{
  "schema_version": "chamgap-public-evidence-check-1.0",
  "public_id": "v3009-s0",
  "verdict_number": "3009",
  "title": "Ginger dry extract × Migraine prevention—no added benefit over placebo in the 50% responder rate",
  "view_version": "1.0",
  "view_created_date": "2026-10-20",
  "criteria_version": "1.0",
  "criteria_date": "2026-10-06",
  "review_date": null,
  "legacy_evidence_date": "2026-09-07",
  "review_scope": {
    "materials_read": "Existing review summaries and stored records of methodological application",
    "clinical_papers_directly_read": false,
    "new_clinical_search": false,
    "limitation": "Existing stored summary and preserved methodology application records. External papers, abstracts, registration, protocols, SAPs, original result tables and support disclosures are unread, and review of existing content remains incomplete.",
    "date_meaning": "This is the date the stored materials were checked, not the date of a new search of the clinical literature."
  },
  "claim_context": {
    "population": "The stored account concerns a trial of 107 adults with episodic migraine. Overall size is not used as an arm-specific responder, completion or analysis denominator. Diagnosis, baseline frequency, age, concurrent care, exclusions and detailed eligibility are unverified.",
    "intervention": "The original intervention is ginger dry extract standardized to 5% active constituents. It is distinguished from culinary ginger, other formulations, feverfew combinations and acute treatment. Product, active-constituent definitions, batch and placebo-composition details are unverified; no new manufacturing or treatment instructions are created.",
    "dose": "The original study schedule of dry extract 200 mg, 3 times daily for 3 months is preserved. Total daily or active-constituent amounts are not calculated or converted into personal dosing or an optimal dose. Actual exposure, adherence and product-specific quantitative details are unverified.",
    "comparator": "The direct control is placebo. Improvement over time in both arms is not converted into an added ginger effect. Sensory matching and concurrent or changed preventive and acute medication details are unverified; sumatriptan active-control studies are not combined as the same prevention comparison.",
    "endpoint": "The selection concerns the proportion achieving at least a 50% reduction in migraine attacks. Original subclaim D and no significant difference from placebo are retained. This is not converted into a 50% reduction in the group mean, improvement in everyone, an exact zero effect or equivalence. Arm-specific responders, denominators, exact effects and CIs are unverified.",
    "duration": "The trial concerns 3-month prevention, distinguished from acute-attack treatment. Exact baseline and measurement windows, post-treatment response maintenance, recurrence and long-term or rare harms are unverified. Study duration is not extended into verification of prevention or persistence over all longer periods.",
    "excluded_extensions": [
      "Do not convert the individual 50% reduction threshold or between-arm responder comparison into a 50% reduction in the group mean.",
      "Do not convert nonsignificance against placebo into verification of exact zero effects, equivalence or noninferiority.",
      "Do not combine acute feverfew combinations, sumatriptan controls or nausea-related materials as replication of the same single-ingredient prevention question.",
      "Do not use reports shared across parent and subclaims or overall trial size as new independent totals or arm-specific outcome denominators.",
      "Do not create new total daily or active-constituent amounts, dosing instructions, changes to preventive medication or treatment guidance."
    ]
  },
  "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.",
      "current_reports": [
        "R01"
      ],
      "existence": "Displayed information exists in the stored parent summary. Public availability, acquisition and actual reading of external detailed materials remain separately unverified.",
      "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols and analysis plans unread",
      "observation": "The selection is at least a 50% reduction in migraine attacks, with original subclaim D. The relevant effect concerns the proportion reaching that threshold; the original conclusion of no significant difference from placebo is retained.",
      "condition_status": "Partly verified",
      "status_reason": "This information was transferred from the stored summary with the selected question distinguished from parent materials. Detailed originals and review of existing content remain incomplete; it does not establish clinical certification or review approval.",
      "missingness": "Responder definitions, baseline periods, measurement windows, arm-specific responders, denominators, effects and CIs are needed. No new grade or independence claim is created.",
      "uncertainty": "The original nonsignificance against placebo and precision gaps are retained. Exact responders, denominators, effects, CIs, missingness, concurrent care, prespecified plans, support and harm details are unverified. Historical full-text checking, the single-independent-trial statement or other symptom signals are not converted into completed current review, equivalence, exact zero effects or safety certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Responder definitions, baseline periods, measurement windows, arm-specific responders, denominators, effects and CIs are needed. No new grade or independence claim is created."
    },
    {
      "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.",
      "current_reports": [
        "R01"
      ],
      "existence": "Displayed information exists in the stored parent summary. Public availability, acquisition and actual reading of external detailed materials remain separately unverified.",
      "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols and analysis plans unread",
      "observation": "The account says the proportion with at least a 50% reduction in attacks did not differ from placebo. This is not converted into a 50% reduction in the ginger group's mean or a 50% improvement in every person.",
      "condition_status": "Partly verified",
      "status_reason": "This information was transferred from the stored summary with the selected question distinguished from parent materials. Detailed originals and review of existing content remain incomplete; it does not establish clinical certification or review approval.",
      "missingness": "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.",
      "uncertainty": "The original nonsignificance against placebo and precision gaps are retained. Exact responders, denominators, effects, CIs, missingness, concurrent care, prespecified plans, support and harm details are unverified. Historical full-text checking, the single-independent-trial statement or other symptom signals are not converted into completed current review, equivalence, exact zero effects or safety certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "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."
    },
    {
      "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.",
      "current_reports": [
        "R01"
      ],
      "existence": "Displayed information exists in the stored parent summary. Public availability, acquisition and actual reading of external detailed materials remain separately unverified.",
      "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols and analysis plans unread",
      "observation": "The original account of no significant between-arm differences in core outcomes and insufficient point estimates or exact CIs in the public abstract is preserved. Arm-specific responders, proportions, direct P, RR, RD and CIs are absent from the stored summary.",
      "condition_status": "Unverified",
      "status_reason": "This information was transferred from the stored summary with the selected question distinguished from parent materials. Detailed originals and review of existing content remain incomplete; it does not establish clinical certification or review approval.",
      "missingness": "Original outcome tables, responders, denominators, effects, CIs, statistical models and missing-data handling are needed. Numbers, CIs and P are not invented.",
      "uncertainty": "The original nonsignificance against placebo and precision gaps are retained. Exact responders, denominators, effects, CIs, missingness, concurrent care, prespecified plans, support and harm details are unverified. Historical full-text checking, the single-independent-trial statement or other symptom signals are not converted into completed current review, equivalence, exact zero effects or safety certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Original outcome tables, responders, denominators, effects, CIs, statistical models and missing-data handling are needed. Numbers, CIs and P are not invented."
    },
    {
      "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.",
      "current_reports": [
        "R01"
      ],
      "existence": "Displayed information exists in the stored parent summary. Public availability, acquisition and actual reading of external detailed materials remain separately unverified.",
      "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols and analysis plans unread",
      "observation": "The parent account says the direct placebo comparison does not support prevention efficacy, but insufficient CIs and importance boundaries prevent fully excluding a small benefit and assigning F. Parent D30 is not converted into proof of an absolute null effect.",
      "condition_status": "Partly verified",
      "status_reason": "This information was transferred from the stored summary with the selected question distinguished from parent materials. Detailed originals and review of existing content remain incomplete; it does not establish clinical certification or review approval.",
      "missingness": "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.",
      "uncertainty": "The original nonsignificance against placebo and precision gaps are retained. Exact responders, denominators, effects, CIs, missingness, concurrent care, prespecified plans, support and harm details are unverified. Historical full-text checking, the single-independent-trial statement or other symptom signals are not converted into completed current review, equivalence, exact zero effects or safety certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "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."
    },
    {
      "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.",
      "current_reports": [
        "R01"
      ],
      "existence": "Displayed information exists in the stored parent summary. Public availability, acquisition and actual reading of external detailed materials remain separately unverified.",
      "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols and analysis plans unread",
      "observation": "The original explanation that improvement in both arms does not mean ginger outperformed placebo is retained. Within-arm changes in another subclaim do not replace the between-arm effect for the selected responder outcome.",
      "condition_status": "Partly verified",
      "status_reason": "This information was transferred from the stored summary with the selected question distinguished from parent materials. Detailed originals and review of existing content remain incomplete; it does not establish clinical certification or review approval.",
      "missingness": "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.",
      "uncertainty": "The original nonsignificance against placebo and precision gaps are retained. Exact responders, denominators, effects, CIs, missingness, concurrent care, prespecified plans, support and harm details are unverified. Historical full-text checking, the single-independent-trial statement or other symptom signals are not converted into completed current review, equivalence, exact zero effects or safety certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "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."
    },
    {
      "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.",
      "current_reports": [
        "R01"
      ],
      "existence": "Displayed information exists in the stored parent summary. Public availability, acquisition and actual reading of external detailed materials remain separately unverified.",
      "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols and analysis plans unread",
      "observation": "The parent scope of 107 adults with episodic migraine is retained. Overall size does not substitute for arm-specific responder denominators or detailed diagnostic and eligibility criteria.",
      "condition_status": "Partly verified",
      "status_reason": "This information was transferred from the stored summary with the selected question distinguished from parent materials. Detailed originals and review of existing content remain incomplete; it does not establish clinical certification or review approval.",
      "missingness": "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.",
      "uncertainty": "The original nonsignificance against placebo and precision gaps are retained. Exact responders, denominators, effects, CIs, missingness, concurrent care, prespecified plans, support and harm details are unverified. Historical full-text checking, the single-independent-trial statement or other symptom signals are not converted into completed current review, equivalence, exact zero effects or safety certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "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."
    },
    {
      "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.",
      "current_reports": [
        "R01"
      ],
      "existence": "Displayed information exists in the stored parent summary. Public availability, acquisition and actual reading of external detailed materials remain separately unverified.",
      "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols and analysis plans unread",
      "observation": "The original comparison of a 200 mg dry extract standardized to 5% active constituents, used 3 times daily for 3 months against placebo, is retained. Total daily or active amounts are not calculated, and culinary ginger is not treated as interchangeable.",
      "condition_status": "Partly verified",
      "status_reason": "This information was transferred from the stored summary with the selected question distinguished from parent materials. Detailed originals and review of existing content remain incomplete; it does not establish clinical certification or review approval.",
      "missingness": "Products, active-constituent definitions, quantification, batches, quality, placebo composition, adherence and original exposure records are needed. New dosing or treatment instructions are not written.",
      "uncertainty": "The original nonsignificance against placebo and precision gaps are retained. Exact responders, denominators, effects, CIs, missingness, concurrent care, prespecified plans, support and harm details are unverified. Historical full-text checking, the single-independent-trial statement or other symptom signals are not converted into completed current review, equivalence, exact zero effects or safety certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Products, active-constituent definitions, quantification, batches, quality, placebo composition, adherence and original exposure records are needed. New dosing or treatment instructions are not written."
    },
    {
      "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.",
      "current_reports": [
        "R01"
      ],
      "existence": "Displayed information exists in the stored parent summary. Public availability, acquisition and actual reading of external detailed materials remain separately unverified.",
      "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols and analysis plans unread",
      "observation": "The original trial concerns 3-month prevention with ginger alone. Acute-attack treatment or nausea improvement is not transferred into the same 50% prevention responder outcome.",
      "condition_status": "Partly verified",
      "status_reason": "This information was transferred from the stored summary with the selected question distinguished from parent materials. Detailed originals and review of existing content remain incomplete; it does not establish clinical certification or review approval.",
      "missingness": "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.",
      "uncertainty": "The original nonsignificance against placebo and precision gaps are retained. Exact responders, denominators, effects, CIs, missingness, concurrent care, prespecified plans, support and harm details are unverified. Historical full-text checking, the single-independent-trial statement or other symptom signals are not converted into completed current review, equivalence, exact zero effects or safety certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "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."
    },
    {
      "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.",
      "current_reports": [
        "R01"
      ],
      "existence": "Displayed information exists in the stored parent summary. Public availability, acquisition and actual reading of external detailed materials remain separately unverified.",
      "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols and analysis plans unread",
      "observation": "The parent account did not count acute feverfew-plus-ginger combinations as replication of 3-month prevention with ginger alone. Combination findings are not copied as direct efficacy for the selected question.",
      "condition_status": "Partly verified",
      "status_reason": "This information was transferred from the stored summary with the selected question distinguished from parent materials. Detailed originals and review of existing content remain incomplete; it does not establish clinical certification or review approval.",
      "missingness": "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.",
      "uncertainty": "The original nonsignificance against placebo and precision gaps are retained. Exact responders, denominators, effects, CIs, missingness, concurrent care, prespecified plans, support and harm details are unverified. Historical full-text checking, the single-independent-trial statement or other symptom signals are not converted into completed current review, equivalence, exact zero effects or safety certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "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."
    },
    {
      "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.",
      "current_reports": [
        "R01"
      ],
      "existence": "Displayed information exists in the stored parent summary. Public availability, acquisition and actual reading of external detailed materials remain separately unverified.",
      "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols and analysis plans unread",
      "observation": "The account did not count sumatriptan active-control studies as replication of 3-month prevention with ginger alone. Findings with other controls or durations are not converted into certification of the selected prevention effect or equivalence.",
      "condition_status": "Partly verified",
      "status_reason": "This information was transferred from the stored summary with the selected question distinguished from parent materials. Detailed originals and review of existing content remain incomplete; it does not establish clinical certification or review approval.",
      "missingness": "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.",
      "uncertainty": "The original nonsignificance against placebo and precision gaps are retained. Exact responders, denominators, effects, CIs, missingness, concurrent care, prespecified plans, support and harm details are unverified. Historical full-text checking, the single-independent-trial statement or other symptom signals are not converted into completed current review, equivalence, exact zero effects or safety certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "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."
    },
    {
      "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.",
      "current_reports": [
        "R01"
      ],
      "existence": "Displayed information exists in the stored parent summary. Public availability, acquisition and actual reading of external detailed materials remain separately unverified.",
      "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols and analysis plans unread",
      "observation": "The original boundary against transferring nausea, other symptoms, combination products or acute-treatment evidence to long-term single-ingredient prevention is retained. Mechanisms or nausea materials are not used as direct evidence for the 50% responder outcome.",
      "condition_status": "Partly verified",
      "status_reason": "This information was transferred from the stored summary with the selected question distinguished from parent materials. Detailed originals and review of existing content remain incomplete; it does not establish clinical certification or review approval.",
      "missingness": "Direct patient outcomes, between-arm estimates and CIs for the same prevention question are needed. No new mechanistic or efficacy judgment is made.",
      "uncertainty": "The original nonsignificance against placebo and precision gaps are retained. Exact responders, denominators, effects, CIs, missingness, concurrent care, prespecified plans, support and harm details are unverified. Historical full-text checking, the single-independent-trial statement or other symptom signals are not converted into completed current review, equivalence, exact zero effects or safety certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Direct patient outcomes, between-arm estimates and CIs for the same prevention question are needed. No new mechanistic or efficacy judgment is made."
    },
    {
      "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.",
      "current_reports": [
        "R01"
      ],
      "existence": "Displayed information exists in the stored parent summary. Public availability, acquisition and actual reading of external detailed materials remain separately unverified.",
      "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols and analysis plans unread",
      "observation": "The original wording of 107 randomized in NCT02570633 and 107 adults is preserved. Arm-specific allocation, completion, responder-analysis counts, missingness and ITT details are absent from the summary and are not treated as complete data for every outcome.",
      "condition_status": "Unverified",
      "status_reason": "This information was transferred from the stored summary with the selected question distinguished from parent materials. Detailed originals and review of existing content remain incomplete; it does not establish clinical certification or review approval.",
      "missingness": "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.",
      "uncertainty": "The original nonsignificance against placebo and precision gaps are retained. Exact responders, denominators, effects, CIs, missingness, concurrent care, prespecified plans, support and harm details are unverified. Historical full-text checking, the single-independent-trial statement or other symptom signals are not converted into completed current review, equivalence, exact zero effects or safety certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "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."
    },
    {
      "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.",
      "current_reports": [
        "R01"
      ],
      "existence": "Displayed information exists in the stored parent summary. Public availability, acquisition and actual reading of external detailed materials remain separately unverified.",
      "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols and analysis plans unread",
      "observation": "The original double-blind placebo-controlled randomized design is preserved. Its label does not verify allocation, concealment, sensory matching, masking success, attack-diary collection or analyst details.",
      "condition_status": "Partly verified",
      "status_reason": "This information was transferred from the stored summary with the selected question distinguished from parent materials. Detailed originals and review of existing content remain incomplete; it does not establish clinical certification or review approval.",
      "missingness": "Original methods, withdrawals, missingness, diaries, analysis, outcome selection, registration and plans are needed. No new official risk-of-bias assessment is performed.",
      "uncertainty": "The original nonsignificance against placebo and precision gaps are retained. Exact responders, denominators, effects, CIs, missingness, concurrent care, prespecified plans, support and harm details are unverified. Historical full-text checking, the single-independent-trial statement or other symptom signals are not converted into completed current review, equivalence, exact zero effects or safety certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Original methods, withdrawals, missingness, diaries, analysis, outcome selection, registration and plans are needed. No new official risk-of-bias assessment is performed."
    },
    {
      "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.",
      "current_reports": [
        "R01"
      ],
      "existence": "Displayed information exists in the stored parent summary. Public availability, acquisition and actual reading of external detailed materials remain separately unverified.",
      "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols and analysis plans unread",
      "observation": "NCT02570633 is preserved in the existing evidence, citation and bilingual explanation. Registration, protocols, SAPs and amendment histories are unread in this work; the identifier alone does not establish prespecified agreement on responder criteria, denominators or analyses.",
      "condition_status": "Partly verified",
      "status_reason": "This information was transferred from the stored summary with the selected question distinguished from parent materials. Detailed originals and review of existing content remain incomplete; it does not establish clinical certification or review approval.",
      "missingness": "Original registration, amendments, protocols, SAPs, the 50% definition, timing, analyses and outcome hierarchy are needed. A registration URL is not newly inferred.",
      "uncertainty": "The original nonsignificance against placebo and precision gaps are retained. Exact responders, denominators, effects, CIs, missingness, concurrent care, prespecified plans, support and harm details are unverified. Historical full-text checking, the single-independent-trial statement or other symptom signals are not converted into completed current review, equivalence, exact zero effects or safety certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Original registration, amendments, protocols, SAPs, the 50% definition, timing, analyses and outcome hierarchy are needed. A registration URL is not newly inferred."
    },
    {
      "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.",
      "current_reports": [
        "R01"
      ],
      "existence": "Displayed information exists in the stored parent summary. Public availability, acquisition and actual reading of external detailed materials remain separately unverified.",
      "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols and analysis plans unread",
      "observation": "The account preserves no between-arm difference for severe-pain days, acute analgesic use and attack duration as well. These differ from the 50% responder outcome; original values, timing and CIs are not transferred between them.",
      "condition_status": "Partly verified",
      "status_reason": "This information was transferred from the stored summary with the selected question distinguished from parent materials. Detailed originals and review of existing content remain incomplete; it does not establish clinical certification or review approval.",
      "missingness": "Outcome-specific definitions, measurement windows, denominators, between-arm effects, CIs, prespecified hierarchies and multiplicity materials are needed. The original null account is retained.",
      "uncertainty": "The original nonsignificance against placebo and precision gaps are retained. Exact responders, denominators, effects, CIs, missingness, concurrent care, prespecified plans, support and harm details are unverified. Historical full-text checking, the single-independent-trial statement or other symptom signals are not converted into completed current review, equivalence, exact zero effects or safety certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Outcome-specific definitions, measurement windows, denominators, between-arm effects, CIs, prespecified hierarchies and multiplicity materials are needed. The original null account is retained."
    },
    {
      "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.",
      "current_reports": [
        "R01"
      ],
      "existence": "Displayed information exists in the stored parent summary. Public availability, acquisition and actual reading of external detailed materials remain separately unverified.",
      "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols and analysis plans unread",
      "observation": "Acute analgesic use is an original outcome. Medication types, concurrent preventive drugs, changes, extract adherence, rescue care and arm-specific withdrawal details are absent from the stored summary.",
      "condition_status": "Unverified",
      "status_reason": "This information was transferred from the stored summary with the selected question distinguished from parent materials. Detailed originals and review of existing content remain incomplete; it does not establish clinical certification or review approval.",
      "missingness": "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.",
      "uncertainty": "The original nonsignificance against placebo and precision gaps are retained. Exact responders, denominators, effects, CIs, missingness, concurrent care, prespecified plans, support and harm details are unverified. Historical full-text checking, the single-independent-trial statement or other symptom signals are not converted into completed current review, equivalence, exact zero effects or safety certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "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."
    },
    {
      "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.",
      "current_reports": [
        "R01"
      ],
      "existence": "Displayed information exists in the stored parent summary. Public availability, acquisition and actual reading of external detailed materials remain separately unverified.",
      "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols and analysis plans unread",
      "observation": "The trial's 3-month prevention condition is retained. Post-treatment attacks, maintained responses, recurrence and long-term or rare harms are unestablished in the account and are not extended into proof of prevention over all longer periods.",
      "condition_status": "Partly verified",
      "status_reason": "This information was transferred from the stored summary with the selected question distinguished from parent materials. Detailed originals and review of existing content remain incomplete; it does not establish clinical certification or review approval.",
      "missingness": "Post-treatment follow-up, continuing or changed care, recurrence, adherence, harms, denominators and direct longer-duration materials are needed.",
      "uncertainty": "The original nonsignificance against placebo and precision gaps are retained. Exact responders, denominators, effects, CIs, missingness, concurrent care, prespecified plans, support and harm details are unverified. Historical full-text checking, the single-independent-trial statement or other symptom signals are not converted into completed current review, equivalence, exact zero effects or safety certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Post-treatment follow-up, continuing or changed care, recurrence, adherence, harms, denominators and direct longer-duration materials are needed."
    },
    {
      "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.",
      "current_reports": [
        "R01"
      ],
      "existence": "Displayed information exists in the stored parent summary. Public availability, acquisition and actual reading of external detailed materials remain separately unverified.",
      "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols and analysis plans unread",
      "observation": "The parent describes a single independent and sole direct prevention trial. The same paper is shared across the parent and subclaims; this is not newly certified as independent replication or an established unique-trial total.",
      "condition_status": "Partly verified",
      "status_reason": "This information was transferred from the stored summary with the selected question distinguished from parent materials. Detailed originals and review of existing content remain incomplete; it does not establish clinical certification or review approval.",
      "missingness": "Registration, institutions, recruitment, participants, report relationships, overlap and support materials are needed. Unique trial and participant totals remain unverified.",
      "uncertainty": "The original nonsignificance against placebo and precision gaps are retained. Exact responders, denominators, effects, CIs, missingness, concurrent care, prespecified plans, support and harm details are unverified. Historical full-text checking, the single-independent-trial statement or other symptom signals are not converted into completed current review, equivalence, exact zero effects or safety certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Registration, institutions, recruitment, participants, report relationships, overlap and support materials are needed. Unique trial and participant totals remain unverified."
    },
    {
      "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.",
      "current_reports": [
        "R01"
      ],
      "existence": "Displayed information exists in the stored parent summary. Public availability, acquisition and actual reading of external detailed materials remain separately unverified.",
      "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols and analysis plans unread",
      "observation": "Original manufacturer-independence and full-text support-checking wording is preserved in both Korean and English. This historical record is not promoted into completed full-text reading or independence verification in this work.",
      "condition_status": "Partly verified",
      "status_reason": "This information was transferred from the stored summary with the selected question distinguished from parent materials. Detailed originals and review of existing content remain incomplete; it does not establish clinical certification or review approval.",
      "missingness": "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.",
      "uncertainty": "The original nonsignificance against placebo and precision gaps are retained. Exact responders, denominators, effects, CIs, missingness, concurrent care, prespecified plans, support and harm details are unverified. Historical full-text checking, the single-independent-trial statement or other symptom signals are not converted into completed current review, equivalence, exact zero effects or safety certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "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."
    },
    {
      "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.",
      "current_reports": [
        "R01"
      ],
      "existence": "Displayed information exists in the stored parent summary. Public availability, acquisition and actual reading of external detailed materials remain separately unverified.",
      "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols and analysis plans unread",
      "observation": "The parent's cautions on heartburn, abdominal discomfort, anticoagulants, antiplatelet drugs, bleeding risks and surgery are preserved. Arm-specific harm counts, exposure, collection, withdrawal reasons and denominators are absent from the stored summary.",
      "condition_status": "Partly verified",
      "status_reason": "This information was transferred from the stored summary with the selected question distinguished from parent materials. Detailed originals and review of existing content remain incomplete; it does not establish clinical certification or review approval.",
      "missingness": "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.",
      "uncertainty": "The original nonsignificance against placebo and precision gaps are retained. Exact responders, denominators, effects, CIs, missingness, concurrent care, prespecified plans, support and harm details are unverified. Historical full-text checking, the single-independent-trial statement or other symptom signals are not converted into completed current review, equivalence, exact zero effects or safety certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "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."
    },
    {
      "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.",
      "current_reports": [
        "R01"
      ],
      "existence": "Displayed information exists in the stored parent summary. Public availability, acquisition and actual reading of external detailed materials remain separately unverified.",
      "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols and analysis plans unread",
      "observation": "The original 50% threshold classifies responders. Gaps in exact CIs and clinical importance boundaries are retained; the threshold alone does not certify an important between-arm benefit or external validation.",
      "condition_status": "Partly verified",
      "status_reason": "This information was transferred from the stored summary with the selected question distinguished from parent materials. Detailed originals and review of existing content remain incomplete; it does not establish clinical certification or review approval.",
      "missingness": "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.",
      "uncertainty": "The original nonsignificance against placebo and precision gaps are retained. Exact responders, denominators, effects, CIs, missingness, concurrent care, prespecified plans, support and harm details are unverified. Historical full-text checking, the single-independent-trial statement or other symptom signals are not converted into completed current review, equivalence, exact zero effects or safety certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "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."
    },
    {
      "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.",
      "current_reports": [
        "R01"
      ],
      "existence": "Displayed information exists in the stored parent summary. Public availability, acquisition and actual reading of external detailed materials remain separately unverified.",
      "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols and analysis plans unread",
      "observation": "The parent centers the 50% responder outcome and core between-arm comparisons while distinguishing within-arm changes, acute combinations and active controls. Original null findings are not replaced with signals from other symptoms or studies.",
      "condition_status": "Partly verified",
      "status_reason": "This information was transferred from the stored summary with the selected question distinguished from parent materials. Detailed originals and review of existing content remain incomplete; it does not establish clinical certification or review approval.",
      "missingness": "Complete original findings, denominators, prespecified hierarchies, analyses, missingness and timing materials are needed. Unread original tables are not described as fully reviewed.",
      "uncertainty": "The original nonsignificance against placebo and precision gaps are retained. Exact responders, denominators, effects, CIs, missingness, concurrent care, prespecified plans, support and harm details are unverified. Historical full-text checking, the single-independent-trial statement or other symptom signals are not converted into completed current review, equivalence, exact zero effects or safety certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Complete original findings, denominators, prespecified hierarchies, analyses, missingness and timing materials are needed. Unread original tables are not described as fully reviewed."
    },
    {
      "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.",
      "current_reports": [
        "R01"
      ],
      "existence": "Displayed information exists in the stored parent summary. Public availability, acquisition and actual reading of external detailed materials remain separately unverified.",
      "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols and analysis plans unread",
      "observation": "The original subclaim grade is D, with no individual score, status or axes. Parent D30, Caution and judgment axes remain separate contexts and do not fill absent subclaim values.",
      "condition_status": "Partly verified",
      "status_reason": "This information was transferred from the stored summary with the selected question distinguished from parent materials. Detailed originals and review of existing content remain incomplete; it does not establish clinical certification or review approval.",
      "missingness": "Parent and subclaim questions and application scope need review. No new grades, scores, clinical statuses or independent certification are created.",
      "uncertainty": "The original nonsignificance against placebo and precision gaps are retained. Exact responders, denominators, effects, CIs, missingness, concurrent care, prespecified plans, support and harm details are unverified. Historical full-text checking, the single-independent-trial statement or other symptom signals are not converted into completed current review, equivalence, exact zero effects or safety certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Parent and subclaim questions and application scope need review. No new grades, scores, clinical statuses or independent certification are created."
    },
    {
      "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.",
      "current_reports": [
        "R01"
      ],
      "existence": "Displayed information exists in the stored parent summary. Public availability, acquisition and actual reading of external detailed materials remain separately unverified.",
      "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols and analysis plans unread",
      "observation": "The complete stored parent summary was read for production. Historical checking, cross-checking, full-text and calculation wording remains historical; external abstracts, full texts, registration, protocols and SAPs are unread in this work.",
      "condition_status": "Partly verified",
      "status_reason": "This information was transferred from the stored summary with the selected question distinguished from parent materials. Detailed originals and review of existing content remain incomplete; it does not establish clinical certification or review approval.",
      "missingness": "External acquisition, actual reading and content review are separate events. A link alone does not establish original reading, accessibility or completed review.",
      "uncertainty": "The original nonsignificance against placebo and precision gaps are retained. Exact responders, denominators, effects, CIs, missingness, concurrent care, prespecified plans, support and harm details are unverified. Historical full-text checking, the single-independent-trial statement or other symptom signals are not converted into completed current review, equivalence, exact zero effects or safety certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "External acquisition, actual reading and content review are separate events. A link alone does not establish original reading, accessibility or completed review."
    },
    {
      "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.",
      "current_reports": [
        "R01"
      ],
      "existence": "Displayed information exists in the stored parent summary. Public availability, acquisition and actual reading of external detailed materials remain separately unverified.",
      "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols and analysis plans unread",
      "observation": "The complete parent Korean and English accounts and representative classifications are preserved. Representative doses, populations and outcomes are not automatically applied as quantitative exposure, denominators or identical findings across all arms and outcomes.",
      "condition_status": "Partly verified",
      "status_reason": "This information was transferred from the stored summary with the selected question distinguished from parent materials. Detailed originals and review of existing content remain incomplete; it does not establish clinical certification or review approval.",
      "missingness": "Report-specific populations, formulations, controls, outcomes, timing and denominators need comparison materials. No new external English-original comparison or correction review was performed.",
      "uncertainty": "The original nonsignificance against placebo and precision gaps are retained. Exact responders, denominators, effects, CIs, missingness, concurrent care, prespecified plans, support and harm details are unverified. Historical full-text checking, the single-independent-trial statement or other symptom signals are not converted into completed current review, equivalence, exact zero effects or safety certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Report-specific populations, formulations, controls, outcomes, timing and denominators need comparison materials. No new external English-original comparison or correction review was performed."
    },
    {
      "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.",
      "current_reports": [
        "R01"
      ],
      "existence": "Displayed information exists in the stored parent summary. Public availability, acquisition and actual reading of external detailed materials remain separately unverified.",
      "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols and analysis plans unread",
      "observation": "The original evidence date of 2026-09-07 and empty correction and deliberation records are retained. Production time is not converted into a new evidence-verification date, and nonexistent corrections are not created.",
      "condition_status": "Partly verified",
      "status_reason": "This information was transferred from the stored summary with the selected question distinguished from parent materials. Detailed originals and review of existing content remain incomplete; it does not establish clinical certification or review approval.",
      "missingness": "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.",
      "uncertainty": "The original nonsignificance against placebo and precision gaps are retained. Exact responders, denominators, effects, CIs, missingness, concurrent care, prespecified plans, support and harm details are unverified. Historical full-text checking, the single-independent-trial statement or other symptom signals are not converted into completed current review, equivalence, exact zero effects or safety certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "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."
    },
    {
      "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.",
      "current_reports": [
        "R01"
      ],
      "existence": "Displayed information exists in the stored parent summary. Public availability, acquisition and actual reading of external detailed materials remain separately unverified.",
      "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols and analysis plans unread",
      "observation": "Report links, stored summaries and needed external-material entries form the table's structure. They are not acquired external papers, unique participants, trials, independent replications or quality scores; shared original reports are not double counted.",
      "condition_status": "Partly verified",
      "status_reason": "This information was transferred from the stored summary with the selected question distinguished from parent materials. Detailed originals and review of existing content remain incomplete; it does not establish clinical certification or review approval.",
      "missingness": "Original trial, report and cohort links and actual material-reading records are needed. Unique trial and participant totals remain unverified.",
      "uncertainty": "The original nonsignificance against placebo and precision gaps are retained. Exact responders, denominators, effects, CIs, missingness, concurrent care, prespecified plans, support and harm details are unverified. Historical full-text checking, the single-independent-trial statement or other symptom signals are not converted into completed current review, equivalence, exact zero effects or safety certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Original trial, report and cohort links and actual material-reading records are needed. Unique trial and participant totals remain unverified."
    },
    {
      "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.",
      "current_reports": [
        "R01"
      ],
      "existence": "Displayed information exists in the stored parent summary. Public availability, acquisition and actual reading of external detailed materials remain separately unverified.",
      "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols and analysis plans unread",
      "observation": "Originals and current conditions and observations are preserved. New materials need linking to the relevant comparisons, denominators, outcomes, reports and subclaims; this production is not a new clinical search or revised judgment.",
      "condition_status": "Partly verified",
      "status_reason": "This information was transferred from the stored summary with the selected question distinguished from parent materials. Detailed originals and review of existing content remain incomplete; it does not establish clinical certification or review approval.",
      "missingness": "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.",
      "uncertainty": "The original nonsignificance against placebo and precision gaps are retained. Exact responders, denominators, effects, CIs, missingness, concurrent care, prespecified plans, support and harm details are unverified. Historical full-text checking, the single-independent-trial statement or other symptom signals are not converted into completed current review, equivalence, exact zero effects or safety certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "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."
    }
  ],
  "reports": [
    {
      "report_id": "R01",
      "title": "Martins LB et al. 2020",
      "url": "https://pubmed.ncbi.nlm.nih.gov/31398997/",
      "report_type": "Stored report of a double-blind placebo-controlled randomized trial",
      "existence": "Report and bibliography records exist in the stored summary. Acquisition and actual reading of external originals are unverified in this work.",
      "acquired_read": "Complete stored parent summary read; external papers, registration and plans unread",
      "study_family": "Original report shared across parent and subclaims; unique trials, participants and independent replication unverified",
      "independent_replication": "The original Martins report is shared across the parent and existing subclaims. The 107 adults and original sole-direct-prevention-trial statement retain their original contexts and are not used as new independent replication, additional participants or a unique-trial total. Unique trial, participant and independent-replication totals are unverified.",
      "observed_result": "No significant between-group difference in the core outcomes",
      "result_level": "No significant between-arm difference in the 50% responder outcome and other core findings from the 3-month trial of 107 adults is preserved. Exact arm-specific responders, denominators, effects, CIs and concurrent-care details are unverified. Parent D30 and historical full-text or support-checking statements are separate historical contexts, not new clinical verification in this work.",
      "source_evidence_date": "2026-09-07",
      "materials": [
        {
          "material_type": "Stored existing review summary",
          "public_status": "Preserved copy of the complete parent-verdict stored summary",
          "access_status": "Stored summary",
          "acquired": true,
          "actually_read": "Summary read",
          "as_of": "2026-09-07",
          "qualification": "Preserve original PMID31398997, DOI10.1177/0333102419869319 and NCT02570633. Manufacturer independence and full-text support checking are historical statements in the original account and do not establish completed current comparison of full text, registration or company involvement. Summary dates belong to the original evidence. Blank external-material dates remain blank; no new external-reading or completed-content-review date is created."
        },
        {
          "material_type": "External abstract",
          "public_status": "Original bibliographic link or needed material; external public availability/access status unverified",
          "access_status": "Unread; access not attempted",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": null,
          "qualification": "Preserve original PMID31398997, DOI10.1177/0333102419869319 and NCT02570633. Manufacturer independence and full-text support checking are historical statements in the original account and do not establish completed current comparison of full text, registration or company involvement. Summary dates belong to the original evidence. Blank external-material dates remain blank; no new external-reading or completed-content-review date is created."
        },
        {
          "material_type": "External full text",
          "public_status": "Original bibliographic link or needed material; external public availability/access status unverified",
          "access_status": "Unread; access not attempted",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": null,
          "qualification": "Preserve original PMID31398997, DOI10.1177/0333102419869319 and NCT02570633. Manufacturer independence and full-text support checking are historical statements in the original account and do not establish completed current comparison of full text, registration or company involvement. Summary dates belong to the original evidence. Blank external-material dates remain blank; no new external-reading or completed-content-review date is created."
        },
        {
          "material_type": "Registration material",
          "public_status": "Original bibliographic link or needed material; external public availability/access status unverified",
          "access_status": "Unread; access not attempted",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": null,
          "qualification": "Preserve original PMID31398997, DOI10.1177/0333102419869319 and NCT02570633. Manufacturer independence and full-text support checking are historical statements in the original account and do not establish completed current comparison of full text, registration or company involvement. Summary dates belong to the original evidence. Blank external-material dates remain blank; no new external-reading or completed-content-review date is created."
        },
        {
          "material_type": "Protocol and analysis plan",
          "public_status": "Original bibliographic link or needed material; external public availability/access status unverified",
          "access_status": "Unread; access not attempted",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": null,
          "qualification": "Preserve original PMID31398997, DOI10.1177/0333102419869319 and NCT02570633. Manufacturer independence and full-text support checking are historical statements in the original account and do not establish completed current comparison of full text, registration or company involvement. Summary dates belong to the original evidence. Blank external-material dates remain blank; no new external-reading or completed-content-review date is created."
        }
      ],
      "links": [
        {
          "label": "PubMed",
          "url": "https://pubmed.ncbi.nlm.nih.gov/31398997/"
        }
      ]
    }
  ],
  "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."
  },
  "study_overlap": {
    "state": "Unverified",
    "unique_trial_count": null,
    "unique_participant_count": null,
    "reason": "The original Martins report is shared across the parent and existing subclaims. The 107 adults and original sole-direct-prevention-trial statement retain their original contexts and are not used as new independent replication, additional participants or a unique-trial total. Unique trial, participant and independent-replication totals are unverified."
  },
  "history": [
    {
      "date": "2026-10-20",
      "kind": "Separation of public-facing pages and materials",
      "view_version": "1.0",
      "change": "Public-facing views and materials were prepared from the existing 28 items. No new clinical search, verification-status change or scoring was performed."
    }
  ],
  "language": "en",
  "translation_date": "2026-10-20"
}