{
  "schema_version": "chamgap-public-criteria-1.0",
  "title": "Amitriptyline · Pediatric 24-week 50% headache-day response — Evidence Check",
  "language": "en",
  "translation_date": "2026-10-12",
  "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": "Link preserved methodological application records; no current clinical-content reassessment or external-link verification was 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": "Link preserved methodological application records; no current clinical-content reassessment or external-link verification was 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": "Link preserved methodological application records; no current clinical-content reassessment or external-link verification was 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": "Link preserved methodological application records; no current clinical-content reassessment or external-link verification was 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": "Link preserved methodological application records; no current clinical-content reassessment or external-link verification was 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 · Pediatric drug response",
      "question": "Selected drug: original question and subclaim verdict",
      "needed": "Each drug’s 50% headache-day response question, grade and note",
      "role": "Required",
      "role_reason": "A production condition distinguishing the selected ingredient’s direct placebo response from required original material and unverified information.",
      "application_exception": "Do not fill gaps in the selected question using the other active drug, adults, reviews, measurement windows or denominators.",
      "criterion": "Each drug’s 50% headache-day response question, grade and note: record only original values, scope and gaps; no new clinical evidence, calculations, verdicts or independence certification are created.",
      "basis": "Retain existing application conditions and preserved methodological links for production; full-definition content review and official certification are incomplete.",
      "condition_origin": "Chamgap-specific application condition; review of existing content incomplete",
      "proposed_research": "Distinguish the original subclaim verdict from this preparation and content review."
    },
    {
      "item_id": "N02",
      "question_type": "Comparative efficacy · Pediatric drug response",
      "question": "Selected placebo comparison",
      "needed": "Distinguish the selected drug, placebo and other active-drug comparisons",
      "role": "Required",
      "role_reason": "A production condition distinguishing the selected ingredient’s direct placebo response from required original material and unverified information.",
      "application_exception": "Do not fill gaps in the selected question using the other active drug, adults, reviews, measurement windows or denominators.",
      "criterion": "Distinguish the selected drug, placebo and other active-drug comparisons: record only original values, scope and gaps; no new clinical evidence, calculations, verdicts or independence certification are created.",
      "basis": "Retain existing application conditions and preserved methodological links for production; full-definition content review and official certification are incomplete.",
      "condition_origin": "Chamgap-specific application condition; review of existing content incomplete",
      "proposed_research": "Separate the selected placebo comparison from other active-drug and natural-history questions."
    },
    {
      "item_id": "N03",
      "question_type": "Comparative efficacy · Pediatric drug response",
      "question": "Actual pediatric population and application scope",
      "needed": "Age, diagnosis, baseline headaches, eligibility, exclusions and centers",
      "role": "Required",
      "role_reason": "A production condition distinguishing the selected ingredient’s direct placebo response from required original material and unverified information.",
      "application_exception": "Do not fill gaps in the selected question using the other active drug, adults, reviews, measurement windows or denominators.",
      "criterion": "Age, diagnosis, baseline headaches, eligibility, exclusions and centers: record only original values, scope and gaps; no new clinical evidence, calculations, verdicts or independence certification are created.",
      "basis": "Retain existing application conditions and preserved methodological links for production; full-definition content review and official certification are incomplete.",
      "condition_origin": "Chamgap-specific application condition; review of existing content incomplete",
      "proposed_research": "Distinguish the original age, diagnosis and period from application to other populations."
    },
    {
      "item_id": "N04",
      "question_type": "Comparative efficacy · Pediatric drug response",
      "question": "Actual drug exposure and dose information",
      "needed": "Product, study exposure, dose, titration and duration specifications",
      "role": "Required",
      "role_reason": "A production condition distinguishing the selected ingredient’s direct placebo response from required original material and unverified information.",
      "application_exception": "Do not fill gaps in the selected question using the other active drug, adults, reviews, measurement windows or denominators.",
      "criterion": "Product, study exposure, dose, titration and duration specifications: record only original values, scope and gaps; no new clinical evidence, calculations, verdicts or independence certification are created.",
      "basis": "Retain existing application conditions and preserved methodological links for production; full-definition content review and official certification are incomplete.",
      "condition_origin": "Chamgap-specific application condition; review of existing content incomplete",
      "proposed_research": "Separate study identity from unverified exposure details."
    },
    {
      "item_id": "N05",
      "question_type": "Comparative efficacy · Pediatric drug response",
      "question": "Placebo identity and masking scope",
      "needed": "Capsules, placebo composition, allocation and role-specific masking",
      "role": "Required",
      "role_reason": "A production condition distinguishing the selected ingredient’s direct placebo response from required original material and unverified information.",
      "application_exception": "Do not fill gaps in the selected question using the other active drug, adults, reviews, measurement windows or denominators.",
      "criterion": "Capsules, placebo composition, allocation and role-specific masking: record only original values, scope and gaps; no new clinical evidence, calculations, verdicts or independence certification are created.",
      "basis": "Retain existing application conditions and preserved methodological links for production; full-definition content review and official certification are incomplete.",
      "condition_origin": "Chamgap-specific application condition; review of existing content incomplete",
      "proposed_research": "Distinguish the masking label from actual implementation material."
    },
    {
      "item_id": "N06",
      "question_type": "Comparative efficacy · Pediatric drug response",
      "question": "Randomization and three-arm denominators",
      "needed": "Allocation ratio, each arm, analysis and follow-up denominators",
      "role": "Required",
      "role_reason": "A production condition distinguishing the selected ingredient’s direct placebo response from required original material and unverified information.",
      "application_exception": "Do not fill gaps in the selected question using the other active drug, adults, reviews, measurement windows or denominators.",
      "criterion": "Allocation ratio, each arm, analysis and follow-up denominators: record only original values, scope and gaps; no new clinical evidence, calculations, verdicts or independence certification are created.",
      "basis": "Retain existing application conditions and preserved methodological links for production; full-definition content review and official certification are incomplete.",
      "condition_origin": "Chamgap-specific application condition; review of existing content incomplete",
      "proposed_research": "Display total and arm-specific randomization separately from response-analysis denominators."
    },
    {
      "item_id": "N07",
      "question_type": "Comparative efficacy · Pediatric drug response",
      "question": "Allocation concealment, baseline balance and measurement methods",
      "needed": "Random sequence, concealment, baseline and role-specific measurement",
      "role": "Required",
      "role_reason": "A production condition distinguishing the selected ingredient’s direct placebo response from required original material and unverified information.",
      "application_exception": "Do not fill gaps in the selected question using the other active drug, adults, reviews, measurement windows or denominators.",
      "criterion": "Random sequence, concealment, baseline and role-specific measurement: record only original values, scope and gaps; no new clinical evidence, calculations, verdicts or independence certification are created.",
      "basis": "Retain existing application conditions and preserved methodological links for production; full-definition content review and official certification are incomplete.",
      "condition_origin": "Chamgap-specific application condition; review of existing content incomplete",
      "proposed_research": "Distinguish design names from limitations in actual implementation material."
    },
    {
      "item_id": "N08",
      "question_type": "Comparative efficacy · Pediatric drug response",
      "question": "Concurrent care, rescue medication, drug changes and adherence",
      "needed": "Arm-specific accompanying exposure, rescue, adherence and change handling",
      "role": "Required",
      "role_reason": "A production condition distinguishing the selected ingredient’s direct placebo response from required original material and unverified information.",
      "application_exception": "Do not fill gaps in the selected question using the other active drug, adults, reviews, measurement windows or denominators.",
      "criterion": "Arm-specific accompanying exposure, rescue, adherence and change handling: record only original values, scope and gaps; no new clinical evidence, calculations, verdicts or independence certification are created.",
      "basis": "Retain existing application conditions and preserved methodological links for production; full-definition content review and official certification are incomplete.",
      "condition_origin": "Chamgap-specific application condition; review of existing content incomplete",
      "proposed_research": "Distinguish assignment effects from actual-use and concurrent-care limitations."
    },
    {
      "item_id": "N09",
      "question_type": "Comparative efficacy · Pediatric drug response",
      "question": "Original 50% headache-day response definition and period",
      "needed": "Baseline/final periods, response threshold and headache-day definition",
      "role": "Required",
      "role_reason": "A production condition distinguishing the selected ingredient’s direct placebo response from required original material and unverified information.",
      "application_exception": "Do not fill gaps in the selected question using the other active drug, adults, reviews, measurement windows or denominators.",
      "criterion": "Baseline/final periods, response threshold and headache-day definition: record only original values, scope and gaps; no new clinical evidence, calculations, verdicts or independence certification are created.",
      "basis": "Retain existing application conditions and preserved methodological links for production; full-definition content review and official certification are incomplete.",
      "condition_origin": "Chamgap-specific application condition; review of existing content incomplete",
      "proposed_research": "Distinguish threshold response from mean change and other symptom measures."
    },
    {
      "item_id": "N10",
      "question_type": "Comparative efficacy · Pediatric drug response",
      "question": "Headache-day collection, recording and missing-data handling",
      "needed": "Headache recording, measurement, omissions, assessment masking and response classification",
      "role": "Required",
      "role_reason": "A production condition distinguishing the selected ingredient’s direct placebo response from required original material and unverified information.",
      "application_exception": "Do not fill gaps in the selected question using the other active drug, adults, reviews, measurement windows or denominators.",
      "criterion": "Headache recording, measurement, omissions, assessment masking and response classification: record only original values, scope and gaps; no new clinical evidence, calculations, verdicts or independence certification are created.",
      "basis": "Retain existing application conditions and preserved methodological links for production; full-definition content review and official certification are incomplete.",
      "condition_origin": "Chamgap-specific application condition; review of existing content incomplete",
      "proposed_research": "Distinguish people from recording days, repeated measurements and adjudication denominators."
    },
    {
      "item_id": "N11",
      "question_type": "Comparative efficacy · Pediatric drug response",
      "question": "Selected-arm and placebo responder percentages",
      "needed": "Original selected/placebo response proportions, denominators and aggregation",
      "role": "Required",
      "role_reason": "A production condition distinguishing the selected ingredient’s direct placebo response from required original material and unverified information.",
      "application_exception": "Do not fill gaps in the selected question using the other active drug, adults, reviews, measurement windows or denominators.",
      "criterion": "Original selected/placebo response proportions, denominators and aggregation: record only original values, scope and gaps; no new clinical evidence, calculations, verdicts or independence certification are created.",
      "basis": "Retain existing application conditions and preserved methodological links for production; full-definition content review and official certification are incomplete.",
      "condition_origin": "Chamgap-specific application condition; review of existing content incomplete",
      "proposed_research": "Show original selected percentages together with gaps in analysis denominators and event counts."
    },
    {
      "item_id": "N12",
      "question_type": "Comparative efficacy · Pediatric drug response",
      "question": "Selected drug’s OR, interval and P value",
      "needed": "Effect measure, original interval and test for the selected placebo comparison",
      "role": "Required",
      "role_reason": "A production condition distinguishing the selected ingredient’s direct placebo response from required original material and unverified information.",
      "application_exception": "Do not fill gaps in the selected question using the other active drug, adults, reviews, measurement windows or denominators.",
      "criterion": "Effect measure, original interval and test for the selected placebo comparison: record only original values, scope and gaps; no new clinical evidence, calculations, verdicts or independence certification are created.",
      "basis": "Retain existing application conditions and preserved methodological links for production; full-definition content review and official certification are incomplete.",
      "condition_origin": "Chamgap-specific application condition; review of existing content incomplete",
      "proposed_research": "Separate selected-drug estimates from other active-drug and review estimates."
    },
    {
      "item_id": "N13",
      "question_type": "Comparative efficacy · Pediatric drug response",
      "question": "Interval level and multiplicity across three comparisons",
      "needed": "Original interval levels, three pairwise tests and adjustment plan",
      "role": "Required",
      "role_reason": "A production condition distinguishing the selected ingredient’s direct placebo response from required original material and unverified information.",
      "application_exception": "Do not fill gaps in the selected question using the other active drug, adults, reviews, measurement windows or denominators.",
      "criterion": "Original interval levels, three pairwise tests and adjustment plan: record only original values, scope and gaps; no new clinical evidence, calculations, verdicts or independence certification are created.",
      "basis": "Retain existing application conditions and preserved methodological links for production; full-definition content review and official certification are incomplete.",
      "condition_origin": "Chamgap-specific application condition; review of existing content incomplete",
      "proposed_research": "Preserve interval labels and the multiple-comparison plan separately."
    },
    {
      "item_id": "N14",
      "question_type": "Comparative efficacy · Pediatric drug response",
      "question": "Numerical percentages versus superiority or equivalence",
      "needed": "Original proportions, comparative effects, intervals and interpretation",
      "role": "Required",
      "role_reason": "A production condition distinguishing the selected ingredient’s direct placebo response from required original material and unverified information.",
      "application_exception": "Do not fill gaps in the selected question using the other active drug, adults, reviews, measurement windows or denominators.",
      "criterion": "Original proportions, comparative effects, intervals and interpretation: record only original values, scope and gaps; no new clinical evidence, calculations, verdicts or independence certification are created.",
      "basis": "Retain existing application conditions and preserved methodological links for production; full-definition content review and official certification are incomplete.",
      "condition_origin": "Chamgap-specific application condition; review of existing content incomplete",
      "proposed_research": "Distinguish numerical ordering from comparative testing, equivalence and precision."
    },
    {
      "item_id": "N15",
      "question_type": "Comparative efficacy · Pediatric drug response",
      "question": "Response estimand and actual analysis population",
      "needed": "Assignment/actual-use effects, analysis populations, missing data and adjustment models",
      "role": "Required",
      "role_reason": "A production condition distinguishing the selected ingredient’s direct placebo response from required original material and unverified information.",
      "application_exception": "Do not fill gaps in the selected question using the other active drug, adults, reviews, measurement windows or denominators.",
      "criterion": "Assignment/actual-use effects, analysis populations, missing data and adjustment models: record only original values, scope and gaps; no new clinical evidence, calculations, verdicts or independence certification are created.",
      "basis": "Retain existing application conditions and preserved methodological links for production; full-definition content review and official certification are incomplete.",
      "condition_origin": "Chamgap-specific application condition; review of existing content incomplete",
      "proposed_research": "Distinguish randomized, actual-use and completer effects and analysis denominators."
    },
    {
      "item_id": "N16",
      "question_type": "Comparative efficacy · Pediatric drug response",
      "question": "24-week completion and incomplete-follow-up limitations",
      "needed": "Arm-specific completion, discontinuation, withdrawal reasons and handling",
      "role": "Required",
      "role_reason": "A production condition distinguishing the selected ingredient’s direct placebo response from required original material and unverified information.",
      "application_exception": "Do not fill gaps in the selected question using the other active drug, adults, reviews, measurement windows or denominators.",
      "criterion": "Arm-specific completion, discontinuation, withdrawal reasons and handling: record only original values, scope and gaps; no new clinical evidence, calculations, verdicts or independence certification are created.",
      "basis": "Retain existing application conditions and preserved methodological links for production; full-definition content review and official certification are incomplete.",
      "condition_origin": "Chamgap-specific application condition; review of existing content incomplete",
      "proposed_research": "Present completion separately from response, observation and analysis denominators."
    },
    {
      "item_id": "N17",
      "question_type": "Comparative efficacy · Pediatric drug response",
      "question": "Selected drug’s prespecified futility-interim values",
      "needed": "Interim analysis, conditional power and prespecified futility threshold",
      "role": "Required",
      "role_reason": "A production condition distinguishing the selected ingredient’s direct placebo response from required original material and unverified information.",
      "application_exception": "Do not fill gaps in the selected question using the other active drug, adults, reviews, measurement windows or denominators.",
      "criterion": "Interim analysis, conditional power and prespecified futility threshold: record only original values, scope and gaps; no new clinical evidence, calculations, verdicts or independence certification are created.",
      "basis": "Retain existing application conditions and preserved methodological links for production; full-definition content review and official certification are incomplete.",
      "condition_origin": "Chamgap-specific application condition; review of existing content incomplete",
      "proposed_research": "Distinguish planned futility values from actual response effects."
    },
    {
      "item_id": "N18",
      "question_type": "Comparative efficacy · Pediatric drug response",
      "question": "Early stopping decision and statistical-boundary names",
      "needed": "DSMB recommendation, NINDS approval, stopping time and original boundary",
      "role": "Required",
      "role_reason": "A production condition distinguishing the selected ingredient’s direct placebo response from required original material and unverified information.",
      "application_exception": "Do not fill gaps in the selected question using the other active drug, adults, reviews, measurement windows or denominators.",
      "criterion": "DSMB recommendation, NINDS approval, stopping time and original boundary: record only original values, scope and gaps; no new clinical evidence, calculations, verdicts or independence certification are created.",
      "basis": "Retain existing application conditions and preserved methodological links for production; full-definition content review and official certification are incomplete.",
      "condition_origin": "Chamgap-specific application condition; review of existing content incomplete",
      "proposed_research": "Connect prespecified stopping rules with actual stopping and incomplete-follow-up limitations."
    },
    {
      "item_id": "N19",
      "question_type": "Comparative efficacy · Pediatric drug response",
      "question": "Prespecified clinical threshold and exclusion of meaningful benefit",
      "needed": "Prespecified response-benefit threshold, intervals and clinical importance",
      "role": "Required",
      "role_reason": "A production condition distinguishing the selected ingredient’s direct placebo response from required original material and unverified information.",
      "application_exception": "Do not fill gaps in the selected question using the other active drug, adults, reviews, measurement windows or denominators.",
      "criterion": "Prespecified response-benefit threshold, intervals and clinical importance: record only original values, scope and gaps; no new clinical evidence, calculations, verdicts or independence certification are created.",
      "basis": "Retain existing application conditions and preserved methodological links for production; full-definition content review and official certification are incomplete.",
      "condition_origin": "Chamgap-specific application condition; review of existing content incomplete",
      "proposed_research": "Distinguish null results from the range of benefit that can be excluded."
    },
    {
      "item_id": "N20",
      "question_type": "Comparative efficacy · Pediatric drug response",
      "question": "Registration, protocol, SAP and prespecified plans actually read",
      "needed": "Original registration, endpoints, interim analyses and amendment history",
      "role": "Required",
      "role_reason": "A production condition distinguishing the selected ingredient’s direct placebo response from required original material and unverified information.",
      "application_exception": "Do not fill gaps in the selected question using the other active drug, adults, reviews, measurement windows or denominators.",
      "criterion": "Original registration, endpoints, interim analyses and amendment history: record only original values, scope and gaps; no new clinical evidence, calculations, verdicts or independence certification are created.",
      "basis": "Retain existing application conditions and preserved methodological links for production; full-definition content review and official certification are incomplete.",
      "condition_origin": "Chamgap-specific application condition; review of existing content incomplete",
      "proposed_research": "Distinguish preserved plan narratives from actual external-original reading."
    },
    {
      "item_id": "N21",
      "question_type": "Comparative efficacy · Pediatric drug response",
      "question": "Direct comparison between the two active drugs",
      "needed": "Original active-drug comparative effects, intervals and question",
      "role": "Required",
      "role_reason": "A production condition distinguishing the selected ingredient’s direct placebo response from required original material and unverified information.",
      "application_exception": "Do not fill gaps in the selected question using the other active drug, adults, reviews, measurement windows or denominators.",
      "criterion": "Original active-drug comparative effects, intervals and question: record only original values, scope and gaps; no new clinical evidence, calculations, verdicts or independence certification are created.",
      "basis": "Retain existing application conditions and preserved methodological links for production; full-definition content review and official certification are incomplete.",
      "condition_origin": "Chamgap-specific application condition; review of existing content incomplete",
      "proposed_research": "Display placebo comparisons separately from direct active-drug comparisons."
    },
    {
      "item_id": "N22",
      "question_type": "Comparative efficacy · Pediatric drug response",
      "question": "Extension to adults, other preventives or other clinical endpoints",
      "needed": "Direct evidence by age, indication, ingredient, function and clinical outcome",
      "role": "Required",
      "role_reason": "A production condition distinguishing the selected ingredient’s direct placebo response from required original material and unverified information.",
      "application_exception": "Do not fill gaps in the selected question using the other active drug, adults, reviews, measurement windows or denominators.",
      "criterion": "Direct evidence by age, indication, ingredient, function and clinical outcome: record only original values, scope and gaps; no new clinical evidence, calculations, verdicts or independence certification are created.",
      "basis": "Retain existing application conditions and preserved methodological links for production; full-definition content review and official certification are incomplete.",
      "condition_origin": "Chamgap-specific application condition; review of existing content incomplete",
      "proposed_research": "Distinguish the selected pediatric response from other populations and outcomes."
    },
    {
      "item_id": "N23",
      "question_type": "Comparative efficacy · Pediatric drug response",
      "question": "One CHAMP report, sibling tables and shared placebo",
      "needed": "Link the same trial, three arms, registration, bibliography and participants",
      "role": "Required",
      "role_reason": "A production condition distinguishing the selected ingredient’s direct placebo response from required original material and unverified information.",
      "application_exception": "Do not fill gaps in the selected question using the other active drug, adults, reviews, measurement windows or denominators.",
      "criterion": "Link the same trial, three arms, registration, bibliography and participants: record only original values, scope and gaps; no new clinical evidence, calculations, verdicts or independence certification are created.",
      "basis": "Retain existing application conditions and preserved methodological links for production; full-definition content review and official certification are incomplete.",
      "condition_origin": "Chamgap-specific application condition; review of existing content incomplete",
      "proposed_research": "Distinguish comparison questions from the same trial, shared control and participant units."
    },
    {
      "item_id": "N24",
      "question_type": "Comparative efficacy · Pediatric drug response",
      "question": "Scope of linking the topiramate review to the selected drug",
      "needed": "Review populations, ingredient, endpoint, duration, included trials and selected applicability",
      "role": "Required",
      "role_reason": "A production condition distinguishing the selected ingredient’s direct placebo response from required original material and unverified information.",
      "application_exception": "Do not fill gaps in the selected question using the other active drug, adults, reviews, measurement windows or denominators.",
      "criterion": "Review populations, ingredient, endpoint, duration, included trials and selected applicability: record only original values, scope and gaps; no new clinical evidence, calculations, verdicts or independence certification are created.",
      "basis": "Retain existing application conditions and preserved methodological links for production; full-definition content review and official certification are incomplete.",
      "condition_origin": "Chamgap-specific application condition; review of existing content incomplete",
      "proposed_research": "Distinguish topiramate-review context from the selected direct placebo trial."
    },
    {
      "item_id": "N25",
      "question_type": "Comparative efficacy · Pediatric drug response",
      "question": "Repeated null findings across the two drugs",
      "needed": "Drug-specific direct evidence, independent replication and unique-trial linkage",
      "role": "Required",
      "role_reason": "A production condition distinguishing the selected ingredient’s direct placebo response from required original material and unverified information.",
      "application_exception": "Do not fill gaps in the selected question using the other active drug, adults, reviews, measurement windows or denominators.",
      "criterion": "Drug-specific direct evidence, independent replication and unique-trial linkage: record only original values, scope and gaps; no new clinical evidence, calculations, verdicts or independence certification are created.",
      "basis": "Retain existing application conditions and preserved methodological links for production; full-definition content review and official certification are incomplete.",
      "condition_origin": "Chamgap-specific application condition; review of existing content incomplete",
      "proposed_research": "Preserve drug-specific evidence scope and differences in replication."
    },
    {
      "item_id": "N26",
      "question_type": "Comparative efficacy · Pediatric drug response",
      "question": "Public grants, drug purchases and product support",
      "needed": "Funding, generic purchases, pharmaceutical support and contracts",
      "role": "Required",
      "role_reason": "A production condition distinguishing the selected ingredient’s direct placebo response from required original material and unverified information.",
      "application_exception": "Do not fill gaps in the selected question using the other active drug, adults, reviews, measurement windows or denominators.",
      "criterion": "Funding, generic purchases, pharmaceutical support and contracts: record only original values, scope and gaps; no new clinical evidence, calculations, verdicts or independence certification are created.",
      "basis": "Retain existing application conditions and preserved methodological links for production; full-definition content review and official certification are incomplete.",
      "condition_origin": "Chamgap-specific application condition; review of existing content incomplete",
      "proposed_research": "Distinguish publicly funded purchases from pharmaceutical support and unverified roles."
    },
    {
      "item_id": "N27",
      "question_type": "Comparative efficacy · Pediatric drug response",
      "question": "Authors, analysis, medical writing, publication costs and data rights",
      "needed": "Author affiliations, company relationships and analysis/writing/publication roles",
      "role": "Required",
      "role_reason": "A production condition distinguishing the selected ingredient’s direct placebo response from required original material and unverified information.",
      "application_exception": "Do not fill gaps in the selected question using the other active drug, adults, reviews, measurement windows or denominators.",
      "criterion": "Author affiliations, company relationships and analysis/writing/publication roles: record only original values, scope and gaps; no new clinical evidence, calculations, verdicts or independence certification are created.",
      "basis": "Retain existing application conditions and preserved methodological links for production; full-definition content review and official certification are incomplete.",
      "condition_origin": "Chamgap-specific application condition; review of existing content incomplete",
      "proposed_research": "Display known funding separately from unverified roles."
    },
    {
      "item_id": "N28",
      "question_type": "Supplementary harm evidence",
      "question": "Selected drug’s common harms",
      "needed": "Selected/placebo event definitions, collection, frequency and denominators",
      "role": "Supplementary",
      "role_reason": "A supplementary condition recording the selected ingredient’s harm/safety observation scope separately from efficacy.",
      "application_exception": "Do not fill gaps in the selected question using the other active drug, adults, reviews, measurement windows or denominators.",
      "criterion": "Selected/placebo event definitions, collection, frequency and denominators: record only original values, scope and gaps; no new clinical evidence, calculations, verdicts or independence certification are created.",
      "basis": "Retain existing application conditions and preserved methodological links for production; full-definition content review and official certification are incomplete.",
      "condition_origin": "Chamgap-specific application condition; review of existing content incomplete",
      "proposed_research": "Separate drug-specific common events from placebo comparisons and collection gaps."
    },
    {
      "item_id": "N29",
      "question_type": "Supplementary harm evidence",
      "question": "Selected drug’s treatment-related serious events",
      "needed": "Serious events, relatedness adjudication, people/events and exposure denominators",
      "role": "Supplementary",
      "role_reason": "A supplementary condition recording the selected ingredient’s harm/safety observation scope separately from efficacy.",
      "application_exception": "Do not fill gaps in the selected question using the other active drug, adults, reviews, measurement windows or denominators.",
      "criterion": "Serious events, relatedness adjudication, people/events and exposure denominators: record only original values, scope and gaps; no new clinical evidence, calculations, verdicts or independence certification are created.",
      "basis": "Retain existing application conditions and preserved methodological links for production; full-definition content review and official certification are incomplete.",
      "condition_origin": "Chamgap-specific application condition; review of existing content incomplete",
      "proposed_research": "Distinguish original reported relatedness from limits in direct causality and person counts."
    },
    {
      "item_id": "N30",
      "question_type": "Supplementary harm evidence",
      "question": "24-week harms versus long-term and rare-event safety",
      "needed": "Long-term exposure, follow-up, withdrawal, rare events and population-specific material",
      "role": "Supplementary",
      "role_reason": "A supplementary condition recording the selected ingredient’s harm/safety observation scope separately from efficacy.",
      "application_exception": "Do not fill gaps in the selected question using the other active drug, adults, reviews, measurement windows or denominators.",
      "criterion": "Long-term exposure, follow-up, withdrawal, rare events and population-specific material: record only original values, scope and gaps; no new clinical evidence, calculations, verdicts or independence certification are created.",
      "basis": "Retain existing application conditions and preserved methodological links for production; full-definition content review and official certification are incomplete.",
      "condition_origin": "Chamgap-specific application condition; review of existing content incomplete",
      "proposed_research": "Separate efficacy comparisons from long-term/rare-harm gaps."
    },
    {
      "item_id": "N31",
      "question_type": "Comparative efficacy · Pediatric drug response",
      "question": "Actual summary reading and unread external materials",
      "needed": "Status of two bibliographic records, stored summary, abstracts, full texts, registration and plans",
      "role": "Required",
      "role_reason": "A production condition distinguishing the selected ingredient’s direct placebo response from required original material and unverified information.",
      "application_exception": "Do not fill gaps in the selected question using the other active drug, adults, reviews, measurement windows or denominators.",
      "criterion": "Status of two bibliographic records, stored summary, abstracts, full texts, registration and plans: record only original values, scope and gaps; no new clinical evidence, calculations, verdicts or independence certification are created.",
      "basis": "Retain existing application conditions and preserved methodological links for production; full-definition content review and official certification are incomplete.",
      "condition_origin": "Chamgap-specific application condition; review of existing content incomplete",
      "proposed_research": "Display summary reading separately from unread external materials."
    },
    {
      "item_id": "N32",
      "question_type": "Comparative efficacy · Pediatric drug response",
      "question": "Original history, verdict linkage, preparation and content review",
      "needed": "Subclaim/parent Korean-English text, axes, dates, corrections, existing selection and condition preservation/application",
      "role": "Required",
      "role_reason": "A production condition distinguishing the selected ingredient’s direct placebo response from required original material and unverified information.",
      "application_exception": "Do not fill gaps in the selected question using the other active drug, adults, reviews, measurement windows or denominators.",
      "criterion": "Subclaim/parent Korean-English text, axes, dates, corrections, existing selection and condition preservation/application: record only original values, scope and gaps; no new clinical evidence, calculations, verdicts or independence certification are created.",
      "basis": "Retain existing application conditions and preserved methodological links for production; full-definition content review and official certification are incomplete.",
      "condition_origin": "Chamgap-specific application condition; review of existing content incomplete",
      "proposed_research": "Record original verdicts/corrections separately from preparation and content review."
    }
  ]
}