{
  "schema_version": "chamgap-public-criteria-1.0",
  "title": "Oral curcumin or curcuminoid supplementation across mixed formulations × Reduction of LDL cholesterol in adults with dyslipidemia or metabolic disease",
  "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 LDL question is addressed?",
      "needed": "Oral curcumin and blood LDL-C change in adults with dyslipidemia or metabolic disease",
      "role": "Required",
      "role_reason": "Material on Oral curcumin and blood LDL-C change in adults with dyslipidemia or metabolic disease is needed to connect the relevant formulation, population, comparator, LDL scale/timepoint, report/trial, denominator, overlap or harm scope.",
      "application_exception": "Reviews with differing scopes, unique original trials and participants remain distinct, as do SMD and MD in mg/dL. Estimates are not added or converted, or extended to product/disease-specific effects, equivalence, optimum doses, medicine replacement, clinical-event prevention or overall safety.",
      "criterion": "Original records on Oral curcumin and blood LDL-C change in adults with dyslipidemia or metabolic disease must link to reports, trials, denominators, formulations, diseases, LDL scales and timepoints, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, population, comparator, endpoint/scale, timepoint, reports/trials, denominators, overlap, support and harms in the retained LDL record.",
      "condition_origin": "These existing conditions are linked to the retained LDL question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Original eligibility criteria matching population, formulation, comparator and LDL are needed. Other lipids, myocardial infarction and medicine replacement are excluded. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N02",
      "question_type": "Evidence condition",
      "question": "Are mixed formulations distinguished from individual products?",
      "needed": "Original-trial composition by conventional, nano and phytosomal formulations",
      "role": "Required",
      "role_reason": "Material on Original-trial composition by conventional, nano and phytosomal formulations is needed to connect the relevant formulation, population, comparator, LDL scale/timepoint, report/trial, denominator, overlap or harm scope.",
      "application_exception": "Reviews with differing scopes, unique original trials and participants remain distinct, as do SMD and MD in mg/dL. Estimates are not added or converted, or extended to product/disease-specific effects, equivalence, optimum doses, medicine replacement, clinical-event prevention or overall safety.",
      "criterion": "Original records on Original-trial composition by conventional, nano and phytosomal formulations must link to reports, trials, denominators, formulations, diseases, LDL scales and timepoints, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, population, comparator, endpoint/scale, timepoint, reports/trials, denominators, overlap, support and harms in the retained LDL record.",
      "condition_origin": "These existing conditions are linked to the retained LDL question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Active amounts, absorption enhancers and product information are needed. A mixed estimate does not establish efficacy or equivalence for an individual formulation. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N03",
      "question_type": "Evidence condition",
      "question": "What doses and actual exposure are recorded?",
      "needed": "Total product and active-curcuminoid amounts, frequency and adherence",
      "role": "Required",
      "role_reason": "Material on Total product and active-curcuminoid amounts, frequency and adherence is needed to connect the relevant formulation, population, comparator, LDL scale/timepoint, report/trial, denominator, overlap or harm scope.",
      "application_exception": "Reviews with differing scopes, unique original trials and participants remain distinct, as do SMD and MD in mg/dL. Estimates are not added or converted, or extended to product/disease-specific effects, equivalence, optimum doses, medicine replacement, clinical-event prevention or overall safety.",
      "criterion": "Original records on Total product and active-curcuminoid amounts, frequency and adherence must link to reports, trials, denominators, formulations, diseases, LDL scales and timepoints, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, population, comparator, endpoint/scale, timepoint, reports/trials, denominators, overlap, support and harms in the retained LDL record.",
      "condition_origin": "These existing conditions are linked to the retained LDL question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Original trial records on formulation, dose, co-ingredients and adherence are needed. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N04",
      "question_type": "Evidence condition",
      "question": "Are treatment duration and LDL measurement timepoints aligned?",
      "needed": "Trial-specific durations and LDL timepoints over weeks to months",
      "role": "Required",
      "role_reason": "Material on Trial-specific durations and LDL timepoints over weeks to months is needed to connect the relevant formulation, population, comparator, LDL scale/timepoint, report/trial, denominator, overlap or harm scope.",
      "application_exception": "Reviews with differing scopes, unique original trials and participants remain distinct, as do SMD and MD in mg/dL. Estimates are not added or converted, or extended to product/disease-specific effects, equivalence, optimum doses, medicine replacement, clinical-event prevention or overall safety.",
      "criterion": "Original records on Trial-specific durations and LDL timepoints over weeks to months must link to reports, trials, denominators, formulations, diseases, LDL scales and timepoints, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, population, comparator, endpoint/scale, timepoint, reports/trials, denominators, overlap, support and harms in the retained LDL record.",
      "condition_origin": "These existing conditions are linked to the retained LDL question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Treatment, measurement, end-of-follow-up and post-discontinuation timepoints, with selection rules, are needed. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N05",
      "question_type": "Evidence condition",
      "question": "Which diagnoses make up the mixed adult population?",
      "needed": "Dyslipidemia, T2D, metabolic syndrome and other diagnoses, with baseline LDL",
      "role": "Required",
      "role_reason": "Material on Dyslipidemia, T2D, metabolic syndrome and other diagnoses, with baseline LDL is needed to connect the relevant formulation, population, comparator, LDL scale/timepoint, report/trial, denominator, overlap or harm scope.",
      "application_exception": "Reviews with differing scopes, unique original trials and participants remain distinct, as do SMD and MD in mg/dL. Estimates are not added or converted, or extended to product/disease-specific effects, equivalence, optimum doses, medicine replacement, clinical-event prevention or overall safety.",
      "criterion": "Original records on Dyslipidemia, T2D, metabolic syndrome and other diagnoses, with baseline LDL must link to reports, trials, denominators, formulations, diseases, LDL scales and timepoints, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, population, comparator, endpoint/scale, timepoint, reports/trials, denominators, overlap, support and harms in the retained LDL record.",
      "condition_origin": "These existing conditions are linked to the retained LDL question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Inclusion tables by diagnosis, baseline LDL, age, comorbidities and eligibility are needed. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N06",
      "question_type": "Evidence condition",
      "question": "How does the T2D analysis relate to the broader analysis?",
      "needed": "Alignment of T2D eligibility with mixed-disease and formulation scopes",
      "role": "Required",
      "role_reason": "Material on Alignment of T2D eligibility with mixed-disease and formulation scopes is needed to connect the relevant formulation, population, comparator, LDL scale/timepoint, report/trial, denominator, overlap or harm scope.",
      "application_exception": "Reviews with differing scopes, unique original trials and participants remain distinct, as do SMD and MD in mg/dL. Estimates are not added or converted, or extended to product/disease-specific effects, equivalence, optimum doses, medicine replacement, clinical-event prevention or overall safety.",
      "criterion": "Original records on Alignment of T2D eligibility with mixed-disease and formulation scopes must link to reports, trials, denominators, formulations, diseases, LDL scales and timepoints, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, population, comparator, endpoint/scale, timepoint, reports/trials, denominators, overlap, support and harms in the retained LDL record.",
      "condition_origin": "These existing conditions are linked to the retained LDL question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Alignment of diseases, formulations and timepoints, with original-trial lists shared by the reviews, is needed. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N07",
      "question_type": "Evidence condition",
      "question": "How do comparator arrangements differ?",
      "needed": "Placebo or control care and common management in each group",
      "role": "Required",
      "role_reason": "Material on Placebo or control care and common management in each group is needed to connect the relevant formulation, population, comparator, LDL scale/timepoint, report/trial, denominator, overlap or harm scope.",
      "application_exception": "Reviews with differing scopes, unique original trials and participants remain distinct, as do SMD and MD in mg/dL. Estimates are not added or converted, or extended to product/disease-specific effects, equivalence, optimum doses, medicine replacement, clinical-event prevention or overall safety.",
      "criterion": "Original records on Placebo or control care and common management in each group must link to reports, trials, denominators, formulations, diseases, LDL scales and timepoints, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, population, comparator, endpoint/scale, timepoint, reports/trials, denominators, overlap, support and harms in the retained LDL record.",
      "condition_origin": "These existing conditions are linked to the retained LDL question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Original-trial records on comparator ingredients, blinding, diet/exercise management and added interventions are needed. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N08",
      "question_type": "Evidence condition",
      "question": "Can lipid and glucose medicines be separated from other interventions?",
      "needed": "Group-specific lipid/glucose medicines, diet and weight changes",
      "role": "Required",
      "role_reason": "Material on Group-specific lipid/glucose medicines, diet and weight changes is needed to connect the relevant formulation, population, comparator, LDL scale/timepoint, report/trial, denominator, overlap or harm scope.",
      "application_exception": "Reviews with differing scopes, unique original trials and participants remain distinct, as do SMD and MD in mg/dL. Estimates are not added or converted, or extended to product/disease-specific effects, equivalence, optimum doses, medicine replacement, clinical-event prevention or overall safety.",
      "criterion": "Original records on Group-specific lipid/glucose medicines, diet and weight changes must link to reports, trials, denominators, formulations, diseases, LDL scales and timepoints, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, population, comparator, endpoint/scale, timepoint, reports/trials, denominators, overlap, support and harms in the retained LDL record.",
      "condition_origin": "These existing conditions are linked to the retained LDL question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Baseline medicines, treatment changes, adherence and shared care are needed. Curcumin alone or a statin-replacement comparison is not established. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N09",
      "question_type": "Evidence condition",
      "question": "Are each review's design and eligibility scope retained separately?",
      "needed": "Search and eligibility criteria for the updated RCT review and T2D RCT review",
      "role": "Required",
      "role_reason": "Material on Search and eligibility criteria for the updated RCT review and T2D RCT review is needed to connect the relevant formulation, population, comparator, LDL scale/timepoint, report/trial, denominator, overlap or harm scope.",
      "application_exception": "Reviews with differing scopes, unique original trials and participants remain distinct, as do SMD and MD in mg/dL. Estimates are not added or converted, or extended to product/disease-specific effects, equivalence, optimum doses, medicine replacement, clinical-event prevention or overall safety.",
      "criterion": "Original records on Search and eligibility criteria for the updated RCT review and T2D RCT review must link to reports, trials, denominators, formulations, diseases, LDL scales and timepoints, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, population, comparator, endpoint/scale, timepoint, reports/trials, denominators, overlap, support and harms in the retained LDL record.",
      "condition_origin": "These existing conditions are linked to the retained LDL question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Search dates, strategies, eligibility, registration/plans and extraction tables are needed for each review. Currentness and directness are not newly certified. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N10",
      "question_type": "Evidence condition",
      "question": "Are the numbers of included trials known?",
      "needed": "Included RCT counts and study/report links for each review",
      "role": "Required",
      "role_reason": "Material on Included RCT counts and study/report links for each review is needed to connect the relevant formulation, population, comparator, LDL scale/timepoint, report/trial, denominator, overlap or harm scope.",
      "application_exception": "Reviews with differing scopes, unique original trials and participants remain distinct, as do SMD and MD in mg/dL. Estimates are not added or converted, or extended to product/disease-specific effects, equivalence, optimum doses, medicine replacement, clinical-event prevention or overall safety.",
      "criterion": "Original records on Included RCT counts and study/report links for each review must link to reports, trials, denominators, formulations, diseases, LDL scales and timepoints, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, population, comparator, endpoint/scale, timepoint, reports/trials, denominators, overlap, support and harms in the retained LDL record.",
      "condition_origin": "These existing conditions are linked to the retained LDL question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Inclusion lists, multiple-arm arrangements and duplicate-report links are needed. Unique-trial counts are not generated. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N11",
      "question_type": "Evidence condition",
      "question": "Are participants and analysis denominators known?",
      "needed": "Trial/group denominators for allocation, analysis, completion and LDL measurement",
      "role": "Required",
      "role_reason": "Material on Trial/group denominators for allocation, analysis, completion and LDL measurement is needed to connect the relevant formulation, population, comparator, LDL scale/timepoint, report/trial, denominator, overlap or harm scope.",
      "application_exception": "Reviews with differing scopes, unique original trials and participants remain distinct, as do SMD and MD in mg/dL. Estimates are not added or converted, or extended to product/disease-specific effects, equivalence, optimum doses, medicine replacement, clinical-event prevention or overall safety.",
      "criterion": "Original records on Trial/group denominators for allocation, analysis, completion and LDL measurement must link to reports, trials, denominators, formulations, diseases, LDL scales and timepoints, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, population, comparator, endpoint/scale, timepoint, reports/trials, denominators, overlap, support and harms in the retained LDL record.",
      "condition_origin": "These existing conditions are linked to the retained LDL question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Allocation, analysis, completion and measurement denominators, with participant-overlap information, are needed. The final unique-participant total remains null. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N12",
      "question_type": "Evidence condition",
      "question": "Can trials shared by the reviews be linked?",
      "needed": "Review-to-original-trial, additional-report and shared-participant links",
      "role": "Required",
      "role_reason": "Material on Review-to-original-trial, additional-report and shared-participant links is needed to connect the relevant formulation, population, comparator, LDL scale/timepoint, report/trial, denominator, overlap or harm scope.",
      "application_exception": "Reviews with differing scopes, unique original trials and participants remain distinct, as do SMD and MD in mg/dL. Estimates are not added or converted, or extended to product/disease-specific effects, equivalence, optimum doses, medicine replacement, clinical-event prevention or overall safety.",
      "criterion": "Original records on Review-to-original-trial, additional-report and shared-participant links must link to reports, trials, denominators, formulations, diseases, LDL scales and timepoints, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, population, comparator, endpoint/scale, timepoint, reports/trials, denominators, overlap, support and harms in the retained LDL record.",
      "condition_origin": "These existing conditions are linked to the retained LDL question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Article, registration, site/time and sample links are needed. Review estimates are not added or certified as two independent replications. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N13",
      "question_type": "Evidence condition",
      "question": "What is the LDL result in the broader updated analysis?",
      "needed": "R01 SMD, CI and P, with original model and scale",
      "role": "Required",
      "role_reason": "Material on R01 SMD, CI and P, with original model and scale is needed to connect the relevant formulation, population, comparator, LDL scale/timepoint, report/trial, denominator, overlap or harm scope.",
      "application_exception": "Reviews with differing scopes, unique original trials and participants remain distinct, as do SMD and MD in mg/dL. Estimates are not added or converted, or extended to product/disease-specific effects, equivalence, optimum doses, medicine replacement, clinical-event prevention or overall safety.",
      "criterion": "Original records on R01 SMD, CI and P, with original model and scale must link to reports, trials, denominators, formulations, diseases, LDL scales and timepoints, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, population, comparator, endpoint/scale, timepoint, reports/trials, denominators, overlap, support and harms in the retained LDL record.",
      "condition_origin": "These existing conditions are linked to the retained LDL question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Original pooling tables, standardization, variances, weights, included-trial and timepoint extraction are needed. New values are not calculated. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N14",
      "question_type": "Evidence condition",
      "question": "What is the LDL result in the T2D analysis?",
      "needed": "R02 MD in mg/dL, CI and P, with the original analysis population",
      "role": "Required",
      "role_reason": "Material on R02 MD in mg/dL, CI and P, with the original analysis population is needed to connect the relevant formulation, population, comparator, LDL scale/timepoint, report/trial, denominator, overlap or harm scope.",
      "application_exception": "Reviews with differing scopes, unique original trials and participants remain distinct, as do SMD and MD in mg/dL. Estimates are not added or converted, or extended to product/disease-specific effects, equivalence, optimum doses, medicine replacement, clinical-event prevention or overall safety.",
      "criterion": "Original records on R02 MD in mg/dL, CI and P, with the original analysis population must link to reports, trials, denominators, formulations, diseases, LDL scales and timepoints, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, population, comparator, endpoint/scale, timepoint, reports/trials, denominators, overlap, support and harms in the retained LDL record.",
      "condition_origin": "These existing conditions are linked to the retained LDL question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: T2D included trials, formulations, timepoints, variances/denominators and analysis models are needed. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N15",
      "question_type": "Evidence condition",
      "question": "Are SMD and MD in mg/dL kept without conversion?",
      "needed": "Units and estimands for standardized and absolute differences",
      "role": "Required",
      "role_reason": "Material on Units and estimands for standardized and absolute differences is needed to connect the relevant formulation, population, comparator, LDL scale/timepoint, report/trial, denominator, overlap or harm scope.",
      "application_exception": "Reviews with differing scopes, unique original trials and participants remain distinct, as do SMD and MD in mg/dL. Estimates are not added or converted, or extended to product/disease-specific effects, equivalence, optimum doses, medicine replacement, clinical-event prevention or overall safety.",
      "criterion": "Original records on Units and estimands for standardized and absolute differences must link to reports, trials, denominators, formulations, diseases, LDL scales and timepoints, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, population, comparator, endpoint/scale, timepoint, reports/trials, denominators, overlap, support and harms in the retained LDL record.",
      "condition_origin": "These existing conditions are linked to the retained LDL question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Original standard deviations, analysis arrangements and direct comparisons addressing the same question are needed. No SMD-to-mg/dL conversion or new pooled estimate is produced. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N16",
      "question_type": "Evidence condition",
      "question": "Are intervals crossing no effect distinguished from equivalence?",
      "needed": "Both original CIs and P values, with prespecified importance/equivalence criteria",
      "role": "Required",
      "role_reason": "Material on Both original CIs and P values, with prespecified importance/equivalence criteria is needed to connect the relevant formulation, population, comparator, LDL scale/timepoint, report/trial, denominator, overlap or harm scope.",
      "application_exception": "Reviews with differing scopes, unique original trials and participants remain distinct, as do SMD and MD in mg/dL. Estimates are not added or converted, or extended to product/disease-specific effects, equivalence, optimum doses, medicine replacement, clinical-event prevention or overall safety.",
      "criterion": "Original records on Both original CIs and P values, with prespecified importance/equivalence criteria must link to reports, trials, denominators, formulations, diseases, LDL scales and timepoints, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, population, comparator, endpoint/scale, timepoint, reports/trials, denominators, overlap, support and harms in the retained LDL record.",
      "condition_origin": "These existing conditions are linked to the retained LDL question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Original analysis tables and prespecified importance/equivalence criteria are needed. Lack of significance does not certify effect 0 or equivalence for every formulation. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N17",
      "question_type": "Evidence condition",
      "question": "Which report underlies the roughly 6–10 mg/dL positive signal?",
      "needed": "Bibliography, formulations, denominators and CIs for earlier positive analyses",
      "role": "Supplementary",
      "role_reason": "Material on Bibliography, formulations, denominators and CIs for earlier positive analyses is needed to connect the relevant formulation, population, comparator, LDL scale/timepoint, report/trial, denominator, overlap or harm scope.",
      "application_exception": "Reviews with differing scopes, unique original trials and participants remain distinct, as do SMD and MD in mg/dL. Estimates are not added or converted, or extended to product/disease-specific effects, equivalence, optimum doses, medicine replacement, clinical-event prevention or overall safety.",
      "criterion": "Original records on Bibliography, formulations, denominators and CIs for earlier positive analyses must link to reports, trials, denominators, formulations, diseases, LDL scales and timepoints, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, population, comparator, endpoint/scale, timepoint, reports/trials, denominators, overlap, support and harms in the retained LDL record.",
      "condition_origin": "These existing conditions are linked to the retained LDL question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Articles/years, original trials and direct LDL tables for the positive analyses are needed. Unidentified reports, effects and CIs are not invented. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N18",
      "question_type": "Evidence condition",
      "question": "Are the 2013–2025 narrative and citation years distinguished?",
      "needed": "Review chronology, search end dates, versions and bibliography alignment",
      "role": "Required",
      "role_reason": "Material on Review chronology, search end dates, versions and bibliography alignment is needed to connect the relevant formulation, population, comparator, LDL scale/timepoint, report/trial, denominator, overlap or harm scope.",
      "application_exception": "Reviews with differing scopes, unique original trials and participants remain distinct, as do SMD and MD in mg/dL. Estimates are not added or converted, or extended to product/disease-specific effects, equivalence, optimum doses, medicine replacement, clinical-event prevention or overall safety.",
      "criterion": "Original records on Review chronology, search end dates, versions and bibliography alignment must link to reports, trials, denominators, formulations, diseases, LDL scales and timepoints, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, population, comparator, endpoint/scale, timepoint, reports/trials, denominators, overlap, support and harms in the retained LDL record.",
      "condition_origin": "These existing conditions are linked to the retained LDL question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Report lists, versions, search dates and original citations for the stated years are needed. No new 2025 paper or completed external current search is created. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N19",
      "question_type": "Evidence condition",
      "question": "What explains differences and heterogeneity across analyses?",
      "needed": "Heterogeneity and sensitivity analyses by disease, formulation, duration and model",
      "role": "Required",
      "role_reason": "Material on Heterogeneity and sensitivity analyses by disease, formulation, duration and model is needed to connect the relevant formulation, population, comparator, LDL scale/timepoint, report/trial, denominator, overlap or harm scope.",
      "application_exception": "Reviews with differing scopes, unique original trials and participants remain distinct, as do SMD and MD in mg/dL. Estimates are not added or converted, or extended to product/disease-specific effects, equivalence, optimum doses, medicine replacement, clinical-event prevention or overall safety.",
      "criterion": "Original records on Heterogeneity and sensitivity analyses by disease, formulation, duration and model must link to reports, trials, denominators, formulations, diseases, LDL scales and timepoints, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, population, comparator, endpoint/scale, timepoint, reports/trials, denominators, overlap, support and harms in the retained LDL record.",
      "condition_origin": "These existing conditions are linked to the retained LDL question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Original heterogeneity, sensitivity/classification and extraction tables are needed. Different review scopes are not established as conflicting results from identical original trials; I² and prediction intervals are not invented. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N20",
      "question_type": "Evidence condition",
      "question": "What is known about original-trial allocation, blinding and risk assessment?",
      "needed": "Original allocation, concealment, blinding/measurement methods and assessment bases",
      "role": "Required",
      "role_reason": "Material on Original allocation, concealment, blinding/measurement methods and assessment bases is needed to connect the relevant formulation, population, comparator, LDL scale/timepoint, report/trial, denominator, overlap or harm scope.",
      "application_exception": "Reviews with differing scopes, unique original trials and participants remain distinct, as do SMD and MD in mg/dL. Estimates are not added or converted, or extended to product/disease-specific effects, equivalence, optimum doses, medicine replacement, clinical-event prevention or overall safety.",
      "criterion": "Original records on Original allocation, concealment, blinding/measurement methods and assessment bases must link to reports, trials, denominators, formulations, diseases, LDL scales and timepoints, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, population, comparator, endpoint/scale, timepoint, reports/trials, denominators, overlap, support and harms in the retained LDL record.",
      "condition_origin": "These existing conditions are linked to the retained LDL question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Original methods, registration/plans and review-level individual assessment bases are needed. Official RoB2/GRADE findings are not generated. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N21",
      "question_type": "Evidence condition",
      "question": "Are LDL measurement, change and adjustment arrangements comparable?",
      "needed": "Assays, fasting, final/change values, baseline adjustment and estimands",
      "role": "Required",
      "role_reason": "Material on Assays, fasting, final/change values, baseline adjustment and estimands is needed to connect the relevant formulation, population, comparator, LDL scale/timepoint, report/trial, denominator, overlap or harm scope.",
      "application_exception": "Reviews with differing scopes, unique original trials and participants remain distinct, as do SMD and MD in mg/dL. Estimates are not added or converted, or extended to product/disease-specific effects, equivalence, optimum doses, medicine replacement, clinical-event prevention or overall safety.",
      "criterion": "Original records on Assays, fasting, final/change values, baseline adjustment and estimands must link to reports, trials, denominators, formulations, diseases, LDL scales and timepoints, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, population, comparator, endpoint/scale, timepoint, reports/trials, denominators, overlap, support and harms in the retained LDL record.",
      "condition_origin": "These existing conditions are linked to the retained LDL question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Assays, timepoints, extraction tables, variance handling and analysis plans are needed. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N22",
      "question_type": "Evidence condition",
      "question": "What attrition, missingness and analysis exclusions are known?",
      "needed": "Trial-specific missing measurements, withdrawals and analysis sets",
      "role": "Required",
      "role_reason": "Material on Trial-specific missing measurements, withdrawals and analysis sets is needed to connect the relevant formulation, population, comparator, LDL scale/timepoint, report/trial, denominator, overlap or harm scope.",
      "application_exception": "Reviews with differing scopes, unique original trials and participants remain distinct, as do SMD and MD in mg/dL. Estimates are not added or converted, or extended to product/disease-specific effects, equivalence, optimum doses, medicine replacement, clinical-event prevention or overall safety.",
      "criterion": "Original records on Trial-specific missing measurements, withdrawals and analysis sets must link to reports, trials, denominators, formulations, diseases, LDL scales and timepoints, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, population, comparator, endpoint/scale, timepoint, reports/trials, denominators, overlap, support and harms in the retained LDL record.",
      "condition_origin": "These existing conditions are linked to the retained LDL question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Group-specific flow diagrams, missingness, exclusion reasons, missing-data handling and sensitivity material are needed. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N23",
      "question_type": "Evidence condition",
      "question": "Are LDL prespecification and reporting choices verified?",
      "needed": "Primary/secondary endpoints, timepoints and multiplicity plans",
      "role": "Required",
      "role_reason": "Material on Primary/secondary endpoints, timepoints and multiplicity plans is needed to connect the relevant formulation, population, comparator, LDL scale/timepoint, report/trial, denominator, overlap or harm scope.",
      "application_exception": "Reviews with differing scopes, unique original trials and participants remain distinct, as do SMD and MD in mg/dL. Estimates are not added or converted, or extended to product/disease-specific effects, equivalence, optimum doses, medicine replacement, clinical-event prevention or overall safety.",
      "criterion": "Original records on Primary/secondary endpoints, timepoints and multiplicity plans must link to reports, trials, denominators, formulations, diseases, LDL scales and timepoints, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, population, comparator, endpoint/scale, timepoint, reports/trials, denominators, overlap, support and harms in the retained LDL record.",
      "condition_origin": "These existing conditions are linked to the retained LDL question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Registration, protocols/SAPs and all-timepoint result tables are needed. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N24",
      "question_type": "Evidence condition",
      "question": "Are disease/formulation subgroups kept separate from overall effects?",
      "needed": "Subgroup effects/CIs, denominators, prespecification and interactions",
      "role": "Supplementary",
      "role_reason": "Material on Subgroup effects/CIs, denominators, prespecification and interactions is needed to connect the relevant formulation, population, comparator, LDL scale/timepoint, report/trial, denominator, overlap or harm scope.",
      "application_exception": "Reviews with differing scopes, unique original trials and participants remain distinct, as do SMD and MD in mg/dL. Estimates are not added or converted, or extended to product/disease-specific effects, equivalence, optimum doses, medicine replacement, clinical-event prevention or overall safety.",
      "criterion": "Original records on Subgroup effects/CIs, denominators, prespecification and interactions must link to reports, trials, denominators, formulations, diseases, LDL scales and timepoints, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, population, comparator, endpoint/scale, timepoint, reports/trials, denominators, overlap, support and harms in the retained LDL record.",
      "condition_origin": "These existing conditions are linked to the retained LDL question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Subgroup tables, interactions and distinctions by formulation/duration are needed. The overall SMD is not copied as a disease-specific or product-specific estimate. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N25",
      "question_type": "Evidence condition",
      "question": "Are other lipid endpoints distinguished from LDL benefit?",
      "needed": "Outcome-specific definitions and results for HDL, TG and total cholesterol",
      "role": "Supplementary",
      "role_reason": "Material on Outcome-specific definitions and results for HDL, TG and total cholesterol is needed to connect the relevant formulation, population, comparator, LDL scale/timepoint, report/trial, denominator, overlap or harm scope.",
      "application_exception": "Reviews with differing scopes, unique original trials and participants remain distinct, as do SMD and MD in mg/dL. Estimates are not added or converted, or extended to product/disease-specific effects, equivalence, optimum doses, medicine replacement, clinical-event prevention or overall safety.",
      "criterion": "Original records on Outcome-specific definitions and results for HDL, TG and total cholesterol must link to reports, trials, denominators, formulations, diseases, LDL scales and timepoints, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, population, comparator, endpoint/scale, timepoint, reports/trials, denominators, overlap, support and harms in the retained LDL record.",
      "condition_origin": "These existing conditions are linked to the retained LDL question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Original results for other lipids address separate questions. Effects and grades are not merged into the LDL table. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N26",
      "question_type": "Evidence condition",
      "question": "Are statin replacement and myocardial-infarction prevention separate questions?",
      "needed": "Direct material distinguishing an LDL surrogate from medicine replacement and clinical events",
      "role": "Supplementary",
      "role_reason": "Material on Direct material distinguishing an LDL surrogate from medicine replacement and clinical events is needed to connect the relevant formulation, population, comparator, LDL scale/timepoint, report/trial, denominator, overlap or harm scope.",
      "application_exception": "Reviews with differing scopes, unique original trials and participants remain distinct, as do SMD and MD in mg/dL. Estimates are not added or converted, or extended to product/disease-specific effects, equivalence, optimum doses, medicine replacement, clinical-event prevention or overall safety.",
      "criterion": "Original records on Direct material distinguishing an LDL surrogate from medicine replacement and clinical events must link to reports, trials, denominators, formulations, diseases, LDL scales and timepoints, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, population, comparator, endpoint/scale, timepoint, reports/trials, denominators, overlap, support and harms in the retained LDL record.",
      "condition_origin": "These existing conditions are linked to the retained LDL question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Direct comparisons on medicine replacement or cardiovascular events are not verified in this material. Efficacy scope is not expanded. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N27",
      "question_type": "Evidence condition",
      "question": "Are replication within a formulation and optimum doses verified?",
      "needed": "Unique trials, independent teams and direct dose comparisons",
      "role": "Supplementary",
      "role_reason": "Material on Unique trials, independent teams and direct dose comparisons is needed to connect the relevant formulation, population, comparator, LDL scale/timepoint, report/trial, denominator, overlap or harm scope.",
      "application_exception": "Reviews with differing scopes, unique original trials and participants remain distinct, as do SMD and MD in mg/dL. Estimates are not added or converted, or extended to product/disease-specific effects, equivalence, optimum doses, medicine replacement, clinical-event prevention or overall safety.",
      "criterion": "Original records on Unique trials, independent teams and direct dose comparisons must link to reports, trials, denominators, formulations, diseases, LDL scales and timepoints, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, population, comparator, endpoint/scale, timepoint, reports/trials, denominators, overlap, support and harms in the retained LDL record.",
      "condition_origin": "These existing conditions are linked to the retained LDL question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Direct material on original-trial families, products, teams, doses and timepoints is needed. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N28",
      "question_type": "Evidence condition",
      "question": "Are four routes of company involvement distinguished?",
      "needed": "Report/trial-specific funding, product support, employee authorship and COI",
      "role": "Required",
      "role_reason": "Material on Report/trial-specific funding, product support, employee authorship and COI is needed to connect the relevant formulation, population, comparator, LDL scale/timepoint, report/trial, denominator, overlap or harm scope.",
      "application_exception": "Reviews with differing scopes, unique original trials and participants remain distinct, as do SMD and MD in mg/dL. Estimates are not added or converted, or extended to product/disease-specific effects, equivalence, optimum doses, medicine replacement, clinical-event prevention or overall safety.",
      "criterion": "Original records on Report/trial-specific funding, product support, employee authorship and COI must link to reports, trials, denominators, formulations, diseases, LDL scales and timepoints, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, population, comparator, endpoint/scale, timepoint, reports/trials, denominators, overlap, support and harms in the retained LDL record.",
      "condition_origin": "These existing conditions are linked to the retained LDL question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Original support, product-provision, affiliation and COI disclosures for reviews/trials are needed. University researchers do not establish absence of company involvement. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N29",
      "question_type": "Evidence condition",
      "question": "Are harm collection methods and event tables known?",
      "needed": "Definitions, collection and discontinuation for gastrointestinal, bleeding and hepatobiliary events",
      "role": "Supplementary",
      "role_reason": "Material on Definitions, collection and discontinuation for gastrointestinal, bleeding and hepatobiliary events is needed to connect the relevant formulation, population, comparator, LDL scale/timepoint, report/trial, denominator, overlap or harm scope.",
      "application_exception": "Reviews with differing scopes, unique original trials and participants remain distinct, as do SMD and MD in mg/dL. Estimates are not added or converted, or extended to product/disease-specific effects, equivalence, optimum doses, medicine replacement, clinical-event prevention or overall safety.",
      "criterion": "Original records on Definitions, collection and discontinuation for gastrointestinal, bleeding and hepatobiliary events must link to reports, trials, denominators, formulations, diseases, LDL scales and timepoints, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, population, comparator, endpoint/scale, timepoint, reports/trials, denominators, overlap, support and harms in the retained LDL record.",
      "condition_origin": "These existing conditions are linked to the retained LDL question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Harm methods, severity, occurrence and discontinuation records are needed. Precautions do not establish incidence, causation or safety certification. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N30",
      "question_type": "Evidence condition",
      "question": "Are harm denominators and exposure kept distinct?",
      "needed": "Safety populations, dosing, duration, event counts and comparators",
      "role": "Supplementary",
      "role_reason": "Material on Safety populations, dosing, duration, event counts and comparators is needed to connect the relevant formulation, population, comparator, LDL scale/timepoint, report/trial, denominator, overlap or harm scope.",
      "application_exception": "Reviews with differing scopes, unique original trials and participants remain distinct, as do SMD and MD in mg/dL. Estimates are not added or converted, or extended to product/disease-specific effects, equivalence, optimum doses, medicine replacement, clinical-event prevention or overall safety.",
      "criterion": "Original records on Safety populations, dosing, duration, event counts and comparators must link to reports, trials, denominators, formulations, diseases, LDL scales and timepoints, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, population, comparator, endpoint/scale, timepoint, reports/trials, denominators, overlap, support and harms in the retained LDL record.",
      "condition_origin": "These existing conditions are linked to the retained LDL question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Group-specific safety sets, exposure amounts/time, withdrawals and comparator events are needed. Harm incidence is not calculated or replaced with LDL denominators. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N31",
      "question_type": "Evidence condition",
      "question": "Are alternative causes and concomitant treatments separated for harms?",
      "needed": "Comorbidities, medicines, event timing and alternative causes",
      "role": "Supplementary",
      "role_reason": "Material on Comorbidities, medicines, event timing and alternative causes is needed to connect the relevant formulation, population, comparator, LDL scale/timepoint, report/trial, denominator, overlap or harm scope.",
      "application_exception": "Reviews with differing scopes, unique original trials and participants remain distinct, as do SMD and MD in mg/dL. Estimates are not added or converted, or extended to product/disease-specific effects, equivalence, optimum doses, medicine replacement, clinical-event prevention or overall safety.",
      "criterion": "Original records on Comorbidities, medicines, event timing and alternative causes must link to reports, trials, denominators, formulations, diseases, LDL scales and timepoints, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, population, comparator, endpoint/scale, timepoint, reports/trials, denominators, overlap, support and harms in the retained LDL record.",
      "condition_origin": "These existing conditions are linked to the retained LDL question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Medicine maintenance/changes, baseline disease, event timing, comparators and post-discontinuation course are needed. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N32",
      "question_type": "Evidence condition",
      "question": "Does a bleeding precaution establish a direct interaction result?",
      "needed": "Distinguishing a bleeding precaution from medicine-specific direct comparisons",
      "role": "Supplementary",
      "role_reason": "Material on Distinguishing a bleeding precaution from medicine-specific direct comparisons is needed to connect the relevant formulation, population, comparator, LDL scale/timepoint, report/trial, denominator, overlap or harm scope.",
      "application_exception": "Reviews with differing scopes, unique original trials and participants remain distinct, as do SMD and MD in mg/dL. Estimates are not added or converted, or extended to product/disease-specific effects, equivalence, optimum doses, medicine replacement, clinical-event prevention or overall safety.",
      "criterion": "Original records on Distinguishing a bleeding precaution from medicine-specific direct comparisons must link to reports, trials, denominators, formulations, diseases, LDL scales and timepoints, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, population, comparator, endpoint/scale, timepoint, reports/trials, denominators, overlap, support and harms in the retained LDL record.",
      "condition_origin": "These existing conditions are linked to the retained LDL question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Concomitant medicine types, exposure, group-specific events, alternative causes and direct comparisons are needed. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N33",
      "question_type": "Evidence condition",
      "question": "Are long-term, hepatobiliary and vulnerable-population harms verified?",
      "needed": "Long-term/rare harms, hepatobiliary outcomes, vulnerable groups, independent reports and exposure",
      "role": "Supplementary",
      "role_reason": "Material on Long-term/rare harms, hepatobiliary outcomes, vulnerable groups, independent reports and exposure is needed to connect the relevant formulation, population, comparator, LDL scale/timepoint, report/trial, denominator, overlap or harm scope.",
      "application_exception": "Reviews with differing scopes, unique original trials and participants remain distinct, as do SMD and MD in mg/dL. Estimates are not added or converted, or extended to product/disease-specific effects, equivalence, optimum doses, medicine replacement, clinical-event prevention or overall safety.",
      "criterion": "Original records on Long-term/rare harms, hepatobiliary outcomes, vulnerable groups, independent reports and exposure must link to reports, trials, denominators, formulations, diseases, LDL scales and timepoints, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, population, comparator, endpoint/scale, timepoint, reports/trials, denominators, overlap, support and harms in the retained LDL record.",
      "condition_origin": "These existing conditions are linked to the retained LDL question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Long-term follow-up, independent harm reports, vulnerable-population, exposure/denominator and causal material are needed. No new harm investigation is undertaken. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N34",
      "question_type": "Evidence condition",
      "question": "Are stored-summary reading and external original links distinguished?",
      "needed": "Access tables for stored reports, abstracts, full texts, registration and protocols/SAPs",
      "role": "Required",
      "role_reason": "Material on Access tables for stored reports, abstracts, full texts, registration and protocols/SAPs is needed to connect the relevant formulation, population, comparator, LDL scale/timepoint, report/trial, denominator, overlap or harm scope.",
      "application_exception": "Reviews with differing scopes, unique original trials and participants remain distinct, as do SMD and MD in mg/dL. Estimates are not added or converted, or extended to product/disease-specific effects, equivalence, optimum doses, medicine replacement, clinical-event prevention or overall safety.",
      "criterion": "Original records on Access tables for stored reports, abstracts, full texts, registration and protocols/SAPs must link to reports, trials, denominators, formulations, diseases, LDL scales and timepoints, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, population, comparator, endpoint/scale, timepoint, reports/trials, denominators, overlap, support and harms in the retained LDL record.",
      "condition_origin": "These existing conditions are linked to the retained LDL question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Unread status remains until actual materials are acquired and reviewed. A URL does not establish reading, accessibility or fulfillment of conditions. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N35",
      "question_type": "Evidence condition",
      "question": "How are generic English wording and the historical correction retained?",
      "needed": "Original Korean/English records and limits of the 2026-09-14 correction",
      "role": "Supplementary",
      "role_reason": "Material on Original Korean/English records and limits of the 2026-09-14 correction is needed to connect the relevant formulation, population, comparator, LDL scale/timepoint, report/trial, denominator, overlap or harm scope.",
      "application_exception": "Reviews with differing scopes, unique original trials and participants remain distinct, as do SMD and MD in mg/dL. Estimates are not added or converted, or extended to product/disease-specific effects, equivalence, optimum doses, medicine replacement, clinical-event prevention or overall safety.",
      "criterion": "Original records on Original Korean/English records and limits of the 2026-09-14 correction must link to reports, trials, denominators, formulations, diseases, LDL scales and timepoints, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, population, comparator, endpoint/scale, timepoint, reports/trials, denominators, overlap, support and harms in the retained LDL record.",
      "condition_origin": "These existing conditions are linked to the retained LDL question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: External English material and historical correction targets are not newly reviewed here. The historical correction is not labeled as completed current QA. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N36",
      "question_type": "Evidence condition",
      "question": "Are original grade, axes, dates and preparation distinguished?",
      "needed": "Preservation of D30, Caution, axes, evidence date and correction",
      "role": "Required",
      "role_reason": "Material on Preservation of D30, Caution, axes, evidence date and correction is needed to connect the relevant formulation, population, comparator, LDL scale/timepoint, report/trial, denominator, overlap or harm scope.",
      "application_exception": "Reviews with differing scopes, unique original trials and participants remain distinct, as do SMD and MD in mg/dL. Estimates are not added or converted, or extended to product/disease-specific effects, equivalence, optimum doses, medicine replacement, clinical-event prevention or overall safety.",
      "criterion": "Original records on Preservation of D30, Caution, axes, evidence date and correction must link to reports, trials, denominators, formulations, diseases, LDL scales and timepoints, distinguishing stored information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, population, comparator, endpoint/scale, timepoint, reports/trials, denominators, overlap, support and harms in the retained LDL record.",
      "condition_origin": "These existing conditions are linked to the retained LDL question. They explain material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: New material, changed conditions and changed verdicts are recorded as separate events after appropriate review. The original date is not reused as a current search or external-reading date. This records needed materials; no new research was executed."
    }
  ]
}