# Aged garlic extract; exact daily dose and SAC specification unverified in accessible sources × Improved brachial-artery FMD in men with coronary artery disease Verdict 3065 · Evidence Check Stored-material review date: 2026-10-05 Original evidence cut-off: 2026-09-08 Review-criteria version: 1.1 Public page/material preparation date: 2026-10-26 Clinical papers were not read directly; existing review summaries were checked. No new clinical-literature search was performed. Unverified does not mean that research is absent or that there is no effect. ## Assessment scope - Population: 15 men with coronary artery disease receiving background treatment including aspirin and statins. Eligibility, baseline characteristics, representativeness and actual completion/analysis denominators remain unverified. - Ingredient, formulation and route: An oral AGE preparation from aged Allium sativum L. clove extract. Product identity, manufacture/batch, extraction/aging method, SAC specification and additives remain unverified. - Dose: Exact daily dose, frequency, SAC specification and actual intake, adherence and exposure remain unverified. Doses from other AGE trials are not imported. - Comparator: A crossover placebo comparison on background standard treatment. It is not converted to AGE monotherapy versus no treatment or to independent parallel groups. Period-specific background treatment, placebo composition, sequence and washout data remain unverified. - Measured outcome: Brachial-artery ultrasound flow-mediated dilation (FMD). Measurement procedures, baseline/maximum diameter definitions, assessment/reproducibility and the exact absolute effect and interval for the selected contrast remain unverified. - Duration: 2 weeks of treatment are recorded. Period-specific start/end, washout, total follow-up, interval from last dose to testing and allowed assessment windows remain unverified. - Questions outside this scope: A 44% relative increase from baseline and P=.03 adjusted for baseline vessel diameter are retained results. They are not converted to, or newly calculated as, an absolute percentage-point contrast versus placebo, a 95% CI or clinical importance.; Distinguish the total-sample expression of 15 men from recruitment, allocation, completion and actual paired-analysis denominators. Crossover periods are not counted as independent patients to make 30, and missingness or losses are not filled as absent.; PWV, CAVI, reflective index and blood pressure are different endpoints. A review mention or Korean/English/synthesis restatements of the same report are not counted as independent direct FMD replication.; FMD is a surrogate. Prevention of myocardial infarction, reversal of atherosclerosis, clinical events, other populations, optimal dose and long-term persistence are separate questions; all are not automatically imposed as mandatory conditions for the current FMD result.; The original caution concerns bleeding and interactions in people with CAD receiving antiplatelet treatment. It is not converted into actual adverse events, frequency, comparative risk, causality or individual intake instructions. ## Checklist items ### N01 · Which independent FMD question is being reviewed? Verification status: Met Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted. - Current findings: AGE versus crossover placebo for brachial FMD in men with coronary artery disease receiving standard treatment. PWV, CAVI, blood pressure and clinical events are separate. - Why unverified: Confirmation is limited to question identity and exclusion boundaries. It does not establish effect magnitude, reproducibility or safety. - Reason for missing information: Confirmation is limited to question identity and exclusion boundaries. It does not establish effect magnitude, reproducibility or safety. - Required materials and conditions: Original wording, locations and preservation identity for the claim, formulation, population, crossover comparator, endpoint and time - Materials to obtain first: Original wording, locations and preservation identity for the claim, formulation, population, crossover comparator, endpoint and time - Further research: If a new question is added, first review its original material and independent comparison boundary. Identifying the current question does not require a new clinical trial. - Conditions for verification: Link the original claim and claim conditions to this question without including other vascular measures. - Why this condition is needed: Which independent FMD question is being reviewed? Separating this item is necessary to read the scope and limitations of the 15-person crossover FMD material accurately. - Application exceptions: Apply only within the observed source material. Confirmation is limited to question identity and exclusion boundaries. It does not establish effect magnitude, reproducibility or safety. - Remaining uncertainty: Confirmation is limited to question identity and exclusion boundaries. It does not establish effect magnitude, reproducibility or safety. - Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application. - Related sources: S1 ### N02 · Are the original trial report and repeated descriptions distinguished? Verification status: Met Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted. - Current findings: The retained evidence and citation identify one report: Williams 2005/PMID16041725. Korean/English/synthesis restatements and the review mention are not additional independent FMD trials. - Why unverified: The complete identity of registration and follow-up report families is unverified. Independent trial counts or participant totals absent from the current source are not invented. - Reason for missing information: The complete identity of registration and follow-up report families is unverified. Independent trial counts or participant totals absent from the current source are not invented. - Required materials and conditions: Linked identifiers for the original trial, protocol, follow-up reports and trials included in the review - Materials to obtain first: Linked identifiers for the original trial, protocol, follow-up reports and trials included in the review - Further research: In a later evidence review, group reports from the same trial and identify independent FMD replication as separate families. - Conditions for verification: Describe the relationship between the currently identified report and repeated descriptions while leaving global unique-trial and participant totals unconfirmed. - Why this condition is needed: Are the original trial report and repeated descriptions distinguished? Separating this item is necessary to read the scope and limitations of the 15-person crossover FMD material accurately. - Application exceptions: Apply only within the observed source material. The complete identity of registration and follow-up report families is unverified. Independent trial counts or participant totals absent from the current source are not invented. - Remaining uncertainty: The complete identity of registration and follow-up report families is unverified. Independent trial counts or participant totals absent from the current source are not invented. - Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application. - Related sources: S1 ### N03 · What material was actually read in this review? Verification status: Met Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted. - Current findings: The complete retained summary and its locations were read. The source describes historical comparison with the original trial and a review, but no external abstract, full text or registration was read in this conversion. - Why unverified: The original URL/PMID is an entry clue. Historical comparison wording is not promoted to current full-text acquisition or reading. - Reason for missing information: The original URL/PMID is an entry clue. Historical comparison wording is not promoted to current full-text acquisition or reading. - Required materials and conditions: Actual acquisition/reading level, date, original location and identity for each material, with lawful original-text gateways - Materials to obtain first: Actual acquisition/reading level, date, original location and identity for each material, with lawful original-text gateways - Further research: In a separately authorized update, acquire the full text/appendix and record the sections actually read, dates and original-file identity as a new event. - Conditions for verification: Distinguish the local summary actually read from unread external material and link reading badges to exact retained quotation locations. - Why this condition is needed: What material was actually read in this review? Separating this item is necessary to read the scope and limitations of the 15-person crossover FMD material accurately. - Application exceptions: Apply only within the observed source material. The original URL/PMID is an entry clue. Historical comparison wording is not promoted to current full-text acquisition or reading. - Remaining uncertainty: The original URL/PMID is an entry clue. Historical comparison wording is not promoted to current full-text acquisition or reading. - Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application. - Related sources: S1 ### N04 · What CAD population do the 15 men represent? Verification status: Partly verified Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted. - Current findings: The record describes 15 men with coronary artery disease receiving standard treatment including aspirin and statins. - Why unverified: Age, CAD diagnosis/severity, eligibility/exclusions, baseline FMD, recruitment sites and representativeness are absent from the retained summary. - Reason for missing information: Age, CAD diagnosis/severity, eligibility/exclusions, baseline FMD, recruitment sites and representativeness are absent from the retained summary. - Required materials and conditions: Eligibility criteria, baseline characteristics, CAD definition, recruitment route and baseline vascular function - Materials to obtain first: Eligibility criteria, baseline characteristics, CAD definition, recruitment route and baseline vascular function - Further research: Extending the population requires comparative FMD data in that population and prespecified effect-modification analyses. - Conditions for verification: Use actual material to compare trial participants with the target population, including mixed or excluded groups. - Why this condition is needed: What CAD population do the 15 men represent? Separating this item is necessary to read the scope and limitations of the 15-person crossover FMD material accurately. - Application exceptions: Apply only within the observed source material. Age, CAD diagnosis/severity, eligibility/exclusions, baseline FMD, recruitment sites and representativeness are absent from the retained summary. - Remaining uncertainty: Age, CAD diagnosis/severity, eligibility/exclusions, baseline FMD, recruitment sites and representativeness are absent from the retained summary. - Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application. - Related sources: S1 ### N05 · What are the AGE product, ingredients and route? Verification status: Partly verified Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted. - Current findings: The record describes an oral AGE preparation from aged Allium sativum cloves; detailed specifications remain unverified. - Why unverified: SAC specification, manufacture/batch, extraction/aging method and additives are absent. Other garlic formulations or isolated SAC are not treated as the same product. - Reason for missing information: SAC specification, manufacture/batch, extraction/aging method and additives are absent. Other garlic formulations or isolated SAC are not treated as the same product. - Required materials and conditions: Exact trial-product specifications, batch/manufacturing material, SAC analysis and the product actually administered - Materials to obtain first: Exact trial-product specifications, batch/manufacturing material, SAC analysis and the product actually administered - Further research: Future replication should disclose the preparation and ingredient specifications so that product-specific results can be separated. - Conditions for verification: Link the actual formulation/ingredients to the question without filling standardized concentrations absent from the source. - Why this condition is needed: What are the AGE product, ingredients and route? Separating this item is necessary to read the scope and limitations of the 15-person crossover FMD material accurately. - Application exceptions: Apply only within the observed source material. SAC specification, manufacture/batch, extraction/aging method and additives are absent. Other garlic formulations or isolated SAC are not treated as the same product. - Remaining uncertainty: SAC specification, manufacture/batch, extraction/aging method and additives are absent. Other garlic formulations or isolated SAC are not treated as the same product. - Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application. - Related sources: S1 ### N06 · Are the exact daily dose and actual intake known? Verification status: Unverified Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted. - Current findings: The original dose field is unverified, and the ingredient description explicitly leaves exact daily dose and SAC specification unverified. - Why unverified: Nominal daily dose, intake frequency, adherence and actual exposure are absent. Doses from other AGE trials are not inherited. - Reason for missing information: Nominal daily dose, intake frequency, adherence and actual exposure are absent. Doses from other AGE trials are not inherited. - Required materials and conditions: Administration schedule, exact dose/frequency, intake checks, returned product, discontinuation and exposure material - Materials to obtain first: Administration schedule, exact dose/frequency, intake checks, returned product, discontinuation and exposure material - Further research: Once actual specification/dose is confirmed, a dose question should use direct comparisons and prespecified exposure measurement. - Conditions for verification: Distinguish nominal dose and actual exposure in this 15-person trial, retaining uncertainty within the source scope. - Why this condition is needed: Are the exact daily dose and actual intake known? Separating this item is necessary to read the scope and limitations of the 15-person crossover FMD material accurately. - Application exceptions: Apply only within the observed source material. Nominal daily dose, intake frequency, adherence and actual exposure are absent. Doses from other AGE trials are not inherited. - Remaining uncertainty: Nominal daily dose, intake frequency, adherence and actual exposure are absent. Doses from other AGE trials are not inherited. - Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application. - Related sources: S1 ### N07 · Are background treatment, changes and adherence documented for each crossover period? Verification status: Partly verified Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted. - Current findings: This is a crossover placebo comparison in men with CAD on standard treatment. It is not AGE monotherapy versus no treatment. - Why unverified: Period-specific aspirin/statin types, doses, changes, rescue treatment, adherence and group/period differences are absent. - Reason for missing information: Period-specific aspirin/statin types, doses, changes, rescue treatment, adherence and group/period differences are absent. - Required materials and conditions: Period-specific concomitant drugs, treatment changes, adherence, rescue treatment and handling in the analysis - Materials to obtain first: Period-specific concomitant drugs, treatment changes, adherence, rescue treatment and handling in the analysis - Further research: Future comparisons should prespecify background-treatment records, the effect of interest and analysis of treatment changes. - Conditions for verification: Actual records must identify period-specific aspirin/statin types, doses, changes, rescue treatment, adherence and period differences to assess the background to the AGE contrast. A summary stating that standard treatment was received does not substitute for these records. - Why this condition is needed: Are standard treatment and the contribution of AGE distinguished? Separating this item is necessary to read the scope and limitations of the 15-person crossover FMD material accurately. - Application exceptions: Apply only within the observed source material. Period-specific aspirin/statin types, doses, changes, rescue treatment, adherence and group/period differences are absent. - Remaining uncertainty: Period-specific aspirin/statin types, doses, changes, rescue treatment, adherence and group/period differences are absent. - Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application. - Related sources: S1 ### N08 · What is the actual crossover placebo comparator? Verification status: Partly verified Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted. - Current findings: Crossover placebo and a randomized placebo-controlled crossover trial are specified in the source. - Why unverified: Placebo composition, matching appearance, exposure in comparator periods and actual sequence-specific treatment records remain unverified. - Reason for missing information: Placebo composition, matching appearance, exposure in comparator periods and actual sequence-specific treatment records remain unverified. - Required materials and conditions: Crossover treatment schedule, placebo composition, period-specific treatment/sequence and background treatment - Materials to obtain first: Crossover treatment schedule, placebo composition, period-specific treatment/sequence and background treatment - Further research: Replicated crossover trials should clearly report placebo composition, periods and sequences. - Conditions for verification: Link actual treatment and comparator in each period without turning the periods into independent parallel groups. - Why this condition is needed: What is the actual crossover placebo comparator? Separating this item is necessary to read the scope and limitations of the 15-person crossover FMD material accurately. - Application exceptions: Apply only within the observed source material. Placebo composition, matching appearance, exposure in comparator periods and actual sequence-specific treatment records remain unverified. - Remaining uncertainty: Placebo composition, matching appearance, exposure in comparator periods and actual sequence-specific treatment records remain unverified. - Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application. - Related sources: S1 ### N09 · Are period schedules and FMD assessment times, including the 2-week treatment, documented? Verification status: Partly verified Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted. - Current findings: Treatment lasted 2 weeks; crossover washout details remain unverified. - Why unverified: Period start/end, total follow-up, interval from last dose to testing and allowed timing windows are absent. - Reason for missing information: Period start/end, total follow-up, interval from last dose to testing and allowed timing windows are absent. - Required materials and conditions: Period-specific schedules, washout and medication/blood-sampling/ultrasound timetables - Materials to obtain first: Period-specific schedules, washout and medication/blood-sampling/ultrasound timetables - Further research: Separate studies of persistence or discontinuation effects should prespecify actual observation times and the relevant comparisons. - Conditions for verification: Actual schedules must identify each treatment period start/end, washout, total follow-up, interval from last dose to FMD testing and allowed windows. The expression 2 weeks of treatment does not confirm the entire observation schedule. - Why this condition is needed: Are 2 weeks of treatment and the full observation schedule the same? Separating this item is necessary to read the scope and limitations of the 15-person crossover FMD material accurately. - Application exceptions: Apply only within the observed source material. Period start/end, total follow-up, interval from last dose to testing and allowed timing windows are absent. - Remaining uncertainty: Period start/end, total follow-up, interval from last dose to testing and allowed timing windows are absent. - Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application. - Related sources: S1 ### N10 · How was brachial-artery FMD measured? Verification status: Partly verified Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted. - Current findings: Brachial-artery ultrasound flow-mediated dilation is recorded as the selected endpoint. - Why unverified: Occlusion/stimulation protocol, diameter measurement, assessors, repeatability/reproducibility and definitions of baseline/maximum values are absent. - Reason for missing information: Occlusion/stimulation protocol, diameter measurement, assessors, repeatability/reproducibility and definitions of baseline/maximum values are absent. - Required materials and conditions: FMD measurement manual, original measurements, image assessment, units and reproducibility material - Materials to obtain first: FMD measurement manual, original measurements, image assessment, units and reproducibility material - Further research: Replication should specify FMD measurement procedures and assessment/reproducibility plans. - Conditions for verification: Confirm FMD definitions and collection conditions in this trial without substituting other vascular tests. - Why this condition is needed: How was brachial-artery FMD measured? Separating this item is necessary to read the scope and limitations of the 15-person crossover FMD material accurately. - Application exceptions: Apply only within the observed source material. Occlusion/stimulation protocol, diameter measurement, assessors, repeatability/reproducibility and definitions of baseline/maximum values are absent. - Remaining uncertainty: Occlusion/stimulation protocol, diameter measurement, assessors, repeatability/reproducibility and definitions of baseline/maximum values are absent. - Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application. - Related sources: S1 ### N11 · Are baseline/period-specific FMD values and the actual between-treatment contrast underlying the 44% relative increase available? Verification status: Partly verified Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted. - Current findings: A 44% relative FMD increase from baseline after AGE is retained. It is not an absolute percentage-point contrast versus placebo. - Why unverified: Baseline FMD, period-specific final values/changes and the exact absolute between-treatment contrast are absent. The value 44 is not relabeled or converted to percentage points. - Reason for missing information: Baseline FMD, period-specific final values/changes and the exact absolute between-treatment contrast are absent. The value 44 is not relabeled or converted to percentage points. - Required materials and conditions: Baseline and period-specific FMD values, variability, change definitions and original between-treatment estimate tables - Materials to obtain first: Baseline and period-specific FMD values, variability, change definitions and original between-treatment estimate tables - Further research: Future reports should provide change definitions and effects/intervals for the between-treatment or period contrasts of interest. - Conditions for verification: Original results must identify baseline FMD, period-specific final values/change definitions and the relevant between-treatment contrast. The known 44% relative increase is not substituted for, or converted to, an absolute between-treatment percentage-point difference. - Why this condition is needed: What direction and scale does the 44% increase represent? Separating this item is necessary to read the scope and limitations of the 15-person crossover FMD material accurately. - Application exceptions: Apply only within the observed source material. Baseline FMD, period-specific final values/changes and the exact absolute between-treatment contrast are absent. The value 44 is not relabeled or converted to percentage points. - Remaining uncertainty: Baseline FMD, period-specific final values/changes and the exact absolute between-treatment contrast are absent. The value 44 is not relabeled or converted to percentage points. - Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application. - Related sources: S1 ### N12 · Are denominators documented for recruitment, allocation, period completion and actual FMD analysis pairs? Verification status: Partly verified Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted. - Current findings: Only the total-sample expression of 15 men is confirmed. Crossover periods are not summed as two groups totaling 30 men. - Why unverified: Recruitment, allocation, period completion, actual paired-analysis n and test/specimen counts are not separately reported. Generic English wording is not an actual denominator. - Reason for missing information: Recruitment, allocation, period completion, actual paired-analysis n and test/specimen counts are not separately reported. Generic English wording is not an actual denominator. - Required materials and conditions: Participant flow, sequence-specific allocation/completion, period-specific measurements and n for analysis pairs - Materials to obtain first: Participant flow, sequence-specific allocation/completion, period-specific measurements and n for analysis pairs - Further research: Future crossover studies should report participant, period and analysis-pair flow with denominators for each result. - Conditions for verification: Actual records must identify participant flow, sequence-specific allocation/completion, period measurements and n for actual paired-analysis sets. The original sample of 15 or generic English wording does not substitute for completion/analysis denominators. - Why this condition is needed: Which denominator does 15 represent? Separating this item is necessary to read the scope and limitations of the 15-person crossover FMD material accurately. - Application exceptions: Apply only within the observed source material. Recruitment, allocation, period completion, actual paired-analysis n and test/specimen counts are not separately reported. Generic English wording is not an actual denominator. - Remaining uncertainty: Recruitment, allocation, period completion, actual paired-analysis n and test/specimen counts are not separately reported. Generic English wording is not an actual denominator. - Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application. - Related sources: S1 ### N13 · Were missing periods and analysis losses handled? Verification status: Unverified Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted. - Current findings: The current summary contains no numbers or reasons for period-specific missingness, losses or analysis exclusions. - Why unverified: Do not assume that all 15 men completed or were analyzed. Unobserved periods and their handling remain unverified. - Reason for missing information: Do not assume that all 15 men completed or were analyzed. Unobserved periods and their handling remain unverified. - Required materials and conditions: Period-specific missingness, losses, exclusion reasons, analysis populations and sensitivity analyses - Materials to obtain first: Period-specific missingness, losses, exclusion reasons, analysis populations and sensitivity analyses - Further research: Future studies should prespecify handling of missingness and sensitivity analyses for unobserved measurements. - Conditions for verification: Confirm actual analysis denominators and missing-data handling without assigning losses of 0 from empty information. - Why this condition is needed: Were missing periods and analysis losses handled? Separating this item is necessary to read the scope and limitations of the 15-person crossover FMD material accurately. - Application exceptions: Apply only within the observed source material. Do not assume that all 15 men completed or were analyzed. Unobserved periods and their handling remain unverified. - Remaining uncertainty: Do not assume that all 15 men completed or were analyzed. Unobserved periods and their handling remain unverified. - Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application. - Related sources: S1 ### N14 · Were randomized sequences and allocation concealment checked? Verification status: Partly verified Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted. - Current findings: The trial is described as randomized, placebo-controlled and crossover. - Why unverified: Sequence generation, concealment, baseline balance between sequence groups and allocation personnel are undocumented. The randomized label alone does not establish completion of these checks. - Reason for missing information: Sequence generation, concealment, baseline balance between sequence groups and allocation personnel are undocumented. The randomized label alone does not establish completion of these checks. - Required materials and conditions: Random sequence generation/concealment, sequence-specific baseline tables and allocation records - Materials to obtain first: Random sequence generation/concealment, sequence-specific baseline tables and allocation records - Further research: Replication should specify sequence allocation, concealment and baseline balance. - Conditions for verification: Describe the actual allocation process relevant to the selected FMD result at the level supported by the material. - Why this condition is needed: Were randomized sequences and allocation concealment checked? Separating this item is necessary to read the scope and limitations of the 15-person crossover FMD material accurately. - Application exceptions: Apply only within the observed source material. Sequence generation, concealment, baseline balance between sequence groups and allocation personnel are undocumented. The randomized label alone does not establish completion of these checks. - Remaining uncertainty: Sequence generation, concealment, baseline balance between sequence groups and allocation personnel are undocumented. The randomized label alone does not establish completion of these checks. - Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application. - Related sources: S1 ### N15 · Were washout, period/sequence effects and carryover addressed in the analysis? Verification status: Unverified Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted. - Current findings: Crossover design and unverified washout details are stated. - Why unverified: Washout length, period/sequence effects, carryover assessment and within-person covariance/paired analysis are absent. - Reason for missing information: Washout length, period/sequence effects, carryover assessment and within-person covariance/paired analysis are absent. - Required materials and conditions: Crossover protocol, period/sequence-specific data, residual effects and within-person analysis model - Materials to obtain first: Crossover protocol, period/sequence-specific data, residual effects and within-person analysis model - Further research: Future crossover comparisons should prespecify washout justification, sequence/period effects and analysis of the contrast of interest. - Conditions for verification: Check dependence and residual-effect handling in the actual crossover treatment without substituting parallel-group analysis. - Why this condition is needed: Were washout, period/sequence effects and carryover addressed in the analysis? Separating this item is necessary to read the scope and limitations of the 15-person crossover FMD material accurately. - Application exceptions: Apply only within the observed source material. Washout length, period/sequence effects, carryover assessment and within-person covariance/paired analysis are absent. - Remaining uncertainty: Washout length, period/sequence effects, carryover assessment and within-person covariance/paired analysis are absent. - Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application. - Related sources: S1 ### N16 · How were assessors and measurement conditions blinded? Verification status: Unverified Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted. - Current findings: The placebo-controlled crossover description does not include assessor blinding or group/period-specific measurement conditions. - Why unverified: Do not assign double blinding or identical measurement conditions. An objective test alone does not establish absence of measurement bias. - Reason for missing information: Do not assign double blinding or identical measurement conditions. An objective test alone does not establish absence of measurement bias. - Required materials and conditions: Participant/measurement/assessment blinding, equipment, test environment and period-specific measurement records - Materials to obtain first: Participant/measurement/assessment blinding, equipment, test environment and period-specific measurement records - Further research: Replication should report feasible assessor/reader blinding and standardized procedures. - Conditions for verification: Link limitations of actual FMD collection and assessment to material that was checked. - Why this condition is needed: How were assessors and measurement conditions blinded? Separating this item is necessary to read the scope and limitations of the 15-person crossover FMD material accurately. - Application exceptions: Apply only within the observed source material. Do not assign double blinding or identical measurement conditions. An objective test alone does not establish absence of measurement bias. - Remaining uncertainty: Do not assign double blinding or identical measurement conditions. An objective test alone does not establish absence of measurement bias. - Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application. - Related sources: S1 ### N17 · Are the effect definition, test model and analysis population corresponding to adjusted P=.03 available? Verification status: Partly verified Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted. - Current findings: P=.03 versus placebo is recorded as adjusted for baseline vessel diameter. - Why unverified: The exact model, dependent variable, estimated contrast, covariates, crossover dependence, analysis population and multiplicity handling remain unverified. - Reason for missing information: The exact model, dependent variable, estimated contrast, covariates, crossover dependence, analysis population and multiplicity handling remain unverified. - Required materials and conditions: Original analysis model, adjustment tables, effect definitions, variance/covariance and testing/SAP - Materials to obtain first: Original analysis model, adjustment tables, effect definitions, variance/covariance and testing/SAP - Further research: Future comparisons should prespecify the within-person treatment effect of interest and adjustment/multiplicity plans. - Conditions for verification: Original analysis material must identify the dependent variable, treatment contrast, covariates, handling of crossover dependence, analysis population and multiple comparisons. The baseline-vessel-diameter adjustment summary and P=.03 alone do not confirm or permit calculation of the model, absolute effect or CI. - Why this condition is needed: What effect and model were tested by adjusted P=.03? Separating this item is necessary to read the scope and limitations of the 15-person crossover FMD material accurately. - Application exceptions: Apply only within the observed source material. The exact model, dependent variable, estimated contrast, covariates, crossover dependence, analysis population and multiplicity handling remain unverified. - Remaining uncertainty: The exact model, dependent variable, estimated contrast, covariates, crossover dependence, analysis population and multiplicity handling remain unverified. - Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application. - Related sources: S1 ### N18 · Are the absolute FMD effect and 95% CI for the selected crossover contrast available? Verification status: Unverified Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted. - Current findings: The exact absolute between-treatment effect and 95% CI remain unverified in the source summary. - Why unverified: A significant P value or sample of 15 alone does not establish effect magnitude, precision or clinical importance. - Reason for missing information: A significant P value or sample of 15 alone does not establish effect magnitude, precision or clinical importance. - Required materials and conditions: Actual between-treatment/crossover effect estimate, variability, 95% CI and a justified important difference - Materials to obtain first: Actual between-treatment/crossover effect estimate, variability, 95% CI and a justified important difference - Further research: Future studies should design precision around the effect of interest, uncertainty and importance criterion. Do not set an arbitrary minimum n. - Conditions for verification: Link the actual effect estimate, units, variability and 95% CI for the crossover contrast to original results. Assess precision/clinical importance only with a justified important-difference criterion; do not calculate unreported values from P or sample size. - Why this condition is needed: Are the absolute effect and 95% CI interpretable? Separating this item is necessary to read the scope and limitations of the 15-person crossover FMD material accurately. - Application exceptions: Apply only within the observed source material. A significant P value or sample of 15 alone does not establish effect magnitude, precision or clinical importance. - Remaining uncertainty: A significant P value or sample of 15 alone does not establish effect magnitude, precision or clinical importance. - Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application. - Related sources: S1 ### N19 · Is material available to compare prespecified FMD endpoints, timing and analysis plans with actual reporting? Verification status: Unverified Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted. - Current findings: The FMD endpoint is retained, but registration could not be confirmed and no direct protocol/SAP comparison is available. - Why unverified: Unverified registration is not converted to confirmed nonregistration or selective reporting. NCT identifiers absent from the citation are not invented. - Reason for missing information: Unverified registration is not converted to confirmed nonregistration or selective reporting. NCT identifiers absent from the citation are not invented. - Required materials and conditions: Contemporaneous registration versions, protocol, SAP and records of endpoint/timing/analysis changes - Materials to obtain first: Contemporaneous registration versions, protocol, SAP and records of endpoint/timing/analysis changes - Further research: Future replication should disclose endpoints, timing and analyses prospectively and record reasons for changes. - Conditions for verification: Acquire contemporaneous registration versions, protocol, SAP and change records for comparison with actual FMD endpoint, timing and analysis reporting. Stating that comparison was not done does not confirm agreement; unverified registration does not establish nonregistration or selective reporting. - Why this condition is needed: Does FMD reporting match prespecified endpoints, timing and analysis? Separating this item is necessary to read the scope and limitations of the 15-person crossover FMD material accurately. - Application exceptions: Apply only within the observed source material. Unverified registration is not converted to confirmed nonregistration or selective reporting. NCT identifiers absent from the citation are not invented. - Remaining uncertainty: Unverified registration is not converted to confirmed nonregistration or selective reporting. NCT identifiers absent from the citation are not invented. - Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application. - Related sources: S1 ### N20 · Are report identities and included-trial data available to assess independent replication of the same FMD question? Verification status: Partly verified Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted. - Current findings: The original text explains that CAVI and reflective index in other AGE studies were not counted as independent FMD replication. - Why unverified: Review identity/included trials and the full scope of direct replication of the same FMD question remain unverified. Other endpoints are not repurposed as confirmation or refutation of FMD. - Reason for missing information: Review identity/included trials and the full scope of direct replication of the same FMD question remain unverified. Other endpoints are not repurposed as confirmation or refutation of FMD. - Required materials and conditions: Review identity, included-trial tables and formulation/population/comparison/analysis families for FMD reports - Materials to obtain first: Review identity, included-trial tables and formulation/population/comparison/analysis families for FMD reports - Further research: In an authorized follow-up review, group related families and determine whether independent comparisons using the same FMD contract are needed. - Conditions for verification: Identify the review, included-trial tables and formulation/population/comparison/analysis families of FMD reports to assess replication of the same question. Do not count other vascular measures or restatements as FMD replication or invent a mandatory number of trials. - Why this condition is needed: Are independent FMD replication and other vascular measures distinguished? Separating this item is necessary to read the scope and limitations of the 15-person crossover FMD material accurately. - Application exceptions: Apply only within the observed source material. Review identity/included trials and the full scope of direct replication of the same FMD question remain unverified. Other endpoints are not repurposed as confirmation or refutation of FMD. - Remaining uncertainty: Review identity/included trials and the full scope of direct replication of the same FMD question remain unverified. Other endpoints are not repurposed as confirmation or refutation of FMD. - Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application. - Related sources: S1 ### N21 · Does the material address long-term effects, dose or subgroups? Verification status: Unverified Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted. - Current findings: The current record concerns 2-week FMD in men with CAD with an unverified dose. - Why unverified: Persistence/discontinuation, optimal dose and effect modification in women/other CAD populations are undocumented. Do not automatically impose these as mandatory conditions for the narrow exploratory FMD result. - Reason for missing information: Persistence/discontinuation, optimal dose and effect modification in women/other CAD populations are undocumented. Do not automatically impose these as mandatory conditions for the narrow exploratory FMD result. - Required materials and conditions: Direct dose/persistence contrasts, follow-up schedules and prespecified subgroup/interaction data - Materials to obtain first: Direct dose/persistence contrasts, follow-up schedules and prespecified subgroup/interaction data - Further research: When an extension is claimed, separately design direct comparisons of its dose, persistence or population with prespecified interaction analyses. - Conditions for verification: Separate the current question from extensions and state only the direct evidence confirmed for each extension. - Why this condition is needed: Does the material address long-term effects, dose or subgroups? Separating this item is necessary to read the scope and limitations of the 15-person crossover FMD material accurately. - Application exceptions: Apply only within the observed source material. Persistence/discontinuation, optimal dose and effect modification in women/other CAD populations are undocumented. Do not automatically impose these as mandatory conditions for the narrow exploratory FMD result. - Remaining uncertainty: Persistence/discontinuation, optimal dose and effect modification in women/other CAD populations are undocumented. Do not automatically impose these as mandatory conditions for the narrow exploratory FMD result. - Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application. - Related sources: S1 ### N22 · Are the FMD signal and clinical events distinguished? Verification status: Met Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted. - Current findings: Brachial FMD is a vascular-function surrogate; the original text prohibits extension to myocardial-infarction prevention or reversal of atherosclerosis. - Why unverified: Confirmation concerns the interpretation boundary. It does not certify direct clinical-event evidence or automatically require event trials for FMD itself. - Reason for missing information: Confirmation concerns the interpretation boundary. It does not certify direct clinical-event evidence or automatically require event trials for FMD itself. - Required materials and conditions: FMD endpoint definition and direct material for separate clinical-event outcomes/comparisons - Materials to obtain first: FMD endpoint definition and direct material for separate clinical-event outcomes/comparisons - Further research: A separate clinical-event prevention question requires direct studies with the relevant events, denominators and follow-up. - Conditions for verification: Explain FMD values separately from event, quality-of-life and mortality questions. - Why this condition is needed: Are the FMD signal and clinical events distinguished? Separating this item is necessary to read the scope and limitations of the 15-person crossover FMD material accurately. - Application exceptions: Apply only within the observed source material. Confirmation concerns the interpretation boundary. It does not certify direct clinical-event evidence or automatically require event trials for FMD itself. - Remaining uncertainty: Confirmation concerns the interpretation boundary. It does not certify direct clinical-event evidence or automatically require event trials for FMD itself. - Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application. - Related sources: S1 ### N23 · What verification dates and search scope does this record represent? Verification status: Met Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted. - Current findings: The original review date is 2026-09-08 and the English correction event is 2026-09-14. The current retained summary was reviewed separately. - Why unverified: Do not infer a search cutoff or individual access dates from the original review date. No new clinical search or exhaustive correction/retraction check was performed. - Reason for missing information: Do not infer a search cutoff or individual access dates from the original review date. No new clinical search or exhaustive correction/retraction check was performed. - Required materials and conditions: Historical search, acquisition/reading and correction checks, with the current material scope/review date - Materials to obtain first: Historical search, acquisition/reading and correction checks, with the current material scope/review date - Further research: If an evidence update is authorized, separately record the historical scope and dates/methods of new searches and correction checks. - Conditions for verification: Limit absence/unverified expressions to the retained material, without turning them into a search yielding 0 or global absence of research. - Why this condition is needed: What verification dates and search scope does this record represent? Separating this item is necessary to read the scope and limitations of the 15-person crossover FMD material accurately. - Application exceptions: Apply only within the observed source material. Do not infer a search cutoff or individual access dates from the original review date. No new clinical search or exhaustive correction/retraction check was performed. - Remaining uncertainty: Do not infer a search cutoff or individual access dates from the original review date. No new clinical search or exhaustive correction/retraction check was performed. - Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application. - Related sources: S1 ### N24 · Are original-trial funding, product supply and author conflict declarations available? Verification status: Unverified Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted. - Current findings: Funding and product-support details remain unverified. The original I1 axis and generic English review statements are historical records. - Why unverified: Do not convert these records into confirmed independent funding, absence of product support, absence of COI or absence of bias. - Reason for missing information: Do not convert these records into confirmed independent funding, absence of product support, absence of COI or absence of bias. - Required materials and conditions: Original disclosures of funding/product supply, author employment/patents, COI, institutions and research teams - Materials to obtain first: Original disclosures of funding/product supply, author employment/patents, COI, institutions and research teams - Further research: Future replication should disclose resources, product support and roles in design/data so that independence can be assessed. - Conditions for verification: Verify actual disclosures of funding, product supply, author employment/patents, COI, institutions and teams. An unverified label or original I1 axis does not confirm independence, absence of support or absence of COI. - Why this condition is needed: Were funding, product supply and author conflicts checked? Separating this item is necessary to read the scope and limitations of the 15-person crossover FMD material accurately. - Application exceptions: Apply only within the observed source material. Do not convert these records into confirmed independent funding, absence of product support, absence of COI or absence of bias. - Remaining uncertainty: Do not convert these records into confirmed independent funding, absence of product support, absence of COI or absence of bias. - Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application. - Related sources: S1 ### N25 · Are actual adverse-event definitions, collection methods and timing documented for the same AGE exposure? Verification status: Partly verified Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted. - Current findings: The original text cautions about bleeding and interactions in people with CAD receiving antiplatelet treatment such as aspirin. - Why unverified: Actual trial event definitions, collection, severity, onset/recovery and exposure/discontinuation times are absent. The caution is not converted to a measured harm increase. - Reason for missing information: Actual trial event definitions, collection, severity, onset/recovery and exposure/discontinuation times are absent. The caution is not converted to a measured harm increase. - Required materials and conditions: Harm definitions, systematic/spontaneous collection, timing, severity, discontinuation/recovery and exposure records - Materials to obtain first: Harm definitions, systematic/spontaneous collection, timing, severity, discontinuation/recovery and exposure records - Further research: Future studies should separately plan harm collection and temporal relationships for the same preparation, population and follow-up. - Conditions for verification: Verify actual event material covering harm definitions, collection, severity, onset/recovery and exposure/discontinuation times. Bleeding/interaction cautions do not substitute for observed events or increased-harm data. - Why this condition is needed: How were harms from the same exposure defined, collected and timed? Separating this item is necessary to read the scope and limitations of the 15-person crossover FMD material accurately. - Application exceptions: Apply only within the observed source material. Actual trial event definitions, collection, severity, onset/recovery and exposure/discontinuation times are absent. The caution is not converted to a measured harm increase. - Remaining uncertainty: Actual trial event definitions, collection, severity, onset/recovery and exposure/discontinuation times are absent. The caution is not converted to a measured harm increase. - Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application. - Related sources: S1 ### N26 · Are harm comparators and incidence denominators available? Verification status: Unverified Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted. - Current findings: Crossover placebo and 15 men are recorded for efficacy, but period-specific participants with harms, event counts and exposure time are absent. - Why unverified: Do not substitute the efficacy sample of 15 for a harm-analysis denominator or turn a caution statement into harm frequency. - Reason for missing information: Do not substitute the efficacy sample of 15 for a harm-analysis denominator or turn a caution statement into harm frequency. - Required materials and conditions: Exposure, participants with events/event counts, follow-up and actual harm comparisons for each treatment period - Materials to obtain first: Exposure, participants with events/event counts, follow-up and actual harm comparisons for each treatment period - Further research: If a harm comparison is planned, collect events and denominators together for the same exposure and period. - Conditions for verification: Link values to frequency/risk estimates only when harm comparisons, denominators and time are reported together. - Why this condition is needed: Are harm comparators and incidence denominators available? Separating this item is necessary to read the scope and limitations of the 15-person crossover FMD material accurately. - Application exceptions: Apply only within the observed source material. Do not substitute the efficacy sample of 15 for a harm-analysis denominator or turn a caution statement into harm frequency. - Remaining uncertainty: Do not substitute the efficacy sample of 15 for a harm-analysis denominator or turn a caution statement into harm frequency. - Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application. - Related sources: S1 ### N27 · Are concomitant drugs, baseline risks and alternative causes documented for each harm event? Verification status: Partly verified Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted. - Current findings: Background treatment such as aspirin/statins and cautions about bleeding/drug interactions are recorded. - Why unverified: Actual events, period-specific concomitant doses, baseline bleeding disorders, other causes/exposures and adjustment data are absent. - Reason for missing information: Actual events, period-specific concomitant doses, baseline bleeding disorders, other causes/exposures and adjustment data are absent. - Required materials and conditions: Event-specific concomitant/baseline risks, other exposures, alternative explanations and period-specific changes - Materials to obtain first: Event-specific concomitant/baseline risks, other exposures, alternative explanations and period-specific changes - Further research: Future harm analyses should collect concomitant drugs, baseline risks and alternative explanations together. - Conditions for verification: Link actual events to period-specific concomitant drugs/doses/changes, baseline bleeding risk, other exposures, alternative explanations and adjustment data. Standard-treatment and interaction cautions alone do not establish review of event causes. - Why this condition is needed: Were concomitant exposures and alternative causes of harm reviewed? Separating this item is necessary to read the scope and limitations of the 15-person crossover FMD material accurately. - Application exceptions: Apply only within the observed source material. Actual events, period-specific concomitant doses, baseline bleeding disorders, other causes/exposures and adjustment data are absent. - Remaining uncertainty: Actual events, period-specific concomitant doses, baseline bleeding disorders, other causes/exposures and adjustment data are absent. - Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application. - Related sources: S1 ### N28 · Are harm-collection/reporting scope, period-specific losses and follow-up gaps documented? Verification status: Unverified Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted. - Current findings: The retained summary contains no actual material on harm-collection scope, follow-up gaps or unreported events. - Why unverified: Do not turn nonreporting into no events or extend absence in a short summary to nonreporting in the full paper. - Reason for missing information: Do not turn nonreporting into no events or extend absence in a short summary to nonreporting in the full paper. - Required materials and conditions: Event collection/reporting scope, losses, detection differences and period-specific completeness - Materials to obtain first: Event collection/reporting scope, losses, detection differences and period-specific completeness - Further research: Harm follow-up studies should disclose collection systems, tracking of missing follow-up and sensitivity analyses. - Conditions for verification: Verify event-collection/reporting scope, period-specific losses, detection differences and completeness. Stating absence in the retained summary alone does not establish these limitations, no events or nonreporting in the full paper. - Why this condition is needed: Are limitations of harm reporting and follow-up losses known? Separating this item is necessary to read the scope and limitations of the 15-person crossover FMD material accurately. - Application exceptions: Apply only within the observed source material. Do not turn nonreporting into no events or extend absence in a short summary to nonreporting in the full paper. - Remaining uncertainty: Do not turn nonreporting into no events or extend absence in a short summary to nonreporting in the full paper. - Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application. - Related sources: S1 ### N29 · Are independent harm-report families and direct long-term/vulnerable-population data available? Verification status: Unverified Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted. - Current findings: Only the original safety wording is present; independent event/harm-report families and direct long-term/female/vulnerable-population material are not linked. - Why unverified: Do not count recitation of the same source as independent events or extend 2-week data in men with CAD to safety in all populations. - Reason for missing information: Do not count recitation of the same source as independent events or extend 2-week data in men with CAD to safety in all populations. - Required materials and conditions: Unique harm reports/event families, product/exposure matching and long-term/vulnerable-population follow-up - Materials to obtain first: Unique harm reports/event families, product/exposure matching and long-term/vulnerable-population follow-up - Further research: When extending the harm scope, use appropriate long-term, rare-event or population-specific designs; do not impose all such conditions on the current FMD question. - Conditions for verification: Identify unique harm reports/event families, product/exposure matching and long-term/vulnerable-population follow-up for each scope. An unverified statement does not confirm material; arbitrary replication counts or extended-harm conditions are not automatically imposed on the current FMD question. - Why this condition is needed: What is the scope of independent harm signals, long-term data and vulnerable populations? Separating this item is necessary to read the scope and limitations of the 15-person crossover FMD material accurately. - Application exceptions: Apply only within the observed source material. Do not count recitation of the same source as independent events or extend 2-week data in men with CAD to safety in all populations. - Remaining uncertainty: Do not count recitation of the same source as independent events or extend 2-week data in men with CAD to safety in all populations. - Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application. - Related sources: S1 ### N30 · Does the safety caution represent a signal, risk estimate or causality? Verification status: Met Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted. - Current findings: Only the retained bleeding/interaction caution was transferred. Actual comparative risk, event causality and individual safety were not newly judged. - Why unverified: Confirmation concerns the limitation of the wording. Gaps in direct event data, comparisons, denominators, time and alternative explanations remain. - Reason for missing information: Confirmation concerns the limitation of the wording. Gaps in direct event data, comparisons, denominators, time and alternative explanations remain. - Required materials and conditions: Events, comparators, denominators, time, alternative explanations and source level for the same exposure - Materials to obtain first: Events, comparators, denominators, time, alternative explanations and source level for the same exposure - Further research: When actual harm material is subsequently linked, review its evidential level within the same scope. - Conditions for verification: Distinguish the caution/signal/comparison/causal scope allowed by the material without creating individual intake instructions or a new safety grade. - Why this condition is needed: Does the safety caution represent a signal, risk estimate or causality? Separating this item is necessary to read the scope and limitations of the 15-person crossover FMD material accurately. - Application exceptions: Apply only within the observed source material. Confirmation concerns the limitation of the wording. Gaps in direct event data, comparisons, denominators, time and alternative explanations remain. - Remaining uncertainty: Confirmation concerns the limitation of the wording. Gaps in direct event data, comparisons, denominators, time and alternative explanations remain. - Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application. - Related sources: S1 ### N31 · Are historical grades, axes and English corrections distinguished from current verification? Verification status: Met Reading scope: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted. - Current findings: C46, Caution, B/S/R1/I1/EX/B2/CX, empty subclaims and the English correction event were preserved in the original bytes. Generic review wording in the English evidence table also remains in the original. - Why unverified: Historical grades/axes or English review wording do not establish current condition fulfillment, full-text reading, independence or effect validation. - Reason for missing information: Historical grades/axes or English review wording do not establish current condition fulfillment, full-text reading, independence or effect validation. - Required materials and conditions: Complete original identity and separate records of historical verdict/axes, both languages, correction events and the new condition version - Materials to obtain first: Complete original identity and separate records of historical verdict/axes, both languages, correction events and the new condition version - Further research: If correction/update is separately requested, preserve the full prior version and separate the event, version and verdict decision. - Conditions for verification: Do not inherit historical values as a new score/verdict; separately retain what was actually checked for each condition. - Why this condition is needed: Are historical grades, axes and English corrections distinguished from current verification? Separating this item is necessary to read the scope and limitations of the 15-person crossover FMD material accurately. - Application exceptions: Apply only within the observed source material. Historical grades/axes or English review wording do not establish current condition fulfillment, full-text reading, independence or effect validation. - Remaining uncertainty: Historical grades/axes or English review wording do not establish current condition fulfillment, full-text reading, independence or effect validation. - Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application. - Related sources: S1 ## Evidence and sources ### S1 Williams MJ et al. Phytother Res. 2005. PMID: 16041725. [PubMed](https://pubmed.ncbi.nlm.nih.gov/16041725/) Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted. Findings recorded in the summary: The retained result is a 44% increase in FMD from baseline and P=.03 versus placebo after adjustment for baseline vessel diameter. The exact absolute between-treatment percentage-point contrast and CI remain unverified. Record level: An exploratory crossover FMD signal in 15 men over 2 weeks. The actual paired-analysis denominator, treatment of crossover dependence/washout, exact dose/SAC, absolute effect, 95% CI and registered plan remain unverified. Independent replication: The retained record identifies one FMD crossover report, Williams2005, PMID16041725. Period-specific measurements in the same participants and Korean/English/synthesis restatements are not added as independent trials or participants. Global unique-trial and participant counts and follow-up report families remain unverified. | Material | Public availability | Access status | Actually read | Notes | |---|---|---|---|---| | Retained verdict summary | Retained verdict summary read | Retained copy acquired; summary read | Stored existing review summary read | Relevant content in the retained summary, evidence and citation was read. This is not the original clinical paper’s bytes or full text. A report linked to the retained summary and citation. External abstracts, full texts, appendices, registration, protocols and analysis plans remain unread in this conversion; independent clinical validation was not performed. The material check date is the original date retained in the summary and condition records. The original verdict-review date does not establish a search cut-off or historical access dates for individual materials; external access was not attempted in this conversion. | | External PubMed bibliographic/abstract gateway | External access not attempted; not acquired; unread | External access not attempted; not acquired | Not read | This is the retained PubMed link. The current response, bibliographic identity, abstract content and public access were not checked. A report linked to the retained summary and citation. External abstracts, full texts, appendices, registration, protocols and analysis plans remain unread in this conversion; independent clinical validation was not performed. The material check date is the original date retained in the summary and condition records. The original verdict-review date does not establish a search cut-off or historical access dates for individual materials; external access was not attempted in this conversion. | | Original paper full text/appendix; location unverified | External access not attempted; not acquired; unread | External access not attempted; not acquired | Not read | DOI, PMCID, identity, original location, public availability, acquisition and actual reading of a lawful full text/appendix remain unverified. No original-text location is invented. A report linked to the retained summary and citation. External abstracts, full texts, appendices, registration, protocols and analysis plans remain unread in this conversion; independent clinical validation was not performed. The material check date is the original date retained in the summary and condition records. The original verdict-review date does not establish a search cut-off or historical access dates for individual materials; external access was not attempted in this conversion. | ## Review criteria and methods These are Chamgap's own application conditions, informed by the relevant sections of official methodological guidance. They do not constitute official assessment-tool certification or a new efficacy score. - M03 [Cochrane Handbook 6.5 (2024), chapter updated 2023-08](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03) · §3.1, §3.2.1–3.2.3, MECIR C5/C7/C13 · Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions. · 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](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04) · §4.5, §4.6.1–4.6.3, MECIR C42 · Distinguish studies from reports and link them; do not omit a study solely because results are unreported. · 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](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08) · §8.1–8.2.3, Table 8.2.a · Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting. · 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](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15) · §15.2.4, §15.3.1–15.3.3 · Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision. · 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](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19) · §19.1.2, §19.2.1–19.2.4 · Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates. · Retained method-application records were reused. External originals were not reread and method content was not reassessed. ## What the statuses mean - Met: The stated retained information, reading, attribution or counting boundary was checked within limits. This does not certify efficacy, safety, full-text reading or reassessment. - Partly verified: Some retained information was checked, but material or conditions required by the criterion remain unverified. - Unverified: The criterion cannot be established in the retained record. This does not mean 0 studies, an effect of 0 or absence of harm. - Not reported: This is limited to a specific material or section actually read. It is not extended to nonreporting in an entire external paper. - Inaccessible: This is limited to an actual failed access attempt. It was not assigned to clinical materials in this conversion. - Not applicable: This is limited to a specific application exception. It does not substitute for unread material. - Review incomplete: Remaining comparison work and its reason are stated separately. This is distinguished from unverified material. - Conflicting data: This is limited to genuinely incompatible comparisons of the same question, time point and analysis. - Insufficient evidence matching the conditions: Used only when relevant studies within a defined scope have been reviewed and evidence answering the conditions is insufficient. It does not substitute for unread material and was not applied across all items here. ## Change history 2026-10-26 · Public page/materials 1.0. The public view and materials were prepared from the existing 31 items. No new clinical search, verification-state change or scoring was performed.