{
  "schema_version": "chamgap-public-criteria-1.0",
  "title": "Lorcaserin × At least 5% weight loss at one year — Evidence sheet separating response, maintenance and cancer reanalysis",
  "language": "en",
  "translation_date": "2026-10-11",
  "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 methodology connections were reused for preparation. No new review of methodological content, reassessment or external-link checks were performed."
    },
    {
      "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 methodology connections were reused for preparation. No new review of methodological content, reassessment or external-link checks were performed."
    },
    {
      "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 methodology connections were reused for preparation. No new review of methodological content, reassessment or external-link checks were performed."
    },
    {
      "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 methodology connections were reused for preparation. No new review of methodological content, reassessment or external-link checks were performed."
    },
    {
      "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 methodology connections were reused for preparation. No new review of methodological content, reassessment or external-link checks were performed."
    }
  ],
  "status_dictionary": {
    "Partly verified": "Some information exists in the preserved review summary; detailed original materials remain unverified. This does not certify a passed review or clinical efficacy.",
    "Unverified": "Detailed materials for the selected condition could not be established within the stored scope; this does not mean zero effect, zero studies or safety",
    "Review incomplete": "Review of existing content incomplete",
    "Met": "Use only within the relevant conditions after existing content review; no automatic designation in this preparation",
    "Not reported": "Distinguish only within materials actually read; do not turn unread external materials into unreported findings",
    "Inaccessible": "Not applied during this preparation because actual access was not tested",
    "Not applicable": "Use with a reason for non-applicability based on an explicit question boundary",
    "Conflicting data": "Judge after actual material comparison; review was not performed during this preparation",
    "Insufficient evidence for the conditions": "Do not use as a clinical grade encompassing currently unread materials"
  },
  "requirements": [
    {
      "item_id": "N01",
      "question_type": "Comparative efficacy",
      "question": "Are the selected one-year 5% response and the parent long-term weight verdict distinguished?",
      "needed": "Separate records of the subclaim, verdict and parent context",
      "role": "Required",
      "role_reason": "Condition for recording direct comparisons, original values and interpretation boundaries for the selected question",
      "application_exception": "Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.",
      "criterion": "Separate records of the subclaim, verdict and parent context",
      "basis": "At least 5% weight loss at one year",
      "condition_origin": "Individual production condition; not completed review or automatic satisfaction of a common definition",
      "proposed_research": "If additional evidence is linked, incorporate it with the subclaim distinguished from the parent long-term and safety context."
    },
    {
      "item_id": "N02",
      "question_type": "Comparative efficacy",
      "question": "Are the actual participants and recruitment scope for the one-year response question preserved?",
      "needed": "Original eligibility, baseline risk and denominator material for participants with obesity or overweight",
      "role": "Required",
      "role_reason": "Condition for recording direct comparisons, original values and interpretation boundaries for the selected question",
      "application_exception": "Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.",
      "criterion": "Original eligibility, baseline risk and denominator material for participants with obesity or overweight",
      "basis": "At least 5% weight loss at one year",
      "condition_origin": "Individual production condition; not completed review or automatic satisfaction of a common definition",
      "proposed_research": "Obtain the original tables of trial eligibility, baseline characteristics and the one-year analysis population."
    },
    {
      "item_id": "N03",
      "question_type": "Comparative efficacy",
      "question": "What were the study intervention, placebo, accompanying care and actual exposure?",
      "needed": "Study records of the original formulation, dose, exposure, placebo and lifestyle care",
      "role": "Required",
      "role_reason": "Condition for recording direct comparisons, original values and interpretation boundaries for the selected question",
      "application_exception": "Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.",
      "criterion": "Study records of the original formulation, dose, exposure, placebo and lifestyle care",
      "basis": "At least 5% weight loss at one year",
      "condition_origin": "Individual production condition; not completed review or automatic satisfaction of a common definition",
      "proposed_research": "Preserve actual intervention, placebo, exposure and accompanying-care material from the original protocol."
    },
    {
      "item_id": "N04",
      "question_type": "Comparative efficacy",
      "question": "Are the one-year response definition of at least 5% and its measurement unit directly specified?",
      "needed": "Original material on baseline weight, measurement time, response determination and analysis unit",
      "role": "Required",
      "role_reason": "Condition for recording direct comparisons, original values and interpretation boundaries for the selected question",
      "application_exception": "Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.",
      "criterion": "Original material on baseline weight, measurement time, response determination and analysis unit",
      "basis": "At least 5% weight loss at one year",
      "condition_origin": "Individual production condition; not completed review or automatic satisfaction of a common definition",
      "proposed_research": "Link the response definition and measurement times from the original report and protocol."
    },
    {
      "item_id": "N05",
      "question_type": "Comparative efficacy",
      "question": "Are the randomization denominator and the one-year response analysis denominator the same information?",
      "needed": "Arm-specific denominators for allocation, analysis, attrition and missing data",
      "role": "Required",
      "role_reason": "Condition for recording direct comparisons, original values and interpretation boundaries for the selected question",
      "application_exception": "Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.",
      "criterion": "Arm-specific denominators for allocation, analysis, attrition and missing data",
      "basis": "At least 5% weight loss at one year",
      "condition_origin": "Individual production condition; not completed review or automatic satisfaction of a common definition",
      "proposed_research": "Obtain original one-year arm-specific analysis populations, observed participant counts, responders and missing-data handling."
    },
    {
      "item_id": "N06",
      "question_type": "Comparative efficacy",
      "question": "Are 38.7% versus 17.4% and the P value preserved as originally recorded?",
      "needed": "Original arm-specific one-year response percentages, between-group effects, CIs and tests",
      "role": "Required",
      "role_reason": "Condition for recording direct comparisons, original values and interpretation boundaries for the selected question",
      "application_exception": "Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.",
      "criterion": "Original arm-specific one-year response percentages, between-group effects, CIs and tests",
      "basis": "At least 5% weight loss at one year",
      "condition_origin": "Individual production condition; not completed review or automatic satisfaction of a common definition",
      "proposed_research": "Link the original between-group estimates, CIs, tests and analysis denominators when supplied."
    },
    {
      "item_id": "N07",
      "question_type": "Comparative efficacy",
      "question": "Are the prespecified weight-response hierarchy and the primary cardiovascular design distinguished?",
      "needed": "Weight-endpoint prespecification, testing hierarchy and multiplicity plan",
      "role": "Required",
      "role_reason": "Condition for recording direct comparisons, original values and interpretation boundaries for the selected question",
      "application_exception": "Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.",
      "criterion": "Weight-endpoint prespecification, testing hierarchy and multiplicity plan",
      "basis": "At least 5% weight loss at one year",
      "condition_origin": "Individual production condition; not completed review or automatic satisfaction of a common definition",
      "proposed_research": "Link the position and testing order of the weight endpoint in the registration, protocol and SAP."
    },
    {
      "item_id": "N08",
      "question_type": "Comparative efficacy",
      "question": "Are randomization, blinding and outcome-analysis procedures preserved?",
      "needed": "Original records of allocation concealment, blinding, analysts and measurement methods",
      "role": "Required",
      "role_reason": "Condition for recording direct comparisons, original values and interpretation boundaries for the selected question",
      "application_exception": "Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.",
      "criterion": "Original records of allocation concealment, blinding, analysts and measurement methods",
      "basis": "At least 5% weight loss at one year",
      "condition_origin": "Individual production condition; not completed review or automatic satisfaction of a common definition",
      "proposed_research": "Obtain the original methods, analysis plan, analysis populations and procedures."
    },
    {
      "item_id": "N09",
      "question_type": "Comparative efficacy",
      "question": "Can the relationship of one-year missing data, discontinuation and adherence to the effect be directly checked?",
      "needed": "Arm-specific adherence, discontinuation, missing-data reasons, adjustments and sensitivity material",
      "role": "Required",
      "role_reason": "Condition for recording direct comparisons, original values and interpretation boundaries for the selected question",
      "application_exception": "Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.",
      "criterion": "Arm-specific adherence, discontinuation, missing-data reasons, adjustments and sensitivity material",
      "basis": "At least 5% weight loss at one year",
      "condition_origin": "Individual production condition; not completed review or automatic satisfaction of a common definition",
      "proposed_research": "Obtain original CAMELLIA one-year observation, discontinuation, missing-data handling and sensitivity-analysis tables."
    },
    {
      "item_id": "N10",
      "question_type": "Comparative efficacy",
      "question": "Is the BLOOM 52-week response distinguished from repeated measurements in the same trial?",
      "needed": "Each trial’s identity, participants, comparison, time point and denominator",
      "role": "Required",
      "role_reason": "Condition for recording direct comparisons, original values and interpretation boundaries for the selected question",
      "application_exception": "Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.",
      "criterion": "Each trial’s identity, participants, comparison, time point and denominator",
      "basis": "At least 5% weight loss at one year",
      "condition_origin": "Individual production condition; not completed review or automatic satisfaction of a common definition",
      "proposed_research": "Link each trial’s 52-week or one-year definition, denominator, intervention and participants separately."
    },
    {
      "item_id": "N11",
      "question_type": "Comparative efficacy",
      "question": "Are BLOOM’s low retention and the response analysis denominator distinguished?",
      "needed": "Original arm-specific retention, analysis and missing-data material",
      "role": "Required",
      "role_reason": "Condition for recording direct comparisons, original values and interpretation boundaries for the selected question",
      "application_exception": "Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.",
      "criterion": "Original arm-specific retention, analysis and missing-data material",
      "basis": "At least 5% weight loss at one year",
      "condition_origin": "Individual production condition; not completed review or automatic satisfaction of a common definition",
      "proposed_research": "Obtain the original report’s analysis populations, missing-data handling, sensitivity analyses and responder tables."
    },
    {
      "item_id": "N12",
      "question_type": "Comparative efficacy",
      "question": "Are the weight trials independent replications with different funding sources and research teams?",
      "needed": "Original links among trials, development programs, funding and author overlap",
      "role": "Required",
      "role_reason": "Condition for recording direct comparisons, original values and interpretation boundaries for the selected question",
      "application_exception": "Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.",
      "criterion": "Original links among trials, development programs, funding and author overlap",
      "basis": "At least 5% weight loss at one year",
      "condition_origin": "Individual production condition; not completed review or automatic satisfaction of a common definition",
      "proposed_research": "Preserve original funding, team and analysis-role material separately; connect any verdict update to a user decision."
    },
    {
      "item_id": "N13",
      "question_type": "Comparative efficacy",
      "question": "Does the maintenance trial after a low-calorie diet use the same comparison as the initial one-year response question?",
      "needed": "Weight-loss entry conditions, maintenance intervention, comparison and denominator",
      "role": "Required",
      "role_reason": "Condition for recording direct comparisons, original values and interpretation boundaries for the selected question",
      "application_exception": "Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.",
      "criterion": "Weight-loss entry conditions, maintenance intervention, comparison and denominator",
      "basis": "At least 5% weight loss at one year",
      "condition_origin": "Individual production condition; not completed review or automatic satisfaction of a common definition",
      "proposed_research": "Obtain original entry weight loss, maintenance definitions, selected participants, arm-specific denominators and counseling/intervention components."
    },
    {
      "item_id": "N14",
      "question_type": "Comparative efficacy",
      "question": "Are the maintenance trial’s 24-week results and 52-week co-primary results separated?",
      "needed": "Time-specific original effects, co-primary endpoints, CIs and analysis hierarchy",
      "role": "Required",
      "role_reason": "Condition for recording direct comparisons, original values and interpretation boundaries for the selected question",
      "application_exception": "Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.",
      "criterion": "Time-specific original effects, co-primary endpoints, CIs and analysis hierarchy",
      "basis": "At least 5% weight loss at one year",
      "condition_origin": "Individual production condition; not completed review or automatic satisfaction of a common definition",
      "proposed_research": "Obtain original estimates and CIs, missing-data handling and multiplicity plans for each co-primary endpoint and time point."
    },
    {
      "item_id": "N15",
      "question_type": "Comparative efficacy",
      "question": "Has weight loss avoided being extended to prevention of clinical cardiovascular events?",
      "needed": "Separate direct results for the weight surrogate and clinical events",
      "role": "Required",
      "role_reason": "Condition for recording direct comparisons, original values and interpretation boundaries for the selected question",
      "application_exception": "Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.",
      "criterion": "Separate direct results for the weight surrogate and clinical events",
      "basis": "At least 5% weight loss at one year",
      "condition_origin": "Individual production condition; not completed review or automatic satisfaction of a common definition",
      "proposed_research": "Link direct definitions, effects, CIs and follow-up for each clinical-event outcome as separate questions."
    },
    {
      "item_id": "N16",
      "question_type": "Supplementary harm evidence",
      "question": "Are MACE safety noninferiority, weight efficacy and cancer safety distinguished?",
      "needed": "Original endpoint-specific prespecified margins, estimates, events and follow-up",
      "role": "Required",
      "role_reason": "Condition for recording direct comparisons, original values and interpretation boundaries for the selected question",
      "application_exception": "Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.",
      "criterion": "Original endpoint-specific prespecified margins, estimates, events and follow-up",
      "basis": "At least 5% weight loss at one year",
      "condition_origin": "Individual production condition; not completed review or automatic satisfaction of a common definition",
      "proposed_research": "Link the MACE noninferiority plan and direct material for other harm endpoints separately."
    },
    {
      "item_id": "N17",
      "question_type": "Comparative efficacy",
      "question": "Has null MACE+ superiority avoided being converted to a null weight response?",
      "needed": "Events, estimates and tests for distinct efficacy endpoints",
      "role": "Required",
      "role_reason": "Condition for recording direct comparisons, original values and interpretation boundaries for the selected question",
      "application_exception": "Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.",
      "criterion": "Events, estimates and tests for distinct efficacy endpoints",
      "basis": "At least 5% weight loss at one year",
      "condition_origin": "Individual production condition; not completed review or automatic satisfaction of a common definition",
      "proposed_research": "Link endpoint definitions, the prespecified superiority plan and the weight-response hierarchy using original material."
    },
    {
      "item_id": "N18",
      "question_type": "Comparative efficacy",
      "question": "Are manufacturer support, affiliated authors, design and manuscript roles separated?",
      "needed": "Separate records of cash funding, product provision, employee authors and external analysis roles",
      "role": "Required",
      "role_reason": "Condition for recording direct comparisons, original values and interpretation boundaries for the selected question",
      "application_exception": "Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.",
      "criterion": "Separate records of cash funding, product provision, employee authors and external analysis roles",
      "basis": "At least 5% weight loss at one year",
      "condition_origin": "Individual production condition; not completed review or automatic satisfaction of a common definition",
      "proposed_research": "Obtain original disclosures of funding, products, affiliations, data access, analysis and manuscript roles separately."
    },
    {
      "item_id": "N19",
      "question_type": "Comparative efficacy",
      "question": "Has the maintenance trial’s funding label avoided being converted to certification of a specific sponsor?",
      "needed": "Actual maintenance-trial funding, product, author and analysis records",
      "role": "Required",
      "role_reason": "Condition for recording direct comparisons, original values and interpretation boundaries for the selected question",
      "application_exception": "Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.",
      "criterion": "Actual maintenance-trial funding, product, author and analysis records",
      "basis": "At least 5% weight loss at one year",
      "condition_origin": "Individual production condition; not completed review or automatic satisfaction of a common definition",
      "proposed_research": "Obtain the maintenance trial’s originally disclosed interests and research roles for each source."
    },
    {
      "item_id": "N20",
      "question_type": "Comparative efficacy",
      "question": "Do the FDA cancer reanalysis and CAMELLIA efficacy report concern the same trial data?",
      "needed": "Relationships among the original trial, completed reanalysis, regulatory documents and paper reports",
      "role": "Required",
      "role_reason": "Condition for recording direct comparisons, original values and interpretation boundaries for the selected question",
      "application_exception": "Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.",
      "criterion": "Relationships among the original trial, completed reanalysis, regulatory documents and paper reports",
      "basis": "At least 5% weight loss at one year",
      "condition_origin": "Individual production condition; not completed review or automatic satisfaction of a common definition",
      "proposed_research": "Link completed reanalysis material and the result sources for each report."
    },
    {
      "item_id": "N21",
      "question_type": "Supplementary harm evidence",
      "question": "Are people diagnosed with cancer, primary cancers and patient-years preserved as different units?",
      "needed": "Original harm-event definitions, people, tumors, observation time and denominators",
      "role": "Required",
      "role_reason": "Condition for recording direct comparisons, original values and interpretation boundaries for the selected question",
      "application_exception": "Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.",
      "criterion": "Original harm-event definitions, people, tumors, observation time and denominators",
      "basis": "At least 5% weight loss at one year",
      "condition_origin": "Individual production condition; not completed review or automatic satisfaction of a common definition",
      "proposed_research": "Obtain original tables of cancer-event definitions, repeated primary cancers, exposure time and denominators."
    },
    {
      "item_id": "N22",
      "question_type": "Supplementary harm evidence",
      "question": "Are cancer-signal timing, cancer types and statistical confirmation distinguished?",
      "needed": "Cancer-type and duration-specific effects, CIs, P values, plans and regulatory decisions",
      "role": "Required",
      "role_reason": "Condition for recording direct comparisons, original values and interpretation boundaries for the selected question",
      "application_exception": "Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.",
      "criterion": "Cancer-type and duration-specific effects, CIs, P values, plans and regulatory decisions",
      "basis": "At least 5% weight loss at one year",
      "condition_origin": "Individual production condition; not completed review or automatic satisfaction of a common definition",
      "proposed_research": "Link completed event tables, prespecified plans, duration-specific estimates and the basis for regulatory decisions separately."
    },
    {
      "item_id": "N23",
      "question_type": "Supplementary harm evidence",
      "question": "Are a prespecified clinical cancer threshold and the weight-response threshold the same?",
      "needed": "Prespecified importance and analysis plans for each efficacy and harm endpoint",
      "role": "Required",
      "role_reason": "Condition for recording direct comparisons, original values and interpretation boundaries for the selected question",
      "application_exception": "Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.",
      "criterion": "Prespecified importance and analysis plans for each efficacy and harm endpoint",
      "basis": "At least 5% weight loss at one year",
      "condition_origin": "Individual production condition; not completed review or automatic satisfaction of a common definition",
      "proposed_research": "Preserve the plans and importance judgments for cancer and weight separately."
    },
    {
      "item_id": "N24",
      "question_type": "Supplementary harm evidence",
      "question": "Are the market-withdrawal record and efficacy grade preserved together?",
      "needed": "Separate records of regulatory-event dates, scope, decisions and clinical efficacy",
      "role": "Required",
      "role_reason": "Condition for recording direct comparisons, original values and interpretation boundaries for the selected question",
      "application_exception": "Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.",
      "criterion": "Separate records of regulatory-event dates, scope, decisions and clinical efficacy",
      "basis": "At least 5% weight loss at one year",
      "condition_origin": "Individual production condition; not completed review or automatic satisfaction of a common definition",
      "proposed_research": "If new regulatory material is supplied, link its original text, date and change event separately."
    },
    {
      "item_id": "N25",
      "question_type": "Supplementary harm evidence",
      "question": "Have withdrawal reasons for other serotonergic drugs avoided being repurposed?",
      "needed": "Direct distinctions among drug-specific efficacy, harms and regulatory events",
      "role": "Required",
      "role_reason": "Condition for recording direct comparisons, original values and interpretation boundaries for the selected question",
      "application_exception": "Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.",
      "criterion": "Direct distinctions among drug-specific efficacy, harms and regulatory events",
      "basis": "At least 5% weight loss at one year",
      "condition_origin": "Individual production condition; not completed review or automatic satisfaction of a common definition",
      "proposed_research": "If direct drug-specific material is supplied, link it with questions, participants and endpoints separated."
    },
    {
      "item_id": "N26",
      "question_type": "Supplementary harm evidence",
      "question": "Do gaps remain for other harms, discontinuation and long-term exposure?",
      "needed": "Arm-specific material on all harms, serious events, discontinuation reasons and exposure denominators",
      "role": "Required",
      "role_reason": "Condition for recording direct comparisons, original values and interpretation boundaries for the selected question",
      "application_exception": "Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.",
      "criterion": "Arm-specific material on all harms, serious events, discontinuation reasons and exposure denominators",
      "basis": "At least 5% weight loss at one year",
      "condition_origin": "Individual production condition; not completed review or automatic satisfaction of a common definition",
      "proposed_research": "Original safety collection, arm-specific events, discontinuation, exposure and long-term material are needed."
    },
    {
      "item_id": "N27",
      "question_type": "Supplementary harm evidence",
      "question": "Are the scope of safety reanalysis and independent harm replication distinguished?",
      "needed": "Relationships between reanalysis of the same trial and independent external harm material",
      "role": "Required",
      "role_reason": "Condition for recording direct comparisons, original values and interpretation boundaries for the selected question",
      "application_exception": "Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.",
      "criterion": "Relationships between reanalysis of the same trial and independent external harm material",
      "basis": "At least 5% weight loss at one year",
      "condition_origin": "Individual production condition; not completed review or automatic satisfaction of a common definition",
      "proposed_research": "If external harm material is supplied, link trial, exposure, population and denominator relationships separately."
    },
    {
      "item_id": "N28",
      "question_type": "Comparative efficacy",
      "question": "Are citation URLs, no-abstract labels and unread full text distinguished?",
      "needed": "Separate actual-access records for papers, regulatory documents and stored summaries",
      "role": "Required",
      "role_reason": "Condition for recording direct comparisons, original values and interpretation boundaries for the selected question",
      "application_exception": "Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.",
      "criterion": "Separate actual-access records for papers, regulatory documents and stored summaries",
      "basis": "At least 5% weight loss at one year",
      "condition_origin": "Individual production condition; not completed review or automatic satisfaction of a common definition",
      "proposed_research": "Link originals obtained by the user for each source and record actual access status."
    },
    {
      "item_id": "N29",
      "question_type": "Comparative efficacy",
      "question": "Are registration identifiers and reading of registrations, protocols and SAPs separated?",
      "needed": "Directly preserved registration, protocol and SAP material for each trial",
      "role": "Required",
      "role_reason": "Condition for recording direct comparisons, original values and interpretation boundaries for the selected question",
      "application_exception": "Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.",
      "criterion": "Directly preserved registration, protocol and SAP material for each trial",
      "basis": "At least 5% weight loss at one year",
      "condition_origin": "Individual production condition; not completed review or automatic satisfaction of a common definition",
      "proposed_research": "If original registrations, protocols and SAPs are supplied, link them to each trial."
    },
    {
      "item_id": "N30",
      "question_type": "Comparative efficacy",
      "question": "Are the reference date, corrections, Korean and English manuscripts and parent axes preserved in their original form?",
      "needed": "Original verdict, language-specific wording, reference date and correction history",
      "role": "Required",
      "role_reason": "Condition for recording direct comparisons, original values and interpretation boundaries for the selected question",
      "application_exception": "Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.",
      "criterion": "Original verdict, language-specific wording, reference date and correction history",
      "basis": "At least 5% weight loss at one year",
      "condition_origin": "Individual production condition; not completed review or automatic satisfaction of a common definition",
      "proposed_research": "If new material arises, link preservation of the original text and a separate update event to review of the existing content."
    },
    {
      "item_id": "N31",
      "question_type": "Comparative efficacy",
      "question": "Has the selected response avoided being extended to all long-term weight loss, maintenance or clinical function?",
      "needed": "Direct distinctions between selected participants, duration and response and long-term maintenance or clinical outcomes",
      "role": "Required",
      "role_reason": "Condition for recording direct comparisons, original values and interpretation boundaries for the selected question",
      "application_exception": "Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.",
      "criterion": "Direct distinctions between selected participants, duration and response and long-term maintenance or clinical outcomes",
      "basis": "At least 5% weight loss at one year",
      "condition_origin": "Individual production condition; not completed review or automatic satisfaction of a common definition",
      "proposed_research": "Link participants, comparators, time points, effects and harms suited to each long-term question separately."
    },
    {
      "item_id": "N32",
      "question_type": "Comparative efficacy",
      "question": "Are production completion, review of the existing content and independence certification separated?",
      "needed": "Separate records of original candidate history, production status and review status",
      "role": "Supplementary",
      "role_reason": "Supplementary condition separating production status and scope of application",
      "application_exception": "Unread external material or results outside the question’s scope are not substituted with satisfied, null-effect or safe labels.",
      "criterion": "Separate records of original candidate history, production status and review status",
      "basis": "At least 5% weight loss at one year",
      "condition_origin": "Individual production condition; not completed review or automatic satisfaction of a common definition",
      "proposed_research": "Incorporate only the user’s subsequent material or decisions as separate events."
    }
  ]
}