{ "schema_version": "chamgap-public-evidence-check-1.0", "public_id": "v3063-main", "verdict_number": "3063", "title": "Garlic-powder tablets 800 mg/day × Improvement of ultrasound steatosis grade in adults with NAFLD", "view_version": "1.0", "view_created_date": "2026-10-26", "criteria_version": "1.0", "criteria_date": "2026-10-06", "review_date": "2026-10-06", "legacy_evidence_date": "2026-09-08", "review_scope": { "materials_read": "Retained Korean/English summaries and case-specific condition/application records", "clinical_papers_directly_read": false, "new_clinical_search": false, "limitation": "Prepared from retained summaries and condition-application records. External abstracts, full texts, registration, protocols and analysis plans remain unread. Historical review records do not establish current independent clinical validation.", "date_meaning": "The material check date is the original date retained in the summary and condition records. The original verdict-review date does not establish a search cut-off or historical access dates for individual materials; external access was not attempted in this conversion." }, "claim_context": { "population": "Adults diagnosed with NAFLD by ultrasound. Detailed eligibility, baseline severity, concurrent treatment and representativeness remain unverified.", "comparator": "Matching-appearance placebo. Actual placebo ingredients, lifestyle advice, concurrent medication and equivalence of adherence and implementation between arms remain unverified.", "endpoint": "Proportion with improvement of at least 1 ultrasound-steatosis grade at 15 weeks. The actual grading system, reader blinding, reproducibility and prespecified endpoint hierarchy remain unverified.", "intervention": "Oral garlic-powder tablets. Alliin specifications, manufacturing, batch, actual product matching and adherence remain unverified.", "dose": "2 tablets of 400 mg, 800 mg/day. Alliin content remains unverified; equivalence with other garlic formulations is not assumed.", "duration": "15-week treatment and assessment. Actual visit schedules, persistence after stopping and long-term clinical outcomes remain unverified.", "excluded_extensions": [ "Distinguish 110 randomized and 98 completed from completer events of 24/47 versus 8/51. Do not newly calculate arm-specific allocation, losses, ITT events or percentages.", "The retained ITT RR 3.0, 95% CI 1.5~6.1 and P=.001 are separately reported values. Do not replace them with calculations from completer events.", "The description of the paper’s 5.6 label and odds is historical wording in the retained summary. Original tables, models and measures were not directly verified, and OR/RR was not newly calculated in this conversion.", "Retain the 1,600 mg/12-week signal as background narrative without an identifier. Do not turn it into a new report, independent replication, dose response or conflict within the same question.", "ALT, AST, weight, MRI-PDFF, histology, fibrosis, cirrhosis, clinical events and other garlic formulations are separate questions. Do not extend imaging-grade improvement to liver-disease prevention or replacement of treatment.", "Retain the original cautions about gastrointestinal discomfort and bleeding. Do not newly establish actual harm frequency, causality, absence of harm, long-term/vulnerable-group safety or individual intake instructions." ] }, "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.", "current_reports": [ "S01" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "The claim conditions specify 800 mg/day, 15 weeks, matching-appearance placebo and ultrasound improvement of at least 1 grade. The original subclaim list is empty; this table addresses a single independent question from the original claim.", "condition_status": "Met", "status_reason": "The question and exclusions were specified from the retained summary. This does not establish a match with the actual trial protocol or product certification.", "missingness": "Current direct verification of the original protocol and product details remains in separate conditions.", "uncertainty": "Current direct verification of the original protocol and product details remains in separate conditions.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Trial documents specifying the same population, formulation, administration, comparison and measurement time." }, { "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.", "current_reports": [ "S01" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "The evidence and citation contain only the report pair for PMID 32753923. It is provisionally linked to the study family for PMID32753923. The separate 1,600 mg/12-week trial appears only as background narrative, and no actual review-report entry is present.", "condition_status": "Partly verified", "status_reason": "The array attribution of the 1 actual report was checked. Independent families and review overlap across the entire literature were not currently verified.", "missingness": "Registration identifiers and family-comparison documents remain unverified. Reports or reviews absent from the arrays are not declared nonexistent.", "uncertainty": "Registration identifiers and family-comparison documents remain unverified. Reports or reviews absent from the arrays are not declared nonexistent.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Trial identifiers in papers, registration and secondary reports, recruitment periods/sites, and material linking participants and endpoints." }, { "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.", "current_reports": [ "S01" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "The entire current retained source was read, including Korean/English content, evidence, citations, empty arrays, corrections and URLs. The retained PubMed URL is a gateway; external abstracts, full texts and registration were not accessed, acquired or read in this conversion.", "condition_status": "Met", "status_reason": "The distinction between actual summary reading and unread external material, and the material identity, were checked. This does not certify clinical full-text verification.", "missingness": "Current access and reading of external responses, bibliographic identity, full-text files and registration documents have not been verified.", "uncertainty": "Current access and reading of external responses, bibliographic identity, full-text files and registration documents have not been verified.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Actual access receipts for each material, original-file identity, bytes, hashes and locations read." }, { "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.", "current_reports": [ "S01" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "The claim conditions record adults diagnosed with NAFLD by ultrasound. Detailed eligibility, exclusions, baseline grades and recruitment sites are not specified in the current retained summary.", "condition_status": "Partly verified", "status_reason": "The population label and diagnostic imaging type were checked, but direct information on selection and representativeness is insufficient.", "missingness": "Diagnostic assessment criteria, baseline severity, concurrent treatment, recruitment setting and population distribution remain unverified.", "uncertainty": "Diagnostic assessment criteria, baseline severity, concurrent treatment, recruitment setting and population distribution remain unverified.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Eligibility tables, recruitment flow, baseline characteristics, diagnostic criteria and comorbidity material." }, { "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.", "current_reports": [ "S01" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "The original formulation is 2 garlic-powder tablets of 400 mg, oral 800 mg/day, for 15 weeks. The original retained wording itself marks alliin specifications as unverified.", "condition_status": "Partly verified", "status_reason": "The stated powder formulation, route, amount and duration were checked, but constituent specifications and actual product identity were not verified.", "missingness": "Alliin content, product/batch details and adherence remain currently unverified.", "uncertainty": "Alliin content, product/batch details and adherence remain currently unverified.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Trial-product composition, manufacturing/batch, alliin specifications, dosing schedules and adherence records." }, { "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.", "current_reports": [ "S01" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "The comparator is recorded as matching-appearance placebo, and the explanation advises considering lifestyle advice and weight change separately. Actual placebo ingredients and balance of lifestyle treatment between arms are not available.", "condition_status": "Partly verified", "status_reason": "The named comparison was checked. Equivalence of actual comparison conditions and concurrent-treatment implementation remains unverified.", "missingness": "Placebo ingredients, concurrent medication, lifestyle advice and implementation differences remain unverified.", "uncertainty": "Placebo ingredients, concurrent medication, lifestyle advice and implementation differences remain unverified.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Placebo ingredients, dosing schedules, concurrent-treatment plans for both arms, and implementation/change records." }, { "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.", "current_reports": [ "S01" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "The claim-condition endpoint is the proportion with ultrasound improvement of at least 1 grade at 15 weeks; the evidence records improvement of ultrasound steatosis grade. The specific grading scale and permitted visit windows are not provided.", "condition_status": "Partly verified", "status_reason": "The stated success threshold and timing were checked, but details of actual imaging grades and assessment rules remain unverified.", "missingness": "The grading system, baseline/follow-up linkage and detailed visit timing remain unverified.", "uncertainty": "The grading system, baseline/follow-up linkage and detailed visit timing remain unverified.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Imaging-grade definitions, measurement visits and tables linking baseline and follow-up assessments." }, { "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.", "current_reports": [ "S01" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "The participant-count and reader-answer sections distinguish 110 randomized from 98 completed. Arm-specific allocation/missing counts and reasons are not specified in the current retained summary.", "condition_status": "Partly verified", "status_reason": "The different overall randomized/completed denominators were retained, but arm-specific losses and handling information are insufficient.", "missingness": "Arm-specific allocation, dropout reasons, measurement and ITT-analysis inclusion criteria remain unverified.", "uncertainty": "Arm-specific allocation, dropout reasons, measurement and ITT-analysis inclusion criteria remain unverified.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Arm-specific allocation and follow-up/measurement/analysis flow, dropout reasons and missing-data handling." }, { "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.", "current_reports": [ "S01" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "The retained Korean/English content and evidence/citation record completer results as 24/47 versus 8/51. Actual original-table rows, improvement assessment and analysis-exclusion reasons were not checked in this conversion.", "condition_status": "Partly verified", "status_reason": "The retained completer events and denominators were checked. External original tables and analysis-inclusion rules remain currently unverified.", "missingness": "Original-table locations, completer-analysis criteria and handling of missing data remain unverified.", "uncertainty": "Original-table locations, completer-analysis criteria and handling of missing data remain unverified.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Arm-specific completer-event tables, analysis-population definitions, and links to improvement assessment and timing." }, { "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.", "current_reports": [ "S01" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "The original reader-answer section and evidence/citation retain ITT RR 3.0, 95% CI 1.5~6.1 and P=.001. These are displayed separately from completers of 24/47 versus 8/51.", "condition_status": "Partly verified", "status_reason": "The existing ITT estimate, interval and P record were checked. Original denominators, models and test definitions were not verified.", "missingness": "ITT events/denominators by arm, missing-data corrections, adjustment status and specific definitions of the CI and test remain unverified.", "uncertainty": "ITT events/denominators by arm, missing-data corrections, adjustment status and specific definitions of the CI and test remain unverified.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "ITT denominators/events by arm, estimation models, missing-data handling, CI/test definitions and original result tables." }, { "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.", "current_reports": [ "S01" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "The original Korean/English content describes the value the paper calls a relative risk of 5.6 as corresponding to odds from the event counts, and advises distinguishing it from ITT RR 3.0. This description was retained unchanged.", "condition_status": "Partly verified", "status_reason": "The existing labeling-issue record and separation principle were checked. The original paper’s measure definition remains currently unread directly.", "missingness": "The actual original-table location, model, population and measure definition for 5.6 remain unverified.", "uncertainty": "The actual original-table location, model, population and measure definition for 5.6 remain unverified.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "The paper’s original tables, effect-measure definitions, statistical methods and analysis population for the estimate." }, { "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.", "current_reports": [ "S01" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "The text records that a separate 1,600 mg/12-week imaging signal was not counted as confirmation of the same formulation because dose and protocol differed. This summary’s evidence/citation has no separate opposing/null report for the same question.", "condition_status": "Partly verified", "status_reason": "The background signal for a different question and its exclusion reason were retained. The full scope of positive/null/opposing reports for the same question remains unverified.", "missingness": "The background trial’s identity and the full result range for the same question remain unverified; no new literature search was performed.", "uncertainty": "The background trial’s identity and the full result range for the same question remain unverified; no new literature search was performed.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "All reports with the same formulation, population, endpoint and time; identified comparative results and explanations of missing results." }, { "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.", "current_reports": [ "S01" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "The original verdict-review date is 2026-09-08 and the correction date is 2026-09-14. This event converts the current original-byte retained summary; no new clinical search, numerical calculation, regrading or external reading was performed.", "condition_status": "Met", "status_reason": "The retained dates and actual reading/prohibited scope of this work were recorded separately. This does not certify completeness of all current evidence.", "missingness": "The current scope of newer papers, registration and corrections outside the original was not searched and remains unverified.", "uncertainty": "The current scope of newer papers, registration and corrections outside the original was not searched and remains unverified.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "The original verdict and correction history, current-input identity, and receipts for actual reading/search scope." }, { "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.", "current_reports": [ "S01" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "The funding section records an academic institution and no reported conflicts of interest. Original I2 and generic English wording are also retained unchanged and are not inherited as new independence certification.", "condition_status": "Partly verified", "status_reason": "The summary’s funding/COI report was checked. Direct review of product provision, author relationships and family-level independence remains outstanding.", "missingness": "Original funding/COI sections, product support, and links between institutions/authors and other reports remain unverified.", "uncertainty": "Original funding/COI sections, product support, and links between institutions/authors and other reports remain unverified.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Original paper sections on funding, product provision, author affiliations and COI, plus study-family linkage material." }, { "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.", "current_reports": [ "S01" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "The evidence records a randomized, double-blind, placebo-controlled trial. Actual sequence generation, allocation concealment and baseline balance between arms are not provided in the current retained summary.", "condition_status": "Partly verified", "status_reason": "The trial-design label was checked, but actual allocation/concealment procedures remain unverified.", "missingness": "Allocation sequence, concealment, baseline balance and details of who was blinded remain unverified.", "uncertainty": "Allocation sequence, concealment, baseline balance and details of who was blinded remain unverified.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Allocation methods, concealment procedures, baseline-characteristic tables and blinding-implementation material." }, { "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.", "current_reports": [ "S01" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "The explanation advises considering lifestyle advice, weight change and ALT/AST separately. Actual records of concurrent-treatment balance, adherence and deviations/cross-exposure in both arms are not currently available.", "condition_status": "Unverified", "status_reason": "Actual implementation material separating the intervention of interest from concurrent treatment/deviations is not verified in the current retained summary.", "missingness": "Arm-specific lifestyle advice, medication, trial-product adherence, cross-exposure and stopping reasons remain unverified.", "uncertainty": "Arm-specific lifestyle advice, medication, trial-product adherence, cross-exposure and stopping reasons remain unverified.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Concurrent/lifestyle-treatment implementation, weight/medication changes, trial-product adherence and deviation records." }, { "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.", "current_reports": [ "S01" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "The retained evidence records a double-blind trial and ultrasound-grade results but provides no information on readers, blinding procedures, agreement or repeated measurements.", "condition_status": "Unverified", "status_reason": "Direct procedures for verifying imaging assessment and measurement error in this question are absent from the current retained summary.", "missingness": "Reader blinding, imaging criteria, reproducibility and baseline/follow-up assessment linkage remain unverified.", "uncertainty": "Reader blinding, imaging criteria, reproducibility and baseline/follow-up assessment linkage remain unverified.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Ultrasound acquisition/grading procedures, reader blinding and reproducibility/agreement material." }, { "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.", "current_reports": [ "S01" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "The retained material distinguishes completer events from ITT RR but does not describe models, adjustments, handling of missing data or analysis-population selection criteria.", "condition_status": "Partly verified", "status_reason": "Different analysis labels and retained results are known, but links to effects of interest, models and missing-data handling remain unverified.", "missingness": "SAP, analysis-population definitions, missing-data handling/sensitivity and model/adjustment details remain unverified.", "uncertainty": "SAP, analysis-population definitions, missing-data handling/sensitivity and model/adjustment details remain unverified.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Original statistical methods, analysis-population definitions, ITT missing-data handling and sensitivity analyses/SAP." }, { "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.", "current_reports": [ "S01" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "ITT CI 1.5~6.1 and P=.001 are existing records. A prespecified importance threshold for ultrasound improvement of 1 grade and original CI methods are not currently provided.", "condition_status": "Partly verified", "status_reason": "Retention of the reported interval was checked. Evidence is insufficient to establish clinical-benefit magnitude or adequate precision from it.", "missingness": "CI methods and material addressing clinical importance/persistence and measurement error remain unverified.", "uncertainty": "CI methods and material addressing clinical importance/persistence and measurement error remain unverified.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Original CI-estimation methods, thresholds for meaningful imaging improvement and material on clinical significance." }, { "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.", "current_reports": [ "S01" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "The evidence registration field records unable to verify. The claim conditions name the selected endpoint, but actual registration, protocols, SAP and changes were not directly read in this conversion.", "condition_status": "Unverified", "status_reason": "Original documents needed to compare planned and reported results remain currently unverified and unread.", "missingness": "Registration identifiers, dates/versions, protocols, SAP and endpoint/time/analysis change material remain unverified.", "uncertainty": "Registration identifiers, dates/versions, protocols, SAP and endpoint/time/analysis change material remain unverified.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Trial-preregistration identifiers/versions, protocols, SAP, reasons for changes and actual result reports." }, { "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.", "current_reports": [ "S01" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "The current direct report belongs to a single provisional PMID family. Identifiers, participants, products and endpoint definitions for the other 1,600 mg/12-week narrative have not been linked; it is not counted as independent replication.", "condition_status": "Partly verified", "status_reason": "Differences between the direct-report question and the background question were recorded, but unique families and the scope of independent replication were not currently verified.", "missingness": "Other trial identifiers/products, participant overlap, question-specific results and the scope of current replication remain unverified.", "uncertainty": "Other trial identifiers/products, participant overlap, question-specific results and the scope of current replication remain unverified.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Identified follow-up/secondary reports, registration, recruitment/site information and results for each defined question." }, { "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.", "current_reports": [ "S01" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "The current original restricts applicability to the stated formulation, route, dose, duration, population, endpoint and comparison, and excludes the other 1,600 mg/12-week narrative from equivalent confirmation.", "condition_status": "Not applicable", "status_reason": "This independent question is limited to 800 mg/day for 15 weeks and makes no claims about effects at other doses/durations or in subgroups. Only that extension obligation does not apply.", "missingness": "The extended effects themselves remain currently unverified. Do not claim that the background trial’s identity or direct comparisons were acquired.", "uncertainty": "The extended effects themselves remain currently unverified. Do not claim that the background trial’s identity or direct comparisons were acquired.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct material for each dose, duration and subgroup with explicit identifiers and question definitions." }, { "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.", "current_reports": [ "S01" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "The reader-answer section states that ultrasound grade is not MRI-PDFF or histology. The advertising section says it cannot be recast as fibrosis reversal, cirrhosis prevention or MRI-measured liver-fat reduction.", "condition_status": "Not applicable", "status_reason": "The current independent question makes no effect claims for other measurements or clinical events, so only that extension obligation does not apply.", "missingness": "Effects on other imaging, histology and clinical events, and long-term applicability, are not established by the current material.", "uncertainty": "Effects on other imaging, histology and clinical events, and long-term applicability, are not established by the current material.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct results and follow-up material for MRI-PDFF/histology or fibrosis, cirrhosis and clinical events." }, { "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.", "current_reports": [ "S01" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "The original safety label and safety details record Caution and checking gastrointestinal discomfort/bleeding risk. Actual harm-event definitions, severity and counts for S01 are not provided in the current summary.", "condition_status": "Unverified", "status_reason": "The existence of the caution was retained, but actual event observations and collection methods in this trial are not verified.", "missingness": "Harm definitions, severity, collection/stopping rules and actual event material remain unverified.", "uncertainty": "Harm definitions, severity, collection/stopping rules and actual event material remain unverified.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Trial harm-event tables, definitions/severity, active/passive collection methods and stopping criteria." }, { "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.", "current_reports": [ "S01" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "The claim conditions record 15 weeks, but there is no record linking the gastrointestinal-discomfort/bleeding cautions to event-specific timing.", "condition_status": "Unverified", "status_reason": "The exposure duration is known, but temporal relationships for actual harm events are not verified in the currently retained material.", "missingness": "Onset, stopping, recovery, re-exposure and event-specific follow-up material remain unverified.", "uncertainty": "Onset, stopping, recovery, re-exposure and event-specific follow-up material remain unverified.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Event-specific administration, onset, stopping/re-exposure, recovery records and follow-up time." }, { "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.", "current_reports": [ "S01" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "The original comparator is matching-appearance placebo, but arm-specific harm results and background risks are not currently recorded.", "condition_status": "Unverified", "status_reason": "The efficacy comparator was specified, but actual between-arm harm comparisons are not verified.", "missingness": "Arm-specific harm events, equivalence of follow-up/collection and background-risk material remain unverified.", "uncertainty": "Arm-specific harm events, equivalence of follow-up/collection and background-risk material remain unverified.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Arm-specific harm results, equal collection, baseline risks and placebo exposure/follow-up material." }, { "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.", "current_reports": [ "S01" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "The retained participant counts are 110 randomized and 98 completed; improvement events are 24/47 versus 8/51. Exposure, affected-person and time denominators for gastrointestinal/bleeding harms are not provided.", "condition_status": "Unverified", "status_reason": "Only efficacy denominators are available; direct denominator/event material for verifying harm frequency is absent.", "missingness": "Arm-specific actual exposure, affected-person/event counts, observation time and collection scope remain unverified.", "uncertainty": "Arm-specific actual exposure, affected-person/event counts, observation time and collection scope remain unverified.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Arm-specific harm-exposure/analysis counts, affected-person/event counts, observation time and collection methods." }, { "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.", "current_reports": [ "S01" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "The original advises checking gastrointestinal/bleeding risk and not replacing liver-disease treatment or lifestyle care. Actual concurrent medications, baseline risks and alternative-cause assessments for events are absent.", "condition_status": "Unverified", "status_reason": "The caution is retained, but baseline/concurrent-treatment material needed to distinguish harm causes or comparisons is not currently verified.", "missingness": "Concurrent medication, baseline risks, simultaneous exposures and alternative-cause assessment of individual events remain unverified.", "uncertainty": "Concurrent medication, baseline risks, simultaneous exposures and alternative-cause assessment of individual events remain unverified.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Baseline risks, concurrent medications/exposures, event assessments and alternative-cause records." }, { "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.", "current_reports": [ "S01" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "The record has 110 randomized and 98 completed, but the currently retained summary provides no harm-related stopping/dropout status, reasons or complete event tables.", "condition_status": "Unverified", "status_reason": "Material linking losses to actual harm collection or selective reporting is unavailable.", "missingness": "Arm-specific dropout/stopping causes, losses to follow-up and completeness of harm reporting against the plan remain unverified.", "uncertainty": "Arm-specific dropout/stopping causes, losses to follow-up and completeness of harm reporting against the plan remain unverified.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Arm-specific stopping/dropout reasons, harm-collection plans, complete event tables and reporting changes." }, { "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.", "current_reports": [ "S01" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "The current safety details are general cautions; no separate actual harm case or regulatory/review report entry is present. Do not multiply S01 and the cautions into new independent harm families.", "condition_status": "Not applicable", "status_reason": "This independent question concerns an efficacy imaging endpoint and makes no repeated harm-signal claim. Only that repetition-claim obligation does not apply; this status does not close missing harm material.", "missingness": "Independent harm cases and the entire scope of repeated signals were not currently verified.", "uncertainty": "Independent harm cases and the entire scope of repeated signals were not currently verified.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Event/report identifiers, exposure, timing, study/case families and recitation links." }, { "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.", "current_reports": [ "S01" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "The retained treatment duration is 15 weeks and the safety label is Caution. Direct results for long-term/rare harms, vulnerable groups and concurrent-treatment interactions are not provided in the current retained summary.", "condition_status": "Unverified", "status_reason": "Actual direct material for the supplementary safety scope is not currently verified. Do not use a duration of 15 weeks as evidence of absence of harm.", "missingness": "Long-term/rare harms, vulnerable-group and concurrent-treatment interaction results, and exposure denominators remain unverified.", "uncertainty": "Long-term/rare harms, vulnerable-group and concurrent-treatment interaction results, and exposure denominators remain unverified.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Harm follow-up by exposure/duration and actual material on vulnerable groups and concurrent-treatment interactions." }, { "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.", "current_reports": [ "S01" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "Retain the original Caution and gastrointestinal/bleeding-risk wording unchanged. Do not derive new harm frequencies, causality or individual safety from S01’s retained imaging-effect values.", "condition_status": "Met", "status_reason": "The current interpretation retains the original cautions and limits conclusions to the material level, without new comparative-harm, causal or safety claims. It does not verify actual absence of harm.", "missingness": "Evidence for actual harm events, comparative risks, causality and individual applicability remains unverified.", "uncertainty": "Evidence for actual harm events, comparative risks, causality and individual applicability remains unverified.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Original material on the relevant harm events, comparators, causal assessments and applicability." } ], "reports": [ { "report_id": "S01", "title": "Therapeutic Effects of Garlic on Hepatic Steatosis in Nonalcoholic Fatty Liver Disease Patients: A Randomized Clinical Trial", "url": "https://pubmed.ncbi.nlm.nih.gov/32753923/", "report_type": "Retained record: a randomized, double-blind, placebo-controlled trial. Actual allocation, concealment and blinding procedures remain unverified.", "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "study_family": "A provisional family linked to the evidence/citation pair for PMID 32753923. Registration, secondary reports, participant overlap and independent replication are not certified.", "independent_replication": "This is a provisional attribution of the retained report. The 1,600 mg/12-week background lacks an identifier and is not counted as direct replication; the full scope of independent replication remains unverified.", "observed_result": "Completers: 24/47 versus 8/51; separately retained ITT RR 3.0, 95% CI 1.5~6.1 and P=.001. The description of the paper’s 5.6 and odds is a historical summary; the original measure was not directly verified in this conversion.", "result_level": "Distinguish 110 randomized and 98 completed from completer events. Original ITT denominators, models, handling of missing data, imaging assessment and preregistration/SAP remain unverified.", "source_evidence_date": "2026-09-08", "materials": [ { "material_type": "External PubMed bibliographic/abstract gateway", "public_status": "Bibliographic link retained; external material unread", "access_status": "External access not attempted; not acquired", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-06", "qualification": "This is the PubMed link in the retained citation. The current response, bibliographic identity, abstract content and public access were not checked. This citation is linked in the retained summary. External abstracts, full texts, registration, protocols and analysis plans were not read in this conversion, and independent clinical validation was not performed. The material check date is the original date retained in the summary and condition records. The original verdict-review date does not establish a search cut-off or historical access dates for individual materials; external access was not attempted in this conversion." }, { "material_type": "Original full text; file and exact location unverified", "public_status": "Full-text file/location unverified; unread", "access_status": "External access not attempted; not acquired", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-06", "qualification": "The report’s full-text file, exact download location and PDF/HTML form were not acquired. Access was not attempted, and it was not read. This citation is linked in the retained summary. External abstracts, full texts, registration, protocols and analysis plans were not read in this conversion, and independent clinical validation was not performed. The material check date is the original date retained in the summary and condition records. The original verdict-review date does not establish a search cut-off or historical access dates for individual materials; external access was not attempted in this conversion." }, { "material_type": "Retained verdict summary", "public_status": "Retained verdict summary read", "access_status": "Retained copy acquired; summary read", "acquired": true, "actually_read": "Stored existing review summary read", "as_of": "2026-10-06", "qualification": "Relevant content in the retained Korean/English summary, evidence and citation was read. This does not establish acquisition or reading of the original clinical paper. This citation is linked in the retained summary. External abstracts, full texts, registration, protocols and analysis plans were not read in this conversion, and independent clinical validation was not performed. The material check date is the original date retained in the summary and condition records. The original verdict-review date does not establish a search cut-off or historical access dates for individual materials; external access was not attempted in this conversion." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/32753923/" } ] } ], "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." }, "study_overlap": { "state": "Unverified", "unique_trial_count": null, "unique_participant_count": null, "reason": "Only the retained evidence/citation pair is linked as an actual report. Registration, secondary reports and participant overlap in its provisional study family remain unverified. Do not add reports from the 1,600 mg/12-week background or reviews absent from the arrays; global unique-study, participant and independent-replication counts remain unverified." }, "history": [ { "date": "2026-10-26", "kind": "Separation of public-facing pages and materials", "view_version": "1.0", "change": "The public view and materials were prepared from the existing 32 items. No new clinical search, verification-state change or scoring was performed." } ], "language": "en", "translation_date": "2026-10-26" }