{
  "schema_version": "chamgap-public-criteria-1.0",
  "title": "Oral Nigella sativa seed oil as adjunctive therapy × Improved DAS28 disease activity and joint symptoms in rheumatoid arthritis",
  "language": "en",
  "translation_date": "2026-10-23",
  "criteria_version": "1.0",
  "criteria_date": "2026-10-06",
  "condition_origin": "Chamgap's own application conditions",
  "method_sources": [
    {
      "id": "M03",
      "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03",
      "section": "§3.1, §3.2.1–3.2.3, MECIR C5/C7/C13",
      "official_principle": "Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.",
      "review_level": "Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed."
    },
    {
      "id": "M04",
      "version": "Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04",
      "section": "§4.5, §4.6.1–4.6.3, MECIR C42",
      "official_principle": "Distinguish studies from reports and link them; do not omit a study solely because results are unreported.",
      "review_level": "Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed."
    },
    {
      "id": "M08",
      "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08",
      "section": "§8.1–8.2.3, Table 8.2.a",
      "official_principle": "Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.",
      "review_level": "Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed."
    },
    {
      "id": "M15",
      "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15",
      "section": "§15.2.4, §15.3.1–15.3.3",
      "official_principle": "Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.",
      "review_level": "Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed."
    },
    {
      "id": "M19",
      "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19",
      "section": "§19.1.2, §19.2.1–19.2.4",
      "official_principle": "Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.",
      "review_level": "Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed."
    }
  ],
  "status_dictionary": {
    "Partly verified": "Partial information from the stored summary is linked; detailed originals and content review remain incomplete.",
    "Unverified": "Required details cannot be established within the preserved scope. This does not establish absence of effects or studies, or safety.",
    "Review incomplete": "Review of existing content remains incomplete.",
    "Met": "This state is used only within the relevant conditions after material verification and content review. It was not automatically assigned in this work.",
    "Not reported": "Unreported within material actually read. Unread external material is not relabeled as unreported.",
    "Inaccessible": "This means actual access failure. External access was not attempted in this work, so this state was not assigned.",
    "Not applicable": "Used only with an application exception and reason based on the question scope.",
    "Conflicting data": "This requires actual comparison of materials; no new conflict judgment was made in this work.",
    "Insufficient evidence for the conditions": "This indicates gaps in additional material for the selected conditions. Unread material as a whole is not converted into an efficacy grade."
  },
  "requirements": [
    {
      "item_id": "N01",
      "question_type": "Evidence condition",
      "question": "Which rheumatoid arthritis question is addressed?",
      "needed": "Adjunctive oral seed oil and DAS28 in women continuing stable antirheumatic medication",
      "role": "Required",
      "role_reason": "Material on Adjunctive oral seed oil and DAS28 in women continuing stable antirheumatic medication is needed to connect adjunctive seed oil to its population, formulation, concomitant treatment, comparison, outcome, timing, denominator or harms.",
      "application_exception": "A fixed-sequence comparison is not converted into randomized period allocation or a concurrent parallel control. Mechanistic papers from the same cohort are not counted as independent clinical replications; inconsistent denominators are not selected or pooled, and no new differences, intervals, harm rates or doses are calculated.",
      "criterion": "Original records on Adjunctive oral seed oil and DAS28 in women continuing stable antirheumatic medication must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.",
      "basis": "Existing principles distinguish the population, formulation, background treatment, comparative design, DAS28, timing, denominators, related reports, company involvement and harms of adjunctive seed oil.",
      "condition_origin": "These existing conditions are linked to oral seed oil as adjunctive therapy in women with rheumatoid arthritis. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Original eligibility, common-treatment and DAS28 endpoint/timepoint tables are needed. Osteoarthritis, drug replacement, prevention of structural damage and cure are excluded. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N02",
      "question_type": "Evidence condition",
      "question": "Are manufacturer-prepared seed-oil capsules distinguished from other formulations?",
      "needed": "Product, content and preparation information for fixed seed-oil capsules",
      "role": "Required",
      "role_reason": "Material on Product, content and preparation information for fixed seed-oil capsules is needed to connect adjunctive seed oil to its population, formulation, concomitant treatment, comparison, outcome, timing, denominator or harms.",
      "application_exception": "A fixed-sequence comparison is not converted into randomized period allocation or a concurrent parallel control. Mechanistic papers from the same cohort are not counted as independent clinical replications; inconsistent denominators are not selected or pooled, and no new differences, intervals, harm rates or doses are calculated.",
      "criterion": "Original records on Product, content and preparation information for fixed seed-oil capsules must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.",
      "basis": "Existing principles distinguish the population, formulation, background treatment, comparative design, DAS28, timing, denominators, related reports, company involvement and harms of adjunctive seed oil.",
      "condition_origin": "These existing conditions are linked to oral seed oil as adjunctive therapy in women with rheumatoid arthritis. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Original manufacturing, active-constituent, standardization, lot and product-support records are needed. Equivalence to other formulations is not established. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N03",
      "question_type": "Evidence condition",
      "question": "What dose, frequency and actual exposure are recorded?",
      "needed": "500 mg, 2 times daily, with the original total of 1 g/day, and adherence",
      "role": "Required",
      "role_reason": "Material on 500 mg, 2 times daily, with the original total of 1 g/day, and adherence is needed to connect adjunctive seed oil to its population, formulation, concomitant treatment, comparison, outcome, timing, denominator or harms.",
      "application_exception": "A fixed-sequence comparison is not converted into randomized period allocation or a concurrent parallel control. Mechanistic papers from the same cohort are not counted as independent clinical replications; inconsistent denominators are not selected or pooled, and no new differences, intervals, harm rates or doses are calculated.",
      "criterion": "Original records on 500 mg, 2 times daily, with the original total of 1 g/day, and adherence must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.",
      "basis": "Existing principles distinguish the population, formulation, background treatment, comparative design, DAS28, timing, denominators, related reports, company involvement and harms of adjunctive seed oil.",
      "condition_origin": "These existing conditions are linked to oral seed oil as adjunctive therapy in women with rheumatoid arthritis. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Original dosing, adherence, product-content, discontinuation and actual-exposure records are needed. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N04",
      "question_type": "Evidence condition",
      "question": "What is the scope of the female population and baseline disease activity?",
      "needed": "Rheumatoid arthritis diagnosis, baseline DAS28, treatment and severity in women",
      "role": "Required",
      "role_reason": "Material on Rheumatoid arthritis diagnosis, baseline DAS28, treatment and severity in women is needed to connect adjunctive seed oil to its population, formulation, concomitant treatment, comparison, outcome, timing, denominator or harms.",
      "application_exception": "A fixed-sequence comparison is not converted into randomized period allocation or a concurrent parallel control. Mechanistic papers from the same cohort are not counted as independent clinical replications; inconsistent denominators are not selected or pooled, and no new differences, intervals, harm rates or doses are calculated.",
      "criterion": "Original records on Rheumatoid arthritis diagnosis, baseline DAS28, treatment and severity in women must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.",
      "basis": "Existing principles distinguish the population, formulation, background treatment, comparative design, DAS28, timing, denominators, related reports, company involvement and harms of adjunctive seed oil.",
      "condition_origin": "These existing conditions are linked to oral seed oil as adjunctive therapy in women with rheumatoid arthritis. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Original tables on diagnosis, baseline scores, comorbidities, inclusion/exclusion, age and treatment composition are needed. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N05",
      "question_type": "Evidence condition",
      "question": "Are maintained DMARD/steroid treatment and drug replacement distinguished?",
      "needed": "Medication types, doses, changes and common management in each arm",
      "role": "Required",
      "role_reason": "Material on Medication types, doses, changes and common management in each arm is needed to connect adjunctive seed oil to its population, formulation, concomitant treatment, comparison, outcome, timing, denominator or harms.",
      "application_exception": "A fixed-sequence comparison is not converted into randomized period allocation or a concurrent parallel control. Mechanistic papers from the same cohort are not counted as independent clinical replications; inconsistent denominators are not selected or pooled, and no new differences, intervals, harm rates or doses are calculated.",
      "criterion": "Original records on Medication types, doses, changes and common management in each arm must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.",
      "basis": "Existing principles distinguish the population, formulation, background treatment, comparative design, DAS28, timing, denominators, related reports, company involvement and harms of adjunctive seed oil.",
      "condition_origin": "These existing conditions are linked to oral seed oil as adjunctive therapy in women with rheumatoid arthritis. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Original records of medication, maintained/changed doses, adherence, rescue medication and additional treatment are needed. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N06",
      "question_type": "Evidence condition",
      "question": "Are the 1–2-month range and the study-specific sequences distinguished?",
      "needed": "Report-specific placebo/oil exposure and DAS28 assessment times",
      "role": "Required",
      "role_reason": "Material on Report-specific placebo/oil exposure and DAS28 assessment times is needed to connect adjunctive seed oil to its population, formulation, concomitant treatment, comparison, outcome, timing, denominator or harms.",
      "application_exception": "A fixed-sequence comparison is not converted into randomized period allocation or a concurrent parallel control. Mechanistic papers from the same cohort are not counted as independent clinical replications; inconsistent denominators are not selected or pooled, and no new differences, intervals, harm rates or doses are calculated.",
      "criterion": "Original records on Report-specific placebo/oil exposure and DAS28 assessment times must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.",
      "basis": "Existing principles distinguish the population, formulation, background treatment, comparative design, DAS28, timing, denominators, related reports, company involvement and harms of adjunctive seed oil.",
      "condition_origin": "These existing conditions are linked to oral seed oil as adjunctive therapy in women with rheumatoid arthritis. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Original report-specific assessment schedules, timing, exposure and discontinuation records are needed. Long-term or persistent effects remain unverified. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N07",
      "question_type": "Evidence condition",
      "question": "Are starch placebo and the fixed-sequence control the same comparison?",
      "needed": "The parallel placebo comparison versus the within-period placebo/oil comparison",
      "role": "Required",
      "role_reason": "Material on The parallel placebo comparison versus the within-period placebo/oil comparison is needed to connect adjunctive seed oil to its population, formulation, concomitant treatment, comparison, outcome, timing, denominator or harms.",
      "application_exception": "A fixed-sequence comparison is not converted into randomized period allocation or a concurrent parallel control. Mechanistic papers from the same cohort are not counted as independent clinical replications; inconsistent denominators are not selected or pooled, and no new differences, intervals, harm rates or doses are calculated.",
      "criterion": "Original records on The parallel placebo comparison versus the within-period placebo/oil comparison must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.",
      "basis": "Existing principles distinguish the population, formulation, background treatment, comparative design, DAS28, timing, denominators, related reports, company involvement and harms of adjunctive seed oil.",
      "condition_origin": "These existing conditions are linked to oral seed oil as adjunctive therapy in women with rheumatoid arthritis. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Original placebo-composition, management, period-comparison, masking and similarity records are needed. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N08",
      "question_type": "Evidence condition",
      "question": "Is each report’s design retained separately?",
      "needed": "The 2012 fixed sequence and the 2016 randomized parallel trial linked to reports and families",
      "role": "Required",
      "role_reason": "Material on The 2012 fixed sequence and the 2016 randomized parallel trial linked to reports and families is needed to connect adjunctive seed oil to its population, formulation, concomitant treatment, comparison, outcome, timing, denominator or harms.",
      "application_exception": "A fixed-sequence comparison is not converted into randomized period allocation or a concurrent parallel control. Mechanistic papers from the same cohort are not counted as independent clinical replications; inconsistent denominators are not selected or pooled, and no new differences, intervals, harm rates or doses are calculated.",
      "criterion": "Original records on The 2012 fixed sequence and the 2016 randomized parallel trial linked to reports and families must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.",
      "basis": "Existing principles distinguish the population, formulation, background treatment, comparative design, DAS28, timing, denominators, related reports, company involvement and harms of adjunctive seed oil.",
      "condition_origin": "These existing conditions are linked to oral seed oil as adjunctive therapy in women with rheumatoid arthritis. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Methods, registration, samples/institutions and links to additional reports are needed. Both reports do not certify a count of unique independent trials. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N09",
      "question_type": "Evidence condition",
      "question": "Is randomized period allocation avoided for the fixed sequence?",
      "needed": "The fixed placebo→oil sequence, period allocation and time effects",
      "role": "Required",
      "role_reason": "Material on The fixed placebo→oil sequence, period allocation and time effects is needed to connect adjunctive seed oil to its population, formulation, concomitant treatment, comparison, outcome, timing, denominator or harms.",
      "application_exception": "A fixed-sequence comparison is not converted into randomized period allocation or a concurrent parallel control. Mechanistic papers from the same cohort are not counted as independent clinical replications; inconsistent denominators are not selected or pooled, and no new differences, intervals, harm rates or doses are calculated.",
      "criterion": "Original records on The fixed placebo→oil sequence, period allocation and time effects must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.",
      "basis": "Existing principles distinguish the population, formulation, background treatment, comparative design, DAS28, timing, denominators, related reports, company involvement and harms of adjunctive seed oil.",
      "condition_origin": "These existing conditions are linked to oral seed oil as adjunctive therapy in women with rheumatoid arthritis. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Original timing/sequence, treatment changes, stability and time-course records are needed. No effect separating time/order influences is newly calculated. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N10",
      "question_type": "Evidence condition",
      "question": "What denominator does the R01 record of 40 people represent?",
      "needed": "Enrollment, analysis, completion and timepoint denominators for the 40 women",
      "role": "Required",
      "role_reason": "Material on Enrollment, analysis, completion and timepoint denominators for the 40 women is needed to connect adjunctive seed oil to its population, formulation, concomitant treatment, comparison, outcome, timing, denominator or harms.",
      "application_exception": "A fixed-sequence comparison is not converted into randomized period allocation or a concurrent parallel control. Mechanistic papers from the same cohort are not counted as independent clinical replications; inconsistent denominators are not selected or pooled, and no new differences, intervals, harm rates or doses are calculated.",
      "criterion": "Original records on Enrollment, analysis, completion and timepoint denominators for the 40 women must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.",
      "basis": "Existing principles distinguish the population, formulation, background treatment, comparative design, DAS28, timing, denominators, related reports, company involvement and harms of adjunctive seed oil.",
      "condition_origin": "These existing conditions are linked to oral seed oil as adjunctive therapy in women with rheumatoid arthritis. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Original flow, measurements in each period, attrition and analysis denominators are needed. No additional participant total is calculated. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N11",
      "question_type": "Evidence condition",
      "question": "What DAS28 values are recorded for R01?",
      "needed": "Original post-placebo and post-oil values, dispersion and P value",
      "role": "Required",
      "role_reason": "Material on Original post-placebo and post-oil values, dispersion and P value is needed to connect adjunctive seed oil to its population, formulation, concomitant treatment, comparison, outcome, timing, denominator or harms.",
      "application_exception": "A fixed-sequence comparison is not converted into randomized period allocation or a concurrent parallel control. Mechanistic papers from the same cohort are not counted as independent clinical replications; inconsistent denominators are not selected or pooled, and no new differences, intervals, harm rates or doses are calculated.",
      "criterion": "Original records on Original post-placebo and post-oil values, dispersion and P value must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.",
      "basis": "Existing principles distinguish the population, formulation, background treatment, comparative design, DAS28, timing, denominators, related reports, company involvement and harms of adjunctive seed oil.",
      "condition_origin": "These existing conditions are linked to oral seed oil as adjunctive therapy in women with rheumatoid arthritis. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Original result tables linking arms/periods, dispersion, baseline/change values, tests and denominators are needed. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N12",
      "question_type": "Evidence condition",
      "question": "Are R01 P/± notation and an exact effect interval distinguished?",
      "needed": "The original test, dispersion definition, effect of interest and CI",
      "role": "Required",
      "role_reason": "Material on The original test, dispersion definition, effect of interest and CI is needed to connect adjunctive seed oil to its population, formulation, concomitant treatment, comparison, outcome, timing, denominator or harms.",
      "application_exception": "A fixed-sequence comparison is not converted into randomized period allocation or a concurrent parallel control. Mechanistic papers from the same cohort are not counted as independent clinical replications; inconsistent denominators are not selected or pooled, and no new differences, intervals, harm rates or doses are calculated.",
      "criterion": "Original records on The original test, dispersion definition, effect of interest and CI must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.",
      "basis": "Existing principles distinguish the population, formulation, background treatment, comparative design, DAS28, timing, denominators, related reports, company involvement and harms of adjunctive seed oil.",
      "condition_origin": "These existing conditions are linked to oral seed oil as adjunctive therapy in women with rheumatoid arthritis. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Original test/variance, within-period correlation, estimand and CI records are needed. The ± notation is not arbitrarily labeled as a CI or SE. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N13",
      "question_type": "Evidence condition",
      "question": "How much is known about allocation and masking in the parallel trial?",
      "needed": "R02 sequence generation, concealment and participant/assessor masking",
      "role": "Required",
      "role_reason": "Material on R02 sequence generation, concealment and participant/assessor masking is needed to connect adjunctive seed oil to its population, formulation, concomitant treatment, comparison, outcome, timing, denominator or harms.",
      "application_exception": "A fixed-sequence comparison is not converted into randomized period allocation or a concurrent parallel control. Mechanistic papers from the same cohort are not counted as independent clinical replications; inconsistent denominators are not selected or pooled, and no new differences, intervals, harm rates or doses are calculated.",
      "criterion": "Original records on R02 sequence generation, concealment and participant/assessor masking must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.",
      "basis": "Existing principles distinguish the population, formulation, background treatment, comparative design, DAS28, timing, denominators, related reports, company involvement and harms of adjunctive seed oil.",
      "condition_origin": "These existing conditions are linked to oral seed oil as adjunctive therapy in women with rheumatoid arthritis. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Original methods, masking, assessor, registration/plan and control-composition records are needed. No new official RoB2/GRADE assessment is created. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N14",
      "question_type": "Evidence condition",
      "question": "Are conflicting completion denominators of 39·42·43 retained?",
      "needed": "Report-specific allocation, completion and analysis matching within the parallel cohort",
      "role": "Required",
      "role_reason": "Material on Report-specific allocation, completion and analysis matching within the parallel cohort is needed to connect adjunctive seed oil to its population, formulation, concomitant treatment, comparison, outcome, timing, denominator or harms.",
      "application_exception": "A fixed-sequence comparison is not converted into randomized period allocation or a concurrent parallel control. Mechanistic papers from the same cohort are not counted as independent clinical replications; inconsistent denominators are not selected or pooled, and no new differences, intervals, harm rates or doses are calculated.",
      "criterion": "Original records on Report-specific allocation, completion and analysis matching within the parallel cohort must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.",
      "basis": "Existing principles distinguish the population, formulation, background treatment, comparative design, DAS28, timing, denominators, related reports, company involvement and harms of adjunctive seed oil.",
      "condition_origin": "These existing conditions are linked to oral seed oil as adjunctive therapy in women with rheumatoid arthritis. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Each report’s original flow, arm counts, endpoint/measurement/exclusion/additional-analysis details and participant matching are needed. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N15",
      "question_type": "Evidence condition",
      "question": "What is the scope of the R02 DAS28 result after 2 months?",
      "needed": "Parallel between-group estimates, adjusted CI, P value and denominators",
      "role": "Required",
      "role_reason": "Material on Parallel between-group estimates, adjusted CI, P value and denominators is needed to connect adjunctive seed oil to its population, formulation, concomitant treatment, comparison, outcome, timing, denominator or harms.",
      "application_exception": "A fixed-sequence comparison is not converted into randomized period allocation or a concurrent parallel control. Mechanistic papers from the same cohort are not counted as independent clinical replications; inconsistent denominators are not selected or pooled, and no new differences, intervals, harm rates or doses are calculated.",
      "criterion": "Original records on Parallel between-group estimates, adjusted CI, P value and denominators must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.",
      "basis": "Existing principles distinguish the population, formulation, background treatment, comparative design, DAS28, timing, denominators, related reports, company involvement and harms of adjunctive seed oil.",
      "condition_origin": "These existing conditions are linked to oral seed oil as adjunctive therapy in women with rheumatoid arthritis. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Original DAS28 overall/adjusted analyses, baseline/change values, models, P/CI and denominators are needed. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N16",
      "question_type": "Evidence condition",
      "question": "What remains unknown about completion, analysis sets and missing data?",
      "needed": "Report/timepoint-specific missingness, attrition, analysis exclusions and handling",
      "role": "Required",
      "role_reason": "Material on Report/timepoint-specific missingness, attrition, analysis exclusions and handling is needed to connect adjunctive seed oil to its population, formulation, concomitant treatment, comparison, outcome, timing, denominator or harms.",
      "application_exception": "A fixed-sequence comparison is not converted into randomized period allocation or a concurrent parallel control. Mechanistic papers from the same cohort are not counted as independent clinical replications; inconsistent denominators are not selected or pooled, and no new differences, intervals, harm rates or doses are calculated.",
      "criterion": "Original records on Report/timepoint-specific missingness, attrition, analysis exclusions and handling must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.",
      "basis": "Existing principles distinguish the population, formulation, background treatment, comparative design, DAS28, timing, denominators, related reports, company involvement and harms of adjunctive seed oil.",
      "condition_origin": "These existing conditions are linked to oral seed oil as adjunctive therapy in women with rheumatoid arthritis. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Original arm-specific flow, missingness/exclusion reasons, analysis plans and sensitivity analyses are needed. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N17",
      "question_type": "Evidence condition",
      "question": "Are inflammatory-marker papers excluded from independent clinical replication counts?",
      "needed": "Clinical DAS28 reports versus hs-CRP/TNF/IL-10/oxidative-stress papers from the same cohort",
      "role": "Required",
      "role_reason": "Material on Clinical DAS28 reports versus hs-CRP/TNF/IL-10/oxidative-stress papers from the same cohort is needed to connect adjunctive seed oil to its population, formulation, concomitant treatment, comparison, outcome, timing, denominator or harms.",
      "application_exception": "A fixed-sequence comparison is not converted into randomized period allocation or a concurrent parallel control. Mechanistic papers from the same cohort are not counted as independent clinical replications; inconsistent denominators are not selected or pooled, and no new differences, intervals, harm rates or doses are calculated.",
      "criterion": "Original records on Clinical DAS28 reports versus hs-CRP/TNF/IL-10/oxidative-stress papers from the same cohort must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.",
      "basis": "Existing principles distinguish the population, formulation, background treatment, comparative design, DAS28, timing, denominators, related reports, company involvement and harms of adjunctive seed oil.",
      "condition_origin": "These existing conditions are linked to oral seed oil as adjunctive therapy in women with rheumatoid arthritis. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Report-specific participant, institution/period, endpoint and denominator links are needed. Values, citations or trial counts for unidentified papers are not invented. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N18",
      "question_type": "Evidence condition",
      "question": "Are the immune-marker title and the selected DAS28 endpoint distinguished?",
      "needed": "R02 T-lymphocyte/immune-marker reporting and the hierarchy of DAS28 outcomes",
      "role": "Required",
      "role_reason": "Material on R02 T-lymphocyte/immune-marker reporting and the hierarchy of DAS28 outcomes is needed to connect adjunctive seed oil to its population, formulation, concomitant treatment, comparison, outcome, timing, denominator or harms.",
      "application_exception": "A fixed-sequence comparison is not converted into randomized period allocation or a concurrent parallel control. Mechanistic papers from the same cohort are not counted as independent clinical replications; inconsistent denominators are not selected or pooled, and no new differences, intervals, harm rates or doses are calculated.",
      "criterion": "Original records on R02 T-lymphocyte/immune-marker reporting and the hierarchy of DAS28 outcomes must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.",
      "basis": "Existing principles distinguish the population, formulation, background treatment, comparative design, DAS28, timing, denominators, related reports, company involvement and harms of adjunctive seed oil.",
      "condition_origin": "These existing conditions are linked to oral seed oil as adjunctive therapy in women with rheumatoid arthritis. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Original protocols, registration, complete results and endpoint/timepoint/denominator links are needed. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N19",
      "question_type": "Evidence condition",
      "question": "Are unique-trial, independent-team and participant totals established?",
      "needed": "Trial families, shared cohorts, institutions, teams and additional-report links",
      "role": "Required",
      "role_reason": "Material on Trial families, shared cohorts, institutions, teams and additional-report links is needed to connect adjunctive seed oil to its population, formulation, concomitant treatment, comparison, outcome, timing, denominator or harms.",
      "application_exception": "A fixed-sequence comparison is not converted into randomized period allocation or a concurrent parallel control. Mechanistic papers from the same cohort are not counted as independent clinical replications; inconsistent denominators are not selected or pooled, and no new differences, intervals, harm rates or doses are calculated.",
      "criterion": "Original records on Trial families, shared cohorts, institutions, teams and additional-report links must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.",
      "basis": "Existing principles distinguish the population, formulation, background treatment, comparative design, DAS28, timing, denominators, related reports, company involvement and harms of adjunctive seed oil.",
      "condition_origin": "These existing conditions are linked to oral seed oil as adjunctive therapy in women with rheumatoid arthritis. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Original trial/report maps, samples, registration, authors and funding records are needed. Final unique-trial and participant totals remain null. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N20",
      "question_type": "Evidence condition",
      "question": "What DAS28 measurement, components and analysis timing were used?",
      "needed": "Original DAS28 definition, assessors, measurement components and baseline/change values",
      "role": "Required",
      "role_reason": "Material on Original DAS28 definition, assessors, measurement components and baseline/change values is needed to connect adjunctive seed oil to its population, formulation, concomitant treatment, comparison, outcome, timing, denominator or harms.",
      "application_exception": "A fixed-sequence comparison is not converted into randomized period allocation or a concurrent parallel control. Mechanistic papers from the same cohort are not counted as independent clinical replications; inconsistent denominators are not selected or pooled, and no new differences, intervals, harm rates or doses are calculated.",
      "criterion": "Original records on Original DAS28 definition, assessors, measurement components and baseline/change values must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.",
      "basis": "Existing principles distinguish the population, formulation, background treatment, comparative design, DAS28, timing, denominators, related reports, company involvement and harms of adjunctive seed oil.",
      "condition_origin": "These existing conditions are linked to oral seed oil as adjunctive therapy in women with rheumatoid arthritis. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Original scale versions, assessment/examination details, assessor masking, timing and analysis models are needed. No new component results are created. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N21",
      "question_type": "Evidence condition",
      "question": "Are joint symptoms distinguished from DAS28 and mechanistic endpoints?",
      "needed": "Symptom-specific results, denominators and times versus the selected DAS28 endpoint",
      "role": "Supplementary",
      "role_reason": "Material on Symptom-specific results, denominators and times versus the selected DAS28 endpoint is needed to connect adjunctive seed oil to its population, formulation, concomitant treatment, comparison, outcome, timing, denominator or harms.",
      "application_exception": "A fixed-sequence comparison is not converted into randomized period allocation or a concurrent parallel control. Mechanistic papers from the same cohort are not counted as independent clinical replications; inconsistent denominators are not selected or pooled, and no new differences, intervals, harm rates or doses are calculated.",
      "criterion": "Original records on Symptom-specific results, denominators and times versus the selected DAS28 endpoint must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.",
      "basis": "Existing principles distinguish the population, formulation, background treatment, comparative design, DAS28, timing, denominators, related reports, company involvement and harms of adjunctive seed oil.",
      "condition_origin": "These existing conditions are linked to oral seed oil as adjunctive therapy in women with rheumatoid arthritis. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Original joint/symptom-scale results, prospective hierarchy and denominators are needed. DAS28 values are not copied into every pain or functional outcome. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N22",
      "question_type": "Evidence condition",
      "question": "Were registration and prospective endpoint/timepoint plans verified?",
      "needed": "Original registration, protocol/SAP and amendment history",
      "role": "Required",
      "role_reason": "Material on Original registration, protocol/SAP and amendment history is needed to connect adjunctive seed oil to its population, formulation, concomitant treatment, comparison, outcome, timing, denominator or harms.",
      "application_exception": "A fixed-sequence comparison is not converted into randomized period allocation or a concurrent parallel control. Mechanistic papers from the same cohort are not counted as independent clinical replications; inconsistent denominators are not selected or pooled, and no new differences, intervals, harm rates or doses are calculated.",
      "criterion": "Original records on Original registration, protocol/SAP and amendment history must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.",
      "basis": "Existing principles distinguish the population, formulation, background treatment, comparative design, DAS28, timing, denominators, related reports, company involvement and harms of adjunctive seed oil.",
      "condition_origin": "These existing conditions are linked to oral seed oil as adjunctive therapy in women with rheumatoid arthritis. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Original registration, plans, all endpoints/timepoints and multiplicity information are needed. No new external registration search is performed here. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N23",
      "question_type": "Evidence condition",
      "question": "Are favorable directions kept separate from an identical comparative effect?",
      "needed": "The differing estimands of the fixed-sequence and parallel designs",
      "role": "Supplementary",
      "role_reason": "Material on The differing estimands of the fixed-sequence and parallel designs is needed to connect adjunctive seed oil to its population, formulation, concomitant treatment, comparison, outcome, timing, denominator or harms.",
      "application_exception": "A fixed-sequence comparison is not converted into randomized period allocation or a concurrent parallel control. Mechanistic papers from the same cohort are not counted as independent clinical replications; inconsistent denominators are not selected or pooled, and no new differences, intervals, harm rates or doses are calculated.",
      "criterion": "Original records on The differing estimands of the fixed-sequence and parallel designs must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.",
      "basis": "Existing principles distinguish the population, formulation, background treatment, comparative design, DAS28, timing, denominators, related reports, company involvement and harms of adjunctive seed oil.",
      "condition_origin": "These existing conditions are linked to oral seed oil as adjunctive therapy in women with rheumatoid arthritis. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Direct matching of original designs, models, CI, denominators and samples is needed. No pooled effect or replication total is newly calculated. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N24",
      "question_type": "Evidence condition",
      "question": "Are importance thresholds, responder rates and remission rates known?",
      "needed": "Prospective importance thresholds, response/remission definitions, arm denominators and CI",
      "role": "Supplementary",
      "role_reason": "Material on Prospective importance thresholds, response/remission definitions, arm denominators and CI is needed to connect adjunctive seed oil to its population, formulation, concomitant treatment, comparison, outcome, timing, denominator or harms.",
      "application_exception": "A fixed-sequence comparison is not converted into randomized period allocation or a concurrent parallel control. Mechanistic papers from the same cohort are not counted as independent clinical replications; inconsistent denominators are not selected or pooled, and no new differences, intervals, harm rates or doses are calculated.",
      "criterion": "Original records on Prospective importance thresholds, response/remission definitions, arm denominators and CI must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.",
      "basis": "Existing principles distinguish the population, formulation, background treatment, comparative design, DAS28, timing, denominators, related reports, company involvement and harms of adjunctive seed oil.",
      "condition_origin": "These existing conditions are linked to oral seed oil as adjunctive therapy in women with rheumatoid arthritis. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Original criteria, response/remission results, denominators and intervals are needed. A DAS28 mean is not converted into a treatment-success rate. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N25",
      "question_type": "Evidence condition",
      "question": "Are long-term effects, structural damage, drug replacement and cure separate questions?",
      "needed": "Direct evidence on long follow-up, structural damage, drug replacement/discontinuation and cure",
      "role": "Supplementary",
      "role_reason": "Material on Direct evidence on long follow-up, structural damage, drug replacement/discontinuation and cure is needed to connect adjunctive seed oil to its population, formulation, concomitant treatment, comparison, outcome, timing, denominator or harms.",
      "application_exception": "A fixed-sequence comparison is not converted into randomized period allocation or a concurrent parallel control. Mechanistic papers from the same cohort are not counted as independent clinical replications; inconsistent denominators are not selected or pooled, and no new differences, intervals, harm rates or doses are calculated.",
      "criterion": "Original records on Direct evidence on long follow-up, structural damage, drug replacement/discontinuation and cure must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.",
      "basis": "Existing principles distinguish the population, formulation, background treatment, comparative design, DAS28, timing, denominators, related reports, company involvement and harms of adjunctive seed oil.",
      "condition_origin": "These existing conditions are linked to oral seed oil as adjunctive therapy in women with rheumatoid arthritis. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Direct long-follow-up, structural/clinical-event and drug-replacement material is needed. Short-term DAS28 is not extended to these effects. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N26",
      "question_type": "Evidence condition",
      "question": "Are the four company-involvement routes distinguished for each report?",
      "needed": "Report-specific funding, product support, employee authorship and conflict disclosures",
      "role": "Required",
      "role_reason": "Material on Report-specific funding, product support, employee authorship and conflict disclosures is needed to connect adjunctive seed oil to its population, formulation, concomitant treatment, comparison, outcome, timing, denominator or harms.",
      "application_exception": "A fixed-sequence comparison is not converted into randomized period allocation or a concurrent parallel control. Mechanistic papers from the same cohort are not counted as independent clinical replications; inconsistent denominators are not selected or pooled, and no new differences, intervals, harm rates or doses are calculated.",
      "criterion": "Original records on Report-specific funding, product support, employee authorship and conflict disclosures must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.",
      "basis": "Existing principles distinguish the population, formulation, background treatment, comparative design, DAS28, timing, denominators, related reports, company involvement and harms of adjunctive seed oil.",
      "condition_origin": "These existing conditions are linked to oral seed oil as adjunctive therapy in women with rheumatoid arthritis. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Original support, product provision/preparation, affiliations and conflict disclosures are needed. University support, manufacturing and employment do not substitute for one another, and unrecorded involvement is not added. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N27",
      "question_type": "Evidence condition",
      "question": "Are historical independence assessments distinguished from current uncertainty?",
      "needed": "The original I1/rationale and the present preserved-material scope",
      "role": "Supplementary",
      "role_reason": "Material on The original I1/rationale and the present preserved-material scope is needed to connect adjunctive seed oil to its population, formulation, concomitant treatment, comparison, outcome, timing, denominator or harms.",
      "application_exception": "A fixed-sequence comparison is not converted into randomized period allocation or a concurrent parallel control. Mechanistic papers from the same cohort are not counted as independent clinical replications; inconsistent denominators are not selected or pooled, and no new differences, intervals, harm rates or doses are calculated.",
      "criterion": "Original records on The original I1/rationale and the present preserved-material scope must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.",
      "basis": "Existing principles distinguish the population, formulation, background treatment, comparative design, DAS28, timing, denominators, related reports, company involvement and harms of adjunctive seed oil.",
      "condition_origin": "These existing conditions are linked to oral seed oil as adjunctive therapy in women with rheumatoid arthritis. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Original funding, author, product-contract and trial-family links are needed. No new score or count of independent teams is created here. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N28",
      "question_type": "Evidence condition",
      "question": "Are harm-collection methods, events and discontinuations known?",
      "needed": "Adverse-event definitions, active/passive collection, discontinuations and severity",
      "role": "Supplementary",
      "role_reason": "Material on Adverse-event definitions, active/passive collection, discontinuations and severity is needed to connect adjunctive seed oil to its population, formulation, concomitant treatment, comparison, outcome, timing, denominator or harms.",
      "application_exception": "A fixed-sequence comparison is not converted into randomized period allocation or a concurrent parallel control. Mechanistic papers from the same cohort are not counted as independent clinical replications; inconsistent denominators are not selected or pooled, and no new differences, intervals, harm rates or doses are calculated.",
      "criterion": "Original records on Adverse-event definitions, active/passive collection, discontinuations and severity must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.",
      "basis": "Existing principles distinguish the population, formulation, background treatment, comparative design, DAS28, timing, denominators, related reports, company involvement and harms of adjunctive seed oil.",
      "condition_origin": "These existing conditions are linked to oral seed oil as adjunctive therapy in women with rheumatoid arthritis. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Original harm methods, events/discontinuations, missingness and arm-specific records are needed. Unread material is not converted into no harm. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N29",
      "question_type": "Evidence condition",
      "question": "What harm denominators, exposure and controls were used?",
      "needed": "Report/period-specific safety sets, actual dosing, events and controls",
      "role": "Supplementary",
      "role_reason": "Material on Report/period-specific safety sets, actual dosing, events and controls is needed to connect adjunctive seed oil to its population, formulation, concomitant treatment, comparison, outcome, timing, denominator or harms.",
      "application_exception": "A fixed-sequence comparison is not converted into randomized period allocation or a concurrent parallel control. Mechanistic papers from the same cohort are not counted as independent clinical replications; inconsistent denominators are not selected or pooled, and no new differences, intervals, harm rates or doses are calculated.",
      "criterion": "Original records on Report/period-specific safety sets, actual dosing, events and controls must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.",
      "basis": "Existing principles distinguish the population, formulation, background treatment, comparative design, DAS28, timing, denominators, related reports, company involvement and harms of adjunctive seed oil.",
      "condition_origin": "These existing conditions are linked to oral seed oil as adjunctive therapy in women with rheumatoid arthritis. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Original safety denominators, event counts, exposure/discontinuation, control groups/periods and participant matching are needed. No incidence rate is calculated. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N30",
      "question_type": "Evidence condition",
      "question": "Are DMARDs, steroids and alternative causes distinguished?",
      "needed": "Concomitant medicines, underlying disease, event timing, changes and course",
      "role": "Supplementary",
      "role_reason": "Material on Concomitant medicines, underlying disease, event timing, changes and course is needed to connect adjunctive seed oil to its population, formulation, concomitant treatment, comparison, outcome, timing, denominator or harms.",
      "application_exception": "A fixed-sequence comparison is not converted into randomized period allocation or a concurrent parallel control. Mechanistic papers from the same cohort are not counted as independent clinical replications; inconsistent denominators are not selected or pooled, and no new differences, intervals, harm rates or doses are calculated.",
      "criterion": "Original records on Concomitant medicines, underlying disease, event timing, changes and course must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.",
      "basis": "Existing principles distinguish the population, formulation, background treatment, comparative design, DAS28, timing, denominators, related reports, company involvement and harms of adjunctive seed oil.",
      "condition_origin": "These existing conditions are linked to oral seed oil as adjunctive therapy in women with rheumatoid arthritis. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Medication, dose, changes, underlying disease, timing/controls, course after discontinuation and alternative-cause records are needed. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N31",
      "question_type": "Evidence condition",
      "question": "Were long-term, rare and vulnerable-population harms verified?",
      "needed": "Independent harm reports, long exposure, vulnerable populations and denominators",
      "role": "Supplementary",
      "role_reason": "Material on Independent harm reports, long exposure, vulnerable populations and denominators is needed to connect adjunctive seed oil to its population, formulation, concomitant treatment, comparison, outcome, timing, denominator or harms.",
      "application_exception": "A fixed-sequence comparison is not converted into randomized period allocation or a concurrent parallel control. Mechanistic papers from the same cohort are not counted as independent clinical replications; inconsistent denominators are not selected or pooled, and no new differences, intervals, harm rates or doses are calculated.",
      "criterion": "Original records on Independent harm reports, long exposure, vulnerable populations and denominators must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.",
      "basis": "Existing principles distinguish the population, formulation, background treatment, comparative design, DAS28, timing, denominators, related reports, company involvement and harms of adjunctive seed oil.",
      "condition_origin": "These existing conditions are linked to oral seed oil as adjunctive therapy in women with rheumatoid arthritis. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Long follow-up, vulnerable-population material, independent reports and exposure/denominators are needed. No new harm search or assessment is performed. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N32",
      "question_type": "Evidence condition",
      "question": "Are stored-summary reading and external original-paper links distinguished?",
      "needed": "Access records for both stored reports, abstracts, full text, registration and protocols/SAPs",
      "role": "Required",
      "role_reason": "Material on Access records for both stored reports, abstracts, full text, registration and protocols/SAPs is needed to connect adjunctive seed oil to its population, formulation, concomitant treatment, comparison, outcome, timing, denominator or harms.",
      "application_exception": "A fixed-sequence comparison is not converted into randomized period allocation or a concurrent parallel control. Mechanistic papers from the same cohort are not counted as independent clinical replications; inconsistent denominators are not selected or pooled, and no new differences, intervals, harm rates or doses are calculated.",
      "criterion": "Original records on Access records for both stored reports, abstracts, full text, registration and protocols/SAPs must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.",
      "basis": "Existing principles distinguish the population, formulation, background treatment, comparative design, DAS28, timing, denominators, related reports, company involvement and harms of adjunctive seed oil.",
      "condition_origin": "These existing conditions are linked to oral seed oil as adjunctive therapy in women with rheumatoid arthritis. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: External material remains unread pending material provision and content review. URL existence does not establish reading, accessibility or fulfilled conditions. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N33",
      "question_type": "Evidence condition",
      "question": "Are generic English wording, actual design and the correction history retained?",
      "needed": "Original Korean/English records, generic evidence-table wording and limits of the 2026-09-14 correction",
      "role": "Supplementary",
      "role_reason": "Material on Original Korean/English records, generic evidence-table wording and limits of the 2026-09-14 correction is needed to connect adjunctive seed oil to its population, formulation, concomitant treatment, comparison, outcome, timing, denominator or harms.",
      "application_exception": "A fixed-sequence comparison is not converted into randomized period allocation or a concurrent parallel control. Mechanistic papers from the same cohort are not counted as independent clinical replications; inconsistent denominators are not selected or pooled, and no new differences, intervals, harm rates or doses are calculated.",
      "criterion": "Original records on Original Korean/English records, generic evidence-table wording and limits of the 2026-09-14 correction must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.",
      "basis": "Existing principles distinguish the population, formulation, background treatment, comparative design, DAS28, timing, denominators, related reports, company involvement and harms of adjunctive seed oil.",
      "condition_origin": "These existing conditions are linked to oral seed oil as adjunctive therapy in women with rheumatoid arthritis. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: External English text and historical correction targets remain uncompared here. Past verification wording is not presented as new content verification. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N34",
      "question_type": "Evidence condition",
      "question": "Are original grade, axes, evidence date and preparation kept separate?",
      "needed": "Preservation of C50, Caution, axes, evidence date and correction history",
      "role": "Required",
      "role_reason": "Material on Preservation of C50, Caution, axes, evidence date and correction history is needed to connect adjunctive seed oil to its population, formulation, concomitant treatment, comparison, outcome, timing, denominator or harms.",
      "application_exception": "A fixed-sequence comparison is not converted into randomized period allocation or a concurrent parallel control. Mechanistic papers from the same cohort are not counted as independent clinical replications; inconsistent denominators are not selected or pooled, and no new differences, intervals, harm rates or doses are calculated.",
      "criterion": "Original records on Preservation of C50, Caution, axes, evidence date and correction history must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.",
      "basis": "Existing principles distinguish the population, formulation, background treatment, comparative design, DAS28, timing, denominators, related reports, company involvement and harms of adjunctive seed oil.",
      "condition_origin": "These existing conditions are linked to oral seed oil as adjunctive therapy in women with rheumatoid arthritis. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: New evidence, condition revisions and verdict changes are separate events following content review. The original evidence date is not changed into a current search or external-reading date. This records needed materials; no new research was executed."
    }
  ]
}