{ "schema_version": "chamgap-public-criteria-1.0", "title": "Aged garlic extract; exact daily dose and SAC specification unverified in accessible sources × Improved brachial-artery FMD in men with coronary artery disease", "language": "en", "translation_date": "2026-10-26", "criteria_version": "1.1", "criteria_date": "2026-10-05", "condition_origin": "Chamgap's own application conditions", "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." }, "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." } ] }