{
  "schema_version": "chamgap-public-criteria-1.0",
  "title": "Garlic-powder tablets 800 mg/day × Improvement of ultrasound steatosis grade in adults with NAFLD",
  "language": "en",
  "translation_date": "2026-10-26",
  "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": "Retained method-application records were reused. External originals were not reread and method content was not reassessed."
    },
    {
      "id": "M04",
      "version": "Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04",
      "section": "§4.5, §4.6.1–4.6.3, MECIR C42",
      "official_principle": "Distinguish studies from reports and link them; do not omit a study solely because results are unreported.",
      "review_level": "Retained method-application records were reused. External originals were not reread and method content was not reassessed."
    },
    {
      "id": "M08",
      "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08",
      "section": "§8.1–8.2.3, Table 8.2.a",
      "official_principle": "Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.",
      "review_level": "Retained method-application records were reused. External originals were not reread and method content was not reassessed."
    },
    {
      "id": "M15",
      "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15",
      "section": "§15.2.4, §15.3.1–15.3.3",
      "official_principle": "Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.",
      "review_level": "Retained method-application records were reused. External originals were not reread and method content was not reassessed."
    },
    {
      "id": "M19",
      "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19",
      "section": "§19.1.2, §19.2.1–19.2.4",
      "official_principle": "Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.",
      "review_level": "Retained method-application records were reused. External originals were not reread and method content was not reassessed."
    }
  ],
  "status_dictionary": {
    "Met": "The retained identity, observation or scope required by this item was checked within stated limits. This is separate from clinical sufficiency or full-text certification.",
    "Partly verified": "Some required facts are known, but the stated conditions involving analyses, populations, formulation or denominators remain unverified.",
    "Unverified": "Direct information is unverified in the retained record. This does not establish an effect of 0, no studies, absence of harm or an unreviewed table.",
    "Not applicable": "An obligation for an extension beyond the narrow question does not apply. This does not substitute for unread or unverified material.",
    "Not applicable (alias)": "An alias for the gray Not applicable display.",
    "Not read": "External material was not directly read in the current work. This is distinguished from reading the retained summary.",
    "Conflicting data": "This covers actual discrepancies between reports about the same question. Differences between separate questions are not automatically treated as conflicts."
  },
  "requirements": [
    {
      "item_id": "N01",
      "question_type": "Evidence condition",
      "question": "Which garlic powder, population, duration and ultrasound result does the question concern?",
      "needed": "Trial documents specifying the same population, formulation, administration, comparison and measurement time.",
      "role": "Required",
      "role_reason": "Changing the identity of the intervention-effect question can combine different results as the same effect.",
      "application_exception": "ALT, AST, weight, MRI-PDFF, histology, fibrosis, cirrhosis and other garlic formulations are not automatically included in this independent question.",
      "criterion": "Define a single question covering adults with ultrasound-diagnosed NAFLD, 2 garlic-powder tablets of 400 mg, oral 800 mg/day for 15 weeks, matching-appearance placebo and the proportion with ultrasound improvement of at least 1 grade.",
      "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These are Chamgap in-house application conditions for the garlic-powder versus placebo ultrasound-steatosis-grade question, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.",
      "proposed_research": "If a new design is discussed, first fix this imaging-endpoint question and separate other formulations and endpoints."
    },
    {
      "item_id": "N02",
      "question_type": "Evidence condition",
      "question": "Are reports, study families and background narratives being counted more than once?",
      "needed": "Trial identifiers in papers, registration and secondary reports, recruitment periods/sites, and material linking participants and endpoints.",
      "role": "Required",
      "role_reason": "Multiple reports from a single trial and background mentions are not independent replications.",
      "application_exception": "Retain unverified family identity, independent-trial counts and unique-participant counts as null. Do not create S02 from background alone.",
      "criterion": "Link actual evidence/citation reports to provisional study families. Do not sum unidentified background, reviews or recitations of the same trial as new independent studies or participants.",
      "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These are Chamgap in-house application conditions for the garlic-powder versus placebo ultrasound-steatosis-grade question, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.",
      "proposed_research": "In an authorized update, first verify report links by family, remove duplicates and then compare results."
    },
    {
      "item_id": "N03",
      "question_type": "Evidence condition",
      "question": "Which materials were actually read in this work, and which were retained only as links?",
      "needed": "Actual access receipts for each material, original-file identity, bytes, hashes and locations read.",
      "role": "Required",
      "role_reason": "A summary-reading link or PMID does not prove that the original paper was read in this work.",
      "application_exception": "Do not mark access as inaccessible when no failed attempt occurred. Do not inherit the retained original verdict-review date as an access date for each material.",
      "criterion": "Record the complete local retained summary and the original locations, types and hashes. Distinguish these from attempted access, acquisition and actual reading of external bibliographic abstracts, full texts and registration.",
      "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These are Chamgap in-house application conditions for the garlic-powder versus placebo ultrasound-steatosis-grade question, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.",
      "proposed_research": "If external reading is separately authorized, link the sections/tables read and the exact analysis for each material and compare them with the retained summary."
    },
    {
      "item_id": "N04",
      "question_type": "Evidence condition",
      "question": "Which adults with NAFLD were selected, and to whom can the result apply?",
      "needed": "Eligibility tables, recruitment flow, baseline characteristics, diagnostic criteria and comorbidity material.",
      "role": "Required",
      "role_reason": "The label adults with NAFLD does not make the result applicable to all liver diseases, severity levels or age groups.",
      "application_exception": "Do not infer missing eligibility details or extend the result to pregnancy, children or advanced liver disease.",
      "criterion": "Link ultrasound diagnosis, inclusion/exclusion criteria, baseline steatosis grade, hepatic/metabolic status and recruitment setting to the actual trial population.",
      "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These are Chamgap in-house application conditions for the garlic-powder versus placebo ultrasound-steatosis-grade question, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.",
      "proposed_research": "Directly assess an extension question requiring representativeness in the relevant population and baseline-severity group."
    },
    {
      "item_id": "N05",
      "question_type": "Evidence condition",
      "question": "Do the trial garlic powder’s formulation, daily amount and alliin specifications match?",
      "needed": "Trial-product composition, manufacturing/batch, alliin specifications, dosing schedules and adherence records.",
      "role": "Required",
      "role_reason": "Even the same daily powder amount does not guarantee the same exposure when ingredients, active constituents or manufacturing differ.",
      "application_exception": "Do not fill unverified alliin with content of 0 or an allicin-generation amount. Do not substitute raw garlic, oil, AGE, black/fermented garlic or isolated SAC.",
      "criterion": "Distinguish 2 powder tablets of 400 mg, oral 800 mg/day for 15 weeks, and verify alliin and product manufacturing/composition specifications from actual documents.",
      "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These are Chamgap in-house application conditions for the garlic-powder versus placebo ultrasound-steatosis-grade question, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.",
      "proposed_research": "If replication with the same product is needed, specify constituent standards and control product differences."
    },
    {
      "item_id": "N06",
      "question_type": "Evidence condition",
      "question": "Do placebo appearance and actual concurrent conditions match?",
      "needed": "Placebo ingredients, dosing schedules, concurrent-treatment plans for both arms, and implementation/change records.",
      "role": "Required",
      "role_reason": "Differences in liver-disease lifestyle treatment or comparator products affect intervention attribution and blinding.",
      "application_exception": "Do not infer equal ingredients, lifestyle advice or adherence from the record of matching appearance.",
      "criterion": "Distinguish the composition/administration of matching-appearance placebo and planned versus actual exposure to lifestyle advice, diet, exercise and hepatic/metabolic medication in both arms.",
      "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These are Chamgap in-house application conditions for the garlic-powder versus placebo ultrasound-steatosis-grade question, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.",
      "proposed_research": "In a new comparison, specify placebo and lifestyle-treatment conditions and measure actual implementation and changes."
    },
    {
      "item_id": "N07",
      "question_type": "Evidence condition",
      "question": "What definition, timing and measurement unit does ultrasound improvement use?",
      "needed": "Imaging-grade definitions, measurement visits and tables linking baseline and follow-up assessments.",
      "role": "Required",
      "role_reason": "Imaging-grade change, continuous liver-fat quantity and liver enzymes have different measurement units and meanings.",
      "application_exception": "The retained primary-endpoint label does not certify the endpoint hierarchy in actual preregistration.",
      "criterion": "Distinguish the proportion with improvement of at least 1 ultrasound-steatosis grade at 15 weeks. Link the grading scale, baseline/follow-up measurements and improvement-assessment rules.",
      "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These are Chamgap in-house application conditions for the garlic-powder versus placebo ultrasound-steatosis-grade question, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.",
      "proposed_research": "When assessing the same endpoint, prespecify the grading scale, assessment time and success threshold."
    },
    {
      "item_id": "N08",
      "question_type": "Evidence condition",
      "question": "Are the denominators and losses for 110 randomized and 98 completed distinguished?",
      "needed": "Arm-specific allocation and follow-up/measurement/analysis flow, dropout reasons and missing-data handling.",
      "role": "Required",
      "role_reason": "Completer results do not automatically represent everyone randomized.",
      "application_exception": "Quote 110 and 98 unchanged. Do not calculate or fill arm-specific allocation counts, loss counts or percentages.",
      "criterion": "Distinguish randomized, completed, measured and analyzed counts by arm and time. Record exclusion/dropout reasons, handling of missing data and possible result bias.",
      "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These are Chamgap in-house application conditions for the garlic-powder versus placebo ultrasound-steatosis-grade question, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.",
      "proposed_research": "In an authorized follow-up check, link the flow diagram and analysis populations and check whether missing-data sensitivity was assessed."
    },
    {
      "item_id": "N09",
      "question_type": "Evidence condition",
      "question": "Which analysis population do the events of 24/47 versus 8/51 belong to?",
      "needed": "Arm-specific completer-event tables, analysis-population definitions, and links to improvement assessment and timing.",
      "role": "Required",
      "role_reason": "Changing the analysis population from event counts alone changes the attribution of the effect estimate.",
      "application_exception": "Do not relabel 24/47 versus 8/51 as ITT events or arm-specific randomized counts. Do not calculate RR, OR, risk differences or percentages.",
      "criterion": "Pair completer-improvement events with arm-specific completer denominators. Distinguish these from ITT events/denominators or results for everyone randomized.",
      "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These are Chamgap in-house application conditions for the garlic-powder versus placebo ultrasound-steatosis-grade question, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.",
      "proposed_research": "In a new assessment, report differences between randomized-population and completer estimates transparently."
    },
    {
      "item_id": "N10",
      "question_type": "Evidence condition",
      "question": "How are the retained ITT RR 3.0, interval and P value attributed?",
      "needed": "ITT denominators/events by arm, estimation models, missing-data handling, CI/test definitions and original result tables.",
      "role": "Required",
      "role_reason": "ITT results and completer values within the same report can represent different analysis questions.",
      "application_exception": "These are quotations of existing numbers, not calculations or original-model verification in this conversion. Do not invent ITT events or intervals.",
      "criterion": "Link the RR 3.0, 95% CI 1.5~6.1 and P=.001 recorded as ITT to the relevant analysis population and measure, and distinguish them from completer events.",
      "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These are Chamgap in-house application conditions for the garlic-powder versus placebo ultrasound-steatosis-grade question, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.",
      "proposed_research": "If reassessment of an existing estimate is authorized, first compare the original analysis population and estimation procedures."
    },
    {
      "item_id": "N11",
      "question_type": "Evidence condition",
      "question": "Are the paper’s 5.6 labeling issue and the ITT risk ratio kept separate?",
      "needed": "The paper’s original tables, effect-measure definitions, statistical methods and analysis population for the estimate.",
      "role": "Required",
      "role_reason": "Confusing effect-measure names can use the same number to claim a different effect size.",
      "application_exception": "The 5.6 description is historical wording in the retained summary. Do not claim to establish it through new OR/RR calculations or current direct verification of the paper.",
      "criterion": "Separate the paper’s RR 5.6 labeling issue described in the retained original from ITT RR 3.0. State how far the actual measures and analysis populations have been verified.",
      "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These are Chamgap in-house application conditions for the garlic-powder versus placebo ultrasound-steatosis-grade question, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.",
      "proposed_research": "If a measure correction is separately authorized, handle it as an event comparing original tables and methods, while preserving the old record."
    },
    {
      "item_id": "N12",
      "question_type": "Evidence condition",
      "question": "How are opposing/null results and signals at another dose retained?",
      "needed": "All reports with the same formulation, population, endpoint and time; identified comparative results and explanations of missing results.",
      "role": "Required",
      "role_reason": "A positive summary alone cannot establish the overall direction of evidence or absence of opposing results.",
      "application_exception": "Imaging signals at different doses/durations are not themselves conflicting data. Do not turn unread material into an effect of 0.",
      "criterion": "Do not omit opposing/null reports on the same question. Distinguish signals at different doses/durations from conflict or confirmation within this question.",
      "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These are Chamgap in-house application conditions for the garlic-powder versus placebo ultrasound-steatosis-grade question, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.",
      "proposed_research": "In an authorized literature update, review material for the same question together regardless of direction or statistical significance."
    },
    {
      "item_id": "N13",
      "question_type": "Evidence condition",
      "question": "What are the retained verdict date, corrections and scope of this check?",
      "needed": "The original verdict and correction history, current-input identity, and receipts for actual reading/search scope.",
      "role": "Required",
      "role_reason": "A historical review date or grading axis does not replace a current literature search or fulfillment of individual conditions.",
      "application_exception": "Preserve original C/54, Caution, all axes, generic English wording, corrections, native types and empty values. Do not create new scores or verdicts.",
      "criterion": "Distinguish the original review date, correction history, current-source identity and scope read in this conversion. Do not claim currency or completeness for unsearched areas.",
      "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These are Chamgap in-house application conditions for the garlic-powder versus placebo ultrasound-steatosis-grade question, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.",
      "proposed_research": "When updating material, separate the search event from condition-version changes and preserve the entire original before changes."
    },
    {
      "item_id": "N14",
      "question_type": "Evidence condition",
      "question": "What is known about academic funding, conflict-of-interest reporting and independence?",
      "needed": "Original paper sections on funding, product provision, author affiliations and COI, plus study-family linkage material.",
      "role": "Supplementary; required for independence claims",
      "role_reason": "A brief academic-institution or no-COI record cannot establish all support arrangements or independent replication.",
      "application_exception": "Existing I2 is a historical value. Do not fill unverified product support as no support or exclude a report solely because of COI.",
      "criterion": "Separate funding, product provision, author relationships and conflict disclosures. Link study families and independence claims to actual material.",
      "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These are Chamgap in-house application conditions for the garlic-powder versus placebo ultrasound-steatosis-grade question, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.",
      "proposed_research": "When discussing independent replication, check institutions, authors, product support and participant overlap separately."
    },
    {
      "item_id": "N15",
      "question_type": "Evidence condition",
      "question": "What allocation process lies behind the randomized, double-blind label?",
      "needed": "Allocation methods, concealment procedures, baseline-characteristic tables and blinding-implementation material.",
      "role": "Required",
      "role_reason": "The RCT label alone does not establish adequate allocation and concealment.",
      "application_exception": "Do not automatically turn original B1 or double-blind wording into fulfillment of detailed bias conditions.",
      "criterion": "Check sequence generation, allocation concealment, baseline balance and actual blinding targets/procedures for each result.",
      "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These are Chamgap in-house application conditions for the garlic-powder versus placebo ultrasound-steatosis-grade question, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.",
      "proposed_research": "In a replication comparison design, specify allocation/concealment procedures and assess bias for each result."
    },
    {
      "item_id": "N16",
      "question_type": "Evidence condition",
      "question": "How might lifestyle advice, weight changes, adherence and deviations affect results?",
      "needed": "Concurrent/lifestyle-treatment implementation, weight/medication changes, trial-product adherence and deviation records.",
      "role": "Required",
      "role_reason": "The 15-week result requires distinguishing actual powder exposure from concurrent-treatment/deviation effects.",
      "application_exception": "Weight, ALT and AST changes are separate endpoints. Do not turn them into surrogate confirmation of ultrasound improvement or a new independent unit.",
      "criterion": "Record lifestyle advice, diet, exercise, metabolic/liver-disease treatment, adherence and stopping/cross-exposure in both arms, and distinguish them from the effect of interest.",
      "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These are Chamgap in-house application conditions for the garlic-powder versus placebo ultrasound-steatosis-grade question, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.",
      "proposed_research": "When studying intervention attribution, record concurrent treatment and actual exposure together and analyze them in line with the planned effect of interest."
    },
    {
      "item_id": "N17",
      "question_type": "Evidence condition",
      "question": "Are ultrasound-reader blinding, reproducibility and assessment error verified?",
      "needed": "Ultrasound acquisition/grading procedures, reader blinding and reproducibility/agreement material.",
      "role": "Required",
      "role_reason": "Grade changes can also be affected by differences in reading and measurement.",
      "application_exception": "A double-blind design label differs from verified imaging-reader blinding and reproducibility.",
      "criterion": "Check consistent imaging measurement, reader blinding, training/agreement, baseline/follow-up reading rules and measurement error.",
      "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These are Chamgap in-house application conditions for the garlic-powder versus placebo ultrasound-steatosis-grade question, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.",
      "proposed_research": "When assessing ultrasound improvement, mask reader and timepoint information separately and check reproducibility under prespecified rules."
    },
    {
      "item_id": "N18",
      "question_type": "Evidence condition",
      "question": "Which effects of interest and missing-data handling do ITT and completer analyses address?",
      "needed": "Original statistical methods, analysis-population definitions, ITT missing-data handling and sensitivity analyses/SAP.",
      "role": "Required",
      "role_reason": "The ITT label alone cannot establish missing-data handling or the effect of interest.",
      "application_exception": "Do not automatically relabel completers as PP or merge them as the same estimate or original event counts.",
      "criterion": "Distinguish assignment effects from actual-adherence/completion effects. Link analysis populations, missing-data handling, models/adjustments and between-arm comparisons to each result.",
      "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These are Chamgap in-house application conditions for the garlic-powder versus placebo ultrasound-steatosis-grade question, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.",
      "proposed_research": "In an authorized check, trace models and effects of interest for event counts and summary estimates separately."
    },
    {
      "item_id": "N19",
      "question_type": "Evidence condition",
      "question": "How are the ITT interval and clinical importance distinguished?",
      "needed": "Original CI-estimation methods, thresholds for meaningful imaging improvement and material on clinical significance.",
      "role": "Required",
      "role_reason": "Significance, sample size and a historical grade are not sufficient conditions for clinical importance and precision.",
      "application_exception": "Do not turn historical rules such as existing CX or fewer than 200 total participants into new arbitrary sample-size, trial-count or duration requirements.",
      "criterion": "Link the reported CI to the relevant effect measure. Distinguish the clinical importance/limits of ultrasound improvement of 1 grade from direct evidence.",
      "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These are Chamgap in-house application conditions for the garlic-powder versus placebo ultrasound-steatosis-grade question, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.",
      "proposed_research": "If better precision is needed, first specify the desired effect range, importance threshold and missing-data/measurement uncertainty."
    },
    {
      "item_id": "N20",
      "question_type": "Evidence condition",
      "question": "Were the endpoint, 15-week timepoint and analysis prespecified?",
      "needed": "Trial-preregistration identifiers/versions, protocols, SAP, reasons for changes and actual result reports.",
      "role": "Required",
      "role_reason": "The retained claim-condition primary-endpoint label or false axis values alone cannot certify actual prespecification or absence of selective reporting.",
      "application_exception": "An unable-to-verify registration field is not evidence of nonregistration. Do not mark unread preregistration/SAP as not applicable.",
      "criterion": "Compare original registration/protocol/SAP versions and dates with changes to reported endpoints, timepoints and analyses.",
      "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These are Chamgap in-house application conditions for the garlic-powder versus placebo ultrasound-steatosis-grade question, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.",
      "proposed_research": "In an update where material is acquired, compare plans with reports for each result and record correction events."
    },
    {
      "item_id": "N21",
      "question_type": "Evidence condition",
      "question": "Are independent replication for the same question and study families at other doses verified?",
      "needed": "Identified follow-up/secondary reports, registration, recruitment/site information and results for each defined question.",
      "role": "Required",
      "role_reason": "A historical R1 value or background imaging signal does not certify independent replication of the same question.",
      "application_exception": "Do not declare all families to be a single confirmed family or close heterogeneity as not applicable merely because there is 1 current report.",
      "criterion": "Compare unique study families and formulation, population, endpoint and analysis definitions to distinguish replication from heterogeneity.",
      "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These are Chamgap in-house application conditions for the garlic-powder versus placebo ultrasound-steatosis-grade question, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.",
      "proposed_research": "When assessing independent replication, link trials of the same product/question separately from trials of other doses/durations."
    },
    {
      "item_id": "N22",
      "question_type": "Evidence condition",
      "question": "Can results be extended to other doses, durations, formulations or subgroups?",
      "needed": "Direct material for each dose, duration and subgroup with explicit identifiers and question definitions.",
      "role": "Supplementary; required for dose, persistence or subgroup extensions",
      "role_reason": "Distinguish evidence obligations for the narrow 800 mg/day, 15-week question from extension questions.",
      "application_exception": "Do not generate same-formulation confirmation, dose response or a new report from the 1,600 mg/12-week background alone.",
      "criterion": "For an extension claim, acquire direct comparisons for the same product/population and relevant doses, durations and subgroups, and record differences.",
      "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These are Chamgap in-house application conditions for the garlic-powder versus placebo ultrasound-steatosis-grade question, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.",
      "proposed_research": "If an extension is needed, define a separate question and design direct comparisons or continued follow-up."
    },
    {
      "item_id": "N23",
      "question_type": "Evidence condition",
      "question": "Does imaging-grade improvement answer questions about MRI, histology or clinical liver-disease prevention?",
      "needed": "Direct results and follow-up material for MRI-PDFF/histology or fibrosis, cirrhosis and clinical events.",
      "role": "Supplementary; required for other-measurement or clinical-event extensions",
      "role_reason": "Ultrasound grade does not automatically represent direct liver-fat quantification, histology or clinical events.",
      "application_exception": "Do not impose MRI, histology or long-term-event trials as mandatory efficacy conditions for this narrow imaging question.",
      "criterion": "When extending to clinical events or another measurement, require direct evidence for that endpoint and distinguish it from imaging grade.",
      "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These are Chamgap in-house application conditions for the garlic-powder versus placebo ultrasound-steatosis-grade question, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.",
      "proposed_research": "If a claim about another endpoint is needed, define an independent question and measure that endpoint directly."
    },
    {
      "item_id": "N24",
      "question_type": "Evidence condition",
      "question": "What actual harm-event material supports the gastrointestinal-discomfort and bleeding cautions?",
      "needed": "Trial harm-event tables, definitions/severity, active/passive collection methods and stopping criteria.",
      "role": "Supplementary; required for harm or safety claims",
      "role_reason": "Retain the original caution without confusing efficacy events with actual harm observations.",
      "application_exception": "General caution wording is not a record that the event was observed in the trial or evidence of no events.",
      "criterion": "For a harm claim, link event definitions, severity, collection methods and stopping criteria to actual observations in the same population/exposure.",
      "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These are Chamgap in-house application conditions for the garlic-powder versus placebo ultrasound-steatosis-grade question, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.",
      "proposed_research": "If a harm question is needed, design separate event collection for the same powder, exposure and NAFLD population."
    },
    {
      "item_id": "N25",
      "question_type": "Evidence condition",
      "question": "Are the exposure, onset, stopping and recovery times of harm events known?",
      "needed": "Event-specific administration, onset, stopping/re-exposure, recovery records and follow-up time.",
      "role": "Supplementary; required for harm-causality or timing claims",
      "role_reason": "Efficacy-trial duration differs from the temporal relationship of an individual event.",
      "application_exception": "Do not infer harm onset, resolution or causality from the 15-week treatment duration alone.",
      "criterion": "For harm-causality/timing claims, link actual administration, onset, stopping, recovery and re-exposure times for each event.",
      "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These are Chamgap in-house application conditions for the garlic-powder versus placebo ultrasound-steatosis-grade question, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.",
      "proposed_research": "In harm research assessing temporal relationships, record actual exposure and event times."
    },
    {
      "item_id": "N26",
      "question_type": "Evidence condition",
      "question": "Which placebo and background risks were used for harm comparisons?",
      "needed": "Arm-specific harm results, equal collection, baseline risks and placebo exposure/follow-up material.",
      "role": "Supplementary; required for comparative-harm claims",
      "role_reason": "The existence of a placebo efficacy comparison does not guarantee the existence of harm-comparison material.",
      "application_exception": "Do not calculate between-arm bleeding or gastrointestinal-harm risks from the efficacy question’s matching-appearance placebo alone.",
      "criterion": "For comparative-harm claims, link comparators with the same population and exposure/follow-up to arm-specific collection and background risks.",
      "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These are Chamgap in-house application conditions for the garlic-powder versus placebo ultrasound-steatosis-grade question, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.",
      "proposed_research": "For harm comparisons, include equal collection/follow-up in both arms and checks of baseline risk."
    },
    {
      "item_id": "N27",
      "question_type": "Evidence condition",
      "question": "Are exposure, event and time denominators available for harm-frequency claims?",
      "needed": "Arm-specific harm-exposure/analysis counts, affected-person/event counts, observation time and collection methods.",
      "role": "Supplementary; required for harm-frequency claims",
      "role_reason": "The 110 randomized, 98 completed and ultrasound-event counts are not harm denominators or numerators.",
      "application_exception": "Do not convert efficacy results of 24/47 versus 8/51 or trial participant counts into harm incidence.",
      "criterion": "For harm-frequency claims, distinguish actually exposed people, affected people, repeated events, follow-up time and collection scope.",
      "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These are Chamgap in-house application conditions for the garlic-powder versus placebo ultrasound-steatosis-grade question, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.",
      "proposed_research": "In harm research, report exposure/follow-up denominators separately from efficacy completers."
    },
    {
      "item_id": "N28",
      "question_type": "Evidence condition",
      "question": "What alternative causes and concurrent exposures, including liver disease and medications, affect harms?",
      "needed": "Baseline risks, concurrent medications/exposures, event assessments and alternative-cause records.",
      "role": "Supplementary; required for causal or comparative harms",
      "role_reason": "Alternative factors must be known before attributing a caution in the NAFLD population to harm from a particular cause.",
      "application_exception": "Do not fill unrecorded medications or causes as absent, or assess individual risk from the original caution alone.",
      "criterion": "For causal or comparative harm claims, distinguish baseline disease, bleeding risk, concurrent medications/exposures and alternative causes.",
      "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These are Chamgap in-house application conditions for the garlic-powder versus placebo ultrasound-steatosis-grade question, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.",
      "proposed_research": "For a harm question, record baseline liver disease and concurrent factors, retaining uncertainty about causal contribution."
    },
    {
      "item_id": "N29",
      "question_type": "Evidence condition",
      "question": "Can stopping/dropout and selective harm reporting be distinguished?",
      "needed": "Arm-specific stopping/dropout reasons, harm-collection plans, complete event tables and reporting changes.",
      "role": "Supplementary; required for safety or complete harm-reporting claims",
      "role_reason": "Completion counts and cautions alone cannot establish stopping causes or completeness of harm results.",
      "application_exception": "Do not extend absence of a harm table in the current retained summary to nonreporting throughout the paper or absence of events.",
      "criterion": "For harm conclusions, compare stopping/dropout reasons, follow-up losses, collection scope and whether all harm results were reported.",
      "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These are Chamgap in-house application conditions for the garlic-powder versus placebo ultrasound-steatosis-grade question, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.",
      "proposed_research": "In follow-up harm assessment, track dropout and harm collection together and specify the scope of nonreporting."
    },
    {
      "item_id": "N30",
      "question_type": "Evidence condition",
      "question": "Is the original caution being counted as an independently repeated harm signal?",
      "needed": "Event/report identifiers, exposure, timing, study/case families and recitation links.",
      "role": "Supplementary; required for repeated harm-signal claims",
      "role_reason": "Recitation of a caution must be distinguished from repetition of independent events.",
      "application_exception": "No new repeated harm-signal claim is made in this conversion. Do not read absence of event reports in the summary as 0 actual events.",
      "criterion": "For repeated harm-signal claims, identify recitations/report families of the same event and independent events/studies.",
      "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These are Chamgap in-house application conditions for the garlic-powder versus placebo ultrasound-steatosis-grade question, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.",
      "proposed_research": "If repeated signals become a separate question, create individual family links and then assess whether records are independent."
    },
    {
      "item_id": "N31",
      "question_type": "Evidence condition",
      "question": "Are long-term/rare harms and vulnerable-group/interactions beyond 15 weeks known?",
      "needed": "Harm follow-up by exposure/duration and actual material on vulnerable groups and concurrent-treatment interactions.",
      "role": "Supplementary; required for safety-scope extensions",
      "role_reason": "A 15-week efficacy result cannot certify long-term/rare-event or vulnerable-group safety.",
      "application_exception": "Do not impose long-term safety research as mandatory for the current imaging-efficacy question or create individual intake advice.",
      "criterion": "For long-term/rare-harm, vulnerable-group or interaction-safety claims, require direct harm material for the relevant exposure, population and duration.",
      "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These are Chamgap in-house application conditions for the garlic-powder versus placebo ultrasound-steatosis-grade question, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.",
      "proposed_research": "If a safety question in this scope is needed, follow actual exposure and events over the long term in a separately defined population."
    },
    {
      "item_id": "N32",
      "question_type": "Evidence condition",
      "question": "What separates general cautions, comparative harms, causality and individual safety?",
      "needed": "Original material on the relevant harm events, comparators, causal assessments and applicability.",
      "role": "Supplementary; required for harm or safety interpretation",
      "role_reason": "Retain the original cautions without presenting positive efficacy values as proof of absence of harm or individual safety.",
      "application_exception": "C/54 and Caution are historical values, not a new grade, safety verdict or individual intake recommendation in this conversion.",
      "criterion": "Distinguish general cautions, observed signals, comparative risks and causality by the actual material level. Do not generate unverified harm values or safety certification.",
      "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These are Chamgap in-house application conditions for the garlic-powder versus placebo ultrasound-steatosis-grade question, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.",
      "proposed_research": "Define a separate harm question and set the conclusion level appropriate to its design, population, exposure and collection."
    }
  ]
}