{ "schema_version": "chamgap-public-evidence-check-1.0", "public_id": "v3065-main", "verdict_number": "3065", "title": "Aged garlic extract; exact daily dose and SAC specification unverified in accessible sources × Improved brachial-artery FMD in men with coronary artery disease", "view_version": "1.0", "view_created_date": "2026-10-26", "criteria_version": "1.1", "criteria_date": "2026-10-05", "review_date": "2026-10-05", "legacy_evidence_date": "2026-09-08", "review_scope": { "materials_read": "Retained Korean/English summaries and case-specific condition/application records", "clinical_papers_directly_read": false, "new_clinical_search": false, "limitation": "Prepared from retained summaries and condition-application records. External abstracts, full texts, registration, protocols and analysis plans remain unread. Historical review records do not establish current independent clinical validation.", "date_meaning": "The material check date is the original date retained in the summary and condition records. The original verdict-review date does not establish a search cut-off or historical access dates for individual materials; external access was not attempted in this conversion." }, "claim_context": { "population": "15 men with coronary artery disease receiving background treatment including aspirin and statins. Eligibility, baseline characteristics, representativeness and actual completion/analysis denominators remain unverified.", "intervention": "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.", "endpoint": "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.", "excluded_extensions": [ "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." ] }, "requirements": [ { "item_id": "N01", "question_type": "Evidence condition", "question": "Which independent FMD question is being reviewed?", "needed": "Original wording, locations and preservation identity for the claim, formulation, population, crossover comparator, endpoint and time", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "Link the original claim and claim conditions to this question without including other vascular measures.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are Chamgap in-house application conditions for the aged-garlic-extract crossover FMD question in men with CAD, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or independent clinical validation.", "proposed_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.", "current_reports": [ "S1" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "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.", "condition_status": "Met", "status_reason": "Confirmation is limited to question identity and exclusion boundaries. It does not establish effect magnitude, reproducibility or safety.", "missingness": "Confirmation is limited to question identity and exclusion boundaries. It does not establish effect magnitude, reproducibility or safety.", "uncertainty": "Confirmation is limited to question identity and exclusion boundaries. It does not establish effect magnitude, reproducibility or safety.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Original wording, locations and preservation identity for the claim, formulation, population, crossover comparator, endpoint and time" }, { "item_id": "N02", "question_type": "Evidence condition", "question": "Are the original trial report and repeated descriptions distinguished?", "needed": "Linked identifiers for the original trial, protocol, follow-up reports and trials included in the review", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "Describe the relationship between the currently identified report and repeated descriptions while leaving global unique-trial and participant totals unconfirmed.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are Chamgap in-house application conditions for the aged-garlic-extract crossover FMD question in men with CAD, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or independent clinical validation.", "proposed_research": "In a later evidence review, group reports from the same trial and identify independent FMD replication as separate families.", "current_reports": [ "S1" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "The retained evidence and citation identify one report: Williams 2005/PMID16041725. Korean/English/synthesis restatements and the review mention are not additional independent FMD trials.", "condition_status": "Met", "status_reason": "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.", "missingness": "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.", "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.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Linked identifiers for the original trial, protocol, follow-up reports and trials included in the review" }, { "item_id": "N03", "question_type": "Evidence condition", "question": "What material was actually read in this review?", "needed": "Actual acquisition/reading level, date, original location and identity for each material, with lawful original-text gateways", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "Distinguish the local summary actually read from unread external material and link reading badges to exact retained quotation locations.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are Chamgap in-house application conditions for the aged-garlic-extract crossover FMD question in men with CAD, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or independent clinical validation.", "proposed_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.", "current_reports": [ "S1" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "The 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.", "condition_status": "Met", "status_reason": "The original URL/PMID is an entry clue. Historical comparison wording is not promoted to current full-text acquisition or reading.", "missingness": "The original URL/PMID is an entry clue. Historical comparison wording is not promoted to current full-text acquisition or reading.", "uncertainty": "The original URL/PMID is an entry clue. Historical comparison wording is not promoted to current full-text acquisition or reading.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Actual acquisition/reading level, date, original location and identity for each material, with lawful original-text gateways" }, { "item_id": "N04", "question_type": "Evidence condition", "question": "What CAD population do the 15 men represent?", "needed": "Eligibility criteria, baseline characteristics, CAD definition, recruitment route and baseline vascular function", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "Use actual material to compare trial participants with the target population, including mixed or excluded groups.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are Chamgap in-house application conditions for the aged-garlic-extract crossover FMD question in men with CAD, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or independent clinical validation.", "proposed_research": "Extending the population requires comparative FMD data in that population and prespecified effect-modification analyses.", "current_reports": [ "S1" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "The record describes 15 men with coronary artery disease receiving standard treatment including aspirin and statins.", "condition_status": "Partly verified", "status_reason": "Age, CAD diagnosis/severity, eligibility/exclusions, baseline FMD, recruitment sites and representativeness are absent from the retained summary.", "missingness": "Age, CAD diagnosis/severity, eligibility/exclusions, baseline FMD, recruitment sites and representativeness are absent from the retained summary.", "uncertainty": "Age, CAD diagnosis/severity, eligibility/exclusions, baseline FMD, recruitment sites and representativeness are absent from the retained summary.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Eligibility criteria, baseline characteristics, CAD definition, recruitment route and baseline vascular function" }, { "item_id": "N05", "question_type": "Evidence condition", "question": "What are the AGE product, ingredients and route?", "needed": "Exact trial-product specifications, batch/manufacturing material, SAC analysis and the product actually administered", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "Link the actual formulation/ingredients to the question without filling standardized concentrations absent from the source.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are Chamgap in-house application conditions for the aged-garlic-extract crossover FMD question in men with CAD, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or independent clinical validation.", "proposed_research": "Future replication should disclose the preparation and ingredient specifications so that product-specific results can be separated.", "current_reports": [ "S1" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "The record describes an oral AGE preparation from aged Allium sativum cloves; detailed specifications remain unverified.", "condition_status": "Partly verified", "status_reason": "SAC specification, manufacture/batch, extraction/aging method and additives are absent. Other garlic formulations or isolated SAC are not treated as the same product.", "missingness": "SAC specification, manufacture/batch, extraction/aging method and additives are absent. Other garlic formulations or isolated SAC are not treated as the same product.", "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.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Exact trial-product specifications, batch/manufacturing material, SAC analysis and the product actually administered" }, { "item_id": "N06", "question_type": "Evidence condition", "question": "Are the exact daily dose and actual intake known?", "needed": "Administration schedule, exact dose/frequency, intake checks, returned product, discontinuation and exposure material", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "Distinguish nominal dose and actual exposure in this 15-person trial, retaining uncertainty within the source scope.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are Chamgap in-house application conditions for the aged-garlic-extract crossover FMD question in men with CAD, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or independent clinical validation.", "proposed_research": "Once actual specification/dose is confirmed, a dose question should use direct comparisons and prespecified exposure measurement.", "current_reports": [ "S1" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "The original dose field is unverified, and the ingredient description explicitly leaves exact daily dose and SAC specification unverified.", "condition_status": "Unverified", "status_reason": "Nominal daily dose, intake frequency, adherence and actual exposure are absent. Doses from other AGE trials are not inherited.", "missingness": "Nominal daily dose, intake frequency, adherence and actual exposure are absent. Doses from other AGE trials are not inherited.", "uncertainty": "Nominal daily dose, intake frequency, adherence and actual exposure are absent. Doses from other AGE trials are not inherited.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Administration schedule, exact dose/frequency, intake checks, returned product, discontinuation and exposure material" }, { "item_id": "N07", "question_type": "Evidence condition", "question": "Are background treatment, changes and adherence documented for each crossover period?", "needed": "Period-specific concomitant drugs, treatment changes, adherence, rescue treatment and handling in the analysis", "role": "Required", "role_reason": "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_exception": "Apply only within the observed source material. Period-specific aspirin/statin types, doses, changes, rescue treatment, adherence and group/period differences are absent.", "criterion": "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.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are Chamgap in-house application conditions for the aged-garlic-extract crossover FMD question in men with CAD, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or independent clinical validation.", "proposed_research": "Future comparisons should prespecify background-treatment records, the effect of interest and analysis of treatment changes.", "current_reports": [ "S1" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "This is a crossover placebo comparison in men with CAD on standard treatment. It is not AGE monotherapy versus no treatment.", "condition_status": "Partly verified", "status_reason": "Period-specific aspirin/statin types, doses, changes, rescue treatment, adherence and group/period differences are absent.", "missingness": "Period-specific aspirin/statin types, doses, changes, rescue treatment, adherence and group/period differences are absent.", "uncertainty": "Period-specific aspirin/statin types, doses, changes, rescue treatment, adherence and group/period differences are absent.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Period-specific concomitant drugs, treatment changes, adherence, rescue treatment and handling in the analysis" }, { "item_id": "N08", "question_type": "Evidence condition", "question": "What is the actual crossover placebo comparator?", "needed": "Crossover treatment schedule, placebo composition, period-specific treatment/sequence and background treatment", "role": "Required", "role_reason": "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_exception": "Apply only within the observed source material. Placebo composition, matching appearance, exposure in comparator periods and actual sequence-specific treatment records remain unverified.", "criterion": "Link actual treatment and comparator in each period without turning the periods into independent parallel groups.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are Chamgap in-house application conditions for the aged-garlic-extract crossover FMD question in men with CAD, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or independent clinical validation.", "proposed_research": "Replicated crossover trials should clearly report placebo composition, periods and sequences.", "current_reports": [ "S1" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "Crossover placebo and a randomized placebo-controlled crossover trial are specified in the source.", "condition_status": "Partly verified", "status_reason": "Placebo composition, matching appearance, exposure in comparator periods and actual sequence-specific treatment records remain unverified.", "missingness": "Placebo composition, matching appearance, exposure in comparator periods and actual sequence-specific treatment records remain unverified.", "uncertainty": "Placebo composition, matching appearance, exposure in comparator periods and actual sequence-specific treatment records remain unverified.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Crossover treatment schedule, placebo composition, period-specific treatment/sequence and background treatment" }, { "item_id": "N09", "question_type": "Evidence condition", "question": "Are period schedules and FMD assessment times, including the 2-week treatment, documented?", "needed": "Period-specific schedules, washout and medication/blood-sampling/ultrasound timetables", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are Chamgap in-house application conditions for the aged-garlic-extract crossover FMD question in men with CAD, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or independent clinical validation.", "proposed_research": "Separate studies of persistence or discontinuation effects should prespecify actual observation times and the relevant comparisons.", "current_reports": [ "S1" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "Treatment lasted 2 weeks; crossover washout details remain unverified.", "condition_status": "Partly verified", "status_reason": "Period start/end, total follow-up, interval from last dose to testing and allowed timing windows are absent.", "missingness": "Period start/end, total follow-up, interval from last dose to testing and allowed timing windows are absent.", "uncertainty": "Period start/end, total follow-up, interval from last dose to testing and allowed timing windows are absent.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Period-specific schedules, washout and medication/blood-sampling/ultrasound timetables" }, { "item_id": "N10", "question_type": "Evidence condition", "question": "How was brachial-artery FMD measured?", "needed": "FMD measurement manual, original measurements, image assessment, units and reproducibility material", "role": "Required", "role_reason": "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_exception": "Apply only within the observed source material. Occlusion/stimulation protocol, diameter measurement, assessors, repeatability/reproducibility and definitions of baseline/maximum values are absent.", "criterion": "Confirm FMD definitions and collection conditions in this trial without substituting other vascular tests.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are Chamgap in-house application conditions for the aged-garlic-extract crossover FMD question in men with CAD, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or independent clinical validation.", "proposed_research": "Replication should specify FMD measurement procedures and assessment/reproducibility plans.", "current_reports": [ "S1" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "Brachial-artery ultrasound flow-mediated dilation is recorded as the selected endpoint.", "condition_status": "Partly verified", "status_reason": "Occlusion/stimulation protocol, diameter measurement, assessors, repeatability/reproducibility and definitions of baseline/maximum values are absent.", "missingness": "Occlusion/stimulation protocol, diameter measurement, assessors, repeatability/reproducibility and definitions of baseline/maximum values are absent.", "uncertainty": "Occlusion/stimulation protocol, diameter measurement, assessors, repeatability/reproducibility and definitions of baseline/maximum values are absent.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "FMD measurement manual, original measurements, image assessment, units and reproducibility material" }, { "item_id": "N11", "question_type": "Evidence condition", "question": "Are baseline/period-specific FMD values and the actual between-treatment contrast underlying the 44% relative increase available?", "needed": "Baseline and period-specific FMD values, variability, change definitions and original between-treatment estimate tables", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are Chamgap in-house application conditions for the aged-garlic-extract crossover FMD question in men with CAD, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or independent clinical validation.", "proposed_research": "Future reports should provide change definitions and effects/intervals for the between-treatment or period contrasts of interest.", "current_reports": [ "S1" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "A 44% relative FMD increase from baseline after AGE is retained. It is not an absolute percentage-point contrast versus placebo.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "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.", "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.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Baseline and period-specific FMD values, variability, change definitions and original between-treatment estimate tables" }, { "item_id": "N12", "question_type": "Evidence condition", "question": "Are denominators documented for recruitment, allocation, period completion and actual FMD analysis pairs?", "needed": "Participant flow, sequence-specific allocation/completion, period-specific measurements and n for analysis pairs", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are Chamgap in-house application conditions for the aged-garlic-extract crossover FMD question in men with CAD, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or independent clinical validation.", "proposed_research": "Future crossover studies should report participant, period and analysis-pair flow with denominators for each result.", "current_reports": [ "S1" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "Only the total-sample expression of 15 men is confirmed. Crossover periods are not summed as two groups totaling 30 men.", "condition_status": "Partly verified", "status_reason": "Recruitment, allocation, period completion, actual paired-analysis n and test/specimen counts are not separately reported. Generic English wording is not an actual denominator.", "missingness": "Recruitment, allocation, period completion, actual paired-analysis n and test/specimen counts are not separately reported. Generic English wording is not an actual denominator.", "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.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Participant flow, sequence-specific allocation/completion, period-specific measurements and n for analysis pairs" }, { "item_id": "N13", "question_type": "Evidence condition", "question": "Were missing periods and analysis losses handled?", "needed": "Period-specific missingness, losses, exclusion reasons, analysis populations and sensitivity analyses", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "Confirm actual analysis denominators and missing-data handling without assigning losses of 0 from empty information.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are Chamgap in-house application conditions for the aged-garlic-extract crossover FMD question in men with CAD, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or independent clinical validation.", "proposed_research": "Future studies should prespecify handling of missingness and sensitivity analyses for unobserved measurements.", "current_reports": [ "S1" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "The current summary contains no numbers or reasons for period-specific missingness, losses or analysis exclusions.", "condition_status": "Unverified", "status_reason": "Do not assume that all 15 men completed or were analyzed. Unobserved periods and their handling remain unverified.", "missingness": "Do not assume that all 15 men completed or were analyzed. Unobserved periods and their handling remain unverified.", "uncertainty": "Do not assume that all 15 men completed or were analyzed. Unobserved periods and their handling remain unverified.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Period-specific missingness, losses, exclusion reasons, analysis populations and sensitivity analyses" }, { "item_id": "N14", "question_type": "Evidence condition", "question": "Were randomized sequences and allocation concealment checked?", "needed": "Random sequence generation/concealment, sequence-specific baseline tables and allocation records", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "Describe the actual allocation process relevant to the selected FMD result at the level supported by the material.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are Chamgap in-house application conditions for the aged-garlic-extract crossover FMD question in men with CAD, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or independent clinical validation.", "proposed_research": "Replication should specify sequence allocation, concealment and baseline balance.", "current_reports": [ "S1" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "The trial is described as randomized, placebo-controlled and crossover.", "condition_status": "Partly verified", "status_reason": "Sequence generation, concealment, baseline balance between sequence groups and allocation personnel are undocumented. The randomized label alone does not establish completion of these checks.", "missingness": "Sequence generation, concealment, baseline balance between sequence groups and allocation personnel are undocumented. The randomized label alone does not establish completion of these checks.", "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.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Random sequence generation/concealment, sequence-specific baseline tables and allocation records" }, { "item_id": "N15", "question_type": "Evidence condition", "question": "Were washout, period/sequence effects and carryover addressed in the analysis?", "needed": "Crossover protocol, period/sequence-specific data, residual effects and within-person analysis model", "role": "Required", "role_reason": "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_exception": "Apply only within the observed source material. Washout length, period/sequence effects, carryover assessment and within-person covariance/paired analysis are absent.", "criterion": "Check dependence and residual-effect handling in the actual crossover treatment without substituting parallel-group analysis.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are Chamgap in-house application conditions for the aged-garlic-extract crossover FMD question in men with CAD, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or independent clinical validation.", "proposed_research": "Future crossover comparisons should prespecify washout justification, sequence/period effects and analysis of the contrast of interest.", "current_reports": [ "S1" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "Crossover design and unverified washout details are stated.", "condition_status": "Unverified", "status_reason": "Washout length, period/sequence effects, carryover assessment and within-person covariance/paired analysis are absent.", "missingness": "Washout length, period/sequence effects, carryover assessment and within-person covariance/paired analysis are absent.", "uncertainty": "Washout length, period/sequence effects, carryover assessment and within-person covariance/paired analysis are absent.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Crossover protocol, period/sequence-specific data, residual effects and within-person analysis model" }, { "item_id": "N16", "question_type": "Evidence condition", "question": "How were assessors and measurement conditions blinded?", "needed": "Participant/measurement/assessment blinding, equipment, test environment and period-specific measurement records", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "Link limitations of actual FMD collection and assessment to material that was checked.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are Chamgap in-house application conditions for the aged-garlic-extract crossover FMD question in men with CAD, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or independent clinical validation.", "proposed_research": "Replication should report feasible assessor/reader blinding and standardized procedures.", "current_reports": [ "S1" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "The placebo-controlled crossover description does not include assessor blinding or group/period-specific measurement conditions.", "condition_status": "Unverified", "status_reason": "Do not assign double blinding or identical measurement conditions. An objective test alone does not establish absence of measurement bias.", "missingness": "Do not assign double blinding or identical measurement conditions. An objective test alone does not establish absence of measurement bias.", "uncertainty": "Do not assign double blinding or identical measurement conditions. An objective test alone does not establish absence of measurement bias.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Participant/measurement/assessment blinding, equipment, test environment and period-specific measurement records" }, { "item_id": "N17", "question_type": "Evidence condition", "question": "Are the effect definition, test model and analysis population corresponding to adjusted P=.03 available?", "needed": "Original analysis model, adjustment tables, effect definitions, variance/covariance and testing/SAP", "role": "Required", "role_reason": "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_exception": "Apply only within the observed source material. The exact model, dependent variable, estimated contrast, covariates, crossover dependence, analysis population and multiplicity handling remain unverified.", "criterion": "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.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are Chamgap in-house application conditions for the aged-garlic-extract crossover FMD question in men with CAD, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or independent clinical validation.", "proposed_research": "Future comparisons should prespecify the within-person treatment effect of interest and adjustment/multiplicity plans.", "current_reports": [ "S1" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "P=.03 versus placebo is recorded as adjusted for baseline vessel diameter.", "condition_status": "Partly verified", "status_reason": "The exact model, dependent variable, estimated contrast, covariates, crossover dependence, analysis population and multiplicity handling remain unverified.", "missingness": "The exact model, dependent variable, estimated contrast, covariates, crossover dependence, analysis population and multiplicity handling remain unverified.", "uncertainty": "The exact model, dependent variable, estimated contrast, covariates, crossover dependence, analysis population and multiplicity handling remain unverified.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Original analysis model, adjustment tables, effect definitions, variance/covariance and testing/SAP" }, { "item_id": "N18", "question_type": "Evidence condition", "question": "Are the absolute FMD effect and 95% CI for the selected crossover contrast available?", "needed": "Actual between-treatment/crossover effect estimate, variability, 95% CI and a justified important difference", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are Chamgap in-house application conditions for the aged-garlic-extract crossover FMD question in men with CAD, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or independent clinical validation.", "proposed_research": "Future studies should design precision around the effect of interest, uncertainty and importance criterion. Do not set an arbitrary minimum n.", "current_reports": [ "S1" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "The exact absolute between-treatment effect and 95% CI remain unverified in the source summary.", "condition_status": "Unverified", "status_reason": "A significant P value or sample of 15 alone does not establish effect magnitude, precision or clinical importance.", "missingness": "A significant P value or sample of 15 alone does not establish effect magnitude, precision or clinical importance.", "uncertainty": "A significant P value or sample of 15 alone does not establish effect magnitude, precision or clinical importance.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Actual between-treatment/crossover effect estimate, variability, 95% CI and a justified important difference" }, { "item_id": "N19", "question_type": "Evidence condition", "question": "Is material available to compare prespecified FMD endpoints, timing and analysis plans with actual reporting?", "needed": "Contemporaneous registration versions, protocol, SAP and records of endpoint/timing/analysis changes", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are Chamgap in-house application conditions for the aged-garlic-extract crossover FMD question in men with CAD, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or independent clinical validation.", "proposed_research": "Future replication should disclose endpoints, timing and analyses prospectively and record reasons for changes.", "current_reports": [ "S1" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "The FMD endpoint is retained, but registration could not be confirmed and no direct protocol/SAP comparison is available.", "condition_status": "Unverified", "status_reason": "Unverified registration is not converted to confirmed nonregistration or selective reporting. NCT identifiers absent from the citation are not invented.", "missingness": "Unverified registration is not converted to confirmed nonregistration or selective reporting. NCT identifiers absent from the citation are not invented.", "uncertainty": "Unverified registration is not converted to confirmed nonregistration or selective reporting. NCT identifiers absent from the citation are not invented.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Contemporaneous registration versions, protocol, SAP and records of endpoint/timing/analysis changes" }, { "item_id": "N20", "question_type": "Evidence condition", "question": "Are report identities and included-trial data available to assess independent replication of the same FMD question?", "needed": "Review identity, included-trial tables and formulation/population/comparison/analysis families for FMD reports", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are Chamgap in-house application conditions for the aged-garlic-extract crossover FMD question in men with CAD, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or independent clinical validation.", "proposed_research": "In an authorized follow-up review, group related families and determine whether independent comparisons using the same FMD contract are needed.", "current_reports": [ "S1" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "The original text explains that CAVI and reflective index in other AGE studies were not counted as independent FMD replication.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "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.", "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.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Review identity, included-trial tables and formulation/population/comparison/analysis families for FMD reports" }, { "item_id": "N21", "question_type": "Evidence condition", "question": "Does the material address long-term effects, dose or subgroups?", "needed": "Direct dose/persistence contrasts, follow-up schedules and prespecified subgroup/interaction data", "role": "Supplementary; required for extension claims", "role_reason": "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_exception": "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.", "criterion": "Separate the current question from extensions and state only the direct evidence confirmed for each extension.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are Chamgap in-house application conditions for the aged-garlic-extract crossover FMD question in men with CAD, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or independent clinical validation.", "proposed_research": "When an extension is claimed, separately design direct comparisons of its dose, persistence or population with prespecified interaction analyses.", "current_reports": [ "S1" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "The current record concerns 2-week FMD in men with CAD with an unverified dose.", "condition_status": "Unverified", "status_reason": "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.", "missingness": "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.", "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.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct dose/persistence contrasts, follow-up schedules and prespecified subgroup/interaction data" }, { "item_id": "N22", "question_type": "Evidence condition", "question": "Are the FMD signal and clinical events distinguished?", "needed": "FMD endpoint definition and direct material for separate clinical-event outcomes/comparisons", "role": "Supplementary; required for clinical extensions", "role_reason": "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_exception": "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.", "criterion": "Explain FMD values separately from event, quality-of-life and mortality questions.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are Chamgap in-house application conditions for the aged-garlic-extract crossover FMD question in men with CAD, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or independent clinical validation.", "proposed_research": "A separate clinical-event prevention question requires direct studies with the relevant events, denominators and follow-up.", "current_reports": [ "S1" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "Brachial FMD is a vascular-function surrogate; the original text prohibits extension to myocardial-infarction prevention or reversal of atherosclerosis.", "condition_status": "Met", "status_reason": "Confirmation concerns the interpretation boundary. It does not certify direct clinical-event evidence or automatically require event trials for FMD itself.", "missingness": "Confirmation concerns the interpretation boundary. It does not certify direct clinical-event evidence or automatically require event trials for FMD itself.", "uncertainty": "Confirmation concerns the interpretation boundary. It does not certify direct clinical-event evidence or automatically require event trials for FMD itself.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "FMD endpoint definition and direct material for separate clinical-event outcomes/comparisons" }, { "item_id": "N23", "question_type": "Evidence condition", "question": "What verification dates and search scope does this record represent?", "needed": "Historical search, acquisition/reading and correction checks, with the current material scope/review date", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "Limit absence/unverified expressions to the retained material, without turning them into a search yielding 0 or global absence of research.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are Chamgap in-house application conditions for the aged-garlic-extract crossover FMD question in men with CAD, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or independent clinical validation.", "proposed_research": "If an evidence update is authorized, separately record the historical scope and dates/methods of new searches and correction checks.", "current_reports": [ "S1" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "The original review date is 2026-09-08 and the English correction event is 2026-09-14. The current retained summary was reviewed separately.", "condition_status": "Met", "status_reason": "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.", "missingness": "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.", "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.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Historical search, acquisition/reading and correction checks, with the current material scope/review date" }, { "item_id": "N24", "question_type": "Evidence condition", "question": "Are original-trial funding, product supply and author conflict declarations available?", "needed": "Original disclosures of funding/product supply, author employment/patents, COI, institutions and research teams", "role": "Supplementary; required for independence claims", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are Chamgap in-house application conditions for the aged-garlic-extract crossover FMD question in men with CAD, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or independent clinical validation.", "proposed_research": "Future replication should disclose resources, product support and roles in design/data so that independence can be assessed.", "current_reports": [ "S1" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "Funding and product-support details remain unverified. The original I1 axis and generic English review statements are historical records.", "condition_status": "Unverified", "status_reason": "Do not convert these records into confirmed independent funding, absence of product support, absence of COI or absence of bias.", "missingness": "Do not convert these records into confirmed independent funding, absence of product support, absence of COI or absence of bias.", "uncertainty": "Do not convert these records into confirmed independent funding, absence of product support, absence of COI or absence of bias.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Original disclosures of funding/product supply, author employment/patents, COI, institutions and research teams" }, { "item_id": "N25", "question_type": "Evidence condition", "question": "Are actual adverse-event definitions, collection methods and timing documented for the same AGE exposure?", "needed": "Harm definitions, systematic/spontaneous collection, timing, severity, discontinuation/recovery and exposure records", "role": "Supplementary; required for harm questions", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are Chamgap in-house application conditions for the aged-garlic-extract crossover FMD question in men with CAD, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or independent clinical validation.", "proposed_research": "Future studies should separately plan harm collection and temporal relationships for the same preparation, population and follow-up.", "current_reports": [ "S1" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "The original text cautions about bleeding and interactions in people with CAD receiving antiplatelet treatment such as aspirin.", "condition_status": "Partly verified", "status_reason": "Actual trial event definitions, collection, severity, onset/recovery and exposure/discontinuation times are absent. The caution is not converted to a measured harm increase.", "missingness": "Actual trial event definitions, collection, severity, onset/recovery and exposure/discontinuation times are absent. The caution is not converted to a measured harm increase.", "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.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Harm definitions, systematic/spontaneous collection, timing, severity, discontinuation/recovery and exposure records" }, { "item_id": "N26", "question_type": "Evidence condition", "question": "Are harm comparators and incidence denominators available?", "needed": "Exposure, participants with events/event counts, follow-up and actual harm comparisons for each treatment period", "role": "Supplementary; required for comparative harm or incidence claims", "role_reason": "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_exception": "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.", "criterion": "Link values to frequency/risk estimates only when harm comparisons, denominators and time are reported together.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are Chamgap in-house application conditions for the aged-garlic-extract crossover FMD question in men with CAD, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or independent clinical validation.", "proposed_research": "If a harm comparison is planned, collect events and denominators together for the same exposure and period.", "current_reports": [ "S1" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "Crossover placebo and 15 men are recorded for efficacy, but period-specific participants with harms, event counts and exposure time are absent.", "condition_status": "Unverified", "status_reason": "Do not substitute the efficacy sample of 15 for a harm-analysis denominator or turn a caution statement into harm frequency.", "missingness": "Do not substitute the efficacy sample of 15 for a harm-analysis denominator or turn a caution statement into harm frequency.", "uncertainty": "Do not substitute the efficacy sample of 15 for a harm-analysis denominator or turn a caution statement into harm frequency.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Exposure, participants with events/event counts, follow-up and actual harm comparisons for each treatment period" }, { "item_id": "N27", "question_type": "Evidence condition", "question": "Are concomitant drugs, baseline risks and alternative causes documented for each harm event?", "needed": "Event-specific concomitant/baseline risks, other exposures, alternative explanations and period-specific changes", "role": "Supplementary; required for causal harm claims", "role_reason": "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_exception": "Apply only within the observed source material. Actual events, period-specific concomitant doses, baseline bleeding disorders, other causes/exposures and adjustment data are absent.", "criterion": "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.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are Chamgap in-house application conditions for the aged-garlic-extract crossover FMD question in men with CAD, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or independent clinical validation.", "proposed_research": "Future harm analyses should collect concomitant drugs, baseline risks and alternative explanations together.", "current_reports": [ "S1" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "Background treatment such as aspirin/statins and cautions about bleeding/drug interactions are recorded.", "condition_status": "Partly verified", "status_reason": "Actual events, period-specific concomitant doses, baseline bleeding disorders, other causes/exposures and adjustment data are absent.", "missingness": "Actual events, period-specific concomitant doses, baseline bleeding disorders, other causes/exposures and adjustment data are absent.", "uncertainty": "Actual events, period-specific concomitant doses, baseline bleeding disorders, other causes/exposures and adjustment data are absent.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Event-specific concomitant/baseline risks, other exposures, alternative explanations and period-specific changes" }, { "item_id": "N28", "question_type": "Evidence condition", "question": "Are harm-collection/reporting scope, period-specific losses and follow-up gaps documented?", "needed": "Event collection/reporting scope, losses, detection differences and period-specific completeness", "role": "Supplementary; required for harm interpretation", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are Chamgap in-house application conditions for the aged-garlic-extract crossover FMD question in men with CAD, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or independent clinical validation.", "proposed_research": "Harm follow-up studies should disclose collection systems, tracking of missing follow-up and sensitivity analyses.", "current_reports": [ "S1" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "The retained summary contains no actual material on harm-collection scope, follow-up gaps or unreported events.", "condition_status": "Unverified", "status_reason": "Do not turn nonreporting into no events or extend absence in a short summary to nonreporting in the full paper.", "missingness": "Do not turn nonreporting into no events or extend absence in a short summary to nonreporting in the full paper.", "uncertainty": "Do not turn nonreporting into no events or extend absence in a short summary to nonreporting in the full paper.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Event collection/reporting scope, losses, detection differences and period-specific completeness" }, { "item_id": "N29", "question_type": "Evidence condition", "question": "Are independent harm-report families and direct long-term/vulnerable-population data available?", "needed": "Unique harm reports/event families, product/exposure matching and long-term/vulnerable-population follow-up", "role": "Supplementary; required for replicated or extended harm claims", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are Chamgap in-house application conditions for the aged-garlic-extract crossover FMD question in men with CAD, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or independent clinical validation.", "proposed_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.", "current_reports": [ "S1" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "Only the original safety wording is present; independent event/harm-report families and direct long-term/female/vulnerable-population material are not linked.", "condition_status": "Unverified", "status_reason": "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.", "missingness": "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.", "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.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Unique harm reports/event families, product/exposure matching and long-term/vulnerable-population follow-up" }, { "item_id": "N30", "question_type": "Evidence condition", "question": "Does the safety caution represent a signal, risk estimate or causality?", "needed": "Events, comparators, denominators, time, alternative explanations and source level for the same exposure", "role": "Supplementary; required for safety or causal harm claims", "role_reason": "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_exception": "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.", "criterion": "Distinguish the caution/signal/comparison/causal scope allowed by the material without creating individual intake instructions or a new safety grade.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are Chamgap in-house application conditions for the aged-garlic-extract crossover FMD question in men with CAD, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or independent clinical validation.", "proposed_research": "When actual harm material is subsequently linked, review its evidential level within the same scope.", "current_reports": [ "S1" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "Only the retained bleeding/interaction caution was transferred. Actual comparative risk, event causality and individual safety were not newly judged.", "condition_status": "Met", "status_reason": "Confirmation concerns the limitation of the wording. Gaps in direct event data, comparisons, denominators, time and alternative explanations remain.", "missingness": "Confirmation concerns the limitation of the wording. Gaps in direct event data, comparisons, denominators, time and alternative explanations remain.", "uncertainty": "Confirmation concerns the limitation of the wording. Gaps in direct event data, comparisons, denominators, time and alternative explanations remain.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Events, comparators, denominators, time, alternative explanations and source level for the same exposure" }, { "item_id": "N31", "question_type": "Evidence condition", "question": "Are historical grades, axes and English corrections distinguished from current verification?", "needed": "Complete original identity and separate records of historical verdict/axes, both languages, correction events and the new condition version", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "Do not inherit historical values as a new score/verdict; separately retain what was actually checked for each condition.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are Chamgap in-house application conditions for the aged-garlic-extract crossover FMD question in men with CAD, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or independent clinical validation.", "proposed_research": "If correction/update is separately requested, preserve the full prior version and separate the event, version and verdict decision.", "current_reports": [ "S1" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "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.", "condition_status": "Met", "status_reason": "Historical grades/axes or English review wording do not establish current condition fulfillment, full-text reading, independence or effect validation.", "missingness": "Historical grades/axes or English review wording do not establish current condition fulfillment, full-text reading, independence or effect validation.", "uncertainty": "Historical grades/axes or English review wording do not establish current condition fulfillment, full-text reading, independence or effect validation.", "review_date": "2026-10-05", "reading_status": "Full text not read · Stored summary read", "additional_material": "Complete original identity and separate records of historical verdict/axes, both languages, correction events and the new condition version" } ], "reports": [ { "report_id": "S1", "title": "Williams MJ et al. Phytother Res. 2005. PMID: 16041725.", "url": "https://pubmed.ncbi.nlm.nih.gov/16041725/", "report_type": "A randomized placebo-controlled crossover trial in the retained record. The original external paper full text was not read in this conversion.", "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "study_family": "A provisional family for the Williams2005 report, PMID16041725. The full scope of registration, follow-up reports, participant overlap and independent replication remains unverified.", "independent_replication": "CAVI and reflective index in other AGE studies are different endpoints and are not direct independent FMD replication. The review identity, included trials and full scope of direct replication remain unverified.", "observed_result": "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.", "result_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.", "source_evidence_date": "2026-09-08", "materials": [ { "material_type": "Retained verdict summary", "public_status": "Retained verdict summary read", "access_status": "Retained copy acquired; summary read", "acquired": true, "actually_read": "Stored existing review summary read", "as_of": "2026-10-05", "qualification": "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." }, { "material_type": "External PubMed bibliographic/abstract gateway", "public_status": "External access not attempted; not acquired; unread", "access_status": "External access not attempted; not acquired", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "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." }, { "material_type": "Original paper full text/appendix; location unverified", "public_status": "External access not attempted; not acquired; unread", "access_status": "External access not attempted; not acquired", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-05", "qualification": "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." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/16041725/" } ] } ], "method_sources": [ { "id": "M03", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03", "section": "§3.1, §3.2.1–3.2.3, MECIR C5/C7/C13", "official_principle": "Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.", "review_level": "Retained method-application records were reused. External originals were not reread and method content was not reassessed." }, { "id": "M04", "version": "Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04", "section": "§4.5, §4.6.1–4.6.3, MECIR C42", "official_principle": "Distinguish studies from reports and link them; do not omit a study solely because results are unreported.", "review_level": "Retained method-application records were reused. External originals were not reread and method content was not reassessed." }, { "id": "M08", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08", "section": "§8.1–8.2.3, Table 8.2.a", "official_principle": "Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.", "review_level": "Retained method-application records were reused. External originals were not reread and method content was not reassessed." }, { "id": "M15", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15", "section": "§15.2.4, §15.3.1–15.3.3", "official_principle": "Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.", "review_level": "Retained method-application records were reused. External originals were not reread and method content was not reassessed." }, { "id": "M19", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19", "section": "§19.1.2, §19.2.1–19.2.4", "official_principle": "Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.", "review_level": "Retained method-application records were reused. External originals were not reread and method content was not reassessed." } ], "status_dictionary": { "Met": "The 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." }, "study_overlap": { "state": "Unverified", "unique_trial_count": null, "unique_participant_count": null, "reason": "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." }, "history": [ { "date": "2026-10-26", "kind": "Separation of public-facing pages and materials", "view_version": "1.0", "change": "The public view and materials were prepared from the existing 31 items. No new clinical search, verification-state change or scoring was performed." } ], "language": "en", "translation_date": "2026-10-26" }