{ "schema_version": "chamgap-public-evidence-check-1.0", "public_id": "v3057-main", "verdict_number": "3057", "title": "Kyolic Reserve aged garlic extract 1.2 g/day, providing 1.2 mg/day S-allylcysteine × Reduction of office systolic blood pressure in uncontrolled hypertension", "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 material-check date distinguishes verification and reading status in the retained record. It is not a new external-original access date or a search cutoff." }, "claim_context": { "population": "Adults with uncontrolled hypertension. The retained Korean description includes stable antihypertensive use or no treatment; the retained English description says stable treatment or no planned medication change. This does not establish that everyone took antihypertensives. Age, eligibility criteria, baseline pressure and medication composition by group remain unverified.", "intervention": "Kyolic Reserve capsules containing extract powder made from Allium sativum cloves aged in aqueous ethanol. AGE mass and SAC marker content remain distinct; other garlic products and isolated SAC are not interchangeable.", "dose": "2 capsules daily, providing AGE 1.2 g and SAC 1.2 mg/day. These are retained trial formulation and dose descriptions, without establishing an optimal dose or a personal dosing recommendation. Batch, measured content, administration timing and adherence remain unverified.", "comparator": "The comparator is matching placebo plus existing blood-pressure care. The retained record describes adding the product to existing care. Actual background drug types, doses, balance between groups, changes and rescue treatment remain unverified; this does not establish replacement of antihypertensive medication.", "endpoint": "The endpoint is the adjusted between-group change from baseline in office systolic blood pressure at 12 weeks. The retained reported estimate is −5.0±2.1 mmHg, P=.016. Whether ±2.1 denotes SD, SE or a CI, the confidence interval, measurement procedure and adjustment model remain unverified. Within-group changes, DBP, central pressure, responder subgroups and clinical events are kept separate.", "duration": "12 weeks of treatment and 12 weeks of follow-up. This does not establish longer-term persistence after treatment, effects after stopping, or long-term and rare harms.", "excluded_extensions": [ "Efficacy of other formulations, including raw garlic, garlic powder, garlic oil, stabilized allicin, black garlic, fermented garlic and isolated SAC", "Optimal dose, higher or lower doses and personal dosing instructions", "Replacing the overall effect with a larger reduction in a responder subgroup", "Extension to DBP, central pressure, 24-hour blood pressure or cardiovascular-event prevention", "Replacement of antihypertensives or an assertion that all participants took them", "Persistence beyond 12 weeks, effects after stopping, or overall safety in long-term use or vulnerable groups", "Counting unidentified earlier studies, other products or the retraction narrative as new direct reports or independent replication" ] }, "requirements": [ { "item_id": "N01", "question_type": "Evidence condition", "question": "What is this sheet's independent question?", "needed": "The 12-week office-SBP comparison after adding Kyolic Reserve AGE 1.2 g/SAC 1.2 mg/day in 2 capsules to stable care, or in untreated adults as described in the retained record, with exact source locations.", "role": "Required", "role_reason": "Needed to keep other formulations, endpoints and time periods on the garlic page separate from the main SBP question.", "application_exception": "DBP, central pressure and responder results must not replace the main effect or automatically become new sheets.", "criterion": "Link the original Korean claim and both language versions of the population/intervention fields to the formulation, dose, 12-week period and placebo comparison as a single question.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.", "condition_origin": "These are Chamgap in-house conditions developed with knowledge of the retained record for Kyolic Reserve AGE/SAC add-on use and the 12-week office systolic blood-pressure comparison. They do not establish blinding, clinical-trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: An original report specifying population, formulation, endpoint, timing and comparison, plus a separate boundary review, would be needed to change the scope. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The retained effect is lower office systolic blood pressure in uncontrolled hypertension; the scope note limits the question to AGE 1.2 g/SAC 1.2 mg and 12-week SBP.", "condition_status": "Met", "status_reason": "The main question and inclusion/exclusion boundaries in the retained record are identified; this is not certification of clinical efficacy.", "missingness": "The main question and inclusion/exclusion boundaries in the retained record are identified; this is not certification of clinical efficacy.", "uncertainty": "The main question and inclusion/exclusion boundaries in the retained record are identified; this is not certification of clinical efficacy.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "An original report specifying population, formulation, endpoint, timing and comparison, plus a separate boundary review, would be needed to change the scope." }, { "item_id": "N02", "question_type": "Evidence condition", "question": "How are the report and the same group's background dose study distinguished?", "needed": "Identity of the AGE at Heart 1 evidence entry/1 citation, and its relationship to earlier studies or other aged-black-garlic products.", "role": "Required", "role_reason": "Needed to avoid counting the evidence table, both languages, synthesis and same-group narrative repeatedly as independent replication.", "application_exception": "Background wording alone must not generate S02, a new direct trial or a unique-participant total.", "criterion": "Link the S01 evidence entry and citation to the same report; leave unidentified background material separately unverified.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.", "condition_origin": "These are Chamgap in-house conditions developed with knowledge of the retained record for Kyolic Reserve AGE/SAC add-on use and the 12-week office systolic blood-pressure comparison. They do not establish blinding, clinical-trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Original trial registration ID, related-report list, and exact bibliography and formulation tables for the earlier dose study and other black-garlic products. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The retained 1 evidence entry/1 citation identifies the AGE at Heart report; the same group's dose study and other products mentioned in the counterview lack separate bibliography or data by group.", "condition_status": "Partly verified", "status_reason": "The local identity of S01 is linked, but identities, overlap and unique study/participant totals for the background studies remain unverified.", "missingness": "The local identity of S01 is linked, but identities, overlap and unique study/participant totals for the background studies remain unverified.", "uncertainty": "The local identity of S01 is linked, but identities, overlap and unique study/participant totals for the background studies remain unverified.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Original trial registration ID, related-report list, and exact bibliography and formulation tables for the earlier dose study and other black-garlic products." }, { "item_id": "N03", "question_type": "Evidence condition", "question": "Were the summary, PubMed, DOI, PMC, supplements and registration actually read in this preparation?", "needed": "Local acquisition, external existence/access, reading level, dates and exact locations for each material.", "role": "Required", "role_reason": "Needed to avoid inheriting historical full-text/registration language or links in the research description as current reading.", "application_exception": "Access not attempted must not be described as failed access, private availability or absence of the original paper.", "criterion": "Record only the current retained material as summary reading; distinguish external entry points, supplements and registration as unread, with access not attempted.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.", "condition_origin": "These are Chamgap in-house conditions developed with knowledge of the retained record for Kyolic Reserve AGE/SAC add-on use and the 12-week office systolic blood-pressure comparison. They do not establish blinding, clinical-trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Actual access/acquisition/reading records, original paper/supplement bytes, versions and checked locations. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The retained evidence and bibliography were read. PMID 26869811, PMCID PMC4734812 and DOI entries are provided as links; there were 0 external readings in this preparation.", "condition_status": "Met", "status_reason": "The distinction between actual actions for each material is verified; this does not establish full-text provision, successful access or supplement existence.", "missingness": "The distinction between actual actions for each material is verified; this does not establish full-text provision, successful access or supplement existence.", "uncertainty": "The distinction between actual actions for each material is verified; this does not establish full-text provision, successful access or supplement existence.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Actual access/acquisition/reading records, original paper/supplement bytes, versions and checked locations." }, { "item_id": "N04", "question_type": "Evidence condition", "question": "How is the population on stable medication or no treatment retained?", "needed": "Uncontrolled hypertension, eligibility/exclusion criteria, baseline SBP, age, existing medication use and composition by group.", "role": "Required", "role_reason": "Needed to retain both the Korean inclusion of untreated adults and the English stable-therapy/no-planned-medication-change wording.", "application_exception": "Do not assert that everyone took antihypertensives or generalize to other hypertensive or normotensive populations.", "criterion": "Retain both original population descriptions exactly and show unverified eligibility, baseline and composition details.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.", "condition_origin": "These are Chamgap in-house conditions developed with knowledge of the retained record for Kyolic Reserve AGE/SAC add-on use and the 12-week office systolic blood-pressure comparison. They do not establish blinding, clinical-trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Eligibility table, baseline tables by group, proportions untreated/on medication and conditions for permitted medication changes. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The Korean population includes adults maintaining stable medication or receiving no treatment; the English text says stable therapy or no planned medication change.", "condition_status": "Partly verified", "status_reason": "The uncontrolled-hypertension population is identified, but age, diagnostic criteria, baseline values and proportions using medication by group remain unverified in the retained material.", "missingness": "The uncontrolled-hypertension population is identified, but age, diagnostic criteria, baseline values and proportions using medication by group remain unverified in the retained material.", "uncertainty": "The uncontrolled-hypertension population is identified, but age, diagnostic criteria, baseline values and proportions using medication by group remain unverified in the retained material.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Eligibility table, baseline tables by group, proportions untreated/on medication and conditions for permitted medication changes." }, { "item_id": "N05", "question_type": "Evidence condition", "question": "What is the formulation contract for AGE, SAC, two capsules and matching placebo?", "needed": "Kyolic Reserve extract powder from Allium sativum cloves aged in aqueous ethanol; AGE 1.2 g/SAC 1.2 mg/day, 2 capsules and placebo.", "role": "Required", "role_reason": "Needed to avoid converting AGE mass into SAC marker content or substituting raw garlic, black garlic or isolated SAC.", "application_exception": "SAC 1.2 mg is the marker content of this formulation; it does not establish isolated-SAC efficacy or equivalence to other products.", "criterion": "Retain the nominal product, ingredient amounts, administration frequency, oral add-on use and placebo; distinguish unverified measured specifications and adherence.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.", "condition_origin": "These are Chamgap in-house conditions developed with knowledge of the retained record for Kyolic Reserve AGE/SAC add-on use and the 12-week office systolic blood-pressure comparison. They do not establish blinding, clinical-trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Trial-product batch and content specifications, placebo composition, administration verification and remaining-capsule records. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The retained population/intervention fields specify Kyolic Reserve capsules providing AGE 1.2 g/SAC 1.2 mg/day in 2 capsules, versus matching placebo plus existing care.", "condition_status": "Partly verified", "status_reason": "The nominal formulation, amounts and comparison are identified, but batch, content testing, placebo composition, actual use and divided administration timing remain unverified.", "missingness": "The nominal formulation, amounts and comparison are identified, but batch, content testing, placebo composition, actual use and divided administration timing remain unverified.", "uncertainty": "The nominal formulation, amounts and comparison are identified, but batch, content testing, placebo composition, actual use and divided administration timing remain unverified.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Trial-product batch and content specifications, placebo composition, administration verification and remaining-capsule records." }, { "item_id": "N06", "question_type": "Evidence condition", "question": "Which measurement, time point and analysis does the 12-week office-SBP value represent?", "needed": "Office systolic pressure in mmHg, the adjusted between-group change from baseline at 12 weeks and its analysis definition.", "role": "Required", "role_reason": "Needed to avoid treating within-group reductions, 24-hour pressure, DBP or central pressure as the same effect.", "application_exception": "Generic English principal-endpoint wording must not be promoted to verification of the registered primary endpoint.", "criterion": "Attribute the value to the adjusted 12-week office-SBP group contrast and retain unverified measurement contract, variance type and model details.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.", "condition_origin": "These are Chamgap in-house conditions developed with knowledge of the retained record for Kyolic Reserve AGE/SAC add-on use and the 12-week office systolic blood-pressure comparison. They do not establish blinding, clinical-trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: 12-week result table, definitions of baseline/final/change values, measurement frequency/equipment and adjustment variables. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The evidence endpoint is 12-week office SBP; the Korean/English reader answers report an adjusted between-group contrast of −5.0±2.1 mmHg (P=.016).", "condition_status": "Partly verified", "status_reason": "Endpoint, timing and attribution to the adjusted group contrast are identified, but the measurement procedure, model and type of the ± value remain unverified.", "missingness": "Endpoint, timing and attribution to the adjusted group contrast are identified, but the measurement procedure, model and type of the ± value remain unverified.", "uncertainty": "Endpoint, timing and attribution to the adjusted group contrast are identified, but the measurement procedure, model and type of the ± value remain unverified.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "12-week result table, definitions of baseline/final/change values, measurement frequency/equipment and adjustment variables." }, { "item_id": "N07", "question_type": "Evidence condition", "question": "Which denominators do 88 completers and 84 in the adjusted analysis represent?", "needed": "Total randomized and allocated/completed/analyzed counts by group, reasons for exclusion/missingness and uncertainty intervals.", "role": "Required", "role_reason": "Needed to avoid substituting completed/analyzed denominators for randomized, ITT or group-specific denominators.", "application_exception": "Do not add 88 and 84 or assume 44/42 per group or a unique-participant total.", "criterion": "Retain 88 completers and 84 in the adjusted analysis separately; show unverified group, allocation and loss information.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.", "condition_origin": "These are Chamgap in-house conditions developed with knowledge of the retained record for Kyolic Reserve AGE/SAC add-on use and the 12-week office systolic blood-pressure comparison. They do not establish blinding, clinical-trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: CONSORT flowchart, analysis tables by group, reasons for protocol exclusions, missing-data handling and CIs. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The original count is 88 completers and 84 in the adjusted analysis; the reader answer notes limitations from protocol-related exclusions.", "condition_status": "Partly verified", "status_reason": "Total randomized and group counts, reasons for exclusions between completion and adjusted analysis, full ITT status and CIs remain unverified in the retained material.", "missingness": "Total randomized and group counts, reasons for exclusions between completion and adjusted analysis, full ITT status and CIs remain unverified in the retained material.", "uncertainty": "Total randomized and group counts, reasons for exclusions between completion and adjusted analysis, full ITT status and CIs remain unverified in the retained material.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "CONSORT flowchart, analysis tables by group, reasons for protocol exclusions, missing-data handling and CIs." }, { "item_id": "N08", "question_type": "Evidence condition", "question": "Are DBP, central pressure and responder signals kept separate from the main SBP result?", "needed": "Boundaries between the overall adjusted SBP estimate and secondary/subgroup results, including contrary or no-difference information.", "role": "Required", "role_reason": "Needed to prevent favorable subgroup values from replacing the overall main estimate.", "application_exception": "Mention of other results in the original explanation must not become a new conclusion of no DBP effect or conflicting data.", "criterion": "Keep other endpoints and responder values separate from the main SBP estimate; retain unverified specific results and hierarchy.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.", "condition_origin": "These are Chamgap in-house conditions developed with knowledge of the retained record for Kyolic Reserve AGE/SAC add-on use and the 12-week office systolic blood-pressure comparison. They do not establish blinding, clinical-trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Complete results by endpoint, subgroup definitions/denominators, prespecified plans and interactions. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The Korean/English explanation states that larger responder reductions, DBP and central pressure were not merged into the main claim.", "condition_status": "Met", "status_reason": "The verified separation boundary is retained. This does not newly verify the magnitudes, absence of effects or independence of those other results.", "missingness": "The verified separation boundary is retained. This does not newly verify the magnitudes, absence of effects or independence of those other results.", "uncertainty": "The verified separation boundary is retained. This does not newly verify the magnitudes, absence of effects or independence of those other results.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Complete results by endpoint, subgroup definitions/denominators, prespecified plans and interactions." }, { "item_id": "N09", "question_type": "Evidence condition", "question": "What are the original review date and the scope of this reading?", "needed": "The retained review date 2026-09-08, correction date, current reading date, retained inputs, search cutoff and individual access dates.", "role": "Required", "role_reason": "Needed to avoid turning the retained manuscript-review date into a current clinical-search cutoff or current full-text access date.", "application_exception": "0 new searches must not be described as 0 studies or no subsequent material.", "criterion": "Separate original dates from current local checks and limit statements of absence to the retained material.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.", "condition_origin": "These are Chamgap in-house conditions developed with knowledge of the retained record for Kyolic Reserve AGE/SAC add-on use and the 12-week office systolic blood-pressure comparison. They do not establish blinding, clinical-trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Historical search strategy/cutoff, material-specific access history and later publication/correction lists. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The retained review date is 2026-09-08 and the correction date is 2026-09-14; this preparation converts an actual reading of the current retained material.", "condition_status": "Partly verified", "status_reason": "Original manuscript-review and correction dates are recorded, but the original fields do not provide search cutoff or individual full-text/registration access dates.", "missingness": "Original manuscript-review and correction dates are recorded, but the original fields do not provide search cutoff or individual full-text/registration access dates.", "uncertainty": "Original manuscript-review and correction dates are recorded, but the original fields do not provide search cutoff or individual full-text/registration access dates.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Historical search strategy/cutoff, material-specific access history and later publication/correction lists." }, { "item_id": "N10", "question_type": "Evidence condition", "question": "How far was the wording about a blood-pressure meta-analysis retracted in 2026 verified?", "needed": "Publication ID, retraction notice, affected results and original exclusion decision for that meta-analysis.", "role": "Supplementary; required for a retraction-update claim", "role_reason": "Needed to avoid promoting an unidentified historical exclusion statement into a currently verified retraction or new report.", "application_exception": "Do not add an unidentified meta-analysis as S02, an independent trial or a main SBP result.", "criterion": "Quote only the historical exclusion statement; leave current verification of the publication and retraction notice unverified.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.", "condition_origin": "These are Chamgap in-house conditions developed with knowledge of the retained record for Kyolic Reserve AGE/SAC add-on use and the 12-week office systolic blood-pressure comparison. They do not establish blinding, clinical-trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Exact DOI/PMID, retraction notice, original report and documented exclusion reason. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The Korean/English research description contains a historical statement about excluding a blood-pressure meta-analysis retracted in 2026, but the evidence/citation entries do not identify it.", "condition_status": "Unverified", "status_reason": "The publication, notice and affected results cannot be identified from the retained material; no external lookup was performed in this preparation.", "missingness": "The publication, notice and affected results cannot be identified from the retained material; no external lookup was performed in this preparation.", "uncertainty": "The publication, notice and affected results cannot be identified from the retained material; no external lookup was performed in this preparation.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Exact DOI/PMID, retraction notice, original report and documented exclusion reason." }, { "item_id": "N11", "question_type": "Evidence condition", "question": "Do company funding, capsule provision and a no-involvement declaration mean the same thing?", "needed": "Wakunaga of America funding/product provision, roles in design/analysis, author roles and declared conflicts.", "role": "Supplementary; required for an independence claim", "role_reason": "Needed to avoid converting company support into independent funding or the no-involvement declaration alone into absence of bias.", "application_exception": "Do not delete the original effect solely because support exists or newly certify the support declaration.", "criterion": "Retain research funding, capsule provision and the no-involvement declaration separately; show unverified COI and institutional/author roles.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.", "condition_origin": "These are Chamgap in-house conditions developed with knowledge of the retained record for Kyolic Reserve AGE/SAC add-on use and the 12-week office systolic blood-pressure comparison. They do not establish blinding, clinical-trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Original funding/COI statements, product-support information, author employment/institutions and analysis-responsibility documents. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The retained funding entry states Wakunaga of America research funding and capsule provision, with a declaration of no involvement in design/analysis; the historical independence axis is I0.", "condition_status": "Partly verified", "status_reason": "The support and no-involvement statements are recorded, but original disclosures, institutional/author roles and independent verification remain unverified.", "missingness": "The support and no-involvement statements are recorded, but original disclosures, institutional/author roles and independent verification remain unverified.", "uncertainty": "The support and no-involvement statements are recorded, but original disclosures, institutional/author roles and independent verification remain unverified.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Original funding/COI statements, product-support information, author employment/institutions and analysis-responsibility documents." }, { "item_id": "N12", "question_type": "Evidence condition", "question": "Is implementation of the double-blind randomized placebo-controlled design verified?", "needed": "Allocation method, concealment, baseline balance, who was blinded, maintenance of blinding and actual design.", "role": "Required", "role_reason": "A design label alone cannot establish that allocation or confounding issues were resolved.", "application_exception": "Do not fill unverified parallel/crossover/cluster design details with an arbitrary not-applicable status or a definite design.", "criterion": "Distinguish the retained design description from unverified implementation material.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.", "condition_origin": "These are Chamgap in-house conditions developed with knowledge of the retained record for Kyolic Reserve AGE/SAC add-on use and the 12-week office systolic blood-pressure comparison. They do not establish blinding, clinical-trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Methods section, allocation/concealment procedures, baseline table and blinding assessment. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The retained Korean/English design fields describe a randomized, double-blind, placebo-controlled study.", "condition_status": "Partly verified", "status_reason": "Specific allocation, concealment, baseline balance, blinded parties/success and details of the actual design type remain unverified.", "missingness": "Specific allocation, concealment, baseline balance, blinded parties/success and details of the actual design type remain unverified.", "uncertainty": "Specific allocation, concealment, baseline balance, blinded parties/success and details of the actual design type remain unverified.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Methods section, allocation/concealment procedures, baseline table and blinding assessment." }, { "item_id": "N13", "question_type": "Evidence condition", "question": "Were concomitant antihypertensives, changes and adherence mixed with the AGE contribution?", "needed": "Group composition on existing care/no treatment, drug types/doses, changes/rescue treatment, AGE adherence and analysis handling.", "role": "Required", "role_reason": "Needed to avoid attributing contributions from changes in other medication to the AGE 1.2 g effect.", "application_exception": "Do not describe an add-on trial as antihypertensive replacement or assume that every participant took medication.", "criterion": "Separate the stable-care plan from verified levels of actual changes and adherence by group.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.", "condition_origin": "These are Chamgap in-house conditions developed with knowledge of the retained record for Kyolic Reserve AGE/SAC add-on use and the 12-week office systolic blood-pressure comparison. They do not establish blinding, clinical-trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Medication lists/changes by group, adherence, rescue treatment and deviation analyses. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The population/intervention fields and central explanation describe AGE added to stable existing treatment; the Korean population also includes untreated adults.", "condition_status": "Partly verified", "status_reason": "Details of background drug types, doses, balance by group, actual changes, AGE adherence and handling of deviations remain unverified.", "missingness": "Details of background drug types, doses, balance by group, actual changes, AGE adherence and handling of deviations remain unverified.", "uncertainty": "Details of background drug types, doses, balance by group, actual changes, AGE adherence and handling of deviations remain unverified.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Medication lists/changes by group, adherence, rescue treatment and deviation analyses." }, { "item_id": "N14", "question_type": "Evidence condition", "question": "Can office-SBP measurement error and assessor blinding be assessed?", "needed": "Equipment, posture, rest, repeated measurements, timing, assessor blinding and differences between groups.", "role": "Required", "role_reason": "A double-blind design label does not automatically establish standardized pressure measurement or verified assessor blinding.", "application_exception": "Do not assume absence of measurement bias because the outcome is a numerical measurement.", "criterion": "Describe actual SBP procedures and conditions by group only to the level verified.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.", "condition_origin": "These are Chamgap in-house conditions developed with knowledge of the retained record for Kyolic Reserve AGE/SAC add-on use and the 12-week office systolic blood-pressure comparison. They do not establish blinding, clinical-trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Blood-pressure measurement protocol, assessor/equipment validation and original measurement tables. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The retained material provides only 12-week office SBP and a double-blind design label.", "condition_status": "Unverified", "status_reason": "Equipment, measurement frequency, posture/timing and implementation of assessor blinding are not verified within the retained material.", "missingness": "Equipment, measurement frequency, posture/timing and implementation of assessor blinding are not verified within the retained material.", "uncertainty": "Equipment, measurement frequency, posture/timing and implementation of assessor blinding are not verified within the retained material.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Blood-pressure measurement protocol, assessor/equipment validation and original measurement tables." }, { "item_id": "N15", "question_type": "Evidence condition", "question": "Which effect does the adjusted analysis of 84 participants estimate?", "needed": "Effect of assignment/adherence, ITT/PP, exclusion criteria, adjustment variables and definition of the group contrast.", "role": "Required", "role_reason": "Needed to avoid promoting 88 completers and the estimate in 84 after protocol exclusions into full ITT.", "application_exception": "Mention of protocol exclusions alone must not newly establish a complete PP model or post hoc selection.", "criterion": "Retain the adjusted contrast and 84 analyzed as originally worded; show unverified analysis-set and model details.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.", "condition_origin": "These are Chamgap in-house conditions developed with knowledge of the retained record for Kyolic Reserve AGE/SAC add-on use and the 12-week office systolic blood-pressure comparison. They do not establish blinding, clinical-trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: SAP, analysis-set definitions, exclusion reasons, adjustment model and ITT/sensitivity tables. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The reader answer reports an adjusted group contrast and limitations from protocol-related exclusions; the evidence count reports 84 in the adjusted analysis.", "condition_status": "Partly verified", "status_reason": "Full ITT/PP terminology, prespecified exclusion rules, adjustment variables, missing-data model and sensitivity analyses remain unverified.", "missingness": "Full ITT/PP terminology, prespecified exclusion rules, adjustment variables, missing-data model and sensitivity analyses remain unverified.", "uncertainty": "Full ITT/PP terminology, prespecified exclusion rules, adjustment variables, missing-data model and sensitivity analyses remain unverified.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "SAP, analysis-set definitions, exclusion reasons, adjustment model and ITT/sensitivity tables." }, { "item_id": "N16", "question_type": "Evidence condition", "question": "Is there material to interpret the precision of −5.0±2.1 mmHg and P=.016?", "needed": "Between-group estimate, whether ±2.1 is SD/SE/CI, confidence interval, group-specific changes and justified clinical importance.", "role": "Required", "role_reason": "The P value and sample size alone cannot establish sufficient effect magnitude, precision or clinical meaning.", "application_exception": "Do not read ± as a CI or calculate a new confidence interval, values by group, minimum sample size or importance threshold.", "criterion": "Retain the original effect, P value and units; explain unverified uncertainty bounds and importance.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.", "condition_origin": "These are Chamgap in-house conditions developed with knowledge of the retained record for Kyolic Reserve AGE/SAC add-on use and the 12-week office systolic blood-pressure comparison. They do not establish blinding, clinical-trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Original result table, variance definition, CI, changes by group and basis for clinical importance. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The retained result is a between-group −5.0±2.1 mmHg, P=.016; the Korean/English reader answers call it an adjusted contrast.", "condition_status": "Partly verified", "status_reason": "The type of the ± value, CI, baseline/final/change values by group, adjustment model and clinical MID remain unverified.", "missingness": "The type of the ± value, CI, baseline/final/change values by group, adjustment model and clinical MID remain unverified.", "uncertainty": "The type of the ± value, CI, baseline/final/change values by group, adjustment model and clinical MID remain unverified.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Original result table, variance definition, CI, changes by group and basis for clinical importance." }, { "item_id": "N17", "question_type": "Evidence condition", "question": "Do the prespecified endpoint/analysis plan and reporting agree for 12-week SBP?", "needed": "Original trial registration, protocol, SAP, endpoint hierarchy and analysis/time-point changes.", "role": "Required", "role_reason": "Needed to avoid inheriting a historical paper/registration comparison narrative as current reading of the registry or SAP.", "application_exception": "A not-verified registration field does not establish non-registration or selective reporting.", "criterion": "Retain both the original registration field and historical narrative; show unverified comparison against actual prespecified plans.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.", "condition_origin": "These are Chamgap in-house conditions developed with knowledge of the retained record for Kyolic Reserve AGE/SAC add-on use and the 12-week office systolic blood-pressure comparison. They do not establish blinding, clinical-trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Exact registration identifier, protocol/SAP versions and a results/change comparison table. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The retained registration field says not verified, while the research description contains a historical statement about comparing the AGE at Heart paper and registration.", "condition_status": "Unverified", "status_reason": "Original registration ID/record, SAP and prespecified SBP hierarchy/analysis were not checked in this preparation and cannot be identified from the retained fields alone.", "missingness": "Original registration ID/record, SAP and prespecified SBP hierarchy/analysis were not checked in this preparation and cannot be identified from the retained fields alone.", "uncertainty": "Original registration ID/record, SAP and prespecified SBP hierarchy/analysis were not checked in this preparation and cannot be identified from the retained fields alone.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Exact registration identifier, protocol/SAP versions and a results/change comparison table." }, { "item_id": "N18", "question_type": "Evidence condition", "question": "Is independent replication verified for the same formulation, dose, population and 12-week SBP?", "needed": "Unique study families, independence of formulation/funding/team and trial-specific estimates.", "role": "Required", "role_reason": "Needed to avoid counting the same-group dose study and another black-garlic product as independent replication of the matched product.", "application_exception": "Do not automatically inherit the historical R1/I0 axes as new condition statuses or new replication counts.", "criterion": "Retain the distinction between S01 and background wording; leave independent replication and unique study counts unverified.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.", "condition_origin": "These are Chamgap in-house conditions developed with knowledge of the retained record for Kyolic Reserve AGE/SAC add-on use and the 12-week office systolic blood-pressure comparison. They do not establish blinding, clinical-trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Bibliography/registration, exact formulations, institutions/funding and individual results for the earlier study and other products. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The counterview says the same group's dose study and another aged-black-garlic product do not establish formulation- and funding-independent replication.", "condition_status": "Unverified", "status_reason": "The current report list contains 1 report; exact identities, equivalent specifications, independent funding and study-specific background results remain unverified.", "missingness": "The current report list contains 1 report; exact identities, equivalent specifications, independent funding and study-specific background results remain unverified.", "uncertainty": "The current report list contains 1 report; exact identities, equivalent specifications, independent funding and study-specific background results remain unverified.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Bibliography/registration, exact formulations, institutions/funding and individual results for the earlier study and other products." }, { "item_id": "N19", "question_type": "Evidence condition", "question": "Can AGE 1.2 g and SAC 1.2 mg be interpreted as the optimal dose?", "needed": "Direct dose comparisons, product specifications, estimates/harms by dose and prespecified analysis.", "role": "Supplementary; required for an expanded dose claim", "role_reason": "Needed to avoid treating mention of the same group's earlier dose study as certification of an optimal dose.", "application_exception": "Do not make all dose trials mandatory for the narrow 12-week SBP question at the exact single dose.", "criterion": "Distinguish the selected dose from unverified optimal-dose or higher/lower-dose effects.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.", "condition_origin": "These are Chamgap in-house conditions developed with knowledge of the retained record for Kyolic Reserve AGE/SAC add-on use and the 12-week office systolic blood-pressure comparison. They do not establish blinding, clinical-trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Exact bibliography of the earlier dose trial, group counts by dose, effects/CIs and support information. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The retained selected amount is AGE 1.2 g/SAC 1.2 mg/day in 2 capsules; the same group's earlier dose study appears only in background wording.", "condition_status": "Unverified", "status_reason": "The retained material lacks direct results/denominators by dose or optimization criteria; no separate dose table is created.", "missingness": "The retained material lacks direct results/denominators by dose or optimization criteria; no separate dose table is created.", "uncertainty": "The retained material lacks direct results/denominators by dose or optimization criteria; no separate dose table is created.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Exact bibliography of the earlier dose trial, group counts by dose, effects/CIs and support information." }, { "item_id": "N20", "question_type": "Evidence condition", "question": "Does this answer persistence, effects after stopping or longer-term pressure beyond 12 weeks?", "needed": "Long-term/post-discontinuation follow-up, persistence in the same population/intervention/comparison and medication changes/adherence.", "role": "Supplementary; required for a persistence claim", "role_reason": "Needed to avoid extending 12-week treatment/follow-up into long-term persistence.", "application_exception": "Do not make long-term trials automatically mandatory for the narrow 12-week SBP result.", "criterion": "Separate the direct 12-week scope from unverified later persistence.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.", "condition_origin": "These are Chamgap in-house conditions developed with knowledge of the retained record for Kyolic Reserve AGE/SAC add-on use and the 12-week office systolic blood-pressure comparison. They do not establish blinding, clinical-trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Long-term/post-discontinuation results, treatment changes by group, missingness and adherence. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The retained duration is 12 weeks of treatment and 12 weeks of follow-up; the scope note also limits the claim to 12-week SBP.", "condition_status": "Unverified", "status_reason": "Pressure beyond 12 weeks, persistence after stopping and long-term medication-change results remain unverified in the retained material.", "missingness": "Pressure beyond 12 weeks, persistence after stopping and long-term medication-change results remain unverified in the retained material.", "uncertainty": "Pressure beyond 12 weeks, persistence after stopping and long-term medication-change results remain unverified in the retained material.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Long-term/post-discontinuation results, treatment changes by group, missingness and adherence." }, { "item_id": "N21", "question_type": "Evidence condition", "question": "Can a larger decrease in responders be read as the overall effect?", "needed": "Responder definition, prespecified plan, subgroup count, group contrast/CI and interaction.", "role": "Supplementary; required for an expanded subgroup claim", "role_reason": "Needed to prevent larger reductions in selected responders from replacing the overall adjusted estimate.", "application_exception": "Do not require every subgroup validation for the present main question or create a new subgroup-efficacy sheet.", "criterion": "Distinguish overall SBP from responder signals; show unverified definitions, plans and denominators.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.", "condition_origin": "These are Chamgap in-house conditions developed with knowledge of the retained record for Kyolic Reserve AGE/SAC add-on use and the 12-week office systolic blood-pressure comparison. They do not establish blinding, clinical-trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Responder criteria, SAP, subgroup denominators/results and effect-modification tests. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The Korean/English explanation records that larger reductions in the responder subgroup were not merged into the main claim.", "condition_status": "Unverified", "status_reason": "Responder criteria, prespecified plan, count, separate controlled estimate, CI and interaction are absent from the retained material.", "missingness": "Responder criteria, prespecified plan, count, separate controlled estimate, CI and interaction are absent from the retained material.", "uncertainty": "Responder criteria, prespecified plan, count, separate controlled estimate, CI and interaction are absent from the retained material.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Responder criteria, SAP, subgroup denominators/results and effect-modification tests." }, { "item_id": "N22", "question_type": "Evidence condition", "question": "Does the office-SBP difference directly answer cardiovascular-event prevention?", "needed": "Boundary between SBP results and myocardial infarction, stroke, death or quality of life.", "role": "Supplementary; required for extension to clinical events", "role_reason": "Needed to avoid automatically extending a pressure difference into prevention of clinical events or replacement of treatment.", "application_exception": "Do not make event trials mandatory for a question about the numerical pressure change itself.", "criterion": "Maintain the current SBP scope and show unverified direct event material.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.", "condition_origin": "These are Chamgap in-house conditions developed with knowledge of the retained record for Kyolic Reserve AGE/SAC add-on use and the 12-week office systolic blood-pressure comparison. They do not establish blinding, clinical-trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Population, formulation, follow-up, event counts/denominators and analysis in separate direct event studies. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The retained advertising explanation says the result cannot be extended to all garlic products or cardiovascular-event prevention.", "condition_status": "Met", "status_reason": "The endpoint-extension boundary is retained. Event effects or surrogate validity were not newly certified.", "missingness": "The endpoint-extension boundary is retained. Event effects or surrogate validity were not newly certified.", "uncertainty": "The endpoint-extension boundary is retained. Event effects or surrogate validity were not newly certified.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Population, formulation, follow-up, event counts/denominators and analysis in separate direct event studies." }, { "item_id": "N23", "question_type": "Evidence condition", "question": "At what level is safety for the same AGE exposure reported?", "needed": "Adverse events/discontinuations, collection, denominators by group and observation time for the same formulation over 12 weeks.", "role": "Supplementary; required for a safety claim", "role_reason": "Needed to avoid converting the original caution into observed trial harms or confirmed safety.", "application_exception": "Do not delete the retained SBP result because harms remain unverified.", "criterion": "Distinguish the original cautions from direct trial harm tables; retain unverified collection and frequency.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.", "condition_origin": "These are Chamgap in-house conditions developed with knowledge of the retained record for Kyolic Reserve AGE/SAC add-on use and the 12-week office systolic blood-pressure comparison. They do not establish blinding, clinical-trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Trial-specific AE/SAE and discontinuation tables, collection methods and exposure denominators by group. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The historical safety label is Caution, with cautions about hypotension/dizziness when combined with antihypertensives and perioperative or anticoagulant/antiplatelet use.", "condition_status": "Partly verified", "status_reason": "The cautions are retained, but actual trial events, denominators, risk estimates and collection procedures remain unverified.", "missingness": "The cautions are retained, but actual trial events, denominators, risk estimates and collection procedures remain unverified.", "uncertainty": "The cautions are retained, but actual trial events, denominators, risk estimates and collection procedures remain unverified.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Trial-specific AE/SAE and discontinuation tables, collection methods and exposure denominators by group." }, { "item_id": "N24", "question_type": "Evidence condition", "question": "Are event definitions and collection recorded for hypotension, dizziness or bleeding?", "needed": "Trial event definitions, severity, systematic collection, discontinuations and ascertainment methods.", "role": "Supplementary; required for a direct harm question", "role_reason": "Needed to avoid converting a general caution into a complete count of diagnosed events.", "application_exception": "Monitoring/consultation wording in the original caution alone must not establish actual events or causality.", "criterion": "Separate original cautions from the existence or unverified status of event-collection material.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.", "condition_origin": "These are Chamgap in-house conditions developed with knowledge of the retained record for Kyolic Reserve AGE/SAC add-on use and the 12-week office systolic blood-pressure comparison. They do not establish blinding, clinical-trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: AE definitions, collection forms, severity/discontinuation records and assessment tables. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The retained safety details contain cautions but no trial event table.", "condition_status": "Unverified", "status_reason": "Direct information on diagnosis, occurrence/worsening, collection methods, severity and discontinuation remains unverified.", "missingness": "Direct information on diagnosis, occurrence/worsening, collection methods, severity and discontinuation remains unverified.", "uncertainty": "Direct information on diagnosis, occurrence/worsening, collection methods, severity and discontinuation remains unverified.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "AE definitions, collection forms, severity/discontinuation records and assessment tables." }, { "item_id": "N25", "question_type": "Evidence condition", "question": "Is the timing of the cautioned events relative to AGE exposure recorded?", "needed": "Start/stop of use, event onset/recovery, re-exposure and latency.", "role": "Supplementary; required for a harm-causality question", "role_reason": "The 12-week trial duration alone cannot establish temporal order or causality for harms.", "application_exception": "Do not infer improvement after discontinuation, re-exposure or individual events when absent.", "criterion": "Show the 12-week efficacy period separately from harm-specific timing information.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.", "condition_origin": "These are Chamgap in-house conditions developed with knowledge of the retained record for Kyolic Reserve AGE/SAC add-on use and the 12-week office systolic blood-pressure comparison. They do not establish blinding, clinical-trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Individual harm timelines, discontinuation/recovery/re-exposure and exposure-duration records. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The efficacy duration is 12 weeks, but the retained material provides no event-specific harm timelines.", "condition_status": "Unverified", "status_reason": "Onset/recovery, discontinuation and re-exposure times remain unverified; 12 weeks must not become event latency or recovery time.", "missingness": "Onset/recovery, discontinuation and re-exposure times remain unverified; 12 weeks must not become event latency or recovery time.", "uncertainty": "Onset/recovery, discontinuation and re-exposure times remain unverified; 12 weeks must not become event latency or recovery time.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Individual harm timelines, discontinuation/recovery/re-exposure and exposure-duration records." }, { "item_id": "N26", "question_type": "Evidence condition", "question": "Was the placebo comparison also used for an actual harm estimate?", "needed": "AGE/placebo adverse events, background treatment and comparative estimates.", "role": "Supplementary; required for a comparative harm claim", "role_reason": "Needed to avoid turning the existence of an efficacy placebo into verification of a between-group harm comparison.", "application_exception": "Do not fill cautions lacking a comparison with extrapolated incidence or risk ratios.", "criterion": "Separate the placebo contract for SBP from an unverified actual harm-comparison table.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.", "condition_origin": "These are Chamgap in-house conditions developed with knowledge of the retained record for Kyolic Reserve AGE/SAC add-on use and the 12-week office systolic blood-pressure comparison. They do not establish blinding, clinical-trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: AE results and denominators by group, harm estimates/intervals and concomitant care. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The original comparator is matching placebo plus existing blood-pressure care; the retained material contains no comparative harm results.", "condition_status": "Unverified", "status_reason": "Harm-specific group comparisons, event counts/denominators, RR/risk difference and CI could not be verified.", "missingness": "Harm-specific group comparisons, event counts/denominators, RR/risk difference and CI could not be verified.", "uncertainty": "Harm-specific group comparisons, event counts/denominators, RR/risk difference and CI could not be verified.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "AE results and denominators by group, harm estimates/intervals and concomitant care." }, { "item_id": "N27", "question_type": "Evidence condition", "question": "Are exposure and event denominators available for harm frequency?", "needed": "Exposed participants by group, people/events, observation time and recruitment/reporting system.", "role": "Supplementary; required for a harm-frequency claim", "role_reason": "Needed to avoid turning 88 completers/84 in the efficacy analysis into denominators for harm incidence.", "application_exception": "Do not use efficacy denominators to assert 0 events or calculate incidence/risk differences.", "criterion": "Report frequency only for reported values linked to the relevant harm denominator and time.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.", "condition_origin": "These are Chamgap in-house conditions developed with knowledge of the retained record for Kyolic Reserve AGE/SAC add-on use and the 12-week office systolic blood-pressure comparison. They do not establish blinding, clinical-trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: AE exposure denominators by group, people/event counts and follow-up time. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The current counts of 88 completers and 84 in the adjusted analysis concern efficacy; harm denominators are not specified.", "condition_status": "Unverified", "status_reason": "Harm-exposure denominators, event counts and time-specific estimates remain unverified.", "missingness": "Harm-exposure denominators, event counts and time-specific estimates remain unverified.", "uncertainty": "Harm-exposure denominators, event counts and time-specific estimates remain unverified.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "AE exposure denominators by group, people/event counts and follow-up time." }, { "item_id": "N28", "question_type": "Evidence condition", "question": "Is there material to attribute hypotension/dizziness during combined antihypertensive and AGE use?", "needed": "Medication types/doses, actual AGE exposure, baseline pressure, concurrent changes and event-specific alternatives.", "role": "Supplementary; required for causality of harms with combined use", "role_reason": "Needed to avoid attributing medication or baseline-factor contributions solely to AGE causality.", "application_exception": "Do not describe the original combined-use caution as an observed trial interaction or an instruction to replace medication.", "criterion": "Retain the original hypotension/dizziness caution; show unverified background medication and alternative event information.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.", "condition_origin": "These are Chamgap in-house conditions developed with knowledge of the retained record for Kyolic Reserve AGE/SAC add-on use and the 12-week office systolic blood-pressure comparison. They do not establish blinding, clinical-trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Medication changes by group, symptom timing, baseline values and harms by concomitant treatment. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The original safety details advise monitoring for hypotension and dizziness with existing antihypertensives.", "condition_status": "Partly verified", "status_reason": "The general caution is recorded, but medication types/doses, event records, alternative causes and risks with combined use remain unverified.", "missingness": "The general caution is recorded, but medication types/doses, event records, alternative causes and risks with combined use remain unverified.", "uncertainty": "The general caution is recorded, but medication types/doses, event records, alternative causes and risks with combined use remain unverified.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Medication changes by group, symptom timing, baseline values and harms by concomitant treatment." }, { "item_id": "N29", "question_type": "Evidence condition", "question": "What direct material supports cautions about surgery or anticoagulant/antiplatelet use?", "needed": "Perioperative exposure, concomitant medication, bleeding events and alternative causes for the same formulation/dose.", "role": "Supplementary; required for a bleeding/perioperative harm claim", "role_reason": "Needed to avoid certifying a general garlic caution as bleeding causality or incidence in this trial.", "application_exception": "Retain the caution without creating personal discontinuation or medical instructions.", "criterion": "Distinguish the original perioperative/combined-use caution from unverified direct trial material.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.", "condition_origin": "These are Chamgap in-house conditions developed with knowledge of the retained record for Kyolic Reserve AGE/SAC add-on use and the 12-week office systolic blood-pressure comparison. They do not establish blinding, clinical-trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Surgery timing, concomitant medication, exposure, bleeding definitions/denominators and original reports for the same formulation. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The original safety details contain cautions about perioperative or anticoagulant/antiplatelet use.", "condition_status": "Partly verified", "status_reason": "Specific perioperative/concomitant-use populations, bleeding events, comparisons/denominators and causal information remain unverified.", "missingness": "Specific perioperative/concomitant-use populations, bleeding events, comparisons/denominators and causal information remain unverified.", "uncertainty": "Specific perioperative/concomitant-use populations, bleeding events, comparisons/denominators and causal information remain unverified.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Surgery timing, concomitant medication, exposure, bleeding definitions/denominators and original reports for the same formulation." }, { "item_id": "N30", "question_type": "Evidence condition", "question": "Can the relationship between follow-up loss, protocol exclusions and missing harms be verified?", "needed": "Recruitment/reporting, exclusions/losses by group, stopping harm collection and scope of complete event disclosure.", "role": "Supplementary; required for completeness of harm collection", "role_reason": "Needed to avoid assuming that the difference between 84 analyzed/88 completed reflects harm-related losses or no events.", "application_exception": "Do not reclassify efficacy-analysis exclusions as actual harm-related dropouts.", "criterion": "Separate the original exclusion limitation from direct information on missing harm data.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.", "condition_origin": "These are Chamgap in-house conditions developed with knowledge of the retained record for Kyolic Reserve AGE/SAC add-on use and the 12-week office systolic blood-pressure comparison. They do not establish blinding, clinical-trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Reasons for losses/exclusions by group, AE-related discontinuations and completeness of follow-up/reporting. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The protocol-exclusion limitation in the reader answer and the counts of 88 completers/84 in the adjusted analysis are retained.", "condition_status": "Unverified", "status_reason": "Direct information on missing/selected harms, discontinuation and reasons for losses remains unverified; the difference between the two denominators is not inferred to be harm events.", "missingness": "Direct information on missing/selected harms, discontinuation and reasons for losses remains unverified; the difference between the two denominators is not inferred to be harm events.", "uncertainty": "Direct information on missing/selected harms, discontinuation and reasons for losses remains unverified; the difference between the two denominators is not inferred to be harm events.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Reasons for losses/exclusions by group, AE-related discontinuations and completeness of follow-up/reporting." }, { "item_id": "N31", "question_type": "Evidence condition", "question": "Were the cautioned events repeated in independent material?", "needed": "Unique harm reports/studies, exact formulation/dose, events and re-citation/regulatory relationships.", "role": "Supplementary; required for a repeated-harm claim", "role_reason": "Needed to avoid counting general cautions, the same report or another black-garlic product as repeated independent signals.", "application_exception": "Absence of original harm reports in the retained material must not become a claim of 0 harms worldwide.", "criterion": "Distinguish S01 cautions from unverified independent harm families.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.", "condition_origin": "These are Chamgap in-house conditions developed with knowledge of the retained record for Kyolic Reserve AGE/SAC add-on use and the 12-week office systolic blood-pressure comparison. They do not establish blinding, clinical-trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Identified direct harm reports, original registration/regulatory material and a re-citation family map. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The retained evidence/citation entries identify 1 report; there is no bibliography for separate harm reports or regulatory material.", "condition_status": "Unverified", "status_reason": "Independent event/study families and repetition counts for the exact AGE exposure remain unverified within the retained material.", "missingness": "Independent event/study families and repetition counts for the exact AGE exposure remain unverified within the retained material.", "uncertainty": "Independent event/study families and repetition counts for the exact AGE exposure remain unverified within the retained material.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Identified direct harm reports, original registration/regulatory material and a re-citation family map." }, { "item_id": "N32", "question_type": "Evidence condition", "question": "Is safety established for rare or long-term harms and vulnerable groups beyond 12 weeks?", "needed": "Long-term/rare events, baseline risks, vulnerable groups, concomitant/perioperative exposures and follow-up.", "role": "Supplementary; required for long-term/vulnerable-group safety", "role_reason": "Needed to avoid extending a small 12-week efficacy record into overall safety.", "application_exception": "Do not make all vulnerable-group/rare-harm material mandatory for the narrow SBP-efficacy question.", "criterion": "Distinguish the present duration/population from unverified long-term or special-exposure scopes.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.", "condition_origin": "These are Chamgap in-house conditions developed with knowledge of the retained record for Kyolic Reserve AGE/SAC add-on use and the 12-week office systolic blood-pressure comparison. They do not establish blinding, clinical-trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Direct material on long-term exposure/rare events and older adults, underlying disease or concomitant/perioperative use. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The current exposure period is 12 weeks, and the original caution mentions combined use and surgery.", "condition_status": "Unverified", "status_reason": "The retained material provides no direct harm estimates or denominators for long-term/rare events or specific vulnerable groups.", "missingness": "The retained material provides no direct harm estimates or denominators for long-term/rare events or specific vulnerable groups.", "uncertainty": "The retained material provides no direct harm estimates or denominators for long-term/rare events or specific vulnerable groups.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct material on long-term exposure/rare events and older adults, underlying disease or concomitant/perioperative use." }, { "item_id": "N33", "question_type": "Evidence condition", "question": "Does the original caution concern signals, comparative risk or causality?", "needed": "Direct design, events, denominators, timing, comparison, alternatives and the scope of currently possible statements.", "role": "Supplementary; required for harm interpretation", "role_reason": "Needed to avoid turning the original caution or positive efficacy result into a safety grade, risk magnitude or established causality.", "application_exception": "Do not create medical dosing instructions or new efficacy/safety scores or grades.", "criterion": "Retain original C50/Caution/axes only as historical quotations and distinguish unverified direct harms.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, support and harms in the retained reports. Detailed conditions are Chamgap's own application.", "condition_origin": "These are Chamgap in-house conditions developed with knowledge of the retained record for Kyolic Reserve AGE/SAC add-on use and the 12-week office systolic blood-pressure comparison. They do not establish blinding, clinical-trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: An exact harm question, original event tables and direct comparative/timing/alternative-explanation material. This records needed materials; no new research was executed.", "current_reports": [ "S01" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The original Caution label, C50 and all axes are retained historical values; direct information on harm occurrence or causality was not verified.", "condition_status": "Met", "status_reason": "The interpretation boundary of the original caution and separation of historical values are verified; this is not certification of safety, causality or a new grade.", "missingness": "The interpretation boundary of the original caution and separation of historical values are verified; this is not certification of safety, causality or a new grade.", "uncertainty": "The interpretation boundary of the original caution and separation of historical values are verified; this is not certification of safety, causality or a new grade.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "An exact harm question, original event tables and direct comparative/timing/alternative-explanation material." } ], "reports": [ { "report_id": "S01", "title": "Ried K et al. Integr Blood Press Control. 2016;9:9-21. PMID: 26869811. PMCID: PMC4734812. DOI: 10.2147/IBPC.S93335.", "url": "https://pubmed.ncbi.nlm.nih.gov/26869811/", "report_type": "Retained summary and bibliography for the direct AGE at Heart trial", "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "Retained Korean/English summaries, conditions and application records were read. External PubMed, DOI, PMC, registration and supplement material remain unread, with access not attempted.", "study_family": "The evidence entry and bibliography identify 1 AGE at Heart report. Korean/English wording, synthesis, DBP, central-pressure and responder results, and DOI/PMC entry links are not independent trials. The identities, overlap and independence of the same group’s earlier dose study, other black-garlic products and the unidentified retraction narrative, as well as unique study and participant totals, remain unverified.", "independent_replication": "The evidence entry and bibliography identify 1 AGE at Heart report. Korean/English wording, synthesis, DBP, central-pressure and responder results, and DOI/PMC entry links are not independent trials. The identities, overlap and independence of the same group’s earlier dose study, other black-garlic products and the unidentified retraction narrative, as well as unique study and participant totals, remain unverified.", "observed_result": "The retained reported adjusted between-group office-SBP contrast at 12 weeks is −5.0±2.1 mmHg, P=.016. The 88 completers and 84 participants in the adjusted analysis remain distinct. The type of ±2.1, CI, allocation/analysis counts by group, full ITT status, exclusion rules and adjustment model remain unverified. Research funding and capsule provision are distinguished from the declaration of no involvement in design or analysis; the declaration alone does not certify independent support or absence of bias.", "result_level": "These are retained reported values and limitations, without a new external full-text check, numerical recalculation or new verdict.", "source_evidence_date": "2026-09-08", "materials": [ { "material_type": "Stored review summary", "public_status": "Locally retained summary", "access_status": "Acquired", "acquired": true, "actually_read": "Stored existing review summary read", "as_of": "2026-10-06", "qualification": "The retained Korean/English evidence and bibliographic summaries were read. This does not mean the original paper file was acquired or its full text newly verified. This is limited to the retained AGE at Heart summary and bibliography. External abstracts, DOI/PMC full text, registration and supplements were not read in this preparation, and current responses, public availability and successful access were not verified. The material-check date distinguishes verification and reading status in the retained record. It is not a new external-original access date or a search cutoff." }, { "material_type": "External bibliography/abstract", "public_status": "Unverified", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-06", "qualification": "The retained PubMed address is provided. Current responses, new reading of the abstract/bibliography and successful external access remain unverified. This is limited to the retained AGE at Heart summary and bibliography. External abstracts, DOI/PMC full text, registration and supplements were not read in this preparation, and current responses, public availability and successful access were not verified. The material-check date distinguishes verification and reading status in the retained record. It is not a new external-original access date or a search cutoff." }, { "material_type": "DOI full-text entry", "public_status": "Unverified", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-06", "qualification": "This is the retained DOI entry for full text. Existence, public availability, access, downloading and reading of full text or supplements remain unverified. This is limited to the retained AGE at Heart summary and bibliography. External abstracts, DOI/PMC full text, registration and supplements were not read in this preparation, and current responses, public availability and successful access were not verified. The material-check date distinguishes verification and reading status in the retained record. It is not a new external-original access date or a search cutoff." }, { "material_type": "Original trial registration", "public_status": "Unverified", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-06", "qualification": "The structured registration status is not verified. The exact registration location, original record, prespecified endpoint, protocol and analysis plan remain unverified. This does not establish non-registration. This is limited to the retained AGE at Heart summary and bibliography. External abstracts, DOI/PMC full text, registration and supplements were not read in this preparation, and current responses, public availability and successful access were not verified. The material-check date distinguishes verification and reading status in the retained record. It is not a new external-original access date or a search cutoff." }, { "material_type": "PMC full-text entry", "public_status": "Unverified", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-06", "qualification": "This is the PMC entry for the retained PMCID. It concerns the same report as the DOI entry and is not an independent trial. Full text, responses, downloading and accessibility were not checked in this preparation. This is limited to the retained AGE at Heart summary and bibliography. External abstracts, DOI/PMC full text, registration and supplements were not read in this preparation, and current responses, public availability and successful access were not verified. The material-check date distinguishes verification and reading status in the retained record. It is not a new external-original access date or a search cutoff." }, { "material_type": "Original-paper supplement", "public_status": "Unverified", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-06", "qualification": "The existence, exact location and original file of a supplement remain unverified. Non-reading does not establish absence of a supplement or a failed access attempt. This is limited to the retained AGE at Heart summary and bibliography. External abstracts, DOI/PMC full text, registration and supplements were not read in this preparation, and current responses, public availability and successful access were not verified. The material-check date distinguishes verification and reading status in the retained record. It is not a new external-original access date or a search cutoff." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/26869811/" } ] } ], "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": { "Partly verified": "Some retained information is verified and necessary unverified material remains.", "Unverified": "The criterion could not be established within the retained material. This does not mean no studies, no effect or established safety.", "Review incomplete": "The necessary source comparison or search was not performed within the authorized scope.", "Not reported": "This is limited to the item not being stated in the particular material or section that was read.", "Inaccessible": "Used only for material where an actual access attempt failed. This status was not assigned to clinical material in this preparation.", "Insufficient evidence for the conditions": "Used only after relevant studies within the defined scope have been reviewed and evidence is insufficient to answer the condition. It was not applied to every item in this preparation.", "Not applicable": "A specific exception under the applicability conditions; it is not a substitute for material remaining unread.", "Conflicting data": "Used when incompatible material has been compared for the same question, time point and analysis. Numerical differences between summaries alone do not establish this status.", "Met": "The stated conditions for retained information, attribution, reading, counting or interpretation boundaries are verified. This is not certification of efficacy, full-text reading or reassessment." }, "study_overlap": { "state": "Unverified", "unique_trial_count": null, "unique_participant_count": null, "reason": "The evidence entry and bibliography identify 1 AGE at Heart report. Korean/English wording, synthesis, DBP, central-pressure and responder results, and DOI/PMC entry links are not independent trials. The identities, overlap and independence of the same group’s earlier dose study, other black-garlic products and the unidentified retraction narrative, as well as unique study and participant totals, 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 33 items. No new clinical search, verification-state change or scoring was performed." } ], "language": "en", "translation_date": "2026-10-25" }