{ "schema_version": "chamgap-public-criteria-1.0", "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", "language": "en", "translation_date": "2026-10-25", "criteria_version": "1.0", "criteria_date": "2026-10-06", "condition_origin": "Chamgap's own application conditions", "method_sources": [ { "id": "M03", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03", "section": "§3.1, §3.2.1–3.2.3, MECIR C5/C7/C13", "official_principle": "Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.", "review_level": "Retained method-application records were reused. External originals were not reread and method content was not reassessed." }, { "id": "M04", "version": "Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04", "section": "§4.5, §4.6.1–4.6.3, MECIR C42", "official_principle": "Distinguish studies from reports and link them; do not omit a study solely because results are unreported.", "review_level": "Retained method-application records were reused. External originals were not reread and method content was not reassessed." }, { "id": "M08", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08", "section": "§8.1–8.2.3, Table 8.2.a", "official_principle": "Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.", "review_level": "Retained method-application records were reused. External originals were not reread and method content was not reassessed." }, { "id": "M15", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15", "section": "§15.2.4, §15.3.1–15.3.3", "official_principle": "Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.", "review_level": "Retained method-application records were reused. External originals were not reread and method content was not reassessed." }, { "id": "M19", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19", "section": "§19.1.2, §19.2.1–19.2.4", "official_principle": "Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.", "review_level": "Retained method-application records were reused. External originals were not reread and method content was not reassessed." } ], "status_dictionary": { "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." }, "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." }, { "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." } ] }