{
  "schema_version": "chamgap-public-criteria-1.0",
  "title": "Ginger dry extract × Migraine prevention—no added benefit over placebo in the 50% responder rate",
  "language": "en",
  "translation_date": "2026-10-20",
  "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": "Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed."
    },
    {
      "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": "Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed."
    },
    {
      "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": "Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed."
    },
    {
      "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": "Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed."
    },
    {
      "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": "Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed."
    }
  ],
  "status_dictionary": {
    "Partly verified": "Partial information from the stored summary is linked; detailed originals and content review remain incomplete.",
    "Unverified": "Required details cannot be established within the preserved scope. This does not establish absence of effects or studies, or safety.",
    "Review incomplete": "Review of existing content remains incomplete.",
    "Met": "This state is used only within the relevant conditions after material verification and content review. It was not automatically assigned in this work.",
    "Not reported": "Unreported within material actually read. Unread external material is not relabeled as unreported.",
    "Inaccessible": "This means actual access failure. External access was not attempted in this work, so this state was not assigned.",
    "Not applicable": "Used only with an application exception and reason based on the question scope.",
    "Conflicting data": "This requires actual comparison of materials; no new conflict judgment was made in this work.",
    "Insufficient evidence for the conditions": "This indicates gaps in additional material for the selected conditions. Unread material as a whole is not converted into an efficacy grade."
  },
  "requirements": [
    {
      "item_id": "N01",
      "question_type": "Evidence condition",
      "question": "What is the original conclusion for the selected 50% responder question?",
      "needed": "Comparison of responder proportions against placebo",
      "role": "Required",
      "role_reason": "This condition links Comparison of responder proportions against placebo with populations, formulations, controls, denominators, measurement windows, prespecified criteria, analyses, support and harms for the selected prevention responder outcome.",
      "application_exception": "Retain original subclaim D and absent individual score, status and axes without inheriting parent D30. Distinguish responder proportions, mean changes, other pain outcomes, single-ingredient prevention, acute combinations and active controls. No new effects, CIs, denominators, independent totals, grades, dosing or treatment instructions are created.",
      "criterion": "Original material for Comparison of responder proportions against placebo must be linked to individual responder definitions, between-arm comparisons, denominators and measurement windows, distinguishing stored summaries, unread external material, within-arm changes and other acute-treatment questions.",
      "basis": "Preserved application criteria were used to distinguish questions, comparisons, reports and trials, outcomes, denominators and harms.",
      "condition_origin": "These conditions apply to the existing subclaim. They do not establish preregistration, official assessment or completed content review.",
      "proposed_research": "Material needed: Responder definitions, baseline periods, measurement windows, arm-specific responders, denominators, effects and CIs are needed. No new grade or independence claim is created. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N02",
      "question_type": "Evidence condition",
      "question": "Is the 50% threshold a reduction in average attacks across the group?",
      "needed": "Distinction between an individual responder threshold and group mean change",
      "role": "Required",
      "role_reason": "This condition links Distinction between an individual responder threshold and group mean change with populations, formulations, controls, denominators, measurement windows, prespecified criteria, analyses, support and harms for the selected prevention responder outcome.",
      "application_exception": "Retain original subclaim D and absent individual score, status and axes without inheriting parent D30. Distinguish responder proportions, mean changes, other pain outcomes, single-ingredient prevention, acute combinations and active controls. No new effects, CIs, denominators, independent totals, grades, dosing or treatment instructions are created.",
      "criterion": "Original material for Distinction between an individual responder threshold and group mean change must be linked to individual responder definitions, between-arm comparisons, denominators and measurement windows, distinguishing stored summaries, unread external material, within-arm changes and other acute-treatment questions.",
      "basis": "Preserved application criteria were used to distinguish questions, comparisons, reports and trials, outcomes, denominators and harms.",
      "condition_origin": "These conditions apply to the existing subclaim. They do not establish preregistration, official assessment or completed content review.",
      "proposed_research": "Material needed: Individual baseline and treatment-period measurements, response classification, arm-specific events, denominators and original comparisons are needed. Responder rates and mean changes are not newly calculated. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N03",
      "question_type": "Evidence condition",
      "question": "Are exact arm-specific responders, effects and intervals known?",
      "needed": "Original material for direct between-arm estimates and precision",
      "role": "Required",
      "role_reason": "This condition links Original material for direct between-arm estimates and precision with populations, formulations, controls, denominators, measurement windows, prespecified criteria, analyses, support and harms for the selected prevention responder outcome.",
      "application_exception": "Retain original subclaim D and absent individual score, status and axes without inheriting parent D30. Distinguish responder proportions, mean changes, other pain outcomes, single-ingredient prevention, acute combinations and active controls. No new effects, CIs, denominators, independent totals, grades, dosing or treatment instructions are created.",
      "criterion": "Original material for Original material for direct between-arm estimates and precision must be linked to individual responder definitions, between-arm comparisons, denominators and measurement windows, distinguishing stored summaries, unread external material, within-arm changes and other acute-treatment questions.",
      "basis": "Preserved application criteria were used to distinguish questions, comparisons, reports and trials, outcomes, denominators and harms.",
      "condition_origin": "These conditions apply to the existing subclaim. They do not establish preregistration, official assessment or completed content review.",
      "proposed_research": "Material needed: Original outcome tables, responders, denominators, effects, CIs, statistical models and missing-data handling are needed. Numbers, CIs and P are not invented. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N04",
      "question_type": "Evidence condition",
      "question": "Does nonsignificance prove the absence of even a small benefit?",
      "needed": "Distinction between null findings, precision gaps and exact zero effects",
      "role": "Required",
      "role_reason": "This condition links Distinction between null findings, precision gaps and exact zero effects with populations, formulations, controls, denominators, measurement windows, prespecified criteria, analyses, support and harms for the selected prevention responder outcome.",
      "application_exception": "Retain original subclaim D and absent individual score, status and axes without inheriting parent D30. Distinguish responder proportions, mean changes, other pain outcomes, single-ingredient prevention, acute combinations and active controls. No new effects, CIs, denominators, independent totals, grades, dosing or treatment instructions are created.",
      "criterion": "Original material for Distinction between null findings, precision gaps and exact zero effects must be linked to individual responder definitions, between-arm comparisons, denominators and measurement windows, distinguishing stored summaries, unread external material, within-arm changes and other acute-treatment questions.",
      "basis": "Preserved application criteria were used to distinguish questions, comparisons, reports and trials, outcomes, denominators and harms.",
      "condition_origin": "These conditions apply to the existing subclaim. They do not establish preregistration, official assessment or completed content review.",
      "proposed_research": "Material needed: Direct effects, CIs, external clinical importance boundaries, denominators, design and power information are needed. No new F or equivalence judgment or boundary calculation is made. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N05",
      "question_type": "Evidence condition",
      "question": "Is improvement over time in both arms an added ginger effect?",
      "needed": "Within-arm change versus the between-arm effect against placebo",
      "role": "Required",
      "role_reason": "This condition links Within-arm change versus the between-arm effect against placebo with populations, formulations, controls, denominators, measurement windows, prespecified criteria, analyses, support and harms for the selected prevention responder outcome.",
      "application_exception": "Retain original subclaim D and absent individual score, status and axes without inheriting parent D30. Distinguish responder proportions, mean changes, other pain outcomes, single-ingredient prevention, acute combinations and active controls. No new effects, CIs, denominators, independent totals, grades, dosing or treatment instructions are created.",
      "criterion": "Original material for Within-arm change versus the between-arm effect against placebo must be linked to individual responder definitions, between-arm comparisons, denominators and measurement windows, distinguishing stored summaries, unread external material, within-arm changes and other acute-treatment questions.",
      "basis": "Preserved application criteria were used to distinguish questions, comparisons, reports and trials, outcomes, denominators and harms.",
      "condition_origin": "These conditions apply to the existing subclaim. They do not establish preregistration, official assessment or completed content review.",
      "proposed_research": "Material needed: Baseline and follow-up data, time and arm comparisons, changes, models, denominators, original estimates and CIs are needed. Within-arm changes are not subtracted to create a new effect. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N06",
      "question_type": "Evidence condition",
      "question": "Is detailed eligibility for adults with episodic migraine known?",
      "needed": "Diagnosis, baseline attack frequency, preventive care and population scope",
      "role": "Required",
      "role_reason": "This condition links Diagnosis, baseline attack frequency, preventive care and population scope with populations, formulations, controls, denominators, measurement windows, prespecified criteria, analyses, support and harms for the selected prevention responder outcome.",
      "application_exception": "Retain original subclaim D and absent individual score, status and axes without inheriting parent D30. Distinguish responder proportions, mean changes, other pain outcomes, single-ingredient prevention, acute combinations and active controls. No new effects, CIs, denominators, independent totals, grades, dosing or treatment instructions are created.",
      "criterion": "Original material for Diagnosis, baseline attack frequency, preventive care and population scope must be linked to individual responder definitions, between-arm comparisons, denominators and measurement windows, distinguishing stored summaries, unread external material, within-arm changes and other acute-treatment questions.",
      "basis": "Preserved application criteria were used to distinguish questions, comparisons, reports and trials, outcomes, denominators and harms.",
      "condition_origin": "These conditions apply to the existing subclaim. They do not establish preregistration, official assessment or completed content review.",
      "proposed_research": "Material needed: Diagnostic criteria, baseline frequency, age, concurrent and prior care, exclusions and acute-medication information are needed. Findings are not extended to chronic migraine or other populations. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N07",
      "question_type": "Evidence condition",
      "question": "Which standardized ginger formulation was compared?",
      "needed": "Dry extract 200 mg, 5% active constituents and the original schedule",
      "role": "Required",
      "role_reason": "This condition links Dry extract 200 mg, 5% active constituents and the original schedule with populations, formulations, controls, denominators, measurement windows, prespecified criteria, analyses, support and harms for the selected prevention responder outcome.",
      "application_exception": "Retain original subclaim D and absent individual score, status and axes without inheriting parent D30. Distinguish responder proportions, mean changes, other pain outcomes, single-ingredient prevention, acute combinations and active controls. No new effects, CIs, denominators, independent totals, grades, dosing or treatment instructions are created.",
      "criterion": "Original material for Dry extract 200 mg, 5% active constituents and the original schedule must be linked to individual responder definitions, between-arm comparisons, denominators and measurement windows, distinguishing stored summaries, unread external material, within-arm changes and other acute-treatment questions.",
      "basis": "Preserved application criteria were used to distinguish questions, comparisons, reports and trials, outcomes, denominators and harms.",
      "condition_origin": "These conditions apply to the existing subclaim. They do not establish preregistration, official assessment or completed content review.",
      "proposed_research": "Material needed: Products, active-constituent definitions, quantification, batches, quality, placebo composition, adherence and original exposure records are needed. New dosing or treatment instructions are not written. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N08",
      "question_type": "Evidence condition",
      "question": "Are 3-month prevention and acute-attack treatment the same question?",
      "needed": "Distinction between prevention intent, measurement periods and acute treatment",
      "role": "Required",
      "role_reason": "This condition links Distinction between prevention intent, measurement periods and acute treatment with populations, formulations, controls, denominators, measurement windows, prespecified criteria, analyses, support and harms for the selected prevention responder outcome.",
      "application_exception": "Retain original subclaim D and absent individual score, status and axes without inheriting parent D30. Distinguish responder proportions, mean changes, other pain outcomes, single-ingredient prevention, acute combinations and active controls. No new effects, CIs, denominators, independent totals, grades, dosing or treatment instructions are created.",
      "criterion": "Original material for Distinction between prevention intent, measurement periods and acute treatment must be linked to individual responder definitions, between-arm comparisons, denominators and measurement windows, distinguishing stored summaries, unread external material, within-arm changes and other acute-treatment questions.",
      "basis": "Preserved application criteria were used to distinguish questions, comparisons, reports and trials, outcomes, denominators and harms.",
      "condition_origin": "These conditions apply to the existing subclaim. They do not establish preregistration, official assessment or completed content review.",
      "proposed_research": "Material needed: Baseline observation, treatment and measurement windows, prevention eligibility, concurrent care and direct findings are needed. Acute studies are not added as replication of the same prevention question. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N09",
      "question_type": "Evidence condition",
      "question": "Are feverfew-plus-ginger combinations distinguished from ginger extract alone?",
      "needed": "Distinction between acute combinations and single-ingredient prevention",
      "role": "Required",
      "role_reason": "This condition links Distinction between acute combinations and single-ingredient prevention with populations, formulations, controls, denominators, measurement windows, prespecified criteria, analyses, support and harms for the selected prevention responder outcome.",
      "application_exception": "Retain original subclaim D and absent individual score, status and axes without inheriting parent D30. Distinguish responder proportions, mean changes, other pain outcomes, single-ingredient prevention, acute combinations and active controls. No new effects, CIs, denominators, independent totals, grades, dosing or treatment instructions are created.",
      "criterion": "Original material for Distinction between acute combinations and single-ingredient prevention must be linked to individual responder definitions, between-arm comparisons, denominators and measurement windows, distinguishing stored summaries, unread external material, within-arm changes and other acute-treatment questions.",
      "basis": "Preserved application criteria were used to distinguish questions, comparisons, reports and trials, outcomes, denominators and harms.",
      "condition_origin": "These conditions apply to the existing subclaim. They do not establish preregistration, official assessment or completed content review.",
      "proposed_research": "Material needed: Direct materials on the same standardized single ingredient, population, control and prevention outcome are needed. Combination findings or trial counts absent from the stored account are not created. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N10",
      "question_type": "Evidence condition",
      "question": "Is a sumatriptan active-control study replication of placebo-controlled prevention?",
      "needed": "Directness of other controls and acute questions for the selected prevention outcome",
      "role": "Required",
      "role_reason": "This condition links Directness of other controls and acute questions for the selected prevention outcome with populations, formulations, controls, denominators, measurement windows, prespecified criteria, analyses, support and harms for the selected prevention responder outcome.",
      "application_exception": "Retain original subclaim D and absent individual score, status and axes without inheriting parent D30. Distinguish responder proportions, mean changes, other pain outcomes, single-ingredient prevention, acute combinations and active controls. No new effects, CIs, denominators, independent totals, grades, dosing or treatment instructions are created.",
      "criterion": "Original material for Directness of other controls and acute questions for the selected prevention outcome must be linked to individual responder definitions, between-arm comparisons, denominators and measurement windows, distinguishing stored summaries, unread external material, within-arm changes and other acute-treatment questions.",
      "basis": "Preserved application criteria were used to distinguish questions, comparisons, reports and trials, outcomes, denominators and harms.",
      "condition_origin": "These conditions apply to the existing subclaim. They do not establish preregistration, official assessment or completed content review.",
      "proposed_research": "Material needed: Prespecified responder comparisons for the selected formulation, preventive population, duration and placebo control are needed. Active-control values or clinical guidance outside the account are not created. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N11",
      "question_type": "Evidence condition",
      "question": "Does a nausea-related signal establish migraine prevention?",
      "needed": "Distinction between other symptoms or mechanisms and direct attack prevention",
      "role": "Required",
      "role_reason": "This condition links Distinction between other symptoms or mechanisms and direct attack prevention with populations, formulations, controls, denominators, measurement windows, prespecified criteria, analyses, support and harms for the selected prevention responder outcome.",
      "application_exception": "Retain original subclaim D and absent individual score, status and axes without inheriting parent D30. Distinguish responder proportions, mean changes, other pain outcomes, single-ingredient prevention, acute combinations and active controls. No new effects, CIs, denominators, independent totals, grades, dosing or treatment instructions are created.",
      "criterion": "Original material for Distinction between other symptoms or mechanisms and direct attack prevention must be linked to individual responder definitions, between-arm comparisons, denominators and measurement windows, distinguishing stored summaries, unread external material, within-arm changes and other acute-treatment questions.",
      "basis": "Preserved application criteria were used to distinguish questions, comparisons, reports and trials, outcomes, denominators and harms.",
      "condition_origin": "These conditions apply to the existing subclaim. They do not establish preregistration, official assessment or completed content review.",
      "proposed_research": "Material needed: Direct patient outcomes, between-arm estimates and CIs for the same prevention question are needed. No new mechanistic or efficacy judgment is made. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N12",
      "question_type": "Evidence condition",
      "question": "Are overall trial size and outcome-specific analysis denominators the same?",
      "needed": "Allocation, completion, responder analysis and missingness handling",
      "role": "Required",
      "role_reason": "This condition links Allocation, completion, responder analysis and missingness handling with populations, formulations, controls, denominators, measurement windows, prespecified criteria, analyses, support and harms for the selected prevention responder outcome.",
      "application_exception": "Retain original subclaim D and absent individual score, status and axes without inheriting parent D30. Distinguish responder proportions, mean changes, other pain outcomes, single-ingredient prevention, acute combinations and active controls. No new effects, CIs, denominators, independent totals, grades, dosing or treatment instructions are created.",
      "criterion": "Original material for Allocation, completion, responder analysis and missingness handling must be linked to individual responder definitions, between-arm comparisons, denominators and measurement windows, distinguishing stored summaries, unread external material, within-arm changes and other acute-treatment questions.",
      "basis": "Preserved application criteria were used to distinguish questions, comparisons, reports and trials, outcomes, denominators and harms.",
      "condition_origin": "These conditions apply to the existing subclaim. They do not establish preregistration, official assessment or completed content review.",
      "proposed_research": "Material needed: Original flow diagrams, arm-specific analysis populations, missingness and withdrawal reasons, diary completeness, missing-responder handling and sensitivity materials are needed. New differences or ratios are not calculated. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N13",
      "question_type": "Evidence condition",
      "question": "Are detailed randomization and double-blinding procedures known?",
      "needed": "Details of allocation, concealment, placebo, measurement and selective reporting",
      "role": "Required",
      "role_reason": "This condition links Details of allocation, concealment, placebo, measurement and selective reporting with populations, formulations, controls, denominators, measurement windows, prespecified criteria, analyses, support and harms for the selected prevention responder outcome.",
      "application_exception": "Retain original subclaim D and absent individual score, status and axes without inheriting parent D30. Distinguish responder proportions, mean changes, other pain outcomes, single-ingredient prevention, acute combinations and active controls. No new effects, CIs, denominators, independent totals, grades, dosing or treatment instructions are created.",
      "criterion": "Original material for Details of allocation, concealment, placebo, measurement and selective reporting must be linked to individual responder definitions, between-arm comparisons, denominators and measurement windows, distinguishing stored summaries, unread external material, within-arm changes and other acute-treatment questions.",
      "basis": "Preserved application criteria were used to distinguish questions, comparisons, reports and trials, outcomes, denominators and harms.",
      "condition_origin": "These conditions apply to the existing subclaim. They do not establish preregistration, official assessment or completed content review.",
      "proposed_research": "Material needed: Original methods, withdrawals, missingness, diaries, analysis, outcome selection, registration and plans are needed. No new official risk-of-bias assessment is performed. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N14",
      "question_type": "Evidence condition",
      "question": "Is the registration identifier distinguished from actual reading of the original plan?",
      "needed": "Registration identifier versus prespecified outcomes and analysis hierarchy",
      "role": "Required",
      "role_reason": "This condition links Registration identifier versus prespecified outcomes and analysis hierarchy with populations, formulations, controls, denominators, measurement windows, prespecified criteria, analyses, support and harms for the selected prevention responder outcome.",
      "application_exception": "Retain original subclaim D and absent individual score, status and axes without inheriting parent D30. Distinguish responder proportions, mean changes, other pain outcomes, single-ingredient prevention, acute combinations and active controls. No new effects, CIs, denominators, independent totals, grades, dosing or treatment instructions are created.",
      "criterion": "Original material for Registration identifier versus prespecified outcomes and analysis hierarchy must be linked to individual responder definitions, between-arm comparisons, denominators and measurement windows, distinguishing stored summaries, unread external material, within-arm changes and other acute-treatment questions.",
      "basis": "Preserved application criteria were used to distinguish questions, comparisons, reports and trials, outcomes, denominators and harms.",
      "condition_origin": "These conditions apply to the existing subclaim. They do not establish preregistration, official assessment or completed content review.",
      "proposed_research": "Material needed: Original registration, amendments, protocols, SAPs, the 50% definition, timing, analyses and outcome hierarchy are needed. A registration URL is not newly inferred. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N15",
      "question_type": "Evidence condition",
      "question": "Are severe-pain days, acute medication and duration the same responder outcome?",
      "needed": "Distinction between other outcomes or subclaims and the key responder outcome",
      "role": "Required",
      "role_reason": "This condition links Distinction between other outcomes or subclaims and the key responder outcome with populations, formulations, controls, denominators, measurement windows, prespecified criteria, analyses, support and harms for the selected prevention responder outcome.",
      "application_exception": "Retain original subclaim D and absent individual score, status and axes without inheriting parent D30. Distinguish responder proportions, mean changes, other pain outcomes, single-ingredient prevention, acute combinations and active controls. No new effects, CIs, denominators, independent totals, grades, dosing or treatment instructions are created.",
      "criterion": "Original material for Distinction between other outcomes or subclaims and the key responder outcome must be linked to individual responder definitions, between-arm comparisons, denominators and measurement windows, distinguishing stored summaries, unread external material, within-arm changes and other acute-treatment questions.",
      "basis": "Preserved application criteria were used to distinguish questions, comparisons, reports and trials, outcomes, denominators and harms.",
      "condition_origin": "These conditions apply to the existing subclaim. They do not establish preregistration, official assessment or completed content review.",
      "proposed_research": "Material needed: Outcome-specific definitions, measurement windows, denominators, between-arm effects, CIs, prespecified hierarchies and multiplicity materials are needed. The original null account is retained. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N16",
      "question_type": "Evidence condition",
      "question": "Are concurrent medication, adherence and withdrawal details known?",
      "needed": "Preventive and acute medication, actual exposure and missingness",
      "role": "Required",
      "role_reason": "This condition links Preventive and acute medication, actual exposure and missingness with populations, formulations, controls, denominators, measurement windows, prespecified criteria, analyses, support and harms for the selected prevention responder outcome.",
      "application_exception": "Retain original subclaim D and absent individual score, status and axes without inheriting parent D30. Distinguish responder proportions, mean changes, other pain outcomes, single-ingredient prevention, acute combinations and active controls. No new effects, CIs, denominators, independent totals, grades, dosing or treatment instructions are created.",
      "criterion": "Original material for Preventive and acute medication, actual exposure and missingness must be linked to individual responder definitions, between-arm comparisons, denominators and measurement windows, distinguishing stored summaries, unread external material, within-arm changes and other acute-treatment questions.",
      "basis": "Preserved application criteria were used to distinguish questions, comparisons, reports and trials, outcomes, denominators and harms.",
      "condition_origin": "These conditions apply to the existing subclaim. They do not establish preregistration, official assessment or completed content review.",
      "proposed_research": "Material needed: Arm-specific concurrent and acute medication, medication changes, actual exposure, adherence, withdrawals and missingness materials are needed. Unverified information is not converted into equality or absence. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N17",
      "question_type": "Evidence condition",
      "question": "Do 3-month findings establish post-treatment persistence or long-term harms?",
      "needed": "Distinction between prevention during treatment and post-treatment follow-up",
      "role": "Required",
      "role_reason": "This condition links Distinction between prevention during treatment and post-treatment follow-up with populations, formulations, controls, denominators, measurement windows, prespecified criteria, analyses, support and harms for the selected prevention responder outcome.",
      "application_exception": "Retain original subclaim D and absent individual score, status and axes without inheriting parent D30. Distinguish responder proportions, mean changes, other pain outcomes, single-ingredient prevention, acute combinations and active controls. No new effects, CIs, denominators, independent totals, grades, dosing or treatment instructions are created.",
      "criterion": "Original material for Distinction between prevention during treatment and post-treatment follow-up must be linked to individual responder definitions, between-arm comparisons, denominators and measurement windows, distinguishing stored summaries, unread external material, within-arm changes and other acute-treatment questions.",
      "basis": "Preserved application criteria were used to distinguish questions, comparisons, reports and trials, outcomes, denominators and harms.",
      "condition_origin": "These conditions apply to the existing subclaim. They do not establish preregistration, official assessment or completed content review.",
      "proposed_research": "Material needed: Post-treatment follow-up, continuing or changed care, recurrence, adherence, harms, denominators and direct longer-duration materials are needed. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N18",
      "question_type": "Evidence condition",
      "question": "Is the original sole-direct-trial statement a new certification of independence?",
      "needed": "Distinction between shared original reports or cohorts and independent replication",
      "role": "Required",
      "role_reason": "This condition links Distinction between shared original reports or cohorts and independent replication with populations, formulations, controls, denominators, measurement windows, prespecified criteria, analyses, support and harms for the selected prevention responder outcome.",
      "application_exception": "Retain original subclaim D and absent individual score, status and axes without inheriting parent D30. Distinguish responder proportions, mean changes, other pain outcomes, single-ingredient prevention, acute combinations and active controls. No new effects, CIs, denominators, independent totals, grades, dosing or treatment instructions are created.",
      "criterion": "Original material for Distinction between shared original reports or cohorts and independent replication must be linked to individual responder definitions, between-arm comparisons, denominators and measurement windows, distinguishing stored summaries, unread external material, within-arm changes and other acute-treatment questions.",
      "basis": "Preserved application criteria were used to distinguish questions, comparisons, reports and trials, outcomes, denominators and harms.",
      "condition_origin": "These conditions apply to the existing subclaim. They do not establish preregistration, official assessment or completed content review.",
      "proposed_research": "Material needed: Registration, institutions, recruitment, participants, report relationships, overlap and support materials are needed. Unique trial and participant totals remain unverified. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N19",
      "question_type": "Evidence condition",
      "question": "Is historical full-text support checking distinguished from current reading?",
      "needed": "Historical funding wording and original company-involvement materials",
      "role": "Required",
      "role_reason": "This condition links Historical funding wording and original company-involvement materials with populations, formulations, controls, denominators, measurement windows, prespecified criteria, analyses, support and harms for the selected prevention responder outcome.",
      "application_exception": "Retain original subclaim D and absent individual score, status and axes without inheriting parent D30. Distinguish responder proportions, mean changes, other pain outcomes, single-ingredient prevention, acute combinations and active controls. No new effects, CIs, denominators, independent totals, grades, dosing or treatment instructions are created.",
      "criterion": "Original material for Historical funding wording and original company-involvement materials must be linked to individual responder definitions, between-arm comparisons, denominators and measurement windows, distinguishing stored summaries, unread external material, within-arm changes and other acute-treatment questions.",
      "basis": "Preserved application criteria were used to distinguish questions, comparisons, reports and trials, outcomes, denominators and harms.",
      "condition_origin": "These conditions apply to the existing subclaim. They do not establish preregistration, official assessment or completed content review.",
      "proposed_research": "Material needed: Original material linking financial and product support, author or company affiliations and design, analysis and publication roles is needed. Historical checking wording is not relabeled as a current check. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N20",
      "question_type": "Evidence condition",
      "question": "Are actual harm-event counts and denominators known?",
      "needed": "Harm collection, exposure, withdrawal and bleeding-related concurrent-medication context",
      "role": "Supplementary",
      "role_reason": "This condition links Harm collection, exposure, withdrawal and bleeding-related concurrent-medication context with populations, formulations, controls, denominators, measurement windows, prespecified criteria, analyses, support and harms for the selected prevention responder outcome.",
      "application_exception": "Retain original subclaim D and absent individual score, status and axes without inheriting parent D30. Distinguish responder proportions, mean changes, other pain outcomes, single-ingredient prevention, acute combinations and active controls. No new effects, CIs, denominators, independent totals, grades, dosing or treatment instructions are created.",
      "criterion": "Original material for Harm collection, exposure, withdrawal and bleeding-related concurrent-medication context must be linked to individual responder definitions, between-arm comparisons, denominators and measurement windows, distinguishing stored summaries, unread external material, within-arm changes and other acute-treatment questions.",
      "basis": "Preserved application criteria were used to distinguish questions, comparisons, reports and trials, outcomes, denominators and harms.",
      "condition_origin": "These conditions apply to the existing subclaim. They do not establish preregistration, official assessment or completed content review.",
      "proposed_research": "Material needed: Harm definitions, collection, events, affected participants, severity, timing, exposure, denominators, concurrent medication, vulnerable groups and long-term materials are needed. No new treatment or dosing guidance is written. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N21",
      "question_type": "Evidence condition",
      "question": "Is the 50% threshold the same as between-arm clinical importance?",
      "needed": "Responder classification, prespecification and external benefit boundaries",
      "role": "Required",
      "role_reason": "This condition links Responder classification, prespecification and external benefit boundaries with populations, formulations, controls, denominators, measurement windows, prespecified criteria, analyses, support and harms for the selected prevention responder outcome.",
      "application_exception": "Retain original subclaim D and absent individual score, status and axes without inheriting parent D30. Distinguish responder proportions, mean changes, other pain outcomes, single-ingredient prevention, acute combinations and active controls. No new effects, CIs, denominators, independent totals, grades, dosing or treatment instructions are created.",
      "criterion": "Original material for Responder classification, prespecification and external benefit boundaries must be linked to individual responder definitions, between-arm comparisons, denominators and measurement windows, distinguishing stored summaries, unread external material, within-arm changes and other acute-treatment questions.",
      "basis": "Preserved application criteria were used to distinguish questions, comparisons, reports and trials, outcomes, denominators and harms.",
      "condition_origin": "These conditions apply to the existing subclaim. They do not establish preregistration, official assessment or completed content review.",
      "proposed_research": "Material needed: Threshold sources, prespecified definitions, patient-importance boundaries, direct effects, CIs and arm-specific denominators are needed. Absolute benefits, NNTs, intervals and boundaries are not newly calculated. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N22",
      "question_type": "Evidence condition",
      "question": "Are null core between-arm findings replaced by other results?",
      "needed": "Distinction between core comparisons, within-arm changes and outcome hierarchy",
      "role": "Required",
      "role_reason": "This condition links Distinction between core comparisons, within-arm changes and outcome hierarchy with populations, formulations, controls, denominators, measurement windows, prespecified criteria, analyses, support and harms for the selected prevention responder outcome.",
      "application_exception": "Retain original subclaim D and absent individual score, status and axes without inheriting parent D30. Distinguish responder proportions, mean changes, other pain outcomes, single-ingredient prevention, acute combinations and active controls. No new effects, CIs, denominators, independent totals, grades, dosing or treatment instructions are created.",
      "criterion": "Original material for Distinction between core comparisons, within-arm changes and outcome hierarchy must be linked to individual responder definitions, between-arm comparisons, denominators and measurement windows, distinguishing stored summaries, unread external material, within-arm changes and other acute-treatment questions.",
      "basis": "Preserved application criteria were used to distinguish questions, comparisons, reports and trials, outcomes, denominators and harms.",
      "condition_origin": "These conditions apply to the existing subclaim. They do not establish preregistration, official assessment or completed content review.",
      "proposed_research": "Material needed: Complete original findings, denominators, prespecified hierarchies, analyses, missingness and timing materials are needed. Unread original tables are not described as fully reviewed. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N23",
      "question_type": "Evidence condition",
      "question": "Are the original subclaim grade and parent score or axes distinguished?",
      "needed": "Subclaim D and absent individual score, status and axes",
      "role": "Required",
      "role_reason": "This condition links Subclaim D and absent individual score, status and axes with populations, formulations, controls, denominators, measurement windows, prespecified criteria, analyses, support and harms for the selected prevention responder outcome.",
      "application_exception": "Retain original subclaim D and absent individual score, status and axes without inheriting parent D30. Distinguish responder proportions, mean changes, other pain outcomes, single-ingredient prevention, acute combinations and active controls. No new effects, CIs, denominators, independent totals, grades, dosing or treatment instructions are created.",
      "criterion": "Original material for Subclaim D and absent individual score, status and axes must be linked to individual responder definitions, between-arm comparisons, denominators and measurement windows, distinguishing stored summaries, unread external material, within-arm changes and other acute-treatment questions.",
      "basis": "Preserved application criteria were used to distinguish questions, comparisons, reports and trials, outcomes, denominators and harms.",
      "condition_origin": "These conditions apply to the existing subclaim. They do not establish preregistration, official assessment or completed content review.",
      "proposed_research": "Material needed: Parent and subclaim questions and application scope need review. No new grades, scores, clinical statuses or independent certification are created. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N24",
      "question_type": "Evidence condition",
      "question": "Are stored summaries distinguished from actual external-material reading?",
      "needed": "Reading states for summaries, abstracts, full texts, registration and plans",
      "role": "Required",
      "role_reason": "This condition links Reading states for summaries, abstracts, full texts, registration and plans with populations, formulations, controls, denominators, measurement windows, prespecified criteria, analyses, support and harms for the selected prevention responder outcome.",
      "application_exception": "Retain original subclaim D and absent individual score, status and axes without inheriting parent D30. Distinguish responder proportions, mean changes, other pain outcomes, single-ingredient prevention, acute combinations and active controls. No new effects, CIs, denominators, independent totals, grades, dosing or treatment instructions are created.",
      "criterion": "Original material for Reading states for summaries, abstracts, full texts, registration and plans must be linked to individual responder definitions, between-arm comparisons, denominators and measurement windows, distinguishing stored summaries, unread external material, within-arm changes and other acute-treatment questions.",
      "basis": "Preserved application criteria were used to distinguish questions, comparisons, reports and trials, outcomes, denominators and harms.",
      "condition_origin": "These conditions apply to the existing subclaim. They do not establish preregistration, official assessment or completed content review.",
      "proposed_research": "Material needed: External acquisition, actual reading and content review are separate events. A link alone does not establish original reading, accessibility or completed review. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N25",
      "question_type": "Evidence condition",
      "question": "Are bilingual representative descriptions applied to every report and outcome?",
      "needed": "Scope of original language, formulations, populations and representative outcomes",
      "role": "Required",
      "role_reason": "This condition links Scope of original language, formulations, populations and representative outcomes with populations, formulations, controls, denominators, measurement windows, prespecified criteria, analyses, support and harms for the selected prevention responder outcome.",
      "application_exception": "Retain original subclaim D and absent individual score, status and axes without inheriting parent D30. Distinguish responder proportions, mean changes, other pain outcomes, single-ingredient prevention, acute combinations and active controls. No new effects, CIs, denominators, independent totals, grades, dosing or treatment instructions are created.",
      "criterion": "Original material for Scope of original language, formulations, populations and representative outcomes must be linked to individual responder definitions, between-arm comparisons, denominators and measurement windows, distinguishing stored summaries, unread external material, within-arm changes and other acute-treatment questions.",
      "basis": "Preserved application criteria were used to distinguish questions, comparisons, reports and trials, outcomes, denominators and harms.",
      "condition_origin": "These conditions apply to the existing subclaim. They do not establish preregistration, official assessment or completed content review.",
      "proposed_research": "Material needed: Report-specific populations, formulations, controls, outcomes, timing and denominators need comparison materials. No new external English-original comparison or correction review was performed. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N26",
      "question_type": "Evidence condition",
      "question": "Are the original evidence date, corrections and production records distinguished?",
      "needed": "Original evidence date and empty correction or deliberation records",
      "role": "Required",
      "role_reason": "This condition links Original evidence date and empty correction or deliberation records with populations, formulations, controls, denominators, measurement windows, prespecified criteria, analyses, support and harms for the selected prevention responder outcome.",
      "application_exception": "Retain original subclaim D and absent individual score, status and axes without inheriting parent D30. Distinguish responder proportions, mean changes, other pain outcomes, single-ingredient prevention, acute combinations and active controls. No new effects, CIs, denominators, independent totals, grades, dosing or treatment instructions are created.",
      "criterion": "Original material for Original evidence date and empty correction or deliberation records must be linked to individual responder definitions, between-arm comparisons, denominators and measurement windows, distinguishing stored summaries, unread external material, within-arm changes and other acute-treatment questions.",
      "basis": "Preserved application criteria were used to distinguish questions, comparisons, reports and trials, outcomes, denominators and harms.",
      "condition_origin": "These conditions apply to the existing subclaim. They do not establish preregistration, official assessment or completed content review.",
      "proposed_research": "Material needed: Additional materials, revised conditions, applied observations and judgment changes are separate events. Complete originals and reasons for changes must be preserved and linked to the required review. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N27",
      "question_type": "Evidence condition",
      "question": "Are report and material counts used as unique trials or quality scores?",
      "needed": "Distinction between preservation structure, unique clinical units and reading",
      "role": "Required",
      "role_reason": "This condition links Distinction between preservation structure, unique clinical units and reading with populations, formulations, controls, denominators, measurement windows, prespecified criteria, analyses, support and harms for the selected prevention responder outcome.",
      "application_exception": "Retain original subclaim D and absent individual score, status and axes without inheriting parent D30. Distinguish responder proportions, mean changes, other pain outcomes, single-ingredient prevention, acute combinations and active controls. No new effects, CIs, denominators, independent totals, grades, dosing or treatment instructions are created.",
      "criterion": "Original material for Distinction between preservation structure, unique clinical units and reading must be linked to individual responder definitions, between-arm comparisons, denominators and measurement windows, distinguishing stored summaries, unread external material, within-arm changes and other acute-treatment questions.",
      "basis": "Preserved application criteria were used to distinguish questions, comparisons, reports and trials, outcomes, denominators and harms.",
      "condition_origin": "These conditions apply to the existing subclaim. They do not establish preregistration, official assessment or completed content review.",
      "proposed_research": "Material needed: Original trial, report and cohort links and actual material-reading records are needed. Unique trial and participant totals remain unverified. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N28",
      "question_type": "Evidence condition",
      "question": "How are new materials or corrections linked?",
      "needed": "Distinction between condition revisions, material updates and judgment changes",
      "role": "Required",
      "role_reason": "This condition links Distinction between condition revisions, material updates and judgment changes with populations, formulations, controls, denominators, measurement windows, prespecified criteria, analyses, support and harms for the selected prevention responder outcome.",
      "application_exception": "Retain original subclaim D and absent individual score, status and axes without inheriting parent D30. Distinguish responder proportions, mean changes, other pain outcomes, single-ingredient prevention, acute combinations and active controls. No new effects, CIs, denominators, independent totals, grades, dosing or treatment instructions are created.",
      "criterion": "Original material for Distinction between condition revisions, material updates and judgment changes must be linked to individual responder definitions, between-arm comparisons, denominators and measurement windows, distinguishing stored summaries, unread external material, within-arm changes and other acute-treatment questions.",
      "basis": "Preserved application criteria were used to distinguish questions, comparisons, reports and trials, outcomes, denominators and harms.",
      "condition_origin": "These conditions apply to the existing subclaim. They do not establish preregistration, official assessment or completed content review.",
      "proposed_research": "Material needed: Complete prior originals, events, versions, reasons for changes and the required review must be recorded. New procedural or treatment instructions or clinical calculations are not created. This records needed materials; no new research was executed."
    }
  ]
}