §15.3.1–15.3.3; Chamgap application

N10 · How do adherence of 70%/52% and restarting of 39% relate to the allocation effect?

Required materials and conditions: Definitions and timing of allocation, actual exposure, adherence and restarting.
Conditions for verification: Relevant original materials and analysis scope for Definitions and timing of allocation, actual exposure, adherence and restarting must be supplied and unverified matters distinguished. Preserved wording is linked during this work; review of existing content remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: Production item to distinguish Definitions and timing of allocation, actual exposure, adherence and restarting and link the materials required for the selected question to currently available materials.
Referenced methods: M03 §3.2.3, M08 §8.2.2–8.2.3; internal application; M08 §8.2.2, M15 §15.3.1; internal application; design-specific harm questions in M19 §19.2; details of temporal relationships are internally designed

N11 · How were withdrawal symptoms distinguished from depression relapse?

Required materials and conditions: Instruments, symptom overlap, timing, classification and misclassification scope.
Conditions for verification: Relevant original materials and analysis scope for Instruments, symptom overlap, timing, classification and misclassification scope must be supplied and unverified matters distinguished. Preserved wording is linked during this work; review of existing content remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: Production item to distinguish Instruments, symptom overlap, timing, classification and misclassification scope and link the materials required for the selected question to currently available materials.
Referenced methods: M08 Table 8.2.a, M03 §3.2.4; internal application; M19 §19.1.2–19.2.4; finer distinctions are internally designed; design-specific harm questions in M19 §19.2; details of temporal relationships are internally designed

N12 · Can DESS means and the between-arm difference be turned into the same arithmetic value?

Required materials and conditions: Estimation specification for original means 3.1/1.3, difference 1.9 and CI.
Conditions for verification: Relevant original materials and analysis scope for Estimation specification for original means 3.1/1.3, difference 1.9 and CI must be supplied and unverified matters distinguished. Preserved wording is linked during this work; review of existing content remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: Production item to distinguish Estimation specification for original means 3.1/1.3, difference 1.9 and CI and link the materials required for the selected question to currently available materials.
Referenced methods: M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are Chamgap's own design; M08 §8.2.2, M15 §15.3.1; Chamgap's own application; M15 §15.3.1–15.3.3; Chamgap's own application

N13 · How does the difference in allocation awareness relate to relapse assessment?

Required materials and conditions: Maintained masking, timing of awareness and unverified measurement-bias magnitude.
Conditions for verification: Relevant original materials and analysis scope for Maintained masking, timing of awareness and unverified measurement-bias magnitude must be supplied and unverified matters distinguished. Preserved wording is linked during this work; review of existing content remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: Production item to distinguish Maintained masking, timing of awareness and unverified measurement-bias magnitude and link the materials required for the selected question to currently available materials.
Referenced methods: M08 Table 8.2.a, M03 §3.2.4; internal application

N14 · Does relapse defined by a symptom instrument also answer other clinical-outcome questions?

Required materials and conditions: Relapse definition separated from suicide, function, hospitalization and other outcomes.
Conditions for verification: Relevant original materials and analysis scope for Relapse definition separated from suicide, function, hospitalization and other outcomes must be supplied and unverified matters distinguished. Preserved wording is linked during this work; review of existing content remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: Production item to distinguish Relapse definition separated from suicide, function, hospitalization and other outcomes and link the materials required for the selected question to currently available materials.
Referenced methods: M03 §3.2.4; internally defined extension boundary; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is internally designed

N15 · Does the 52-week benefit describe later persistence or lifetime risk?

Required materials and conditions: Actual observation period, outcomes outside observation and subgroups by drug.
Conditions for verification: Relevant original materials and analysis scope for Actual observation period, outcomes outside observation and subgroups by drug must be supplied and unverified matters distinguished. Preserved wording is linked during this work; review of existing content remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: Production item to distinguish Actual observation period, outcomes outside observation and subgroups by drug and link the materials required for the selected question to currently available materials.
Referenced methods: M03 §3.2.1–3.2.4; dose, duration and effect-modification details are our own design

N16 · How does average relapse reduction differ from prevention for everyone or inevitable relapse?

Required materials and conditions: Original 39% relapse during maintenance and 44% without relapse after discontinuation, with gaps in individual prediction.
Conditions for verification: Relevant original materials and analysis scope for Original 39% relapse during maintenance and 44% without relapse after discontinuation, with gaps in individual prediction must be supplied and unverified matters distinguished. Preserved wording is linked during this work; review of existing content remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: Production item to distinguish Original 39% relapse during maintenance and 44% without relapse after discontinuation, with gaps in individual prediction and link the materials required for the selected question to currently available materials.
Referenced methods: Question-clarification principles in M03 §3.1, §3.2.1–3.2.4; detailed separation rules are internally designed; M03 §3.2.1–3.2.4; dose, duration and effect-modification details are internally designed; M03 §3.2.4; internally defined extension boundary

N17 · Which reports of the same trial are NEJM and NIHR HTA?

Required materials and conditions: Shared relationships among reports, trial, population and the two bibliographic records and URLs.
Conditions for verification: Relevant original materials and analysis scope for Shared relationships among reports, trial, population and the two bibliographic records and URLs must be supplied and unverified matters distinguished. Preserved wording is linked during this work; review of existing content remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: Production item to distinguish Shared relationships among reports, trial, population and the two bibliographic records and URLs and link the materials required for the selected question to currently available materials.
Referenced methods: Distinction between studies and reports in M04 §4.6.1–4.6.2; cohort/outcome linkage is an internal application; data collection and selection principles in M04 §4.5–4.6; separation of access from reading and the hyperlink contract are internally designed

N18 · Is the Kato meta-analysis an independent replication of the same question?

Required materials and conditions: Relationships among 40 studies, 8890 participants, other maintenance trials and ANTLER conditions.
Conditions for verification: Relevant original materials and analysis scope for Relationships among 40 studies, 8890 participants, other maintenance trials and ANTLER conditions must be supplied and unverified matters distinguished. Preserved wording is linked during this work; review of existing content remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: Production item to distinguish Relationships among 40 studies, 8890 participants, other maintenance trials and ANTLER conditions and link the materials required for the selected question to currently available materials.
Referenced methods: Study/report distinction in M04 §4.6.1–4.6.2; Cohort/outcome linkage is Chamgap application; M04 §4.6.1–4.6.2 and M15 §15.3.1; Chamgap application

N19 · How do the review's proportions and OR differ from ANTLER HR and difference?

Required materials and conditions: Endpoints, denominators and directions for proportions, OR, HR and absolute difference.
Conditions for verification: Relevant original materials and analysis scope for Endpoints, denominators and directions for proportions, OR, HR and absolute difference must be supplied and unverified matters distinguished. Preserved wording is linked during this work; review of existing content remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: Production item to distinguish Endpoints, denominators and directions for proportions, OR, HR and absolute difference and link the materials required for the selected question to currently available materials.
Referenced methods: M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are internally designed; M08 §8.2.2, M15 §15.3.1; internal application; M15 §15.3.1–15.3.3; internal application

N20 · Are the same participants, two sheets and review kept from being added together?

Required materials and conditions: Preservation of shared and overlapping relationships among the two subclaim sheets, NEJM/HTA and the review.
Conditions for verification: Relevant original materials and analysis scope for Preservation of shared and overlapping relationships among the two subclaim sheets, NEJM/HTA and the review must be supplied and unverified matters distinguished. Preserved wording is linked during this work; review of existing content remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: Production item to distinguish Preservation of shared and overlapping relationships among the two subclaim sheets, NEJM/HTA and the review and link the materials required for the selected question to currently available materials.
Referenced methods: Study/report distinction in M04 §4.6.1–4.6.2; Cohort/outcome linkage is Chamgap application; M04 §4.6.1–4.6.2 and M15 §15.3.1; Chamgap application

N21 · What public support and sponsor did ANTLER have, and what remains unverified?

Required materials and conditions: NIHR, PRIMENT and UCL, separated from products, employees, conflicts of interest and roles.
Conditions for verification: Relevant original materials and analysis scope for NIHR, PRIMENT and UCL, separated from products, employees, conflicts of interest and roles must be supplied and unverified matters distinguished. Preserved wording is linked during this work; review of existing content remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: Production item to distinguish NIHR, PRIMENT and UCL, separated from products, employees, conflicts of interest and roles and link the materials required for the selected question to currently available materials.
Referenced methods: Chamgap's own conditions for independence and attribution. The official methodological sections used in this example do not validate every detail of these items.

N22 · Does unreported free trial-drug or placebo provision mean no provision occurred?

Required materials and conditions: Historical statements of unreported provision, separated from unverified actual product support.
Conditions for verification: Relevant original materials and analysis scope for Historical statements of unreported provision, separated from unverified actual product support must be supplied and unverified matters distinguished. Preserved wording is linked during this work; review of existing content remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: Production item to distinguish Historical statements of unreported provision, separated from unverified actual product support and link the materials required for the selected question to currently available materials.
Referenced methods: Chamgap independence/attribution conditions. The referenced official method sections do not certify every detail of these items; Data collection/selection principles in M04 §4.5–4.6; Access/reading separation and hyperlink rules are Chamgap design

N23 · What scope of independence information does public funding of the review provide?

Required materials and conditions: Japanese research grants for the review, separated from funding and conflicts of interest in included trials.
Conditions for verification: Relevant original materials and analysis scope for Japanese research grants for the review, separated from funding and conflicts of interest in included trials must be supplied and unverified matters distinguished. Preserved wording is linked during this work; review of existing content remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: Production item to distinguish Japanese research grants for the review, separated from funding and conflicts of interest in included trials and link the materials required for the selected question to currently available materials.
Referenced methods: Chamgap's own conditions for independence and attribution. The official methodological sections used in this example do not validate every detail of these items.

N24 · At what level are registry identifiers and actual prespecified endpoints and plans recorded?

Required materials and conditions: Original ISRCTN and EudraCT identifiers, plans and amendment histories.
Conditions for verification: Relevant original materials and analysis scope for Original ISRCTN and EudraCT identifiers, plans and amendment histories must be supplied and unverified matters distinguished. Preserved wording is linked during this work; review of existing content remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: Production item to distinguish Original ISRCTN and EudraCT identifiers, plans and amendment histories and link the materials required for the selected question to currently available materials.
Referenced methods: Data collection and selection principles in M04 §4.5–4.6; separation of access from reading and the hyperlink contract are internally designed; M08 Table 8.2.a, M04 §4.6.3; internal application; M04 §4.5, §4.6.3; limits of this material conversion reflect the review scope and internal design

N25 · What outcomes do serious adverse events, deaths and suicide attempts represent?

Required materials and conditions: Definitions and scope of safety events, 9/8 participants, 4%/3% and 0 events in both arms.
Conditions for verification: Relevant original materials and analysis scope for Definitions and scope of safety events, 9/8 participants, 4%/3% and 0 events in both arms must be supplied and unverified matters distinguished. Preserved wording is linked during this work; review of existing content remains incomplete.
Requirement and applicability: Supplementary
Application exceptions: Addresses gaps in withdrawal and safety materials for the selected relapse question. Relapse, absence of relapse or original safety wording is not used to assess overall safety or an individual's ability to discontinue, or to generate harm incidence or guidance on maintenance, discontinuation, tapering, dosing or treatment.
Why this condition is needed: Production item to distinguish Definitions and scope of safety events, 9/8 participants, 4%/3% and 0 events in both arms and link the materials required for the selected question to currently available materials.
Referenced methods: M19 §19.1.2–19.2.4; internal application; M19 §19.1.2–19.2.4; finer distinctions are internally designed; M19 §19.1.2–19.2.4; internal application; M19 §19.1.2–19.2.4; internal application

N26 · Are safety, relapse and withdrawal different measurements?

Required materials and conditions: Collection, timepoints and occurrence units for serious events, withdrawal and relapse.
Conditions for verification: Relevant original materials and analysis scope for Collection, timepoints and occurrence units for serious events, withdrawal and relapse must be supplied and unverified matters distinguished. Preserved wording is linked during this work; review of existing content remains incomplete.
Requirement and applicability: Supplementary
Application exceptions: Addresses gaps in withdrawal and safety materials for the selected relapse question. Relapse, absence of relapse or original safety wording is not used to assess overall safety or an individual's ability to discontinue, or to generate harm incidence or guidance on maintenance, discontinuation, tapering, dosing or treatment.
Why this condition is needed: Production item to distinguish Collection, timepoints and occurrence units for serious events, withdrawal and relapse and link the materials required for the selected question to currently available materials.
Referenced methods: M19 §19.1.2–19.2.4; internal application; M19 §19.1.2–19.2.4; finer distinctions are internally designed; design-specific harm questions in M19 §19.2; details of temporal relationships are internally designed; Chamgap's own interpretation boundary. M19 principles are referenced; no official causality tool was executed

N27 · To whom can the result generalize, and what lies outside its scope?

Required materials and conditions: Boundaries between long-term primary-care users in remission considering discontinuation and other situations.
Conditions for verification: Relevant original materials and analysis scope for Boundaries between long-term primary-care users in remission considering discontinuation and other situations must be supplied and unverified matters distinguished. Preserved wording is linked during this work; review of existing content remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: Production item to distinguish Boundaries between long-term primary-care users in remission considering discontinuation and other situations and link the materials required for the selected question to currently available materials.
Referenced methods: M03 §3.2.1; detailed population conditions are our own design; M03 §3.2.2–3.2.3; reverse-direction labels and test adaptations are our own design; M03 §3.2.1–3.2.4; dose, duration and effect-modification details are our own design

N28 · How are actual summary reading and external-material access labeled?

Required materials and conditions: Levels of the preserved summary, NEJM/HTA/Kato URLs, registries, plans and conflicts of interest.
Conditions for verification: Relevant original materials and analysis scope for Levels of the preserved summary, NEJM/HTA/Kato URLs, registries, plans and conflicts of interest must be supplied and unverified matters distinguished. Preserved wording is linked during this work; review of existing content remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: Production item to distinguish Levels of the preserved summary, NEJM/HTA/Kato URLs, registries, plans and conflicts of interest and link the materials required for the selected question to currently available materials.
Referenced methods: M04 §4.5–4.6 material collection/selection principles; acquisition/reading separation and hyperlink specifications are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design

N29 · How are original Korean and English texts, dates, corrections and empty values preserved?

Required materials and conditions: Parent B70, Korean and English texts, 2026-08-26, and empty correction, deliberation, unrecorded and false values.
Conditions for verification: Relevant original materials and analysis scope for Parent B70, Korean and English texts, 2026-08-26, and empty correction, deliberation, unrecorded and false values must be supplied and unverified matters distinguished. Preserved wording is linked during this work; review of existing content remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: Production item to distinguish Parent B70, Korean and English texts, 2026-08-26, and empty correction, deliberation, unrecorded and false values and link the materials required for the selected question to currently available materials.
Referenced methods: M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design

N30 · How are condition freezing, application and content review separate events?

Required materials and conditions: Condition preservation, freezing, application, case production and incomplete content review
Conditions for verification: Relevant original materials and analysis scope for Condition preservation, freezing, application, case production and incomplete content review must be supplied and unverified matters distinguished. Preserved wording is linked during this work; review of existing content remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: This production item distinguishes "Condition preservation, freezing, application, case production and incomplete content review" to link materials needed for the selected question with the currently available material.
Referenced methods: M04 §4.5–4.6 material collection/selection principles; acquisition/reading separation and hyperlink specifications are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design

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: Preserved method HTML copies; no current method-content re-review or official tool execution

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: Preserved method HTML copies; no current method-content re-review or official tool execution

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: Preserved method HTML copies; no current method-content re-review or official tool execution

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: Preserved method HTML copies; no current method-content re-review or official tool execution

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: Preserved method HTML copies; no current method-content re-review or official tool execution

What the statuses mean

Met: Status for necessary evidence confirmed after existing content review. No completion is declared in the current presentation.
Partly verified: Some information in the stored summary is linked into the table. External comparison/content review is not complete.
Unverified: The article leaves this unverified, or required material is absent from the current stored summary. This is distinct from zero, absence or safety.
Review incomplete: Existing content review incomplete.
Not reported: Not reported within the stored material actually read; not extended to the entire primary paper.
Inaccessible: Means an actual access failure. Access not attempted here is not assigned this state.
Not applicable: Not used as a substitute for an evidence gap.
Conflicting data: Requires an observed disagreement under the same comparison criteria; not automatically judged in this production.
Insufficient evidence for the conditions: Marks a gap in additional material required by the selected conditions; not a new efficacy grade.

Change history

2026-10-10 · Public page/material version 1.0

The public page and data were prepared from the existing 30 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 · How do the selected 52-week relapse-reduction record and parent values differ?

Current findings: The selected existing question is ‘Reduced depression relapse by 52 weeks’, with original grade B and note ‘39% versus 56%, absolute difference 17%p’. Score, status and axes are absent. Parent B70, Caution and original axes including R1/I2 and E+ are parent verdict context.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Subclaim score, status and axes were originally absent; no new grade or score is written. Review of existing content remains incomplete.
Reason for missing information: Subclaim score, status and axes were originally absent; no new grade or score is written.
Required materials and conditions: Separate preservation of subclaim B/note and absent values, and parent B70, axes and verdict.
Materials to obtain first: Additional materials for the subclaim or user comments.
Further research: Proposal: Separate source records for the selected question and parent verdict; no new investigation, calculation or trial was conducted.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Relevant original materials and analysis scope for Separate preservation of subclaim B/note and absent values, and parent B70, axes and verdict must be supplied and unverified matters distinguished. Preserved wording is linked during this work; review of existing content remains incomplete.
Why this condition is needed: Production item to distinguish Separate preservation of subclaim B/note and absent values, and parent B70, axes and verdict and link the materials required for the selected question to currently available materials.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design

Related sources S01 S02

N02 · Who were the long-term antidepressant users in ANTLER?

Current findings: Adults who felt well enough to consider stopping were recruited at 150 UK general practices. Original conditions included at least 2 previous depressive episodes or at least 2 years of treatment, and long-term use of four antidepressants.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Exact remission and eligibility criteria, symptom thresholds, age and baseline characteristics, exclusions and representativeness are unverified. Review of existing content remains incomplete.
Reason for missing information: Exact remission and eligibility criteria, symptom thresholds, age and baseline characteristics, exclusions and representativeness are unverified.
Required materials and conditions: Remission, consideration of discontinuation, prior episodes, treatment duration and primary-care recruitment conditions.
Materials to obtain first: Eligibility/exclusions, baseline tables and recruitment flow
Further research: Proposal: Linking actual eligibility conditions to relapse materials; no new investigation, calculation or trial was conducted.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Relevant original materials and analysis scope for Remission, consideration of discontinuation, prior episodes, treatment duration and primary-care recruitment conditions must be supplied and unverified matters distinguished. Preserved wording is linked during this work; review of existing content remains incomplete.
Why this condition is needed: Production item to distinguish Remission, consideration of discontinuation, prior episodes, treatment duration and primary-care recruitment conditions and link the materials required for the selected question to currently available materials.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M03 §3.2.1; detailed population conditions are Chamgap's own design

Related sources S01 S02

N03 · What study exposure was compared between maintenance and tapering to placebo?

Current findings: ANTLER assigned users of original specified doses of citalopram, fluoxetine, sertraline or mirtazapine to maintenance or matching placebo after a 1–2-month taper. Drugs and periods are historical trial conditions, not instructions for taking or tapering medication.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Actual denominators by drug, adherent exposure, individual taper trajectories and concomitant treatment are unverified. Review of existing content remains incomplete.
Reason for missing information: Actual denominators by drug, adherent exposure, individual taper trajectories and concomitant treatment are unverified.
Required materials and conditions: Historical scope of the four drugs, maintenance, tapering to placebo and matching appearance.
Materials to obtain first: Actual exposure by arm, concomitant treatment and baseline tables by drug.
Further research: Proposal: Distinguishing study allocation conditions from actual exposure; no new investigation, calculation or trial was conducted.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Relevant original materials and analysis scope for Historical scope of the four drugs, maintenance, tapering to placebo and matching appearance must be supplied and unverified matters distinguished. Preserved wording is linked during this work; review of existing content remains incomplete.
Why this condition is needed: Production item to distinguish Historical scope of the four drugs, maintenance, tapering to placebo and matching appearance and link the materials required for the selected question to currently available materials.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M03 §3.2.2–3.2.3; Reverse-direction labels and assessment adaptation are Chamgap design; M03 §3.2.3 and M08 §8.2.2–8.2.3; Chamgap application

Related sources S01 S02

N04 · What were the actual randomization and masking procedures?

Current findings: The multicenter double-blind placebo-controlled superiority RCT randomized 478 participants to maintenance, 238, or tapering to placebo, 240, using matching tablets.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Allocation generation and concealment, assessor masking, and numbers, timing and procedures for allocation guesses are unverified. Review of existing content remains incomplete.
Reason for missing information: Allocation generation and concealment, assessor masking, and numbers, timing and procedures for allocation guesses are unverified.
Required materials and conditions: Allocation of 478 participants, 238 maintenance and 240 placebo, allocation concealment and masking.
Materials to obtain first: Allocation and masking procedures, and allocation-guess results.
Further research: Proposal: Documenting design, measurement and allocation awareness; no new investigation, calculation or trial was conducted.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Relevant original materials and analysis scope for Allocation of 478 participants, 238 maintenance and 240 placebo, allocation concealment and masking must be supplied and unverified matters distinguished. Preserved wording is linked during this work; review of existing content remains incomplete.
Why this condition is needed: Production item to distinguish Allocation of 478 participants, 238 maintenance and 240 placebo, allocation concealment and masking and link the materials required for the selected question to currently available materials.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M08 §8.1–8.2.3; internal application; M08 Table 8.2.a, M03 §3.2.4; internal application

Related sources S01 S02

N05 · Was the primary endpoint time to first relapse or an event proportion?

Current findings: The primary endpoint was time to first depression relapse within 52 weeks. 92/238 and 135/240 are absolute relapse counts, not total repeated relapses or mean symptom-scale scores.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Details of the first-relapse symptom instrument, diagnostic threshold, assessment schedule, repeated events and censoring rules are unverified. Review of existing content remains incomplete.
Reason for missing information: Details of the first-relapse symptom instrument, diagnostic threshold, assessment schedule, repeated events and censoring rules are unverified.
Required materials and conditions: Time to first relapse within 52 weeks, original events and participants, and separation from repeated events.
Materials to obtain first: Relapse definition, assessment schedule, endpoints and SAP.
Further research: Proposal: Separating first events from symptoms and repeated events; no new investigation, calculation or trial was conducted.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Relevant original materials and analysis scope for Time to first relapse within 52 weeks, original events and participants, and separation from repeated events must be supplied and unverified matters distinguished. Preserved wording is linked during this work; review of existing content remains incomplete.
Why this condition is needed: Production item to distinguish Time to first relapse within 52 weeks, original events and participants, and separation from repeated events and link the materials required for the selected question to currently available materials.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific result adaptation is our own design; M08 Table 8.2.a, M04 §4.6.3; own application

Related sources S01 S02

N06 · Which arms do the absolute relapse counts, proportions and difference represent?

Current findings: Original maintenance 92/238 (39%) versus discontinuation after tapering 135/240 (56%) and absolute difference 17%p are preserved. No new proportion, difference, NNT or individual risk is calculated.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Original CI for the absolute difference, events and missingness by timepoint, and interval-estimation models are unverified. Review of existing content remains incomplete.
Reason for missing information: Original CI for the absolute difference, events and missingness by timepoint, and interval-estimation models are unverified.
Required materials and conditions: Arms and denominators for original 92/238 (39%), 135/240 (56%) and 17%p.
Materials to obtain first: Original absolute results and CI, with populations by timepoint.
Further research: Proposal: Linking events, denominators and absolute-effect intervals; no new investigation, calculation or trial was conducted.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Relevant original materials and analysis scope for Arms and denominators for original 92/238 (39%), 135/240 (56%) and 17%p must be supplied and unverified matters distinguished. Preserved wording is linked during this work; review of existing content remains incomplete.
Why this condition is needed: Production item to distinguish Arms and denominators for original 92/238 (39%), 135/240 (56%) and 17%p and link the materials required for the selected question to currently available materials.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is internally designed; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is internally designed; M15 §15.3.1–15.3.3; internal application

Related sources S01 S02

N07 · Which comparison direction does HR 2.06 represent?

Current findings: Discontinuation-versus-maintenance HR 2.06 (95% CI 1.56–2.70), P<.001 is the original time-to-event estimate. 39%/56% and 17%p are different measures. HR is not inverted to maintenance versus discontinuation or renamed a risk ratio or individual probability.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Model covariates, proportional-hazards assumptions, censoring and the exact analysis specification are unverified. Review of existing content remains incomplete.
Reason for missing information: Model covariates, proportional-hazards assumptions, censoring and the exact analysis specification are unverified.
Required materials and conditions: Discontinuation-versus-maintenance HR, CI and P, distinguished from absolute proportions.
Materials to obtain first: Time-to-event analysis tables, SAP and censoring records.
Further research: Proposal: Distinguishing comparison direction and model; no new investigation, calculation or trial was conducted.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Relevant original materials and analysis scope for Discontinuation-versus-maintenance HR, CI and P, distinguished from absolute proportions must be supplied and unverified matters distinguished. Preserved wording is linked during this work; review of existing content remains incomplete.
Why this condition is needed: Production item to distinguish Discontinuation-versus-maintenance HR, CI and P, distinguished from absolute proportions and link the materials required for the selected question to currently available materials.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M08 §8.2.2, M15 §15.3.1; Chamgap's own application; M15 §15.3.1–15.3.3; Chamgap's own application; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are Chamgap's own design

Related sources S01 S02

N08 · How do the 478 randomized participants differ from the 468 in the time-to-event analysis?

Current findings: Of 478 randomized participants, 10 without relapse timing, 6 maintenance and 4 discontinuation, were excluded from the primary time-to-event analysis, leaving 468. The original statement that they remained in absolute relapse counts is preserved.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Actual timing and status of the 10 participants, missingness reasons, analysis denominators by arm and follow-up ending details are unverified. Review of existing content remains incomplete.
Reason for missing information: Actual timing and status of the 10 participants, missingness reasons, analysis denominators by arm and follow-up ending details are unverified.
Required materials and conditions: Roles of each denominator and preservation of 10 participants without timing, 6 and 4 by arm.
Materials to obtain first: Participant flow, missingness and analysis populations, and relapse-timing materials.
Further research: Proposal: Linking absolute-event and time-to-event denominators; no new investigation, calculation or trial was conducted.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Relevant original materials and analysis scope for Roles of each denominator and preservation of 10 participants without timing, 6 and 4 by arm must be supplied and unverified matters distinguished. Preserved wording is linked during this work; review of existing content remains incomplete.
Why this condition is needed: Production item to distinguish Roles of each denominator and preservation of 10 participants without timing, 6 and 4 by arm and link the materials required for the selected question to currently available materials.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; Design-specific adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap application

Related sources S01 S02

N09 · What scope is supported by missing-data sensitivity analyses?

Current findings: The original states that best- and worst-case missing-data sensitivity analyses remained directionally consistent. This statement is not substituted for absence of all missingness or censoring bias, or new numbers.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Events, denominators, HR, CI, models and sensitivity values under each assumption are unverified. Review of existing content remains incomplete.
Reason for missing information: Events, denominators, HR, CI, models and sensitivity values under each assumption are unverified.
Required materials and conditions: Original direction under best- and worst-case assumptions and specific estimates.
Materials to obtain first: Sensitivity-analysis tables, assumptions and SAP.
Further research: Proposal: Documenting results and precision under each missingness assumption; no new investigation, calculation or trial was conducted.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Relevant original materials and analysis scope for Original direction under best- and worst-case assumptions and specific estimates must be supplied and unverified matters distinguished. Preserved wording is linked during this work; review of existing content remains incomplete.
Why this condition is needed: Production item to distinguish Original direction under best- and worst-case assumptions and specific estimates and link the materials required for the selected question to currently available materials.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; Design-specific adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap application; M15 §15.3.1–15.3.3; Chamgap application

Related sources S01 S02

N10 · How do adherence of 70%/52% and restarting of 39% relate to the allocation effect?

Current findings: Original values are adherence of 70% in maintenance and 52% in discontinuation, and 39% of the discontinuation group restarting a clinician-prescribed antidepressant before trial end. The allocation comparison is not changed to a pure exposure effect of complete discontinuation versus complete maintenance.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Adherence definition and measurement, restart timing and reasons, treatment–relapse timing and actual-exposure analyses are unverified. Review of existing content remains incomplete.
Reason for missing information: Adherence definition and measurement, restart timing and reasons, treatment–relapse timing and actual-exposure analyses are unverified.
Required materials and conditions: Definitions and timing of allocation, actual exposure, adherence and restarting.
Materials to obtain first: Adherence and restarting records, timing materials and analysis plans.
Further research: Proposal: Linking allocation to actual exposure and rescue treatment; no new investigation, calculation or trial was conducted.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Relevant original materials and analysis scope for Definitions and timing of allocation, actual exposure, adherence and restarting must be supplied and unverified matters distinguished. Preserved wording is linked during this work; review of existing content remains incomplete.
Why this condition is needed: Production item to distinguish Definitions and timing of allocation, actual exposure, adherence and restarting and link the materials required for the selected question to currently available materials.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M03 §3.2.3, M08 §8.2.2–8.2.3; internal application; M08 §8.2.2, M15 §15.3.1; internal application; design-specific harm questions in M19 §19.2; details of temporal relationships are internally designed

Related sources S01 S02

N11 · How were withdrawal symptoms distinguished from depression relapse?

Current findings: Withdrawal was greater at 12 weeks in the discontinuation group. Original modified DESS means 3.1 versus 1.3 and between-arm difference 1.9 (95% CI 1.5–2.3) are recorded. The original retains possible partial misclassification of withdrawal as relapse and allocation awareness, without establishing their magnitude.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Relapse and withdrawal classification criteria, case assessment, misclassification magnitude and separate analyses are unverified. Review of existing content remains incomplete.
Reason for missing information: Relapse and withdrawal classification criteria, case assessment, misclassification magnitude and separate analyses are unverified.
Required materials and conditions: Instruments, symptom overlap, timing, classification and misclassification scope.
Materials to obtain first: DESS and relapse items, schedule, original analysis tables and assessment rules.
Further research: Proposal: Separating measurement and timing of withdrawal and relapse; no new investigation, calculation or trial was conducted.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Relevant original materials and analysis scope for Instruments, symptom overlap, timing, classification and misclassification scope must be supplied and unverified matters distinguished. Preserved wording is linked during this work; review of existing content remains incomplete.
Why this condition is needed: Production item to distinguish Instruments, symptom overlap, timing, classification and misclassification scope and link the materials required for the selected question to currently available materials.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M08 Table 8.2.a, M03 §3.2.4; internal application; M19 §19.1.2–19.2.4; finer distinctions are internally designed; design-specific harm questions in M19 §19.2; details of temporal relationships are internally designed

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N12 · Can DESS means and the between-arm difference be turned into the same arithmetic value?

Current findings: Original modified DESS means 3.1/1.3 and between-arm difference 1.9 (1.5–2.3) are preserved unchanged. The difference is not recalculated from the means, and original values are not corrected.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Adjustment, rounding, analysis populations and original-table details for the means and difference are unverified. Review of existing content remains incomplete.
Reason for missing information: Adjustment, rounding, analysis populations and original-table details for the means and difference are unverified.
Required materials and conditions: Estimation specification for original means 3.1/1.3, difference 1.9 and CI.
Materials to obtain first: Original DESS tables, models, denominators and summary-value definitions.
Further research: Proposal: Linking estimation specifications for each reported value; no new investigation, calculation or trial was conducted.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Relevant original materials and analysis scope for Estimation specification for original means 3.1/1.3, difference 1.9 and CI must be supplied and unverified matters distinguished. Preserved wording is linked during this work; review of existing content remains incomplete.
Why this condition is needed: Production item to distinguish Estimation specification for original means 3.1/1.3, difference 1.9 and CI and link the materials required for the selected question to currently available materials.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are Chamgap's own design; M08 §8.2.2, M15 §15.3.1; Chamgap's own application; M15 §15.3.1–15.3.3; Chamgap's own application

Related sources S01 S02

N13 · How does the difference in allocation awareness relate to relapse assessment?

Current findings: The original statement that discontinuation participants guessed allocation more often is preserved. It is not newly established as the cause of every relapse difference, a bias magnitude or invalidation of the trial.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Guess proportions, timing, assessor awareness and analyses involving withdrawal and relapse are unverified. Review of existing content remains incomplete.
Reason for missing information: Guess proportions, timing, assessor awareness and analyses involving withdrawal and relapse are unverified.
Required materials and conditions: Maintained masking, timing of awareness and unverified measurement-bias magnitude.
Materials to obtain first: Allocation-guess results, assessor masking and related analyses.
Further research: Proposal: Documenting allocation awareness and outcome measurement; no new investigation, calculation or trial was conducted.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Relevant original materials and analysis scope for Maintained masking, timing of awareness and unverified measurement-bias magnitude must be supplied and unverified matters distinguished. Preserved wording is linked during this work; review of existing content remains incomplete.
Why this condition is needed: Production item to distinguish Maintained masking, timing of awareness and unverified measurement-bias magnitude and link the materials required for the selected question to currently available materials.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M08 Table 8.2.a, M03 §3.2.4; internal application

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N14 · Does relapse defined by a symptom instrument also answer other clinical-outcome questions?

Current findings: The parent describes relapse assessed through a depression symptom scale as a patient-important treatment target. This is not moved to all depressive symptoms, function, hospitalization or suicide-prevention outcomes.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Scale details, clinical diagnosis, function, hospitalization and effects for other endpoints are unverified. Review of existing content remains incomplete.
Reason for missing information: Scale details, clinical diagnosis, function, hospitalization and effects for other endpoints are unverified.
Required materials and conditions: Relapse definition separated from suicide, function, hospitalization and other outcomes.
Materials to obtain first: Endpoint-specific definitions and clinical and functional result tables.
Further research: Proposal: Linking selected relapse to separate clinical outcomes; no new investigation, calculation or trial was conducted.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Relevant original materials and analysis scope for Relapse definition separated from suicide, function, hospitalization and other outcomes must be supplied and unverified matters distinguished. Preserved wording is linked during this work; review of existing content remains incomplete.
Why this condition is needed: Production item to distinguish Relapse definition separated from suicide, function, hospitalization and other outcomes and link the materials required for the selected question to currently available materials.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M03 §3.2.4; internally defined extension boundary; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is internally designed

Related sources S01 S02

N15 · Does the 52-week benefit describe later persistence or lifetime risk?

Current findings: The selected question is first relapse within 52 weeks. Original values are not used to fill in long-term remission, later relapse, drug- or episode-specific effects, or lifetime effects of continuing maintenance.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Follow-up beyond 52 weeks, prespecified subgroups and results by drug, episodes or treatment duration are unverified. Review of existing content remains incomplete.
Reason for missing information: Follow-up beyond 52 weeks, prespecified subgroups and results by drug, episodes or treatment duration are unverified.
Required materials and conditions: Actual observation period, outcomes outside observation and subgroups by drug.
Materials to obtain first: Long-term follow-up and subgroup plans, with direct results.
Further research: Proposal: Separate follow-up materials by period and condition; no new investigation, calculation or trial was conducted.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Relevant original materials and analysis scope for Actual observation period, outcomes outside observation and subgroups by drug must be supplied and unverified matters distinguished. Preserved wording is linked during this work; review of existing content remains incomplete.
Why this condition is needed: Production item to distinguish Actual observation period, outcomes outside observation and subgroups by drug and link the materials required for the selected question to currently available materials.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M03 §3.2.1–3.2.4; dose, duration and effect-modification details are our own design

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N16 · How does average relapse reduction differ from prevention for everyone or inevitable relapse?

Current findings: Original statements are that 39% relapsed despite maintenance and 44% of discontinuation participants did not relapse within 52 weeks. An average between-arm difference is not changed to every individual's outcome or inevitable relapse after discontinuation.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Validated individual predictions of who will or will not relapse under which conditions are unverified in these materials. Review of existing content remains incomplete.
Reason for missing information: Validated individual predictions of who will or will not relapse under which conditions are unverified in these materials.
Required materials and conditions: Original 39% relapse during maintenance and 44% without relapse after discontinuation, with gaps in individual prediction.
Materials to obtain first: Individual prediction models and validation in external populations or periods, if supplied.
Further research: Proposal: Distinguishing individual prediction from arm comparisons; no new investigation, calculation or trial was conducted.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Relevant original materials and analysis scope for Original 39% relapse during maintenance and 44% without relapse after discontinuation, with gaps in individual prediction must be supplied and unverified matters distinguished. Preserved wording is linked during this work; review of existing content remains incomplete.
Why this condition is needed: Production item to distinguish Original 39% relapse during maintenance and 44% without relapse after discontinuation, with gaps in individual prediction and link the materials required for the selected question to currently available materials.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: Question-clarification principles in M03 §3.1, §3.2.1–3.2.4; detailed separation rules are internally designed; M03 §3.2.1–3.2.4; dose, duration and effect-modification details are internally designed; M03 §3.2.4; internally defined extension boundary

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N17 · Which reports of the same trial are NEJM and NIHR HTA?

Current findings: NEJM PMID 34587384 and NIHR HTA PMID 34842135 report the same ANTLER trial. The first evidence-list record groups them; HTA is an existing citation providing detailed design, missingness, withdrawal and adherence reporting. They are not counted as two separate trials of 478 participants.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Direct mapping of report-specific tables and analyses to shared results remains externally unread. Review of existing content remains incomplete.
Reason for missing information: Direct mapping of report-specific tables and analyses to shared results remains externally unread.
Required materials and conditions: Shared relationships among reports, trial, population and the two bibliographic records and URLs.
Materials to obtain first: The two original reports, result tables and a trial-registry relationship table.
Further research: Proposal: Linking main and detailed reports of the same trial; no new investigation, calculation or trial was conducted.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Relevant original materials and analysis scope for Shared relationships among reports, trial, population and the two bibliographic records and URLs must be supplied and unverified matters distinguished. Preserved wording is linked during this work; review of existing content remains incomplete.
Why this condition is needed: Production item to distinguish Shared relationships among reports, trial, population and the two bibliographic records and URLs and link the materials required for the selected question to currently available materials.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: Distinction between studies and reports in M04 §4.6.1–4.6.2; cohort/outcome linkage is an internal application; data collection and selection principles in M04 §4.5–4.6; separation of access from reading and the hyperlink contract are internally designed

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N18 · Is the Kato meta-analysis an independent replication of the same question?

Current findings: Kato synthesizes 40 maintenance-versus-placebo-switch trials involving 8,890 participants. Maintenance 20.9% versus 39.7%, OR .38 (95% CI .33–.43), P<.00001 provide directionally consistent context. The original statement that heterogeneous post-acute maintenance trials were not counted as independent replication of the long-term primary-care discontinuation decision is preserved.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Included trial lists, populations, periods, drugs, overlap, timepoint-specific links to ANTLER and heterogeneity are unverified. Review of existing content remains incomplete.
Reason for missing information: Included trial lists, populations, periods, drugs, overlap, timepoint-specific links to ANTLER and heterogeneity are unverified.
Required materials and conditions: Relationships among 40 studies, 8890 participants, other maintenance trials and ANTLER conditions.
Materials to obtain first: Review inclusion and exclusion tables, trial characteristics, endpoints and denominators.
Further research: Proposal: Linking different maintenance questions to synthesis materials; no new investigation, calculation or trial was conducted.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Relevant original materials and analysis scope for Relationships among 40 studies, 8890 participants, other maintenance trials and ANTLER conditions must be supplied and unverified matters distinguished. Preserved wording is linked during this work; review of existing content remains incomplete.
Why this condition is needed: Production item to distinguish Relationships among 40 studies, 8890 participants, other maintenance trials and ANTLER conditions and link the materials required for the selected question to currently available materials.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: Study/report distinction in M04 §4.6.1–4.6.2; Cohort/outcome linkage is Chamgap application; M04 §4.6.1–4.6.2 and M15 §15.3.1; Chamgap application

Related sources S03

N19 · How do the review's proportions and OR differ from ANTLER HR and difference?

Current findings: Kato maintenance 20.9%/placebo 39.7%, OR .38 (.33–.43), and ANTLER discontinuation-versus-maintenance HR 2.06 and 17%p are each original estimates. They are not divided, inverted, combined into a new pooled effect or changed to incidence for the same period.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Actual denominators, periods, event definitions, models and weights for each analysis, and absolute-difference CI are unverified. Review of existing content remains incomplete.
Reason for missing information: Actual denominators, periods, event definitions, models and weights for each analysis, and absolute-difference CI are unverified.
Required materials and conditions: Endpoints, denominators and directions for proportions, OR, HR and absolute difference.
Materials to obtain first: Meta-analysis results, denominators and models, and individual trial tables.
Further research: Proposal: Separating measures, periods and estimands; no new investigation, calculation or trial was conducted.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Relevant original materials and analysis scope for Endpoints, denominators and directions for proportions, OR, HR and absolute difference must be supplied and unverified matters distinguished. Preserved wording is linked during this work; review of existing content remains incomplete.
Why this condition is needed: Production item to distinguish Endpoints, denominators and directions for proportions, OR, HR and absolute difference and link the materials required for the selected question to currently available materials.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are internally designed; M08 §8.2.2, M15 §15.3.1; internal application; M15 §15.3.1–15.3.3; internal application

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N20 · Are the same participants, two sheets and review kept from being added together?

Current findings: This sheet and the ‘Discontinuation inevitably causes relapse’ sheet share the same parent summary and ANTLER reports and population. NEJM/HTA are not counted as duplicate trials, and 478 and 8,890 participants are not added as a total.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Unique trial, participant and independent-replication totals are unconfirmed and unrecorded. Review of existing content remains incomplete.
Reason for missing information: Unique trial, participant and independent-replication totals are unconfirmed and unrecorded.
Required materials and conditions: Preservation of shared and overlapping relationships among the two subclaim sheets, NEJM/HTA and the review.
Materials to obtain first: Trial, report and population relationships and review inclusion relationships, if supplied.
Further research: Proposal: Recording report families and overlap; no new investigation, calculation or trial was conducted.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Relevant original materials and analysis scope for Preservation of shared and overlapping relationships among the two subclaim sheets, NEJM/HTA and the review must be supplied and unverified matters distinguished. Preserved wording is linked during this work; review of existing content remains incomplete.
Why this condition is needed: Production item to distinguish Preservation of shared and overlapping relationships among the two subclaim sheets, NEJM/HTA and the review and link the materials required for the selected question to currently available materials.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: Study/report distinction in M04 §4.6.1–4.6.2; Cohort/outcome linkage is Chamgap application; M04 §4.6.1–4.6.2 and M15 §15.3.1; Chamgap application

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N21 · What public support and sponsor did ANTLER have, and what remains unverified?

Current findings: Original funding was NIHR HTA award 13/115/48 and NIHR core support for PRIMENT CTU; UCL was the sponsor. Public support is not changed to absence of all company involvement, employee authors or conflicts of interest, or current certification of independence.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Specific research, analysis and manuscript roles, authors and conflicts of interest, and other support remain externally unread. Review of existing content remains incomplete.
Reason for missing information: Specific research, analysis and manuscript roles, authors and conflicts of interest, and other support remain externally unread.
Required materials and conditions: NIHR, PRIMENT and UCL, separated from products, employees, conflicts of interest and roles.
Materials to obtain first: Funding and sponsor roles, authors, conflicts of interest and contribution declarations.
Further research: Proposal: Separating funding from actual research roles; no new investigation, calculation or trial was conducted.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Relevant original materials and analysis scope for NIHR, PRIMENT and UCL, separated from products, employees, conflicts of interest and roles must be supplied and unverified matters distinguished. Preserved wording is linked during this work; review of existing content remains incomplete.
Why this condition is needed: Production item to distinguish NIHR, PRIMENT and UCL, separated from products, employees, conflicts of interest and roles and link the materials required for the selected question to currently available materials.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: Chamgap's own conditions for independence and attribution. The official methodological sections used in this example do not validate every detail of these items.

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N22 · Does unreported free trial-drug or placebo provision mean no provision occurred?

Current findings: The original states that donated pharmaceutical-company trial drugs or placebo were not described in NEJM or NIHR HTA. Neither external report was read during this work, and non-reporting is not asserted to mean no actual support.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Supply, purchase and manufacturing contracts, free support, companies, employee authors and conflicts of interest are unverified. Review of existing content remains incomplete.
Reason for missing information: Supply, purchase and manufacturing contracts, free support, companies, employee authors and conflicts of interest are unverified.
Required materials and conditions: Historical statements of unreported provision, separated from unverified actual product support.
Materials to obtain first: Drug and placebo supply contracts, product support, authors and conflicts-of-interest materials.
Further research: Proposal: Separately documenting support types and actual roles; no new investigation, calculation or trial was conducted.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Relevant original materials and analysis scope for Historical statements of unreported provision, separated from unverified actual product support must be supplied and unverified matters distinguished. Preserved wording is linked during this work; review of existing content remains incomplete.
Why this condition is needed: Production item to distinguish Historical statements of unreported provision, separated from unverified actual product support and link the materials required for the selected question to currently available materials.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: Chamgap independence/attribution conditions. The referenced official method sections do not certify every detail of these items; Data collection/selection principles in M04 §4.5–4.6; Access/reading separation and hyperlink rules are Chamgap design

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N23 · What scope of independence information does public funding of the review provide?

Current findings: Kato's original Ministry of Health, Labour and Welfare of Japan grants H29-SEISHIN-ippan-001 and 19GC1012 are preserved. Review funding and included trials' funding, products, authors and conflicts of interest are different items.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Actual review roles and conflicts of interest, and company, product and employee relationships in each included trial are unverified. Review of existing content remains incomplete.
Reason for missing information: Actual review roles and conflicts of interest, and company, product and employee relationships in each included trial are unverified.
Required materials and conditions: Japanese research grants for the review, separated from funding and conflicts of interest in included trials.
Materials to obtain first: Funding, roles and conflicts-of-interest materials for the review and included trials.
Further research: Proposal: Linking independence materials for synthesis and individual trials; no new investigation, calculation or trial was conducted.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Relevant original materials and analysis scope for Japanese research grants for the review, separated from funding and conflicts of interest in included trials must be supplied and unverified matters distinguished. Preserved wording is linked during this work; review of existing content remains incomplete.
Why this condition is needed: Production item to distinguish Japanese research grants for the review, separated from funding and conflicts of interest in included trials and link the materials required for the selected question to currently available materials.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: Chamgap's own conditions for independence and attribution. The official methodological sections used in this example do not validate every detail of these items.

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N24 · At what level are registry identifiers and actual prespecified endpoints and plans recorded?

Current findings: Original ANTLER registry identifiers are ‘ISRCTN15969819 · EudraCT 2015-004210-26’. Preserving the two identifiers is separate from reading the actual registry, protocol or SAP; Kato's ‘Not applicable’ is original wording.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Registry source text, amendments, prespecified endpoints, analysis and missing-data plans remain unread; access was not attempted. Review of existing content remains incomplete.
Reason for missing information: Registry source text, amendments, prespecified endpoints, analysis and missing-data plans remain unread; access was not attempted.
Required materials and conditions: Original ISRCTN and EudraCT identifiers, plans and amendment histories.
Materials to obtain first: Registry, protocol and SAP copies or user-provided materials.
Further research: Proposal: Linking registry and plan versions by report; no new investigation, calculation or trial was conducted.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Relevant original materials and analysis scope for Original ISRCTN and EudraCT identifiers, plans and amendment histories must be supplied and unverified matters distinguished. Preserved wording is linked during this work; review of existing content remains incomplete.
Why this condition is needed: Production item to distinguish Original ISRCTN and EudraCT identifiers, plans and amendment histories and link the materials required for the selected question to currently available materials.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: Data collection and selection principles in M04 §4.5–4.6; separation of access from reading and the hyperlink contract are internally designed; M08 Table 8.2.a, M04 §4.6.3; internal application; M04 §4.5, §4.6.3; limits of this material conversion reflect the review scope and internal design

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N25 · What outcomes do serious adverse events, deaths and suicide attempts represent?

Current findings: Original serious adverse events occurred in 9 maintenance participants (4%) versus 8 discontinuation participants (3%). Deaths and suicide attempts were 0 in both arms. Zero events are not changed to zero risk, long-term safety or treatment guidance.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Safety denominators, collection and assessment, exposure, follow-up, censoring, CI, and rare and long-term harms are unverified. Review of existing content remains incomplete.
Reason for missing information: Safety denominators, collection and assessment, exposure, follow-up, censoring, CI, and rare and long-term harms are unverified.
Required materials and conditions: Definitions and scope of safety events, 9/8 participants, 4%/3% and 0 events in both arms.
Materials to obtain first: Safety tables, collection, exposure, follow-up and denominators.
Further research: Proposal: Linking event-specific safety materials and precision; no new investigation, calculation or trial was conducted.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Relevant original materials and analysis scope for Definitions and scope of safety events, 9/8 participants, 4%/3% and 0 events in both arms must be supplied and unverified matters distinguished. Preserved wording is linked during this work; review of existing content remains incomplete.
Why this condition is needed: Production item to distinguish Definitions and scope of safety events, 9/8 participants, 4%/3% and 0 events in both arms and link the materials required for the selected question to currently available materials.
Application exceptions: Addresses gaps in withdrawal and safety materials for the selected relapse question. Relapse, absence of relapse or original safety wording is not used to assess overall safety or an individual's ability to discontinue, or to generate harm incidence or guidance on maintenance, discontinuation, tapering, dosing or treatment.
Referenced methods: M19 §19.1.2–19.2.4; internal application; M19 §19.1.2–19.2.4; finer distinctions are internally designed; M19 §19.1.2–19.2.4; internal application; M19 §19.1.2–19.2.4; internal application

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N26 · Are safety, relapse and withdrawal different measurements?

Current findings: Withdrawal symptoms at 12 weeks, first relapse by 52 weeks, and serious adverse events, deaths and suicide attempts are different endpoints. Statements about increased withdrawal and reduced relapse are not newly combined into a single safety or efficacy score.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Harm-collection definitions, periods, populations and adverse-effect materials by other drugs are unverified. Review of existing content remains incomplete.
Reason for missing information: Harm-collection definitions, periods, populations and adverse-effect materials by other drugs are unverified.
Required materials and conditions: Collection, timepoints and occurrence units for serious events, withdrawal and relapse.
Materials to obtain first: Endpoint-specific original safety, withdrawal and relapse tables and timing materials.
Further research: Proposal: Separating event and symptom measurements by endpoint; no new investigation, calculation or trial was conducted.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Relevant original materials and analysis scope for Collection, timepoints and occurrence units for serious events, withdrawal and relapse must be supplied and unverified matters distinguished. Preserved wording is linked during this work; review of existing content remains incomplete.
Why this condition is needed: Production item to distinguish Collection, timepoints and occurrence units for serious events, withdrawal and relapse and link the materials required for the selected question to currently available materials.
Application exceptions: Addresses gaps in withdrawal and safety materials for the selected relapse question. Relapse, absence of relapse or original safety wording is not used to assess overall safety or an individual's ability to discontinue, or to generate harm incidence or guidance on maintenance, discontinuation, tapering, dosing or treatment.
Referenced methods: M19 §19.1.2–19.2.4; internal application; M19 §19.1.2–19.2.4; finer distinctions are internally designed; design-specific harm questions in M19 §19.2; details of temporal relationships are internally designed; Chamgap's own interpretation boundary. M19 principles are referenced; no official causality tool was executed

Related sources S01 S02

N27 · To whom can the result generalize, and what lies outside its scope?

Current findings: Selected materials concern the original 52-week comparison in long-term users, adults in remission considering discontinuation. This trial does not establish effects for newly started acute treatment, other drugs or doses, abrupt stopping, lifetime maintenance or individually safe discontinuation.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Direct materials for other populations, exposures, periods and individual prediction are unverified. Review of existing content remains incomplete.
Reason for missing information: Direct materials for other populations, exposures, periods and individual prediction are unverified.
Required materials and conditions: Boundaries between long-term primary-care users in remission considering discontinuation and other situations.
Materials to obtain first: Direct materials for the separate question, if provided
Further research: Proposal: Recording evidence gaps by population, exposure and period; no new investigation, calculation or trial was conducted.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Relevant original materials and analysis scope for Boundaries between long-term primary-care users in remission considering discontinuation and other situations must be supplied and unverified matters distinguished. Preserved wording is linked during this work; review of existing content remains incomplete.
Why this condition is needed: Production item to distinguish Boundaries between long-term primary-care users in remission considering discontinuation and other situations and link the materials required for the selected question to currently available materials.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M03 §3.2.1; detailed population conditions are our own design; M03 §3.2.2–3.2.3; reverse-direction labels and test adaptations are our own design; M03 §3.2.1–3.2.4; dose, duration and effect-modification details are our own design

Related sources S01 S02

N28 · How are actual summary reading and external-material access labeled?

Current findings: The full preserved summary was read for production and labeled ‘Summary read’. External NEJM, HTA, Kato, registry, plan and conflicts-of-interest materials are labeled ‘Unread’. URLs, identifiers and historical statements of full-text review alone do not upgrade reading status.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. External abstracts, full texts, registries, protocols and SAP remain unread; external link and click tests were not conducted. Review of existing content remains incomplete.
Reason for missing information: External abstracts, full texts, registries, protocols and SAP remain unread; external link and click tests were not conducted.
Required materials and conditions: Levels of the preserved summary, NEJM/HTA/Kato URLs, registries, plans and conflicts of interest.
Materials to obtain first: User-provided original materials and actual reading records.
Further research: Proposal: Recording acquisition, reading and versions by material; no new investigation, calculation or trial was conducted.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Relevant original materials and analysis scope for Levels of the preserved summary, NEJM/HTA/Kato URLs, registries, plans and conflicts of interest must be supplied and unverified matters distinguished. Preserved wording is linked during this work; review of existing content remains incomplete.
Why this condition is needed: Production item to distinguish Levels of the preserved summary, NEJM/HTA/Kato URLs, registries, plans and conflicts of interest and link the materials required for the selected question to currently available materials.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M04 §4.5–4.6 material collection/selection principles; acquisition/reading separation and hyperlink specifications are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design

Related sources S01 S02 S03

N29 · How are original Korean and English texts, dates, corrections and empty values preserved?

Current findings: The full summary's parent B70, original axes with unrecorded precision and false values, Caution, Korean and English texts, 2026-08-26, empty corrections and empty deliberation are preserved. Subclaim B/note and absent score, status and axes are distinguished and not filled from parent values.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only the relevant preserved-summary information is recorded; detailed original materials are unread and existing content review remains incomplete. At original authoring, external updating, verdict-manuscript translation, clinical-original review and added corrections were not performed. Existing content review remains incomplete.
Reason for missing information: At original authoring, external updating, verdict-manuscript translation, clinical-original review and added corrections were not performed.
Required materials and conditions: Parent B70, Korean and English texts, 2026-08-26, and empty correction, deliberation, unrecorded and false values.
Materials to obtain first: User comments and original correction materials.
Further research: Proposal: Linking original versions and dates to production content; no new investigation, calculation or trial was conducted.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Relevant original materials and analysis scope for Parent B70, Korean and English texts, 2026-08-26, and empty correction, deliberation, unrecorded and false values must be supplied and unverified matters distinguished. Preserved wording is linked during this work; review of existing content remains incomplete.
Why this condition is needed: Production item to distinguish Parent B70, Korean and English texts, 2026-08-26, and empty correction, deliberation, unrecorded and false values and link the materials required for the selected question to currently available materials.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design

Related sources S01 S02 S03

N30 · How are condition freezing, application and content review separate events?

Current findings: Condition preservation, freezing, application, case production and content review are separate records. Existing content review remains incomplete; production-row, report and material counts are not unique trial or participant totals.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only relevant preserved-summary information has been recorded; detailed original materials remain unread and existing content review is incomplete. Existing content review remains incomplete. Additional content review, testing, screen checks and link tests were not conducted during the original production. Review of existing content remains incomplete.
Reason for missing information: Existing content review remains incomplete. Additional content review, testing, screen checks and link tests were not conducted during the original production.
Required materials and conditions: Condition preservation, freezing, application, case production and incomplete content review
Materials to obtain first: Content-review comments and additional materials.
Further research: Proposal: Recording condition and production versions and user revision comments; no new investigation, calculation or trial was conducted.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Relevant original materials and analysis scope for Condition preservation, freezing, application, case production and incomplete content review must be supplied and unverified matters distinguished. Preserved wording is linked during this work; review of existing content remains incomplete.
Why this condition is needed: This production item distinguishes "Condition preservation, freezing, application, case production and incomplete content review" to link materials needed for the selected question with the currently available material.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M04 §4.5–4.6 material collection/selection principles; acquisition/reading separation and hyperlink specifications are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design

Related sources S01 S02 S03