Aged garlic extract 2,400 mg/day × Reduced progression of low-attenuation coronary plaque in metabolic syndrome

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 AGE product, population, time frame and imaging endpoint does this question concern?Required	The Korean claim concerns reduced progression of low-attenuation coronary plaque in adults with metabolic syndrome. The intervention and population description links AGE capsules, 2,400 mg/day, about 12 months/a CCTA interval of 354±41 days, and matching placebo plus usual care. There are no additional subclaims. S01	The retained text identifies the distinct question and its exclusions. This does not establish verification of the trial plan or confirmation of imaging efficacy.	The original protocol and result tables linking this population, formulation, route, dose, comparator and time point.	Material needed: The original protocol and result tables linking this population, formulation, route, dose, comparator and time point. This records needed materials; no new research was executed.
2	Partly verified	Full text not readStored summary read	N02 · Evidence conditionAre multiple analyses or repeated citations of a report being counted as separate trials?Required	The 1 evidence summary and 1 citation correspond to a report by Matsumoto2016. The research description separates unadjusted values from adjusted β. The diabetes trial appears only as background described as sharing the product company and research lineage. S01	The local report pair and analysis levels are linked, but external recruitment identities and related report families have not been newly verified.	Study-family material linking registration, recruitment identity, the population/time points of each report, related reports and an included-trial table.	Material needed: Study-family material linking registration, recruitment identity, the population/time points of each report, related reports and an included-trial table. This records needed materials; no new research was executed.
3	Met	Full text not readStored summary read	N03 · Evidence conditionIs the summary actually read distinguished from unread external material?Required	The retained Korean and English verdict summary was read. A PubMed URL, DOI and NCT01534910 identifier are present, but external abstracts, full text and registration have not been accessed, acquired or read. S01	The local summary reading is separated from unread external material, with citation locations and hashes linked. This does not establish verification of external content.	For each material, the actual access date, attempts/success, acquired file, source location, reading scope and safe link.	Material needed: For each material, the actual access date, attempts/success, acquired file, source location, reading scope and safe link. This records needed materials; no new research was executed.
4	Partly verified	Full text not readStored summary read	N04 · Evidence conditionHow were the analyzed adults with metabolic syndrome selected?Required	The intervention and population description records 55 adults with metabolic syndrome continuing their usual risk-factor treatment. The evidence count separately distinguishes 65 enrolled from 55 analyzed. S01	The diagnosis label and continued treatment are identified, but detailed selection, age, baseline characteristics and recruitment setting remain unverified.	Eligibility/exclusion criteria, the metabolic-syndrome definition, baseline tables, age, comorbidities, recruitment setting and a flow diagram.	Material needed: Eligibility/exclusion criteria, the metabolic-syndrome definition, baseline tables, age, comorbidities, recruitment setting and a flow diagram. This records needed materials; no new research was executed.
5	Partly verified	Full text not readStored summary read	N05 · Evidence conditionAre the AGE capsule product and SAC specifications identified?Required	The formulation is AGE capsules; detailed SAC specifications are unverified. The source part is aged clove extract, and both the Korean and English texts caution against treating other garlic formulations as interchangeable. S01	The aged-extract capsule formulation is identified, but detailed product and SAC specifications remain unverified.	Product name, manufacturing/aging process, standardization specifications such as SAC, and trial-batch analyses.	Material needed: Product name, manufacturing/aging process, standardization specifications such as SAC, and trial-batch analyses. This records needed materials; no new research was executed.
6	Partly verified	Full text not readStored summary read	N06 · Evidence conditionWhat are the actual oral exposure and placebo comparison?Required	The original dose is 2,400 mg/day, given orally as add-on treatment, with matching placebo plus usual care as comparator. Actual capsule count, placebo composition and adherence remain unverified in the retained summary. S01	The nominal dosing and comparison are retained, while actual exposure, placebo details and adherence remain to be verified.	Dosing records, capsule schedule, placebo composition/appearance, adherence and actual exposure by group.	Material needed: Dosing records, capsule schedule, placebo composition/appearance, adherence and actual exposure by group. This records needed materials; no new research was executed.
7	Partly verified	Full text not readStored summary read	N07 · Evidence conditionWhich imaging component and denominator does %LAP measure?Required	The named endpoint is change in CCTA percent low-attenuation plaque volume. The original central explanation limits interpretation to the low-attenuation component rather than total plaque. S01	The imaging endpoint name is identified, but the attenuation cutoff, segmentation, percentage numerator/denominator and exact scale specification remain unverified.	The LAP measurement definition, attenuation cutoff, segmentation criteria, percentage calculation specification and result-table notes.	Material needed: The LAP measurement definition, attenuation cutoff, segmentation criteria, percentage calculation specification and result-table notes. This records needed materials; no new research was executed.
8	Partly verified	Full text not readStored summary read	N08 · Evidence conditionHow are treatment duration and the CCTA scan interval distinguished?Required	The original duration is about 12 months, and the CCTA interval is 354±41 days. Details of group and individual scan times and time windows are not separately retained. S01	The reported time notation is retained, but correspondence between scans and treatment exposure by group remains unverified.	Treatment duration by group, scan dates/windows and baseline-to-follow-up image matching.	Material needed: Treatment duration by group, scan dates/windows and baseline-to-follow-up image matching. This records needed materials; no new research was executed.
9	Partly verified	Full text not readStored summary read	N09 · Evidence conditionWhich values describe unadjusted group percentage changes?Required	The original result distinguishes −1.5±2.3% versus +0.2±2.0%, P=.0049, from adjusted β. The Korean and English reader answers also report group values of −1.5% versus +0.2% separately. S01	Group values, signs, percentages and P are identified, but the change definition, testing, dispersion and exact analysis specification remain unverified.	Group result tables, change definitions, dispersion notes, testing specifications and the analysis population.	Material needed: Group result tables, change definitions, dispersion notes, testing specifications and the analysis population. This records needed materials; no new research was executed.
10	Partly verified	Full text not readStored summary read	N10 · Evidence conditionWhich analysis does the adjusted β estimate come from?Required	The original adjusted β is −1.61, with 95% CI −2.79~−0.43, P=.008. The research description distinguishes unadjusted values from β. S01	The β and CI/P strings are retained, but variables, model, coefficient unit and SAP remain unverified.	The regression model, adjustment variables and selection rationale, SAP, coefficient unit and result table.	Material needed: The regression model, adjustment variables and selection rationale, SAP, coefficient unit and result table. This records needed materials; no new research was executed.
11	Partly verified	Full text not readStored summary read	N11 · Evidence conditionWhat are the enrollment, analysis and group denominators?Required	The original count is 65 enrolled and 55 analyzed; AGE 27 and placebo 28. The evidence weighting states completers and industry support, while the reader answer states that full ITT is unverified. S01	Enrollment, analysis and reported group counts are identified, but original allocation, completion and exact outcome-denominator documents remain unverified.	A group flow diagram from recruitment through allocation, treatment, scanning, completion and analysis, and the outcome denominators.	Material needed: A group flow diagram from recruitment through allocation, treatment, scanning, completion and analysis, and the outcome denominators. This records needed materials; no new research was executed.
12	Unverified	Full text not readStored summary read	N12 · Evidence conditionHow do missing data, completer analysis and ITT differ?Required	The reader answer states that full ITT is unverified, and the evidence weighting labels completers. Beyond 65 enrolled and 55 analyzed, reasons for missingness, handling and analysis-set details are absent from the retained summary. S01	The retained summary cannot verify missing-data handling, full ITT or sensitivity specifications. This is not a finding of effect 0 or nonreporting throughout the full text.	Missingness/dropout by group, exclusion rules, ITT/completer specifications, missing-data handling and sensitivity analyses.	Material needed: Missingness/dropout by group, exclusion rules, ITT/completer specifications, missing-data handling and sensitivity analyses. This records needed materials; no new research was executed.
13	Partly verified	Full text not readStored summary read	N13 · Evidence conditionAre the meanings of dispersion and reported intervals verified?Required	Group values of −1.5±2.3% versus +0.2±2.0% and the adjusted β 95% CI of −2.79~−0.43 are retained separately. The statistical type of ± remains unverified. S01	The reported intervals and dispersion are identified, but their definitions, estimation methods and denominators have not been directly compared.	SD/SE/CI notes, interval estimation method, denominators, distributions and the original result table.	Material needed: SD/SE/CI notes, interval estimation method, denominators, distributions and the original result table. This records needed materials; no new research was executed.
14	Unverified	Full text not readStored summary read	N14 · Evidence conditionIs a threshold for the importance of the imaging signal justified?Required	The original grade rationale records EX because the prespecified LAP-only hierarchy and clinical threshold are unclear. β, CI, P and the imaging result are retained. S01	The retained material does not verify a justified LAP importance threshold. The imaging signal is retained without assigning a new grade.	Material justifying LAP measurement error and an importance/interpretation threshold, together with the relevant intervals.	Material needed: Material justifying LAP measurement error and an importance/interpretation threshold, together with the relevant intervals. This records needed materials; no new research was executed.
15	Met	Full text not readStored summary read	N15 · Evidence conditionAre results showing no difference outside LAP also retained?Required	The original rationale records null changes in TPV, noncalcified plaque and dense calcium. The central explanation limits the positive signal to the LAP component. S01	The original text retains both the LAP signal and null descriptions of other imaging measures. This does not establish verification of detailed tables or the prespecified hierarchy.	Component-specific result tables, time points, denominators, scales, analyses and selection rationales.	Material needed: Component-specific result tables, time points, denominators, scales, analyses and selection rationales. This records needed materials; no new research was executed.
16	Met	Full text not readStored summary read	N16 · Evidence conditionWhich dates and verification scope define these evidence gaps?Required	The original verdict date is 2026-09-08, with a correction to temporary English wording on 2026-09-14. The conversion read retained Korean/English summaries and method definitions, without an external clinical search. S01	The retained verdict/correction dates and conversion reading scope are distinguished. This is not completion of an updated search.	The historical search scope, access history, evidence cutoff, checks for unpublished material/corrections/retractions, and a new update event.	Material needed: The historical search scope, access history, evidence cutoff, checks for unpublished material/corrections/retractions, and a new update event. This records needed materials; no new research was executed.
17	Partly verified	Full text not readStored summary read	N17 · Evidence conditionWhat is known about product-company support and research independence?Required (independence interpretation boundary)	Funding is recorded as support from Wakunaga of America, and evidence weighting states completers and industry support. A retained description places the diabetes trial within the same product company and research lineage. S01	The funding party and historical industry support are known, but product provision, author employment, design/analysis involvement and detailed declarations remain unverified.	Funding, product provision, author employment/patents/interests, design/analysis roles and research-lineage declarations.	Material needed: Funding, product provision, author employment/patents/interests, design/analysis roles and research-lineage declarations. This records needed materials; no new research was executed.
18	Partly verified	Full text not readStored summary read	N18 · Evidence conditionDoes the randomized/blinded label match the actual allocation process?Required	The original design label is prospective, double-blind, randomized and placebo-controlled. Sequence generation, concealment, baseline balance and implementation details are absent from the retained summary. S01	The design label is identified, but material on allocation/concealment and baseline implementation remains unverified.	Allocation methods, concealment, baseline tables, implementation of blinding and the methods section.	Material needed: Allocation methods, concealment, baseline tables, implementation of blinding and the methods section. This records needed materials; no new research was executed.
19	Partly verified	Full text not readStored summary read	N19 · Evidence conditionCould usual risk-factor treatment and adherence differences be mixed into the result?Required	The intervention and population description specifies continued usual risk-factor treatment and matching placebo plus usual care. Drug/diet changes and actual adherence remain unverified. S01	The shared-care specification is retained, but the effects of concomitant treatment, adherence and changes on interpretation remain unverified.	Group background drugs/treatment, lifestyle factors, changes, adherence, rescue treatment and handling of these factors.	Material needed: Group background drugs/treatment, lifestyle factors, changes, adherence, rescue treatment and handling of these factors. This records needed materials; no new research was executed.
20	Unverified	Full text not readStored summary read	N20 · Evidence conditionAre CCTA reading, reproducibility and assessor blinding verified?Required	CCTA %LAP and the double-blind design label are present, but details of readers, reproducibility and assessor blinding are absent from the retained summary. S01	The retained material provides no location to verify implementation of reading and measurement, so this remains unverified.	Imaging conditions, image quality, reading/segmentation procedures, blinding, reproducibility and error handling.	Material needed: Imaging conditions, image quality, reading/segmentation procedures, blinding, reproducibility and error handling. This records needed materials; no new research was executed.
21	Unverified	Full text not readStored summary read	N21 · Evidence conditionWere the prespecified LAP endpoint hierarchy and SAP compared?Required	The citation and research description contain NCT01534910, while the manuscript's registration-verification field says not verified. Endpoint, answer and grade explanations leave the prespecified LAP-only hierarchy and full ITT unverified. S01	The identifier and unverified labels are retained, but registration/planning documents have not actually been compared.	Dated registration text, protocol, SAP, endpoint/analysis change history and actual result tables.	Material needed: Dated registration text, protocol, SAP, endpoint/analysis change history and actual result tables. This records needed materials; no new research was executed.
22	Partly verified	Full text not readStored summary read	N22 · Evidence conditionIs another report an independent replication of the same product and population question?Required	The retained manuscript states that the diabetes trial's LAP signal was not upgraded to independent R2 because it shared the company and research lineage. AGE combination-product trials were excluded. S01	Historical descriptions of different populations, shared lineage and excluded combinations are retained, but report families and independent replication have not been newly verified.	Recruitment, product specifications, population, endpoint/time point, funding/lineage and a trial-family table.	Material needed: Recruitment, product specifications, population, endpoint/time point, funding/lineage and a trial-family table. This records needed materials; no new research was executed.
23	Not applicable	Full text not readStored summary read	N23 · Evidence conditionDoes this question also require an optimal dose?Supplementary; required to extend to optimal dosing	The original question concerns %LAP with AGE 2,400 mg/day for about 12 months. Direct dose-response data and an optimal-dose estimate are absent from the retained summary. S01	The selected question makes no optimal-dose claim, so only the obligation for that extension research is not applicable. This is not a substitute status for unread material.	For a dose-optimization claim: direct comparisons of doses with matching specifications, exposure/adherence and a separate estimate.	Material needed: For a dose-optimization claim: direct comparisons of doses with matching specifications, exposure/adherence and a separate estimate. This records needed materials; no new research was executed.
24	Not applicable	Full text not readStored summary read	N24 · Evidence conditionIs persistence of the imaging effect after treatment stops being claimed?Supplementary; required for persistence after stopping	The original duration is about 12 months, with a CCTA interval of 354±41 days. Separate post-treatment imaging material is absent from the retained summary. S01	The current question makes no post-treatment persistence claim, so only the extension-research obligation is not applicable.	For a persistence claim: post-treatment scan times, exposure, treatment changes, group follow-up denominators and results.	Material needed: For a persistence claim: post-treatment scan times, exposure, treatment changes, group follow-up denominators and results. This records needed materials; no new research was executed.
25	Not applicable	Full text not readStored summary read	N25 · Evidence conditionIs a larger effect in a particular subgroup being claimed?Supplementary; required for subgroup extensions	The question concerns adults with metabolic syndrome; the diabetes trial is background. Prespecified subgroup and interaction estimates are absent from the retained summary. S01	The current question makes no additional subgroup-effect claim, so only the extension-research obligation is not applicable.	For a subgroup claim: prespecified hypotheses, denominators, direct interaction estimates and plans.	Material needed: For a subgroup claim: prespecified hypotheses, denominators, direct interaction estimates and plans. This records needed materials; no new research was executed.
26	Met	Full text not readStored summary read	N26 · Evidence conditionIs the LAP signal being extended to plaque disappearance or prevention of clinical events?Required (clinical interpretation boundary)	The original rationale explicitly says myocardial infarction and death were not tested. The advertising-interpretation explanation rules out claims of plaque disappearance or myocardial-infarction prevention. S01	The original text explicitly separates imaging from clinical events. This does not establish event efficacy or long-term prevention.	For an event extension: event definitions, denominators/follow-up, direct between-group results and plans.	Material needed: For an event extension: event definitions, denominators/follow-up, direct between-group results and plans. This records needed materials; no new research was executed.
27	Unverified	Full text not readStored summary read	N27 · Evidence conditionAre harm-event definitions and collection verified?Supplementary; required for harm and safety questions	The manuscript says this imaging trial cannot establish long-term bleeding or interactions. The retained summary lacks definitions and counts of harm events by group. S01	The retained summary cannot verify collection specifications or event data. This does not mean nonreporting throughout the full text or 0 events.	Adverse-event definitions, collection methods, group reports, discontinuation/severity and source data.	Material needed: Adverse-event definitions, collection methods, group reports, discontinuation/severity and source data. This records needed materials; no new research was executed.
28	Unverified	Full text not readStored summary read	N28 · Evidence conditionIs the temporal sequence of exposure and harm events known?Supplementary; required for harm timing questions	An imaging interval of about 12 months and long-term harm cautions are present, but event, discontinuation and recovery timelines are absent from the retained summary. S01	Event timing cannot be verified within the current scope, so it is not promoted into causality or re-exposure evidence.	Times of exposure initiation, events, discontinuation, recovery and re-exposure, with follow-up records.	Material needed: Times of exposure initiation, events, discontinuation, recovery and re-exposure, with follow-up records. This records needed materials; no new research was executed.
29	Unverified	Full text not readStored summary read	N29 · Evidence conditionAre event and exposure denominators available to interpret harm comparisons?Supplementary; required for incidence or comparative-risk claims	The original counts are 65 enrolled, 55 analyzed, AGE 27 and placebo 28. The retained summary lacks harm events, exposure time and harm-comparison estimates. S01	Event/exposure denominators cannot be linked with duration, so comparative risks and frequencies remain unverified within the current scope.	Group harm-exposure/event denominators, people/event counts, duration, placebo comparisons and result tables.	Material needed: Group harm-exposure/event denominators, people/event counts, duration, placebo comparisons and result tables. This records needed materials; no new research was executed.
30	Partly verified	Full text not readStored summary read	N30 · Evidence conditionWere concomitant drugs and alternative explanations verified?Supplementary; required for causal or comparative harm	The original caution explicitly calls for checking anticoagulants, antiplatelet drugs and perioperative use. Actual group drugs, surgery and bleeding risks remain unverified. S01	The original caution and usual-care scope are retained, but actual simultaneous exposure and alternatives/confounding remain unverified.	Concomitant drugs/doses, surgery, baseline risks, simultaneous exposure, alternatives and relevant harm material.	Material needed: Concomitant drugs/doses, surgery, baseline risks, simultaneous exposure, alternatives and relevant harm material. This records needed materials; no new research was executed.
31	Unverified	Full text not readStored summary read	N31 · Evidence conditionIs the scope missed by harm collection and follow-up known?Supplementary; required for the scope of harm surveillance	The 65 enrolled, 55 analyzed and unverified ITT refer to the imaging result. Harm collection, detection and loss information is absent from the retained summary. S01	The current scope does not directly verify selection, missingness or disclosure limits in safety surveillance.	Group safety follow-up, reasons for missingness, detection differences and the disclosure scope for all events.	Material needed: Group safety follow-up, reasons for missingness, detection differences and the disclosure scope for all events. This records needed materials; no new research was executed.
32	Unverified	Full text not readStored summary read	N32 · Evidence conditionAre repeated harm warnings being counted as independent events?Supplementary; required for repeated harm signals	The same general caution repeats in the Korean and English texts and the synthesized summary. The retained evidence and citation contain no separate independent harm case report. S01	Harm families or repeated events cannot be verified within the current scope. The same caution is not counted as duplicated signals.	Unique harm report/case identifiers, exposure/event matching, repeated citations and family material.	Material needed: Unique harm report/case identifiers, exposure/event matching, repeated citations and family material. This records needed materials; no new research was executed.
33	Unverified	Full text not readStored summary read	N33 · Evidence conditionWhat about long-term or rare harms and vulnerable groups beyond the imaging observation?Supplementary; required for long-term or vulnerable-group harms	The manuscript explicitly states that this imaging trial cannot establish long-term bleeding or interactions. S01	Direct harm evidence for long-term/rare events and vulnerable conditions cannot be verified within the current scope.	Suitable designs and denominators/follow-up for long-term/rare events and interactions under the same exposure and by population.	Material needed: Suitable designs and denominators/follow-up for long-term/rare events and interactions under the same exposure and by population. This records needed materials; no new research was executed.
34	Partly verified	Full text not readStored summary read	N34 · Evidence conditionHow far can harms and safety be described from this material?Required (safety interpretation boundary)	The original safety label is Caution, with warnings about long-term bleeding and interactions. Direct information linking events, denominators, timing, comparison and alternatives is absent from the retained summary. S01	The general caution boundary is retained, but direct material to classify signals, risk or causality remains unverified.	Harm source data connecting events, exposure/denominators, timing, comparison and alternatives, with the interpretation scope.	Material needed: Harm source data connecting events, exposure/denominators, timing, comparison and alternatives, with the interpretation scope. This records needed materials; no new research was executed.

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34 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 date is the original check date in retained summary and condition records. The retained verdict’s evidence date, historical access dates for individual materials and current external-access status are distinguished.
Population: Adults with metabolic syndrome continuing usual risk-factor care. The retained record distinguishes 65 enrolled from 55 analyzed.
Ingredient, formulation and route: Oral aged garlic extract (AGE) capsules as an add-on. Product name, study batch and exact SAC specification remain unverified.
Dose: AGE 2,400 mg/day. Details of actual intake, capsule count and adherence remain unverified.
Comparator: Matching placebo plus usual risk-factor care. Original material on placebo composition and changes in background care remains unverified.
Measured outcome: Change in percent low-attenuation coronary plaque volume (%LAP) on CCTA. A prespecified LAP-only primary (1st) outcome hierarchy remains unverified.
Duration: About 12 months; CCTA imaging interval 354±41 days. The statistical meaning of ±41, such as SD or SE, remains unverified.
Questions outside this scope: Total plaque, noncalcified plaque and dense calcium are separate imaging endpoints; the null descriptions in the retained record are preserved.; The finding is not extended to plaque elimination, myocardial-infarction prevention or reduced mortality.; Other garlic formulations, other AGE products and isolated SAC are not treated as the same intervention.; The unidentified diabetes background reference is not added as a new report or independent replication.; Effects of AGE combined with B vitamins, folate and L-arginine are not transferred to AGE alone.; Optimal dosing, persistence after stopping and additional subgroup effects are separate from the current narrow question.; General caution is not converted into bleeding-event counts, comparative risk, causality or confirmation of overall safety.

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 · Aged Garlic Extract Reduces Low Attenuation Plaque in Coronary Arteries of Patients with Metabolic Syndrome in a Prospective Randomized Double-Blind Study

PubMed

Material type: Retained record: prospective, randomized, double-blind, placebo-controlled trial. Allocation methods, assessor blinding and full ITT remain unverified.
Materials actually read: Retained verdict summary read; external PubMed, DOI, full-text and registration material remain unread, with access not attempted.
Findings recorded in the stored summary: Reported group %LAP changes are −1.5±2.3% versus +0.2±2.0%, P=.0049. Adjusted β is −1.61 (95% CI −2.79 to −0.43; P=.008). The original count description is 65 enrolled and 55 analyzed; AGE 27 and placebo 28.
Record level: These are reported imaging-surrogate values, with group %changes and the adjusted regression coefficient kept distinct. The exact %denominator, meaning of ±, β unit, analysis set, prespecified hierarchy and full ITT remain unverified.
Study overlap and independent replication: The retained evidence and citation link to a report by Matsumoto2016. Group changes and adjusted β are different analysis layers for the same imaging endpoint. Unique-trial counts, participant totals and independent replication remain unverified.

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
PubMed bibliographic/abstract index	Bibliographic link retained; external material unread	External access not attempted; not acquired	Not read	This is the PubMed link from the retained citation. The current response, bibliographic identity, abstract content and public access were not checked. Matsumoto2016 is a report linked in the retained summary. External abstracts, full texts, registration, protocols and analysis plans were not checked in this conversion, and independent clinical validation was not performed. The date is the original check date in retained summary and condition records. The retained verdict’s evidence date, historical access dates for individual materials and current external-access status are distinguished.
DOI identifier gateway	DOI gateway retained; external material unread	External access not attempted; not acquired	Not read	This gateway was constructed from the retained DOI. It does not represent the original URL field or the format of an acquired physical document. Matsumoto2016 is a report linked in the retained summary. External abstracts, full texts, registration, protocols and analysis plans were not checked in this conversion, and independent clinical validation was not performed. The date is the original check date in retained summary and condition records. The retained verdict’s evidence date, historical access dates for individual materials and current external-access status are distinguished.
Article full text	Full text not acquired; unread	External access not attempted; not acquired	Not read	The report’s full text is not acquired or read. Its exact download URL and PDF/HTML format also remain unverified. Matsumoto2016 is a report linked in the retained summary. External abstracts, full texts, registration, protocols and analysis plans were not checked in this conversion, and independent clinical validation was not performed. The date is the original check date in retained summary and condition records. The retained verdict’s evidence date, historical access dates for individual materials and current external-access status are distinguished.
Trial registration identifier gateway	Registration identifier gateway; original registration unread	External access not attempted; not acquired	Not read	This gateway was constructed from citation identifier NCT01534910. The original registration field remains unverified, as do the original registration, preregistration and SAP. Matsumoto2016 is a report linked in the retained summary. External abstracts, full texts, registration, protocols and analysis plans were not checked in this conversion, and independent clinical validation was not performed. The date is the original check date in retained summary and condition records. The retained verdict’s evidence date, historical access dates for individual materials and current external-access status are distinguished.
Retained verdict summary	Retained verdict summary read	Retained copy acquired; summary read	Stored existing review summary read	The retained Korean/English verdict summary, evidence and citation were read. This does not establish reading of the original abstract, full text or registration. Matsumoto2016 is a report linked in the retained summary. External abstracts, full texts, registration, protocols and analysis plans were not checked in this conversion, and independent clinical validation was not performed. The date is the original check date in retained summary and condition records. The retained verdict’s evidence date, historical access dates for individual materials and current external-access status are distinguished.

Report counts versus independent study counts

The retained evidence and citation link to a report by Matsumoto2016. Group changes and adjusted β are different analysis layers for the same imaging endpoint. Unique-trial counts, participant totals and independent replication 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 AGE product, population, time frame and imaging endpoint does this question concern?

Required materials and conditions: The original protocol and result tables linking this population, formulation, route, dose, comparator and time point.
Conditions for verification: Limit the question to change in CCTA %LAP after about 12 months of AGE capsules at 2,400 mg/day versus matching placebo plus usual care in adults with metabolic syndrome continuing their usual risk-factor treatment.
Requirement and applicability: Required
Application exceptions: Do not combine total plaque, noncalcified plaque, dense calcium, plaque disappearance, myocardial infarction/death or other garlic formulations with this question.
Why this condition is needed: Different question identities can mix different effects under the same garlic or plaque label.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.

N02 · Are multiple analyses or repeated citations of a report being counted as separate trials?

Required materials and conditions: Study-family material linking registration, recruitment identity, the population/time points of each report, related reports and an included-trial table.
Conditions for verification: Link the first evidence summary and first citation within the same retained report context, and distinguish group percentage changes from adjusted β as different analyses of the same endpoint. Leave the background diabetes trial unidentified.
Requirement and applicability: Required
Application exceptions: Without a study-family linkage and an independent citation for the diabetes report, do not estimate the unique study count or participant total.
Why this condition is needed: A paper citation and an evidence table, or group values and a regression coefficient, do not each constitute independent replication.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.

N03 · Is the summary actually read distinguished from unread external material?

Required materials and conditions: For each material, the actual access date, attempts/success, acquired file, source location, reading scope and safe link.
Conditions for verification: Link the reading of all fields, Korean and English text, evidence and citations in the retained summary to source locations and identity checks, and distinguish existence, access, acquisition and reading for PubMed, DOI, full text and registration separately.
Requirement and applicability: Required
Application exceptions: Do not describe an unattempted access as a failed access, or replace an absent historical access date with the current reading date.
Why this condition is needed: An identifier or the word verified in the original English text is not evidence of full-text reading during this work.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.

N04 · How were the analyzed adults with metabolic syndrome selected?

Required materials and conditions: Eligibility/exclusion criteria, the metabolic-syndrome definition, baseline tables, age, comorbidities, recruitment setting and a flow diagram.
Conditions for verification: Retain the population definition of metabolic syndrome with continued usual treatment, and distinguish diagnostic criteria, age, eligibility/exclusions, baseline balance and analysis losses.
Requirement and applicability: Required
Application exceptions: Do not reinterpret the 55 adults in the population description as the entire enrollment denominator or as participants in the separate diabetes trial.
Why this condition is needed: The analyzed sample of 55 alone cannot establish representativeness for all people with metabolic syndrome or all patients with diabetes.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.

N05 · Are the AGE capsule product and SAC specifications identified?

Required materials and conditions: Product name, manufacturing/aging process, standardization specifications such as SAC, and trial-batch analyses.
Conditions for verification: Separately compare the AGE capsule formulation of aged Allium sativum clove extract with SAC standardization, aging process, content and product identity.
Requirement and applicability: Required
Application exceptions: Do not interchange raw garlic, powder, oil, stabilized allicin, black garlic, fermented garlic or isolated SAC with AGE, or convert AGE mg into SAC mg.
Why this condition is needed: The same AGE dose in mg does not establish identical SAC content or processed formulation.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.

N06 · What are the actual oral exposure and placebo comparison?

Required materials and conditions: Dosing records, capsule schedule, placebo composition/appearance, adherence and actual exposure by group.
Conditions for verification: Link nominal oral add-on AGE at 2,400 mg/day with matching placebo plus usual care, and separately compare actual intake, capsule count, placebo content and adherence.
Requirement and applicability: Required
Application exceptions: Do not invent capsule counts, SAC amounts or adherence rates without source material, or turn this into a trial of replacing usual treatment.
Why this condition is needed: A planned dose or placebo label does not establish actual exposure or the full implementation of blinding.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.

N07 · Which imaging component and denominator does %LAP measure?

Required materials and conditions: The LAP measurement definition, attenuation cutoff, segmentation criteria, percentage calculation specification and result-table notes.
Conditions for verification: Attribute the result to change in CCTA percent low-attenuation plaque volume, and compare the attenuation cutoff, segmentation, percentage numerator/denominator and scale direction.
Requirement and applicability: Required
Application exceptions: Do not convert the original percentage into a new percentage-point or relative change, or interpret it as plaque disappearance.
Why this condition is needed: The low-attenuation plaque component, total plaque, calcium and volume scales are different endpoints.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.

N08 · How are treatment duration and the CCTA scan interval distinguished?

Required materials and conditions: Treatment duration by group, scan dates/windows and baseline-to-follow-up image matching.
Conditions for verification: Retain the original notation of about 12 months of treatment and a CCTA interval of 354±41 days, and verify group scan windows, individual time points and the scope of baseline/follow-up image pairs.
Requirement and applicability: Required
Application exceptions: Do not assume the dispersion type of 354±41, or convert it into exactly 12 months or long-term persistence.
Why this condition is needed: Differences between treatment duration and outcome collection time can affect interpretation of progression.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.

N09 · Which values describe unadjusted group percentage changes?

Required materials and conditions: Group result tables, change definitions, dispersion notes, testing specifications and the analysis population.
Conditions for verification: Retain −1.5±2.3% versus +0.2±2.0%, P=.0049, at the group-change level, distinct from adjusted β and new between-group calculations.
Requirement and applicability: Required
Application exceptions: Do not calculate a new between-group difference or RR/OR, or turn the ± values into confidence intervals.
Why this condition is needed: Simple subtraction of group changes does not substitute for the effect the trial estimated.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.

N10 · Which analysis does the adjusted β estimate come from?

Required materials and conditions: The regression model, adjustment variables and selection rationale, SAP, coefficient unit and result table.
Conditions for verification: Retain β −1.61, 95% CI −2.79~−0.43, P=.008, and compare adjustment variables, model, target effect and analysis set.
Requirement and applicability: Required
Application exceptions: Do not turn β into a separate trial, OR/RR or new clinical effect, or invent its unit.
Why this condition is needed: A regression coefficient and group changes are different analysis levels of the same imaging endpoint.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.

N11 · What are the enrollment, analysis and group denominators?

Required materials and conditions: A group flow diagram from recruitment through allocation, treatment, scanning, completion and analysis, and the outcome denominators.
Conditions for verification: Keep 65 enrolled, 55 analyzed and AGE 27/placebo 28 as separate levels, and compare total/group randomized allocation, completion and imaging-analysis denominators.
Requirement and applicability: Required
Application exceptions: Do not newly subtract dropout counts/rates, or relabel 27 and 28 as the originally allocated group sizes.
Why this condition is needed: Enrollment of 65 does not prove randomized allocation of 65 or the ITT denominator for each outcome.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.

N12 · How do missing data, completer analysis and ITT differ?

Required materials and conditions: Missingness/dropout by group, exclusion rules, ITT/completer specifications, missing-data handling and sensitivity analyses.
Conditions for verification: Compare losses from enrollment to analysis, reasons, handling, sensitivity and the target effect, and state that full ITT remains unverified.
Requirement and applicability: Required
Application exceptions: Do not treat generic English participant-count wording as proof of ITT, or turn unverified missingness into confirmed selection bias.
Why this condition is needed: Whether results only from scannable participants equal the effect in all allocated participants requires separate verification.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.

N13 · Are the meanings of dispersion and reported intervals verified?

Required materials and conditions: SD/SE/CI notes, interval estimation method, denominators, distributions and the original result table.
Conditions for verification: Keep group ± and the β 95% CI as different statistical expressions, and compare dispersion type, denominator and interval estimation method.
Requirement and applicability: Required
Application exceptions: Do not calculate a new CI from ± or substitute the adjusted CI for an unadjusted between-group interval.
Why this condition is needed: Sample size or P alone cannot establish precision or the meaning of an interval.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.

N14 · Is a threshold for the importance of the imaging signal justified?

Required materials and conditions: Material justifying LAP measurement error and an importance/interpretation threshold, together with the relevant intervals.
Conditions for verification: Distinguish statistical reporting of CCTA %LAP/β from a justified threshold for important or clinical change in this population.
Requirement and applicability: Required
Application exceptions: Do not automatically inherit C46/EX as this row's status or as a new efficacy score.
Why this condition is needed: A statistically significant imaging value and a clinically important patient effect are different judgments.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.

N15 · Are results showing no difference outside LAP also retained?

Required materials and conditions: Component-specific result tables, time points, denominators, scales, analyses and selection rationales.
Conditions for verification: Attribute the LAP signal and original null descriptions of TPV, noncalcified plaque and dense calcium separately; do not label different endpoints as conflicting results from the same analysis.
Requirement and applicability: Required
Application exceptions: These are other imaging measures; do not newly designate them as confirmed prespecified secondary (2nd) endpoints. Do not convert nonsignificance into exactly 0 or equivalence.
Why this condition is needed: Keeping only a signal in a component can encourage extending the answer to total plaque.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.

N16 · Which dates and verification scope define these evidence gaps?

Required materials and conditions: The historical search scope, access history, evidence cutoff, checks for unpublished material/corrections/retractions, and a new update event.
Conditions for verification: Distinguish the verdict date 2026-09-08, correction 09-14 and retained-summary review date, and state that no new literature or registration search was performed.
Requirement and applicability: Required
Application exceptions: Do not label this unverified status as 0 studies, no recent retractions, or nonreporting throughout the paper.
Why this condition is needed: The historical review date and conversion date are not dates of a current comprehensive literature check.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.

N17 · What is known about product-company support and research independence?

Required materials and conditions: Funding, product provision, author employment/patents/interests, design/analysis roles and research-lineage declarations.
Conditions for verification: Distinguish Wakunaga/industry support from product provision, authors/institutions and analytical involvement; do not promote unverified information into independent replication.
Requirement and applicability: Required (independence interpretation boundary)
Application exceptions: Do not automatically exclude a report solely because of company funding, or treat generic English funding wording as verification of detailed conflicts of interest.
Why this condition is needed: Funding, recruitment family and product identity are separate elements of independence.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.

N18 · Does the randomized/blinded label match the actual allocation process?

Required materials and conditions: Allocation methods, concealment, baseline tables, implementation of blinding and the methods section.
Conditions for verification: Retain the prospective double-blind randomized placebo-controlled label, and compare sequence generation/concealment, baseline balance, implementation and analysis unit.
Requirement and applicability: Required
Application exceptions: Do not replace unverified design information with crossover/cluster NA, or treat double-blind as confirmation of blinded CCTA assessors.
Why this condition is needed: The RCT/double-blind label is not certification that allocation problems or confounding were resolved.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.

N19 · Could usual risk-factor treatment and adherence differences be mixed into the result?

Required materials and conditions: Group background drugs/treatment, lifestyle factors, changes, adherence, rescue treatment and handling of these factors.
Conditions for verification: Retain continued usual treatment and placebo plus usual care, and compare the contributions of group drugs, diet, changes, adherence and rescue treatment.
Requirement and applicability: Required
Application exceptions: Do not require every change to be identical, or reinterpret this as a trial replacing usual treatment.
Why this condition is needed: Attributing changes in other treatment to AGE would change the add-on treatment question.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.

N20 · Are CCTA reading, reproducibility and assessor blinding verified?

Required materials and conditions: Imaging conditions, image quality, reading/segmentation procedures, blinding, reproducibility and error handling.
Conditions for verification: Separately compare scanning/segmentation, readers, reproducibility, group measurement conditions and assessor blinding.
Requirement and applicability: Required
Application exceptions: Do not certify assessor blinding from the double-blind label or assume an objective image is free of bias.
Why this condition is needed: Differences in measurement conditions must be distinguished from actual differences in plaque.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.

N21 · Were the prespecified LAP endpoint hierarchy and SAP compared?

Required materials and conditions: Dated registration text, protocol, SAP, endpoint/analysis change history and actual result tables.
Conditions for verification: Retain both the named endpoint in the intervention/population description and the evidence summary's unverified prespecified LAP-only primary (1st) hierarchy, and compare registration/protocol/SAP with actual results.
Requirement and applicability: Required
Application exceptions: The NCT string does not establish successful reading of registration/SAP. Do not turn unverified information into confirmed nonregistration, selective reporting or a positive secondary endpoint after a failed primary endpoint.
Why this condition is needed: The original plan is needed to assess possible selection of favorable components or analyses.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.

N22 · Is another report an independent replication of the same product and population question?

Required materials and conditions: Recruitment, product specifications, population, endpoint/time point, funding/lineage and a trial-family table.
Conditions for verification: Distinguish metabolic-syndrome AGE-LAP from the diabetes background and excluded combinations, and compare whether product, population, institution/funding and recruitment family are the same, different or unknown.
Requirement and applicability: Required
Application exceptions: Do not create S02 from the diabetes background or transfer effects of AGE+B vitamins+folic acid+L-arginine to AGE alone. Do not turn an unverified family into NA.
Why this condition is needed: Signals in another population and reports sharing a product company cannot be combined as independent confirmation.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.

N23 · Does this question also require an optimal dose?

Required materials and conditions: For a dose-optimization claim: direct comparisons of doses with matching specifications, exposure/adherence and a separate estimate.
Conditions for verification: Separate the selected imaging question at 2,400 mg/day from additional dose-optimization/dose-response claims.
Requirement and applicability: Supplementary; required to extend to optimal dosing
Application exceptions: NA applies only to the obligation for a dose-optimization extension. Unverified direct dose evidence and specification gaps remain.
Why this condition is needed: A dose is not certification of an optimal dose, but dose research is not required for the narrow question.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.

N24 · Is persistence of the imaging effect after treatment stops being claimed?

Required materials and conditions: For a persistence claim: post-treatment scan times, exposure, treatment changes, group follow-up denominators and results.
Conditions for verification: Distinguish observation over about 12 months from separate questions of post-treatment persistence or long-term progression.
Requirement and applicability: Supplementary; required for persistence after stopping
Application exceptions: NA applies only to the post-treatment extension obligation; it does not exclude the current duration or scan conditions.
Why this condition is needed: Observation during treatment and persistence after stopping treatment have different time specifications.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.

N25 · Is a larger effect in a particular subgroup being claimed?

Required materials and conditions: For a subgroup claim: prespecified hypotheses, denominators, direct interaction estimates and plans.
Conditions for verification: Separate the selected metabolic-syndrome result from prespecified subgroups/interactions and the separate diabetes population.
Requirement and applicability: Supplementary; required for subgroup extensions
Application exceptions: NA applies only to the subgroup-extension obligation; population representativeness and the diabetes family remain unverified.
Why this condition is needed: A favorable subgroup value or a trial in another population is not the magnitude of the overall result.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.

N26 · Is the LAP signal being extended to plaque disappearance or prevention of clinical events?

Required materials and conditions: For an event extension: event definitions, denominators/follow-up, direct between-group results and plans.
Conditions for verification: Distinguish the imaging component from separate questions of total plaque disappearance, myocardial infarction and death; retain the boundary around unmeasured events.
Requirement and applicability: Required (clinical interpretation boundary)
Application exceptions: Retain the imaging observation without requiring an event trial as a condition for the existence of that result.
Why this condition is needed: A signal in an imaging surrogate component does not prove clinical prevention or plaque disappearance.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.

N27 · Are harm-event definitions and collection verified?

Required materials and conditions: Adverse-event definitions, collection methods, group reports, discontinuation/severity and source data.
Conditions for verification: Distinguish actual bleeding/adverse events, definitions, collection, severity and discontinuation for the same AGE/population from general caution.
Requirement and applicability: Supplementary; required for harm and safety questions
Application exceptions: Do not turn caution into actual bleeding counts or causality, or delete the imaging result because harm remains unverified.
Why this condition is needed: An efficacy summary or caution does not establish complete accounting of actual harms.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.

N28 · Is the temporal sequence of exposure and harm events known?

Required materials and conditions: Times of exposure initiation, events, discontinuation, recovery and re-exposure, with follow-up records.
Conditions for verification: Distinguish AGE initiation/discontinuation, events/recovery, re-exposure and harm-observation duration from the imaging interval.
Requirement and applicability: Supplementary; required for harm timing questions
Application exceptions: Do not infer events, improvement or re-exposure without source text, or fill harm timelines solely from treatment duration.
Why this condition is needed: An imaging interval does not substitute for the timing of bleeding or interactions.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.

N29 · Are event and exposure denominators available to interpret harm comparisons?

Required materials and conditions: Group harm-exposure/event denominators, people/event counts, duration, placebo comparisons and result tables.
Conditions for verification: Link exposed participants, people/event counts, duration and placebo events, distinct from imaging-analysis counts of 55/27/28.
Requirement and applicability: Supplementary; required for incidence or comparative-risk claims
Application exceptions: Do not substitute 55, 27 or 28 as safety denominators, or newly calculate incidence, background rates or RR.
Why this condition is needed: Imaging-analysis denominators are not denominators for harm frequency or increased risk.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.

N30 · Were concomitant drugs and alternative explanations verified?

Required materials and conditions: Concomitant drugs/doses, surgery, baseline risks, simultaneous exposure, alternatives and relevant harm material.
Conditions for verification: Distinguish usual treatment from anticoagulant/antiplatelet and surgery warnings, and compare actual simultaneous exposure, baseline risks and alternatives.
Requirement and applicability: Supplementary; required for causal or comparative harm
Application exceptions: Do not interpret unverified alternatives as absence of other causes, or extend the original caution into new individual dosing instructions.
Why this condition is needed: A warning list does not verify actual concomitant use in the trial or the cause of an event.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.

N31 · Is the scope missed by harm collection and follow-up known?

Required materials and conditions: Group safety follow-up, reasons for missingness, detection differences and the disclosure scope for all events.
Conditions for verification: Distinguish harm detection, follow-up loss, collection and disclosure from imaging-analysis losses.
Requirement and applicability: Supplementary; required for the scope of harm surveillance
Application exceptions: Do not turn unverified collection into event absence or a confirmed magnitude of bias.
Why this condition is needed: There is no guarantee that imaging loss and harm-surveillance loss are identical.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.

N32 · Are repeated harm warnings being counted as independent events?

Required materials and conditions: Unique harm report/case identifiers, exposure/event matching, repeated citations and family material.
Conditions for verification: Distinguish general caution and recitation of the same material from new harm events/studies, and link product, population and event families.
Requirement and applicability: Supplementary; required for repeated harm signals
Application exceptions: Do not query new regulatory/case material during this work or turn diabetes efficacy background into repeated harm evidence.
Why this condition is needed: Repetition of caution across Korean, English and synthesized summaries does not increase independent event counts.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.

N33 · What about long-term or rare harms and vulnerable groups beyond the imaging observation?

Required materials and conditions: Suitable designs and denominators/follow-up for long-term/rare events and interactions under the same exposure and by population.
Conditions for verification: Separate the imaging question over about 12 months from harms involving long-term bleeding, interactions and surgical/anticoagulant conditions.
Requirement and applicability: Supplementary; required for long-term or vulnerable-group harms
Application exceptions: Do not require every long-term harm study for the narrow imaging question, or convert unverified information into harmlessness.
Why this condition is needed: An imaging study in a limited population does not guarantee overall safety.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.

N34 · How far can harms and safety be described from this material?

Required materials and conditions: Harm source data connecting events, exposure/denominators, timing, comparison and alternatives, with the interpretation scope.
Conditions for verification: Distinguish caution from actual signals, comparative risk and causality, and limit the current scope separately from imaging efficacy and the historical safety label.
Requirement and applicability: Required (safety interpretation boundary)
Application exceptions: Do not create individual dosing instructions, a new safety grade, a guarantee of harmlessness or a confirmed causal link to bleeding.
Why this condition is needed: Historical caution and the current verification level of harm source data are separate matters.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. 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 does not establish 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 extension obligation outside the narrow question does not apply. This state does not substitute for unread or unverified material.
Not applicable (alias): This is the gray-display alias of Not applicable.
Not read: External material was not directly read in this conversion. This is distinguished from reading the retained verdict summary.
Conflicting data: This covers an actual discrepancy between reports of the same question, denominator and timing. Differences between separate questions are not automatically treated as conflicting data.

Change history

2026-10-25 · Public page/material version 1.0

The public view and materials were prepared from the existing 34 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 AGE product, population, time frame and imaging endpoint does this question concern?

Current findings: The Korean claim concerns reduced progression of low-attenuation coronary plaque in adults with metabolic syndrome. The intervention and population description links AGE capsules, 2,400 mg/day, about 12 months/a CCTA interval of 354±41 days, and matching placebo plus usual care. There are no additional subclaims.
Verification status: Met
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External PubMed, DOI, full-text and registration material remain unread, with access not attempted.
Why unverified: The retained text identifies the distinct question and its exclusions. This does not establish verification of the trial plan or confirmation of imaging efficacy.
Reason for missing information: Direct comparison with the original protocol and detailed product and imaging specifications remains unverified under the conditions below.
Required materials and conditions: The original protocol and result tables linking this population, formulation, route, dose, comparator and time point.
Materials to obtain first: The original protocol and result tables linking this population, formulation, route, dose, comparator and time point.
Further research: Material needed: The original protocol and result tables linking this population, formulation, route, dose, comparator and time point. This records needed materials; no new research was executed.
Remaining uncertainty: Direct comparison with the original protocol and detailed product and imaging specifications remains unverified under the conditions below.
Conditions for verification: Limit the question to change in CCTA %LAP after about 12 months of AGE capsules at 2,400 mg/day versus matching placebo plus usual care in adults with metabolic syndrome continuing their usual risk-factor treatment.
Why this condition is needed: Different question identities can mix different effects under the same garlic or plaque label.
Application exceptions: Do not combine total plaque, noncalcified plaque, dense calcium, plaque disappearance, myocardial infarction/death or other garlic formulations with this question.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.

Related sources S01

N02 · Are multiple analyses or repeated citations of a report being counted as separate trials?

Current findings: The 1 evidence summary and 1 citation correspond to a report by Matsumoto2016. The research description separates unadjusted values from adjusted β. The diabetes trial appears only as background described as sharing the product company and research lineage.
Verification status: Partly verified
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External PubMed, DOI, full-text and registration material remain unread, with access not attempted.
Why unverified: The local report pair and analysis levels are linked, but external recruitment identities and related report families have not been newly verified.
Reason for missing information: Identifiers for the background diabetes report, recruitment overlap, the unique family count and the participant total remain unverified in the retained material.
Required materials and conditions: Study-family material linking registration, recruitment identity, the population/time points of each report, related reports and an included-trial table.
Materials to obtain first: Study-family material linking registration, recruitment identity, the population/time points of each report, related reports and an included-trial table.
Further research: Material needed: Study-family material linking registration, recruitment identity, the population/time points of each report, related reports and an included-trial table. This records needed materials; no new research was executed.
Remaining uncertainty: Identifiers for the background diabetes report, recruitment overlap, the unique family count and the participant total remain unverified in the retained material.
Conditions for verification: Link the first evidence summary and first citation within the same retained report context, and distinguish group percentage changes from adjusted β as different analyses of the same endpoint. Leave the background diabetes trial unidentified.
Why this condition is needed: A paper citation and an evidence table, or group values and a regression coefficient, do not each constitute independent replication.
Application exceptions: Without a study-family linkage and an independent citation for the diabetes report, do not estimate the unique study count or participant total.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.

Related sources S01

N03 · Is the summary actually read distinguished from unread external material?

Current findings: The retained Korean and English verdict summary was read. A PubMed URL, DOI and NCT01534910 identifier are present, but external abstracts, full text and registration have not been accessed, acquired or read.
Verification status: Met
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External PubMed, DOI, full-text and registration material remain unread, with access not attempted.
Why unverified: The local summary reading is separated from unread external material, with citation locations and hashes linked. This does not establish verification of external content.
Reason for missing information: Past access dates, reading levels and the physical bytes of an acquired full text for each report are absent from the retained summary and remain unverified.
Required materials and conditions: For each material, the actual access date, attempts/success, acquired file, source location, reading scope and safe link.
Materials to obtain first: For each material, the actual access date, attempts/success, acquired file, source location, reading scope and safe link.
Further research: Material needed: For each material, the actual access date, attempts/success, acquired file, source location, reading scope and safe link. This records needed materials; no new research was executed.
Remaining uncertainty: Past access dates, reading levels and the physical bytes of an acquired full text for each report are absent from the retained summary and remain unverified.
Conditions for verification: Link the reading of all fields, Korean and English text, evidence and citations in the retained summary to source locations and identity checks, and distinguish existence, access, acquisition and reading for PubMed, DOI, full text and registration separately.
Why this condition is needed: An identifier or the word verified in the original English text is not evidence of full-text reading during this work.
Application exceptions: Do not describe an unattempted access as a failed access, or replace an absent historical access date with the current reading date.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.

Related sources S01

N04 · How were the analyzed adults with metabolic syndrome selected?

Current findings: The intervention and population description records 55 adults with metabolic syndrome continuing their usual risk-factor treatment. The evidence count separately distinguishes 65 enrolled from 55 analyzed.
Verification status: Partly verified
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External PubMed, DOI, full-text and registration material remain unread, with access not attempted.
Why unverified: The diagnosis label and continued treatment are identified, but detailed selection, age, baseline characteristics and recruitment setting remain unverified.
Reason for missing information: The metabolic-syndrome definition, age distribution, eligibility/exclusions, baseline balance and characteristics of people excluded from analysis remain unverified.
Required materials and conditions: Eligibility/exclusion criteria, the metabolic-syndrome definition, baseline tables, age, comorbidities, recruitment setting and a flow diagram.
Materials to obtain first: Eligibility/exclusion criteria, the metabolic-syndrome definition, baseline tables, age, comorbidities, recruitment setting and a flow diagram.
Further research: Material needed: Eligibility/exclusion criteria, the metabolic-syndrome definition, baseline tables, age, comorbidities, recruitment setting and a flow diagram. This records needed materials; no new research was executed.
Remaining uncertainty: The metabolic-syndrome definition, age distribution, eligibility/exclusions, baseline balance and characteristics of people excluded from analysis remain unverified.
Conditions for verification: Retain the population definition of metabolic syndrome with continued usual treatment, and distinguish diagnostic criteria, age, eligibility/exclusions, baseline balance and analysis losses.
Why this condition is needed: The analyzed sample of 55 alone cannot establish representativeness for all people with metabolic syndrome or all patients with diabetes.
Application exceptions: Do not reinterpret the 55 adults in the population description as the entire enrollment denominator or as participants in the separate diabetes trial.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.

Related sources S01

N05 · Are the AGE capsule product and SAC specifications identified?

Current findings: The formulation is AGE capsules; detailed SAC specifications are unverified. The source part is aged clove extract, and both the Korean and English texts caution against treating other garlic formulations as interchangeable.
Verification status: Partly verified
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External PubMed, DOI, full-text and registration material remain unread, with access not attempted.
Why unverified: The aged-extract capsule formulation is identified, but detailed product and SAC specifications remain unverified.
Reason for missing information: Product name, trial batch, aging process, SAC content/specifications and equivalence to other AGE products remain unverified.
Required materials and conditions: Product name, manufacturing/aging process, standardization specifications such as SAC, and trial-batch analyses.
Materials to obtain first: Product name, manufacturing/aging process, standardization specifications such as SAC, and trial-batch analyses.
Further research: Material needed: Product name, manufacturing/aging process, standardization specifications such as SAC, and trial-batch analyses. This records needed materials; no new research was executed.
Remaining uncertainty: Product name, trial batch, aging process, SAC content/specifications and equivalence to other AGE products remain unverified.
Conditions for verification: Separately compare the AGE capsule formulation of aged Allium sativum clove extract with SAC standardization, aging process, content and product identity.
Why this condition is needed: The same AGE dose in mg does not establish identical SAC content or processed formulation.
Application exceptions: Do not interchange raw garlic, powder, oil, stabilized allicin, black garlic, fermented garlic or isolated SAC with AGE, or convert AGE mg into SAC mg.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.

Related sources S01

N06 · What are the actual oral exposure and placebo comparison?

Current findings: The original dose is 2,400 mg/day, given orally as add-on treatment, with matching placebo plus usual care as comparator. Actual capsule count, placebo composition and adherence remain unverified in the retained summary.
Verification status: Partly verified
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External PubMed, DOI, full-text and registration material remain unread, with access not attempted.
Why unverified: The nominal dosing and comparison are retained, while actual exposure, placebo details and adherence remain to be verified.
Reason for missing information: Direct material on capsule count, actual dosing/adherence, placebo ingredients and matching appearance remains unverified.
Required materials and conditions: Dosing records, capsule schedule, placebo composition/appearance, adherence and actual exposure by group.
Materials to obtain first: Dosing records, capsule schedule, placebo composition/appearance, adherence and actual exposure by group.
Further research: Material needed: Dosing records, capsule schedule, placebo composition/appearance, adherence and actual exposure by group. This records needed materials; no new research was executed.
Remaining uncertainty: Direct material on capsule count, actual dosing/adherence, placebo ingredients and matching appearance remains unverified.
Conditions for verification: Link nominal oral add-on AGE at 2,400 mg/day with matching placebo plus usual care, and separately compare actual intake, capsule count, placebo content and adherence.
Why this condition is needed: A planned dose or placebo label does not establish actual exposure or the full implementation of blinding.
Application exceptions: Do not invent capsule counts, SAC amounts or adherence rates without source material, or turn this into a trial of replacing usual treatment.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.

Related sources S01

N07 · Which imaging component and denominator does %LAP measure?

Current findings: The named endpoint is change in CCTA percent low-attenuation plaque volume. The original central explanation limits interpretation to the low-attenuation component rather than total plaque.
Verification status: Partly verified
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External PubMed, DOI, full-text and registration material remain unread, with access not attempted.
Why unverified: The imaging endpoint name is identified, but the attenuation cutoff, segmentation, percentage numerator/denominator and exact scale specification remain unverified.
Reason for missing information: Details of the attenuation cutoff, numerator/denominator, measurement algorithm, scale direction and unit interpretation remain unverified.
Required materials and conditions: The LAP measurement definition, attenuation cutoff, segmentation criteria, percentage calculation specification and result-table notes.
Materials to obtain first: The LAP measurement definition, attenuation cutoff, segmentation criteria, percentage calculation specification and result-table notes.
Further research: Material needed: The LAP measurement definition, attenuation cutoff, segmentation criteria, percentage calculation specification and result-table notes. This records needed materials; no new research was executed.
Remaining uncertainty: Details of the attenuation cutoff, numerator/denominator, measurement algorithm, scale direction and unit interpretation remain unverified.
Conditions for verification: Attribute the result to change in CCTA percent low-attenuation plaque volume, and compare the attenuation cutoff, segmentation, percentage numerator/denominator and scale direction.
Why this condition is needed: The low-attenuation plaque component, total plaque, calcium and volume scales are different endpoints.
Application exceptions: Do not convert the original percentage into a new percentage-point or relative change, or interpret it as plaque disappearance.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.

Related sources S01

N08 · How are treatment duration and the CCTA scan interval distinguished?

Current findings: The original duration is about 12 months, and the CCTA interval is 354±41 days. Details of group and individual scan times and time windows are not separately retained.
Verification status: Partly verified
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External PubMed, DOI, full-text and registration material remain unread, with access not attempted.
Why unverified: The reported time notation is retained, but correspondence between scans and treatment exposure by group remains unverified.
Reason for missing information: Scan windows, discontinued/missing scans and the statistical meaning of ±41 remain unverified in the current material.
Required materials and conditions: Treatment duration by group, scan dates/windows and baseline-to-follow-up image matching.
Materials to obtain first: Treatment duration by group, scan dates/windows and baseline-to-follow-up image matching.
Further research: Material needed: Treatment duration by group, scan dates/windows and baseline-to-follow-up image matching. This records needed materials; no new research was executed.
Remaining uncertainty: Scan windows, discontinued/missing scans and the statistical meaning of ±41 remain unverified in the current material.
Conditions for verification: Retain the original notation of about 12 months of treatment and a CCTA interval of 354±41 days, and verify group scan windows, individual time points and the scope of baseline/follow-up image pairs.
Why this condition is needed: Differences between treatment duration and outcome collection time can affect interpretation of progression.
Application exceptions: Do not assume the dispersion type of 354±41, or convert it into exactly 12 months or long-term persistence.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.

Related sources S01

N09 · Which values describe unadjusted group percentage changes?

Current findings: The original result distinguishes −1.5±2.3% versus +0.2±2.0%, P=.0049, from adjusted β. The Korean and English reader answers also report group values of −1.5% versus +0.2% separately.
Verification status: Partly verified
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External PubMed, DOI, full-text and registration material remain unread, with access not attempted.
Why unverified: Group values, signs, percentages and P are identified, but the change definition, testing, dispersion and exact analysis specification remain unverified.
Reason for missing information: The types of ±2.3/±2.0, such as SD/SE, the percentage-change specification, test method and analysis set remain unverified.
Required materials and conditions: Group result tables, change definitions, dispersion notes, testing specifications and the analysis population.
Materials to obtain first: Group result tables, change definitions, dispersion notes, testing specifications and the analysis population.
Further research: Material needed: Group result tables, change definitions, dispersion notes, testing specifications and the analysis population. This records needed materials; no new research was executed.
Remaining uncertainty: The types of ±2.3/±2.0, such as SD/SE, the percentage-change specification, test method and analysis set remain unverified.
Conditions for verification: Retain −1.5±2.3% versus +0.2±2.0%, P=.0049, at the group-change level, distinct from adjusted β and new between-group calculations.
Why this condition is needed: Simple subtraction of group changes does not substitute for the effect the trial estimated.
Application exceptions: Do not calculate a new between-group difference or RR/OR, or turn the ± values into confidence intervals.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.

Related sources S01

N10 · Which analysis does the adjusted β estimate come from?

Current findings: The original adjusted β is −1.61, with 95% CI −2.79~−0.43, P=.008. The research description distinguishes unadjusted values from β.
Verification status: Partly verified
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External PubMed, DOI, full-text and registration material remain unread, with access not attempted.
Why unverified: The β and CI/P strings are retained, but variables, model, coefficient unit and SAP remain unverified.
Reason for missing information: Adjustment variables, model, coefficient unit, diagnostics, and alignment of the target effect and analysis set remain unverified.
Required materials and conditions: The regression model, adjustment variables and selection rationale, SAP, coefficient unit and result table.
Materials to obtain first: The regression model, adjustment variables and selection rationale, SAP, coefficient unit and result table.
Further research: Material needed: The regression model, adjustment variables and selection rationale, SAP, coefficient unit and result table. This records needed materials; no new research was executed.
Remaining uncertainty: Adjustment variables, model, coefficient unit, diagnostics, and alignment of the target effect and analysis set remain unverified.
Conditions for verification: Retain β −1.61, 95% CI −2.79~−0.43, P=.008, and compare adjustment variables, model, target effect and analysis set.
Why this condition is needed: A regression coefficient and group changes are different analysis levels of the same imaging endpoint.
Application exceptions: Do not turn β into a separate trial, OR/RR or new clinical effect, or invent its unit.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.

Related sources S01

N11 · What are the enrollment, analysis and group denominators?

Current findings: The original count is 65 enrolled and 55 analyzed; AGE 27 and placebo 28. The evidence weighting states completers and industry support, while the reader answer states that full ITT is unverified.
Verification status: Partly verified
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External PubMed, DOI, full-text and registration material remain unread, with access not attempted.
Why unverified: Enrollment, analysis and reported group counts are identified, but original allocation, completion and exact outcome-denominator documents remain unverified.
Reason for missing information: Original total/group allocation, completion and outcome denominators, and their links to the analysis set, remain unverified.
Required materials and conditions: A group flow diagram from recruitment through allocation, treatment, scanning, completion and analysis, and the outcome denominators.
Materials to obtain first: A group flow diagram from recruitment through allocation, treatment, scanning, completion and analysis, and the outcome denominators.
Further research: Material needed: A group flow diagram from recruitment through allocation, treatment, scanning, completion and analysis, and the outcome denominators. This records needed materials; no new research was executed.
Remaining uncertainty: Original total/group allocation, completion and outcome denominators, and their links to the analysis set, remain unverified.
Conditions for verification: Keep 65 enrolled, 55 analyzed and AGE 27/placebo 28 as separate levels, and compare total/group randomized allocation, completion and imaging-analysis denominators.
Why this condition is needed: Enrollment of 65 does not prove randomized allocation of 65 or the ITT denominator for each outcome.
Application exceptions: Do not newly subtract dropout counts/rates, or relabel 27 and 28 as the originally allocated group sizes.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.

Related sources S01

N12 · How do missing data, completer analysis and ITT differ?

Current findings: The reader answer states that full ITT is unverified, and the evidence weighting labels completers. Beyond 65 enrolled and 55 analyzed, reasons for missingness, handling and analysis-set details are absent from the retained summary.
Verification status: Unverified
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External PubMed, DOI, full-text and registration material remain unread, with access not attempted.
Why unverified: The retained summary cannot verify missing-data handling, full ITT or sensitivity specifications. This is not a finding of effect 0 or nonreporting throughout the full text.
Reason for missing information: Group-specific reasons for missingness, inclusion of allocated participants, handling of missing scans and sensitivity analyses remain unverified.
Required materials and conditions: Missingness/dropout by group, exclusion rules, ITT/completer specifications, missing-data handling and sensitivity analyses.
Materials to obtain first: Missingness/dropout by group, exclusion rules, ITT/completer specifications, missing-data handling and sensitivity analyses.
Further research: Material needed: Missingness/dropout by group, exclusion rules, ITT/completer specifications, missing-data handling and sensitivity analyses. This records needed materials; no new research was executed.
Remaining uncertainty: Group-specific reasons for missingness, inclusion of allocated participants, handling of missing scans and sensitivity analyses remain unverified.
Conditions for verification: Compare losses from enrollment to analysis, reasons, handling, sensitivity and the target effect, and state that full ITT remains unverified.
Why this condition is needed: Whether results only from scannable participants equal the effect in all allocated participants requires separate verification.
Application exceptions: Do not treat generic English participant-count wording as proof of ITT, or turn unverified missingness into confirmed selection bias.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.

Related sources S01

N13 · Are the meanings of dispersion and reported intervals verified?

Current findings: Group values of −1.5±2.3% versus +0.2±2.0% and the adjusted β 95% CI of −2.79~−0.43 are retained separately. The statistical type of ± remains unverified.
Verification status: Partly verified
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External PubMed, DOI, full-text and registration material remain unread, with access not attempted.
Why unverified: The reported intervals and dispersion are identified, but their definitions, estimation methods and denominators have not been directly compared.
Reason for missing information: Whether ± means SD/SE, the interval estimation method, units, denominators and distributional assumptions remain unverified.
Required materials and conditions: SD/SE/CI notes, interval estimation method, denominators, distributions and the original result table.
Materials to obtain first: SD/SE/CI notes, interval estimation method, denominators, distributions and the original result table.
Further research: Material needed: SD/SE/CI notes, interval estimation method, denominators, distributions and the original result table. This records needed materials; no new research was executed.
Remaining uncertainty: Whether ± means SD/SE, the interval estimation method, units, denominators and distributional assumptions remain unverified.
Conditions for verification: Keep group ± and the β 95% CI as different statistical expressions, and compare dispersion type, denominator and interval estimation method.
Why this condition is needed: Sample size or P alone cannot establish precision or the meaning of an interval.
Application exceptions: Do not calculate a new CI from ± or substitute the adjusted CI for an unadjusted between-group interval.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.

Related sources S01

N14 · Is a threshold for the importance of the imaging signal justified?

Current findings: The original grade rationale records EX because the prespecified LAP-only hierarchy and clinical threshold are unclear. β, CI, P and the imaging result are retained.
Verification status: Unverified
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External PubMed, DOI, full-text and registration material remain unread, with access not attempted.
Why unverified: The retained material does not verify a justified LAP importance threshold. The imaging signal is retained without assigning a new grade.
Reason for missing information: Measurement error, a threshold for important change and its link to patient-important outcomes remain unverified.
Required materials and conditions: Material justifying LAP measurement error and an importance/interpretation threshold, together with the relevant intervals.
Materials to obtain first: Material justifying LAP measurement error and an importance/interpretation threshold, together with the relevant intervals.
Further research: Material needed: Material justifying LAP measurement error and an importance/interpretation threshold, together with the relevant intervals. This records needed materials; no new research was executed.
Remaining uncertainty: Measurement error, a threshold for important change and its link to patient-important outcomes remain unverified.
Conditions for verification: Distinguish statistical reporting of CCTA %LAP/β from a justified threshold for important or clinical change in this population.
Why this condition is needed: A statistically significant imaging value and a clinically important patient effect are different judgments.
Application exceptions: Do not automatically inherit C46/EX as this row's status or as a new efficacy score.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.

Related sources S01

N15 · Are results showing no difference outside LAP also retained?

Current findings: The original rationale records null changes in TPV, noncalcified plaque and dense calcium. The central explanation limits the positive signal to the LAP component.
Verification status: Met
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External PubMed, DOI, full-text and registration material remain unread, with access not attempted.
Why unverified: The original text retains both the LAP signal and null descriptions of other imaging measures. This does not establish verification of detailed tables or the prespecified hierarchy.
Reason for missing information: Effect estimates, CIs, denominators and the prespecified hierarchy for other plaque measures remain unverified in the retained summary.
Required materials and conditions: Component-specific result tables, time points, denominators, scales, analyses and selection rationales.
Materials to obtain first: Component-specific result tables, time points, denominators, scales, analyses and selection rationales.
Further research: Material needed: Component-specific result tables, time points, denominators, scales, analyses and selection rationales. This records needed materials; no new research was executed.
Remaining uncertainty: Effect estimates, CIs, denominators and the prespecified hierarchy for other plaque measures remain unverified in the retained summary.
Conditions for verification: Attribute the LAP signal and original null descriptions of TPV, noncalcified plaque and dense calcium separately; do not label different endpoints as conflicting results from the same analysis.
Why this condition is needed: Keeping only a signal in a component can encourage extending the answer to total plaque.
Application exceptions: These are other imaging measures; do not newly designate them as confirmed prespecified secondary (2nd) endpoints. Do not convert nonsignificance into exactly 0 or equivalence.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.

Related sources S01

N16 · Which dates and verification scope define these evidence gaps?

Current findings: The original verdict date is 2026-09-08, with a correction to temporary English wording on 2026-09-14. The conversion read retained Korean/English summaries and method definitions, without an external clinical search.
Verification status: Met
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External PubMed, DOI, full-text and registration material remain unread, with access not attempted.
Why unverified: The retained verdict/correction dates and conversion reading scope are distinguished. This is not completion of an updated search.
Reason for missing information: The historical search strategy, scope and cutoff, and current unpublished, registration-change or retraction status remain unverified in the retained summary.
Required materials and conditions: The historical search scope, access history, evidence cutoff, checks for unpublished material/corrections/retractions, and a new update event.
Materials to obtain first: The historical search scope, access history, evidence cutoff, checks for unpublished material/corrections/retractions, and a new update event.
Further research: Material needed: The historical search scope, access history, evidence cutoff, checks for unpublished material/corrections/retractions, and a new update event. This records needed materials; no new research was executed.
Remaining uncertainty: The historical search strategy, scope and cutoff, and current unpublished, registration-change or retraction status remain unverified in the retained summary.
Conditions for verification: Distinguish the verdict date 2026-09-08, correction 09-14 and retained-summary review date, and state that no new literature or registration search was performed.
Why this condition is needed: The historical review date and conversion date are not dates of a current comprehensive literature check.
Application exceptions: Do not label this unverified status as 0 studies, no recent retractions, or nonreporting throughout the paper.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.

Related sources S01

N17 · What is known about product-company support and research independence?

Current findings: Funding is recorded as support from Wakunaga of America, and evidence weighting states completers and industry support. A retained description places the diabetes trial within the same product company and research lineage.
Verification status: Partly verified
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External PubMed, DOI, full-text and registration material remain unread, with access not attempted.
Why unverified: The funding party and historical industry support are known, but product provision, author employment, design/analysis involvement and detailed declarations remain unverified.
Reason for missing information: Product donation, author employment/patents, involvement and detailed independence declarations by family remain unverified.
Required materials and conditions: Funding, product provision, author employment/patents/interests, design/analysis roles and research-lineage declarations.
Materials to obtain first: Funding, product provision, author employment/patents/interests, design/analysis roles and research-lineage declarations.
Further research: Material needed: Funding, product provision, author employment/patents/interests, design/analysis roles and research-lineage declarations. This records needed materials; no new research was executed.
Remaining uncertainty: Product donation, author employment/patents, involvement and detailed independence declarations by family remain unverified.
Conditions for verification: Distinguish Wakunaga/industry support from product provision, authors/institutions and analytical involvement; do not promote unverified information into independent replication.
Why this condition is needed: Funding, recruitment family and product identity are separate elements of independence.
Application exceptions: Do not automatically exclude a report solely because of company funding, or treat generic English funding wording as verification of detailed conflicts of interest.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.

Related sources S01

N18 · Does the randomized/blinded label match the actual allocation process?

Current findings: The original design label is prospective, double-blind, randomized and placebo-controlled. Sequence generation, concealment, baseline balance and implementation details are absent from the retained summary.
Verification status: Partly verified
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External PubMed, DOI, full-text and registration material remain unread, with access not attempted.
Why unverified: The design label is identified, but material on allocation/concealment and baseline implementation remains unverified.
Reason for missing information: Sequence generation/concealment, analysis unit, baseline balance and specific implementation of blinding remain unverified.
Required materials and conditions: Allocation methods, concealment, baseline tables, implementation of blinding and the methods section.
Materials to obtain first: Allocation methods, concealment, baseline tables, implementation of blinding and the methods section.
Further research: Material needed: Allocation methods, concealment, baseline tables, implementation of blinding and the methods section. This records needed materials; no new research was executed.
Remaining uncertainty: Sequence generation/concealment, analysis unit, baseline balance and specific implementation of blinding remain unverified.
Conditions for verification: Retain the prospective double-blind randomized placebo-controlled label, and compare sequence generation/concealment, baseline balance, implementation and analysis unit.
Why this condition is needed: The RCT/double-blind label is not certification that allocation problems or confounding were resolved.
Application exceptions: Do not replace unverified design information with crossover/cluster NA, or treat double-blind as confirmation of blinded CCTA assessors.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.

Related sources S01

N19 · Could usual risk-factor treatment and adherence differences be mixed into the result?

Current findings: The intervention and population description specifies continued usual risk-factor treatment and matching placebo plus usual care. Drug/diet changes and actual adherence remain unverified.
Verification status: Partly verified
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External PubMed, DOI, full-text and registration material remain unread, with access not attempted.
Why unverified: The shared-care specification is retained, but the effects of concomitant treatment, adherence and changes on interpretation remain unverified.
Reason for missing information: Drugs/doses, diet, rescue treatment, adherence/changes by group and analytical handling remain unverified.
Required materials and conditions: Group background drugs/treatment, lifestyle factors, changes, adherence, rescue treatment and handling of these factors.
Materials to obtain first: Group background drugs/treatment, lifestyle factors, changes, adherence, rescue treatment and handling of these factors.
Further research: Material needed: Group background drugs/treatment, lifestyle factors, changes, adherence, rescue treatment and handling of these factors. This records needed materials; no new research was executed.
Remaining uncertainty: Drugs/doses, diet, rescue treatment, adherence/changes by group and analytical handling remain unverified.
Conditions for verification: Retain continued usual treatment and placebo plus usual care, and compare the contributions of group drugs, diet, changes, adherence and rescue treatment.
Why this condition is needed: Attributing changes in other treatment to AGE would change the add-on treatment question.
Application exceptions: Do not require every change to be identical, or reinterpret this as a trial replacing usual treatment.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.

Related sources S01

N20 · Are CCTA reading, reproducibility and assessor blinding verified?

Current findings: CCTA %LAP and the double-blind design label are present, but details of readers, reproducibility and assessor blinding are absent from the retained summary.
Verification status: Unverified
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External PubMed, DOI, full-text and registration material remain unread, with access not attempted.
Why unverified: The retained material provides no location to verify implementation of reading and measurement, so this remains unverified.
Reason for missing information: Scanning/segmentation, readers, group image quality, reproducibility and assessor-blinding details remain unverified.
Required materials and conditions: Imaging conditions, image quality, reading/segmentation procedures, blinding, reproducibility and error handling.
Materials to obtain first: Imaging conditions, image quality, reading/segmentation procedures, blinding, reproducibility and error handling.
Further research: Material needed: Imaging conditions, image quality, reading/segmentation procedures, blinding, reproducibility and error handling. This records needed materials; no new research was executed.
Remaining uncertainty: Scanning/segmentation, readers, group image quality, reproducibility and assessor-blinding details remain unverified.
Conditions for verification: Separately compare scanning/segmentation, readers, reproducibility, group measurement conditions and assessor blinding.
Why this condition is needed: Differences in measurement conditions must be distinguished from actual differences in plaque.
Application exceptions: Do not certify assessor blinding from the double-blind label or assume an objective image is free of bias.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.

Related sources S01

N21 · Were the prespecified LAP endpoint hierarchy and SAP compared?

Current findings: The citation and research description contain NCT01534910, while the manuscript's registration-verification field says not verified. Endpoint, answer and grade explanations leave the prespecified LAP-only hierarchy and full ITT unverified.
Verification status: Unverified
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External PubMed, DOI, full-text and registration material remain unread, with access not attempted.
Why unverified: The identifier and unverified labels are retained, but registration/planning documents have not actually been compared.
Reason for missing information: Prospective registration timing, LAP hierarchy, SAP, multiple analyses and change reasons/history remain unverified.
Required materials and conditions: Dated registration text, protocol, SAP, endpoint/analysis change history and actual result tables.
Materials to obtain first: Dated registration text, protocol, SAP, endpoint/analysis change history and actual result tables.
Further research: Material needed: Dated registration text, protocol, SAP, endpoint/analysis change history and actual result tables. This records needed materials; no new research was executed.
Remaining uncertainty: Prospective registration timing, LAP hierarchy, SAP, multiple analyses and change reasons/history remain unverified.
Conditions for verification: Retain both the named endpoint in the intervention/population description and the evidence summary's unverified prespecified LAP-only primary (1st) hierarchy, and compare registration/protocol/SAP with actual results.
Why this condition is needed: The original plan is needed to assess possible selection of favorable components or analyses.
Application exceptions: The NCT string does not establish successful reading of registration/SAP. Do not turn unverified information into confirmed nonregistration, selective reporting or a positive secondary endpoint after a failed primary endpoint.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.

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N22 · Is another report an independent replication of the same product and population question?

Current findings: The retained manuscript states that the diabetes trial's LAP signal was not upgraded to independent R2 because it shared the company and research lineage. AGE combination-product trials were excluded.
Verification status: Partly verified
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External PubMed, DOI, full-text and registration material remain unread, with access not attempted.
Why unverified: Historical descriptions of different populations, shared lineage and excluded combinations are retained, but report families and independent replication have not been newly verified.
Reason for missing information: The diabetes citation, product details, recruitment overlap, independent replication of the same question and distribution of results remain unverified.
Required materials and conditions: Recruitment, product specifications, population, endpoint/time point, funding/lineage and a trial-family table.
Materials to obtain first: Recruitment, product specifications, population, endpoint/time point, funding/lineage and a trial-family table.
Further research: Material needed: Recruitment, product specifications, population, endpoint/time point, funding/lineage and a trial-family table. This records needed materials; no new research was executed.
Remaining uncertainty: The diabetes citation, product details, recruitment overlap, independent replication of the same question and distribution of results remain unverified.
Conditions for verification: Distinguish metabolic-syndrome AGE-LAP from the diabetes background and excluded combinations, and compare whether product, population, institution/funding and recruitment family are the same, different or unknown.
Why this condition is needed: Signals in another population and reports sharing a product company cannot be combined as independent confirmation.
Application exceptions: Do not create S02 from the diabetes background or transfer effects of AGE+B vitamins+folic acid+L-arginine to AGE alone. Do not turn an unverified family into NA.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.

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N23 · Does this question also require an optimal dose?

Current findings: The original question concerns %LAP with AGE 2,400 mg/day for about 12 months. Direct dose-response data and an optimal-dose estimate are absent from the retained summary.
Verification status: Not applicable
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External PubMed, DOI, full-text and registration material remain unread, with access not attempted.
Why unverified: The selected question makes no optimal-dose claim, so only the obligation for that extension research is not applicable. This is not a substitute status for unread material.
Reason for missing information: Direct optimal-dose and dose-response material remains unverified and would be needed if a separate question were selected.
Required materials and conditions: For a dose-optimization claim: direct comparisons of doses with matching specifications, exposure/adherence and a separate estimate.
Materials to obtain first: For a dose-optimization claim: direct comparisons of doses with matching specifications, exposure/adherence and a separate estimate.
Further research: Material needed: For a dose-optimization claim: direct comparisons of doses with matching specifications, exposure/adherence and a separate estimate. This records needed materials; no new research was executed.
Remaining uncertainty: Direct optimal-dose and dose-response material remains unverified and would be needed if a separate question were selected.
Conditions for verification: Separate the selected imaging question at 2,400 mg/day from additional dose-optimization/dose-response claims.
Why this condition is needed: A dose is not certification of an optimal dose, but dose research is not required for the narrow question.
Application exceptions: NA applies only to the obligation for a dose-optimization extension. Unverified direct dose evidence and specification gaps remain.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.

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N24 · Is persistence of the imaging effect after treatment stops being claimed?

Current findings: The original duration is about 12 months, with a CCTA interval of 354±41 days. Separate post-treatment imaging material is absent from the retained summary.
Verification status: Not applicable
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External PubMed, DOI, full-text and registration material remain unread, with access not attempted.
Why unverified: The current question makes no post-treatment persistence claim, so only the extension-research obligation is not applicable.
Reason for missing information: Post-treatment long-term CCTA and persistence remain unverified in the current scope. Direct material would be needed if an extension question were selected.
Required materials and conditions: For a persistence claim: post-treatment scan times, exposure, treatment changes, group follow-up denominators and results.
Materials to obtain first: For a persistence claim: post-treatment scan times, exposure, treatment changes, group follow-up denominators and results.
Further research: Material needed: For a persistence claim: post-treatment scan times, exposure, treatment changes, group follow-up denominators and results. This records needed materials; no new research was executed.
Remaining uncertainty: Post-treatment long-term CCTA and persistence remain unverified in the current scope. Direct material would be needed if an extension question were selected.
Conditions for verification: Distinguish observation over about 12 months from separate questions of post-treatment persistence or long-term progression.
Why this condition is needed: Observation during treatment and persistence after stopping treatment have different time specifications.
Application exceptions: NA applies only to the post-treatment extension obligation; it does not exclude the current duration or scan conditions.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.

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N25 · Is a larger effect in a particular subgroup being claimed?

Current findings: The question concerns adults with metabolic syndrome; the diabetes trial is background. Prespecified subgroup and interaction estimates are absent from the retained summary.
Verification status: Not applicable
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External PubMed, DOI, full-text and registration material remain unread, with access not attempted.
Why unverified: The current question makes no additional subgroup-effect claim, so only the extension-research obligation is not applicable.
Reason for missing information: Prespecified subgroups and interactions remain unverified. A different diabetes question is not combined with the current denominator or effect.
Required materials and conditions: For a subgroup claim: prespecified hypotheses, denominators, direct interaction estimates and plans.
Materials to obtain first: For a subgroup claim: prespecified hypotheses, denominators, direct interaction estimates and plans.
Further research: Material needed: For a subgroup claim: prespecified hypotheses, denominators, direct interaction estimates and plans. This records needed materials; no new research was executed.
Remaining uncertainty: Prespecified subgroups and interactions remain unverified. A different diabetes question is not combined with the current denominator or effect.
Conditions for verification: Separate the selected metabolic-syndrome result from prespecified subgroups/interactions and the separate diabetes population.
Why this condition is needed: A favorable subgroup value or a trial in another population is not the magnitude of the overall result.
Application exceptions: NA applies only to the subgroup-extension obligation; population representativeness and the diabetes family remain unverified.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.

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N26 · Is the LAP signal being extended to plaque disappearance or prevention of clinical events?

Current findings: The original rationale explicitly says myocardial infarction and death were not tested. The advertising-interpretation explanation rules out claims of plaque disappearance or myocardial-infarction prevention.
Verification status: Met
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External PubMed, DOI, full-text and registration material remain unread, with access not attempted.
Why unverified: The original text explicitly separates imaging from clinical events. This does not establish event efficacy or long-term prevention.
Reason for missing information: Direct event effects/denominators and links to clinical importance remain unverified in the current scope and cannot be supplied by this trial's result.
Required materials and conditions: For an event extension: event definitions, denominators/follow-up, direct between-group results and plans.
Materials to obtain first: For an event extension: event definitions, denominators/follow-up, direct between-group results and plans.
Further research: Material needed: For an event extension: event definitions, denominators/follow-up, direct between-group results and plans. This records needed materials; no new research was executed.
Remaining uncertainty: Direct event effects/denominators and links to clinical importance remain unverified in the current scope and cannot be supplied by this trial's result.
Conditions for verification: Distinguish the imaging component from separate questions of total plaque disappearance, myocardial infarction and death; retain the boundary around unmeasured events.
Why this condition is needed: A signal in an imaging surrogate component does not prove clinical prevention or plaque disappearance.
Application exceptions: Retain the imaging observation without requiring an event trial as a condition for the existence of that result.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.

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N27 · Are harm-event definitions and collection verified?

Current findings: The manuscript says this imaging trial cannot establish long-term bleeding or interactions. The retained summary lacks definitions and counts of harm events by group.
Verification status: Unverified
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External PubMed, DOI, full-text and registration material remain unread, with access not attempted.
Why unverified: The retained summary cannot verify collection specifications or event data. This does not mean nonreporting throughout the full text or 0 events.
Reason for missing information: Event types, collection, occurrence/worsening, severity and discontinuation for harm remain unverified in the current scope.
Required materials and conditions: Adverse-event definitions, collection methods, group reports, discontinuation/severity and source data.
Materials to obtain first: Adverse-event definitions, collection methods, group reports, discontinuation/severity and source data.
Further research: Material needed: Adverse-event definitions, collection methods, group reports, discontinuation/severity and source data. This records needed materials; no new research was executed.
Remaining uncertainty: Event types, collection, occurrence/worsening, severity and discontinuation for harm remain unverified in the current scope.
Conditions for verification: Distinguish actual bleeding/adverse events, definitions, collection, severity and discontinuation for the same AGE/population from general caution.
Why this condition is needed: An efficacy summary or caution does not establish complete accounting of actual harms.
Application exceptions: Do not turn caution into actual bleeding counts or causality, or delete the imaging result because harm remains unverified.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.

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N28 · Is the temporal sequence of exposure and harm events known?

Current findings: An imaging interval of about 12 months and long-term harm cautions are present, but event, discontinuation and recovery timelines are absent from the retained summary.
Verification status: Unverified
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External PubMed, DOI, full-text and registration material remain unread, with access not attempted.
Why unverified: Event timing cannot be verified within the current scope, so it is not promoted into causality or re-exposure evidence.
Reason for missing information: Onset, recovery, re-exposure and latency remain unverified; the imaging period is not used as the entire harm follow-up period.
Required materials and conditions: Times of exposure initiation, events, discontinuation, recovery and re-exposure, with follow-up records.
Materials to obtain first: Times of exposure initiation, events, discontinuation, recovery and re-exposure, with follow-up records.
Further research: Material needed: Times of exposure initiation, events, discontinuation, recovery and re-exposure, with follow-up records. This records needed materials; no new research was executed.
Remaining uncertainty: Onset, recovery, re-exposure and latency remain unverified; the imaging period is not used as the entire harm follow-up period.
Conditions for verification: Distinguish AGE initiation/discontinuation, events/recovery, re-exposure and harm-observation duration from the imaging interval.
Why this condition is needed: An imaging interval does not substitute for the timing of bleeding or interactions.
Application exceptions: Do not infer events, improvement or re-exposure without source text, or fill harm timelines solely from treatment duration.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.

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N29 · Are event and exposure denominators available to interpret harm comparisons?

Current findings: The original counts are 65 enrolled, 55 analyzed, AGE 27 and placebo 28. The retained summary lacks harm events, exposure time and harm-comparison estimates.
Verification status: Unverified
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External PubMed, DOI, full-text and registration material remain unread, with access not attempted.
Why unverified: Event/exposure denominators cannot be linked with duration, so comparative risks and frequencies remain unverified within the current scope.
Reason for missing information: Harm-exposed participants, people/events, duration, placebo events and comparative estimates remain unverified.
Required materials and conditions: Group harm-exposure/event denominators, people/event counts, duration, placebo comparisons and result tables.
Materials to obtain first: Group harm-exposure/event denominators, people/event counts, duration, placebo comparisons and result tables.
Further research: Material needed: Group harm-exposure/event denominators, people/event counts, duration, placebo comparisons and result tables. This records needed materials; no new research was executed.
Remaining uncertainty: Harm-exposed participants, people/events, duration, placebo events and comparative estimates remain unverified.
Conditions for verification: Link exposed participants, people/event counts, duration and placebo events, distinct from imaging-analysis counts of 55/27/28.
Why this condition is needed: Imaging-analysis denominators are not denominators for harm frequency or increased risk.
Application exceptions: Do not substitute 55, 27 or 28 as safety denominators, or newly calculate incidence, background rates or RR.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.

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N30 · Were concomitant drugs and alternative explanations verified?

Current findings: The original caution explicitly calls for checking anticoagulants, antiplatelet drugs and perioperative use. Actual group drugs, surgery and bleeding risks remain unverified.
Verification status: Partly verified
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External PubMed, DOI, full-text and registration material remain unread, with access not attempted.
Why unverified: The original caution and usual-care scope are retained, but actual simultaneous exposure and alternatives/confounding remain unverified.
Reason for missing information: Actual concomitant use/doses, baseline bleeding, surgery, alternative causes and adjustment remain unverified.
Required materials and conditions: Concomitant drugs/doses, surgery, baseline risks, simultaneous exposure, alternatives and relevant harm material.
Materials to obtain first: Concomitant drugs/doses, surgery, baseline risks, simultaneous exposure, alternatives and relevant harm material.
Further research: Material needed: Concomitant drugs/doses, surgery, baseline risks, simultaneous exposure, alternatives and relevant harm material. This records needed materials; no new research was executed.
Remaining uncertainty: Actual concomitant use/doses, baseline bleeding, surgery, alternative causes and adjustment remain unverified.
Conditions for verification: Distinguish usual treatment from anticoagulant/antiplatelet and surgery warnings, and compare actual simultaneous exposure, baseline risks and alternatives.
Why this condition is needed: A warning list does not verify actual concomitant use in the trial or the cause of an event.
Application exceptions: Do not interpret unverified alternatives as absence of other causes, or extend the original caution into new individual dosing instructions.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.

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N31 · Is the scope missed by harm collection and follow-up known?

Current findings: The 65 enrolled, 55 analyzed and unverified ITT refer to the imaging result. Harm collection, detection and loss information is absent from the retained summary.
Verification status: Unverified
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External PubMed, DOI, full-text and registration material remain unread, with access not attempted.
Why unverified: The current scope does not directly verify selection, missingness or disclosure limits in safety surveillance.
Reason for missing information: Safety-surveillance denominators, detection/collection differences, losses and disclosure of all events remain unverified.
Required materials and conditions: Group safety follow-up, reasons for missingness, detection differences and the disclosure scope for all events.
Materials to obtain first: Group safety follow-up, reasons for missingness, detection differences and the disclosure scope for all events.
Further research: Material needed: Group safety follow-up, reasons for missingness, detection differences and the disclosure scope for all events. This records needed materials; no new research was executed.
Remaining uncertainty: Safety-surveillance denominators, detection/collection differences, losses and disclosure of all events remain unverified.
Conditions for verification: Distinguish harm detection, follow-up loss, collection and disclosure from imaging-analysis losses.
Why this condition is needed: There is no guarantee that imaging loss and harm-surveillance loss are identical.
Application exceptions: Do not turn unverified collection into event absence or a confirmed magnitude of bias.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.

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N32 · Are repeated harm warnings being counted as independent events?

Current findings: The same general caution repeats in the Korean and English texts and the synthesized summary. The retained evidence and citation contain no separate independent harm case report.
Verification status: Unverified
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External PubMed, DOI, full-text and registration material remain unread, with access not attempted.
Why unverified: Harm families or repeated events cannot be verified within the current scope. The same caution is not counted as duplicated signals.
Reason for missing information: Unique harm cases, study/replication families and contrary records remain unverified; this does not mean 0 cases worldwide.
Required materials and conditions: Unique harm report/case identifiers, exposure/event matching, repeated citations and family material.
Materials to obtain first: Unique harm report/case identifiers, exposure/event matching, repeated citations and family material.
Further research: Material needed: Unique harm report/case identifiers, exposure/event matching, repeated citations and family material. This records needed materials; no new research was executed.
Remaining uncertainty: Unique harm cases, study/replication families and contrary records remain unverified; this does not mean 0 cases worldwide.
Conditions for verification: Distinguish general caution and recitation of the same material from new harm events/studies, and link product, population and event families.
Why this condition is needed: Repetition of caution across Korean, English and synthesized summaries does not increase independent event counts.
Application exceptions: Do not query new regulatory/case material during this work or turn diabetes efficacy background into repeated harm evidence.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.

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N33 · What about long-term or rare harms and vulnerable groups beyond the imaging observation?

Current findings: The manuscript explicitly states that this imaging trial cannot establish long-term bleeding or interactions.
Verification status: Unverified
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External PubMed, DOI, full-text and registration material remain unread, with access not attempted.
Why unverified: Direct harm evidence for long-term/rare events and vulnerable conditions cannot be verified within the current scope.
Reason for missing information: Direct material on long-term bleeding, rare harms, interactions and surgical/anticoagulant conditions remains unverified.
Required materials and conditions: Suitable designs and denominators/follow-up for long-term/rare events and interactions under the same exposure and by population.
Materials to obtain first: Suitable designs and denominators/follow-up for long-term/rare events and interactions under the same exposure and by population.
Further research: Material needed: Suitable designs and denominators/follow-up for long-term/rare events and interactions under the same exposure and by population. This records needed materials; no new research was executed.
Remaining uncertainty: Direct material on long-term bleeding, rare harms, interactions and surgical/anticoagulant conditions remains unverified.
Conditions for verification: Separate the imaging question over about 12 months from harms involving long-term bleeding, interactions and surgical/anticoagulant conditions.
Why this condition is needed: An imaging study in a limited population does not guarantee overall safety.
Application exceptions: Do not require every long-term harm study for the narrow imaging question, or convert unverified information into harmlessness.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.

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N34 · How far can harms and safety be described from this material?

Current findings: The original safety label is Caution, with warnings about long-term bleeding and interactions. Direct information linking events, denominators, timing, comparison and alternatives is absent from the retained summary.
Verification status: Partly verified
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External PubMed, DOI, full-text and registration material remain unread, with access not attempted.
Why unverified: The general caution boundary is retained, but direct material to classify signals, risk or causality remains unverified.
Reason for missing information: Events, denominators, timing, comparison and alternatives needed for a direct harm judgment remain unverified; the original caution is not new safety certification.
Required materials and conditions: Harm source data connecting events, exposure/denominators, timing, comparison and alternatives, with the interpretation scope.
Materials to obtain first: Harm source data connecting events, exposure/denominators, timing, comparison and alternatives, with the interpretation scope.
Further research: Material needed: Harm source data connecting events, exposure/denominators, timing, comparison and alternatives, with the interpretation scope. This records needed materials; no new research was executed.
Remaining uncertainty: Events, denominators, timing, comparison and alternatives needed for a direct harm judgment remain unverified; the original caution is not new safety certification.
Conditions for verification: Distinguish caution from actual signals, comparative risk and causality, and limit the current scope separately from imaging efficacy and the historical safety label.
Why this condition is needed: Historical caution and the current verification level of harm source data are separate matters.
Application exceptions: Do not create individual dosing instructions, a new safety grade, a guarantee of harmlessness or a confirmed causal link to bleeding.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.

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