Aged garlic extract; exact daily dose and SAC specification unverified in accessible sources × Improved brachial-artery FMD in men with coronary artery disease

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 independent FMD question is being reviewed?Required	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. S1	Confirmation is limited to question identity and exclusion boundaries. It does not establish effect magnitude, reproducibility or safety.	Original wording, locations and preservation identity for the claim, formulation, population, crossover comparator, endpoint and time	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.
2	Met	Full text not readStored summary read	N02 · Evidence conditionAre the original trial report and repeated descriptions distinguished?Required	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. S1	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.	Linked identifiers for the original trial, protocol, follow-up reports and trials included in the review	In a later evidence review, group reports from the same trial and identify independent FMD replication as separate families.
3	Met	Full text not readStored summary read	N03 · Evidence conditionWhat material was actually read in this review?Required	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. S1	The original URL/PMID is an entry clue. Historical comparison wording is not promoted to current full-text acquisition or reading.	Actual acquisition/reading level, date, original location and identity for each material, with lawful original-text gateways	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.
4	Partly verified	Full text not readStored summary read	N04 · Evidence conditionWhat CAD population do the 15 men represent?Required	The record describes 15 men with coronary artery disease receiving standard treatment including aspirin and statins. S1	Age, CAD diagnosis/severity, eligibility/exclusions, baseline FMD, recruitment sites and representativeness are absent from the retained summary.	Eligibility criteria, baseline characteristics, CAD definition, recruitment route and baseline vascular function	Extending the population requires comparative FMD data in that population and prespecified effect-modification analyses.
5	Partly verified	Full text not readStored summary read	N05 · Evidence conditionWhat are the AGE product, ingredients and route?Required	The record describes an oral AGE preparation from aged Allium sativum cloves; detailed specifications remain unverified. S1	SAC specification, manufacture/batch, extraction/aging method and additives are absent. Other garlic formulations or isolated SAC are not treated as the same product.	Exact trial-product specifications, batch/manufacturing material, SAC analysis and the product actually administered	Future replication should disclose the preparation and ingredient specifications so that product-specific results can be separated.
6	Unverified	Full text not readStored summary read	N06 · Evidence conditionAre the exact daily dose and actual intake known?Required	The original dose field is unverified, and the ingredient description explicitly leaves exact daily dose and SAC specification unverified. S1	Nominal daily dose, intake frequency, adherence and actual exposure are absent. Doses from other AGE trials are not inherited.	Administration schedule, exact dose/frequency, intake checks, returned product, discontinuation and exposure material	Once actual specification/dose is confirmed, a dose question should use direct comparisons and prespecified exposure measurement.
7	Partly verified	Full text not readStored summary read	N07 · Evidence conditionAre background treatment, changes and adherence documented for each crossover period?Required	This is a crossover placebo comparison in men with CAD on standard treatment. It is not AGE monotherapy versus no treatment. S1	Period-specific aspirin/statin types, doses, changes, rescue treatment, adherence and group/period differences are absent.	Period-specific concomitant drugs, treatment changes, adherence, rescue treatment and handling in the analysis	Future comparisons should prespecify background-treatment records, the effect of interest and analysis of treatment changes.
8	Partly verified	Full text not readStored summary read	N08 · Evidence conditionWhat is the actual crossover placebo comparator?Required	Crossover placebo and a randomized placebo-controlled crossover trial are specified in the source. S1	Placebo composition, matching appearance, exposure in comparator periods and actual sequence-specific treatment records remain unverified.	Crossover treatment schedule, placebo composition, period-specific treatment/sequence and background treatment	Replicated crossover trials should clearly report placebo composition, periods and sequences.
9	Partly verified	Full text not readStored summary read	N09 · Evidence conditionAre period schedules and FMD assessment times, including the 2-week treatment, documented?Required	Treatment lasted 2 weeks; crossover washout details remain unverified. S1	Period start/end, total follow-up, interval from last dose to testing and allowed timing windows are absent.	Period-specific schedules, washout and medication/blood-sampling/ultrasound timetables	Separate studies of persistence or discontinuation effects should prespecify actual observation times and the relevant comparisons.
10	Partly verified	Full text not readStored summary read	N10 · Evidence conditionHow was brachial-artery FMD measured?Required	Brachial-artery ultrasound flow-mediated dilation is recorded as the selected endpoint. S1	Occlusion/stimulation protocol, diameter measurement, assessors, repeatability/reproducibility and definitions of baseline/maximum values are absent.	FMD measurement manual, original measurements, image assessment, units and reproducibility material	Replication should specify FMD measurement procedures and assessment/reproducibility plans.
11	Partly verified	Full text not readStored summary read	N11 · Evidence conditionAre baseline/period-specific FMD values and the actual between-treatment contrast underlying the 44% relative increase available?Required	A 44% relative FMD increase from baseline after AGE is retained. It is not an absolute percentage-point contrast versus placebo. S1	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.	Baseline and period-specific FMD values, variability, change definitions and original between-treatment estimate tables	Future reports should provide change definitions and effects/intervals for the between-treatment or period contrasts of interest.
12	Partly verified	Full text not readStored summary read	N12 · Evidence conditionAre denominators documented for recruitment, allocation, period completion and actual FMD analysis pairs?Required	Only the total-sample expression of 15 men is confirmed. Crossover periods are not summed as two groups totaling 30 men. S1	Recruitment, allocation, period completion, actual paired-analysis n and test/specimen counts are not separately reported. Generic English wording is not an actual denominator.	Participant flow, sequence-specific allocation/completion, period-specific measurements and n for analysis pairs	Future crossover studies should report participant, period and analysis-pair flow with denominators for each result.
13	Unverified	Full text not readStored summary read	N13 · Evidence conditionWere missing periods and analysis losses handled?Required	The current summary contains no numbers or reasons for period-specific missingness, losses or analysis exclusions. S1	Do not assume that all 15 men completed or were analyzed. Unobserved periods and their handling remain unverified.	Period-specific missingness, losses, exclusion reasons, analysis populations and sensitivity analyses	Future studies should prespecify handling of missingness and sensitivity analyses for unobserved measurements.
14	Partly verified	Full text not readStored summary read	N14 · Evidence conditionWere randomized sequences and allocation concealment checked?Required	The trial is described as randomized, placebo-controlled and crossover. S1	Sequence generation, concealment, baseline balance between sequence groups and allocation personnel are undocumented. The randomized label alone does not establish completion of these checks.	Random sequence generation/concealment, sequence-specific baseline tables and allocation records	Replication should specify sequence allocation, concealment and baseline balance.
15	Unverified	Full text not readStored summary read	N15 · Evidence conditionWere washout, period/sequence effects and carryover addressed in the analysis?Required	Crossover design and unverified washout details are stated. S1	Washout length, period/sequence effects, carryover assessment and within-person covariance/paired analysis are absent.	Crossover protocol, period/sequence-specific data, residual effects and within-person analysis model	Future crossover comparisons should prespecify washout justification, sequence/period effects and analysis of the contrast of interest.
16	Unverified	Full text not readStored summary read	N16 · Evidence conditionHow were assessors and measurement conditions blinded?Required	The placebo-controlled crossover description does not include assessor blinding or group/period-specific measurement conditions. S1	Do not assign double blinding or identical measurement conditions. An objective test alone does not establish absence of measurement bias.	Participant/measurement/assessment blinding, equipment, test environment and period-specific measurement records	Replication should report feasible assessor/reader blinding and standardized procedures.
17	Partly verified	Full text not readStored summary read	N17 · Evidence conditionAre the effect definition, test model and analysis population corresponding to adjusted P=.03 available?Required	P=.03 versus placebo is recorded as adjusted for baseline vessel diameter. S1	The exact model, dependent variable, estimated contrast, covariates, crossover dependence, analysis population and multiplicity handling remain unverified.	Original analysis model, adjustment tables, effect definitions, variance/covariance and testing/SAP	Future comparisons should prespecify the within-person treatment effect of interest and adjustment/multiplicity plans.
18	Unverified	Full text not readStored summary read	N18 · Evidence conditionAre the absolute FMD effect and 95% CI for the selected crossover contrast available?Required	The exact absolute between-treatment effect and 95% CI remain unverified in the source summary. S1	A significant P value or sample of 15 alone does not establish effect magnitude, precision or clinical importance.	Actual between-treatment/crossover effect estimate, variability, 95% CI and a justified important difference	Future studies should design precision around the effect of interest, uncertainty and importance criterion. Do not set an arbitrary minimum n.
19	Unverified	Full text not readStored summary read	N19 · Evidence conditionIs material available to compare prespecified FMD endpoints, timing and analysis plans with actual reporting?Required	The FMD endpoint is retained, but registration could not be confirmed and no direct protocol/SAP comparison is available. S1	Unverified registration is not converted to confirmed nonregistration or selective reporting. NCT identifiers absent from the citation are not invented.	Contemporaneous registration versions, protocol, SAP and records of endpoint/timing/analysis changes	Future replication should disclose endpoints, timing and analyses prospectively and record reasons for changes.
20	Partly verified	Full text not readStored summary read	N20 · Evidence conditionAre report identities and included-trial data available to assess independent replication of the same FMD question?Required	The original text explains that CAVI and reflective index in other AGE studies were not counted as independent FMD replication. S1	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.	Review identity, included-trial tables and formulation/population/comparison/analysis families for FMD reports	In an authorized follow-up review, group related families and determine whether independent comparisons using the same FMD contract are needed.
21	Unverified	Full text not readStored summary read	N21 · Evidence conditionDoes the material address long-term effects, dose or subgroups?Supplementary; required for extension claims	The current record concerns 2-week FMD in men with CAD with an unverified dose. S1	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.	Direct dose/persistence contrasts, follow-up schedules and prespecified subgroup/interaction data	When an extension is claimed, separately design direct comparisons of its dose, persistence or population with prespecified interaction analyses.
22	Met	Full text not readStored summary read	N22 · Evidence conditionAre the FMD signal and clinical events distinguished?Supplementary; required for clinical extensions	Brachial FMD is a vascular-function surrogate; the original text prohibits extension to myocardial-infarction prevention or reversal of atherosclerosis. S1	Confirmation concerns the interpretation boundary. It does not certify direct clinical-event evidence or automatically require event trials for FMD itself.	FMD endpoint definition and direct material for separate clinical-event outcomes/comparisons	A separate clinical-event prevention question requires direct studies with the relevant events, denominators and follow-up.
23	Met	Full text not readStored summary read	N23 · Evidence conditionWhat verification dates and search scope does this record represent?Required	The original review date is 2026-09-08 and the English correction event is 2026-09-14. The current retained summary was reviewed separately. S1	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.	Historical search, acquisition/reading and correction checks, with the current material scope/review date	If an evidence update is authorized, separately record the historical scope and dates/methods of new searches and correction checks.
24	Unverified	Full text not readStored summary read	N24 · Evidence conditionAre original-trial funding, product supply and author conflict declarations available?Supplementary; required for independence claims	Funding and product-support details remain unverified. The original I1 axis and generic English review statements are historical records. S1	Do not convert these records into confirmed independent funding, absence of product support, absence of COI or absence of bias.	Original disclosures of funding/product supply, author employment/patents, COI, institutions and research teams	Future replication should disclose resources, product support and roles in design/data so that independence can be assessed.
25	Partly verified	Full text not readStored summary read	N25 · Evidence conditionAre actual adverse-event definitions, collection methods and timing documented for the same AGE exposure?Supplementary; required for harm questions	The original text cautions about bleeding and interactions in people with CAD receiving antiplatelet treatment such as aspirin. S1	Actual trial event definitions, collection, severity, onset/recovery and exposure/discontinuation times are absent. The caution is not converted to a measured harm increase.	Harm definitions, systematic/spontaneous collection, timing, severity, discontinuation/recovery and exposure records	Future studies should separately plan harm collection and temporal relationships for the same preparation, population and follow-up.
26	Unverified	Full text not readStored summary read	N26 · Evidence conditionAre harm comparators and incidence denominators available?Supplementary; required for comparative harm or incidence claims	Crossover placebo and 15 men are recorded for efficacy, but period-specific participants with harms, event counts and exposure time are absent. S1	Do not substitute the efficacy sample of 15 for a harm-analysis denominator or turn a caution statement into harm frequency.	Exposure, participants with events/event counts, follow-up and actual harm comparisons for each treatment period	If a harm comparison is planned, collect events and denominators together for the same exposure and period.
27	Partly verified	Full text not readStored summary read	N27 · Evidence conditionAre concomitant drugs, baseline risks and alternative causes documented for each harm event?Supplementary; required for causal harm claims	Background treatment such as aspirin/statins and cautions about bleeding/drug interactions are recorded. S1	Actual events, period-specific concomitant doses, baseline bleeding disorders, other causes/exposures and adjustment data are absent.	Event-specific concomitant/baseline risks, other exposures, alternative explanations and period-specific changes	Future harm analyses should collect concomitant drugs, baseline risks and alternative explanations together.
28	Unverified	Full text not readStored summary read	N28 · Evidence conditionAre harm-collection/reporting scope, period-specific losses and follow-up gaps documented?Supplementary; required for harm interpretation	The retained summary contains no actual material on harm-collection scope, follow-up gaps or unreported events. S1	Do not turn nonreporting into no events or extend absence in a short summary to nonreporting in the full paper.	Event collection/reporting scope, losses, detection differences and period-specific completeness	Harm follow-up studies should disclose collection systems, tracking of missing follow-up and sensitivity analyses.
29	Unverified	Full text not readStored summary read	N29 · Evidence conditionAre independent harm-report families and direct long-term/vulnerable-population data available?Supplementary; required for replicated or extended harm claims	Only the original safety wording is present; independent event/harm-report families and direct long-term/female/vulnerable-population material are not linked. S1	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.	Unique harm reports/event families, product/exposure matching and long-term/vulnerable-population follow-up	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.
30	Met	Full text not readStored summary read	N30 · Evidence conditionDoes the safety caution represent a signal, risk estimate or causality?Supplementary; required for safety or causal harm claims	Only the retained bleeding/interaction caution was transferred. Actual comparative risk, event causality and individual safety were not newly judged. S1	Confirmation concerns the limitation of the wording. Gaps in direct event data, comparisons, denominators, time and alternative explanations remain.	Events, comparators, denominators, time, alternative explanations and source level for the same exposure	When actual harm material is subsequently linked, review its evidential level within the same scope.
31	Met	Full text not readStored summary read	N31 · Evidence conditionAre historical grades, axes and English corrections distinguished from current verification?Required	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. S1	Historical grades/axes or English review wording do not establish current condition fulfillment, full-text reading, independence or effect validation.	Complete original identity and separate records of historical verdict/axes, both languages, correction events and the new condition version	If correction/update is separately requested, preserve the full prior version and separate the event, version and verdict decision.

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31 itemsWhat the statuses mean

Assessment scope

Stored-material review date: 2026-10-05
Original evidence cut-off: 2026-09-08
Scope actually checked: Retained Korean/English summaries and case-specific condition/application records. Full papers, supplements, registrations, plans and original data were not read.
What the dates mean: The material check date is the original date retained in the summary and condition records. The original verdict-review date does not establish a search cut-off or historical access dates for individual materials; external access was not attempted in this conversion.
Population: 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.

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.

S1 · Williams MJ et al. Phytother Res. 2005. PMID: 16041725.

PubMed

Material type: A randomized placebo-controlled crossover trial in the retained record. The original external paper full text was not read in this conversion.
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.
Findings recorded in the stored summary: 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.
Study overlap and 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.

Public availability, access and reading status by material
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.

Report counts versus independent study counts

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.

Review criteria

Version 1.1 · Criteria record date 2026-10-05. 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 independent FMD question is being reviewed?

Required materials and conditions: Original wording, locations and preservation identity for the claim, formulation, population, crossover comparator, endpoint and time
Conditions for verification: Link the original claim and claim conditions to this question without including other vascular measures.
Requirement and applicability: Required
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.
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.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.

N02 · Are the original trial report and repeated descriptions distinguished?

Required materials and conditions: Linked identifiers for the original trial, protocol, follow-up reports and trials included in the review
Conditions for verification: Describe the relationship between the currently identified report and repeated descriptions while leaving global unique-trial and participant totals unconfirmed.
Requirement and applicability: Required
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.
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.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.

N03 · What material was actually read in this review?

Required materials and conditions: Actual acquisition/reading level, date, original location and identity for each material, with lawful original-text gateways
Conditions for verification: Distinguish the local summary actually read from unread external material and link reading badges to exact retained quotation locations.
Requirement and applicability: Required
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.
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.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.

N04 · What CAD population do the 15 men represent?

Required materials and conditions: Eligibility criteria, baseline characteristics, CAD definition, recruitment route and baseline vascular function
Conditions for verification: Use actual material to compare trial participants with the target population, including mixed or excluded groups.
Requirement and applicability: Required
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.
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.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.

N05 · What are the AGE product, ingredients and route?

Required materials and conditions: Exact trial-product specifications, batch/manufacturing material, SAC analysis and the product actually administered
Conditions for verification: Link the actual formulation/ingredients to the question without filling standardized concentrations absent from the source.
Requirement and applicability: Required
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.
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.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.

N06 · Are the exact daily dose and actual intake known?

Required materials and conditions: Administration schedule, exact dose/frequency, intake checks, returned product, discontinuation and exposure material
Conditions for verification: Distinguish nominal dose and actual exposure in this 15-person trial, retaining uncertainty within the source scope.
Requirement and applicability: Required
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.
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.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.

N07 · Are background treatment, changes and adherence documented for each crossover period?

Required materials and conditions: Period-specific concomitant drugs, treatment changes, adherence, rescue treatment and handling in the analysis
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.
Requirement and applicability: Required
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.
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.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.

N08 · What is the actual crossover placebo comparator?

Required materials and conditions: Crossover treatment schedule, placebo composition, period-specific treatment/sequence and background treatment
Conditions for verification: Link actual treatment and comparator in each period without turning the periods into independent parallel groups.
Requirement and applicability: Required
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.
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.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.

N09 · Are period schedules and FMD assessment times, including the 2-week treatment, documented?

Required materials and conditions: Period-specific schedules, washout and medication/blood-sampling/ultrasound timetables
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.
Requirement and applicability: Required
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.
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.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.

N10 · How was brachial-artery FMD measured?

Required materials and conditions: FMD measurement manual, original measurements, image assessment, units and reproducibility material
Conditions for verification: Confirm FMD definitions and collection conditions in this trial without substituting other vascular tests.
Requirement and applicability: Required
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.
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.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.

N11 · Are baseline/period-specific FMD values and the actual between-treatment contrast underlying the 44% relative increase available?

Required materials and conditions: Baseline and period-specific FMD values, variability, change definitions and original between-treatment estimate tables
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.
Requirement and applicability: Required
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.
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.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.

N12 · Are denominators documented for recruitment, allocation, period completion and actual FMD analysis pairs?

Required materials and conditions: Participant flow, sequence-specific allocation/completion, period-specific measurements and n for analysis pairs
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.
Requirement and applicability: Required
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.
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.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.

N13 · Were missing periods and analysis losses handled?

Required materials and conditions: Period-specific missingness, losses, exclusion reasons, analysis populations and sensitivity analyses
Conditions for verification: Confirm actual analysis denominators and missing-data handling without assigning losses of 0 from empty information.
Requirement and applicability: Required
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.
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.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.

N14 · Were randomized sequences and allocation concealment checked?

Required materials and conditions: Random sequence generation/concealment, sequence-specific baseline tables and allocation records
Conditions for verification: Describe the actual allocation process relevant to the selected FMD result at the level supported by the material.
Requirement and applicability: Required
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.
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.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.

N15 · Were washout, period/sequence effects and carryover addressed in the analysis?

Required materials and conditions: Crossover protocol, period/sequence-specific data, residual effects and within-person analysis model
Conditions for verification: Check dependence and residual-effect handling in the actual crossover treatment without substituting parallel-group analysis.
Requirement and applicability: Required
Application exceptions: Apply only within the observed source material. Washout length, period/sequence effects, carryover assessment and within-person covariance/paired analysis are absent.
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.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.

N16 · How were assessors and measurement conditions blinded?

Required materials and conditions: Participant/measurement/assessment blinding, equipment, test environment and period-specific measurement records
Conditions for verification: Link limitations of actual FMD collection and assessment to material that was checked.
Requirement and applicability: Required
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.
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.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.

N17 · Are the effect definition, test model and analysis population corresponding to adjusted P=.03 available?

Required materials and conditions: Original analysis model, adjustment tables, effect definitions, variance/covariance and testing/SAP
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.
Requirement and applicability: Required
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.
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.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.

N18 · Are the absolute FMD effect and 95% CI for the selected crossover contrast available?

Required materials and conditions: Actual between-treatment/crossover effect estimate, variability, 95% CI and a justified important difference
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.
Requirement and applicability: Required
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.
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.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.

N19 · Is material available to compare prespecified FMD endpoints, timing and analysis plans with actual reporting?

Required materials and conditions: Contemporaneous registration versions, protocol, SAP and records of endpoint/timing/analysis 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.
Requirement and applicability: Required
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.
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.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.

N20 · Are report identities and included-trial data available to assess independent replication of the same FMD question?

Required materials and conditions: Review identity, included-trial tables and formulation/population/comparison/analysis families for FMD reports
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.
Requirement and applicability: Required
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.
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.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.

N21 · Does the material address long-term effects, dose or subgroups?

Required materials and conditions: Direct dose/persistence contrasts, follow-up schedules and prespecified subgroup/interaction data
Conditions for verification: Separate the current question from extensions and state only the direct evidence confirmed for each extension.
Requirement and applicability: Supplementary; required for extension claims
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.
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.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.

N22 · Are the FMD signal and clinical events distinguished?

Required materials and conditions: FMD endpoint definition and direct material for separate clinical-event outcomes/comparisons
Conditions for verification: Explain FMD values separately from event, quality-of-life and mortality questions.
Requirement and applicability: Supplementary; required for clinical extensions
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.
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.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.

N23 · What verification dates and search scope does this record represent?

Required materials and conditions: Historical search, acquisition/reading and correction checks, with the current material scope/review date
Conditions for verification: Limit absence/unverified expressions to the retained material, without turning them into a search yielding 0 or global absence of research.
Requirement and applicability: Required
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.
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.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.

N24 · Are original-trial funding, product supply and author conflict declarations available?

Required materials and conditions: Original disclosures of funding/product supply, author employment/patents, COI, institutions and research teams
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.
Requirement and applicability: Supplementary; required for independence claims
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.
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.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.

N25 · Are actual adverse-event definitions, collection methods and timing documented for the same AGE exposure?

Required materials and conditions: Harm definitions, systematic/spontaneous collection, timing, severity, discontinuation/recovery and exposure records
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.
Requirement and applicability: Supplementary; required for harm questions
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.
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.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.

N26 · Are harm comparators and incidence denominators available?

Required materials and conditions: Exposure, participants with events/event counts, follow-up and actual harm comparisons for each treatment period
Conditions for verification: Link values to frequency/risk estimates only when harm comparisons, denominators and time are reported together.
Requirement and applicability: Supplementary; required for comparative harm or incidence claims
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.
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.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.

N27 · Are concomitant drugs, baseline risks and alternative causes documented for each harm event?

Required materials and conditions: Event-specific concomitant/baseline risks, other exposures, alternative explanations and period-specific changes
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.
Requirement and applicability: Supplementary; required for causal harm claims
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.
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.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.

N28 · Are harm-collection/reporting scope, period-specific losses and follow-up gaps documented?

Required materials and conditions: Event collection/reporting scope, losses, detection differences and period-specific completeness
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.
Requirement and applicability: Supplementary; required for harm interpretation
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.
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.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.

N29 · Are independent harm-report families and direct long-term/vulnerable-population data available?

Required materials and conditions: Unique harm reports/event families, product/exposure matching and long-term/vulnerable-population follow-up
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.
Requirement and applicability: Supplementary; required for replicated or extended harm claims
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.
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.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.

N30 · Does the safety caution represent a signal, risk estimate or causality?

Required materials and conditions: Events, comparators, denominators, time, alternative explanations and source level for the same exposure
Conditions for verification: Distinguish the caution/signal/comparison/causal scope allowed by the material without creating individual intake instructions or a new safety grade.
Requirement and applicability: Supplementary; required for safety or causal harm claims
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.
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.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.

N31 · Are historical grades, axes and English corrections distinguished from current verification?

Required materials and conditions: Complete original identity and separate records of historical verdict/axes, both languages, correction events and the new condition version
Conditions for verification: Do not inherit historical values as a new score/verdict; separately retain what was actually checked for each condition.
Requirement and applicability: Required
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.
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.
Referenced methods: Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.

Referenced methods and the sections actually reviewed

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

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

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

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

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

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

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

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

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

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

Official methodology · §15.2.4, §15.3.1–15.3.3

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

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

Official methodology · §19.1.2, §19.2.1–19.2.4

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

What the statuses mean

Met: The 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/material version 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.

The stored-material review date (2026-10-05) 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 independent FMD question is being reviewed?

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.
Verification status: Met
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.
Why unverified: 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.
Remaining uncertainty: Confirmation is limited to question identity and exclusion boundaries. It does not establish effect magnitude, reproducibility or safety.
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.
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?

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.
Verification status: Met
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.
Why unverified: The 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.
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.
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.
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?

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.
Verification status: Met
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.
Why unverified: The 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.
Remaining uncertainty: The original URL/PMID is an entry clue. Historical comparison wording is not promoted to current full-text acquisition or reading.
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.
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?

Current findings: The record describes 15 men with coronary artery disease receiving standard treatment including aspirin and statins.
Verification status: Partly verified
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.
Why unverified: 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.
Remaining uncertainty: Age, CAD diagnosis/severity, eligibility/exclusions, baseline FMD, recruitment sites and representativeness are absent from the retained summary.
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.
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?

Current findings: The record describes an oral AGE preparation from aged Allium sativum cloves; detailed specifications remain unverified.
Verification status: Partly verified
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.
Why unverified: 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.
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.
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.
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?

Current findings: The original dose field is unverified, and the ingredient description explicitly leaves exact daily dose and SAC specification unverified.
Verification status: Unverified
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.
Why unverified: 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.
Remaining uncertainty: Nominal daily dose, intake frequency, adherence and actual exposure are absent. Doses from other AGE trials are not inherited.
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.
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.

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N07 · Are background treatment, changes and adherence documented for each crossover period?

Current findings: This is a crossover placebo comparison in men with CAD on standard treatment. It is not AGE monotherapy versus no treatment.
Verification status: Partly verified
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.
Why unverified: 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.
Remaining uncertainty: Period-specific aspirin/statin types, doses, changes, rescue treatment, adherence and group/period differences are absent.
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.
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.

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N08 · What is the actual crossover placebo comparator?

Current findings: Crossover placebo and a randomized placebo-controlled crossover trial are specified in the source.
Verification status: Partly verified
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.
Why unverified: 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.
Remaining uncertainty: Placebo composition, matching appearance, exposure in comparator periods and actual sequence-specific treatment records remain unverified.
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.
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.

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N09 · Are period schedules and FMD assessment times, including the 2-week treatment, documented?

Current findings: Treatment lasted 2 weeks; crossover washout details remain unverified.
Verification status: Partly verified
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.
Why unverified: 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.
Remaining uncertainty: Period start/end, total follow-up, interval from last dose to testing and allowed timing windows are absent.
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.
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.

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N10 · How was brachial-artery FMD measured?

Current findings: Brachial-artery ultrasound flow-mediated dilation is recorded as the selected endpoint.
Verification status: Partly verified
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.
Why unverified: 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.
Remaining uncertainty: Occlusion/stimulation protocol, diameter measurement, assessors, repeatability/reproducibility and definitions of baseline/maximum values are absent.
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.
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.

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N11 · Are baseline/period-specific FMD values and the actual between-treatment contrast underlying the 44% relative increase available?

Current findings: A 44% relative FMD increase from baseline after AGE is retained. It is not an absolute percentage-point contrast versus placebo.
Verification status: Partly verified
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.
Why unverified: 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.
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.
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.
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.

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N12 · Are denominators documented for recruitment, allocation, period completion and actual FMD analysis pairs?

Current findings: Only the total-sample expression of 15 men is confirmed. Crossover periods are not summed as two groups totaling 30 men.
Verification status: Partly verified
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.
Why unverified: 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.
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.
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.
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.

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N13 · Were missing periods and analysis losses handled?

Current findings: The current summary contains no numbers or reasons for period-specific missingness, losses or analysis exclusions.
Verification status: Unverified
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.
Why unverified: 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.
Remaining uncertainty: Do not assume that all 15 men completed or were analyzed. Unobserved periods and their handling remain unverified.
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.
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.

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N14 · Were randomized sequences and allocation concealment checked?

Current findings: The trial is described as randomized, placebo-controlled and crossover.
Verification status: Partly verified
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.
Why unverified: 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.
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.
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.
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.

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N15 · Were washout, period/sequence effects and carryover addressed in the analysis?

Current findings: Crossover design and unverified washout details are stated.
Verification status: Unverified
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.
Why unverified: 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.
Remaining uncertainty: Washout length, period/sequence effects, carryover assessment and within-person covariance/paired analysis are absent.
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.
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.

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N16 · How were assessors and measurement conditions blinded?

Current findings: The placebo-controlled crossover description does not include assessor blinding or group/period-specific measurement conditions.
Verification status: Unverified
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.
Why unverified: 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.
Remaining uncertainty: Do not assign double blinding or identical measurement conditions. An objective test alone does not establish absence of measurement bias.
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.
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.

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N17 · Are the effect definition, test model and analysis population corresponding to adjusted P=.03 available?

Current findings: P=.03 versus placebo is recorded as adjusted for baseline vessel diameter.
Verification status: Partly verified
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.
Why unverified: The 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.
Remaining uncertainty: The exact model, dependent variable, estimated contrast, covariates, crossover dependence, analysis population and multiplicity handling remain unverified.
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.
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.

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N18 · Are the absolute FMD effect and 95% CI for the selected crossover contrast available?

Current findings: The exact absolute between-treatment effect and 95% CI remain unverified in the source summary.
Verification status: Unverified
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.
Why unverified: 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.
Remaining uncertainty: A significant P value or sample of 15 alone does not establish effect magnitude, precision or clinical importance.
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.
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.

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N19 · Is material available to compare prespecified FMD endpoints, timing and analysis plans with actual reporting?

Current findings: The FMD endpoint is retained, but registration could not be confirmed and no direct protocol/SAP comparison is available.
Verification status: Unverified
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.
Why unverified: 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.
Remaining uncertainty: Unverified registration is not converted to confirmed nonregistration or selective reporting. NCT identifiers absent from the citation are not invented.
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.
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.

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N20 · Are report identities and included-trial data available to assess independent replication of the same FMD question?

Current findings: The original text explains that CAVI and reflective index in other AGE studies were not counted as independent FMD replication.
Verification status: Partly verified
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.
Why unverified: 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.
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.
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.
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.

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N21 · Does the material address long-term effects, dose or subgroups?

Current findings: The current record concerns 2-week FMD in men with CAD with an unverified dose.
Verification status: Unverified
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.
Why unverified: 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.
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.
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.
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.

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N22 · Are the FMD signal and clinical events distinguished?

Current findings: Brachial FMD is a vascular-function surrogate; the original text prohibits extension to myocardial-infarction prevention or reversal of atherosclerosis.
Verification status: Met
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.
Why unverified: 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.
Remaining uncertainty: Confirmation concerns the interpretation boundary. It does not certify direct clinical-event evidence or automatically require event trials for FMD itself.
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.
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.

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N23 · What verification dates and search scope does this record represent?

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.
Verification status: Met
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.
Why unverified: 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.
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.
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.
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.

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N24 · Are original-trial funding, product supply and author conflict declarations available?

Current findings: Funding and product-support details remain unverified. The original I1 axis and generic English review statements are historical records.
Verification status: Unverified
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.
Why unverified: 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.
Remaining uncertainty: Do not convert these records into confirmed independent funding, absence of product support, absence of COI or absence of bias.
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.
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.

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N25 · Are actual adverse-event definitions, collection methods and timing documented for the same AGE exposure?

Current findings: The original text cautions about bleeding and interactions in people with CAD receiving antiplatelet treatment such as aspirin.
Verification status: Partly verified
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.
Why unverified: 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.
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.
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.
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.

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N26 · Are harm comparators and incidence denominators available?

Current findings: Crossover placebo and 15 men are recorded for efficacy, but period-specific participants with harms, event counts and exposure time are absent.
Verification status: Unverified
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.
Why unverified: 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.
Remaining uncertainty: Do not substitute the efficacy sample of 15 for a harm-analysis denominator or turn a caution statement into harm frequency.
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.
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.

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N27 · Are concomitant drugs, baseline risks and alternative causes documented for each harm event?

Current findings: Background treatment such as aspirin/statins and cautions about bleeding/drug interactions are recorded.
Verification status: Partly verified
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.
Why unverified: 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.
Remaining uncertainty: Actual events, period-specific concomitant doses, baseline bleeding disorders, other causes/exposures and adjustment data are absent.
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.
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.

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N28 · Are harm-collection/reporting scope, period-specific losses and follow-up gaps documented?

Current findings: The retained summary contains no actual material on harm-collection scope, follow-up gaps or unreported events.
Verification status: Unverified
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.
Why unverified: 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.
Remaining uncertainty: Do not turn nonreporting into no events or extend absence in a short summary to nonreporting in the full paper.
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.
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.

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N29 · Are independent harm-report families and direct long-term/vulnerable-population data available?

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.
Verification status: Unverified
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.
Why unverified: 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.
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.
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.
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.

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N30 · Does the safety caution represent a signal, risk estimate or causality?

Current findings: Only the retained bleeding/interaction caution was transferred. Actual comparative risk, event causality and individual safety were not newly judged.
Verification status: Met
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.
Why unverified: 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.
Remaining uncertainty: Confirmation concerns the limitation of the wording. Gaps in direct event data, comparisons, denominators, time and alternative explanations remain.
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.
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.

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N31 · Are historical grades, axes and English corrections distinguished from current verification?

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.
Verification status: Met
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.
Why unverified: 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.
Remaining uncertainty: Historical grades/axes or English review wording do not establish current condition fulfillment, full-text reading, independence or effect validation.
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.
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