{
  "schema_version": "chamgap-public-criteria-1.0",
  "title": "Quercetin 500 mg daily × Reduced MRI liver fat over 12 weeks — Evidence Check",
  "language": "en",
  "translation_date": "2026-10-12",
  "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": "Preserved method HTML copies; no current method-content re-review or official tool execution"
    },
    {
      "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": "Preserved method HTML copies; no current method-content re-review or official tool execution"
    },
    {
      "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": "Preserved method HTML copies; no current method-content re-review or official tool execution"
    },
    {
      "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": "Preserved method HTML copies; no current method-content re-review or official tool execution"
    },
    {
      "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": "Preserved method HTML copies; no current method-content re-review or official tool execution"
    }
  ],
  "status_dictionary": {
    "Met": "Status for necessary evidence confirmed after existing content review. No completion is declared in the current presentation.",
    "Partly verified": "Some information in the stored summary is linked into the table. External comparison/content review is not complete.",
    "Unverified": "The article leaves this unverified, or required material is absent from the current stored summary. This is distinct from zero, absence or safety.",
    "Review incomplete": "Existing content review remains incomplete.",
    "Not reported": "Not reported within the stored material actually read; not extended to the entire primary paper.",
    "Inaccessible": "Means an actual access failure. Access not attempted here is not assigned this state.",
    "Not applicable": "Not used as a substitute for an evidence gap.",
    "Conflicting data": "Requires an observed disagreement under the same comparison criteria; not automatically judged in this production.",
    "Insufficient evidence for the conditions": "Marks a gap in additional material required by the selected conditions; not a new efficacy grade."
  },
  "requirements": [
    {
      "item_id": "N01",
      "question_type": "Evidence condition",
      "question": "Selected 12-week MRI outcome and original values",
      "needed": "Selected existing question, grade/note, parent context and presence of score/status/axes",
      "role": "Required",
      "role_reason": "Distinguish Selected existing question, grade/note, parent context and presence of score/status/axes to connect materials needed for the selected question with the current materials in this production item.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Selected existing question, grade/note, parent context and presence of score/status/axes requires corresponding original material/analysis scope and a distinction of unverified matters. Original wording is linked here; content review remains incomplete.",
      "basis": "M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are custom design; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is custom design; M04 §4.5, §4.6.3; limits on current material conversion reflect the review scope and custom design",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Connect the original question to additional materials in proposed update research; no new investigation, calculation or trial is performed now."
    },
    {
      "item_id": "N02",
      "question_type": "Evidence condition",
      "question": "Participants with nonalcoholic fatty liver disease",
      "needed": "Disease, recruitment/eligibility, baseline risk and arm/period characteristics",
      "role": "Required",
      "role_reason": "Distinguish Disease, recruitment/eligibility, baseline risk and arm/period characteristics to connect materials needed for the selected question with the current materials in this production item.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Disease, recruitment/eligibility, baseline risk and arm/period characteristics requires corresponding original material/analysis scope and a distinction of unverified matters. Original wording is linked here; content review remains incomplete.",
      "basis": "M03 §3.2.1; detailed population conditions are custom design; M03 §3.2.1–3.2.4; dose/duration/effect-modification details are custom design; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is custom design",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Propose follow-up research on population conditions and applicability; no new investigation, calculation or trial is performed now."
    },
    {
      "item_id": "N03",
      "question_type": "Evidence condition",
      "question": "Quercetin 500 mg and formulation",
      "needed": "Specific study product, formulation/ingredients/batch and exposure",
      "role": "Required",
      "role_reason": "Distinguish Specific study product, formulation/ingredients/batch and exposure to connect materials needed for the selected question with the current materials in this production item.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Specific study product, formulation/ingredients/batch and exposure requires corresponding original material/analysis scope and a distinction of unverified matters. Original wording is linked here; content review remains incomplete.",
      "basis": "M03 §3.2.2–3.2.3; reverse-direction labels and checking adaptations are internally designed; M03 §3.2.3, M08 §8.2.2–8.2.3; internal application; M03 §3.2.1–3.2.4; dose, duration and effect-modification details are internally designed",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Propose follow-up research distinguishing formulation from result attribution; no new investigation, calculation or trial is performed now."
    },
    {
      "item_id": "N04",
      "question_type": "Evidence condition",
      "question": "Placebo and crossover comparison",
      "needed": "Actual placebo, sensory matching and conditions in each period",
      "role": "Required",
      "role_reason": "Distinguish Actual placebo, sensory matching and conditions in each period to connect materials needed for the selected question with the current materials in this production item.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Actual placebo, sensory matching and conditions in each period requires corresponding original material/analysis scope and a distinction of unverified matters. Original wording is linked here; content review remains incomplete.",
      "basis": "M03 §3.2.2–3.2.3; reverse-direction labeling and test adaptation are custom design; M03 §3.2.3, M08 §8.2.2–8.2.3; custom application; M08 §8.2.2, M15 §15.3.1; custom application; M04 §4.6.1–4.6.2 distinction between studies and reports; cohort/outcome linkage is a custom application",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Propose follow-up research on comparator conditions and period-specific comparison definitions; no new investigation, calculation or trial is performed now."
    },
    {
      "item_id": "N05",
      "question_type": "Evidence condition",
      "question": "12 weeks and four-week washout",
      "needed": "Intervention/measurement periods, washout and actual sequence",
      "role": "Required",
      "role_reason": "Distinguish Intervention/measurement periods, washout and actual sequence to connect materials needed for the selected question with the current materials in this production item.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Intervention/measurement periods, washout and actual sequence requires corresponding original material/analysis scope and a distinction of unverified matters. Original wording is linked here; content review remains incomplete.",
      "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is custom design; M08 §8.2.2, M15 §15.3.1; custom application; M03 §3.2.3, M08 §8.2.2–8.2.3; custom application; M03 §3.2.1–3.2.4; dose/duration/effect-modification details are custom design",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Propose follow-up research on time/carryover and observed results; no new investigation, calculation or trial is performed now."
    },
    {
      "item_id": "N06",
      "question_type": "Evidence condition",
      "question": "Randomized sequence and concealment",
      "needed": "Crossover allocation sequence, generation/concealment and actual procedures",
      "role": "Required",
      "role_reason": "Distinguish Crossover allocation sequence, generation/concealment and actual procedures to connect materials needed for the selected question with the current materials in this production item.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Crossover allocation sequence, generation/concealment and actual procedures requires corresponding original material/analysis scope and a distinction of unverified matters. Original wording is linked here; content review remains incomplete.",
      "basis": "M08 §8.1–8.2.3; custom application; M04 §4.5–4.6 material-collection/selection principles; separation of access/reading and hyperlink conventions are custom design; M08 §8.2.2, M15 §15.3.1; custom application",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Propose follow-up research on allocation and period-specific population relationships; no new investigation, calculation or trial is performed now."
    },
    {
      "item_id": "N07",
      "question_type": "Evidence condition",
      "question": "Masking and MRI assessment",
      "needed": "Role-specific masking, measurement/image assessment and analysis procedures",
      "role": "Required",
      "role_reason": "Distinguish Role-specific masking, measurement/image assessment and analysis procedures to connect materials needed for the selected question with the current materials in this production item.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Role-specific masking, measurement/image assessment and analysis procedures requires corresponding original material/analysis scope and a distinction of unverified matters. Original wording is linked here; content review remains incomplete.",
      "basis": "M08 Table 8.2.a, M03 §3.2.4; custom application; M04 §4.5–4.6 material-collection/selection principles; separation of access/reading and hyperlink conventions are custom design; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is custom design",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Propose follow-up research on measurement/assessment bias and MRI results; no new investigation, calculation or trial is performed now."
    },
    {
      "item_id": "N08",
      "question_type": "Evidence condition",
      "question": "MRI-PDFF and the 12-week measure",
      "needed": "Definition, units/measurement and timing of the intrahepatic-lipid measure",
      "role": "Required",
      "role_reason": "Distinguish Definition, units/measurement and timing of the intrahepatic-lipid measure to connect materials needed for the selected question with the current materials in this production item.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Definition, units/measurement and timing of the intrahepatic-lipid measure requires corresponding original material/analysis scope and a distinction of unverified matters. Original wording is linked here; content review remains incomplete.",
      "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is custom design; M08 Table 8.2.a, M03 §3.2.4; custom application; M08 Table 8.2.a, M04 §4.6.3; custom application; M03 §3.2.4; custom extension boundary",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Propose follow-up research distinguishing imaging measures from other outcomes; no new investigation, calculation or trial is performed now."
    },
    {
      "item_id": "N09",
      "question_type": "Evidence condition",
      "question": "Quercetin-period baseline and final values",
      "needed": "Periods/populations, dispersion and distinction from change in original MRI values",
      "role": "Required",
      "role_reason": "Distinguish Periods/populations, dispersion and distinction from change in original MRI values to connect materials needed for the selected question with the current materials in this production item.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Periods/populations, dispersion and distinction from change in original MRI values requires corresponding original material/analysis scope and a distinction of unverified matters. Original wording is linked here; content review remains incomplete.",
      "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is custom design; M08 §8.2.2, M15 §15.3.1; custom application; M15 §15.3.1–15.3.3; custom application; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is custom design",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Propose follow-up research on final values/change and period-specific analysis definitions; no new investigation, calculation or trial is performed now."
    },
    {
      "item_id": "N10",
      "question_type": "Evidence condition",
      "question": "Placebo change and units",
      "needed": "Placebo-period change/final values, original units and estimands",
      "role": "Required",
      "role_reason": "Distinguish Placebo-period change/final values, original units and estimands to connect materials needed for the selected question with the current materials in this production item.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Placebo-period change/final values, original units and estimands requires corresponding original material/analysis scope and a distinction of unverified matters. Original wording is linked here; content review remains incomplete.",
      "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is custom design; M08 §8.2.2, M15 §15.3.1; custom application; M15 §15.3.1–15.3.3; custom application; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is custom design",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Propose follow-up research distinguishing original estimands/units and comparison relationships; no new investigation, calculation or trial is performed now."
    },
    {
      "item_id": "N11",
      "question_type": "Evidence condition",
      "question": "P=.013 and adjusted P=.028",
      "needed": "Original test for the selected comparison, multiplicity/models and precision",
      "role": "Required",
      "role_reason": "Distinguish Original test for the selected comparison, multiplicity/models and precision to connect materials needed for the selected question with the current materials in this production item.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Original test for the selected comparison, multiplicity/models and precision requires corresponding original material/analysis scope and a distinction of unverified matters. Original wording is linked here; content review remains incomplete.",
      "basis": "M15 §15.3.1–15.3.3; custom application; M08 Table 8.2.a, M04 §4.6.3; custom application; M08 §8.2.2, M15 §15.3.1; custom application; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is custom design",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Propose follow-up research on tests/multiplicity and uncertainty; no new investigation, calculation or trial is performed now."
    },
    {
      "item_id": "N12",
      "question_type": "Evidence condition",
      "question": "Between-treatment CI and historical checking scope",
      "needed": "Precision and abstract/public-table checking versus current reading scope",
      "role": "Required",
      "role_reason": "Distinguish Precision and abstract/public-table checking versus current reading scope to connect materials needed for the selected question with the current materials in this production item.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Precision and abstract/public-table checking versus current reading scope requires corresponding original material/analysis scope and a distinction of unverified matters. Original wording is linked here; content review remains incomplete.",
      "basis": "M04 §4.5–4.6 material-collection/selection principles; separation of access/reading and hyperlink conventions are custom design; M15 §15.3.1–15.3.3; custom application; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is custom design; M04 §4.5, §4.6.3; limits on current material conversion reflect the review scope and custom design",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Propose update research distinguishing precision data from materials actually read; no new investigation, calculation or trial is performed now."
    },
    {
      "item_id": "N13",
      "question_type": "Evidence condition",
      "question": "Prespecified important MRI threshold",
      "needed": "Prespecified minimum clinically important difference and interpretation/success definitions",
      "role": "Required",
      "role_reason": "Distinguish Prespecified minimum clinically important difference and interpretation/success definitions to connect materials needed for the selected question with the current materials in this production item.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Prespecified minimum clinically important difference and interpretation/success definitions requires corresponding original material/analysis scope and a distinction of unverified matters. Original wording is linked here; content review remains incomplete.",
      "basis": "M15 §15.3.1–15.3.3; custom application; M08 Table 8.2.a, M04 §4.6.3; custom application; M03 §3.2.4; custom extension boundary",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Propose research distinguishing statistical results from important differences/clinical meaning; no new investigation, calculation or trial is performed now."
    },
    {
      "item_id": "N14",
      "question_type": "Evidence condition",
      "question": "41 to 36: completion and analysis",
      "needed": "Randomized/completed participants, period-specific observations/analysis and missingness",
      "role": "Required",
      "role_reason": "Distinguish Randomized/completed participants, period-specific observations/analysis and missingness to connect materials needed for the selected question with the current materials in this production item.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Randomized/completed participants, period-specific observations/analysis and missingness requires corresponding original material/analysis scope and a distinction of unverified matters. Original wording is linked here; content review remains incomplete.",
      "basis": "M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is custom design; M08 §8.2.2, M15 §15.3.1; custom application; M04 §4.6.1–4.6.2 distinction between studies and reports; cohort/outcome linkage is a custom application",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Propose follow-up research on selected populations and missing-data assumptions; no new investigation, calculation or trial is performed now."
    },
    {
      "item_id": "N15",
      "question_type": "Evidence condition",
      "question": "ITT and crossover model",
      "needed": "Actual ITT/allocation and period/sequence/within-person comparison definitions",
      "role": "Required",
      "role_reason": "Distinguish Actual ITT/allocation and period/sequence/within-person comparison definitions to connect materials needed for the selected question with the current materials in this production item.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Actual ITT/allocation and period/sequence/within-person comparison definitions requires corresponding original material/analysis scope and a distinction of unverified matters. Original wording is linked here; content review remains incomplete.",
      "basis": "M08 §8.2.2, M15 §15.3.1; custom application; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is custom design; M15 §15.3.1–15.3.3; custom application",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Propose follow-up research on allocation/period, missing-data assumptions and estimation; no new investigation, calculation or trial is performed now."
    },
    {
      "item_id": "N16",
      "question_type": "Evidence condition",
      "question": "Washout, carryover and period effects",
      "needed": "Carryover/sequence, period-specific baselines and analytical handling",
      "role": "Required",
      "role_reason": "Distinguish Carryover/sequence, period-specific baselines and analytical handling to connect materials needed for the selected question with the current materials in this production item.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Carryover/sequence, period-specific baselines and analytical handling requires corresponding original material/analysis scope and a distinction of unverified matters. Original wording is linked here; content review remains incomplete.",
      "basis": "M08 §8.2.2, M15 §15.3.1; custom application; M03 §3.2.3, M08 §8.2.2–8.2.3; custom application; M04 §4.6.1–4.6.2 distinction between studies and reports; cohort/outcome linkage is a custom application; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is custom design",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Propose research distinguishing carryover/period effects from same-participant outcomes; no new investigation, calculation or trial is performed now."
    },
    {
      "item_id": "N17",
      "question_type": "Evidence condition",
      "question": "Weight change and correlation",
      "needed": "Separate weight/liver-fat measures and causal/mediation relationships",
      "role": "Required",
      "role_reason": "Distinguish Separate weight/liver-fat measures and causal/mediation relationships to connect materials needed for the selected question with the current materials in this production item.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Separate weight/liver-fat measures and causal/mediation relationships requires corresponding original material/analysis scope and a distinction of unverified matters. Original wording is linked here; content review remains incomplete.",
      "basis": "M03 §3.2.3, M08 §8.2.2–8.2.3; custom application; M08 §8.2.2, M15 §15.3.1; custom application; M03 §3.2.4; custom extension boundary; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is custom design",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Propose follow-up research distinguishing weight/exposure from result attribution; no new investigation, calculation or trial is performed now."
    },
    {
      "item_id": "N18",
      "question_type": "Evidence condition",
      "question": "Null liver-enzyme and other secondary outcomes",
      "needed": "Definitions/hierarchy of other endpoints, original results and the selected measure",
      "role": "Required",
      "role_reason": "Distinguish Definitions/hierarchy of other endpoints, original results and the selected measure to connect materials needed for the selected question with the current materials in this production item.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Definitions/hierarchy of other endpoints, original results and the selected measure requires corresponding original material/analysis scope and a distinction of unverified matters. Original wording is linked here; content review remains incomplete.",
      "basis": "M04 §4.6.3, M15 §15.3.1–15.3.3; status separation is custom design; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is custom design; M08 Table 8.2.a, M04 §4.6.3; custom application; M15 §15.3.1–15.3.3; custom application",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Propose research on other measures, discordance and uncertainty; no new investigation, calculation or trial is performed now."
    },
    {
      "item_id": "N19",
      "question_type": "Evidence condition",
      "question": "Concomitant exposure, adherence and subsequent care",
      "needed": "Arm/period-specific activity/diet, drugs/products and actual exposure",
      "role": "Required",
      "role_reason": "Distinguish Arm/period-specific activity/diet, drugs/products and actual exposure to connect materials needed for the selected question with the current materials in this production item.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Arm/period-specific activity/diet, drugs/products and actual exposure requires corresponding original material/analysis scope and a distinction of unverified matters. Original wording is linked here; content review remains incomplete.",
      "basis": "M03 §3.2.3, M08 §8.2.2–8.2.3; custom application; M03 §3.2.2–3.2.3; reverse-direction labeling and test adaptation are custom design; M03 §3.2.1–3.2.4; dose/duration/effect-modification details are custom design",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Propose research on concomitant exposure and result attribution; no new investigation, calculation or trial is performed now."
    },
    {
      "item_id": "N20",
      "question_type": "Evidence condition",
      "question": "ChiCTR and prespecified plans",
      "needed": "Registration identity, plans/changes and correspondence to reports",
      "role": "Required",
      "role_reason": "Distinguish Registration identity, plans/changes and correspondence to reports to connect materials needed for the selected question with the current materials in this production item.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Registration identity, plans/changes and correspondence to reports requires corresponding original material/analysis scope and a distinction of unverified matters. Original wording is linked here; content review remains incomplete.",
      "basis": "M08 Table 8.2.a, M04 §4.6.3; custom application; M04 §4.5–4.6 material-collection/selection principles; separation of access/reading and hyperlink conventions are custom design; M04 §4.5, §4.6.3; limits on current material conversion reflect the review scope and custom design",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Propose research connecting prespecified plans to result reporting; no new investigation, calculation or trial is performed now."
    },
    {
      "item_id": "N21",
      "question_type": "Evidence condition",
      "question": "Funding-agency names and unverified scope",
      "needed": "Funders, roles and the scope of the public text",
      "role": "Required",
      "role_reason": "Distinguish Funders, roles and the scope of the public text to connect materials needed for the selected question with the current materials in this production item.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Funders, roles and the scope of the public text requires corresponding original material/analysis scope and a distinction of unverified matters. Original wording is linked here; content review remains incomplete.",
      "basis": "Chamgap’s own independence/attribution conditions; official methodology sections in this pilot do not certify all these detailed items; M04 §4.5–4.6 material-collection/selection principles; separation of access/reading and hyperlink conventions are custom design; M04 §4.5, §4.6.3; limits on current material conversion reflect the review scope and custom design",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Propose update research on historical checking scope and current materials; no new investigation, calculation or trial is performed now."
    },
    {
      "item_id": "N22",
      "question_type": "Evidence condition",
      "question": "Manufacturer, product and analysis disclosures",
      "needed": "Individual records of commercial funding/products and analysis/writing/publication support",
      "role": "Required",
      "role_reason": "Distinguish Individual records of commercial funding/products and analysis/writing/publication support to connect materials needed for the selected question with the current materials in this production item.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Individual records of commercial funding/products and analysis/writing/publication support requires corresponding original material/analysis scope and a distinction of unverified matters. Original wording is linked here; content review remains incomplete.",
      "basis": "Chamgap independence/attribution conditions. The referenced official method sections do not certify every detail of these items; Data collection/selection principles in M04 §4.5–4.6; Access/reading separation and hyperlink rules are Chamgap design",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Propose research distinguishing gaps in individual disclosures/support; no new investigation, calculation or trial is performed now."
    },
    {
      "item_id": "N23",
      "question_type": "Evidence condition",
      "question": "Institutional affiliations and COI declarations",
      "needed": "Distinguish author affiliations/employment from contributions/interests",
      "role": "Required",
      "role_reason": "Distinguish Distinguish author affiliations/employment from contributions/interests to connect materials needed for the selected question with the current materials in this production item.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Distinguish author affiliations/employment from contributions/interests requires corresponding original material/analysis scope and a distinction of unverified matters. Original wording is linked here; content review remains incomplete.",
      "basis": "Chamgap’s own independence/attribution conditions; official methodology sections in this pilot do not certify all these detailed items; M04 §4.5–4.6 material-collection/selection principles; separation of access/reading and hyperlink conventions are custom design; M04 §4.5, §4.6.3; limits on current material conversion reflect the review scope and custom design",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Propose research on declarations and author/institutional roles; no new investigation, calculation or trial is performed now."
    },
    {
      "item_id": "N24",
      "question_type": "Harm-information gaps supplementing the efficacy table",
      "question": "Safety measures and rare harms",
      "needed": "Harm collection/definitions, populations/periods and original reporting scope",
      "role": "Supplementary",
      "role_reason": "Distinguish Harm collection/definitions, populations/periods and original reporting scope to connect materials needed for the selected question with the current materials in this production item.",
      "application_exception": "Supplement gaps in safety materials for the selected subclaim. Do not judge safety from MRI/clinical results or parent safety wording, or create harm-incidence estimates/new use instructions.",
      "criterion": "Harm collection/definitions, populations/periods and original reporting scope requires corresponding original material/analysis scope and a distinction of unverified matters. Original wording is linked here; content review remains incomplete.",
      "basis": "M19 §19.1.2–19.2.4; detailed distinctions are custom design; M19 §19.1.2–19.2.4; custom application; M19 §19.1.2–19.2.4, M04 §4.6.3; custom application; M19 §19.1.2–19.2.4; custom application; M19 §19.1.2–19.2.4; custom application",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Propose research on harm-reporting scope and rare/long-term outcomes; no new investigation, calculation or trial is performed now."
    },
    {
      "item_id": "N25",
      "question_type": "Evidence condition",
      "question": "Relationships within the same trial across periods/reports",
      "needed": "Distinguish reports/trials/participants, crossover/measures and independent replication",
      "role": "Required",
      "role_reason": "Distinguish Distinguish reports/trials/participants, crossover/measures and independent replication to connect materials needed for the selected question with the current materials in this production item.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Distinguish reports/trials/participants, crossover/measures and independent replication requires corresponding original material/analysis scope and a distinction of unverified matters. Original wording is linked here; content review remains incomplete.",
      "basis": "M04 §4.6.1–4.6.2 distinction between studies and reports; cohort/outcome linkage is a custom application; M04 §4.6.1–4.6.2, M15 §15.3.1; custom application; M04 §4.5, §4.6.3; limits on current material conversion reflect the review scope and custom design",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Propose research on same-data/period relationships and separate replication; no new investigation, calculation or trial is performed now."
    },
    {
      "item_id": "N26",
      "question_type": "Evidence condition",
      "question": "Clinical outcomes and other formulations/durations",
      "needed": "Distinguish selected MRI results from actual clinical outcomes/outside populations",
      "role": "Required",
      "role_reason": "Distinguish Distinguish selected MRI results from actual clinical outcomes/outside populations to connect materials needed for the selected question with the current materials in this production item.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Distinguish selected MRI results from actual clinical outcomes/outside populations requires corresponding original material/analysis scope and a distinction of unverified matters. Original wording is linked here; content review remains incomplete.",
      "basis": "M03 §3.2.4; custom extension boundary; M03 §3.2.1–3.2.4; dose/duration/effect-modification details are custom design; M03 §3.2.1; detailed population conditions are custom design; M03 §3.2.2–3.2.3; reverse-direction labeling and test adaptation are custom design",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Propose research distinguishing imaging from clinical outcomes and selected conditions; no new investigation, calculation or trial is performed now."
    },
    {
      "item_id": "N27",
      "question_type": "Evidence condition",
      "question": "Original axes, Korean/English text, dates and corrections",
      "needed": "Distinguish subclaim/parent values, original evidence date/corrections and history",
      "role": "Required",
      "role_reason": "Distinguish Distinguish subclaim/parent values, original evidence date/corrections and history to connect materials needed for the selected question with the current materials in this production item.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Distinguish subclaim/parent values, original evidence date/corrections and history requires corresponding original material/analysis scope and a distinction of unverified matters. Original wording is linked here; content review remains incomplete.",
      "basis": "M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design; M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are internally designed",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Propose update research on source-material changes and production versions; no new investigation, calculation or trial is performed now."
    },
    {
      "item_id": "N28",
      "question_type": "Evidence condition",
      "question": "Summary reading and externally unread materials",
      "needed": "Actual reading for each material, citations/URLs and gaps in additional materials",
      "role": "Required",
      "role_reason": "Distinguish Actual reading for each material, citations/URLs and gaps in additional materials to connect materials needed for the selected question with the current materials in this production item.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Actual reading for each material, citations/URLs and gaps in additional materials requires corresponding original material/analysis scope and a distinction of unverified matters. Original wording is linked here; content review remains incomplete.",
      "basis": "M04 §4.5–4.6 material collection/selection principles; acquisition/reading separation and hyperlink specifications are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Propose scoped update research based on materials actually acquired; no new investigation, calculation or trial is performed now."
    }
  ]
}