Garlic-powder tablets 800 mg/day × Improvement of ultrasound steatosis grade in adults with NAFLD

Required evidence, verification status and materials actually read
Item	AVerification status	BReading scope	CReview item	DCurrent findings	EWhy unverified	FRequired materials and conditions	GFurther research
1	Met	Full text not readStored summary read	N01 · Evidence conditionWhich garlic powder, population, duration and ultrasound result does the question concern?Required	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. S01	The question and exclusions were specified from the retained summary. This does not establish a match with the actual trial protocol or product certification.	Trial documents specifying the same population, formulation, administration, comparison and measurement time.	If a new design is discussed, first fix this imaging-endpoint question and separate other formulations and endpoints.
2	Partly verified	Full text not readStored summary read	N02 · Evidence conditionAre reports, study families and background narratives being counted more than once?Required	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. S01	The array attribution of the 1 actual report was checked. Independent families and review overlap across the entire literature were not currently verified.	Trial identifiers in papers, registration and secondary reports, recruitment periods/sites, and material linking participants and endpoints.	In an authorized update, first verify report links by family, remove duplicates and then compare results.
3	Met	Full text not readStored summary read	N03 · Evidence conditionWhich materials were actually read in this work, and which were retained only as links?Required	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. S01	The distinction between actual summary reading and unread external material, and the material identity, were checked. This does not certify clinical full-text verification.	Actual access receipts for each material, original-file identity, bytes, hashes and locations read.	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.
4	Partly verified	Full text not readStored summary read	N04 · Evidence conditionWhich adults with NAFLD were selected, and to whom can the result apply?Required	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. S01	The population label and diagnostic imaging type were checked, but direct information on selection and representativeness is insufficient.	Eligibility tables, recruitment flow, baseline characteristics, diagnostic criteria and comorbidity material.	Directly assess an extension question requiring representativeness in the relevant population and baseline-severity group.
5	Partly verified	Full text not readStored summary read	N05 · Evidence conditionDo the trial garlic powder’s formulation, daily amount and alliin specifications match?Required	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. S01	The stated powder formulation, route, amount and duration were checked, but constituent specifications and actual product identity were not verified.	Trial-product composition, manufacturing/batch, alliin specifications, dosing schedules and adherence records.	If replication with the same product is needed, specify constituent standards and control product differences.
6	Partly verified	Full text not readStored summary read	N06 · Evidence conditionDo placebo appearance and actual concurrent conditions match?Required	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. S01	The named comparison was checked. Equivalence of actual comparison conditions and concurrent-treatment implementation remains unverified.	Placebo ingredients, dosing schedules, concurrent-treatment plans for both arms, and implementation/change records.	In a new comparison, specify placebo and lifestyle-treatment conditions and measure actual implementation and changes.
7	Partly verified	Full text not readStored summary read	N07 · Evidence conditionWhat definition, timing and measurement unit does ultrasound improvement use?Required	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. S01	The stated success threshold and timing were checked, but details of actual imaging grades and assessment rules remain unverified.	Imaging-grade definitions, measurement visits and tables linking baseline and follow-up assessments.	When assessing the same endpoint, prespecify the grading scale, assessment time and success threshold.
8	Partly verified	Full text not readStored summary read	N08 · Evidence conditionAre the denominators and losses for 110 randomized and 98 completed distinguished?Required	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. S01	The different overall randomized/completed denominators were retained, but arm-specific losses and handling information are insufficient.	Arm-specific allocation and follow-up/measurement/analysis flow, dropout reasons and missing-data handling.	In an authorized follow-up check, link the flow diagram and analysis populations and check whether missing-data sensitivity was assessed.
9	Partly verified	Full text not readStored summary read	N09 · Evidence conditionWhich analysis population do the events of 24/47 versus 8/51 belong to?Required	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. S01	The retained completer events and denominators were checked. External original tables and analysis-inclusion rules remain currently unverified.	Arm-specific completer-event tables, analysis-population definitions, and links to improvement assessment and timing.	In a new assessment, report differences between randomized-population and completer estimates transparently.
10	Partly verified	Full text not readStored summary read	N10 · Evidence conditionHow are the retained ITT RR 3.0, interval and P value attributed?Required	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. S01	The existing ITT estimate, interval and P record were checked. Original denominators, models and test definitions were not verified.	ITT denominators/events by arm, estimation models, missing-data handling, CI/test definitions and original result tables.	If reassessment of an existing estimate is authorized, first compare the original analysis population and estimation procedures.
11	Partly verified	Full text not readStored summary read	N11 · Evidence conditionAre the paper’s 5.6 labeling issue and the ITT risk ratio kept separate?Required	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. S01	The existing labeling-issue record and separation principle were checked. The original paper’s measure definition remains currently unread directly.	The paper’s original tables, effect-measure definitions, statistical methods and analysis population for the estimate.	If a measure correction is separately authorized, handle it as an event comparing original tables and methods, while preserving the old record.
12	Partly verified	Full text not readStored summary read	N12 · Evidence conditionHow are opposing/null results and signals at another dose retained?Required	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. S01	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.	All reports with the same formulation, population, endpoint and time; identified comparative results and explanations of missing results.	In an authorized literature update, review material for the same question together regardless of direction or statistical significance.
13	Met	Full text not readStored summary read	N13 · Evidence conditionWhat are the retained verdict date, corrections and scope of this check?Required	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. S01	The retained dates and actual reading/prohibited scope of this work were recorded separately. This does not certify completeness of all current evidence.	The original verdict and correction history, current-input identity, and receipts for actual reading/search scope.	When updating material, separate the search event from condition-version changes and preserve the entire original before changes.
14	Partly verified	Full text not readStored summary read	N14 · Evidence conditionWhat is known about academic funding, conflict-of-interest reporting and independence?Supplementary; required for independence claims	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. S01	The summary’s funding/COI report was checked. Direct review of product provision, author relationships and family-level independence remains outstanding.	Original paper sections on funding, product provision, author affiliations and COI, plus study-family linkage material.	When discussing independent replication, check institutions, authors, product support and participant overlap separately.
15	Partly verified	Full text not readStored summary read	N15 · Evidence conditionWhat allocation process lies behind the randomized, double-blind label?Required	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. S01	The trial-design label was checked, but actual allocation/concealment procedures remain unverified.	Allocation methods, concealment procedures, baseline-characteristic tables and blinding-implementation material.	In a replication comparison design, specify allocation/concealment procedures and assess bias for each result.
16	Unverified	Full text not readStored summary read	N16 · Evidence conditionHow might lifestyle advice, weight changes, adherence and deviations affect results?Required	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. S01	Actual implementation material separating the intervention of interest from concurrent treatment/deviations is not verified in the current retained summary.	Concurrent/lifestyle-treatment implementation, weight/medication changes, trial-product adherence and deviation records.	When studying intervention attribution, record concurrent treatment and actual exposure together and analyze them in line with the planned effect of interest.
17	Unverified	Full text not readStored summary read	N17 · Evidence conditionAre ultrasound-reader blinding, reproducibility and assessment error verified?Required	The retained evidence records a double-blind trial and ultrasound-grade results but provides no information on readers, blinding procedures, agreement or repeated measurements. S01	Direct procedures for verifying imaging assessment and measurement error in this question are absent from the current retained summary.	Ultrasound acquisition/grading procedures, reader blinding and reproducibility/agreement material.	When assessing ultrasound improvement, mask reader and timepoint information separately and check reproducibility under prespecified rules.
18	Partly verified	Full text not readStored summary read	N18 · Evidence conditionWhich effects of interest and missing-data handling do ITT and completer analyses address?Required	The retained material distinguishes completer events from ITT RR but does not describe models, adjustments, handling of missing data or analysis-population selection criteria. S01	Different analysis labels and retained results are known, but links to effects of interest, models and missing-data handling remain unverified.	Original statistical methods, analysis-population definitions, ITT missing-data handling and sensitivity analyses/SAP.	In an authorized check, trace models and effects of interest for event counts and summary estimates separately.
19	Partly verified	Full text not readStored summary read	N19 · Evidence conditionHow are the ITT interval and clinical importance distinguished?Required	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. S01	Retention of the reported interval was checked. Evidence is insufficient to establish clinical-benefit magnitude or adequate precision from it.	Original CI-estimation methods, thresholds for meaningful imaging improvement and material on clinical significance.	If better precision is needed, first specify the desired effect range, importance threshold and missing-data/measurement uncertainty.
20	Unverified	Full text not readStored summary read	N20 · Evidence conditionWere the endpoint, 15-week timepoint and analysis prespecified?Required	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. S01	Original documents needed to compare planned and reported results remain currently unverified and unread.	Trial-preregistration identifiers/versions, protocols, SAP, reasons for changes and actual result reports.	In an update where material is acquired, compare plans with reports for each result and record correction events.
21	Partly verified	Full text not readStored summary read	N21 · Evidence conditionAre independent replication for the same question and study families at other doses verified?Required	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. S01	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.	Identified follow-up/secondary reports, registration, recruitment/site information and results for each defined question.	When assessing independent replication, link trials of the same product/question separately from trials of other doses/durations.
22	Not applicable	Full text not readStored summary read	N22 · Evidence conditionCan results be extended to other doses, durations, formulations or subgroups?Supplementary; required for dose, persistence or subgroup extensions	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. S01	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.	Direct material for each dose, duration and subgroup with explicit identifiers and question definitions.	If an extension is needed, define a separate question and design direct comparisons or continued follow-up.
23	Not applicable	Full text not readStored summary read	N23 · Evidence conditionDoes imaging-grade improvement answer questions about MRI, histology or clinical liver-disease prevention?Supplementary; required for other-measurement or clinical-event extensions	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. S01	The current independent question makes no effect claims for other measurements or clinical events, so only that extension obligation does not apply.	Direct results and follow-up material for MRI-PDFF/histology or fibrosis, cirrhosis and clinical events.	If a claim about another endpoint is needed, define an independent question and measure that endpoint directly.
24	Unverified	Full text not readStored summary read	N24 · Evidence conditionWhat actual harm-event material supports the gastrointestinal-discomfort and bleeding cautions?Supplementary; required for harm or safety claims	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. S01	The existence of the caution was retained, but actual event observations and collection methods in this trial are not verified.	Trial harm-event tables, definitions/severity, active/passive collection methods and stopping criteria.	If a harm question is needed, design separate event collection for the same powder, exposure and NAFLD population.
25	Unverified	Full text not readStored summary read	N25 · Evidence conditionAre the exposure, onset, stopping and recovery times of harm events known?Supplementary; required for harm-causality or timing claims	The claim conditions record 15 weeks, but there is no record linking the gastrointestinal-discomfort/bleeding cautions to event-specific timing. S01	The exposure duration is known, but temporal relationships for actual harm events are not verified in the currently retained material.	Event-specific administration, onset, stopping/re-exposure, recovery records and follow-up time.	In harm research assessing temporal relationships, record actual exposure and event times.
26	Unverified	Full text not readStored summary read	N26 · Evidence conditionWhich placebo and background risks were used for harm comparisons?Supplementary; required for comparative-harm claims	The original comparator is matching-appearance placebo, but arm-specific harm results and background risks are not currently recorded. S01	The efficacy comparator was specified, but actual between-arm harm comparisons are not verified.	Arm-specific harm results, equal collection, baseline risks and placebo exposure/follow-up material.	For harm comparisons, include equal collection/follow-up in both arms and checks of baseline risk.
27	Unverified	Full text not readStored summary read	N27 · Evidence conditionAre exposure, event and time denominators available for harm-frequency claims?Supplementary; required for harm-frequency claims	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. S01	Only efficacy denominators are available; direct denominator/event material for verifying harm frequency is absent.	Arm-specific harm-exposure/analysis counts, affected-person/event counts, observation time and collection methods.	In harm research, report exposure/follow-up denominators separately from efficacy completers.
28	Unverified	Full text not readStored summary read	N28 · Evidence conditionWhat alternative causes and concurrent exposures, including liver disease and medications, affect harms?Supplementary; required for causal or comparative harms	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. S01	The caution is retained, but baseline/concurrent-treatment material needed to distinguish harm causes or comparisons is not currently verified.	Baseline risks, concurrent medications/exposures, event assessments and alternative-cause records.	For a harm question, record baseline liver disease and concurrent factors, retaining uncertainty about causal contribution.
29	Unverified	Full text not readStored summary read	N29 · Evidence conditionCan stopping/dropout and selective harm reporting be distinguished?Supplementary; required for safety or complete harm-reporting claims	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. S01	Material linking losses to actual harm collection or selective reporting is unavailable.	Arm-specific stopping/dropout reasons, harm-collection plans, complete event tables and reporting changes.	In follow-up harm assessment, track dropout and harm collection together and specify the scope of nonreporting.
30	Not applicable	Full text not readStored summary read	N30 · Evidence conditionIs the original caution being counted as an independently repeated harm signal?Supplementary; required for repeated harm-signal claims	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. S01	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.	Event/report identifiers, exposure, timing, study/case families and recitation links.	If repeated signals become a separate question, create individual family links and then assess whether records are independent.
31	Unverified	Full text not readStored summary read	N31 · Evidence conditionAre long-term/rare harms and vulnerable-group/interactions beyond 15 weeks known?Supplementary; required for safety-scope extensions	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. S01	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.	Harm follow-up by exposure/duration and actual material on vulnerable groups and concurrent-treatment interactions.	If a safety question in this scope is needed, follow actual exposure and events over the long term in a separately defined population.
32	Met	Full text not readStored summary read	N32 · Evidence conditionWhat separates general cautions, comparative harms, causality and individual safety?Supplementary; required for harm or safety interpretation	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. S01	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.	Original material on the relevant harm events, comparators, causal assessments and applicability.	Define a separate harm question and set the conclusion level appropriate to its design, population, exposure and collection.

No items match your search or filter.

32 itemsWhat the statuses mean

Assessment scope

Stored-material review date: 2026-10-06
Original evidence cut-off: 2026-09-08
Scope actually checked: Retained Korean/English summaries and case-specific condition/application records. Full papers, supplements, registrations, plans and original data were not read.
What the dates mean: 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.
Population: Adults diagnosed with NAFLD by ultrasound. Detailed eligibility, baseline severity, concurrent treatment and representativeness remain unverified.
Ingredient, formulation and route: 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.
Comparator: Matching-appearance placebo. Actual placebo ingredients, lifestyle advice, concurrent medication and equivalence of adherence and implementation between arms remain unverified.
Measured outcome: 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.
Duration: 15-week treatment and assessment. Actual visit schedules, persistence after stopping and long-term clinical outcomes remain unverified.
Questions outside this scope: 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.

Evidence and sources

The links below lead to the sources. A link alone does not mean the original source was read or its latest publication status verified.

S01 · Therapeutic Effects of Garlic on Hepatic Steatosis in Nonalcoholic Fatty Liver Disease Patients: A Randomized Clinical Trial

PubMed

Material type: Retained record: a randomized, double-blind, placebo-controlled trial. Actual allocation, concealment and blinding procedures remain unverified.
Materials actually 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.
Findings recorded in the stored summary: 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.
Record 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.
Study overlap and independent replication: 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.

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
External PubMed bibliographic/abstract gateway	Bibliographic link retained; external material unread	External access not attempted; not acquired	Not read	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.
Original full text; file and exact location unverified	Full-text file/location unverified; unread	External access not attempted; not acquired	Not read	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.
Retained verdict summary	Retained verdict summary read	Retained copy acquired; summary read	Stored existing review summary read	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.

Report counts versus independent study counts

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.

Review criteria

Version 1.0 · Criteria record date 2026-10-06. These are Chamgap's own application conditions, informed by the referenced methods. They do not constitute official assessment-tool certification or a new efficacy score.

N01 · Which garlic powder, population, duration and ultrasound result does the question concern?

Required materials and conditions: Trial documents specifying the same population, formulation, administration, comparison and measurement time.
Conditions for verification: 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.
Requirement and applicability: Required
Application exceptions: ALT, AST, weight, MRI-PDFF, histology, fibrosis, cirrhosis and other garlic formulations are not automatically included in this independent question.
Why this condition is needed: Changing the identity of the intervention-effect question can combine different results as the same effect.
Referenced methods: 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.

N02 · Are reports, study families and background narratives being counted more than once?

Required materials and conditions: Trial identifiers in papers, registration and secondary reports, recruitment periods/sites, and material linking participants and endpoints.
Conditions for verification: 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.
Requirement and applicability: Required
Application exceptions: Retain unverified family identity, independent-trial counts and unique-participant counts as null. Do not create S02 from background alone.
Why this condition is needed: Multiple reports from a single trial and background mentions are not independent replications.
Referenced methods: 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.

N03 · Which materials were actually read in this work, and which were retained only as links?

Required materials and conditions: Actual access receipts for each material, original-file identity, bytes, hashes and locations read.
Conditions for verification: 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.
Requirement and applicability: Required
Application exceptions: 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.
Why this condition is needed: A summary-reading link or PMID does not prove that the original paper was read in this work.
Referenced methods: 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.

N04 · Which adults with NAFLD were selected, and to whom can the result apply?

Required materials and conditions: Eligibility tables, recruitment flow, baseline characteristics, diagnostic criteria and comorbidity material.
Conditions for verification: Link ultrasound diagnosis, inclusion/exclusion criteria, baseline steatosis grade, hepatic/metabolic status and recruitment setting to the actual trial population.
Requirement and applicability: Required
Application exceptions: Do not infer missing eligibility details or extend the result to pregnancy, children or advanced liver disease.
Why this condition is needed: The label adults with NAFLD does not make the result applicable to all liver diseases, severity levels or age groups.
Referenced methods: 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.

N05 · Do the trial garlic powder’s formulation, daily amount and alliin specifications match?

Required materials and conditions: Trial-product composition, manufacturing/batch, alliin specifications, dosing schedules and adherence records.
Conditions for verification: 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.
Requirement and applicability: Required
Application exceptions: 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.
Why this condition is needed: Even the same daily powder amount does not guarantee the same exposure when ingredients, active constituents or manufacturing differ.
Referenced methods: 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.

N06 · Do placebo appearance and actual concurrent conditions match?

Required materials and conditions: Placebo ingredients, dosing schedules, concurrent-treatment plans for both arms, and implementation/change records.
Conditions for verification: 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.
Requirement and applicability: Required
Application exceptions: Do not infer equal ingredients, lifestyle advice or adherence from the record of matching appearance.
Why this condition is needed: Differences in liver-disease lifestyle treatment or comparator products affect intervention attribution and blinding.
Referenced methods: 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.

N07 · What definition, timing and measurement unit does ultrasound improvement use?

Required materials and conditions: Imaging-grade definitions, measurement visits and tables linking baseline and follow-up assessments.
Conditions for verification: 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.
Requirement and applicability: Required
Application exceptions: The retained primary-endpoint label does not certify the endpoint hierarchy in actual preregistration.
Why this condition is needed: Imaging-grade change, continuous liver-fat quantity and liver enzymes have different measurement units and meanings.
Referenced methods: 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.

N08 · Are the denominators and losses for 110 randomized and 98 completed distinguished?

Required materials and conditions: Arm-specific allocation and follow-up/measurement/analysis flow, dropout reasons and missing-data handling.
Conditions for verification: Distinguish randomized, completed, measured and analyzed counts by arm and time. Record exclusion/dropout reasons, handling of missing data and possible result bias.
Requirement and applicability: Required
Application exceptions: Quote 110 and 98 unchanged. Do not calculate or fill arm-specific allocation counts, loss counts or percentages.
Why this condition is needed: Completer results do not automatically represent everyone randomized.
Referenced methods: 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.

N09 · Which analysis population do the events of 24/47 versus 8/51 belong to?

Required materials and conditions: Arm-specific completer-event tables, analysis-population definitions, and links to improvement assessment and timing.
Conditions for verification: Pair completer-improvement events with arm-specific completer denominators. Distinguish these from ITT events/denominators or results for everyone randomized.
Requirement and applicability: Required
Application exceptions: 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.
Why this condition is needed: Changing the analysis population from event counts alone changes the attribution of the effect estimate.
Referenced methods: 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.

N10 · How are the retained ITT RR 3.0, interval and P value attributed?

Required materials and conditions: ITT denominators/events by arm, estimation models, missing-data handling, CI/test definitions and original result tables.
Conditions for verification: 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.
Requirement and applicability: Required
Application exceptions: These are quotations of existing numbers, not calculations or original-model verification in this conversion. Do not invent ITT events or intervals.
Why this condition is needed: ITT results and completer values within the same report can represent different analysis questions.
Referenced methods: 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.

N11 · Are the paper’s 5.6 labeling issue and the ITT risk ratio kept separate?

Required materials and conditions: The paper’s original tables, effect-measure definitions, statistical methods and analysis population for the estimate.
Conditions for verification: 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.
Requirement and applicability: Required
Application exceptions: 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.
Why this condition is needed: Confusing effect-measure names can use the same number to claim a different effect size.
Referenced methods: 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.

N12 · How are opposing/null results and signals at another dose retained?

Required materials and conditions: All reports with the same formulation, population, endpoint and time; identified comparative results and explanations of missing results.
Conditions for verification: Do not omit opposing/null reports on the same question. Distinguish signals at different doses/durations from conflict or confirmation within this question.
Requirement and applicability: Required
Application exceptions: Imaging signals at different doses/durations are not themselves conflicting data. Do not turn unread material into an effect of 0.
Why this condition is needed: A positive summary alone cannot establish the overall direction of evidence or absence of opposing results.
Referenced methods: 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.

N13 · What are the retained verdict date, corrections and scope of this check?

Required materials and conditions: The original verdict and correction history, current-input identity, and receipts for actual reading/search scope.
Conditions for verification: 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.
Requirement and applicability: Required
Application exceptions: Preserve original C/54, Caution, all axes, generic English wording, corrections, native types and empty values. Do not create new scores or verdicts.
Why this condition is needed: A historical review date or grading axis does not replace a current literature search or fulfillment of individual conditions.
Referenced methods: 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.

N14 · What is known about academic funding, conflict-of-interest reporting and independence?

Required materials and conditions: Original paper sections on funding, product provision, author affiliations and COI, plus study-family linkage material.
Conditions for verification: Separate funding, product provision, author relationships and conflict disclosures. Link study families and independence claims to actual material.
Requirement and applicability: Supplementary; required for independence claims
Application exceptions: Existing I2 is a historical value. Do not fill unverified product support as no support or exclude a report solely because of COI.
Why this condition is needed: A brief academic-institution or no-COI record cannot establish all support arrangements or independent replication.
Referenced methods: 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.

N15 · What allocation process lies behind the randomized, double-blind label?

Required materials and conditions: Allocation methods, concealment procedures, baseline-characteristic tables and blinding-implementation material.
Conditions for verification: Check sequence generation, allocation concealment, baseline balance and actual blinding targets/procedures for each result.
Requirement and applicability: Required
Application exceptions: Do not automatically turn original B1 or double-blind wording into fulfillment of detailed bias conditions.
Why this condition is needed: The RCT label alone does not establish adequate allocation and concealment.
Referenced methods: 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.

N16 · How might lifestyle advice, weight changes, adherence and deviations affect results?

Required materials and conditions: Concurrent/lifestyle-treatment implementation, weight/medication changes, trial-product adherence and deviation records.
Conditions for verification: 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.
Requirement and applicability: Required
Application exceptions: Weight, ALT and AST changes are separate endpoints. Do not turn them into surrogate confirmation of ultrasound improvement or a new independent unit.
Why this condition is needed: The 15-week result requires distinguishing actual powder exposure from concurrent-treatment/deviation effects.
Referenced methods: 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.

N17 · Are ultrasound-reader blinding, reproducibility and assessment error verified?

Required materials and conditions: Ultrasound acquisition/grading procedures, reader blinding and reproducibility/agreement material.
Conditions for verification: Check consistent imaging measurement, reader blinding, training/agreement, baseline/follow-up reading rules and measurement error.
Requirement and applicability: Required
Application exceptions: A double-blind design label differs from verified imaging-reader blinding and reproducibility.
Why this condition is needed: Grade changes can also be affected by differences in reading and measurement.
Referenced methods: 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.

N18 · Which effects of interest and missing-data handling do ITT and completer analyses address?

Required materials and conditions: Original statistical methods, analysis-population definitions, ITT missing-data handling and sensitivity analyses/SAP.
Conditions for verification: Distinguish assignment effects from actual-adherence/completion effects. Link analysis populations, missing-data handling, models/adjustments and between-arm comparisons to each result.
Requirement and applicability: Required
Application exceptions: Do not automatically relabel completers as PP or merge them as the same estimate or original event counts.
Why this condition is needed: The ITT label alone cannot establish missing-data handling or the effect of interest.
Referenced methods: 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.

N19 · How are the ITT interval and clinical importance distinguished?

Required materials and conditions: Original CI-estimation methods, thresholds for meaningful imaging improvement and material on clinical significance.
Conditions for verification: Link the reported CI to the relevant effect measure. Distinguish the clinical importance/limits of ultrasound improvement of 1 grade from direct evidence.
Requirement and applicability: Required
Application exceptions: 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.
Why this condition is needed: Significance, sample size and a historical grade are not sufficient conditions for clinical importance and precision.
Referenced methods: 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.

N20 · Were the endpoint, 15-week timepoint and analysis prespecified?

Required materials and conditions: Trial-preregistration identifiers/versions, protocols, SAP, reasons for changes and actual result reports.
Conditions for verification: Compare original registration/protocol/SAP versions and dates with changes to reported endpoints, timepoints and analyses.
Requirement and applicability: Required
Application exceptions: An unable-to-verify registration field is not evidence of nonregistration. Do not mark unread preregistration/SAP as not applicable.
Why this condition is needed: The retained claim-condition primary-endpoint label or false axis values alone cannot certify actual prespecification or absence of selective reporting.
Referenced methods: 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.

N21 · Are independent replication for the same question and study families at other doses verified?

Required materials and conditions: Identified follow-up/secondary reports, registration, recruitment/site information and results for each defined question.
Conditions for verification: Compare unique study families and formulation, population, endpoint and analysis definitions to distinguish replication from heterogeneity.
Requirement and applicability: Required
Application exceptions: Do not declare all families to be a single confirmed family or close heterogeneity as not applicable merely because there is 1 current report.
Why this condition is needed: A historical R1 value or background imaging signal does not certify independent replication of the same question.
Referenced methods: 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.

N22 · Can results be extended to other doses, durations, formulations or subgroups?

Required materials and conditions: Direct material for each dose, duration and subgroup with explicit identifiers and question definitions.
Conditions for verification: For an extension claim, acquire direct comparisons for the same product/population and relevant doses, durations and subgroups, and record differences.
Requirement and applicability: Supplementary; required for dose, persistence or subgroup extensions
Application exceptions: Do not generate same-formulation confirmation, dose response or a new report from the 1,600 mg/12-week background alone.
Why this condition is needed: Distinguish evidence obligations for the narrow 800 mg/day, 15-week question from extension questions.
Referenced methods: 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.

N23 · Does imaging-grade improvement answer questions about MRI, histology or clinical liver-disease prevention?

Required materials and conditions: Direct results and follow-up material for MRI-PDFF/histology or fibrosis, cirrhosis and clinical events.
Conditions for verification: When extending to clinical events or another measurement, require direct evidence for that endpoint and distinguish it from imaging grade.
Requirement and applicability: Supplementary; required for other-measurement or clinical-event extensions
Application exceptions: Do not impose MRI, histology or long-term-event trials as mandatory efficacy conditions for this narrow imaging question.
Why this condition is needed: Ultrasound grade does not automatically represent direct liver-fat quantification, histology or clinical events.
Referenced methods: 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.

N24 · What actual harm-event material supports the gastrointestinal-discomfort and bleeding cautions?

Required materials and conditions: Trial harm-event tables, definitions/severity, active/passive collection methods and stopping criteria.
Conditions for verification: For a harm claim, link event definitions, severity, collection methods and stopping criteria to actual observations in the same population/exposure.
Requirement and applicability: Supplementary; required for harm or safety claims
Application exceptions: General caution wording is not a record that the event was observed in the trial or evidence of no events.
Why this condition is needed: Retain the original caution without confusing efficacy events with actual harm observations.
Referenced methods: 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.

N25 · Are the exposure, onset, stopping and recovery times of harm events known?

Required materials and conditions: Event-specific administration, onset, stopping/re-exposure, recovery records and follow-up time.
Conditions for verification: For harm-causality/timing claims, link actual administration, onset, stopping, recovery and re-exposure times for each event.
Requirement and applicability: Supplementary; required for harm-causality or timing claims
Application exceptions: Do not infer harm onset, resolution or causality from the 15-week treatment duration alone.
Why this condition is needed: Efficacy-trial duration differs from the temporal relationship of an individual event.
Referenced methods: 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.

N26 · Which placebo and background risks were used for harm comparisons?

Required materials and conditions: Arm-specific harm results, equal collection, baseline risks and placebo exposure/follow-up material.
Conditions for verification: For comparative-harm claims, link comparators with the same population and exposure/follow-up to arm-specific collection and background risks.
Requirement and applicability: Supplementary; required for comparative-harm claims
Application exceptions: Do not calculate between-arm bleeding or gastrointestinal-harm risks from the efficacy question’s matching-appearance placebo alone.
Why this condition is needed: The existence of a placebo efficacy comparison does not guarantee the existence of harm-comparison material.
Referenced methods: 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.

N27 · Are exposure, event and time denominators available for harm-frequency claims?

Required materials and conditions: Arm-specific harm-exposure/analysis counts, affected-person/event counts, observation time and collection methods.
Conditions for verification: For harm-frequency claims, distinguish actually exposed people, affected people, repeated events, follow-up time and collection scope.
Requirement and applicability: Supplementary; required for harm-frequency claims
Application exceptions: Do not convert efficacy results of 24/47 versus 8/51 or trial participant counts into harm incidence.
Why this condition is needed: The 110 randomized, 98 completed and ultrasound-event counts are not harm denominators or numerators.
Referenced methods: 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.

N28 · What alternative causes and concurrent exposures, including liver disease and medications, affect harms?

Required materials and conditions: Baseline risks, concurrent medications/exposures, event assessments and alternative-cause records.
Conditions for verification: For causal or comparative harm claims, distinguish baseline disease, bleeding risk, concurrent medications/exposures and alternative causes.
Requirement and applicability: Supplementary; required for causal or comparative harms
Application exceptions: Do not fill unrecorded medications or causes as absent, or assess individual risk from the original caution alone.
Why this condition is needed: Alternative factors must be known before attributing a caution in the NAFLD population to harm from a particular cause.
Referenced methods: 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.

N29 · Can stopping/dropout and selective harm reporting be distinguished?

Required materials and conditions: Arm-specific stopping/dropout reasons, harm-collection plans, complete event tables and reporting changes.
Conditions for verification: For harm conclusions, compare stopping/dropout reasons, follow-up losses, collection scope and whether all harm results were reported.
Requirement and applicability: Supplementary; required for safety or complete harm-reporting claims
Application exceptions: Do not extend absence of a harm table in the current retained summary to nonreporting throughout the paper or absence of events.
Why this condition is needed: Completion counts and cautions alone cannot establish stopping causes or completeness of harm results.
Referenced methods: 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.

N30 · Is the original caution being counted as an independently repeated harm signal?

Required materials and conditions: Event/report identifiers, exposure, timing, study/case families and recitation links.
Conditions for verification: For repeated harm-signal claims, identify recitations/report families of the same event and independent events/studies.
Requirement and applicability: Supplementary; required for repeated harm-signal claims
Application exceptions: 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.
Why this condition is needed: Recitation of a caution must be distinguished from repetition of independent events.
Referenced methods: 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.

N31 · Are long-term/rare harms and vulnerable-group/interactions beyond 15 weeks known?

Required materials and conditions: Harm follow-up by exposure/duration and actual material on vulnerable groups and concurrent-treatment interactions.
Conditions for verification: For long-term/rare-harm, vulnerable-group or interaction-safety claims, require direct harm material for the relevant exposure, population and duration.
Requirement and applicability: Supplementary; required for safety-scope extensions
Application exceptions: Do not impose long-term safety research as mandatory for the current imaging-efficacy question or create individual intake advice.
Why this condition is needed: A 15-week efficacy result cannot certify long-term/rare-event or vulnerable-group safety.
Referenced methods: 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.

N32 · What separates general cautions, comparative harms, causality and individual safety?

Required materials and conditions: Original material on the relevant harm events, comparators, causal assessments and applicability.
Conditions for verification: Distinguish general cautions, observed signals, comparative risks and causality by the actual material level. Do not generate unverified harm values or safety certification.
Requirement and applicability: Supplementary; required for harm or safety interpretation
Application exceptions: C/54 and Caution are historical values, not a new grade, safety verdict or individual intake recommendation in this conversion.
Why this condition is needed: Retain the original cautions without presenting positive efficacy values as proof of absence of harm or individual safety.
Referenced methods: 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.

Referenced methods and the sections actually reviewed

M03 · Cochrane Handbook 6.5 (2024), chapter updated 2023-08

Official methodology · §3.1, §3.2.1–3.2.3, MECIR C5/C7/C13

Referenced principle: Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.
Extent of review: Retained method-application records were reused. External originals were not reread and method content was not reassessed.

M04 · Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03

Official methodology · §4.5, §4.6.1–4.6.3, MECIR C42

Referenced principle: Distinguish studies from reports and link them; do not omit a study solely because results are unreported.
Extent of review: Retained method-application records were reused. External originals were not reread and method content was not reassessed.

M08 · Cochrane Handbook 6.5 (2024), chapter updated 2019-10

Official methodology · §8.1–8.2.3, Table 8.2.a

Referenced principle: Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.
Extent of review: Retained method-application records were reused. External originals were not reread and method content was not reassessed.

M15 · Cochrane Handbook 6.5 (2024), chapter updated 2023-08

Official methodology · §15.2.4, §15.3.1–15.3.3

Referenced principle: Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.
Extent of review: Retained method-application records were reused. External originals were not reread and method content was not reassessed.

M19 · Cochrane Handbook 6.5 (2024), chapter updated 2019-10

Official methodology · §19.1.2, §19.2.1–19.2.4

Referenced principle: Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.
Extent of review: Retained method-application records were reused. External originals were not reread and method content was not reassessed.

What the statuses mean

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.

Change history

2026-10-26 · Public page/material version 1.0

The public view and materials were prepared from the existing 32 items. No new clinical search, verification-state change or scoring was performed.

The stored-material review date (2026-10-06) and original evidence cut-off (2026-09-08) were retained unchanged.

Researcher downloads

These materials provide the same evidence, scope and verification status as this page.

View all item details

N01 · Which garlic powder, population, duration and ultrasound result does the question concern?

Current findings: 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.
Verification status: Met
Materials actually 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.
Why unverified: The question and exclusions were specified from the retained summary. This does not establish a match with the actual trial protocol or product certification.
Reason for missing information: Current direct verification of the original protocol and product details remains in separate conditions.
Required materials and conditions: Trial documents specifying the same population, formulation, administration, comparison and measurement time.
Materials to obtain first: Trial documents specifying the same population, formulation, administration, comparison and measurement time.
Further research: If a new design is discussed, first fix this imaging-endpoint question and separate other formulations and endpoints.
Remaining uncertainty: Current direct verification of the original protocol and product details remains in separate conditions.
Conditions for verification: 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.
Why this condition is needed: Changing the identity of the intervention-effect question can combine different results as the same effect.
Application exceptions: ALT, AST, weight, MRI-PDFF, histology, fibrosis, cirrhosis and other garlic formulations are not automatically included in this independent question.
Referenced methods: 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.

Related sources S01

N02 · Are reports, study families and background narratives being counted more than once?

Current findings: 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.
Verification status: Partly verified
Materials actually 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.
Why unverified: The array attribution of the 1 actual report was checked. Independent families and review overlap across the entire literature were not currently verified.
Reason for missing information: Registration identifiers and family-comparison documents remain unverified. Reports or reviews absent from the arrays are not declared nonexistent.
Required materials and conditions: Trial identifiers in papers, registration and secondary reports, recruitment periods/sites, and material linking participants and endpoints.
Materials to obtain first: Trial identifiers in papers, registration and secondary reports, recruitment periods/sites, and material linking participants and endpoints.
Further research: In an authorized update, first verify report links by family, remove duplicates and then compare results.
Remaining uncertainty: Registration identifiers and family-comparison documents remain unverified. Reports or reviews absent from the arrays are not declared nonexistent.
Conditions for verification: 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.
Why this condition is needed: Multiple reports from a single trial and background mentions are not independent replications.
Application exceptions: Retain unverified family identity, independent-trial counts and unique-participant counts as null. Do not create S02 from background alone.
Referenced methods: 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.

Related sources S01

N03 · Which materials were actually read in this work, and which were retained only as links?

Current findings: 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.
Verification status: Met
Materials actually 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.
Why unverified: The distinction between actual summary reading and unread external material, and the material identity, were checked. This does not certify clinical full-text verification.
Reason for missing information: Current access and reading of external responses, bibliographic identity, full-text files and registration documents have not been verified.
Required materials and conditions: Actual access receipts for each material, original-file identity, bytes, hashes and locations read.
Materials to obtain first: Actual access receipts for each material, original-file identity, bytes, hashes and locations read.
Further 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.
Remaining uncertainty: Current access and reading of external responses, bibliographic identity, full-text files and registration documents have not been verified.
Conditions for verification: 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.
Why this condition is needed: A summary-reading link or PMID does not prove that the original paper was read in this work.
Application exceptions: 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.
Referenced methods: 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.

Related sources S01

N04 · Which adults with NAFLD were selected, and to whom can the result apply?

Current findings: 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.
Verification status: Partly verified
Materials actually 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.
Why unverified: The population label and diagnostic imaging type were checked, but direct information on selection and representativeness is insufficient.
Reason for missing information: Diagnostic assessment criteria, baseline severity, concurrent treatment, recruitment setting and population distribution remain unverified.
Required materials and conditions: Eligibility tables, recruitment flow, baseline characteristics, diagnostic criteria and comorbidity material.
Materials to obtain first: Eligibility tables, recruitment flow, baseline characteristics, diagnostic criteria and comorbidity material.
Further research: Directly assess an extension question requiring representativeness in the relevant population and baseline-severity group.
Remaining uncertainty: Diagnostic assessment criteria, baseline severity, concurrent treatment, recruitment setting and population distribution remain unverified.
Conditions for verification: Link ultrasound diagnosis, inclusion/exclusion criteria, baseline steatosis grade, hepatic/metabolic status and recruitment setting to the actual trial population.
Why this condition is needed: The label adults with NAFLD does not make the result applicable to all liver diseases, severity levels or age groups.
Application exceptions: Do not infer missing eligibility details or extend the result to pregnancy, children or advanced liver disease.
Referenced methods: 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.

Related sources S01

N05 · Do the trial garlic powder’s formulation, daily amount and alliin specifications match?

Current findings: 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.
Verification status: Partly verified
Materials actually 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.
Why unverified: The stated powder formulation, route, amount and duration were checked, but constituent specifications and actual product identity were not verified.
Reason for missing information: Alliin content, product/batch details and adherence remain currently unverified.
Required materials and conditions: Trial-product composition, manufacturing/batch, alliin specifications, dosing schedules and adherence records.
Materials to obtain first: Trial-product composition, manufacturing/batch, alliin specifications, dosing schedules and adherence records.
Further research: If replication with the same product is needed, specify constituent standards and control product differences.
Remaining uncertainty: Alliin content, product/batch details and adherence remain currently unverified.
Conditions for verification: 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.
Why this condition is needed: Even the same daily powder amount does not guarantee the same exposure when ingredients, active constituents or manufacturing differ.
Application exceptions: 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.
Referenced methods: 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.

Related sources S01

N06 · Do placebo appearance and actual concurrent conditions match?

Current findings: 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.
Verification status: Partly verified
Materials actually 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.
Why unverified: The named comparison was checked. Equivalence of actual comparison conditions and concurrent-treatment implementation remains unverified.
Reason for missing information: Placebo ingredients, concurrent medication, lifestyle advice and implementation differences remain unverified.
Required materials and conditions: Placebo ingredients, dosing schedules, concurrent-treatment plans for both arms, and implementation/change records.
Materials to obtain first: Placebo ingredients, dosing schedules, concurrent-treatment plans for both arms, and implementation/change records.
Further research: In a new comparison, specify placebo and lifestyle-treatment conditions and measure actual implementation and changes.
Remaining uncertainty: Placebo ingredients, concurrent medication, lifestyle advice and implementation differences remain unverified.
Conditions for verification: 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.
Why this condition is needed: Differences in liver-disease lifestyle treatment or comparator products affect intervention attribution and blinding.
Application exceptions: Do not infer equal ingredients, lifestyle advice or adherence from the record of matching appearance.
Referenced methods: 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.

Related sources S01

N07 · What definition, timing and measurement unit does ultrasound improvement use?

Current findings: 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.
Verification status: Partly verified
Materials actually 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.
Why unverified: The stated success threshold and timing were checked, but details of actual imaging grades and assessment rules remain unverified.
Reason for missing information: The grading system, baseline/follow-up linkage and detailed visit timing remain unverified.
Required materials and conditions: Imaging-grade definitions, measurement visits and tables linking baseline and follow-up assessments.
Materials to obtain first: Imaging-grade definitions, measurement visits and tables linking baseline and follow-up assessments.
Further research: When assessing the same endpoint, prespecify the grading scale, assessment time and success threshold.
Remaining uncertainty: The grading system, baseline/follow-up linkage and detailed visit timing remain unverified.
Conditions for verification: 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.
Why this condition is needed: Imaging-grade change, continuous liver-fat quantity and liver enzymes have different measurement units and meanings.
Application exceptions: The retained primary-endpoint label does not certify the endpoint hierarchy in actual preregistration.
Referenced methods: 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.

Related sources S01

N08 · Are the denominators and losses for 110 randomized and 98 completed distinguished?

Current findings: 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.
Verification status: Partly verified
Materials actually 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.
Why unverified: The different overall randomized/completed denominators were retained, but arm-specific losses and handling information are insufficient.
Reason for missing information: Arm-specific allocation, dropout reasons, measurement and ITT-analysis inclusion criteria remain unverified.
Required materials and conditions: Arm-specific allocation and follow-up/measurement/analysis flow, dropout reasons and missing-data handling.
Materials to obtain first: Arm-specific allocation and follow-up/measurement/analysis flow, dropout reasons and missing-data handling.
Further research: In an authorized follow-up check, link the flow diagram and analysis populations and check whether missing-data sensitivity was assessed.
Remaining uncertainty: Arm-specific allocation, dropout reasons, measurement and ITT-analysis inclusion criteria remain unverified.
Conditions for verification: Distinguish randomized, completed, measured and analyzed counts by arm and time. Record exclusion/dropout reasons, handling of missing data and possible result bias.
Why this condition is needed: Completer results do not automatically represent everyone randomized.
Application exceptions: Quote 110 and 98 unchanged. Do not calculate or fill arm-specific allocation counts, loss counts or percentages.
Referenced methods: 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.

Related sources S01

N09 · Which analysis population do the events of 24/47 versus 8/51 belong to?

Current findings: 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.
Verification status: Partly verified
Materials actually 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.
Why unverified: The retained completer events and denominators were checked. External original tables and analysis-inclusion rules remain currently unverified.
Reason for missing information: Original-table locations, completer-analysis criteria and handling of missing data remain unverified.
Required materials and conditions: Arm-specific completer-event tables, analysis-population definitions, and links to improvement assessment and timing.
Materials to obtain first: Arm-specific completer-event tables, analysis-population definitions, and links to improvement assessment and timing.
Further research: In a new assessment, report differences between randomized-population and completer estimates transparently.
Remaining uncertainty: Original-table locations, completer-analysis criteria and handling of missing data remain unverified.
Conditions for verification: Pair completer-improvement events with arm-specific completer denominators. Distinguish these from ITT events/denominators or results for everyone randomized.
Why this condition is needed: Changing the analysis population from event counts alone changes the attribution of the effect estimate.
Application exceptions: 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.
Referenced methods: 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.

Related sources S01

N10 · How are the retained ITT RR 3.0, interval and P value attributed?

Current findings: 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.
Verification status: Partly verified
Materials actually 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.
Why unverified: The existing ITT estimate, interval and P record were checked. Original denominators, models and test definitions were not verified.
Reason for missing information: ITT events/denominators by arm, missing-data corrections, adjustment status and specific definitions of the CI and test remain unverified.
Required materials and conditions: ITT denominators/events by arm, estimation models, missing-data handling, CI/test definitions and original result tables.
Materials to obtain first: ITT denominators/events by arm, estimation models, missing-data handling, CI/test definitions and original result tables.
Further research: If reassessment of an existing estimate is authorized, first compare the original analysis population and estimation procedures.
Remaining uncertainty: ITT events/denominators by arm, missing-data corrections, adjustment status and specific definitions of the CI and test remain unverified.
Conditions for verification: 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.
Why this condition is needed: ITT results and completer values within the same report can represent different analysis questions.
Application exceptions: These are quotations of existing numbers, not calculations or original-model verification in this conversion. Do not invent ITT events or intervals.
Referenced methods: 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.

Related sources S01

N11 · Are the paper’s 5.6 labeling issue and the ITT risk ratio kept separate?

Current findings: 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.
Verification status: Partly verified
Materials actually 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.
Why unverified: The existing labeling-issue record and separation principle were checked. The original paper’s measure definition remains currently unread directly.
Reason for missing information: The actual original-table location, model, population and measure definition for 5.6 remain unverified.
Required materials and conditions: The paper’s original tables, effect-measure definitions, statistical methods and analysis population for the estimate.
Materials to obtain first: The paper’s original tables, effect-measure definitions, statistical methods and analysis population for the estimate.
Further research: If a measure correction is separately authorized, handle it as an event comparing original tables and methods, while preserving the old record.
Remaining uncertainty: The actual original-table location, model, population and measure definition for 5.6 remain unverified.
Conditions for verification: 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.
Why this condition is needed: Confusing effect-measure names can use the same number to claim a different effect size.
Application exceptions: 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.
Referenced methods: 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.

Related sources S01

N12 · How are opposing/null results and signals at another dose retained?

Current findings: 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.
Verification status: Partly verified
Materials actually 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.
Why unverified: 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.
Reason for missing information: The background trial’s identity and the full result range for the same question remain unverified; no new literature search was performed.
Required materials and conditions: All reports with the same formulation, population, endpoint and time; identified comparative results and explanations of missing results.
Materials to obtain first: All reports with the same formulation, population, endpoint and time; identified comparative results and explanations of missing results.
Further research: In an authorized literature update, review material for the same question together regardless of direction or statistical significance.
Remaining uncertainty: The background trial’s identity and the full result range for the same question remain unverified; no new literature search was performed.
Conditions for verification: Do not omit opposing/null reports on the same question. Distinguish signals at different doses/durations from conflict or confirmation within this question.
Why this condition is needed: A positive summary alone cannot establish the overall direction of evidence or absence of opposing results.
Application exceptions: Imaging signals at different doses/durations are not themselves conflicting data. Do not turn unread material into an effect of 0.
Referenced methods: 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.

Related sources S01

N13 · What are the retained verdict date, corrections and scope of this check?

Current findings: 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.
Verification status: Met
Materials actually 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.
Why unverified: The retained dates and actual reading/prohibited scope of this work were recorded separately. This does not certify completeness of all current evidence.
Reason for missing information: The current scope of newer papers, registration and corrections outside the original was not searched and remains unverified.
Required materials and conditions: The original verdict and correction history, current-input identity, and receipts for actual reading/search scope.
Materials to obtain first: The original verdict and correction history, current-input identity, and receipts for actual reading/search scope.
Further research: When updating material, separate the search event from condition-version changes and preserve the entire original before changes.
Remaining uncertainty: The current scope of newer papers, registration and corrections outside the original was not searched and remains unverified.
Conditions for verification: 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.
Why this condition is needed: A historical review date or grading axis does not replace a current literature search or fulfillment of individual conditions.
Application exceptions: Preserve original C/54, Caution, all axes, generic English wording, corrections, native types and empty values. Do not create new scores or verdicts.
Referenced methods: 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.

Related sources S01

N14 · What is known about academic funding, conflict-of-interest reporting and independence?

Current findings: 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.
Verification status: Partly verified
Materials actually 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.
Why unverified: The summary’s funding/COI report was checked. Direct review of product provision, author relationships and family-level independence remains outstanding.
Reason for missing information: Original funding/COI sections, product support, and links between institutions/authors and other reports remain unverified.
Required materials and conditions: Original paper sections on funding, product provision, author affiliations and COI, plus study-family linkage material.
Materials to obtain first: Original paper sections on funding, product provision, author affiliations and COI, plus study-family linkage material.
Further research: When discussing independent replication, check institutions, authors, product support and participant overlap separately.
Remaining uncertainty: Original funding/COI sections, product support, and links between institutions/authors and other reports remain unverified.
Conditions for verification: Separate funding, product provision, author relationships and conflict disclosures. Link study families and independence claims to actual material.
Why this condition is needed: A brief academic-institution or no-COI record cannot establish all support arrangements or independent replication.
Application exceptions: Existing I2 is a historical value. Do not fill unverified product support as no support or exclude a report solely because of COI.
Referenced methods: 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.

Related sources S01

N15 · What allocation process lies behind the randomized, double-blind label?

Current findings: 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.
Verification status: Partly verified
Materials actually 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.
Why unverified: The trial-design label was checked, but actual allocation/concealment procedures remain unverified.
Reason for missing information: Allocation sequence, concealment, baseline balance and details of who was blinded remain unverified.
Required materials and conditions: Allocation methods, concealment procedures, baseline-characteristic tables and blinding-implementation material.
Materials to obtain first: Allocation methods, concealment procedures, baseline-characteristic tables and blinding-implementation material.
Further research: In a replication comparison design, specify allocation/concealment procedures and assess bias for each result.
Remaining uncertainty: Allocation sequence, concealment, baseline balance and details of who was blinded remain unverified.
Conditions for verification: Check sequence generation, allocation concealment, baseline balance and actual blinding targets/procedures for each result.
Why this condition is needed: The RCT label alone does not establish adequate allocation and concealment.
Application exceptions: Do not automatically turn original B1 or double-blind wording into fulfillment of detailed bias conditions.
Referenced methods: 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.

Related sources S01

N16 · How might lifestyle advice, weight changes, adherence and deviations affect results?

Current findings: 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.
Verification status: Unverified
Materials actually 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.
Why unverified: Actual implementation material separating the intervention of interest from concurrent treatment/deviations is not verified in the current retained summary.
Reason for missing information: Arm-specific lifestyle advice, medication, trial-product adherence, cross-exposure and stopping reasons remain unverified.
Required materials and conditions: Concurrent/lifestyle-treatment implementation, weight/medication changes, trial-product adherence and deviation records.
Materials to obtain first: Concurrent/lifestyle-treatment implementation, weight/medication changes, trial-product adherence and deviation records.
Further research: When studying intervention attribution, record concurrent treatment and actual exposure together and analyze them in line with the planned effect of interest.
Remaining uncertainty: Arm-specific lifestyle advice, medication, trial-product adherence, cross-exposure and stopping reasons remain unverified.
Conditions for verification: 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.
Why this condition is needed: The 15-week result requires distinguishing actual powder exposure from concurrent-treatment/deviation effects.
Application exceptions: Weight, ALT and AST changes are separate endpoints. Do not turn them into surrogate confirmation of ultrasound improvement or a new independent unit.
Referenced methods: 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.

Related sources S01

N17 · Are ultrasound-reader blinding, reproducibility and assessment error verified?

Current findings: The retained evidence records a double-blind trial and ultrasound-grade results but provides no information on readers, blinding procedures, agreement or repeated measurements.
Verification status: Unverified
Materials actually 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.
Why unverified: Direct procedures for verifying imaging assessment and measurement error in this question are absent from the current retained summary.
Reason for missing information: Reader blinding, imaging criteria, reproducibility and baseline/follow-up assessment linkage remain unverified.
Required materials and conditions: Ultrasound acquisition/grading procedures, reader blinding and reproducibility/agreement material.
Materials to obtain first: Ultrasound acquisition/grading procedures, reader blinding and reproducibility/agreement material.
Further research: When assessing ultrasound improvement, mask reader and timepoint information separately and check reproducibility under prespecified rules.
Remaining uncertainty: Reader blinding, imaging criteria, reproducibility and baseline/follow-up assessment linkage remain unverified.
Conditions for verification: Check consistent imaging measurement, reader blinding, training/agreement, baseline/follow-up reading rules and measurement error.
Why this condition is needed: Grade changes can also be affected by differences in reading and measurement.
Application exceptions: A double-blind design label differs from verified imaging-reader blinding and reproducibility.
Referenced methods: 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.

Related sources S01

N18 · Which effects of interest and missing-data handling do ITT and completer analyses address?

Current findings: The retained material distinguishes completer events from ITT RR but does not describe models, adjustments, handling of missing data or analysis-population selection criteria.
Verification status: Partly verified
Materials actually 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.
Why unverified: Different analysis labels and retained results are known, but links to effects of interest, models and missing-data handling remain unverified.
Reason for missing information: SAP, analysis-population definitions, missing-data handling/sensitivity and model/adjustment details remain unverified.
Required materials and conditions: Original statistical methods, analysis-population definitions, ITT missing-data handling and sensitivity analyses/SAP.
Materials to obtain first: Original statistical methods, analysis-population definitions, ITT missing-data handling and sensitivity analyses/SAP.
Further research: In an authorized check, trace models and effects of interest for event counts and summary estimates separately.
Remaining uncertainty: SAP, analysis-population definitions, missing-data handling/sensitivity and model/adjustment details remain unverified.
Conditions for verification: Distinguish assignment effects from actual-adherence/completion effects. Link analysis populations, missing-data handling, models/adjustments and between-arm comparisons to each result.
Why this condition is needed: The ITT label alone cannot establish missing-data handling or the effect of interest.
Application exceptions: Do not automatically relabel completers as PP or merge them as the same estimate or original event counts.
Referenced methods: 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.

Related sources S01

N19 · How are the ITT interval and clinical importance distinguished?

Current findings: 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.
Verification status: Partly verified
Materials actually 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.
Why unverified: Retention of the reported interval was checked. Evidence is insufficient to establish clinical-benefit magnitude or adequate precision from it.
Reason for missing information: CI methods and material addressing clinical importance/persistence and measurement error remain unverified.
Required materials and conditions: Original CI-estimation methods, thresholds for meaningful imaging improvement and material on clinical significance.
Materials to obtain first: Original CI-estimation methods, thresholds for meaningful imaging improvement and material on clinical significance.
Further research: If better precision is needed, first specify the desired effect range, importance threshold and missing-data/measurement uncertainty.
Remaining uncertainty: CI methods and material addressing clinical importance/persistence and measurement error remain unverified.
Conditions for verification: Link the reported CI to the relevant effect measure. Distinguish the clinical importance/limits of ultrasound improvement of 1 grade from direct evidence.
Why this condition is needed: Significance, sample size and a historical grade are not sufficient conditions for clinical importance and precision.
Application exceptions: 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.
Referenced methods: 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.

Related sources S01

N20 · Were the endpoint, 15-week timepoint and analysis prespecified?

Current findings: 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.
Verification status: Unverified
Materials actually 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.
Why unverified: Original documents needed to compare planned and reported results remain currently unverified and unread.
Reason for missing information: Registration identifiers, dates/versions, protocols, SAP and endpoint/time/analysis change material remain unverified.
Required materials and conditions: Trial-preregistration identifiers/versions, protocols, SAP, reasons for changes and actual result reports.
Materials to obtain first: Trial-preregistration identifiers/versions, protocols, SAP, reasons for changes and actual result reports.
Further research: In an update where material is acquired, compare plans with reports for each result and record correction events.
Remaining uncertainty: Registration identifiers, dates/versions, protocols, SAP and endpoint/time/analysis change material remain unverified.
Conditions for verification: Compare original registration/protocol/SAP versions and dates with changes to reported endpoints, timepoints and analyses.
Why this condition is needed: The retained claim-condition primary-endpoint label or false axis values alone cannot certify actual prespecification or absence of selective reporting.
Application exceptions: An unable-to-verify registration field is not evidence of nonregistration. Do not mark unread preregistration/SAP as not applicable.
Referenced methods: 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.

Related sources S01

N21 · Are independent replication for the same question and study families at other doses verified?

Current findings: 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.
Verification status: Partly verified
Materials actually 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.
Why unverified: 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.
Reason for missing information: Other trial identifiers/products, participant overlap, question-specific results and the scope of current replication remain unverified.
Required materials and conditions: Identified follow-up/secondary reports, registration, recruitment/site information and results for each defined question.
Materials to obtain first: Identified follow-up/secondary reports, registration, recruitment/site information and results for each defined question.
Further research: When assessing independent replication, link trials of the same product/question separately from trials of other doses/durations.
Remaining uncertainty: Other trial identifiers/products, participant overlap, question-specific results and the scope of current replication remain unverified.
Conditions for verification: Compare unique study families and formulation, population, endpoint and analysis definitions to distinguish replication from heterogeneity.
Why this condition is needed: A historical R1 value or background imaging signal does not certify independent replication of the same question.
Application exceptions: Do not declare all families to be a single confirmed family or close heterogeneity as not applicable merely because there is 1 current report.
Referenced methods: 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.

Related sources S01

N22 · Can results be extended to other doses, durations, formulations or subgroups?

Current findings: 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.
Verification status: Not applicable
Materials actually 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.
Why unverified: 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.
Reason for missing information: The extended effects themselves remain currently unverified. Do not claim that the background trial’s identity or direct comparisons were acquired.
Required materials and conditions: Direct material for each dose, duration and subgroup with explicit identifiers and question definitions.
Materials to obtain first: Direct material for each dose, duration and subgroup with explicit identifiers and question definitions.
Further research: If an extension is needed, define a separate question and design direct comparisons or continued follow-up.
Remaining uncertainty: The extended effects themselves remain currently unverified. Do not claim that the background trial’s identity or direct comparisons were acquired.
Conditions for verification: For an extension claim, acquire direct comparisons for the same product/population and relevant doses, durations and subgroups, and record differences.
Why this condition is needed: Distinguish evidence obligations for the narrow 800 mg/day, 15-week question from extension questions.
Application exceptions: Do not generate same-formulation confirmation, dose response or a new report from the 1,600 mg/12-week background alone.
Referenced methods: 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.

Related sources S01

N23 · Does imaging-grade improvement answer questions about MRI, histology or clinical liver-disease prevention?

Current findings: 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.
Verification status: Not applicable
Materials actually 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.
Why unverified: The current independent question makes no effect claims for other measurements or clinical events, so only that extension obligation does not apply.
Reason for missing information: Effects on other imaging, histology and clinical events, and long-term applicability, are not established by the current material.
Required materials and conditions: Direct results and follow-up material for MRI-PDFF/histology or fibrosis, cirrhosis and clinical events.
Materials to obtain first: Direct results and follow-up material for MRI-PDFF/histology or fibrosis, cirrhosis and clinical events.
Further research: If a claim about another endpoint is needed, define an independent question and measure that endpoint directly.
Remaining uncertainty: Effects on other imaging, histology and clinical events, and long-term applicability, are not established by the current material.
Conditions for verification: When extending to clinical events or another measurement, require direct evidence for that endpoint and distinguish it from imaging grade.
Why this condition is needed: Ultrasound grade does not automatically represent direct liver-fat quantification, histology or clinical events.
Application exceptions: Do not impose MRI, histology or long-term-event trials as mandatory efficacy conditions for this narrow imaging question.
Referenced methods: 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.

Related sources S01

N24 · What actual harm-event material supports the gastrointestinal-discomfort and bleeding cautions?

Current findings: 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.
Verification status: Unverified
Materials actually 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.
Why unverified: The existence of the caution was retained, but actual event observations and collection methods in this trial are not verified.
Reason for missing information: Harm definitions, severity, collection/stopping rules and actual event material remain unverified.
Required materials and conditions: Trial harm-event tables, definitions/severity, active/passive collection methods and stopping criteria.
Materials to obtain first: Trial harm-event tables, definitions/severity, active/passive collection methods and stopping criteria.
Further research: If a harm question is needed, design separate event collection for the same powder, exposure and NAFLD population.
Remaining uncertainty: Harm definitions, severity, collection/stopping rules and actual event material remain unverified.
Conditions for verification: For a harm claim, link event definitions, severity, collection methods and stopping criteria to actual observations in the same population/exposure.
Why this condition is needed: Retain the original caution without confusing efficacy events with actual harm observations.
Application exceptions: General caution wording is not a record that the event was observed in the trial or evidence of no events.
Referenced methods: 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.

Related sources S01

N25 · Are the exposure, onset, stopping and recovery times of harm events known?

Current findings: The claim conditions record 15 weeks, but there is no record linking the gastrointestinal-discomfort/bleeding cautions to event-specific timing.
Verification status: Unverified
Materials actually 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.
Why unverified: The exposure duration is known, but temporal relationships for actual harm events are not verified in the currently retained material.
Reason for missing information: Onset, stopping, recovery, re-exposure and event-specific follow-up material remain unverified.
Required materials and conditions: Event-specific administration, onset, stopping/re-exposure, recovery records and follow-up time.
Materials to obtain first: Event-specific administration, onset, stopping/re-exposure, recovery records and follow-up time.
Further research: In harm research assessing temporal relationships, record actual exposure and event times.
Remaining uncertainty: Onset, stopping, recovery, re-exposure and event-specific follow-up material remain unverified.
Conditions for verification: For harm-causality/timing claims, link actual administration, onset, stopping, recovery and re-exposure times for each event.
Why this condition is needed: Efficacy-trial duration differs from the temporal relationship of an individual event.
Application exceptions: Do not infer harm onset, resolution or causality from the 15-week treatment duration alone.
Referenced methods: 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.

Related sources S01

N26 · Which placebo and background risks were used for harm comparisons?

Current findings: The original comparator is matching-appearance placebo, but arm-specific harm results and background risks are not currently recorded.
Verification status: Unverified
Materials actually 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.
Why unverified: The efficacy comparator was specified, but actual between-arm harm comparisons are not verified.
Reason for missing information: Arm-specific harm events, equivalence of follow-up/collection and background-risk material remain unverified.
Required materials and conditions: Arm-specific harm results, equal collection, baseline risks and placebo exposure/follow-up material.
Materials to obtain first: Arm-specific harm results, equal collection, baseline risks and placebo exposure/follow-up material.
Further research: For harm comparisons, include equal collection/follow-up in both arms and checks of baseline risk.
Remaining uncertainty: Arm-specific harm events, equivalence of follow-up/collection and background-risk material remain unverified.
Conditions for verification: For comparative-harm claims, link comparators with the same population and exposure/follow-up to arm-specific collection and background risks.
Why this condition is needed: The existence of a placebo efficacy comparison does not guarantee the existence of harm-comparison material.
Application exceptions: Do not calculate between-arm bleeding or gastrointestinal-harm risks from the efficacy question’s matching-appearance placebo alone.
Referenced methods: 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.

Related sources S01

N27 · Are exposure, event and time denominators available for harm-frequency claims?

Current findings: 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.
Verification status: Unverified
Materials actually 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.
Why unverified: Only efficacy denominators are available; direct denominator/event material for verifying harm frequency is absent.
Reason for missing information: Arm-specific actual exposure, affected-person/event counts, observation time and collection scope remain unverified.
Required materials and conditions: Arm-specific harm-exposure/analysis counts, affected-person/event counts, observation time and collection methods.
Materials to obtain first: Arm-specific harm-exposure/analysis counts, affected-person/event counts, observation time and collection methods.
Further research: In harm research, report exposure/follow-up denominators separately from efficacy completers.
Remaining uncertainty: Arm-specific actual exposure, affected-person/event counts, observation time and collection scope remain unverified.
Conditions for verification: For harm-frequency claims, distinguish actually exposed people, affected people, repeated events, follow-up time and collection scope.
Why this condition is needed: The 110 randomized, 98 completed and ultrasound-event counts are not harm denominators or numerators.
Application exceptions: Do not convert efficacy results of 24/47 versus 8/51 or trial participant counts into harm incidence.
Referenced methods: 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.

Related sources S01

N28 · What alternative causes and concurrent exposures, including liver disease and medications, affect harms?

Current findings: 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.
Verification status: Unverified
Materials actually 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.
Why unverified: The caution is retained, but baseline/concurrent-treatment material needed to distinguish harm causes or comparisons is not currently verified.
Reason for missing information: Concurrent medication, baseline risks, simultaneous exposures and alternative-cause assessment of individual events remain unverified.
Required materials and conditions: Baseline risks, concurrent medications/exposures, event assessments and alternative-cause records.
Materials to obtain first: Baseline risks, concurrent medications/exposures, event assessments and alternative-cause records.
Further research: For a harm question, record baseline liver disease and concurrent factors, retaining uncertainty about causal contribution.
Remaining uncertainty: Concurrent medication, baseline risks, simultaneous exposures and alternative-cause assessment of individual events remain unverified.
Conditions for verification: For causal or comparative harm claims, distinguish baseline disease, bleeding risk, concurrent medications/exposures and alternative causes.
Why this condition is needed: Alternative factors must be known before attributing a caution in the NAFLD population to harm from a particular cause.
Application exceptions: Do not fill unrecorded medications or causes as absent, or assess individual risk from the original caution alone.
Referenced methods: 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.

Related sources S01

N29 · Can stopping/dropout and selective harm reporting be distinguished?

Current findings: 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.
Verification status: Unverified
Materials actually 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.
Why unverified: Material linking losses to actual harm collection or selective reporting is unavailable.
Reason for missing information: Arm-specific dropout/stopping causes, losses to follow-up and completeness of harm reporting against the plan remain unverified.
Required materials and conditions: Arm-specific stopping/dropout reasons, harm-collection plans, complete event tables and reporting changes.
Materials to obtain first: Arm-specific stopping/dropout reasons, harm-collection plans, complete event tables and reporting changes.
Further research: In follow-up harm assessment, track dropout and harm collection together and specify the scope of nonreporting.
Remaining uncertainty: Arm-specific dropout/stopping causes, losses to follow-up and completeness of harm reporting against the plan remain unverified.
Conditions for verification: For harm conclusions, compare stopping/dropout reasons, follow-up losses, collection scope and whether all harm results were reported.
Why this condition is needed: Completion counts and cautions alone cannot establish stopping causes or completeness of harm results.
Application exceptions: Do not extend absence of a harm table in the current retained summary to nonreporting throughout the paper or absence of events.
Referenced methods: 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.

Related sources S01

N30 · Is the original caution being counted as an independently repeated harm signal?

Current findings: 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.
Verification status: Not applicable
Materials actually 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.
Why unverified: 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.
Reason for missing information: Independent harm cases and the entire scope of repeated signals were not currently verified.
Required materials and conditions: Event/report identifiers, exposure, timing, study/case families and recitation links.
Materials to obtain first: Event/report identifiers, exposure, timing, study/case families and recitation links.
Further research: If repeated signals become a separate question, create individual family links and then assess whether records are independent.
Remaining uncertainty: Independent harm cases and the entire scope of repeated signals were not currently verified.
Conditions for verification: For repeated harm-signal claims, identify recitations/report families of the same event and independent events/studies.
Why this condition is needed: Recitation of a caution must be distinguished from repetition of independent events.
Application exceptions: 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.
Referenced methods: 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.

Related sources S01

N31 · Are long-term/rare harms and vulnerable-group/interactions beyond 15 weeks known?

Current findings: 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.
Verification status: Unverified
Materials actually 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.
Why unverified: 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.
Reason for missing information: Long-term/rare harms, vulnerable-group and concurrent-treatment interaction results, and exposure denominators remain unverified.
Required materials and conditions: Harm follow-up by exposure/duration and actual material on vulnerable groups and concurrent-treatment interactions.
Materials to obtain first: Harm follow-up by exposure/duration and actual material on vulnerable groups and concurrent-treatment interactions.
Further research: If a safety question in this scope is needed, follow actual exposure and events over the long term in a separately defined population.
Remaining uncertainty: Long-term/rare harms, vulnerable-group and concurrent-treatment interaction results, and exposure denominators remain unverified.
Conditions for verification: For long-term/rare-harm, vulnerable-group or interaction-safety claims, require direct harm material for the relevant exposure, population and duration.
Why this condition is needed: A 15-week efficacy result cannot certify long-term/rare-event or vulnerable-group safety.
Application exceptions: Do not impose long-term safety research as mandatory for the current imaging-efficacy question or create individual intake advice.
Referenced methods: 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.

Related sources S01

N32 · What separates general cautions, comparative harms, causality and individual safety?

Current findings: 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.
Verification status: Met
Materials actually 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.
Why unverified: 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.
Reason for missing information: Evidence for actual harm events, comparative risks, causality and individual applicability remains unverified.
Required materials and conditions: Original material on the relevant harm events, comparators, causal assessments and applicability.
Materials to obtain first: Original material on the relevant harm events, comparators, causal assessments and applicability.
Further research: Define a separate harm question and set the conclusion level appropriate to its design, population, exposure and collection.
Remaining uncertainty: Evidence for actual harm events, comparative risks, causality and individual applicability remains unverified.
Conditions for verification: Distinguish general cautions, observed signals, comparative risks and causality by the actual material level. Do not generate unverified harm values or safety certification.
Why this condition is needed: Retain the original cautions without presenting positive efficacy values as proof of absence of harm or individual safety.
Application exceptions: C/54 and Caution are historical values, not a new grade, safety verdict or individual intake recommendation in this conversion.
Referenced methods: 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.

Related sources S01