{
  "schema_version": "chamgap-public-criteria-1.0",
  "title": "Ginger dry extract × Migraine—evidence sheet on reduced severe-pain days, acute analgesic use, or attack duration",
  "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 selected pain-related question?",
      "needed": "Original question covering severe-pain days, acute analgesic use and attack duration",
      "role": "Required",
      "role_reason": "This condition links Original question covering severe-pain days, acute analgesic use and attack duration with populations, interventions, controls, measurement, denominators, analyses, support and harms for the selected pain-day, analgesic-use and duration outcomes.",
      "application_exception": "Retain selected D and absent individual score, status and axes without inheriting parent D30. Distinguish pain days, analgesic use, duration and parent responder outcomes, within-arm and between-arm comparisons, single-ingredient prevention and acute combinations. No new effects, CIs, denominators, independent totals, grades, dosing or treatment instructions are created.",
      "criterion": "Original material for Original question covering severe-pain days, acute analgesic use and attack duration must be linked to each outcome definition, unit, denominator, time point and between-arm contrast, distinguishing stored summaries, unread external material, within-arm changes, parent responder outcomes and 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 wording and change records linking the selection with its parent prevention context are needed. Explaining outcomes separately does not make them new independent trials. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N02",
      "question_type": "Evidence condition",
      "question": "How do selected D and parent D30 differ?",
      "needed": "Distinction between question-specific grades, scores, status and original explanations",
      "role": "Required",
      "role_reason": "This condition links Distinction between question-specific grades, scores, status and original explanations with populations, interventions, controls, measurement, denominators, analyses, support and harms for the selected pain-day, analgesic-use and duration outcomes.",
      "application_exception": "Retain selected D and absent individual score, status and axes without inheriting parent D30. Distinguish pain days, analgesic use, duration and parent responder outcomes, within-arm and between-arm comparisons, single-ingredient prevention and acute combinations. No new effects, CIs, denominators, independent totals, grades, dosing or treatment instructions are created.",
      "criterion": "Original material for Distinction between question-specific grades, scores, status and original explanations must be linked to each outcome definition, unit, denominator, time point and between-arm contrast, distinguishing stored summaries, unread external material, within-arm changes, parent responder outcomes and 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: Separate score, status and axes are absent from the selection. Original selected and parent records must be preserved, with their scopes distinguished if an authorized correction occurs. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N03",
      "question_type": "Evidence condition",
      "question": "Which ginger dry extract do these findings concern?",
      "needed": "Single-ingredient oral extract, active-constituent standardization and product conditions",
      "role": "Required",
      "role_reason": "This condition links Single-ingredient oral extract, active-constituent standardization and product conditions with populations, interventions, controls, measurement, denominators, analyses, support and harms for the selected pain-day, analgesic-use and duration outcomes.",
      "application_exception": "Retain selected D and absent individual score, status and axes without inheriting parent D30. Distinguish pain days, analgesic use, duration and parent responder outcomes, within-arm and between-arm comparisons, single-ingredient prevention and acute combinations. No new effects, CIs, denominators, independent totals, grades, dosing or treatment instructions are created.",
      "criterion": "Original material for Single-ingredient oral extract, active-constituent standardization and product conditions must be linked to each outcome definition, unit, denominator, time point and between-arm contrast, distinguishing stored summaries, unread external material, within-arm changes, parent responder outcomes and 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 constituent markers, quantities, manufacturing, excipients, raw materials and quality records are needed. Direct effects are not transferred merely because products share a name. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N04",
      "question_type": "Evidence condition",
      "question": "What does 200 mg, 3 times daily for 3 months describe?",
      "needed": "Original trial exposure schedule, adherence, discontinuation and measurement timing",
      "role": "Required",
      "role_reason": "This condition links Original trial exposure schedule, adherence, discontinuation and measurement timing with populations, interventions, controls, measurement, denominators, analyses, support and harms for the selected pain-day, analgesic-use and duration outcomes.",
      "application_exception": "Retain selected D and absent individual score, status and axes without inheriting parent D30. Distinguish pain days, analgesic use, duration and parent responder outcomes, within-arm and between-arm comparisons, single-ingredient prevention and acute combinations. No new effects, CIs, denominators, independent totals, grades, dosing or treatment instructions are created.",
      "criterion": "Original material for Original trial exposure schedule, adherence, discontinuation and measurement timing must be linked to each outcome definition, unit, denominator, time point and between-arm contrast, distinguishing stored summaries, unread external material, within-arm changes, parent responder outcomes and 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 records linking actual administration, adherence, discontinuation and changes to visit-specific outcome denominators are needed. Scheduled and actual exposure are not treated as identical. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N05",
      "question_type": "Evidence condition",
      "question": "Which adults with episodic migraine were studied?",
      "needed": "Diagnosis, baseline severity, eligibility and concurrent care",
      "role": "Required",
      "role_reason": "This condition links Diagnosis, baseline severity, eligibility and concurrent care with populations, interventions, controls, measurement, denominators, analyses, support and harms for the selected pain-day, analgesic-use and duration outcomes.",
      "application_exception": "Retain selected D and absent individual score, status and axes without inheriting parent D30. Distinguish pain days, analgesic use, duration and parent responder outcomes, within-arm and between-arm comparisons, single-ingredient prevention and acute combinations. No new effects, CIs, denominators, independent totals, grades, dosing or treatment instructions are created.",
      "criterion": "Original material for Diagnosis, baseline severity, eligibility and concurrent care must be linked to each outcome definition, unit, denominator, time point and between-arm contrast, distinguishing stored summaries, unread external material, within-arm changes, parent responder outcomes and 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 eligibility, diagnosis, baseline attacks and pain, preventive and acute medication, exclusions and arm-specific distributions are needed. Applicability is not extended to other patient groups. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N06",
      "question_type": "Evidence condition",
      "question": "What placebo provided the direct comparison?",
      "needed": "Placebo composition, blinding, background care and direct between-arm comparisons",
      "role": "Required",
      "role_reason": "This condition links Placebo composition, blinding, background care and direct between-arm comparisons with populations, interventions, controls, measurement, denominators, analyses, support and harms for the selected pain-day, analgesic-use and duration outcomes.",
      "application_exception": "Retain selected D and absent individual score, status and axes without inheriting parent D30. Distinguish pain days, analgesic use, duration and parent responder outcomes, within-arm and between-arm comparisons, single-ingredient prevention and acute combinations. No new effects, CIs, denominators, independent totals, grades, dosing or treatment instructions are created.",
      "criterion": "Original material for Placebo composition, blinding, background care and direct between-arm comparisons must be linked to each outcome definition, unit, denominator, time point and between-arm contrast, distinguishing stored summaries, unread external material, within-arm changes, parent responder outcomes and 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: Placebo ingredients, appearance and sensory matching, arm-specific concurrent care, adherence and contrast plans are needed. Design labels alone do not verify procedural details. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N07",
      "question_type": "Evidence condition",
      "question": "Are 3-month prevention and acute-attack treatment the same question?",
      "needed": "Distinction between outcomes within prevention, acute treatment and post-treatment persistence",
      "role": "Required",
      "role_reason": "This condition links Distinction between outcomes within prevention, acute treatment and post-treatment persistence with populations, interventions, controls, measurement, denominators, analyses, support and harms for the selected pain-day, analgesic-use and duration outcomes.",
      "application_exception": "Retain selected D and absent individual score, status and axes without inheriting parent D30. Distinguish pain days, analgesic use, duration and parent responder outcomes, within-arm and between-arm comparisons, single-ingredient prevention and acute combinations. No new effects, CIs, denominators, independent totals, grades, dosing or treatment instructions are created.",
      "criterion": "Original material for Distinction between outcomes within prevention, acute treatment and post-treatment persistence must be linked to each outcome definition, unit, denominator, time point and between-arm contrast, distinguishing stored summaries, unread external material, within-arm changes, parent responder outcomes and 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, visits, attack definitions, diaries and outcome-specific measurement windows are needed. Post-treatment persistence and contributions from acute treatment require separate information. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N08",
      "question_type": "Evidence condition",
      "question": "How were the three outcomes measured and expressed?",
      "needed": "Definitions and aggregation of severe-pain days, acute medication use and attack duration",
      "role": "Required",
      "role_reason": "This condition links Definitions and aggregation of severe-pain days, acute medication use and attack duration with populations, interventions, controls, measurement, denominators, analyses, support and harms for the selected pain-day, analgesic-use and duration outcomes.",
      "application_exception": "Retain selected D and absent individual score, status and axes without inheriting parent D30. Distinguish pain days, analgesic use, duration and parent responder outcomes, within-arm and between-arm comparisons, single-ingredient prevention and acute combinations. No new effects, CIs, denominators, independent totals, grades, dosing or treatment instructions are created.",
      "criterion": "Original material for Definitions and aggregation of severe-pain days, acute medication use and attack duration must be linked to each outcome definition, unit, denominator, time point and between-arm contrast, distinguishing stored summaries, unread external material, within-arm changes, parent responder outcomes and 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: The severe-pain threshold, aggregation of days, attacks and medication use, time units, recorders, timing and individual denominators are needed. Outcome names in the summary do not establish measurement details. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N09",
      "question_type": "Evidence condition",
      "question": "What is the original finding for severe-pain days?",
      "needed": "Direct between-arm estimate, interval, units and denominator for severe-pain days",
      "role": "Required",
      "role_reason": "This condition links Direct between-arm estimate, interval, units and denominator for severe-pain days with populations, interventions, controls, measurement, denominators, analyses, support and harms for the selected pain-day, analgesic-use and duration outcomes.",
      "application_exception": "Retain selected D and absent individual score, status and axes without inheriting parent D30. Distinguish pain days, analgesic use, duration and parent responder outcomes, within-arm and between-arm comparisons, single-ingredient prevention and acute combinations. No new effects, CIs, denominators, independent totals, grades, dosing or treatment instructions are created.",
      "criterion": "Original material for Direct between-arm estimate, interval, units and denominator for severe-pain days must be linked to each outcome definition, unit, denominator, time point and between-arm contrast, distinguishing stored summaries, unread external material, within-arm changes, parent responder outcomes and 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 result tables specifying pain-day definitions, aggregation, denominators, adjustment and exact effects, CIs and P values are needed. Missing values are not filled using another outcome's numbers. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N10",
      "question_type": "Evidence condition",
      "question": "What is the original finding for acute analgesic use?",
      "needed": "Acute medication types, use aggregation and direct comparison with placebo",
      "role": "Required",
      "role_reason": "This condition links Acute medication types, use aggregation and direct comparison with placebo with populations, interventions, controls, measurement, denominators, analyses, support and harms for the selected pain-day, analgesic-use and duration outcomes.",
      "application_exception": "Retain selected D and absent individual score, status and axes without inheriting parent D30. Distinguish pain days, analgesic use, duration and parent responder outcomes, within-arm and between-arm comparisons, single-ingredient prevention and acute combinations. No new effects, CIs, denominators, independent totals, grades, dosing or treatment instructions are created.",
      "criterion": "Original material for Acute medication types, use aggregation and direct comparison with placebo must be linked to each outcome definition, unit, denominator, time point and between-arm contrast, distinguishing stored summaries, unread external material, within-arm changes, parent responder outcomes and 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: Medication types, rescue rules, quantities and frequency, background-medication changes, denominators, exact effects and intervals are needed. No new tapering or treatment guidance is created. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N11",
      "question_type": "Evidence condition",
      "question": "What is the original finding for attack duration?",
      "needed": "Attack onset, ending, time aggregation and between-arm estimation",
      "role": "Required",
      "role_reason": "This condition links Attack onset, ending, time aggregation and between-arm estimation with populations, interventions, controls, measurement, denominators, analyses, support and harms for the selected pain-day, analgesic-use and duration outcomes.",
      "application_exception": "Retain selected D and absent individual score, status and axes without inheriting parent D30. Distinguish pain days, analgesic use, duration and parent responder outcomes, within-arm and between-arm comparisons, single-ingredient prevention and acute combinations. No new effects, CIs, denominators, independent totals, grades, dosing or treatment instructions are created.",
      "criterion": "Original material for Attack onset, ending, time aggregation and between-arm estimation must be linked to each outcome definition, unit, denominator, time point and between-arm contrast, distinguishing stored summaries, unread external material, within-arm changes, parent responder outcomes and 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 attack diaries, onset and ending definitions, time units, duplicate aggregation, acute-medication effects, models, denominators and CIs are needed. Exact durations or effects are not newly calculated. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N12",
      "question_type": "Evidence condition",
      "question": "Is the 50% responder outcome the same as the selected pain outcomes?",
      "needed": "Distinction between the parent responder outcome and pain days, medication use and duration",
      "role": "Required",
      "role_reason": "This condition links Distinction between the parent responder outcome and pain days, medication use and duration with populations, interventions, controls, measurement, denominators, analyses, support and harms for the selected pain-day, analgesic-use and duration outcomes.",
      "application_exception": "Retain selected D and absent individual score, status and axes without inheriting parent D30. Distinguish pain days, analgesic use, duration and parent responder outcomes, within-arm and between-arm comparisons, single-ingredient prevention and acute combinations. No new effects, CIs, denominators, independent totals, grades, dosing or treatment instructions are created.",
      "criterion": "Original material for Distinction between the parent responder outcome and pain days, medication use and duration must be linked to each outcome definition, unit, denominator, time point and between-arm contrast, distinguishing stored summaries, unread external material, within-arm changes, parent responder outcomes and 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 plans, hierarchy, full result tables, denominators and analyses for each outcome are needed. The responder criterion is not used as a clinical threshold for other outcomes. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N13",
      "question_type": "Evidence condition",
      "question": "How should changes over time in both arms be interpreted?",
      "needed": "Distinction between within-arm changes and direct effects versus placebo",
      "role": "Required",
      "role_reason": "This condition links Distinction between within-arm changes and direct effects versus placebo with populations, interventions, controls, measurement, denominators, analyses, support and harms for the selected pain-day, analgesic-use and duration outcomes.",
      "application_exception": "Retain selected D and absent individual score, status and axes without inheriting parent D30. Distinguish pain days, analgesic use, duration and parent responder outcomes, within-arm and between-arm comparisons, single-ingredient prevention and acute combinations. No new effects, CIs, denominators, independent totals, grades, dosing or treatment instructions are created.",
      "criterion": "Original material for Distinction between within-arm changes and direct effects versus placebo must be linked to each outcome definition, unit, denominator, time point and between-arm contrast, distinguishing stored summaries, unread external material, within-arm changes, parent responder outcomes and 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, final and time-specific values, direct between-arm contrasts, adjustment models, intervals and denominators are needed. Within-arm changes are not subtracted to create a new effect. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N14",
      "question_type": "Evidence condition",
      "question": "Does no between-arm difference prove an exact zero effect?",
      "needed": "Distinction between effect magnitude, exact intervals, precision and importance",
      "role": "Required",
      "role_reason": "This condition links Distinction between effect magnitude, exact intervals, precision and importance with populations, interventions, controls, measurement, denominators, analyses, support and harms for the selected pain-day, analgesic-use and duration outcomes.",
      "application_exception": "Retain selected D and absent individual score, status and axes without inheriting parent D30. Distinguish pain days, analgesic use, duration and parent responder outcomes, within-arm and between-arm comparisons, single-ingredient prevention and acute combinations. No new effects, CIs, denominators, independent totals, grades, dosing or treatment instructions are created.",
      "criterion": "Original material for Distinction between effect magnitude, exact intervals, precision and importance must be linked to each outcome definition, unit, denominator, time point and between-arm contrast, distinguishing stored summaries, unread external material, within-arm changes, parent responder outcomes and 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: Exact point estimates, CIs, variance, denominators, models and clinical importance thresholds for each outcome are needed. No new CIs, effects, grades or equivalence judgments are created. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N15",
      "question_type": "Evidence condition",
      "question": "What denominator does the figure of 107 adults describe?",
      "needed": "Overall randomized size versus arm, outcome, attack and diary analysis denominators",
      "role": "Required",
      "role_reason": "This condition links Overall randomized size versus arm, outcome, attack and diary analysis denominators with populations, interventions, controls, measurement, denominators, analyses, support and harms for the selected pain-day, analgesic-use and duration outcomes.",
      "application_exception": "Retain selected D and absent individual score, status and axes without inheriting parent D30. Distinguish pain days, analgesic use, duration and parent responder outcomes, within-arm and between-arm comparisons, single-ingredient prevention and acute combinations. No new effects, CIs, denominators, independent totals, grades, dosing or treatment instructions are created.",
      "criterion": "Original material for Overall randomized size versus arm, outcome, attack and diary analysis denominators must be linked to each outcome definition, unit, denominator, time point and between-arm contrast, distinguishing stored summaries, unread external material, within-arm changes, parent responder outcomes and 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: Flow diagrams, arm-specific allocation, completion, exclusions, outcome denominators, diary and attack units and observation time are needed. New participant or event totals are not calculated. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N16",
      "question_type": "Evidence condition",
      "question": "Do randomized and double-blind labels verify the procedures?",
      "needed": "Details of allocation, concealment, blinding and outcome measurement",
      "role": "Required",
      "role_reason": "This condition links Details of allocation, concealment, blinding and outcome measurement with populations, interventions, controls, measurement, denominators, analyses, support and harms for the selected pain-day, analgesic-use and duration outcomes.",
      "application_exception": "Retain selected D and absent individual score, status and axes without inheriting parent D30. Distinguish pain days, analgesic use, duration and parent responder outcomes, within-arm and between-arm comparisons, single-ingredient prevention and acute combinations. No new effects, CIs, denominators, independent totals, grades, dosing or treatment instructions are created.",
      "criterion": "Original material for Details of allocation, concealment, blinding and outcome measurement must be linked to each outcome definition, unit, denominator, time point and between-arm contrast, distinguishing stored summaries, unread external material, within-arm changes, parent responder outcomes and 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: Sequence generation, concealment, blinded parties and maintenance, assessors, baseline balance and measurement procedures are needed. External originals are not labeled as read. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N17",
      "question_type": "Evidence condition",
      "question": "Are the selected outcomes' prespecified hierarchy and analyses verified?",
      "needed": "Outcome hierarchy and changes in registration, protocols and analysis plans",
      "role": "Required",
      "role_reason": "This condition links Outcome hierarchy and changes in registration, protocols and analysis plans with populations, interventions, controls, measurement, denominators, analyses, support and harms for the selected pain-day, analgesic-use and duration outcomes.",
      "application_exception": "Retain selected D and absent individual score, status and axes without inheriting parent D30. Distinguish pain days, analgesic use, duration and parent responder outcomes, within-arm and between-arm comparisons, single-ingredient prevention and acute combinations. No new effects, CIs, denominators, independent totals, grades, dosing or treatment instructions are created.",
      "criterion": "Original material for Outcome hierarchy and changes in registration, protocols and analysis plans must be linked to each outcome definition, unit, denominator, time point and between-arm contrast, distinguishing stored summaries, unread external material, within-arm changes, parent responder outcomes and 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 history, protocols, analysis plans, plan timing, changes and multiplicity handling are needed. Current materials are not used as certification of preregistration. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N18",
      "question_type": "Evidence condition",
      "question": "Who measured the outcomes, using which diaries and instruments?",
      "needed": "Recording, validation and measurement windows for pain, medication use and duration",
      "role": "Required",
      "role_reason": "This condition links Recording, validation and measurement windows for pain, medication use and duration with populations, interventions, controls, measurement, denominators, analyses, support and harms for the selected pain-day, analgesic-use and duration outcomes.",
      "application_exception": "Retain selected D and absent individual score, status and axes without inheriting parent D30. Distinguish pain days, analgesic use, duration and parent responder outcomes, within-arm and between-arm comparisons, single-ingredient prevention and acute combinations. No new effects, CIs, denominators, independent totals, grades, dosing or treatment instructions are created.",
      "criterion": "Original material for Recording, validation and measurement windows for pain, medication use and duration must be linked to each outcome definition, unit, denominator, time point and between-arm contrast, distinguishing stored summaries, unread external material, within-arm changes, parent responder outcomes and 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 diaries, scales, recorders, assessor blinding, record validation, missing entries and time-window records are needed. Measurement procedures unverified within the preserved scope remain unverified. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N19",
      "question_type": "Evidence condition",
      "question": "Are adherence, deviations and background medication distinguished from ginger's contribution?",
      "needed": "Actual exposure, preventive and acute medications, changes and analysis targets",
      "role": "Required",
      "role_reason": "This condition links Actual exposure, preventive and acute medications, changes and analysis targets with populations, interventions, controls, measurement, denominators, analyses, support and harms for the selected pain-day, analgesic-use and duration outcomes.",
      "application_exception": "Retain selected D and absent individual score, status and axes without inheriting parent D30. Distinguish pain days, analgesic use, duration and parent responder outcomes, within-arm and between-arm comparisons, single-ingredient prevention and acute combinations. No new effects, CIs, denominators, independent totals, grades, dosing or treatment instructions are created.",
      "criterion": "Original material for Actual exposure, preventive and acute medications, changes and analysis targets must be linked to each outcome definition, unit, denominator, time point and between-arm contrast, distinguishing stored summaries, unread external material, within-arm changes, parent responder outcomes and 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: Administration, concurrent care, changes, discontinuation, crossover, arm-specific records and analysis plans are needed. Changes in concurrent care are not attributed solely to ginger itself. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N20",
      "question_type": "Evidence condition",
      "question": "Which outcomes and records were missing from analysis?",
      "needed": "Missing data and follow-up loss by arm, outcome, attack and diary",
      "role": "Required",
      "role_reason": "This condition links Missing data and follow-up loss by arm, outcome, attack and diary with populations, interventions, controls, measurement, denominators, analyses, support and harms for the selected pain-day, analgesic-use and duration outcomes.",
      "application_exception": "Retain selected D and absent individual score, status and axes without inheriting parent D30. Distinguish pain days, analgesic use, duration and parent responder outcomes, within-arm and between-arm comparisons, single-ingredient prevention and acute combinations. No new effects, CIs, denominators, independent totals, grades, dosing or treatment instructions are created.",
      "criterion": "Original material for Missing data and follow-up loss by arm, outcome, attack and diary must be linked to each outcome definition, unit, denominator, time point and between-arm contrast, distinguishing stored summaries, unread external material, within-arm changes, parent responder outcomes and 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: Dropout, exclusions, record-validity criteria, arm-specific missingness, adjustments and sensitivity analyses are needed. Absence of missing data or analysis of every participant is not assumed. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N21",
      "question_type": "Evidence condition",
      "question": "Which effect was estimated for each outcome?",
      "needed": "Analysis populations, units, direct contrasts, adjustment and repeated measurements",
      "role": "Required",
      "role_reason": "This condition links Analysis populations, units, direct contrasts, adjustment and repeated measurements with populations, interventions, controls, measurement, denominators, analyses, support and harms for the selected pain-day, analgesic-use and duration outcomes.",
      "application_exception": "Retain selected D and absent individual score, status and axes without inheriting parent D30. Distinguish pain days, analgesic use, duration and parent responder outcomes, within-arm and between-arm comparisons, single-ingredient prevention and acute combinations. No new effects, CIs, denominators, independent totals, grades, dosing or treatment instructions are created.",
      "criterion": "Original material for Analysis populations, units, direct contrasts, adjustment and repeated measurements must be linked to each outcome definition, unit, denominator, time point and between-arm contrast, distinguishing stored summaries, unread external material, within-arm changes, parent responder outcomes and 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: ITT and PP distinctions, baseline adjustment, repeated-attack and measurement models, exact estimates, CIs and denominators are needed. Different analysis levels are not combined as the same result. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N22",
      "question_type": "Evidence condition",
      "question": "Is the clinical importance of the pain outcomes established?",
      "needed": "Units, importance thresholds and patient-important changes for each measure",
      "role": "Required",
      "role_reason": "This condition links Units, importance thresholds and patient-important changes for each measure with populations, interventions, controls, measurement, denominators, analyses, support and harms for the selected pain-day, analgesic-use and duration outcomes.",
      "application_exception": "Retain selected D and absent individual score, status and axes without inheriting parent D30. Distinguish pain days, analgesic use, duration and parent responder outcomes, within-arm and between-arm comparisons, single-ingredient prevention and acute combinations. No new effects, CIs, denominators, independent totals, grades, dosing or treatment instructions are created.",
      "criterion": "Original material for Units, importance thresholds and patient-important changes for each measure must be linked to each outcome definition, unit, denominator, time point and between-arm contrast, distinguishing stored summaries, unread external material, within-arm changes, parent responder outcomes and 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: Measurement evidence, thresholds, distributions, intervals and patient-importance information for each outcome are needed. Arbitrary importance boundaries or individual applications are not created. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N23",
      "question_type": "Evidence condition",
      "question": "Can 3-month findings be applied to longer periods, other populations or doses?",
      "needed": "Scope of trial duration, population, dose and post-treatment persistence",
      "role": "Required",
      "role_reason": "This condition links Scope of trial duration, population, dose and post-treatment persistence with populations, interventions, controls, measurement, denominators, analyses, support and harms for the selected pain-day, analgesic-use and duration outcomes.",
      "application_exception": "Retain selected D and absent individual score, status and axes without inheriting parent D30. Distinguish pain days, analgesic use, duration and parent responder outcomes, within-arm and between-arm comparisons, single-ingredient prevention and acute combinations. No new effects, CIs, denominators, independent totals, grades, dosing or treatment instructions are created.",
      "criterion": "Original material for Scope of trial duration, population, dose and post-treatment persistence must be linked to each outcome definition, unit, denominator, time point and between-arm contrast, distinguishing stored summaries, unread external material, within-arm changes, parent responder outcomes and 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, direct comparisons, original exposure and prespecified subgroup and interaction information are needed. Persistence or effects in other populations are not newly established. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N24",
      "question_type": "Evidence condition",
      "question": "Are no between-arm differences and within-arm changes both preserved?",
      "needed": "Complete results, within-arm changes, direct comparisons and precision gaps",
      "role": "Required",
      "role_reason": "This condition links Complete results, within-arm changes, direct comparisons and precision gaps with populations, interventions, controls, measurement, denominators, analyses, support and harms for the selected pain-day, analgesic-use and duration outcomes.",
      "application_exception": "Retain selected D and absent individual score, status and axes without inheriting parent D30. Distinguish pain days, analgesic use, duration and parent responder outcomes, within-arm and between-arm comparisons, single-ingredient prevention and acute combinations. No new effects, CIs, denominators, independent totals, grades, dosing or treatment instructions are created.",
      "criterion": "Original material for Complete results, within-arm changes, direct comparisons and precision gaps must be linked to each outcome definition, unit, denominator, time point and between-arm contrast, distinguishing stored summaries, unread external material, within-arm changes, parent responder outcomes and 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 result tables, outcome and report lists, exact estimates and intervals are needed. No new conflict judgment is created without establishing the scope of conflicting or additional reports. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N25",
      "question_type": "Evidence condition",
      "question": "Are shared reports and outcomes counted as independent trials?",
      "needed": "Links between the same report, trial, cohort and selected or parent outcomes",
      "role": "Required",
      "role_reason": "This condition links Links between the same report, trial, cohort and selected or parent outcomes with populations, interventions, controls, measurement, denominators, analyses, support and harms for the selected pain-day, analgesic-use and duration outcomes.",
      "application_exception": "Retain selected D and absent individual score, status and axes without inheriting parent D30. Distinguish pain days, analgesic use, duration and parent responder outcomes, within-arm and between-arm comparisons, single-ingredient prevention and acute combinations. No new effects, CIs, denominators, independent totals, grades, dosing or treatment instructions are created.",
      "criterion": "Original material for Links between the same report, trial, cohort and selected or parent outcomes must be linked to each outcome definition, unit, denominator, time point and between-arm contrast, distinguishing stored summaries, unread external material, within-arm changes, parent responder outcomes and 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, recruitment, related reports and family links between outcomes and analyses are needed. Unique trial, participant, attack and event totals remain unverified. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N26",
      "question_type": "Evidence condition",
      "question": "Do acute combination and active-control studies replicate the same prevention question?",
      "needed": "Distinction between feverfew combinations, sumatriptan controls and single-ingredient prevention",
      "role": "Required",
      "role_reason": "This condition links Distinction between feverfew combinations, sumatriptan controls and single-ingredient prevention with populations, interventions, controls, measurement, denominators, analyses, support and harms for the selected pain-day, analgesic-use and duration outcomes.",
      "application_exception": "Retain selected D and absent individual score, status and axes without inheriting parent D30. Distinguish pain days, analgesic use, duration and parent responder outcomes, within-arm and between-arm comparisons, single-ingredient prevention and acute combinations. No new effects, CIs, denominators, independent totals, grades, dosing or treatment instructions are created.",
      "criterion": "Original material for Distinction between feverfew combinations, sumatriptan controls and single-ingredient prevention must be linked to each outcome definition, unit, denominator, time point and between-arm contrast, distinguishing stored summaries, unread external material, within-arm changes, parent responder outcomes and 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: Authorized existing originals and information on intervention, population, comparator, period and outcome relevance are needed. Bibliographies, effects or independent-replication counts absent from the original account are not created. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N27",
      "question_type": "Evidence condition",
      "question": "What does the identifier NCT02570633 establish?",
      "needed": "Distinction between the registration string, registration content and prespecification",
      "role": "Required",
      "role_reason": "This condition links Distinction between the registration string, registration content and prespecification with populations, interventions, controls, measurement, denominators, analyses, support and harms for the selected pain-day, analgesic-use and duration outcomes.",
      "application_exception": "Retain selected D and absent individual score, status and axes without inheriting parent D30. Distinguish pain days, analgesic use, duration and parent responder outcomes, within-arm and between-arm comparisons, single-ingredient prevention and acute combinations. No new effects, CIs, denominators, independent totals, grades, dosing or treatment instructions are created.",
      "criterion": "Original material for Distinction between the registration string, registration content and prespecification must be linked to each outcome definition, unit, denominator, time point and between-arm contrast, distinguishing stored summaries, unread external material, within-arm changes, parent responder outcomes and 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 history, protocols, analysis plans and links to reports are needed. Registration URLs are not guessed and unread content is not labeled as verified. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N28",
      "question_type": "Evidence condition",
      "question": "What do manufacturer independence and full-text support checking describe?",
      "needed": "Distinction between historical support-checking statements and current reading or role verification",
      "role": "Required",
      "role_reason": "This condition links Distinction between historical support-checking statements and current reading or role verification with populations, interventions, controls, measurement, denominators, analyses, support and harms for the selected pain-day, analgesic-use and duration outcomes.",
      "application_exception": "Retain selected D and absent individual score, status and axes without inheriting parent D30. Distinguish pain days, analgesic use, duration and parent responder outcomes, within-arm and between-arm comparisons, single-ingredient prevention and acute combinations. No new effects, CIs, denominators, independent totals, grades, dosing or treatment instructions are created.",
      "criterion": "Original material for Distinction between historical support-checking statements and current reading or role verification must be linked to each outcome definition, unit, denominator, time point and between-arm contrast, distinguishing stored summaries, unread external material, within-arm changes, parent responder outcomes and 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 funding, COI and roles in finance, product provision, authorship, analysis and publication are needed. Historical checking statements are not inherited as completed current external comparison. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N29",
      "question_type": "Evidence condition",
      "question": "Which materials were actually read and which are needed?",
      "needed": "Distinction between stored summaries, external abstracts, full texts, registration and needed materials",
      "role": "Required",
      "role_reason": "This condition links Distinction between stored summaries, external abstracts, full texts, registration and needed materials with populations, interventions, controls, measurement, denominators, analyses, support and harms for the selected pain-day, analgesic-use and duration outcomes.",
      "application_exception": "Retain selected D and absent individual score, status and axes without inheriting parent D30. Distinguish pain days, analgesic use, duration and parent responder outcomes, within-arm and between-arm comparisons, single-ingredient prevention and acute combinations. No new effects, CIs, denominators, independent totals, grades, dosing or treatment instructions are created.",
      "criterion": "Original material for Distinction between stored summaries, external abstracts, full texts, registration and needed materials must be linked to each outcome definition, unit, denominator, time point and between-arm contrast, distinguishing stored summaries, unread external material, within-arm changes, parent responder outcomes and 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: Authorized originals, individual result tables, diaries, registration and plans are needed. Links or needed-material entries are not converted into acquisition, full-text reading or access failure. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N30",
      "question_type": "Evidence condition",
      "question": "How do the original evidence date and this production date differ?",
      "needed": "Preserved evidence date, historical checking, corrections and production timing",
      "role": "Required",
      "role_reason": "This condition links Preserved evidence date, historical checking, corrections and production timing with populations, interventions, controls, measurement, denominators, analyses, support and harms for the selected pain-day, analgesic-use and duration outcomes.",
      "application_exception": "Retain selected D and absent individual score, status and axes without inheriting parent D30. Distinguish pain days, analgesic use, duration and parent responder outcomes, within-arm and between-arm comparisons, single-ingredient prevention and acute combinations. No new effects, CIs, denominators, independent totals, grades, dosing or treatment instructions are created.",
      "criterion": "Original material for Preserved evidence date, historical checking, corrections and production timing must be linked to each outcome definition, unit, denominator, time point and between-arm contrast, distinguishing stored summaries, unread external material, within-arm changes, parent responder outcomes and 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: Actual historical access locations, timing, search scope and original correction records are needed. Evidence dates, condition-authoring dates and view-production dates are preserved as separate roles. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N31",
      "question_type": "Evidence condition",
      "question": "Are the selected Korean and English wording and parent context retained?",
      "needed": "Original wording, grade and explanation for pain outcomes versus parent prevention context",
      "role": "Required",
      "role_reason": "This condition links Original wording, grade and explanation for pain outcomes versus parent prevention context with populations, interventions, controls, measurement, denominators, analyses, support and harms for the selected pain-day, analgesic-use and duration outcomes.",
      "application_exception": "Retain selected D and absent individual score, status and axes without inheriting parent D30. Distinguish pain days, analgesic use, duration and parent responder outcomes, within-arm and between-arm comparisons, single-ingredient prevention and acute combinations. No new effects, CIs, denominators, independent totals, grades, dosing or treatment instructions are created.",
      "criterion": "Original material for Original wording, grade and explanation for pain outcomes versus parent prevention context must be linked to each outcome definition, unit, denominator, time point and between-arm contrast, distinguishing stored summaries, unread external material, within-arm changes, parent responder outcomes and 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: The original selected and parent wording in both languages must be linked to authorized correction records. Scores or status absent from the selection are not created during translation. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N32",
      "question_type": "Evidence condition",
      "question": "Do parent axes and empty fields certify review of the selected outcomes?",
      "needed": "Parent axes and flags versus absence of a separate selected-question assessment",
      "role": "Required",
      "role_reason": "This condition links Parent axes and flags versus absence of a separate selected-question assessment with populations, interventions, controls, measurement, denominators, analyses, support and harms for the selected pain-day, analgesic-use and duration outcomes.",
      "application_exception": "Retain selected D and absent individual score, status and axes without inheriting parent D30. Distinguish pain days, analgesic use, duration and parent responder outcomes, within-arm and between-arm comparisons, single-ingredient prevention and acute combinations. No new effects, CIs, denominators, independent totals, grades, dosing or treatment instructions are created.",
      "criterion": "Original material for Parent axes and flags versus absence of a separate selected-question assessment must be linked to each outcome definition, unit, denominator, time point and between-arm contrast, distinguishing stored summaries, unread external material, within-arm changes, parent responder outcomes and 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: The applicable question for each original field and authorized change records must be distinguished. Numbers or empty fields are not used as new certification of independence, precision or safety. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N33",
      "question_type": "Evidence condition",
      "question": "What harm information concerns heartburn and abdominal discomfort?",
      "needed": "General cautions versus direct event data for the selected product",
      "role": "Required",
      "role_reason": "This condition links General cautions versus direct event data for the selected product with populations, interventions, controls, measurement, denominators, analyses, support and harms for the selected pain-day, analgesic-use and duration outcomes.",
      "application_exception": "Retain selected D and absent individual score, status and axes without inheriting parent D30. Distinguish pain days, analgesic use, duration and parent responder outcomes, within-arm and between-arm comparisons, single-ingredient prevention and acute combinations. No new effects, CIs, denominators, independent totals, grades, dosing or treatment instructions are created.",
      "criterion": "Original material for General cautions versus direct event data for the selected product must be linked to each outcome definition, unit, denominator, time point and between-arm contrast, distinguishing stored summaries, unread external material, within-arm changes, parent responder outcomes and 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 adverse-event definitions, collection, severity, arm-specific people and events, exposure and denominators are needed. Reporting gaps are not labeled as absence of events or safety. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N34",
      "question_type": "Evidence condition",
      "question": "Are harm onset, discontinuation and recovery times known?",
      "needed": "Timing of exposure, event onset, recovery and re-exposure",
      "role": "Required",
      "role_reason": "This condition links Timing of exposure, event onset, recovery and re-exposure with populations, interventions, controls, measurement, denominators, analyses, support and harms for the selected pain-day, analgesic-use and duration outcomes.",
      "application_exception": "Retain selected D and absent individual score, status and axes without inheriting parent D30. Distinguish pain days, analgesic use, duration and parent responder outcomes, within-arm and between-arm comparisons, single-ingredient prevention and acute combinations. No new effects, CIs, denominators, independent totals, grades, dosing or treatment instructions are created.",
      "criterion": "Original material for Timing of exposure, event onset, recovery and re-exposure must be linked to each outcome definition, unit, denominator, time point and between-arm contrast, distinguishing stored summaries, unread external material, within-arm changes, parent responder outcomes and 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 records of exposure, onset, latency, discontinuation, recovery, re-exposure and observation periods are needed. Missing timing information does not establish absence of harm. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N35",
      "question_type": "Evidence condition",
      "question": "Can harm frequency and comparative risk be established?",
      "needed": "Denominators for exposed people, events, time and direct comparisons",
      "role": "Required",
      "role_reason": "This condition links Denominators for exposed people, events, time and direct comparisons with populations, interventions, controls, measurement, denominators, analyses, support and harms for the selected pain-day, analgesic-use and duration outcomes.",
      "application_exception": "Retain selected D and absent individual score, status and axes without inheriting parent D30. Distinguish pain days, analgesic use, duration and parent responder outcomes, within-arm and between-arm comparisons, single-ingredient prevention and acute combinations. No new effects, CIs, denominators, independent totals, grades, dosing or treatment instructions are created.",
      "criterion": "Original material for Denominators for exposed people, events, time and direct comparisons must be linked to each outcome definition, unit, denominator, time point and between-arm contrast, distinguishing stored summaries, unread external material, within-arm changes, parent responder outcomes and 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 events, people, duplication, exposure, observation time, collection methods, direct comparisons and CIs are needed. Risk numbers are not created from material without denominators. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N36",
      "question_type": "Evidence condition",
      "question": "What is the scope of anticoagulant, antiplatelet, bleeding and surgery cautions?",
      "needed": "Existing concurrent-medication and baseline-risk cautions versus direct interaction data",
      "role": "Required",
      "role_reason": "This condition links Existing concurrent-medication and baseline-risk cautions versus direct interaction data with populations, interventions, controls, measurement, denominators, analyses, support and harms for the selected pain-day, analgesic-use and duration outcomes.",
      "application_exception": "Retain selected D and absent individual score, status and axes without inheriting parent D30. Distinguish pain days, analgesic use, duration and parent responder outcomes, within-arm and between-arm comparisons, single-ingredient prevention and acute combinations. No new effects, CIs, denominators, independent totals, grades, dosing or treatment instructions are created.",
      "criterion": "Original material for Existing concurrent-medication and baseline-risk cautions versus direct interaction data must be linked to each outcome definition, unit, denominator, time point and between-arm contrast, distinguishing stored summaries, unread external material, within-arm changes, parent responder outcomes and 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: Concurrent medication, baseline risk, alternative causes, direct events and long-term, rare-harm and special-population information are needed. New medication changes or discontinuation instructions are not proposed. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N37",
      "question_type": "Evidence condition",
      "question": "Can missing reports and repeated citations be counted as independent harm events?",
      "needed": "Harms collection, follow-up loss, unique people and events, and report families",
      "role": "Required",
      "role_reason": "This condition links Harms collection, follow-up loss, unique people and events, and report families with populations, interventions, controls, measurement, denominators, analyses, support and harms for the selected pain-day, analgesic-use and duration outcomes.",
      "application_exception": "Retain selected D and absent individual score, status and axes without inheriting parent D30. Distinguish pain days, analgesic use, duration and parent responder outcomes, within-arm and between-arm comparisons, single-ingredient prevention and acute combinations. No new effects, CIs, denominators, independent totals, grades, dosing or treatment instructions are created.",
      "criterion": "Original material for Harms collection, follow-up loss, unique people and events, and report families must be linked to each outcome definition, unit, denominator, time point and between-arm contrast, distinguishing stored summaries, unread external material, within-arm changes, parent responder outcomes and 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 collection, detection, reporting, follow-up loss and family links between related reports are needed. Repeated citations are not added as events, and missing reporting is not converted into absence of events. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N38",
      "question_type": "Evidence condition",
      "question": "How far do the original null findings and evidence gaps extend?",
      "needed": "Between-arm nonsignificance, within-arm changes, precision and interpretation for each outcome",
      "role": "Required",
      "role_reason": "This condition links Between-arm nonsignificance, within-arm changes, precision and interpretation for each outcome with populations, interventions, controls, measurement, denominators, analyses, support and harms for the selected pain-day, analgesic-use and duration outcomes.",
      "application_exception": "Retain selected D and absent individual score, status and axes without inheriting parent D30. Distinguish pain days, analgesic use, duration and parent responder outcomes, within-arm and between-arm comparisons, single-ingredient prevention and acute combinations. No new effects, CIs, denominators, independent totals, grades, dosing or treatment instructions are created.",
      "criterion": "Original material for Between-arm nonsignificance, within-arm changes, precision and interpretation for each outcome must be linked to each outcome definition, unit, denominator, time point and between-arm contrast, distinguishing stored summaries, unread external material, within-arm changes, parent responder outcomes and 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 effects, CIs, clinical importance thresholds, denominators, prespecified plans, long-term and harms information are needed. Limits of findings, precision and individual applicability must be distinguished. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N39",
      "question_type": "Evidence condition",
      "question": "Do preserved methodological and condition links establish completed content review?",
      "needed": "Distinction between methodological records, condition production and clinical content review",
      "role": "Required",
      "role_reason": "This condition links Distinction between methodological records, condition production and clinical content review with populations, interventions, controls, measurement, denominators, analyses, support and harms for the selected pain-day, analgesic-use and duration outcomes.",
      "application_exception": "Retain selected D and absent individual score, status and axes without inheriting parent D30. Distinguish pain days, analgesic use, duration and parent responder outcomes, within-arm and between-arm comparisons, single-ingredient prevention and acute combinations. No new effects, CIs, denominators, independent totals, grades, dosing or treatment instructions are created.",
      "criterion": "Original material for Distinction between methodological records, condition production and clinical content review must be linked to each outcome definition, unit, denominator, time point and between-arm contrast, distinguishing stored summaries, unread external material, within-arm changes, parent responder outcomes and 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: The source, scope and incomplete-review state of each condition must be retained. Technical view and file checks do not substitute for clinical content approval or a new judgment. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N40",
      "question_type": "Evidence condition",
      "question": "Which incoming materials would update the gaps?",
      "needed": "Outcome-specific definitions, denominators, effects, plans, families and change records",
      "role": "Required",
      "role_reason": "This condition links Outcome-specific definitions, denominators, effects, plans, families and change records with populations, interventions, controls, measurement, denominators, analyses, support and harms for the selected pain-day, analgesic-use and duration outcomes.",
      "application_exception": "Retain selected D and absent individual score, status and axes without inheriting parent D30. Distinguish pain days, analgesic use, duration and parent responder outcomes, within-arm and between-arm comparisons, single-ingredient prevention and acute combinations. No new effects, CIs, denominators, independent totals, grades, dosing or treatment instructions are created.",
      "criterion": "Original material for Outcome-specific definitions, denominators, effects, plans, families and change records must be linked to each outcome definition, unit, denominator, time point and between-arm contrast, distinguishing stored summaries, unread external material, within-arm changes, parent responder outcomes and 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: When authorized original results, diaries, plans, family information or corrections arrive, the complete prior version must be preserved. Evidence additions, condition changes and judgment changes are distinguished while retaining each outcome's boundaries. This records needed materials; no new research was executed."
    }
  ]
}