{
  "schema_version": "chamgap-public-criteria-1.0",
  "title": "Bundled green-MED diet × Eighteen-month MRS intrahepatic-fat reduction",
  "language": "en",
  "translation_date": "2026-10-15",
  "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 records of methodological application were referenced. Methodological source content was not newly reviewed in this work."
    },
    {
      "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 records of methodological application were referenced. Methodological source content was not newly reviewed in this work."
    },
    {
      "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 records of methodological application were referenced. Methodological source content was not newly reviewed in this work."
    },
    {
      "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 records of methodological application were referenced. Methodological source content was not newly reviewed in this work."
    },
    {
      "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 records of methodological application were referenced. Methodological source content was not newly reviewed in this work."
    }
  ],
  "status_dictionary": {
    "Met": "The original content has been reviewed as meeting the conditions. This status is not used in this preparation.",
    "Partly verified": "Some information in the stored summary was linked during preparation; clinical verification or review is not complete.",
    "Unverified": "Required direct values, definitions or materials have not been established within the current storage and reading scope. This does not mean zero effect, no papers or failed access.",
    "Review incomplete": "Review of existing content or actual review incomplete.",
    "Not reported": "Used only when original materials were actually read and the outcome was judged unreported. Not used for external materials unread in this work.",
    "Inaccessible": "Used only when an actual access attempt has a recorded failure. Not used for access that was not attempted in this work.",
    "Insufficient evidence for the conditions": "Indicates insufficient direct materials for the relevant scope or conditions; it is not a new grade.",
    "Not applicable": "Used when the reason it does not apply to the original question is stated.",
    "Conflicting data": "Retains the scope of conflicting statements in original materials; it is not an arbitrary reassessment."
  },
  "requirements": [
    {
      "item_id": "N01",
      "question_type": "Evidence condition",
      "question": "How are the selected question and the isolated-component question distinguished?",
      "needed": "Selected question and verdict record, with parent and isolated-component boundaries",
      "role": "Required",
      "role_reason": "This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: How are the selected question and the isolated-component question distinguished?",
      "application_exception": "The original isolated-component question has grade ? and a note that individual effects were not separated. These are not filled with the bundled-diet grade C.",
      "criterion": "Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Selected question and verdict record, with parent and isolated-component boundaries.",
      "basis": "M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are internally designed; M03 §3.2.4; internally defined extension boundaries",
      "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete",
      "proposed_research": "Research questions distinguishing bundled diets from individual components"
    },
    {
      "item_id": "N02",
      "question_type": "Evidence condition",
      "question": "How are the original subclaim grade, note and absent values preserved?",
      "needed": "Subclaim C and note, absent score, status and axes, and parent history",
      "role": "Required",
      "role_reason": "This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: How are the original subclaim grade, note and absent values preserved?",
      "application_exception": "Parent 46 points are not transferred into the subclaim score, and C is not inherited as a current passed content review or efficacy certification.",
      "criterion": "Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Subclaim C and note, absent score, status and axes, and parent history.",
      "basis": "M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design",
      "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete",
      "proposed_research": "Records distinguishing additional evidence from preservation of the original grade"
    },
    {
      "item_id": "N03",
      "question_type": "Evidence condition",
      "question": "What was the actual study population?",
      "needed": "Adults with abdominal obesity or dyslipidemia and enrollment scope",
      "role": "Required",
      "role_reason": "This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: What was the actual study population?",
      "application_exception": "MRS liver-fat changes are not extended into treatment effects for liver disease generally.",
      "criterion": "Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Adults with abdominal obesity or dyslipidemia and enrollment scope.",
      "basis": "M03 §3.2.1; detailed population conditions are internally designed; M04 §4.6.1–4.6.2, M15 §15.3.1; internal application",
      "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete",
      "proposed_research": "Diet research with an explicit population boundary"
    },
    {
      "item_id": "N04",
      "question_type": "Evidence condition",
      "question": "How are sex, baseline liver fat and subgroups distinguished?",
      "needed": "Baseline characteristics, liver-fat levels and population-specific denominators",
      "role": "Required",
      "role_reason": "This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: How are sex, baseline liver fat and subgroups distinguished?",
      "application_exception": "Population counts or proportions possibly known from other reports are not newly added, and overall findings are not copied into subgroups.",
      "criterion": "Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Baseline characteristics, liver-fat levels and population-specific denominators.",
      "basis": "M03 §3.2.1; detailed population conditions are internally designed; M04 §4.6.1–4.6.2, M15 §15.3.1; internal application",
      "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete",
      "proposed_research": "Research with explicit population and subgroup plans"
    },
    {
      "item_id": "N05",
      "question_type": "Evidence condition",
      "question": "What did the bundled green-MED exposure include?",
      "needed": "The original package of walnuts, green tea, Mankai and meat restriction",
      "role": "Required",
      "role_reason": "This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: What did the bundled green-MED exposure include?",
      "application_exception": "No new implementation guidance for menus, intake, products or dose conversions is produced.",
      "criterion": "Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: The original package of walnuts, green tea, Mankai and meat restriction.",
      "basis": "M03 §§3.2.2–3.2.3; reverse-direction labels and assessment adaptation are Chamgap-designed; M03 §§3.2.1–3.2.4; dose, durability and effect-modification details are Chamgap-designed",
      "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete",
      "proposed_research": "Research specifying the bundled pattern and exposure scope"
    },
    {
      "item_id": "N06",
      "question_type": "Evidence condition",
      "question": "How are common physical activity and walnut exposure distinguished across groups?",
      "needed": "Physical activity in all groups and 28 g/day walnuts in both MED groups",
      "role": "Required",
      "role_reason": "This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: How are common physical activity and walnut exposure distinguished across groups?",
      "application_exception": "Common-exposure quantities are original research information, not exercise or intake instructions.",
      "criterion": "Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Physical activity in all groups and 28 g/day walnuts in both MED groups.",
      "basis": "M03 §3.2.2–3.2.3; Reverse-direction labels and assessment adaptation are Chamgap design; M03 §3.2.3 and M08 §8.2.2–8.2.3; Chamgap application",
      "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete",
      "proposed_research": "Research specifying common co-exposures and the dietary contrast of interest"
    },
    {
      "item_id": "N07",
      "question_type": "Evidence condition",
      "question": "What were the separate green-MED, conventional MED and HDG comparisons?",
      "needed": "Three-group comparisons and contrast-specific effects of interest",
      "role": "Required",
      "role_reason": "This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: What were the separate green-MED, conventional MED and HDG comparisons?",
      "application_exception": "The adjusted green-MED versus MED P value is not copied into green-MED versus HDG or MED versus HDG.",
      "criterion": "Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Three-group comparisons and contrast-specific effects of interest.",
      "basis": "M03 §3.2.2–3.2.3; reverse-direction labels and test adaptations are Chamgap design; M08 §8.2.2, M15 §15.3.1; Chamgap adaptation",
      "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete",
      "proposed_research": "Research distinguishing comparator-specific effects of interest in advance"
    },
    {
      "item_id": "N08",
      "question_type": "Evidence condition",
      "question": "Were food provision and actual dietary adherence established?",
      "needed": "Provided exposure, intake and meat restriction, and departures",
      "role": "Required",
      "role_reason": "This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: Were food provision and actual dietary adherence established?",
      "application_exception": "Provision targets are not treated as every participant's actual intake or dose.",
      "criterion": "Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Provided exposure, intake and meat restriction, and departures.",
      "basis": "M03 §3.2.3, M08 §8.2.2–8.2.3; internal application; M08 §8.2.2, M15 §15.3.1; internal application; M03 §3.2.1–3.2.4; dose/duration/effect-modification details are internally designed",
      "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete",
      "proposed_research": "Research distinguishing exposure departures from allocation effects"
    },
    {
      "item_id": "N09",
      "question_type": "Evidence condition",
      "question": "How are the 18-month endpoint and persistence after stopping distinguished?",
      "needed": "Intervention duration, outcome visits and additional follow-up",
      "role": "Required",
      "role_reason": "This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: How are the 18-month endpoint and persistence after stopping distinguished?",
      "application_exception": "18 months is not recast as guaranteed persistence for everyone or a liver-disease management schedule.",
      "criterion": "Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Intervention duration, outcome visits and additional follow-up.",
      "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed; M03 §3.2.1–3.2.4; dose, duration and effect-modification details are internally designed",
      "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete",
      "proposed_research": "Research distinguishing the intervention endpoint from persistent effects"
    },
    {
      "item_id": "N10",
      "question_type": "Evidence condition",
      "question": "What were the units and methods for proton-MRS intrahepatic fat?",
      "needed": "MRS liver-fat measurement, original units and calculation definitions",
      "role": "Required",
      "role_reason": "This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: What were the units and methods for proton-MRS intrahepatic fat?",
      "application_exception": "Proportional reductions are not recast as absolute fat content, percentage-point change or disappearance of liver fat.",
      "criterion": "Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: MRS liver-fat measurement, original units and calculation definitions.",
      "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; Question-specific outcome adaptations are internally designed; M08 Table 8.2.a, M03 §3.2.4; Internal application; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; Design-specific adaptations are internally designed",
      "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete",
      "proposed_research": "Intrahepatic-fat research with specified measurement and calculation methods"
    },
    {
      "item_id": "N11",
      "question_type": "Evidence condition",
      "question": "How are the three group-specific proportional reductions preserved?",
      "needed": "Original scope of green-MED -38.9%, MED -19.6% and HDG -12.2%",
      "role": "Required",
      "role_reason": "This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: How are the three group-specific proportional reductions preserved?",
      "application_exception": "-38.9% is not attributed to Mankai alone or presented as a guaranteed personal reduction.",
      "criterion": "Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Original scope of green-MED -38.9%, MED -19.6% and HDG -12.2%.",
      "basis": "M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; Design-specific adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap application; M15 §15.3.1–15.3.3; Chamgap application",
      "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete",
      "proposed_research": "Plans distinguishing within-group changes from between-group effects of interest"
    },
    {
      "item_id": "N12",
      "question_type": "Evidence condition",
      "question": "Were baseline and final absolute liver fat and absolute changes established?",
      "needed": "Baseline and 18-month absolute MRS values, units and changes",
      "role": "Required",
      "role_reason": "This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: Were baseline and final absolute liver fat and absolute changes established?",
      "application_exception": "Absolute liver-fat quantities or percentage points are not reconstructed from original proportional values.",
      "criterion": "Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Baseline and 18-month absolute MRS values, units and changes.",
      "basis": "M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; Design-specific adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap application; M15 §15.3.1–15.3.3; Chamgap application",
      "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete",
      "proposed_research": "Research specifying absolute and proportional effects of interest together"
    },
    {
      "item_id": "N13",
      "question_type": "Evidence condition",
      "question": "Which contrast does weight-adjusted P=.035 describe?",
      "needed": "Green-MED versus MED adjusted for weight loss",
      "role": "Required",
      "role_reason": "This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: Which contrast does weight-adjusted P=.035 describe?",
      "application_exception": "Weight adjustment does not isolate individual components or conclusively establish mechanisms beyond weight change.",
      "criterion": "Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Green-MED versus MED adjusted for weight loss.",
      "basis": "M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; Design-specific adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap application; M15 §15.3.1–15.3.3; Chamgap application",
      "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete",
      "proposed_research": "Research distinguishing allocation contrasts from adjusted effects of interest"
    },
    {
      "item_id": "N14",
      "question_type": "Evidence condition",
      "question": "Are other contrasts and unadjusted or adjusted effects kept separate?",
      "needed": "Green-MED versus HDG and MED versus HDG, and adjustment status",
      "role": "Required",
      "role_reason": "This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: Are other contrasts and unadjusted or adjusted effects kept separate?",
      "application_exception": "The ordering of the three proportional reductions does not establish significance for every between-group comparison.",
      "criterion": "Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Green-MED versus HDG and MED versus HDG, and adjustment status.",
      "basis": "M08 §8.2.2, M15 §15.3.1; internal application; M15 §15.3.1–15.3.3; internal application; M08 Table 8.2.a, M04 §4.6.3; internal application",
      "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete",
      "proposed_research": "Research specifying group changes and planned comparisons"
    },
    {
      "item_id": "N15",
      "question_type": "Evidence condition",
      "question": "What numerical scope supports the historical wording of a small standardized effect?",
      "needed": "Original small-effect wording and exact standardized values and CIs",
      "role": "Required",
      "role_reason": "This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: What numerical scope supports the historical wording of a small standardized effect?",
      "application_exception": "Original E~, unrecorded precision and small-effect wording are historical values, not current recalculation or regrading results.",
      "criterion": "Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Original small-effect wording and exact standardized values and CIs.",
      "basis": "M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is internally designed; M15 §15.3.1–15.3.3; internal application",
      "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete",
      "proposed_research": "Research prespecifying the effect of interest, precision and importance"
    },
    {
      "item_id": "N16",
      "question_type": "Evidence condition",
      "question": "What are the total 294 randomized participants and group denominators?",
      "needed": "Total allocation, group allocation and analysis, and time-specific denominators",
      "role": "Required",
      "role_reason": "This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: What are the total 294 randomized participants and group denominators?",
      "application_exception": "The total is not divided by the number of groups, and participant counts are not newly added or estimated.",
      "criterion": "Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Total allocation, group allocation and analysis, and time-specific denominators.",
      "basis": "M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; Design-specific adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap application",
      "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete",
      "proposed_research": "Research distinguishing allocation from measurement and analysis denominators"
    },
    {
      "item_id": "N17",
      "question_type": "Evidence condition",
      "question": "Are 89.8% retention, 78% eligible MRS and the original 22% distinguished?",
      "needed": "Overall follow-up retention, imaging eligibility and original missingness wording",
      "role": "Required",
      "role_reason": "This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: Are 89.8% retention, 78% eligible MRS and the original 22% distinguished?",
      "application_exception": "Original proportions are not converted into new participant counts or attrition rates, and 22% is not calculated from 89.8%.",
      "criterion": "Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Overall follow-up retention, imaging eligibility and original missingness wording.",
      "basis": "M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is our own design; M08 §8.2.2, M15 §15.3.1; own application; M19 §19.1.2–19.2.4, M04 §4.6.3; own application",
      "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete",
      "proposed_research": "Plans distinguishing clinical follow-up from measurement eligibility"
    },
    {
      "item_id": "N18",
      "question_type": "Evidence condition",
      "question": "Are subgroup and baseline liver-fat analysis denominators available?",
      "needed": "Overall MRS population and denominators by subgroup and baseline status",
      "role": "Required",
      "role_reason": "This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: Are subgroup and baseline liver-fat analysis denominators available?",
      "application_exception": "The overall 294 participants or 78% are not copied as analysis counts for every subgroup.",
      "criterion": "Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Overall MRS population and denominators by subgroup and baseline status.",
      "basis": "M03 §3.2.1; detailed population conditions are internally designed; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are internally designed; M04 §4.6.1–4.6.2, M15 §15.3.1; internal application",
      "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete",
      "proposed_research": "Research distinguishing overall and subgroup effects of interest"
    },
    {
      "item_id": "N19",
      "question_type": "Evidence condition",
      "question": "Were imaging missingness, eligibility exclusions and analysis populations established?",
      "needed": "Reasons for missing MRS, analysis populations, imputation and sensitivity analyses",
      "role": "Required",
      "role_reason": "This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: Were imaging missingness, eligibility exclusions and analysis populations established?",
      "application_exception": "All absent imaging is not recast as attrition or harm events, or treated as zero effect.",
      "criterion": "Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Reasons for missing MRS, analysis populations, imputation and sensitivity analyses.",
      "basis": "M08 §8.2.2, M15 §15.3.1; Internal application; M08 Table 8.2.a, M04 §4.6.3; Internal application",
      "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete",
      "proposed_research": "Prespecified plans for imaging missingness and the effect of interest"
    },
    {
      "item_id": "N20",
      "question_type": "Evidence condition",
      "question": "What were three-group randomization, allocation concealment and baseline balance?",
      "needed": "Random sequence, concealment and three-group baseline information",
      "role": "Required",
      "role_reason": "This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: What were three-group randomization, allocation concealment and baseline balance?",
      "application_exception": "The RCT label and historical parent B1/I1 axes do not certify adequate allocation or absence of bias in a current review.",
      "criterion": "Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Random sequence, concealment and three-group baseline information.",
      "basis": "M08 §8.1–8.2.3; own application",
      "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete",
      "proposed_research": "Research with explicit three-group allocation, population and effects of interest"
    },
    {
      "item_id": "N21",
      "question_type": "Evidence condition",
      "question": "Were MRS masking, standardization and assessment procedures established?",
      "needed": "Equipment, reader and time-point masking, and measurement consistency",
      "role": "Required",
      "role_reason": "This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: Were MRS masking, standardization and assessment procedures established?",
      "application_exception": "Objective imaging alone does not establish absence of measurement influences or bias.",
      "criterion": "Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Equipment, reader and time-point masking, and measurement consistency.",
      "basis": "M08 Table 8.2.a and M03 §3.2.4; Chamgap adaptation; M08 §§8.1–8.2.3; Chamgap adaptation",
      "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete",
      "proposed_research": "Research with designated measurement and reading plans"
    },
    {
      "item_id": "N22",
      "question_type": "Evidence condition",
      "question": "What were common exposures from baseline disease, medication and lifestyle?",
      "needed": "Concurrent treatment, baseline status and common support and activity",
      "role": "Required",
      "role_reason": "This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: What were common exposures from baseline disease, medication and lifestyle?",
      "application_exception": "Unknown medications or diseases, or treatment replacement, are not added as original study components.",
      "criterion": "Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Concurrent treatment, baseline status and common support and activity.",
      "basis": "M03 §3.2.3, M08 §8.2.2–8.2.3; internal application; M19 §19.2.2–19.2.4 design considerations; detailed confounding records are internally designed",
      "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete",
      "proposed_research": "Research specifying common exposures and allocation contrasts"
    },
    {
      "item_id": "N23",
      "question_type": "Evidence condition",
      "question": "Are weight loss, adherence, component contributions and effects of interest distinguished?",
      "needed": "Boundaries of weight adjustment, dietary adherence and single-component attribution",
      "role": "Required",
      "role_reason": "This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: Are weight loss, adherence, component contributions and effects of interest distinguished?",
      "application_exception": "The adjusted P value and similar weight loss do not certify Mankai or green-tea efficacy alone.",
      "criterion": "Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Boundaries of weight adjustment, dietary adherence and single-component attribution.",
      "basis": "M08 §8.2.2, M15 §15.3.1; internal application; M03 §3.2.3, M08 §8.2.2–8.2.3; internal application; M03 §3.2.4; internally defined extension boundaries",
      "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete",
      "proposed_research": "Research distinguishing the bundled pattern from component and mediation questions"
    },
    {
      "item_id": "N24",
      "question_type": "Evidence condition",
      "question": "Are registration, outcome hierarchy, reports and prior plans distinguished?",
      "needed": "NCT03020186 identification, actual plan reading and primary-outcome hierarchy",
      "role": "Required",
      "role_reason": "This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: Are registration, outcome hierarchy, reports and prior plans distinguished?",
      "application_exception": "Identifiers, original outcome labels and false axis flags alone do not certify prespecified primary status or reading of registration content.",
      "criterion": "Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: NCT03020186 identification, actual plan reading and primary-outcome hierarchy.",
      "basis": "M08 Table 8.2.a, M04 §4.6.3; internal application; M04 §4.5–4.6 material collection and selection principles; separation of access and reading and the hyperlink contract are internally designed; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is internally designed",
      "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete",
      "proposed_research": "Research preserving designated outcomes, effects of interest and plan changes"
    },
    {
      "item_id": "N25",
      "question_type": "Evidence condition",
      "question": "How are identities of reports, trials, groups and time points linked?",
      "needed": "DIRECT-PLUS report identity and duplicate observations and participants",
      "role": "Required",
      "role_reason": "This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: How are identities of reports, trials, groups and time points linked?",
      "application_exception": "The one currently linked report is not a total count of independent trials or new independence certification.",
      "criterion": "Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: DIRECT-PLUS report identity and duplicate observations and participants.",
      "basis": "Study/report distinction in M04 §4.6.1–4.6.2; Cohort/outcome linkage is Chamgap application; M04 §4.6.1–4.6.2 and M15 §15.3.1; Chamgap application",
      "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete",
      "proposed_research": "Records distinguishing reports from the same study family"
    },
    {
      "item_id": "N26",
      "question_type": "Evidence condition",
      "question": "Is independent confirmation or direct replication available?",
      "needed": "Independent studies and trial relationships for the same bundled-diet question",
      "role": "Required",
      "role_reason": "This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: Is independent confirmation or direct replication available?",
      "application_exception": "Original absence wording is not promoted into a current worldwide absence check, and reports from the same trial are not counted as independent replication.",
      "criterion": "Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Independent studies and trial relationships for the same bundled-diet question.",
      "basis": "Study/report distinction in M04 §4.6.1–4.6.2; Cohort/outcome linkage is Chamgap application; M04 §4.6.1–4.6.2 and M15 §15.3.1; Chamgap application",
      "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete",
      "proposed_research": "Separate confirmation research explicitly addressing the same question"
    },
    {
      "item_id": "N27",
      "question_type": "Evidence condition",
      "question": "Can effects by component, other dietary patterns or subgroup be established?",
      "needed": "Direct comparisons of the bundled pattern with isolated components or other populations",
      "role": "Supplementary",
      "role_reason": "This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: Can effects by component, other dietary patterns or subgroup be established?",
      "application_exception": "The advertising example of 39% is not adopted as a new trial figure or component effect.",
      "criterion": "Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Direct comparisons of the bundled pattern with isolated components or other populations.",
      "basis": "M03 §3.2.2–3.2.3; reverse-direction labels and testing adaptations are internally designed; M04 §4.6.1–4.6.2, M15 §15.3.1; internal application; M03 §3.2.1–3.2.4; dose/duration/effect-modification details are internally designed",
      "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete",
      "proposed_research": "Research distinguishing dietary-pattern contrasts from individual-component questions"
    },
    {
      "item_id": "N28",
      "question_type": "Evidence condition",
      "question": "Which clinical outcomes does MRS liver fat address?",
      "needed": "Surrogates, liver-disease events and patient-important outcomes",
      "role": "Supplementary",
      "role_reason": "This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: Which clinical outcomes does MRS liver fat address?",
      "application_exception": "No new liver-disease management or treatment-replacement instructions or disease-event prevention efficacy are created.",
      "criterion": "Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Surrogates, liver-disease events and patient-important outcomes.",
      "basis": "M03 §3.2.4; internally defined extension boundaries",
      "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete",
      "proposed_research": "Plans distinguishing MRS from clinical events"
    },
    {
      "item_id": "N29",
      "question_type": "Evidence condition",
      "question": "What are the boundaries of the original long-term wording, persistence and extrapolation?",
      "needed": "18-month results, post-treatment follow-up and other long-term exposures",
      "role": "Supplementary",
      "role_reason": "This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: What are the boundaries of the original long-term wording, persistence and extrapolation?",
      "application_exception": "18 months is not recast as a lifelong management effect or a recommended diet for every liver-disease population.",
      "criterion": "Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: 18-month results, post-treatment follow-up and other long-term exposures.",
      "basis": "M03 §3.2.1–3.2.4; dose, duration and effect-modification details are Chamgap’s own design; M04 §4.6.1–4.6.2 and M15 §15.3.1; Chamgap application",
      "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete",
      "proposed_research": "Research distinguishing persistence from extrapolation questions"
    },
    {
      "item_id": "N30",
      "question_type": "Evidence condition",
      "question": "What original information describes mixed funding and product interests?",
      "needed": "Public and industry funding, advisory roles and funder involvement",
      "role": "Required",
      "role_reason": "This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: What original information describes mixed funding and product interests?",
      "application_exception": "Reported non-involvement is not recast as current certification of no interests, and support alone does not lead to a verdict of ineffective treatment.",
      "criterion": "Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Public and industry funding, advisory roles and funder involvement.",
      "basis": "Chamgap’s own independence/attribution conditions. The official methodological sections used in this pilot do not guarantee every detailed item; M08 §8.1–8.2.3; internal application",
      "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete",
      "proposed_research": "Explicit reporting of funding and decision-making and analysis roles"
    },
    {
      "item_id": "N31",
      "question_type": "Evidence condition",
      "question": "What do stored-summary reading, external reading and URL access indicators mean?",
      "needed": "Reading scope of the complete stored summary, abstract, full text, registration and needed material",
      "role": "Required",
      "role_reason": "This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: What do stored-summary reading, external reading and URL access indicators mean?",
      "application_exception": "The presence of a link, PMCID or NCT identifier is not assigned acquisition, reading or successful-access status.",
      "criterion": "Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Reading scope of the complete stored summary, abstract, full text, registration and needed material.",
      "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": "Individual applied conditions based on preserved original material; review of existing content incomplete",
      "proposed_research": "Production records distinguishing stored summaries from newly acquired material"
    },
    {
      "item_id": "N32",
      "question_type": "Evidence condition",
      "question": "What are the original Korean and English text, cut-off, empty values and historical axes?",
      "needed": "Original language versions, dates, corrections, axes and parent verdict",
      "role": "Required",
      "role_reason": "This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: What are the original Korean and English text, cut-off, empty values and historical axes?",
      "application_exception": "Historical Codex full-text, registry and scoring verification wording is not inherited as a current passed external reading or content review.",
      "criterion": "Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Original language versions, dates, corrections, axes and parent verdict.",
      "basis": "M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed splitting rules are internally designed; M04 §4.5, §4.6.3; current material-conversion limits follow review scope and internal design; Chamgap’s own independence/attribution conditions. The official methodological sections used in this pilot do not guarantee every detailed item",
      "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete",
      "proposed_research": "Separation of original values from new material and changes"
    },
    {
      "item_id": "N33",
      "question_type": "Evidence condition",
      "question": "How were adverse events collected?",
      "needed": "Event definitions, active or passive collection, severity and denominators",
      "role": "Supplementary",
      "role_reason": "This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: How were adverse events collected?",
      "application_exception": "Not being central is not recast as zero adverse events or confirmed absence of actual collection.",
      "criterion": "Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Event definitions, active or passive collection, severity and denominators.",
      "basis": "M19 §19.1.2–19.2.4; Detailed distinctions are designed by CHAMGAP",
      "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete",
      "proposed_research": "Research with explicit harm ascertainment alongside efficacy"
    },
    {
      "item_id": "N34",
      "question_type": "Evidence condition",
      "question": "Do nut-allergy and caffeine-sensitivity statements describe actual events?",
      "needed": "Original cautionary context distinguished from collected harms",
      "role": "Supplementary",
      "role_reason": "This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: Do nut-allergy and caffeine-sensitivity statements describe actual events?",
      "application_exception": "No new intake, product avoidance or recommendation, disease-specific diet or treatment instructions are written.",
      "criterion": "Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Original cautionary context distinguished from collected harms.",
      "basis": "M19 §19.1.2–19.2.4; detailed distinctions are internally designed; Internally defined Chamgap interpretation boundaries, referring to M19 principles without applying an official causality tool; M19 §19.1.2–19.2.4; internal application",
      "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete",
      "proposed_research": "Safety questions specifying the relevant vulnerable scope"
    },
    {
      "item_id": "N35",
      "question_type": "Evidence condition",
      "question": "Were group-specific harm events, denominators and comparisons established?",
      "needed": "Valid harm ascertainment in three groups, event and exposure denominators and effects",
      "role": "Supplementary",
      "role_reason": "This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: Were group-specific harm events, denominators and comparisons established?",
      "application_exception": "No new zero-event counts, zero incidence, risk differences or CIs are calculated.",
      "criterion": "Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Valid harm ascertainment in three groups, event and exposure denominators and effects.",
      "basis": "M19 §19.2.2–19.2.4, M03 §3.2.3; internal application; M19 §19.1.2–19.2.4; internal application",
      "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete",
      "proposed_research": "Research distinguishing efficacy measurements from harm-collection populations"
    },
    {
      "item_id": "N36",
      "question_type": "Evidence condition",
      "question": "What were harm timing, exposure duration and delayed follow-up?",
      "needed": "Time-specific symptoms and harm observation after discontinuation or study end",
      "role": "Supplementary",
      "role_reason": "This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: What were harm timing, exposure duration and delayed follow-up?",
      "application_exception": "18-month efficacy follow-up is not recast as completed verification of long-term safety.",
      "criterion": "Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Time-specific symptoms and harm observation after discontinuation or study end.",
      "basis": "M19 §19.2 design-specific harm questions; temporal-relationship details are internally designed; M19 §19.1.2–19.2.4; internal application",
      "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete",
      "proposed_research": "Research with symptom, timing and delayed-observation plans"
    },
    {
      "item_id": "N37",
      "question_type": "Evidence condition",
      "question": "How is harm attribution handled for the bundled diet, common exposures and medical history?",
      "needed": "Food, activity, concurrent medication, disease and event causality",
      "role": "Supplementary",
      "role_reason": "This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: How is harm attribution handled for the bundled diet, common exposures and medical history?",
      "application_exception": "General food-risk warnings are not recast as confirmed causes or events in this trial.",
      "criterion": "Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Food, activity, concurrent medication, disease and event causality.",
      "basis": "M19 §19.2.2–19.2.4 design considerations; detailed confounding records are Chamgap design; M03 §3.2.3, M08 §8.2.2–8.2.3; Chamgap adaptation",
      "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete",
      "proposed_research": "Harm research distinguishing bundled interventions from alternative causes"
    },
    {
      "item_id": "N38",
      "question_type": "Evidence condition",
      "question": "Are retention, imaging missingness, harms and discontinuation reasons distinguished?",
      "needed": "Harm-related discontinuation, missingness and ineligibility reasons, and collection",
      "role": "Supplementary",
      "role_reason": "This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: Are retention, imaging missingness, harms and discontinuation reasons distinguished?",
      "application_exception": "The original 22% is not converted into an adverse-effect rate or a count of participants lost to follow-up.",
      "criterion": "Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Harm-related discontinuation, missingness and ineligibility reasons, and collection.",
      "basis": "M19 §19.1.2–19.2.4, M04 §4.6.3; internal application; M08 §8.2.2, M15 §15.3.1; internal application",
      "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete",
      "proposed_research": "A plan separating missingness from harm-related discontinuation"
    },
    {
      "item_id": "N39",
      "question_type": "Evidence condition",
      "question": "Were independent harm studies or separate event material acquired?",
      "needed": "Independent safety material matching the diet, population and exposure",
      "role": "Supplementary",
      "role_reason": "This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: Were independent harm studies or separate event material acquired?",
      "application_exception": "Absence of a separate current slot does not establish worldwide absence of harm reports.",
      "criterion": "Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Independent safety material matching the diet, population and exposure.",
      "basis": "M04 §§4.6.1–4.6.2; harm-material adaptation is Chamgap-designed; M04 §§4.6.1–4.6.2 distinction between studies and reports; cohort/outcome links are Chamgap adaptations",
      "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete",
      "proposed_research": "Independent harm research with explicit population and dietary exposure"
    },
    {
      "item_id": "N40",
      "question_type": "Evidence condition",
      "question": "What are the safety boundaries for vulnerable populations, baseline liver disease and long-term exposure?",
      "needed": "Subtypes, disease, medication, allergy, sensitivity and long-term observation",
      "role": "Supplementary",
      "role_reason": "This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: What are the safety boundaries for vulnerable populations, baseline liver disease and long-term exposure?",
      "application_exception": "No new dietary management, product or intake, weight-management or liver-disease treatment-replacement guidance is produced.",
      "criterion": "Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Subtypes, disease, medication, allergy, sensitivity and long-term observation.",
      "basis": "M19 §19.1.2–19.2.4; Internal application; Design considerations in M19 §19.2.2–19.2.4; Detailed confounding records are internally designed",
      "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete",
      "proposed_research": "Research specifying population and long-term safety questions"
    },
    {
      "item_id": "N41",
      "question_type": "Evidence condition",
      "question": "Are liver-fat reduction, unknown safety and causal judgments distinguished?",
      "needed": "Efficacy surrogates, original safety and comparative harms",
      "role": "Supplementary",
      "role_reason": "This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: Are liver-fat reduction, unknown safety and causal judgments distinguished?",
      "application_exception": "Unknown is not recast as zero events, confirmed harm or guaranteed safety.",
      "criterion": "Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Efficacy surrogates, original safety and comparative harms.",
      "basis": "Chamgap internal interpretation boundaries, informed by M19 principles without running an official causality tool; M03 §3.2.4; Internally defined extrapolation boundaries",
      "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete",
      "proposed_research": "Research separating safety from surrogate effects of interest"
    },
    {
      "item_id": "N42",
      "question_type": "Evidence condition",
      "question": "How are later material, condition versions and original values updated?",
      "needed": "Identity, population, comparator, units, denominators, timing, reading and change events",
      "role": "Supplementary",
      "role_reason": "This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: How are later material, condition versions and original values updated?",
      "application_exception": "Production completion does not establish completed clinical review or publication.",
      "criterion": "Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Identity, population, comparator, units, denominators, timing, reading and change events.",
      "basis": "M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed splitting rules are internally designed; M04 §4.6.3, M15 §15.3.1–15.3.3; status separation is internally designed; M04 §4.5, §4.6.3; current material-conversion limits follow review scope and internal design; M08 Table 8.2.a, M04 §4.6.3; internal application",
      "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete",
      "proposed_research": "Research addressing direct gaps in the selected bundled-diet question"
    },
    {
      "item_id": "N43",
      "question_type": "Evidence condition",
      "question": "How are historical candidate records distinguished from current content-review status?",
      "needed": "Historical candidate records, production status and new-unit counts",
      "role": "Supplementary",
      "role_reason": "This condition is needed to distinguish the original population, comparisons, measurements and unverified scope for the question: How are historical candidate records distinguished from current content-review status?",
      "application_exception": "Historical full-text, registration and scoring verification wording is not invented as a current passed clinical review or external reading.",
      "criterion": "Separate original information, unverified details and boundaries of extension to individual components or clinical events for this requirement: Historical candidate records, production status and new-unit counts.",
      "basis": "M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design",
      "condition_origin": "Individual applied conditions based on preserved original material; review of existing content incomplete",
      "proposed_research": "Records distinguishing the original question, production and review decisions"
    }
  ]
}
