{
  "schema_version": "chamgap-public-criteria-1.0",
  "title": "Antidepressant maintenance × reduced depression relapse within 52 weeks after remission: evidence checklist",
  "language": "en",
  "translation_date": "2026-10-10",
  "criteria_version": "1.0",
  "criteria_date": "2026-10-06",
  "condition_origin": "Chamgap's own application conditions",
  "method_sources": [
    {
      "id": "M03",
      "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03",
      "section": "§3.1, §3.2.1–3.2.3, MECIR C5/C7/C13",
      "official_principle": "Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.",
      "review_level": "Preserved method HTML copies; no current method-content re-review or official tool execution"
    },
    {
      "id": "M04",
      "version": "Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04",
      "section": "§4.5, §4.6.1–4.6.3, MECIR C42",
      "official_principle": "Distinguish studies from reports and link them; do not omit a study solely because results are unreported.",
      "review_level": "Preserved method HTML copies; no current method-content re-review or official tool execution"
    },
    {
      "id": "M08",
      "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08",
      "section": "§8.1–8.2.3, Table 8.2.a",
      "official_principle": "Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.",
      "review_level": "Preserved method HTML copies; no current method-content re-review or official tool execution"
    },
    {
      "id": "M15",
      "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15",
      "section": "§15.2.4, §15.3.1–15.3.3",
      "official_principle": "Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.",
      "review_level": "Preserved method HTML copies; no current method-content re-review or official tool execution"
    },
    {
      "id": "M19",
      "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19",
      "section": "§19.1.2, §19.2.1–19.2.4",
      "official_principle": "Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.",
      "review_level": "Preserved method HTML copies; no current method-content re-review or official tool execution"
    }
  ],
  "status_dictionary": {
    "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."
  },
  "requirements": [
    {
      "item_id": "N01",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "How do the selected 52-week relapse-reduction record and parent values differ?",
      "needed": "Separate preservation of subclaim B/note and absent values, and parent B70, axes and verdict.",
      "role": "Required",
      "role_reason": "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_exception": "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.",
      "criterion": "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.",
      "basis": "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",
      "condition_origin": "Production conditions for turning preserved manuscripts into tables; existing content review pending. This is not a record of running official tools or completing content review",
      "proposed_research": "Proposal: Separate source records for the selected question and parent verdict; no new investigation, calculation or trial was conducted."
    },
    {
      "item_id": "N02",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "Who were the long-term antidepressant users in ANTLER?",
      "needed": "Remission, consideration of discontinuation, prior episodes, treatment duration and primary-care recruitment conditions.",
      "role": "Required",
      "role_reason": "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_exception": "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.",
      "criterion": "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.",
      "basis": "M03 §3.2.1; detailed population conditions are Chamgap's own design",
      "condition_origin": "Production conditions for turning preserved manuscripts into tables; existing content review pending. This is not a record of running official tools or completing content review",
      "proposed_research": "Proposal: Linking actual eligibility conditions to relapse materials; no new investigation, calculation or trial was conducted."
    },
    {
      "item_id": "N03",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "What study exposure was compared between maintenance and tapering to placebo?",
      "needed": "Historical scope of the four drugs, maintenance, tapering to placebo and matching appearance.",
      "role": "Required",
      "role_reason": "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_exception": "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.",
      "criterion": "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.",
      "basis": "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",
      "condition_origin": "Production conditions for turning preserved manuscripts into tables; existing content review pending. This is not a record of running official tools or completing content review",
      "proposed_research": "Proposal: Distinguishing study allocation conditions from actual exposure; no new investigation, calculation or trial was conducted."
    },
    {
      "item_id": "N04",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "What were the actual randomization and masking procedures?",
      "needed": "Allocation of 478 participants, 238 maintenance and 240 placebo, allocation concealment and masking.",
      "role": "Required",
      "role_reason": "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_exception": "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.",
      "criterion": "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.",
      "basis": "M08 §8.1–8.2.3; internal application; M08 Table 8.2.a, M03 §3.2.4; internal application",
      "condition_origin": "Production conditions for turning preserved manuscripts into tables; existing content review pending. This is not a record of running official tools or completing content review",
      "proposed_research": "Proposal: Documenting design, measurement and allocation awareness; no new investigation, calculation or trial was conducted."
    },
    {
      "item_id": "N05",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "Was the primary endpoint time to first relapse or an event proportion?",
      "needed": "Time to first relapse within 52 weeks, original events and participants, and separation from repeated events.",
      "role": "Required",
      "role_reason": "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_exception": "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.",
      "criterion": "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.",
      "basis": "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",
      "condition_origin": "Production conditions for turning preserved manuscripts into tables; existing content review pending. This is not a record of running official tools or completing content review",
      "proposed_research": "Proposal: Separating first events from symptoms and repeated events; no new investigation, calculation or trial was conducted."
    },
    {
      "item_id": "N06",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "Which arms do the absolute relapse counts, proportions and difference represent?",
      "needed": "Arms and denominators for original 92/238 (39%), 135/240 (56%) and 17%p.",
      "role": "Required",
      "role_reason": "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_exception": "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.",
      "criterion": "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.",
      "basis": "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",
      "condition_origin": "Production conditions for turning preserved manuscripts into tables; existing content review pending. This is not a record of running official tools or completing content review",
      "proposed_research": "Proposal: Linking events, denominators and absolute-effect intervals; no new investigation, calculation or trial was conducted."
    },
    {
      "item_id": "N07",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "Which comparison direction does HR 2.06 represent?",
      "needed": "Discontinuation-versus-maintenance HR, CI and P, distinguished from absolute proportions.",
      "role": "Required",
      "role_reason": "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_exception": "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.",
      "criterion": "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.",
      "basis": "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",
      "condition_origin": "Production conditions for turning preserved manuscripts into tables; existing content review pending. This is not a record of running official tools or completing content review",
      "proposed_research": "Proposal: Distinguishing comparison direction and model; no new investigation, calculation or trial was conducted."
    },
    {
      "item_id": "N08",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "How do the 478 randomized participants differ from the 468 in the time-to-event analysis?",
      "needed": "Roles of each denominator and preservation of 10 participants without timing, 6 and 4 by arm.",
      "role": "Required",
      "role_reason": "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_exception": "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.",
      "criterion": "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.",
      "basis": "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",
      "condition_origin": "Production conditions for turning preserved manuscripts into tables; existing content review pending. This is not a record of running official tools or completing content review",
      "proposed_research": "Proposal: Linking absolute-event and time-to-event denominators; no new investigation, calculation or trial was conducted."
    },
    {
      "item_id": "N09",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "What scope is supported by missing-data sensitivity analyses?",
      "needed": "Original direction under best- and worst-case assumptions and specific estimates.",
      "role": "Required",
      "role_reason": "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_exception": "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.",
      "criterion": "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.",
      "basis": "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",
      "condition_origin": "Production conditions for turning preserved manuscripts into tables; existing content review pending. This is not a record of running official tools or completing content review",
      "proposed_research": "Proposal: Documenting results and precision under each missingness assumption; no new investigation, calculation or trial was conducted."
    },
    {
      "item_id": "N10",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "How do adherence of 70%/52% and restarting of 39% relate to the allocation effect?",
      "needed": "Definitions and timing of allocation, actual exposure, adherence and restarting.",
      "role": "Required",
      "role_reason": "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_exception": "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.",
      "criterion": "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.",
      "basis": "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",
      "condition_origin": "Production conditions for turning preserved manuscripts into tables; existing content review pending. This is not a record of running official tools or completing content review",
      "proposed_research": "Proposal: Linking allocation to actual exposure and rescue treatment; no new investigation, calculation or trial was conducted."
    },
    {
      "item_id": "N11",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "How were withdrawal symptoms distinguished from depression relapse?",
      "needed": "Instruments, symptom overlap, timing, classification and misclassification scope.",
      "role": "Required",
      "role_reason": "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_exception": "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.",
      "criterion": "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.",
      "basis": "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",
      "condition_origin": "Production conditions for turning preserved manuscripts into tables; existing content review pending. This is not a record of running official tools or completing content review",
      "proposed_research": "Proposal: Separating measurement and timing of withdrawal and relapse; no new investigation, calculation or trial was conducted."
    },
    {
      "item_id": "N12",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "Can DESS means and the between-arm difference be turned into the same arithmetic value?",
      "needed": "Estimation specification for original means 3.1/1.3, difference 1.9 and CI.",
      "role": "Required",
      "role_reason": "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_exception": "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.",
      "criterion": "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.",
      "basis": "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",
      "condition_origin": "Production conditions for turning preserved manuscripts into tables; existing content review pending. This is not a record of running official tools or completing content review",
      "proposed_research": "Proposal: Linking estimation specifications for each reported value; no new investigation, calculation or trial was conducted."
    },
    {
      "item_id": "N13",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "How does the difference in allocation awareness relate to relapse assessment?",
      "needed": "Maintained masking, timing of awareness and unverified measurement-bias magnitude.",
      "role": "Required",
      "role_reason": "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_exception": "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.",
      "criterion": "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.",
      "basis": "M08 Table 8.2.a, M03 §3.2.4; internal application",
      "condition_origin": "Production conditions for turning preserved manuscripts into tables; existing content review pending. This is not a record of running official tools or completing content review",
      "proposed_research": "Proposal: Documenting allocation awareness and outcome measurement; no new investigation, calculation or trial was conducted."
    },
    {
      "item_id": "N14",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "Does relapse defined by a symptom instrument also answer other clinical-outcome questions?",
      "needed": "Relapse definition separated from suicide, function, hospitalization and other outcomes.",
      "role": "Required",
      "role_reason": "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_exception": "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.",
      "criterion": "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.",
      "basis": "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",
      "condition_origin": "Production conditions for turning preserved manuscripts into tables; existing content review pending. This is not a record of running official tools or completing content review",
      "proposed_research": "Proposal: Linking selected relapse to separate clinical outcomes; no new investigation, calculation or trial was conducted."
    },
    {
      "item_id": "N15",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "Does the 52-week benefit describe later persistence or lifetime risk?",
      "needed": "Actual observation period, outcomes outside observation and subgroups by drug.",
      "role": "Required",
      "role_reason": "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_exception": "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.",
      "criterion": "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.",
      "basis": "M03 §3.2.1–3.2.4; dose, duration and effect-modification details are our own design",
      "condition_origin": "Production conditions for turning preserved manuscripts into tables; existing content review pending. This is not a record of running official tools or completing content review",
      "proposed_research": "Proposal: Separate follow-up materials by period and condition; no new investigation, calculation or trial was conducted."
    },
    {
      "item_id": "N16",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "How does average relapse reduction differ from prevention for everyone or inevitable relapse?",
      "needed": "Original 39% relapse during maintenance and 44% without relapse after discontinuation, with gaps in individual prediction.",
      "role": "Required",
      "role_reason": "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_exception": "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.",
      "criterion": "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.",
      "basis": "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",
      "condition_origin": "Production conditions for turning preserved manuscripts into tables; existing content review pending. This is not a record of running official tools or completing content review",
      "proposed_research": "Proposal: Distinguishing individual prediction from arm comparisons; no new investigation, calculation or trial was conducted."
    },
    {
      "item_id": "N17",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "Which reports of the same trial are NEJM and NIHR HTA?",
      "needed": "Shared relationships among reports, trial, population and the two bibliographic records and URLs.",
      "role": "Required",
      "role_reason": "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_exception": "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.",
      "criterion": "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.",
      "basis": "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",
      "condition_origin": "Production conditions for turning preserved manuscripts into tables; existing content review pending. This is not a record of running official tools or completing content review",
      "proposed_research": "Proposal: Linking main and detailed reports of the same trial; no new investigation, calculation or trial was conducted."
    },
    {
      "item_id": "N18",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "Is the Kato meta-analysis an independent replication of the same question?",
      "needed": "Relationships among 40 studies, 8890 participants, other maintenance trials and ANTLER conditions.",
      "role": "Required",
      "role_reason": "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_exception": "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.",
      "criterion": "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.",
      "basis": "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",
      "condition_origin": "Production conditions for turning preserved manuscripts into tables; existing content review pending. This is not a record of running official tools or completing content review",
      "proposed_research": "Proposal: Linking different maintenance questions to synthesis materials; no new investigation, calculation or trial was conducted."
    },
    {
      "item_id": "N19",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "How do the review's proportions and OR differ from ANTLER HR and difference?",
      "needed": "Endpoints, denominators and directions for proportions, OR, HR and absolute difference.",
      "role": "Required",
      "role_reason": "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_exception": "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.",
      "criterion": "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.",
      "basis": "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",
      "condition_origin": "Production conditions for turning preserved manuscripts into tables; existing content review pending. This is not a record of running official tools or completing content review",
      "proposed_research": "Proposal: Separating measures, periods and estimands; no new investigation, calculation or trial was conducted."
    },
    {
      "item_id": "N20",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "Are the same participants, two sheets and review kept from being added together?",
      "needed": "Preservation of shared and overlapping relationships among the two subclaim sheets, NEJM/HTA and the review.",
      "role": "Required",
      "role_reason": "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_exception": "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.",
      "criterion": "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.",
      "basis": "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",
      "condition_origin": "Production conditions for turning preserved manuscripts into tables; existing content review pending. This is not a record of running official tools or completing content review",
      "proposed_research": "Proposal: Recording report families and overlap; no new investigation, calculation or trial was conducted."
    },
    {
      "item_id": "N21",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "What public support and sponsor did ANTLER have, and what remains unverified?",
      "needed": "NIHR, PRIMENT and UCL, separated from products, employees, conflicts of interest and roles.",
      "role": "Required",
      "role_reason": "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_exception": "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.",
      "criterion": "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.",
      "basis": "Chamgap's own conditions for independence and attribution. The official methodological sections used in this example do not validate every detail of these items.",
      "condition_origin": "Production conditions for turning preserved manuscripts into tables; existing content review pending. This is not a record of running official tools or completing content review",
      "proposed_research": "Proposal: Separating funding from actual research roles; no new investigation, calculation or trial was conducted."
    },
    {
      "item_id": "N22",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "Does unreported free trial-drug or placebo provision mean no provision occurred?",
      "needed": "Historical statements of unreported provision, separated from unverified actual product support.",
      "role": "Required",
      "role_reason": "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_exception": "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.",
      "criterion": "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.",
      "basis": "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",
      "condition_origin": "Production conditions for turning preserved manuscripts into tables; existing content review pending. This is not a record of running official tools or completing content review",
      "proposed_research": "Proposal: Separately documenting support types and actual roles; no new investigation, calculation or trial was conducted."
    },
    {
      "item_id": "N23",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "What scope of independence information does public funding of the review provide?",
      "needed": "Japanese research grants for the review, separated from funding and conflicts of interest in included trials.",
      "role": "Required",
      "role_reason": "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_exception": "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.",
      "criterion": "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.",
      "basis": "Chamgap's own conditions for independence and attribution. The official methodological sections used in this example do not validate every detail of these items.",
      "condition_origin": "Production conditions for turning preserved manuscripts into tables; existing content review pending. This is not a record of running official tools or completing content review",
      "proposed_research": "Proposal: Linking independence materials for synthesis and individual trials; no new investigation, calculation or trial was conducted."
    },
    {
      "item_id": "N24",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "At what level are registry identifiers and actual prespecified endpoints and plans recorded?",
      "needed": "Original ISRCTN and EudraCT identifiers, plans and amendment histories.",
      "role": "Required",
      "role_reason": "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_exception": "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.",
      "criterion": "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.",
      "basis": "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",
      "condition_origin": "Production conditions for turning preserved manuscripts into tables; existing content review pending. This is not a record of running official tools or completing content review",
      "proposed_research": "Proposal: Linking registry and plan versions by report; no new investigation, calculation or trial was conducted."
    },
    {
      "item_id": "N25",
      "question_type": "Harm-information gaps supplementing the efficacy table",
      "question": "What outcomes do serious adverse events, deaths and suicide attempts represent?",
      "needed": "Definitions and scope of safety events, 9/8 participants, 4%/3% and 0 events in both arms.",
      "role": "Supplementary",
      "role_reason": "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_exception": "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.",
      "criterion": "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.",
      "basis": "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",
      "condition_origin": "Production conditions for turning preserved manuscripts into tables; existing content review pending. This is not a record of running official tools or completing content review",
      "proposed_research": "Proposal: Linking event-specific safety materials and precision; no new investigation, calculation or trial was conducted."
    },
    {
      "item_id": "N26",
      "question_type": "Harm-information gaps supplementing the efficacy table",
      "question": "Are safety, relapse and withdrawal different measurements?",
      "needed": "Collection, timepoints and occurrence units for serious events, withdrawal and relapse.",
      "role": "Supplementary",
      "role_reason": "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_exception": "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.",
      "criterion": "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.",
      "basis": "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",
      "condition_origin": "Production conditions for turning preserved manuscripts into tables; existing content review pending. This is not a record of running official tools or completing content review",
      "proposed_research": "Proposal: Separating event and symptom measurements by endpoint; no new investigation, calculation or trial was conducted."
    },
    {
      "item_id": "N27",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "To whom can the result generalize, and what lies outside its scope?",
      "needed": "Boundaries between long-term primary-care users in remission considering discontinuation and other situations.",
      "role": "Required",
      "role_reason": "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_exception": "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.",
      "criterion": "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.",
      "basis": "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",
      "condition_origin": "Production conditions for turning preserved manuscripts into tables; existing content review pending. This is not a record of running official tools or completing content review",
      "proposed_research": "Proposal: Recording evidence gaps by population, exposure and period; no new investigation, calculation or trial was conducted."
    },
    {
      "item_id": "N28",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "How are actual summary reading and external-material access labeled?",
      "needed": "Levels of the preserved summary, NEJM/HTA/Kato URLs, registries, plans and conflicts of interest.",
      "role": "Required",
      "role_reason": "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_exception": "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.",
      "criterion": "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.",
      "basis": "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",
      "condition_origin": "Production conditions for turning preserved manuscripts into tables; existing content review pending. This is not a record of running official tools or completing content review",
      "proposed_research": "Proposal: Recording acquisition, reading and versions by material; no new investigation, calculation or trial was conducted."
    },
    {
      "item_id": "N29",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "How are original Korean and English texts, dates, corrections and empty values preserved?",
      "needed": "Parent B70, Korean and English texts, 2026-08-26, and empty correction, deliberation, unrecorded and false values.",
      "role": "Required",
      "role_reason": "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_exception": "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.",
      "criterion": "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.",
      "basis": "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",
      "condition_origin": "Production conditions for turning preserved manuscripts into tables; existing content review pending. This is not a record of running official tools or completing content review",
      "proposed_research": "Proposal: Linking original versions and dates to production content; no new investigation, calculation or trial was conducted."
    },
    {
      "item_id": "N30",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "How are condition freezing, application and content review separate events?",
      "needed": "Condition preservation, freezing, application, case production and incomplete content review",
      "role": "Required",
      "role_reason": "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_exception": "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.",
      "criterion": "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.",
      "basis": "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",
      "condition_origin": "Production conditions for turning preserved manuscripts into tables; existing content review pending. This is not a record of running official tools or completing content review",
      "proposed_research": "Proposal: Recording condition and production versions and user revision comments; no new investigation, calculation or trial was conducted."
    }
  ]
}