{
  "schema_version": "chamgap-public-criteria-1.0",
  "title": "Metformin × birthweight above 4000 g: evidence checklist for pregnancy with overweight or obesity and no diabetes",
  "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": "Is the original birthweight-above-4000-g claim and subclaim verdict separate from the parent z-score context?",
      "needed": "Distinction between selected wording, grade and note, and parent values",
      "role": "Required",
      "role_reason": "An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries",
      "application_exception": "Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.",
      "criterion": "Distinction between selected wording, grade and note, and parent values",
      "basis": "Fewer births above 4000 g",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "If additional material arrives, link the selected endpoint and parent context separately."
    },
    {
      "item_id": "N02",
      "question_type": "Comparative efficacy",
      "question": "Is the actual GRoW population distinguished from other pregnancy and diabetes contexts?",
      "needed": "Eligibility criteria for diabetes status, obesity, overweight, pregnancy timing and baseline status",
      "role": "Required",
      "role_reason": "An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries",
      "application_exception": "Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.",
      "criterion": "Eligibility criteria for diabetes status, obesity, overweight, pregnancy timing and baseline status",
      "basis": "Fewer births above 4000 g",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "Obtain original GRoW eligibility, baseline characteristics, recruitment conditions and denominators."
    },
    {
      "item_id": "N03",
      "question_type": "Comparative efficacy",
      "question": "Are GRoW intervention, placebo and research exposure directly preserved?",
      "needed": "Trial-specific original records of ingredient, formulation, dose, exposure and adherence",
      "role": "Required",
      "role_reason": "An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries",
      "application_exception": "Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.",
      "criterion": "Trial-specific original records of ingredient, formulation, dose, exposure and adherence",
      "basis": "Fewer births above 4000 g",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "Link supplied original GRoW protocol and actual exposure material."
    },
    {
      "item_id": "N04",
      "question_type": "Comparative efficacy",
      "question": "Is the comparison of medication added to dietary and lifestyle advice preserved?",
      "needed": "Original material on common advice, placebo, added intervention and other care",
      "role": "Required",
      "role_reason": "An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries",
      "application_exception": "Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.",
      "criterion": "Original material on common advice, placebo, added intervention and other care",
      "basis": "Fewer births above 4000 g",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "Obtain original trial arm-specific common and differing care and actual exposure."
    },
    {
      "item_id": "N05",
      "question_type": "Comparative efficacy",
      "question": "Are the above-4000-g threshold, birth measurement and assessment unit distinguished?",
      "needed": "Strictly-above definition, measurement timing, measurement method and analysis unit",
      "role": "Required",
      "role_reason": "An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries",
      "application_exception": "Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.",
      "criterion": "Strictly-above definition, measurement timing, measurement method and analysis unit",
      "basis": "Fewer births above 4000 g",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "Obtain the original endpoint definition, birthweight measurement, boundary-value handling and analysis unit."
    },
    {
      "item_id": "N06",
      "question_type": "Comparative efficacy",
      "question": "What are trial-specific primary/secondary hierarchies and plans for the birth endpoint?",
      "needed": "Registration, protocol, SAP and multiplicity hierarchy for the selected endpoint",
      "role": "Required",
      "role_reason": "An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries",
      "application_exception": "Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.",
      "criterion": "Registration, protocol, SAP and multiplicity hierarchy for the selected endpoint",
      "basis": "Fewer births above 4000 g",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "Link endpoint hierarchies and change histories separately from each trial’s registration, protocol and SAP."
    },
    {
      "item_id": "N07",
      "question_type": "Comparative efficacy",
      "question": "Are GRoW randomized and analyzed counts distinguished?",
      "needed": "Original arm-specific assignment, analysis, follow-up and missingness flow and denominators",
      "role": "Required",
      "role_reason": "An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries",
      "application_exception": "Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.",
      "criterion": "Original arm-specific assignment, analysis, follow-up and missingness flow and denominators",
      "basis": "Fewer births above 4000 g",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "Obtain original tables of arm-specific participant flow, exclusion, follow-up and outcome-specific analysis denominators."
    },
    {
      "item_id": "N08",
      "question_type": "Comparative efficacy",
      "question": "Are denominators for pregnant women, infants, birth events and repeated measurements the same?",
      "needed": "Analysis units for people, pregnancies, infants and birth events, with handling of overlap",
      "role": "Required",
      "role_reason": "An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries",
      "application_exception": "Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.",
      "criterion": "Analysis units for people, pregnancies, infants and birth events, with handling of overlap",
      "basis": "Fewer births above 4000 g",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "Obtain original analysis units, pregnancy/birth mapping, exclusions and denominators."
    },
    {
      "item_id": "N09",
      "question_type": "Comparative efficacy",
      "question": "Are the original 40 (16%) versus 37 (14%) values and arm order maintained?",
      "needed": "Original arm-specific events, proportions, denominators and outcome tables",
      "role": "Required",
      "role_reason": "An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries",
      "application_exception": "Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.",
      "criterion": "Original arm-specific events, proportions, denominators and outcome tables",
      "basis": "Fewer births above 4000 g",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "Link original table arm labels, events, denominators and proportions exactly as recorded."
    },
    {
      "item_id": "N10",
      "question_type": "Comparative efficacy",
      "question": "Are adjusted RR, CI and P preserved separately from original proportions?",
      "needed": "Original material on adjusted effect, model, variables, interval and test",
      "role": "Required",
      "role_reason": "An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries",
      "application_exception": "Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.",
      "criterion": "Original material on adjusted effect, model, variables, interval and test",
      "basis": "Fewer births above 4000 g",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "Obtain adjustment plans, variables, arm-specific denominators and original between-arm effect tables."
    },
    {
      "item_id": "N11",
      "question_type": "Comparative efficacy",
      "question": "Has a null result been kept separate from confirmed exclusion of meaningful reduction?",
      "needed": "A validated prespecified clinical threshold and effect interval",
      "role": "Required",
      "role_reason": "An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries",
      "application_exception": "Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.",
      "criterion": "A validated prespecified clinical threshold and effect interval",
      "basis": "Fewer births above 4000 g",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "Obtain importance criteria, a prespecified validated threshold and plans suited to the population and endpoint."
    },
    {
      "item_id": "N12",
      "question_type": "Comparative efficacy",
      "question": "Were GRoW allocation and masking details kept separate from EMPOWaR?",
      "needed": "Trial-specific allocation concealment, masking and outcome-measurement procedures",
      "role": "Required",
      "role_reason": "An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries",
      "application_exception": "Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.",
      "criterion": "Trial-specific allocation concealment, masking and outcome-measurement procedures",
      "basis": "Fewer births above 4000 g",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "Obtain allocation, concealment, measurement and analysis procedures from the original GRoW methods."
    },
    {
      "item_id": "N13",
      "question_type": "Comparative efficacy",
      "question": "Are GRoW analysis population, missingness and follow-up methods directly supplied?",
      "needed": "Original material on ITT status, analysis exclusions, missingness reasons and sensitivity analyses",
      "role": "Required",
      "role_reason": "An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries",
      "application_exception": "Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.",
      "criterion": "Original material on ITT status, analysis exclusions, missingness reasons and sensitivity analyses",
      "basis": "Fewer births above 4000 g",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "Obtain GRoW analysis-population definitions, arm exclusions, missing-data handling and sensitivity material."
    },
    {
      "item_id": "N14",
      "question_type": "Comparative efficacy",
      "question": "Are actual exposure, gastrointestinal symptoms and adherence linked to the birth analysis?",
      "needed": "Trial-specific records of actual exposure, adherence, discontinuation and outcomes",
      "role": "Required",
      "role_reason": "An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries",
      "application_exception": "Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.",
      "criterion": "Trial-specific records of actual exposure, adherence, discontinuation and outcomes",
      "basis": "Fewer births above 4000 g",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "Obtain actual GRoW exposure, discontinuation and adherence material and the prespecified effect of interest."
    },
    {
      "item_id": "N15",
      "question_type": "Comparative efficacy",
      "question": "Are birthweight above 4000 g, mean grams and z score the same endpoint?",
      "needed": "Separate original definitions, denominators, timepoints and effects for each measure",
      "role": "Required",
      "role_reason": "An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries",
      "application_exception": "Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.",
      "criterion": "Separate original definitions, denominators, timepoints and effects for each measure",
      "basis": "Fewer births above 4000 g",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "If trial- and measure-specific results are supplied, link original endpoints and denominators separately."
    },
    {
      "item_id": "N16",
      "question_type": "Comparative efficacy",
      "question": "Are the EMPOWaR primary z-score result and analysis denominators maintained as context?",
      "needed": "Endpoint, denominator and plan boundaries of another trial",
      "role": "Required",
      "role_reason": "An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries",
      "application_exception": "Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.",
      "criterion": "Endpoint, denominator and plan boundaries of another trial",
      "basis": "Fewer births above 4000 g",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "If EMPOWaR material for the selected event endpoint is supplied, link it with direct definitions and denominators."
    },
    {
      "item_id": "N17",
      "question_type": "Comparative efficacy",
      "question": "Is the MOP z-score report and registration link kept separate from direct evidence for the selected event?",
      "needed": "Distinction between trial-specific bibliographies, material types, endpoints and effects",
      "role": "Required",
      "role_reason": "An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries",
      "application_exception": "Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.",
      "criterion": "Distinction between trial-specific bibliographies, material types, endpoints and effects",
      "basis": "Fewer births above 4000 g",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "Obtain registration and the paper separately to link the selected event endpoint, plans and denominators."
    },
    {
      "item_id": "N18",
      "question_type": "Comparative efficacy",
      "question": "Are original repeated-null and independence wording distinguished from certification in this work?",
      "needed": "Links between ingredient, pregnancy without diabetes, trial identity and study families",
      "role": "Required",
      "role_reason": "An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries",
      "application_exception": "Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.",
      "criterion": "Links between ingredient, pregnancy without diabetes, trial identity and study families",
      "basis": "Fewer births above 4000 g",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "Link only direct trial-to-endpoint relationships and pass additional material to content review."
    },
    {
      "item_id": "N19",
      "question_type": "Comparative efficacy",
      "question": "Do the two related sheets share the same reports, trials and cohorts?",
      "needed": "Explicit links between stored summary, bibliographies, trials and participants",
      "role": "Required",
      "role_reason": "An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries",
      "application_exception": "Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.",
      "criterion": "Explicit links between stored summary, bibliographies, trials and participants",
      "basis": "Fewer births above 4000 g",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "Link additional reports to existing identifiers and preserve same-population relationships."
    },
    {
      "item_id": "N20",
      "question_type": "Comparative efficacy",
      "question": "Has the birth event been kept separate from later obesity and other clinical pregnancy outcomes?",
      "needed": "Direct distinction between birth measures, long-term clinical outcomes and other pregnancy outcomes",
      "role": "Required",
      "role_reason": "An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries",
      "application_exception": "Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.",
      "criterion": "Direct distinction between birth measures, long-term clinical outcomes and other pregnancy outcomes",
      "basis": "Fewer births above 4000 g",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "Each clinical outcome requires separate direct measurement, follow-up, denominators and effects."
    },
    {
      "item_id": "N21",
      "question_type": "Comparative efficacy",
      "question": "Has the verdict’s scope been kept separate from other diabetes treatment and pregnancy management?",
      "needed": "Direct evidence and boundaries for disease and indication contexts",
      "role": "Required",
      "role_reason": "An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries",
      "application_exception": "Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.",
      "criterion": "Direct evidence and boundaries for disease and indication contexts",
      "basis": "Fewer births above 4000 g",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "Link evidence for a new indication to its separate population, comparator and endpoint."
    },
    {
      "item_id": "N22",
      "question_type": "Comparative efficacy",
      "question": "Are GRoW public funding and gaps in the four company roles distinguished?",
      "needed": "Separate records for cash support, product provision, affiliated authors and outside analysis providers",
      "role": "Required",
      "role_reason": "An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries",
      "application_exception": "Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.",
      "criterion": "Separate records for cash support, product provision, affiliated authors and outside analysis providers",
      "basis": "Fewer births above 4000 g",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "Obtain original GRoW funding, product supply, affiliations, analysis and writing roles separately."
    },
    {
      "item_id": "N23",
      "question_type": "Comparative efficacy",
      "question": "Were EMPOWaR Merck supply and role declarations kept separate from GRoW funding?",
      "needed": "Trial-specific relationships of public support, sponsorship, products and company roles",
      "role": "Required",
      "role_reason": "An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries",
      "application_exception": "Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.",
      "criterion": "Trial-specific relationships of public support, sponsorship, products and company roles",
      "basis": "Fewer births above 4000 g",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "Link original conflict-of-interest material for the three trials separately."
    },
    {
      "item_id": "N24",
      "question_type": "Supplementary harm evidence",
      "question": "Are person, event and exposure denominators available for gastrointestinal harm, discontinuation and adherence?",
      "needed": "Original trial- and arm-specific harm definition, collection, denominator, discontinuation and exposure tables",
      "role": "Required",
      "role_reason": "An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries",
      "application_exception": "Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.",
      "criterion": "Original trial- and arm-specific harm definition, collection, denominator, discontinuation and exposure tables",
      "basis": "Fewer births above 4000 g",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "Obtain original GRoW safety tables and exposure, discontinuation and adherence material."
    },
    {
      "item_id": "N25",
      "question_type": "Supplementary harm evidence",
      "question": "Has the EMPOWaR fatal composite’s composition and figures been kept separate from GRoW harm?",
      "needed": "Distinction between trials, arms, component events, follow-up and denominators",
      "role": "Required",
      "role_reason": "An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries",
      "application_exception": "Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.",
      "criterion": "Distinction between trials, arms, component events, follow-up and denominators",
      "basis": "Fewer births above 4000 g",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "Link each trial’s component event definitions, original arm event tables and denominators."
    },
    {
      "item_id": "N26",
      "question_type": "Supplementary harm evidence",
      "question": "Are nonsignificance and wide CIs for rare harm distinguished from confirmed safety?",
      "needed": "Material directly addressing effects, precision, exposure and rare harm",
      "role": "Required",
      "role_reason": "An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries",
      "application_exception": "Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.",
      "criterion": "Material directly addressing effects, precision, exposure and rare harm",
      "basis": "Fewer births above 4000 g",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "Adequate arm-specific follow-up, component events, original effects and rare-harm material are needed."
    },
    {
      "item_id": "N27",
      "question_type": "Supplementary harm evidence",
      "question": "Are gaps for maternal, infant and long-term harm and replication material maintained?",
      "needed": "Direct trial-specific maternal, fetal and neonatal material on long-term exposure and follow-up",
      "role": "Required",
      "role_reason": "An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries",
      "application_exception": "Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.",
      "criterion": "Direct trial-specific maternal, fetal and neonatal material on long-term exposure and follow-up",
      "basis": "Fewer births above 4000 g",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "Link population-specific direct harm, long-term follow-up and report relationships to original trials."
    },
    {
      "item_id": "N28",
      "question_type": "Comparative efficacy",
      "question": "Are original URLs, registration identifiers and actual reading status shown individually?",
      "needed": "Individual material entries for summary, abstract, full text, registration, protocol and SAP",
      "role": "Required",
      "role_reason": "An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries",
      "application_exception": "Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.",
      "criterion": "Individual material entries for summary, abstract, full text, registration, protocol and SAP",
      "basis": "Fewer births above 4000 g",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "Link user-obtained original material with its individual material type and access status."
    },
    {
      "item_id": "N29",
      "question_type": "Comparative efficacy",
      "question": "Are reference date, original languages, corrections, empty values and parent history preserved?",
      "needed": "Separate preservation of the entire stored summary, selected verdict record and parent values",
      "role": "Required",
      "role_reason": "An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries",
      "application_exception": "Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.",
      "criterion": "Separate preservation of the entire stored summary, selected verdict record and parent values",
      "basis": "Fewer births above 4000 g",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "Reflect new material and decisions as separate change events while preserving the entire original."
    },
    {
      "item_id": "N30",
      "question_type": "Comparative efficacy",
      "question": "Is the incomplete content-review marker distinguished from actual production and independence status?",
      "needed": "Separate records of original candidate history, production status and review status",
      "role": "Supplementary",
      "role_reason": "An individual application condition recording the selected question’s existing values, direct comparisons and interpretation boundaries",
      "application_exception": "Unread external material or results outside the question’s scope are not interpreted as condition fulfillment, zero effect or safety.",
      "criterion": "Separate records of original candidate history, production status and review status",
      "basis": "Fewer births above 4000 g",
      "condition_origin": "Question-specific application conditions; existing content review remains incomplete and common definitions are not automatically fulfilled",
      "proposed_research": "Reflect only user-provided decisions and materials as separate events."
    }
  ]
}