{ "schema_version": "chamgap-public-evidence-check-1.0", "public_id": "v3059-main", "verdict_number": "3059", "title": "Aged garlic extract 2,400 mg/day × Reduced progression of low-attenuation coronary plaque in metabolic syndrome", "view_version": "1.0", "view_created_date": "2026-10-25", "criteria_version": "1.0", "criteria_date": "2026-10-06", "review_date": "2026-10-06", "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 date is the original check date in retained summary and condition records. The retained verdict’s evidence date, historical access dates for individual materials and current external-access status are distinguished." }, "claim_context": { "population": "Adults with metabolic syndrome continuing usual risk-factor care. The retained record distinguishes 65 enrolled from 55 analyzed.", "comparator": "Matching placebo plus usual risk-factor care. Original material on placebo composition and changes in background care remains unverified.", "endpoint": "Change in percent low-attenuation coronary plaque volume (%LAP) on CCTA. A prespecified LAP-only primary (1st) outcome hierarchy remains unverified.", "intervention": "Oral aged garlic extract (AGE) capsules as an add-on. Product name, study batch and exact SAC specification remain unverified.", "dose": "AGE 2,400 mg/day. Details of actual intake, capsule count and adherence remain unverified.", "duration": "About 12 months; CCTA imaging interval 354±41 days. The statistical meaning of ±41, such as SD or SE, remains unverified.", "excluded_extensions": [ "Total plaque, noncalcified plaque and dense calcium are separate imaging endpoints; the null descriptions in the retained record are preserved.", "The finding is not extended to plaque elimination, myocardial-infarction prevention or reduced mortality.", "Other garlic formulations, other AGE products and isolated SAC are not treated as the same intervention.", "The unidentified diabetes background reference is not added as a new report or independent replication.", "Effects of AGE combined with B vitamins, folate and L-arginine are not transferred to AGE alone.", "Optimal dosing, persistence after stopping and additional subgroup effects are separate from the current narrow question.", "General caution is not converted into bleeding-event counts, comparative risk, causality or confirmation of overall safety." ] }, "requirements": [ { "item_id": "N01", "question_type": "Evidence condition", "question": "Which AGE product, population, time frame and imaging endpoint does this question concern?", "needed": "The original protocol and result tables linking this population, formulation, route, dose, comparator and time point.", "role": "Required", "role_reason": "Different question identities can mix different effects under the same garlic or plaque label.", "application_exception": "Do not combine total plaque, noncalcified plaque, dense calcium, plaque disappearance, myocardial infarction/death or other garlic formulations with this question.", "criterion": "Limit the question to change in CCTA %LAP after about 12 months of AGE capsules at 2,400 mg/day versus matching placebo plus usual care in adults with metabolic syndrome continuing their usual risk-factor treatment.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are Chamgap in-house application conditions developed with knowledge of the retained AGE and low-attenuation coronary-plaque record. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: The original protocol and result tables linking this population, formulation, route, dose, comparator and time point. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "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 PubMed, DOI, full-text and registration material remain unread, with access not attempted.", "observation": "The Korean claim concerns reduced progression of low-attenuation coronary plaque in adults with metabolic syndrome. The intervention and population description links AGE capsules, 2,400 mg/day, about 12 months/a CCTA interval of 354±41 days, and matching placebo plus usual care. There are no additional subclaims.", "condition_status": "Met", "status_reason": "The retained text identifies the distinct question and its exclusions. This does not establish verification of the trial plan or confirmation of imaging efficacy.", "missingness": "Direct comparison with the original protocol and detailed product and imaging specifications remains unverified under the conditions below.", "uncertainty": "Direct comparison with the original protocol and detailed product and imaging specifications remains unverified under the conditions below.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "The original protocol and result tables linking this population, formulation, route, dose, comparator and time point." }, { "item_id": "N02", "question_type": "Evidence condition", "question": "Are multiple analyses or repeated citations of a report being counted as separate trials?", "needed": "Study-family material linking registration, recruitment identity, the population/time points of each report, related reports and an included-trial table.", "role": "Required", "role_reason": "A paper citation and an evidence table, or group values and a regression coefficient, do not each constitute independent replication.", "application_exception": "Without a study-family linkage and an independent citation for the diabetes report, do not estimate the unique study count or participant total.", "criterion": "Link the first evidence summary and first citation within the same retained report context, and distinguish group percentage changes from adjusted β as different analyses of the same endpoint. Leave the background diabetes trial unidentified.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are Chamgap in-house application conditions developed with knowledge of the retained AGE and low-attenuation coronary-plaque record. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Study-family material linking registration, recruitment identity, the population/time points of each report, related reports and an included-trial table. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "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 PubMed, DOI, full-text and registration material remain unread, with access not attempted.", "observation": "The 1 evidence summary and 1 citation correspond to a report by Matsumoto2016. The research description separates unadjusted values from adjusted β. The diabetes trial appears only as background described as sharing the product company and research lineage.", "condition_status": "Partly verified", "status_reason": "The local report pair and analysis levels are linked, but external recruitment identities and related report families have not been newly verified.", "missingness": "Identifiers for the background diabetes report, recruitment overlap, the unique family count and the participant total remain unverified in the retained material.", "uncertainty": "Identifiers for the background diabetes report, recruitment overlap, the unique family count and the participant total remain unverified in the retained material.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Study-family material linking registration, recruitment identity, the population/time points of each report, related reports and an included-trial table." }, { "item_id": "N03", "question_type": "Evidence condition", "question": "Is the summary actually read distinguished from unread external material?", "needed": "For each material, the actual access date, attempts/success, acquired file, source location, reading scope and safe link.", "role": "Required", "role_reason": "An identifier or the word verified in the original English text is not evidence of full-text reading during this work.", "application_exception": "Do not describe an unattempted access as a failed access, or replace an absent historical access date with the current reading date.", "criterion": "Link the reading of all fields, Korean and English text, evidence and citations in the retained summary to source locations and identity checks, and distinguish existence, access, acquisition and reading for PubMed, DOI, full text and registration separately.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are Chamgap in-house application conditions developed with knowledge of the retained AGE and low-attenuation coronary-plaque record. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: For each material, the actual access date, attempts/success, acquired file, source location, reading scope and safe link. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "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 PubMed, DOI, full-text and registration material remain unread, with access not attempted.", "observation": "The retained Korean and English verdict summary was read. A PubMed URL, DOI and NCT01534910 identifier are present, but external abstracts, full text and registration have not been accessed, acquired or read.", "condition_status": "Met", "status_reason": "The local summary reading is separated from unread external material, with citation locations and hashes linked. This does not establish verification of external content.", "missingness": "Past access dates, reading levels and the physical bytes of an acquired full text for each report are absent from the retained summary and remain unverified.", "uncertainty": "Past access dates, reading levels and the physical bytes of an acquired full text for each report are absent from the retained summary and remain unverified.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "For each material, the actual access date, attempts/success, acquired file, source location, reading scope and safe link." }, { "item_id": "N04", "question_type": "Evidence condition", "question": "How were the analyzed adults with metabolic syndrome selected?", "needed": "Eligibility/exclusion criteria, the metabolic-syndrome definition, baseline tables, age, comorbidities, recruitment setting and a flow diagram.", "role": "Required", "role_reason": "The analyzed sample of 55 alone cannot establish representativeness for all people with metabolic syndrome or all patients with diabetes.", "application_exception": "Do not reinterpret the 55 adults in the population description as the entire enrollment denominator or as participants in the separate diabetes trial.", "criterion": "Retain the population definition of metabolic syndrome with continued usual treatment, and distinguish diagnostic criteria, age, eligibility/exclusions, baseline balance and analysis losses.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are Chamgap in-house application conditions developed with knowledge of the retained AGE and low-attenuation coronary-plaque record. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Eligibility/exclusion criteria, the metabolic-syndrome definition, baseline tables, age, comorbidities, recruitment setting and a flow diagram. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "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 PubMed, DOI, full-text and registration material remain unread, with access not attempted.", "observation": "The intervention and population description records 55 adults with metabolic syndrome continuing their usual risk-factor treatment. The evidence count separately distinguishes 65 enrolled from 55 analyzed.", "condition_status": "Partly verified", "status_reason": "The diagnosis label and continued treatment are identified, but detailed selection, age, baseline characteristics and recruitment setting remain unverified.", "missingness": "The metabolic-syndrome definition, age distribution, eligibility/exclusions, baseline balance and characteristics of people excluded from analysis remain unverified.", "uncertainty": "The metabolic-syndrome definition, age distribution, eligibility/exclusions, baseline balance and characteristics of people excluded from analysis remain unverified.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Eligibility/exclusion criteria, the metabolic-syndrome definition, baseline tables, age, comorbidities, recruitment setting and a flow diagram." }, { "item_id": "N05", "question_type": "Evidence condition", "question": "Are the AGE capsule product and SAC specifications identified?", "needed": "Product name, manufacturing/aging process, standardization specifications such as SAC, and trial-batch analyses.", "role": "Required", "role_reason": "The same AGE dose in mg does not establish identical SAC content or processed formulation.", "application_exception": "Do not interchange raw garlic, powder, oil, stabilized allicin, black garlic, fermented garlic or isolated SAC with AGE, or convert AGE mg into SAC mg.", "criterion": "Separately compare the AGE capsule formulation of aged Allium sativum clove extract with SAC standardization, aging process, content and product identity.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are Chamgap in-house application conditions developed with knowledge of the retained AGE and low-attenuation coronary-plaque record. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Product name, manufacturing/aging process, standardization specifications such as SAC, and trial-batch analyses. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "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 PubMed, DOI, full-text and registration material remain unread, with access not attempted.", "observation": "The formulation is AGE capsules; detailed SAC specifications are unverified. The source part is aged clove extract, and both the Korean and English texts caution against treating other garlic formulations as interchangeable.", "condition_status": "Partly verified", "status_reason": "The aged-extract capsule formulation is identified, but detailed product and SAC specifications remain unverified.", "missingness": "Product name, trial batch, aging process, SAC content/specifications and equivalence to other AGE products remain unverified.", "uncertainty": "Product name, trial batch, aging process, SAC content/specifications and equivalence to other AGE products remain unverified.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Product name, manufacturing/aging process, standardization specifications such as SAC, and trial-batch analyses." }, { "item_id": "N06", "question_type": "Evidence condition", "question": "What are the actual oral exposure and placebo comparison?", "needed": "Dosing records, capsule schedule, placebo composition/appearance, adherence and actual exposure by group.", "role": "Required", "role_reason": "A planned dose or placebo label does not establish actual exposure or the full implementation of blinding.", "application_exception": "Do not invent capsule counts, SAC amounts or adherence rates without source material, or turn this into a trial of replacing usual treatment.", "criterion": "Link nominal oral add-on AGE at 2,400 mg/day with matching placebo plus usual care, and separately compare actual intake, capsule count, placebo content and adherence.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are Chamgap in-house application conditions developed with knowledge of the retained AGE and low-attenuation coronary-plaque record. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Dosing records, capsule schedule, placebo composition/appearance, adherence and actual exposure by group. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "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 PubMed, DOI, full-text and registration material remain unread, with access not attempted.", "observation": "The original dose is 2,400 mg/day, given orally as add-on treatment, with matching placebo plus usual care as comparator. Actual capsule count, placebo composition and adherence remain unverified in the retained summary.", "condition_status": "Partly verified", "status_reason": "The nominal dosing and comparison are retained, while actual exposure, placebo details and adherence remain to be verified.", "missingness": "Direct material on capsule count, actual dosing/adherence, placebo ingredients and matching appearance remains unverified.", "uncertainty": "Direct material on capsule count, actual dosing/adherence, placebo ingredients and matching appearance remains unverified.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Dosing records, capsule schedule, placebo composition/appearance, adherence and actual exposure by group." }, { "item_id": "N07", "question_type": "Evidence condition", "question": "Which imaging component and denominator does %LAP measure?", "needed": "The LAP measurement definition, attenuation cutoff, segmentation criteria, percentage calculation specification and result-table notes.", "role": "Required", "role_reason": "The low-attenuation plaque component, total plaque, calcium and volume scales are different endpoints.", "application_exception": "Do not convert the original percentage into a new percentage-point or relative change, or interpret it as plaque disappearance.", "criterion": "Attribute the result to change in CCTA percent low-attenuation plaque volume, and compare the attenuation cutoff, segmentation, percentage numerator/denominator and scale direction.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are Chamgap in-house application conditions developed with knowledge of the retained AGE and low-attenuation coronary-plaque record. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: The LAP measurement definition, attenuation cutoff, segmentation criteria, percentage calculation specification and result-table notes. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "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 PubMed, DOI, full-text and registration material remain unread, with access not attempted.", "observation": "The named endpoint is change in CCTA percent low-attenuation plaque volume. The original central explanation limits interpretation to the low-attenuation component rather than total plaque.", "condition_status": "Partly verified", "status_reason": "The imaging endpoint name is identified, but the attenuation cutoff, segmentation, percentage numerator/denominator and exact scale specification remain unverified.", "missingness": "Details of the attenuation cutoff, numerator/denominator, measurement algorithm, scale direction and unit interpretation remain unverified.", "uncertainty": "Details of the attenuation cutoff, numerator/denominator, measurement algorithm, scale direction and unit interpretation remain unverified.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "The LAP measurement definition, attenuation cutoff, segmentation criteria, percentage calculation specification and result-table notes." }, { "item_id": "N08", "question_type": "Evidence condition", "question": "How are treatment duration and the CCTA scan interval distinguished?", "needed": "Treatment duration by group, scan dates/windows and baseline-to-follow-up image matching.", "role": "Required", "role_reason": "Differences between treatment duration and outcome collection time can affect interpretation of progression.", "application_exception": "Do not assume the dispersion type of 354±41, or convert it into exactly 12 months or long-term persistence.", "criterion": "Retain the original notation of about 12 months of treatment and a CCTA interval of 354±41 days, and verify group scan windows, individual time points and the scope of baseline/follow-up image pairs.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are Chamgap in-house application conditions developed with knowledge of the retained AGE and low-attenuation coronary-plaque record. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Treatment duration by group, scan dates/windows and baseline-to-follow-up image matching. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "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 PubMed, DOI, full-text and registration material remain unread, with access not attempted.", "observation": "The original duration is about 12 months, and the CCTA interval is 354±41 days. Details of group and individual scan times and time windows are not separately retained.", "condition_status": "Partly verified", "status_reason": "The reported time notation is retained, but correspondence between scans and treatment exposure by group remains unverified.", "missingness": "Scan windows, discontinued/missing scans and the statistical meaning of ±41 remain unverified in the current material.", "uncertainty": "Scan windows, discontinued/missing scans and the statistical meaning of ±41 remain unverified in the current material.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Treatment duration by group, scan dates/windows and baseline-to-follow-up image matching." }, { "item_id": "N09", "question_type": "Evidence condition", "question": "Which values describe unadjusted group percentage changes?", "needed": "Group result tables, change definitions, dispersion notes, testing specifications and the analysis population.", "role": "Required", "role_reason": "Simple subtraction of group changes does not substitute for the effect the trial estimated.", "application_exception": "Do not calculate a new between-group difference or RR/OR, or turn the ± values into confidence intervals.", "criterion": "Retain −1.5±2.3% versus +0.2±2.0%, P=.0049, at the group-change level, distinct from adjusted β and new between-group calculations.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are Chamgap in-house application conditions developed with knowledge of the retained AGE and low-attenuation coronary-plaque record. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Group result tables, change definitions, dispersion notes, testing specifications and the analysis population. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "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 PubMed, DOI, full-text and registration material remain unread, with access not attempted.", "observation": "The original result distinguishes −1.5±2.3% versus +0.2±2.0%, P=.0049, from adjusted β. The Korean and English reader answers also report group values of −1.5% versus +0.2% separately.", "condition_status": "Partly verified", "status_reason": "Group values, signs, percentages and P are identified, but the change definition, testing, dispersion and exact analysis specification remain unverified.", "missingness": "The types of ±2.3/±2.0, such as SD/SE, the percentage-change specification, test method and analysis set remain unverified.", "uncertainty": "The types of ±2.3/±2.0, such as SD/SE, the percentage-change specification, test method and analysis set remain unverified.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Group result tables, change definitions, dispersion notes, testing specifications and the analysis population." }, { "item_id": "N10", "question_type": "Evidence condition", "question": "Which analysis does the adjusted β estimate come from?", "needed": "The regression model, adjustment variables and selection rationale, SAP, coefficient unit and result table.", "role": "Required", "role_reason": "A regression coefficient and group changes are different analysis levels of the same imaging endpoint.", "application_exception": "Do not turn β into a separate trial, OR/RR or new clinical effect, or invent its unit.", "criterion": "Retain β −1.61, 95% CI −2.79~−0.43, P=.008, and compare adjustment variables, model, target effect and analysis set.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are Chamgap in-house application conditions developed with knowledge of the retained AGE and low-attenuation coronary-plaque record. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: The regression model, adjustment variables and selection rationale, SAP, coefficient unit and result table. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "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 PubMed, DOI, full-text and registration material remain unread, with access not attempted.", "observation": "The original adjusted β is −1.61, with 95% CI −2.79~−0.43, P=.008. The research description distinguishes unadjusted values from β.", "condition_status": "Partly verified", "status_reason": "The β and CI/P strings are retained, but variables, model, coefficient unit and SAP remain unverified.", "missingness": "Adjustment variables, model, coefficient unit, diagnostics, and alignment of the target effect and analysis set remain unverified.", "uncertainty": "Adjustment variables, model, coefficient unit, diagnostics, and alignment of the target effect and analysis set remain unverified.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "The regression model, adjustment variables and selection rationale, SAP, coefficient unit and result table." }, { "item_id": "N11", "question_type": "Evidence condition", "question": "What are the enrollment, analysis and group denominators?", "needed": "A group flow diagram from recruitment through allocation, treatment, scanning, completion and analysis, and the outcome denominators.", "role": "Required", "role_reason": "Enrollment of 65 does not prove randomized allocation of 65 or the ITT denominator for each outcome.", "application_exception": "Do not newly subtract dropout counts/rates, or relabel 27 and 28 as the originally allocated group sizes.", "criterion": "Keep 65 enrolled, 55 analyzed and AGE 27/placebo 28 as separate levels, and compare total/group randomized allocation, completion and imaging-analysis denominators.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are Chamgap in-house application conditions developed with knowledge of the retained AGE and low-attenuation coronary-plaque record. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: A group flow diagram from recruitment through allocation, treatment, scanning, completion and analysis, and the outcome denominators. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "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 PubMed, DOI, full-text and registration material remain unread, with access not attempted.", "observation": "The original count is 65 enrolled and 55 analyzed; AGE 27 and placebo 28. The evidence weighting states completers and industry support, while the reader answer states that full ITT is unverified.", "condition_status": "Partly verified", "status_reason": "Enrollment, analysis and reported group counts are identified, but original allocation, completion and exact outcome-denominator documents remain unverified.", "missingness": "Original total/group allocation, completion and outcome denominators, and their links to the analysis set, remain unverified.", "uncertainty": "Original total/group allocation, completion and outcome denominators, and their links to the analysis set, remain unverified.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "A group flow diagram from recruitment through allocation, treatment, scanning, completion and analysis, and the outcome denominators." }, { "item_id": "N12", "question_type": "Evidence condition", "question": "How do missing data, completer analysis and ITT differ?", "needed": "Missingness/dropout by group, exclusion rules, ITT/completer specifications, missing-data handling and sensitivity analyses.", "role": "Required", "role_reason": "Whether results only from scannable participants equal the effect in all allocated participants requires separate verification.", "application_exception": "Do not treat generic English participant-count wording as proof of ITT, or turn unverified missingness into confirmed selection bias.", "criterion": "Compare losses from enrollment to analysis, reasons, handling, sensitivity and the target effect, and state that full ITT remains unverified.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are Chamgap in-house application conditions developed with knowledge of the retained AGE and low-attenuation coronary-plaque record. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Missingness/dropout by group, exclusion rules, ITT/completer specifications, missing-data handling and sensitivity analyses. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "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 PubMed, DOI, full-text and registration material remain unread, with access not attempted.", "observation": "The reader answer states that full ITT is unverified, and the evidence weighting labels completers. Beyond 65 enrolled and 55 analyzed, reasons for missingness, handling and analysis-set details are absent from the retained summary.", "condition_status": "Unverified", "status_reason": "The retained summary cannot verify missing-data handling, full ITT or sensitivity specifications. This is not a finding of effect 0 or nonreporting throughout the full text.", "missingness": "Group-specific reasons for missingness, inclusion of allocated participants, handling of missing scans and sensitivity analyses remain unverified.", "uncertainty": "Group-specific reasons for missingness, inclusion of allocated participants, handling of missing scans and sensitivity analyses remain unverified.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Missingness/dropout by group, exclusion rules, ITT/completer specifications, missing-data handling and sensitivity analyses." }, { "item_id": "N13", "question_type": "Evidence condition", "question": "Are the meanings of dispersion and reported intervals verified?", "needed": "SD/SE/CI notes, interval estimation method, denominators, distributions and the original result table.", "role": "Required", "role_reason": "Sample size or P alone cannot establish precision or the meaning of an interval.", "application_exception": "Do not calculate a new CI from ± or substitute the adjusted CI for an unadjusted between-group interval.", "criterion": "Keep group ± and the β 95% CI as different statistical expressions, and compare dispersion type, denominator and interval estimation method.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are Chamgap in-house application conditions developed with knowledge of the retained AGE and low-attenuation coronary-plaque record. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: SD/SE/CI notes, interval estimation method, denominators, distributions and the original result table. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "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 PubMed, DOI, full-text and registration material remain unread, with access not attempted.", "observation": "Group values of −1.5±2.3% versus +0.2±2.0% and the adjusted β 95% CI of −2.79~−0.43 are retained separately. The statistical type of ± remains unverified.", "condition_status": "Partly verified", "status_reason": "The reported intervals and dispersion are identified, but their definitions, estimation methods and denominators have not been directly compared.", "missingness": "Whether ± means SD/SE, the interval estimation method, units, denominators and distributional assumptions remain unverified.", "uncertainty": "Whether ± means SD/SE, the interval estimation method, units, denominators and distributional assumptions remain unverified.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "SD/SE/CI notes, interval estimation method, denominators, distributions and the original result table." }, { "item_id": "N14", "question_type": "Evidence condition", "question": "Is a threshold for the importance of the imaging signal justified?", "needed": "Material justifying LAP measurement error and an importance/interpretation threshold, together with the relevant intervals.", "role": "Required", "role_reason": "A statistically significant imaging value and a clinically important patient effect are different judgments.", "application_exception": "Do not automatically inherit C46/EX as this row's status or as a new efficacy score.", "criterion": "Distinguish statistical reporting of CCTA %LAP/β from a justified threshold for important or clinical change in this population.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are Chamgap in-house application conditions developed with knowledge of the retained AGE and low-attenuation coronary-plaque record. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Material justifying LAP measurement error and an importance/interpretation threshold, together with the relevant intervals. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "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 PubMed, DOI, full-text and registration material remain unread, with access not attempted.", "observation": "The original grade rationale records EX because the prespecified LAP-only hierarchy and clinical threshold are unclear. β, CI, P and the imaging result are retained.", "condition_status": "Unverified", "status_reason": "The retained material does not verify a justified LAP importance threshold. The imaging signal is retained without assigning a new grade.", "missingness": "Measurement error, a threshold for important change and its link to patient-important outcomes remain unverified.", "uncertainty": "Measurement error, a threshold for important change and its link to patient-important outcomes remain unverified.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Material justifying LAP measurement error and an importance/interpretation threshold, together with the relevant intervals." }, { "item_id": "N15", "question_type": "Evidence condition", "question": "Are results showing no difference outside LAP also retained?", "needed": "Component-specific result tables, time points, denominators, scales, analyses and selection rationales.", "role": "Required", "role_reason": "Keeping only a signal in a component can encourage extending the answer to total plaque.", "application_exception": "These are other imaging measures; do not newly designate them as confirmed prespecified secondary (2nd) endpoints. Do not convert nonsignificance into exactly 0 or equivalence.", "criterion": "Attribute the LAP signal and original null descriptions of TPV, noncalcified plaque and dense calcium separately; do not label different endpoints as conflicting results from the same analysis.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are Chamgap in-house application conditions developed with knowledge of the retained AGE and low-attenuation coronary-plaque record. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Component-specific result tables, time points, denominators, scales, analyses and selection rationales. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "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 PubMed, DOI, full-text and registration material remain unread, with access not attempted.", "observation": "The original rationale records null changes in TPV, noncalcified plaque and dense calcium. The central explanation limits the positive signal to the LAP component.", "condition_status": "Met", "status_reason": "The original text retains both the LAP signal and null descriptions of other imaging measures. This does not establish verification of detailed tables or the prespecified hierarchy.", "missingness": "Effect estimates, CIs, denominators and the prespecified hierarchy for other plaque measures remain unverified in the retained summary.", "uncertainty": "Effect estimates, CIs, denominators and the prespecified hierarchy for other plaque measures remain unverified in the retained summary.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Component-specific result tables, time points, denominators, scales, analyses and selection rationales." }, { "item_id": "N16", "question_type": "Evidence condition", "question": "Which dates and verification scope define these evidence gaps?", "needed": "The historical search scope, access history, evidence cutoff, checks for unpublished material/corrections/retractions, and a new update event.", "role": "Required", "role_reason": "The historical review date and conversion date are not dates of a current comprehensive literature check.", "application_exception": "Do not label this unverified status as 0 studies, no recent retractions, or nonreporting throughout the paper.", "criterion": "Distinguish the verdict date 2026-09-08, correction 09-14 and retained-summary review date, and state that no new literature or registration search was performed.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are Chamgap in-house application conditions developed with knowledge of the retained AGE and low-attenuation coronary-plaque record. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: The historical search scope, access history, evidence cutoff, checks for unpublished material/corrections/retractions, and a new update event. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "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 PubMed, DOI, full-text and registration material remain unread, with access not attempted.", "observation": "The original verdict date is 2026-09-08, with a correction to temporary English wording on 2026-09-14. The conversion read retained Korean/English summaries and method definitions, without an external clinical search.", "condition_status": "Met", "status_reason": "The retained verdict/correction dates and conversion reading scope are distinguished. This is not completion of an updated search.", "missingness": "The historical search strategy, scope and cutoff, and current unpublished, registration-change or retraction status remain unverified in the retained summary.", "uncertainty": "The historical search strategy, scope and cutoff, and current unpublished, registration-change or retraction status remain unverified in the retained summary.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "The historical search scope, access history, evidence cutoff, checks for unpublished material/corrections/retractions, and a new update event." }, { "item_id": "N17", "question_type": "Evidence condition", "question": "What is known about product-company support and research independence?", "needed": "Funding, product provision, author employment/patents/interests, design/analysis roles and research-lineage declarations.", "role": "Required (independence interpretation boundary)", "role_reason": "Funding, recruitment family and product identity are separate elements of independence.", "application_exception": "Do not automatically exclude a report solely because of company funding, or treat generic English funding wording as verification of detailed conflicts of interest.", "criterion": "Distinguish Wakunaga/industry support from product provision, authors/institutions and analytical involvement; do not promote unverified information into independent replication.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are Chamgap in-house application conditions developed with knowledge of the retained AGE and low-attenuation coronary-plaque record. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Funding, product provision, author employment/patents/interests, design/analysis roles and research-lineage declarations. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "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 PubMed, DOI, full-text and registration material remain unread, with access not attempted.", "observation": "Funding is recorded as support from Wakunaga of America, and evidence weighting states completers and industry support. A retained description places the diabetes trial within the same product company and research lineage.", "condition_status": "Partly verified", "status_reason": "The funding party and historical industry support are known, but product provision, author employment, design/analysis involvement and detailed declarations remain unverified.", "missingness": "Product donation, author employment/patents, involvement and detailed independence declarations by family remain unverified.", "uncertainty": "Product donation, author employment/patents, involvement and detailed independence declarations by family remain unverified.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Funding, product provision, author employment/patents/interests, design/analysis roles and research-lineage declarations." }, { "item_id": "N18", "question_type": "Evidence condition", "question": "Does the randomized/blinded label match the actual allocation process?", "needed": "Allocation methods, concealment, baseline tables, implementation of blinding and the methods section.", "role": "Required", "role_reason": "The RCT/double-blind label is not certification that allocation problems or confounding were resolved.", "application_exception": "Do not replace unverified design information with crossover/cluster NA, or treat double-blind as confirmation of blinded CCTA assessors.", "criterion": "Retain the prospective double-blind randomized placebo-controlled label, and compare sequence generation/concealment, baseline balance, implementation and analysis unit.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are Chamgap in-house application conditions developed with knowledge of the retained AGE and low-attenuation coronary-plaque record. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Allocation methods, concealment, baseline tables, implementation of blinding and the methods section. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "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 PubMed, DOI, full-text and registration material remain unread, with access not attempted.", "observation": "The original design label is prospective, double-blind, randomized and placebo-controlled. Sequence generation, concealment, baseline balance and implementation details are absent from the retained summary.", "condition_status": "Partly verified", "status_reason": "The design label is identified, but material on allocation/concealment and baseline implementation remains unverified.", "missingness": "Sequence generation/concealment, analysis unit, baseline balance and specific implementation of blinding remain unverified.", "uncertainty": "Sequence generation/concealment, analysis unit, baseline balance and specific implementation of blinding remain unverified.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Allocation methods, concealment, baseline tables, implementation of blinding and the methods section." }, { "item_id": "N19", "question_type": "Evidence condition", "question": "Could usual risk-factor treatment and adherence differences be mixed into the result?", "needed": "Group background drugs/treatment, lifestyle factors, changes, adherence, rescue treatment and handling of these factors.", "role": "Required", "role_reason": "Attributing changes in other treatment to AGE would change the add-on treatment question.", "application_exception": "Do not require every change to be identical, or reinterpret this as a trial replacing usual treatment.", "criterion": "Retain continued usual treatment and placebo plus usual care, and compare the contributions of group drugs, diet, changes, adherence and rescue treatment.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are Chamgap in-house application conditions developed with knowledge of the retained AGE and low-attenuation coronary-plaque record. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Group background drugs/treatment, lifestyle factors, changes, adherence, rescue treatment and handling of these factors. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "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 PubMed, DOI, full-text and registration material remain unread, with access not attempted.", "observation": "The intervention and population description specifies continued usual risk-factor treatment and matching placebo plus usual care. Drug/diet changes and actual adherence remain unverified.", "condition_status": "Partly verified", "status_reason": "The shared-care specification is retained, but the effects of concomitant treatment, adherence and changes on interpretation remain unverified.", "missingness": "Drugs/doses, diet, rescue treatment, adherence/changes by group and analytical handling remain unverified.", "uncertainty": "Drugs/doses, diet, rescue treatment, adherence/changes by group and analytical handling remain unverified.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Group background drugs/treatment, lifestyle factors, changes, adherence, rescue treatment and handling of these factors." }, { "item_id": "N20", "question_type": "Evidence condition", "question": "Are CCTA reading, reproducibility and assessor blinding verified?", "needed": "Imaging conditions, image quality, reading/segmentation procedures, blinding, reproducibility and error handling.", "role": "Required", "role_reason": "Differences in measurement conditions must be distinguished from actual differences in plaque.", "application_exception": "Do not certify assessor blinding from the double-blind label or assume an objective image is free of bias.", "criterion": "Separately compare scanning/segmentation, readers, reproducibility, group measurement conditions and assessor blinding.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are Chamgap in-house application conditions developed with knowledge of the retained AGE and low-attenuation coronary-plaque record. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Imaging conditions, image quality, reading/segmentation procedures, blinding, reproducibility and error handling. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "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 PubMed, DOI, full-text and registration material remain unread, with access not attempted.", "observation": "CCTA %LAP and the double-blind design label are present, but details of readers, reproducibility and assessor blinding are absent from the retained summary.", "condition_status": "Unverified", "status_reason": "The retained material provides no location to verify implementation of reading and measurement, so this remains unverified.", "missingness": "Scanning/segmentation, readers, group image quality, reproducibility and assessor-blinding details remain unverified.", "uncertainty": "Scanning/segmentation, readers, group image quality, reproducibility and assessor-blinding details remain unverified.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Imaging conditions, image quality, reading/segmentation procedures, blinding, reproducibility and error handling." }, { "item_id": "N21", "question_type": "Evidence condition", "question": "Were the prespecified LAP endpoint hierarchy and SAP compared?", "needed": "Dated registration text, protocol, SAP, endpoint/analysis change history and actual result tables.", "role": "Required", "role_reason": "The original plan is needed to assess possible selection of favorable components or analyses.", "application_exception": "The NCT string does not establish successful reading of registration/SAP. Do not turn unverified information into confirmed nonregistration, selective reporting or a positive secondary endpoint after a failed primary endpoint.", "criterion": "Retain both the named endpoint in the intervention/population description and the evidence summary's unverified prespecified LAP-only primary (1st) hierarchy, and compare registration/protocol/SAP with actual results.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are Chamgap in-house application conditions developed with knowledge of the retained AGE and low-attenuation coronary-plaque record. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Dated registration text, protocol, SAP, endpoint/analysis change history and actual result tables. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "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 PubMed, DOI, full-text and registration material remain unread, with access not attempted.", "observation": "The citation and research description contain NCT01534910, while the manuscript's registration-verification field says not verified. Endpoint, answer and grade explanations leave the prespecified LAP-only hierarchy and full ITT unverified.", "condition_status": "Unverified", "status_reason": "The identifier and unverified labels are retained, but registration/planning documents have not actually been compared.", "missingness": "Prospective registration timing, LAP hierarchy, SAP, multiple analyses and change reasons/history remain unverified.", "uncertainty": "Prospective registration timing, LAP hierarchy, SAP, multiple analyses and change reasons/history remain unverified.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Dated registration text, protocol, SAP, endpoint/analysis change history and actual result tables." }, { "item_id": "N22", "question_type": "Evidence condition", "question": "Is another report an independent replication of the same product and population question?", "needed": "Recruitment, product specifications, population, endpoint/time point, funding/lineage and a trial-family table.", "role": "Required", "role_reason": "Signals in another population and reports sharing a product company cannot be combined as independent confirmation.", "application_exception": "Do not create S02 from the diabetes background or transfer effects of AGE+B vitamins+folic acid+L-arginine to AGE alone. Do not turn an unverified family into NA.", "criterion": "Distinguish metabolic-syndrome AGE-LAP from the diabetes background and excluded combinations, and compare whether product, population, institution/funding and recruitment family are the same, different or unknown.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are Chamgap in-house application conditions developed with knowledge of the retained AGE and low-attenuation coronary-plaque record. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Recruitment, product specifications, population, endpoint/time point, funding/lineage and a trial-family table. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "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 PubMed, DOI, full-text and registration material remain unread, with access not attempted.", "observation": "The retained manuscript states that the diabetes trial's LAP signal was not upgraded to independent R2 because it shared the company and research lineage. AGE combination-product trials were excluded.", "condition_status": "Partly verified", "status_reason": "Historical descriptions of different populations, shared lineage and excluded combinations are retained, but report families and independent replication have not been newly verified.", "missingness": "The diabetes citation, product details, recruitment overlap, independent replication of the same question and distribution of results remain unverified.", "uncertainty": "The diabetes citation, product details, recruitment overlap, independent replication of the same question and distribution of results remain unverified.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Recruitment, product specifications, population, endpoint/time point, funding/lineage and a trial-family table." }, { "item_id": "N23", "question_type": "Evidence condition", "question": "Does this question also require an optimal dose?", "needed": "For a dose-optimization claim: direct comparisons of doses with matching specifications, exposure/adherence and a separate estimate.", "role": "Supplementary; required to extend to optimal dosing", "role_reason": "A dose is not certification of an optimal dose, but dose research is not required for the narrow question.", "application_exception": "NA applies only to the obligation for a dose-optimization extension. Unverified direct dose evidence and specification gaps remain.", "criterion": "Separate the selected imaging question at 2,400 mg/day from additional dose-optimization/dose-response claims.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are Chamgap in-house application conditions developed with knowledge of the retained AGE and low-attenuation coronary-plaque record. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: For a dose-optimization claim: direct comparisons of doses with matching specifications, exposure/adherence and a separate estimate. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "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 PubMed, DOI, full-text and registration material remain unread, with access not attempted.", "observation": "The original question concerns %LAP with AGE 2,400 mg/day for about 12 months. Direct dose-response data and an optimal-dose estimate are absent from the retained summary.", "condition_status": "Not applicable", "status_reason": "The selected question makes no optimal-dose claim, so only the obligation for that extension research is not applicable. This is not a substitute status for unread material.", "missingness": "Direct optimal-dose and dose-response material remains unverified and would be needed if a separate question were selected.", "uncertainty": "Direct optimal-dose and dose-response material remains unverified and would be needed if a separate question were selected.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "For a dose-optimization claim: direct comparisons of doses with matching specifications, exposure/adherence and a separate estimate." }, { "item_id": "N24", "question_type": "Evidence condition", "question": "Is persistence of the imaging effect after treatment stops being claimed?", "needed": "For a persistence claim: post-treatment scan times, exposure, treatment changes, group follow-up denominators and results.", "role": "Supplementary; required for persistence after stopping", "role_reason": "Observation during treatment and persistence after stopping treatment have different time specifications.", "application_exception": "NA applies only to the post-treatment extension obligation; it does not exclude the current duration or scan conditions.", "criterion": "Distinguish observation over about 12 months from separate questions of post-treatment persistence or long-term progression.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are Chamgap in-house application conditions developed with knowledge of the retained AGE and low-attenuation coronary-plaque record. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: For a persistence claim: post-treatment scan times, exposure, treatment changes, group follow-up denominators and results. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "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 PubMed, DOI, full-text and registration material remain unread, with access not attempted.", "observation": "The original duration is about 12 months, with a CCTA interval of 354±41 days. Separate post-treatment imaging material is absent from the retained summary.", "condition_status": "Not applicable", "status_reason": "The current question makes no post-treatment persistence claim, so only the extension-research obligation is not applicable.", "missingness": "Post-treatment long-term CCTA and persistence remain unverified in the current scope. Direct material would be needed if an extension question were selected.", "uncertainty": "Post-treatment long-term CCTA and persistence remain unverified in the current scope. Direct material would be needed if an extension question were selected.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "For a persistence claim: post-treatment scan times, exposure, treatment changes, group follow-up denominators and results." }, { "item_id": "N25", "question_type": "Evidence condition", "question": "Is a larger effect in a particular subgroup being claimed?", "needed": "For a subgroup claim: prespecified hypotheses, denominators, direct interaction estimates and plans.", "role": "Supplementary; required for subgroup extensions", "role_reason": "A favorable subgroup value or a trial in another population is not the magnitude of the overall result.", "application_exception": "NA applies only to the subgroup-extension obligation; population representativeness and the diabetes family remain unverified.", "criterion": "Separate the selected metabolic-syndrome result from prespecified subgroups/interactions and the separate diabetes population.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are Chamgap in-house application conditions developed with knowledge of the retained AGE and low-attenuation coronary-plaque record. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: For a subgroup claim: prespecified hypotheses, denominators, direct interaction estimates and plans. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "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 PubMed, DOI, full-text and registration material remain unread, with access not attempted.", "observation": "The question concerns adults with metabolic syndrome; the diabetes trial is background. Prespecified subgroup and interaction estimates are absent from the retained summary.", "condition_status": "Not applicable", "status_reason": "The current question makes no additional subgroup-effect claim, so only the extension-research obligation is not applicable.", "missingness": "Prespecified subgroups and interactions remain unverified. A different diabetes question is not combined with the current denominator or effect.", "uncertainty": "Prespecified subgroups and interactions remain unverified. A different diabetes question is not combined with the current denominator or effect.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "For a subgroup claim: prespecified hypotheses, denominators, direct interaction estimates and plans." }, { "item_id": "N26", "question_type": "Evidence condition", "question": "Is the LAP signal being extended to plaque disappearance or prevention of clinical events?", "needed": "For an event extension: event definitions, denominators/follow-up, direct between-group results and plans.", "role": "Required (clinical interpretation boundary)", "role_reason": "A signal in an imaging surrogate component does not prove clinical prevention or plaque disappearance.", "application_exception": "Retain the imaging observation without requiring an event trial as a condition for the existence of that result.", "criterion": "Distinguish the imaging component from separate questions of total plaque disappearance, myocardial infarction and death; retain the boundary around unmeasured events.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are Chamgap in-house application conditions developed with knowledge of the retained AGE and low-attenuation coronary-plaque record. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: For an event extension: event definitions, denominators/follow-up, direct between-group results and plans. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "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 PubMed, DOI, full-text and registration material remain unread, with access not attempted.", "observation": "The original rationale explicitly says myocardial infarction and death were not tested. The advertising-interpretation explanation rules out claims of plaque disappearance or myocardial-infarction prevention.", "condition_status": "Met", "status_reason": "The original text explicitly separates imaging from clinical events. This does not establish event efficacy or long-term prevention.", "missingness": "Direct event effects/denominators and links to clinical importance remain unverified in the current scope and cannot be supplied by this trial's result.", "uncertainty": "Direct event effects/denominators and links to clinical importance remain unverified in the current scope and cannot be supplied by this trial's result.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "For an event extension: event definitions, denominators/follow-up, direct between-group results and plans." }, { "item_id": "N27", "question_type": "Evidence condition", "question": "Are harm-event definitions and collection verified?", "needed": "Adverse-event definitions, collection methods, group reports, discontinuation/severity and source data.", "role": "Supplementary; required for harm and safety questions", "role_reason": "An efficacy summary or caution does not establish complete accounting of actual harms.", "application_exception": "Do not turn caution into actual bleeding counts or causality, or delete the imaging result because harm remains unverified.", "criterion": "Distinguish actual bleeding/adverse events, definitions, collection, severity and discontinuation for the same AGE/population from general caution.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are Chamgap in-house application conditions developed with knowledge of the retained AGE and low-attenuation coronary-plaque record. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Adverse-event definitions, collection methods, group reports, discontinuation/severity and source data. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "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 PubMed, DOI, full-text and registration material remain unread, with access not attempted.", "observation": "The manuscript says this imaging trial cannot establish long-term bleeding or interactions. The retained summary lacks definitions and counts of harm events by group.", "condition_status": "Unverified", "status_reason": "The retained summary cannot verify collection specifications or event data. This does not mean nonreporting throughout the full text or 0 events.", "missingness": "Event types, collection, occurrence/worsening, severity and discontinuation for harm remain unverified in the current scope.", "uncertainty": "Event types, collection, occurrence/worsening, severity and discontinuation for harm remain unverified in the current scope.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Adverse-event definitions, collection methods, group reports, discontinuation/severity and source data." }, { "item_id": "N28", "question_type": "Evidence condition", "question": "Is the temporal sequence of exposure and harm events known?", "needed": "Times of exposure initiation, events, discontinuation, recovery and re-exposure, with follow-up records.", "role": "Supplementary; required for harm timing questions", "role_reason": "An imaging interval does not substitute for the timing of bleeding or interactions.", "application_exception": "Do not infer events, improvement or re-exposure without source text, or fill harm timelines solely from treatment duration.", "criterion": "Distinguish AGE initiation/discontinuation, events/recovery, re-exposure and harm-observation duration from the imaging interval.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are Chamgap in-house application conditions developed with knowledge of the retained AGE and low-attenuation coronary-plaque record. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Times of exposure initiation, events, discontinuation, recovery and re-exposure, with follow-up records. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "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 PubMed, DOI, full-text and registration material remain unread, with access not attempted.", "observation": "An imaging interval of about 12 months and long-term harm cautions are present, but event, discontinuation and recovery timelines are absent from the retained summary.", "condition_status": "Unverified", "status_reason": "Event timing cannot be verified within the current scope, so it is not promoted into causality or re-exposure evidence.", "missingness": "Onset, recovery, re-exposure and latency remain unverified; the imaging period is not used as the entire harm follow-up period.", "uncertainty": "Onset, recovery, re-exposure and latency remain unverified; the imaging period is not used as the entire harm follow-up period.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Times of exposure initiation, events, discontinuation, recovery and re-exposure, with follow-up records." }, { "item_id": "N29", "question_type": "Evidence condition", "question": "Are event and exposure denominators available to interpret harm comparisons?", "needed": "Group harm-exposure/event denominators, people/event counts, duration, placebo comparisons and result tables.", "role": "Supplementary; required for incidence or comparative-risk claims", "role_reason": "Imaging-analysis denominators are not denominators for harm frequency or increased risk.", "application_exception": "Do not substitute 55, 27 or 28 as safety denominators, or newly calculate incidence, background rates or RR.", "criterion": "Link exposed participants, people/event counts, duration and placebo events, distinct from imaging-analysis counts of 55/27/28.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are Chamgap in-house application conditions developed with knowledge of the retained AGE and low-attenuation coronary-plaque record. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Group harm-exposure/event denominators, people/event counts, duration, placebo comparisons and result tables. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "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 PubMed, DOI, full-text and registration material remain unread, with access not attempted.", "observation": "The original counts are 65 enrolled, 55 analyzed, AGE 27 and placebo 28. The retained summary lacks harm events, exposure time and harm-comparison estimates.", "condition_status": "Unverified", "status_reason": "Event/exposure denominators cannot be linked with duration, so comparative risks and frequencies remain unverified within the current scope.", "missingness": "Harm-exposed participants, people/events, duration, placebo events and comparative estimates remain unverified.", "uncertainty": "Harm-exposed participants, people/events, duration, placebo events and comparative estimates remain unverified.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Group harm-exposure/event denominators, people/event counts, duration, placebo comparisons and result tables." }, { "item_id": "N30", "question_type": "Evidence condition", "question": "Were concomitant drugs and alternative explanations verified?", "needed": "Concomitant drugs/doses, surgery, baseline risks, simultaneous exposure, alternatives and relevant harm material.", "role": "Supplementary; required for causal or comparative harm", "role_reason": "A warning list does not verify actual concomitant use in the trial or the cause of an event.", "application_exception": "Do not interpret unverified alternatives as absence of other causes, or extend the original caution into new individual dosing instructions.", "criterion": "Distinguish usual treatment from anticoagulant/antiplatelet and surgery warnings, and compare actual simultaneous exposure, baseline risks and alternatives.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are Chamgap in-house application conditions developed with knowledge of the retained AGE and low-attenuation coronary-plaque record. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Concomitant drugs/doses, surgery, baseline risks, simultaneous exposure, alternatives and relevant harm material. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "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 PubMed, DOI, full-text and registration material remain unread, with access not attempted.", "observation": "The original caution explicitly calls for checking anticoagulants, antiplatelet drugs and perioperative use. Actual group drugs, surgery and bleeding risks remain unverified.", "condition_status": "Partly verified", "status_reason": "The original caution and usual-care scope are retained, but actual simultaneous exposure and alternatives/confounding remain unverified.", "missingness": "Actual concomitant use/doses, baseline bleeding, surgery, alternative causes and adjustment remain unverified.", "uncertainty": "Actual concomitant use/doses, baseline bleeding, surgery, alternative causes and adjustment remain unverified.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Concomitant drugs/doses, surgery, baseline risks, simultaneous exposure, alternatives and relevant harm material." }, { "item_id": "N31", "question_type": "Evidence condition", "question": "Is the scope missed by harm collection and follow-up known?", "needed": "Group safety follow-up, reasons for missingness, detection differences and the disclosure scope for all events.", "role": "Supplementary; required for the scope of harm surveillance", "role_reason": "There is no guarantee that imaging loss and harm-surveillance loss are identical.", "application_exception": "Do not turn unverified collection into event absence or a confirmed magnitude of bias.", "criterion": "Distinguish harm detection, follow-up loss, collection and disclosure from imaging-analysis losses.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are Chamgap in-house application conditions developed with knowledge of the retained AGE and low-attenuation coronary-plaque record. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Group safety follow-up, reasons for missingness, detection differences and the disclosure scope for all events. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "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 PubMed, DOI, full-text and registration material remain unread, with access not attempted.", "observation": "The 65 enrolled, 55 analyzed and unverified ITT refer to the imaging result. Harm collection, detection and loss information is absent from the retained summary.", "condition_status": "Unverified", "status_reason": "The current scope does not directly verify selection, missingness or disclosure limits in safety surveillance.", "missingness": "Safety-surveillance denominators, detection/collection differences, losses and disclosure of all events remain unverified.", "uncertainty": "Safety-surveillance denominators, detection/collection differences, losses and disclosure of all events remain unverified.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Group safety follow-up, reasons for missingness, detection differences and the disclosure scope for all events." }, { "item_id": "N32", "question_type": "Evidence condition", "question": "Are repeated harm warnings being counted as independent events?", "needed": "Unique harm report/case identifiers, exposure/event matching, repeated citations and family material.", "role": "Supplementary; required for repeated harm signals", "role_reason": "Repetition of caution across Korean, English and synthesized summaries does not increase independent event counts.", "application_exception": "Do not query new regulatory/case material during this work or turn diabetes efficacy background into repeated harm evidence.", "criterion": "Distinguish general caution and recitation of the same material from new harm events/studies, and link product, population and event families.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are Chamgap in-house application conditions developed with knowledge of the retained AGE and low-attenuation coronary-plaque record. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Unique harm report/case identifiers, exposure/event matching, repeated citations and family material. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "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 PubMed, DOI, full-text and registration material remain unread, with access not attempted.", "observation": "The same general caution repeats in the Korean and English texts and the synthesized summary. The retained evidence and citation contain no separate independent harm case report.", "condition_status": "Unverified", "status_reason": "Harm families or repeated events cannot be verified within the current scope. The same caution is not counted as duplicated signals.", "missingness": "Unique harm cases, study/replication families and contrary records remain unverified; this does not mean 0 cases worldwide.", "uncertainty": "Unique harm cases, study/replication families and contrary records remain unverified; this does not mean 0 cases worldwide.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Unique harm report/case identifiers, exposure/event matching, repeated citations and family material." }, { "item_id": "N33", "question_type": "Evidence condition", "question": "What about long-term or rare harms and vulnerable groups beyond the imaging observation?", "needed": "Suitable designs and denominators/follow-up for long-term/rare events and interactions under the same exposure and by population.", "role": "Supplementary; required for long-term or vulnerable-group harms", "role_reason": "An imaging study in a limited population does not guarantee overall safety.", "application_exception": "Do not require every long-term harm study for the narrow imaging question, or convert unverified information into harmlessness.", "criterion": "Separate the imaging question over about 12 months from harms involving long-term bleeding, interactions and surgical/anticoagulant conditions.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are Chamgap in-house application conditions developed with knowledge of the retained AGE and low-attenuation coronary-plaque record. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Suitable designs and denominators/follow-up for long-term/rare events and interactions under the same exposure and by population. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "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 PubMed, DOI, full-text and registration material remain unread, with access not attempted.", "observation": "The manuscript explicitly states that this imaging trial cannot establish long-term bleeding or interactions.", "condition_status": "Unverified", "status_reason": "Direct harm evidence for long-term/rare events and vulnerable conditions cannot be verified within the current scope.", "missingness": "Direct material on long-term bleeding, rare harms, interactions and surgical/anticoagulant conditions remains unverified.", "uncertainty": "Direct material on long-term bleeding, rare harms, interactions and surgical/anticoagulant conditions remains unverified.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Suitable designs and denominators/follow-up for long-term/rare events and interactions under the same exposure and by population." }, { "item_id": "N34", "question_type": "Evidence condition", "question": "How far can harms and safety be described from this material?", "needed": "Harm source data connecting events, exposure/denominators, timing, comparison and alternatives, with the interpretation scope.", "role": "Required (safety interpretation boundary)", "role_reason": "Historical caution and the current verification level of harm source data are separate matters.", "application_exception": "Do not create individual dosing instructions, a new safety grade, a guarantee of harmlessness or a confirmed causal link to bleeding.", "criterion": "Distinguish caution from actual signals, comparative risk and causality, and limit the current scope separately from imaging efficacy and the historical safety label.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are Chamgap in-house application conditions developed with knowledge of the retained AGE and low-attenuation coronary-plaque record. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Harm source data connecting events, exposure/denominators, timing, comparison and alternatives, with the interpretation scope. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "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 PubMed, DOI, full-text and registration material remain unread, with access not attempted.", "observation": "The original safety label is Caution, with warnings about long-term bleeding and interactions. Direct information linking events, denominators, timing, comparison and alternatives is absent from the retained summary.", "condition_status": "Partly verified", "status_reason": "The general caution boundary is retained, but direct material to classify signals, risk or causality remains unverified.", "missingness": "Events, denominators, timing, comparison and alternatives needed for a direct harm judgment remain unverified; the original caution is not new safety certification.", "uncertainty": "Events, denominators, timing, comparison and alternatives needed for a direct harm judgment remain unverified; the original caution is not new safety certification.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Harm source data connecting events, exposure/denominators, timing, comparison and alternatives, with the interpretation scope." } ], "reports": [ { "report_id": "S01", "title": "Aged Garlic Extract Reduces Low Attenuation Plaque in Coronary Arteries of Patients with Metabolic Syndrome in a Prospective Randomized Double-Blind Study", "url": "https://pubmed.ncbi.nlm.nih.gov/26764322/", "report_type": "Retained record: prospective, randomized, double-blind, placebo-controlled trial. Allocation methods, assessor blinding and full ITT remain unverified.", "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": "Retained verdict summary read; external PubMed, DOI, full-text and registration material remain unread, with access not attempted.", "study_family": "Matsumoto2016 retained-report context. This linkage does not certify the external recruitment family or independence.", "independent_replication": "Unique-trial counts, participant totals and independent replication remain unverified. The diabetes background reference, group changes and adjusted β are not counted as new independent trials.", "observed_result": "Reported group %LAP changes are −1.5±2.3% versus +0.2±2.0%, P=.0049. Adjusted β is −1.61 (95% CI −2.79 to −0.43; P=.008). The original count description is 65 enrolled and 55 analyzed; AGE 27 and placebo 28.", "result_level": "These are reported imaging-surrogate values, with group %changes and the adjusted regression coefficient kept distinct. The exact %denominator, meaning of ±, β unit, analysis set, prespecified hierarchy and full ITT remain unverified.", "source_evidence_date": "2026-09-08", "materials": [ { "material_type": "PubMed bibliographic/abstract index", "public_status": "Bibliographic link retained; external material unread", "access_status": "External access not attempted; not acquired", "acquired": false, "actually_read": false, "as_of": "2026-10-06", "qualification": "This is the PubMed link from the retained citation. The current response, bibliographic identity, abstract content and public access were not checked. Matsumoto2016 is a report linked in the retained summary. External abstracts, full texts, registration, protocols and analysis plans were not checked in this conversion, and independent clinical validation was not performed. The date is the original check date in retained summary and condition records. The retained verdict’s evidence date, historical access dates for individual materials and current external-access status are distinguished." }, { "material_type": "DOI identifier gateway", "public_status": "DOI gateway retained; external material unread", "access_status": "External access not attempted; not acquired", "acquired": false, "actually_read": false, "as_of": "2026-10-06", "qualification": "This gateway was constructed from the retained DOI. It does not represent the original URL field or the format of an acquired physical document. Matsumoto2016 is a report linked in the retained summary. External abstracts, full texts, registration, protocols and analysis plans were not checked in this conversion, and independent clinical validation was not performed. The date is the original check date in retained summary and condition records. The retained verdict’s evidence date, historical access dates for individual materials and current external-access status are distinguished." }, { "material_type": "Article full text", "public_status": "Full text not acquired; unread", "access_status": "External access not attempted; not acquired", "acquired": false, "actually_read": false, "as_of": "2026-10-06", "qualification": "The report’s full text is not acquired or read. Its exact download URL and PDF/HTML format also remain unverified. Matsumoto2016 is a report linked in the retained summary. External abstracts, full texts, registration, protocols and analysis plans were not checked in this conversion, and independent clinical validation was not performed. The date is the original check date in retained summary and condition records. The retained verdict’s evidence date, historical access dates for individual materials and current external-access status are distinguished." }, { "material_type": "Trial registration identifier gateway", "public_status": "Registration identifier gateway; original registration unread", "access_status": "External access not attempted; not acquired", "acquired": false, "actually_read": false, "as_of": "2026-10-06", "qualification": "This gateway was constructed from citation identifier NCT01534910. The original registration field remains unverified, as do the original registration, preregistration and SAP. Matsumoto2016 is a report linked in the retained summary. External abstracts, full texts, registration, protocols and analysis plans were not checked in this conversion, and independent clinical validation was not performed. The date is the original check date in retained summary and condition records. The retained verdict’s evidence date, historical access dates for individual materials and current external-access status are distinguished." }, { "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": "2026-10-06", "qualification": "The retained Korean/English verdict summary, evidence and citation were read. This does not establish reading of the original abstract, full text or registration. Matsumoto2016 is a report linked in the retained summary. External abstracts, full texts, registration, protocols and analysis plans were not checked in this conversion, and independent clinical validation was not performed. The date is the original check date in retained summary and condition records. The retained verdict’s evidence date, historical access dates for individual materials and current external-access status are distinguished." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/26764322/" } ] } ], "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 retained identity, observation or scope required by this item was checked within stated limits. This does not establish clinical sufficiency or full-text certification.", "Partly verified": "Some required facts are known, but the stated conditions involving analyses, populations, formulation or denominators remain unverified.", "Unverified": "Direct information is unverified in the retained record. This does not establish an effect of 0, no studies, absence of harm or an unreviewed table.", "Not applicable": "An extension obligation outside the narrow question does not apply. This state does not substitute for unread or unverified material.", "Not applicable (alias)": "This is the gray-display alias of Not applicable.", "Not read": "External material was not directly read in this conversion. This is distinguished from reading the retained verdict summary.", "Conflicting data": "This covers an actual discrepancy between reports of the same question, denominator and timing. Differences between separate questions are not automatically treated as conflicting data." }, "study_overlap": { "state": "Unverified", "unique_trial_count": null, "unique_participant_count": null, "reason": "The retained evidence and citation link to a report by Matsumoto2016. Group changes and adjusted β are different analysis layers for the same imaging endpoint. Unique-trial counts, participant totals and independent replication remain unverified." }, "history": [ { "date": "2026-10-25", "kind": "Separation of public-facing pages and materials", "view_version": "1.0", "change": "The public view and materials were prepared from the existing 34 items. No new clinical search, verification-state change or scoring was performed." } ], "language": "en", "translation_date": "2026-10-25" }