{
  "schema_version": "chamgap-public-criteria-1.0",
  "title": "Nanocurcumin 80 mg three times daily × Improvement of HOMA-IR in polycystic ovary syndrome",
  "language": "en",
  "translation_date": "2026-10-24",
  "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 PCOS HOMA-IR question is presented?",
      "needed": "Nanocurcumin HOMA-IR and attribution to monotherapy/combination in a factorial trial",
      "role": "Required",
      "role_reason": "Material on Nanocurcumin HOMA-IR and attribution to monotherapy/combination in a factorial trial is needed to connect the relevant PCOS population, nanoformulation, factorial arm, HOMA-IR measurement/timepoint, main effect/interaction, denominator or harm scope.",
      "application_exception": "Arms, main effects and interactions within one factorial trial remain distinct. A combination-arm value is not transferred to a monotherapy main effect, and allocation ratios are not used to calculate group analysis counts. Scope is not extended to other formulations, weight/hormones, ovulation/fertility/pregnancy outcomes or overall safety.",
      "criterion": "Original records on Nanocurcumin HOMA-IR and attribution to monotherapy/combination in a factorial trial must link to populations, products, factorial comparisons, denominators, HOMA-IR analyses and timepoints, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish population, nanoformulation, dose/duration, factorial arms, main effects/interactions, measurement, denominators, support and harms in the retained PCOS HOMA-IR record.",
      "condition_origin": "These existing conditions are linked to the retained PCOS HOMA-IR question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Factorial analysis plans, group results, main effects and interaction tables. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N02",
      "question_type": "Evidence condition",
      "question": "What are the diagnostic and baseline conditions of the PCOS population?",
      "needed": "PCOS diagnosis, age, baseline metabolism, recruitment and exclusion criteria",
      "role": "Required",
      "role_reason": "Material on PCOS diagnosis, age, baseline metabolism, recruitment and exclusion criteria is needed to connect the relevant PCOS population, nanoformulation, factorial arm, HOMA-IR measurement/timepoint, main effect/interaction, denominator or harm scope.",
      "application_exception": "Arms, main effects and interactions within one factorial trial remain distinct. A combination-arm value is not transferred to a monotherapy main effect, and allocation ratios are not used to calculate group analysis counts. Scope is not extended to other formulations, weight/hormones, ovulation/fertility/pregnancy outcomes or overall safety.",
      "criterion": "Original records on PCOS diagnosis, age, baseline metabolism, recruitment and exclusion criteria must link to populations, products, factorial comparisons, denominators, HOMA-IR analyses and timepoints, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish population, nanoformulation, dose/duration, factorial arms, main effects/interactions, measurement, denominators, support and harms in the retained PCOS HOMA-IR record.",
      "condition_origin": "These existing conditions are linked to the retained PCOS HOMA-IR question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Eligibility, diagnosis and baseline-characteristic tables. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N03",
      "question_type": "Evidence condition",
      "question": "Which nanocurcumin formulation is involved?",
      "needed": "Distinguishing nanocurcumin soft-gels from other curcumin delivery formulations",
      "role": "Required",
      "role_reason": "Material on Distinguishing nanocurcumin soft-gels from other curcumin delivery formulations is needed to connect the relevant PCOS population, nanoformulation, factorial arm, HOMA-IR measurement/timepoint, main effect/interaction, denominator or harm scope.",
      "application_exception": "Arms, main effects and interactions within one factorial trial remain distinct. A combination-arm value is not transferred to a monotherapy main effect, and allocation ratios are not used to calculate group analysis counts. Scope is not extended to other formulations, weight/hormones, ovulation/fertility/pregnancy outcomes or overall safety.",
      "criterion": "Original records on Distinguishing nanocurcumin soft-gels from other curcumin delivery formulations must link to populations, products, factorial comparisons, denominators, HOMA-IR analyses and timepoints, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish population, nanoformulation, dose/duration, factorial arms, main effects/interactions, measurement, denominators, support and harms in the retained PCOS HOMA-IR record.",
      "condition_origin": "These existing conditions are linked to the retained PCOS HOMA-IR question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Product, batch, nano-characteristic and quantification material. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N04",
      "question_type": "Evidence condition",
      "question": "What are the oral dose and dosing interval?",
      "needed": "Actual administration of 80 mg every 8 hours, totaling 240 mg/day",
      "role": "Required",
      "role_reason": "Material on Actual administration of 80 mg every 8 hours, totaling 240 mg/day is needed to connect the relevant PCOS population, nanoformulation, factorial arm, HOMA-IR measurement/timepoint, main effect/interaction, denominator or harm scope.",
      "application_exception": "Arms, main effects and interactions within one factorial trial remain distinct. A combination-arm value is not transferred to a monotherapy main effect, and allocation ratios are not used to calculate group analysis counts. Scope is not extended to other formulations, weight/hormones, ovulation/fertility/pregnancy outcomes or overall safety.",
      "criterion": "Original records on Actual administration of 80 mg every 8 hours, totaling 240 mg/day must link to populations, products, factorial comparisons, denominators, HOMA-IR analyses and timepoints, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish population, nanoformulation, dose/duration, factorial arms, main effects/interactions, measurement, denominators, support and harms in the retained PCOS HOMA-IR record.",
      "condition_origin": "These existing conditions are linked to the retained PCOS HOMA-IR question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Dosing schedules, product amounts and adherence records. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N05",
      "question_type": "Evidence condition",
      "question": "What do 12 weeks of treatment and effect persistence mean?",
      "needed": "12 weeks of treatment/follow-up and post-treatment persistence",
      "role": "Required",
      "role_reason": "Material on 12 weeks of treatment/follow-up and post-treatment persistence is needed to connect the relevant PCOS population, nanoformulation, factorial arm, HOMA-IR measurement/timepoint, main effect/interaction, denominator or harm scope.",
      "application_exception": "Arms, main effects and interactions within one factorial trial remain distinct. A combination-arm value is not transferred to a monotherapy main effect, and allocation ratios are not used to calculate group analysis counts. Scope is not extended to other formulations, weight/hormones, ovulation/fertility/pregnancy outcomes or overall safety.",
      "criterion": "Original records on 12 weeks of treatment/follow-up and post-treatment persistence must link to populations, products, factorial comparisons, denominators, HOMA-IR analyses and timepoints, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish population, nanoformulation, dose/duration, factorial arms, main effects/interactions, measurement, denominators, support and harms in the retained PCOS HOMA-IR record.",
      "condition_origin": "These existing conditions are linked to the retained PCOS HOMA-IR question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Follow-up schedules and post-treatment material. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N06",
      "question_type": "Evidence condition",
      "question": "What are the four arms in the 2×2 factorial trial?",
      "needed": "Factorial arrangement of metformin, nanocurcumin, combination and double placebo",
      "role": "Required",
      "role_reason": "Material on Factorial arrangement of metformin, nanocurcumin, combination and double placebo is needed to connect the relevant PCOS population, nanoformulation, factorial arm, HOMA-IR measurement/timepoint, main effect/interaction, denominator or harm scope.",
      "application_exception": "Arms, main effects and interactions within one factorial trial remain distinct. A combination-arm value is not transferred to a monotherapy main effect, and allocation ratios are not used to calculate group analysis counts. Scope is not extended to other formulations, weight/hormones, ovulation/fertility/pregnancy outcomes or overall safety.",
      "criterion": "Original records on Factorial arrangement of metformin, nanocurcumin, combination and double placebo must link to populations, products, factorial comparisons, denominators, HOMA-IR analyses and timepoints, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish population, nanoformulation, dose/duration, factorial arms, main effects/interactions, measurement, denominators, support and harms in the retained PCOS HOMA-IR record.",
      "condition_origin": "These existing conditions are linked to the retained PCOS HOMA-IR question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Group-specific interventions, factors and analysis specifications. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N07",
      "question_type": "Evidence condition",
      "question": "What denominators do 200 people and 1:1:1:1 represent?",
      "needed": "Total 200 people, 4-arm allocation ratio and group-specific allocated/completed/analyzed counts",
      "role": "Required",
      "role_reason": "Material on Total 200 people, 4-arm allocation ratio and group-specific allocated/completed/analyzed counts is needed to connect the relevant PCOS population, nanoformulation, factorial arm, HOMA-IR measurement/timepoint, main effect/interaction, denominator or harm scope.",
      "application_exception": "Arms, main effects and interactions within one factorial trial remain distinct. A combination-arm value is not transferred to a monotherapy main effect, and allocation ratios are not used to calculate group analysis counts. Scope is not extended to other formulations, weight/hormones, ovulation/fertility/pregnancy outcomes or overall safety.",
      "criterion": "Original records on Total 200 people, 4-arm allocation ratio and group-specific allocated/completed/analyzed counts must link to populations, products, factorial comparisons, denominators, HOMA-IR analyses and timepoints, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish population, nanoformulation, dose/duration, factorial arms, main effects/interactions, measurement, denominators, support and harms in the retained PCOS HOMA-IR record.",
      "condition_origin": "These existing conditions are linked to the retained PCOS HOMA-IR question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Group flow, analysis populations and original HOMA-IR tables. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N08",
      "question_type": "Evidence condition",
      "question": "What are the metformin dose and common treatments?",
      "needed": "Actual metformin-factor dose/administration, lifestyle care and concomitant medicines",
      "role": "Required",
      "role_reason": "Material on Actual metformin-factor dose/administration, lifestyle care and concomitant medicines is needed to connect the relevant PCOS population, nanoformulation, factorial arm, HOMA-IR measurement/timepoint, main effect/interaction, denominator or harm scope.",
      "application_exception": "Arms, main effects and interactions within one factorial trial remain distinct. A combination-arm value is not transferred to a monotherapy main effect, and allocation ratios are not used to calculate group analysis counts. Scope is not extended to other formulations, weight/hormones, ovulation/fertility/pregnancy outcomes or overall safety.",
      "criterion": "Original records on Actual metformin-factor dose/administration, lifestyle care and concomitant medicines must link to populations, products, factorial comparisons, denominators, HOMA-IR analyses and timepoints, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish population, nanoformulation, dose/duration, factorial arms, main effects/interactions, measurement, denominators, support and harms in the retained PCOS HOMA-IR record.",
      "condition_origin": "These existing conditions are linked to the retained PCOS HOMA-IR question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Metformin, lifestyle-care and concomitant-medicine records. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N09",
      "question_type": "Evidence condition",
      "question": "What is the identity of the direct report?",
      "needed": "Feghhi report title, PMID, DOI and stored result",
      "role": "Required",
      "role_reason": "Material on Feghhi report title, PMID, DOI and stored result is needed to connect the relevant PCOS population, nanoformulation, factorial arm, HOMA-IR measurement/timepoint, main effect/interaction, denominator or harm scope.",
      "application_exception": "Arms, main effects and interactions within one factorial trial remain distinct. A combination-arm value is not transferred to a monotherapy main effect, and allocation ratios are not used to calculate group analysis counts. Scope is not extended to other formulations, weight/hormones, ovulation/fertility/pregnancy outcomes or overall safety.",
      "criterion": "Original records on Feghhi report title, PMID, DOI and stored result must link to populations, products, factorial comparisons, denominators, HOMA-IR analyses and timepoints, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish population, nanoformulation, dose/duration, factorial arms, main effects/interactions, measurement, denominators, support and harms in the retained PCOS HOMA-IR record.",
      "condition_origin": "These existing conditions are linked to the retained PCOS HOMA-IR question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Original paper and bibliographic records. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N10",
      "question_type": "Evidence condition",
      "question": "Are registration, protocol and SAP publicly available?",
      "needed": "Registration identifier, prespecification timing, study plans and factorial analysis plans",
      "role": "Required",
      "role_reason": "Material on Registration identifier, prespecification timing, study plans and factorial analysis plans is needed to connect the relevant PCOS population, nanoformulation, factorial arm, HOMA-IR measurement/timepoint, main effect/interaction, denominator or harm scope.",
      "application_exception": "Arms, main effects and interactions within one factorial trial remain distinct. A combination-arm value is not transferred to a monotherapy main effect, and allocation ratios are not used to calculate group analysis counts. Scope is not extended to other formulations, weight/hormones, ovulation/fertility/pregnancy outcomes or overall safety.",
      "criterion": "Original records on Registration identifier, prespecification timing, study plans and factorial analysis plans must link to populations, products, factorial comparisons, denominators, HOMA-IR analyses and timepoints, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish population, nanoformulation, dose/duration, factorial arms, main effects/interactions, measurement, denominators, support and harms in the retained PCOS HOMA-IR record.",
      "condition_origin": "These existing conditions are linked to the retained PCOS HOMA-IR question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Registration, protocol, SAP and amendments. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N11",
      "question_type": "Evidence condition",
      "question": "What is the prespecified hierarchy of HOMA-IR?",
      "needed": "Prespecified endpoints, timepoints and analyses for HOMA-IR and other metabolic markers",
      "role": "Required",
      "role_reason": "Material on Prespecified endpoints, timepoints and analyses for HOMA-IR and other metabolic markers is needed to connect the relevant PCOS population, nanoformulation, factorial arm, HOMA-IR measurement/timepoint, main effect/interaction, denominator or harm scope.",
      "application_exception": "Arms, main effects and interactions within one factorial trial remain distinct. A combination-arm value is not transferred to a monotherapy main effect, and allocation ratios are not used to calculate group analysis counts. Scope is not extended to other formulations, weight/hormones, ovulation/fertility/pregnancy outcomes or overall safety.",
      "criterion": "Original records on Prespecified endpoints, timepoints and analyses for HOMA-IR and other metabolic markers must link to populations, products, factorial comparisons, denominators, HOMA-IR analyses and timepoints, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish population, nanoformulation, dose/duration, factorial arms, main effects/interactions, measurement, denominators, support and harms in the retained PCOS HOMA-IR record.",
      "condition_origin": "These existing conditions are linked to the retained PCOS HOMA-IR question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Endpoint hierarchy in registration, protocol and SAP. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N12",
      "question_type": "Evidence condition",
      "question": "What are the randomization and concealment methods?",
      "needed": "2×2 factorial randomization, allocation concealment and recruitment flow",
      "role": "Required",
      "role_reason": "Material on 2×2 factorial randomization, allocation concealment and recruitment flow is needed to connect the relevant PCOS population, nanoformulation, factorial arm, HOMA-IR measurement/timepoint, main effect/interaction, denominator or harm scope.",
      "application_exception": "Arms, main effects and interactions within one factorial trial remain distinct. A combination-arm value is not transferred to a monotherapy main effect, and allocation ratios are not used to calculate group analysis counts. Scope is not extended to other formulations, weight/hormones, ovulation/fertility/pregnancy outcomes or overall safety.",
      "criterion": "Original records on 2×2 factorial randomization, allocation concealment and recruitment flow must link to populations, products, factorial comparisons, denominators, HOMA-IR analyses and timepoints, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish population, nanoformulation, dose/duration, factorial arms, main effects/interactions, measurement, denominators, support and harms in the retained PCOS HOMA-IR record.",
      "condition_origin": "These existing conditions are linked to the retained PCOS HOMA-IR question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Allocation, concealment and participant-flow material. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N13",
      "question_type": "Evidence condition",
      "question": "How were double blinding and double placebo implemented?",
      "needed": "Factor-specific placebos, appearance, blinded parties and maintenance",
      "role": "Required",
      "role_reason": "Material on Factor-specific placebos, appearance, blinded parties and maintenance is needed to connect the relevant PCOS population, nanoformulation, factorial arm, HOMA-IR measurement/timepoint, main effect/interaction, denominator or harm scope.",
      "application_exception": "Arms, main effects and interactions within one factorial trial remain distinct. A combination-arm value is not transferred to a monotherapy main effect, and allocation ratios are not used to calculate group analysis counts. Scope is not extended to other formulations, weight/hormones, ovulation/fertility/pregnancy outcomes or overall safety.",
      "criterion": "Original records on Factor-specific placebos, appearance, blinded parties and maintenance must link to populations, products, factorial comparisons, denominators, HOMA-IR analyses and timepoints, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish population, nanoformulation, dose/duration, factorial arms, main effects/interactions, measurement, denominators, support and harms in the retained PCOS HOMA-IR record.",
      "condition_origin": "These existing conditions are linked to the retained PCOS HOMA-IR question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Factor-specific placebo and blinding methods. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N14",
      "question_type": "Evidence condition",
      "question": "What is known about observation loss and ITT?",
      "needed": "Group completion, attrition, missing-data handling and ITT analysis",
      "role": "Required",
      "role_reason": "Material on Group completion, attrition, missing-data handling and ITT analysis is needed to connect the relevant PCOS population, nanoformulation, factorial arm, HOMA-IR measurement/timepoint, main effect/interaction, denominator or harm scope.",
      "application_exception": "Arms, main effects and interactions within one factorial trial remain distinct. A combination-arm value is not transferred to a monotherapy main effect, and allocation ratios are not used to calculate group analysis counts. Scope is not extended to other formulations, weight/hormones, ovulation/fertility/pregnancy outcomes or overall safety.",
      "criterion": "Original records on Group completion, attrition, missing-data handling and ITT analysis must link to populations, products, factorial comparisons, denominators, HOMA-IR analyses and timepoints, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish population, nanoformulation, dose/duration, factorial arms, main effects/interactions, measurement, denominators, support and harms in the retained PCOS HOMA-IR record.",
      "condition_origin": "These existing conditions are linked to the retained PCOS HOMA-IR question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Group flow, analysis populations and missing-data handling. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N15",
      "question_type": "Evidence condition",
      "question": "What is the HOMA-IR measurement arrangement?",
      "needed": "Measurement formula, fasting conditions, insulin/glucose assays, baseline and 12 weeks",
      "role": "Required",
      "role_reason": "Material on Measurement formula, fasting conditions, insulin/glucose assays, baseline and 12 weeks is needed to connect the relevant PCOS population, nanoformulation, factorial arm, HOMA-IR measurement/timepoint, main effect/interaction, denominator or harm scope.",
      "application_exception": "Arms, main effects and interactions within one factorial trial remain distinct. A combination-arm value is not transferred to a monotherapy main effect, and allocation ratios are not used to calculate group analysis counts. Scope is not extended to other formulations, weight/hormones, ovulation/fertility/pregnancy outcomes or overall safety.",
      "criterion": "Original records on Measurement formula, fasting conditions, insulin/glucose assays, baseline and 12 weeks must link to populations, products, factorial comparisons, denominators, HOMA-IR analyses and timepoints, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish population, nanoformulation, dose/duration, factorial arms, main effects/interactions, measurement, denominators, support and harms in the retained PCOS HOMA-IR record.",
      "condition_origin": "These existing conditions are linked to the retained PCOS HOMA-IR question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Measurement methods, assays, baseline values and result tables. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N16",
      "question_type": "Evidence condition",
      "question": "Which analysis underlies approximately −0.99 in the combination arm?",
      "needed": "Reference, comparator and denominator for combination-arm HOMA-IR approximately −0.99",
      "role": "Required",
      "role_reason": "Material on Reference, comparator and denominator for combination-arm HOMA-IR approximately −0.99 is needed to connect the relevant PCOS population, nanoformulation, factorial arm, HOMA-IR measurement/timepoint, main effect/interaction, denominator or harm scope.",
      "application_exception": "Arms, main effects and interactions within one factorial trial remain distinct. A combination-arm value is not transferred to a monotherapy main effect, and allocation ratios are not used to calculate group analysis counts. Scope is not extended to other formulations, weight/hormones, ovulation/fertility/pregnancy outcomes or overall safety.",
      "criterion": "Original records on Reference, comparator and denominator for combination-arm HOMA-IR approximately −0.99 must link to populations, products, factorial comparisons, denominators, HOMA-IR analyses and timepoints, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish population, nanoformulation, dose/duration, factorial arms, main effects/interactions, measurement, denominators, support and harms in the retained PCOS HOMA-IR record.",
      "condition_origin": "These existing conditions are linked to the retained PCOS HOMA-IR question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Original combination-arm result tables and analysis definitions. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N17",
      "question_type": "Evidence condition",
      "question": "What is the nanocurcumin-only arm comparison?",
      "needed": "Exact comparison between nanocurcumin-only and double-placebo arms",
      "role": "Required",
      "role_reason": "Material on Exact comparison between nanocurcumin-only and double-placebo arms is needed to connect the relevant PCOS population, nanoformulation, factorial arm, HOMA-IR measurement/timepoint, main effect/interaction, denominator or harm scope.",
      "application_exception": "Arms, main effects and interactions within one factorial trial remain distinct. A combination-arm value is not transferred to a monotherapy main effect, and allocation ratios are not used to calculate group analysis counts. Scope is not extended to other formulations, weight/hormones, ovulation/fertility/pregnancy outcomes or overall safety.",
      "criterion": "Original records on Exact comparison between nanocurcumin-only and double-placebo arms must link to populations, products, factorial comparisons, denominators, HOMA-IR analyses and timepoints, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish population, nanoformulation, dose/duration, factorial arms, main effects/interactions, measurement, denominators, support and harms in the retained PCOS HOMA-IR record.",
      "condition_origin": "These existing conditions are linked to the retained PCOS HOMA-IR question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Monotherapy-arm and double-placebo result tables. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N18",
      "question_type": "Evidence condition",
      "question": "Is the nanocurcumin main effect the same as a combination-arm value?",
      "needed": "Factorial marginal main effects, analysis models and exact estimates",
      "role": "Required",
      "role_reason": "Material on Factorial marginal main effects, analysis models and exact estimates is needed to connect the relevant PCOS population, nanoformulation, factorial arm, HOMA-IR measurement/timepoint, main effect/interaction, denominator or harm scope.",
      "application_exception": "Arms, main effects and interactions within one factorial trial remain distinct. A combination-arm value is not transferred to a monotherapy main effect, and allocation ratios are not used to calculate group analysis counts. Scope is not extended to other formulations, weight/hormones, ovulation/fertility/pregnancy outcomes or overall safety.",
      "criterion": "Original records on Factorial marginal main effects, analysis models and exact estimates must link to populations, products, factorial comparisons, denominators, HOMA-IR analyses and timepoints, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish population, nanoformulation, dose/duration, factorial arms, main effects/interactions, measurement, denominators, support and harms in the retained PCOS HOMA-IR record.",
      "condition_origin": "These existing conditions are linked to the retained PCOS HOMA-IR question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Original factorial main-effect tables, models and SAP. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N19",
      "question_type": "Evidence condition",
      "question": "Are metformin main effects distinguished from nanocurcumin contribution?",
      "needed": "Separating metformin-factor effects from nanocurcumin effects",
      "role": "Required",
      "role_reason": "Material on Separating metformin-factor effects from nanocurcumin effects is needed to connect the relevant PCOS population, nanoformulation, factorial arm, HOMA-IR measurement/timepoint, main effect/interaction, denominator or harm scope.",
      "application_exception": "Arms, main effects and interactions within one factorial trial remain distinct. A combination-arm value is not transferred to a monotherapy main effect, and allocation ratios are not used to calculate group analysis counts. Scope is not extended to other formulations, weight/hormones, ovulation/fertility/pregnancy outcomes or overall safety.",
      "criterion": "Original records on Separating metformin-factor effects from nanocurcumin effects must link to populations, products, factorial comparisons, denominators, HOMA-IR analyses and timepoints, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish population, nanoformulation, dose/duration, factorial arms, main effects/interactions, measurement, denominators, support and harms in the retained PCOS HOMA-IR record.",
      "condition_origin": "These existing conditions are linked to the retained PCOS HOMA-IR question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Both-factor effect tables and analysis models. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N20",
      "question_type": "Evidence condition",
      "question": "Was interaction between the factors estimated?",
      "needed": "Metformin×nanocurcumin interaction tests and intervals",
      "role": "Required",
      "role_reason": "Material on Metformin×nanocurcumin interaction tests and intervals is needed to connect the relevant PCOS population, nanoformulation, factorial arm, HOMA-IR measurement/timepoint, main effect/interaction, denominator or harm scope.",
      "application_exception": "Arms, main effects and interactions within one factorial trial remain distinct. A combination-arm value is not transferred to a monotherapy main effect, and allocation ratios are not used to calculate group analysis counts. Scope is not extended to other formulations, weight/hormones, ovulation/fertility/pregnancy outcomes or overall safety.",
      "criterion": "Original records on Metformin×nanocurcumin interaction tests and intervals must link to populations, products, factorial comparisons, denominators, HOMA-IR analyses and timepoints, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish population, nanoformulation, dose/duration, factorial arms, main effects/interactions, measurement, denominators, support and harms in the retained PCOS HOMA-IR record.",
      "condition_origin": "These existing conditions are linked to the retained PCOS HOMA-IR question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Original interaction tables, tests and SAP. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N21",
      "question_type": "Evidence condition",
      "question": "Are CIs available for main effects and interaction?",
      "needed": "95% CIs for each factor, the selected monotherapy comparison and interaction",
      "role": "Required",
      "role_reason": "Material on 95% CIs for each factor, the selected monotherapy comparison and interaction is needed to connect the relevant PCOS population, nanoformulation, factorial arm, HOMA-IR measurement/timepoint, main effect/interaction, denominator or harm scope.",
      "application_exception": "Arms, main effects and interactions within one factorial trial remain distinct. A combination-arm value is not transferred to a monotherapy main effect, and allocation ratios are not used to calculate group analysis counts. Scope is not extended to other formulations, weight/hormones, ovulation/fertility/pregnancy outcomes or overall safety.",
      "criterion": "Original records on 95% CIs for each factor, the selected monotherapy comparison and interaction must link to populations, products, factorial comparisons, denominators, HOMA-IR analyses and timepoints, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish population, nanoformulation, dose/duration, factorial arms, main effects/interactions, measurement, denominators, support and harms in the retained PCOS HOMA-IR record.",
      "condition_origin": "These existing conditions are linked to the retained PCOS HOMA-IR question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Factor-specific estimates, 95% CIs and model output. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N22",
      "question_type": "Evidence condition",
      "question": "What are the P values, multiplicity and model choices?",
      "needed": "Exact factor-specific tests, multiple endpoints and analysis plans",
      "role": "Required",
      "role_reason": "Material on Exact factor-specific tests, multiple endpoints and analysis plans is needed to connect the relevant PCOS population, nanoformulation, factorial arm, HOMA-IR measurement/timepoint, main effect/interaction, denominator or harm scope.",
      "application_exception": "Arms, main effects and interactions within one factorial trial remain distinct. A combination-arm value is not transferred to a monotherapy main effect, and allocation ratios are not used to calculate group analysis counts. Scope is not extended to other formulations, weight/hormones, ovulation/fertility/pregnancy outcomes or overall safety.",
      "criterion": "Original records on Exact factor-specific tests, multiple endpoints and analysis plans must link to populations, products, factorial comparisons, denominators, HOMA-IR analyses and timepoints, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish population, nanoformulation, dose/duration, factorial arms, main effects/interactions, measurement, denominators, support and harms in the retained PCOS HOMA-IR record.",
      "condition_origin": "These existing conditions are linked to the retained PCOS HOMA-IR question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: SAP, all tests and analysis output. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N23",
      "question_type": "Evidence condition",
      "question": "Does HOMA-IR establish improvement in weight and hormones too?",
      "needed": "Separate results for metabolic markers, weight and hormones",
      "role": "Required",
      "role_reason": "Material on Separate results for metabolic markers, weight and hormones is needed to connect the relevant PCOS population, nanoformulation, factorial arm, HOMA-IR measurement/timepoint, main effect/interaction, denominator or harm scope.",
      "application_exception": "Arms, main effects and interactions within one factorial trial remain distinct. A combination-arm value is not transferred to a monotherapy main effect, and allocation ratios are not used to calculate group analysis counts. Scope is not extended to other formulations, weight/hormones, ovulation/fertility/pregnancy outcomes or overall safety.",
      "criterion": "Original records on Separate results for metabolic markers, weight and hormones must link to populations, products, factorial comparisons, denominators, HOMA-IR analyses and timepoints, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish population, nanoformulation, dose/duration, factorial arms, main effects/interactions, measurement, denominators, support and harms in the retained PCOS HOMA-IR record.",
      "condition_origin": "These existing conditions are linked to the retained PCOS HOMA-IR question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Endpoint-specific results and prespecified hierarchy. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N24",
      "question_type": "Evidence condition",
      "question": "Is HOMA-IR change clinically important?",
      "needed": "Important differences in metabolic markers and long-term clinical outcomes",
      "role": "Required",
      "role_reason": "Material on Important differences in metabolic markers and long-term clinical outcomes is needed to connect the relevant PCOS population, nanoformulation, factorial arm, HOMA-IR measurement/timepoint, main effect/interaction, denominator or harm scope.",
      "application_exception": "Arms, main effects and interactions within one factorial trial remain distinct. A combination-arm value is not transferred to a monotherapy main effect, and allocation ratios are not used to calculate group analysis counts. Scope is not extended to other formulations, weight/hormones, ovulation/fertility/pregnancy outcomes or overall safety.",
      "criterion": "Original records on Important differences in metabolic markers and long-term clinical outcomes must link to populations, products, factorial comparisons, denominators, HOMA-IR analyses and timepoints, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish population, nanoformulation, dose/duration, factorial arms, main effects/interactions, measurement, denominators, support and harms in the retained PCOS HOMA-IR record.",
      "condition_origin": "These existing conditions are linked to the retained PCOS HOMA-IR question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Important-difference and clinical-outcome material. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N25",
      "question_type": "Evidence condition",
      "question": "What are the unique trial, endpoint and independent-replication units?",
      "needed": "Reporting relationships among one factorial trial, four arms and multiple outcomes",
      "role": "Required",
      "role_reason": "Material on Reporting relationships among one factorial trial, four arms and multiple outcomes is needed to connect the relevant PCOS population, nanoformulation, factorial arm, HOMA-IR measurement/timepoint, main effect/interaction, denominator or harm scope.",
      "application_exception": "Arms, main effects and interactions within one factorial trial remain distinct. A combination-arm value is not transferred to a monotherapy main effect, and allocation ratios are not used to calculate group analysis counts. Scope is not extended to other formulations, weight/hormones, ovulation/fertility/pregnancy outcomes or overall safety.",
      "criterion": "Original records on Reporting relationships among one factorial trial, four arms and multiple outcomes must link to populations, products, factorial comparisons, denominators, HOMA-IR analyses and timepoints, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish population, nanoformulation, dose/duration, factorial arms, main effects/interactions, measurement, denominators, support and harms in the retained PCOS HOMA-IR record.",
      "condition_origin": "These existing conditions are linked to the retained PCOS HOMA-IR question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Report-to-trial, factor and endpoint links. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N26",
      "question_type": "Evidence condition",
      "question": "What funding information is retained?",
      "needed": "Distinguishing funding sources/research roles from a no-conflict declaration",
      "role": "Required",
      "role_reason": "Material on Distinguishing funding sources/research roles from a no-conflict declaration is needed to connect the relevant PCOS population, nanoformulation, factorial arm, HOMA-IR measurement/timepoint, main effect/interaction, denominator or harm scope.",
      "application_exception": "Arms, main effects and interactions within one factorial trial remain distinct. A combination-arm value is not transferred to a monotherapy main effect, and allocation ratios are not used to calculate group analysis counts. Scope is not extended to other formulations, weight/hormones, ovulation/fertility/pregnancy outcomes or overall safety.",
      "criterion": "Original records on Distinguishing funding sources/research roles from a no-conflict declaration must link to populations, products, factorial comparisons, denominators, HOMA-IR analyses and timepoints, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish population, nanoformulation, dose/duration, factorial arms, main effects/interactions, measurement, denominators, support and harms in the retained PCOS HOMA-IR record.",
      "condition_origin": "These existing conditions are linked to the retained PCOS HOMA-IR question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Original funding and institutional-role disclosures. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N27",
      "question_type": "Evidence condition",
      "question": "Are product provision, manufacturer roles, employee authors and COI distinguished?",
      "needed": "Individual records on product support, employment, manufacturer roles and declared COI",
      "role": "Required",
      "role_reason": "Material on Individual records on product support, employment, manufacturer roles and declared COI is needed to connect the relevant PCOS population, nanoformulation, factorial arm, HOMA-IR measurement/timepoint, main effect/interaction, denominator or harm scope.",
      "application_exception": "Arms, main effects and interactions within one factorial trial remain distinct. A combination-arm value is not transferred to a monotherapy main effect, and allocation ratios are not used to calculate group analysis counts. Scope is not extended to other formulations, weight/hormones, ovulation/fertility/pregnancy outcomes or overall safety.",
      "criterion": "Original records on Individual records on product support, employment, manufacturer roles and declared COI must link to populations, products, factorial comparisons, denominators, HOMA-IR analyses and timepoints, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish population, nanoformulation, dose/duration, factorial arms, main effects/interactions, measurement, denominators, support and harms in the retained PCOS HOMA-IR record.",
      "condition_origin": "These existing conditions are linked to the retained PCOS HOMA-IR question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Original product-support, author-affiliation and COI disclosures. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N28",
      "question_type": "Evidence condition",
      "question": "How were harms in monotherapy and combination arms collected?",
      "needed": "Four-arm adverse-event definitions, collection, events and exposure denominators",
      "role": "Supplementary",
      "role_reason": "Material on Four-arm adverse-event definitions, collection, events and exposure denominators is needed to connect the relevant PCOS population, nanoformulation, factorial arm, HOMA-IR measurement/timepoint, main effect/interaction, denominator or harm scope.",
      "application_exception": "Arms, main effects and interactions within one factorial trial remain distinct. A combination-arm value is not transferred to a monotherapy main effect, and allocation ratios are not used to calculate group analysis counts. Scope is not extended to other formulations, weight/hormones, ovulation/fertility/pregnancy outcomes or overall safety.",
      "criterion": "Original records on Four-arm adverse-event definitions, collection, events and exposure denominators must link to populations, products, factorial comparisons, denominators, HOMA-IR analyses and timepoints, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish population, nanoformulation, dose/duration, factorial arms, main effects/interactions, measurement, denominators, support and harms in the retained PCOS HOMA-IR record.",
      "condition_origin": "These existing conditions are linked to the retained PCOS HOMA-IR question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Group adverse events, concomitant medicines and exposure denominators. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N29",
      "question_type": "Evidence condition",
      "question": "Is safety during pregnancy and pregnancy planning known?",
      "needed": "Nanocurcumin exposure during pregnancy, pregnancy planning and vulnerable populations",
      "role": "Supplementary",
      "role_reason": "Material on Nanocurcumin exposure during pregnancy, pregnancy planning and vulnerable populations is needed to connect the relevant PCOS population, nanoformulation, factorial arm, HOMA-IR measurement/timepoint, main effect/interaction, denominator or harm scope.",
      "application_exception": "Arms, main effects and interactions within one factorial trial remain distinct. A combination-arm value is not transferred to a monotherapy main effect, and allocation ratios are not used to calculate group analysis counts. Scope is not extended to other formulations, weight/hormones, ovulation/fertility/pregnancy outcomes or overall safety.",
      "criterion": "Original records on Nanocurcumin exposure during pregnancy, pregnancy planning and vulnerable populations must link to populations, products, factorial comparisons, denominators, HOMA-IR analyses and timepoints, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish population, nanoformulation, dose/duration, factorial arms, main effects/interactions, measurement, denominators, support and harms in the retained PCOS HOMA-IR record.",
      "condition_origin": "These existing conditions are linked to the retained PCOS HOMA-IR question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Pregnancy exposure, reproductive-safety and follow-up material. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N30",
      "question_type": "Evidence condition",
      "question": "Are ovulation, fertility and pregnancy outcomes the same as HOMA-IR?",
      "needed": "Separate questions on ovulation, fertility and pregnancy outcomes",
      "role": "Required",
      "role_reason": "Material on Separate questions on ovulation, fertility and pregnancy outcomes is needed to connect the relevant PCOS population, nanoformulation, factorial arm, HOMA-IR measurement/timepoint, main effect/interaction, denominator or harm scope.",
      "application_exception": "Arms, main effects and interactions within one factorial trial remain distinct. A combination-arm value is not transferred to a monotherapy main effect, and allocation ratios are not used to calculate group analysis counts. Scope is not extended to other formulations, weight/hormones, ovulation/fertility/pregnancy outcomes or overall safety.",
      "criterion": "Original records on Separate questions on ovulation, fertility and pregnancy outcomes must link to populations, products, factorial comparisons, denominators, HOMA-IR analyses and timepoints, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish population, nanoformulation, dose/duration, factorial arms, main effects/interactions, measurement, denominators, support and harms in the retained PCOS HOMA-IR record.",
      "condition_origin": "These existing conditions are linked to the retained PCOS HOMA-IR question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Ovulation, fertility and pregnancy-outcome material. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N31",
      "question_type": "Evidence condition",
      "question": "Can findings extend to other curcumin products or monotherapy?",
      "needed": "Distinguishing nano soft-gels from conventional, phytosomal or combination products and combination-arm results",
      "role": "Required",
      "role_reason": "Material on Distinguishing nano soft-gels from conventional, phytosomal or combination products and combination-arm results is needed to connect the relevant PCOS population, nanoformulation, factorial arm, HOMA-IR measurement/timepoint, main effect/interaction, denominator or harm scope.",
      "application_exception": "Arms, main effects and interactions within one factorial trial remain distinct. A combination-arm value is not transferred to a monotherapy main effect, and allocation ratios are not used to calculate group analysis counts. Scope is not extended to other formulations, weight/hormones, ovulation/fertility/pregnancy outcomes or overall safety.",
      "criterion": "Original records on Distinguishing nano soft-gels from conventional, phytosomal or combination products and combination-arm results must link to populations, products, factorial comparisons, denominators, HOMA-IR analyses and timepoints, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish population, nanoformulation, dose/duration, factorial arms, main effects/interactions, measurement, denominators, support and harms in the retained PCOS HOMA-IR record.",
      "condition_origin": "These existing conditions are linked to the retained PCOS HOMA-IR question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Direct formulation-specific and monotherapy comparisons. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N32",
      "question_type": "Evidence condition",
      "question": "What are the current Korean/English records and historical English correction?",
      "needed": "Current English wording, generic evidence wording and correction of 1 field on 2026-09-14",
      "role": "Required",
      "role_reason": "Material on Current English wording, generic evidence wording and correction of 1 field on 2026-09-14 is needed to connect the relevant PCOS population, nanoformulation, factorial arm, HOMA-IR measurement/timepoint, main effect/interaction, denominator or harm scope.",
      "application_exception": "Arms, main effects and interactions within one factorial trial remain distinct. A combination-arm value is not transferred to a monotherapy main effect, and allocation ratios are not used to calculate group analysis counts. Scope is not extended to other formulations, weight/hormones, ovulation/fertility/pregnancy outcomes or overall safety.",
      "criterion": "Original records on Current English wording, generic evidence wording and correction of 1 field on 2026-09-14 must link to populations, products, factorial comparisons, denominators, HOMA-IR analyses and timepoints, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish population, nanoformulation, dose/duration, factorial arms, main effects/interactions, measurement, denominators, support and harms in the retained PCOS HOMA-IR record.",
      "condition_origin": "These existing conditions are linked to the retained PCOS HOMA-IR question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Before/after-correction and language-alignment material. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N33",
      "question_type": "Evidence condition",
      "question": "How are C/54, original axes and historical cross-checking retained?",
      "needed": "Original C/54, EX/CX, all axes and historical verification wording",
      "role": "Required",
      "role_reason": "Material on Original C/54, EX/CX, all axes and historical verification wording is needed to connect the relevant PCOS population, nanoformulation, factorial arm, HOMA-IR measurement/timepoint, main effect/interaction, denominator or harm scope.",
      "application_exception": "Arms, main effects and interactions within one factorial trial remain distinct. A combination-arm value is not transferred to a monotherapy main effect, and allocation ratios are not used to calculate group analysis counts. Scope is not extended to other formulations, weight/hormones, ovulation/fertility/pregnancy outcomes or overall safety.",
      "criterion": "Original records on Original C/54, EX/CX, all axes and historical verification wording must link to populations, products, factorial comparisons, denominators, HOMA-IR analyses and timepoints, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish population, nanoformulation, dose/duration, factorial arms, main effects/interactions, measurement, denominators, support and harms in the retained PCOS HOMA-IR record.",
      "condition_origin": "These existing conditions are linked to the retained PCOS HOMA-IR question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Review comments and future correction material. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N34",
      "question_type": "Evidence condition",
      "question": "What are the original dates, blank fields and actual reading scope?",
      "needed": "Original verdict date, correction date, blank original fields and external unread status",
      "role": "Required",
      "role_reason": "Material on Original verdict date, correction date, blank original fields and external unread status is needed to connect the relevant PCOS population, nanoformulation, factorial arm, HOMA-IR measurement/timepoint, main effect/interaction, denominator or harm scope.",
      "application_exception": "Arms, main effects and interactions within one factorial trial remain distinct. A combination-arm value is not transferred to a monotherapy main effect, and allocation ratios are not used to calculate group analysis counts. Scope is not extended to other formulations, weight/hormones, ovulation/fertility/pregnancy outcomes or overall safety.",
      "criterion": "Original records on Original verdict date, correction date, blank original fields and external unread status must link to populations, products, factorial comparisons, denominators, HOMA-IR analyses and timepoints, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish population, nanoformulation, dose/duration, factorial arms, main effects/interactions, measurement, denominators, support and harms in the retained PCOS HOMA-IR record.",
      "condition_origin": "These existing conditions are linked to the retained PCOS HOMA-IR question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Needed original material and factorial analysis plans when provided. This records needed materials; no new research was executed."
    }
  ]
}