{ "schema_version": "chamgap-public-criteria-1.0", "title": "Chemically characterized raw garlic equivalent to about 4 g, six days per week × Reduction of LDL-C in adults with moderate hypercholesterolemia", "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": { "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.", "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.", "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.", "Not applicable": "A specific exception under the applicability conditions; it is not a substitute for material remaining unread.", "Review incomplete": "The necessary source comparison or search was not performed within the authorized scope.", "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." }, "requirements": [ { "item_id": "N01", "question_type": "Evidence condition", "question": "Which raw-garlic LDL-C question does this table link to the original claim?", "needed": "The current Korean claim, Korean/English intervention and population descriptors, scope note and selected question boundary", "role": "Required", "role_reason": "This is needed to keep a broad ingredient claim distinct from the narrow LDL-C question for the original raw-garlic formulation.", "application_exception": "Keep powder, AGE and oil reports as formulation-specific auxiliary context without automatically extending them to new independent questions or general garlic efficacy.", "criterion": "Link California Early raw garlic, food intake, about 4 g on 6 days weekly for 6 months, the stated population, LDL-C and matched garlic-free sandwich placebo to the original description.", "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 the raw-garlic food and 6-month LDL-C comparison. They do not establish blinding, clinical-trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: The current Korean claim, Korean/English intervention and population descriptors, scope note and selected question boundary. This records needed materials; no new research was executed." }, { "item_id": "N02", "question_type": "Evidence condition", "question": "Who is covered by the LDL-C range, age range and absence of lipid-lowering medicine?", "needed": "The original population description of LDL-C 130~190 mg/dL, age 30~65 and no medicine use, plus eligibility/exclusion and baseline-balance tables", "role": "Required", "role_reason": "A population contract is needed so that the label moderate hypercholesterolemia is not generalized to other groups.", "application_exception": "Do not use the total of 192 across 4 arms as the raw-garlic count. Do not infer that recruitment, sex/comorbidities or baseline differences were absent.", "criterion": "Distinguish the original population from unverified populations in auxiliary trials of other formulations, and state limits concerning eligibility, baseline characteristics and representativeness.", "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 the raw-garlic food and 6-month LDL-C comparison. They do not establish blinding, clinical-trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: The original population description of LDL-C 130~190 mg/dL, age 30~65 and no medicine use, plus eligibility/exclusion and baseline-balance tables. This records needed materials; no new research was executed." }, { "item_id": "N03", "question_type": "Evidence condition", "question": "Were the California Early raw-garlic food formulation and chemical specifications verified?", "needed": "Fresh cloves, sandwich provision and the original chemical-characterization description, with original batch, constituent and processing specifications", "role": "Required", "role_reason": "This is needed to distinguish raw-garlic food from powder, AGE, oil, allicin, black/fermented garlic and isolated SAC.", "application_exception": "Do not present the original chemical-characterization narrative as acquisition of the constituent report in this preparation, or convert the nominal 4 g to active-constituent content.", "criterion": "Link the original raw-garlic formulation to unverified specifications, without transferring doses or effects from other formulations.", "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 the raw-garlic food and 6-month LDL-C comparison. They do not establish blinding, clinical-trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Fresh cloves, sandwich provision and the original chemical-characterization description, with original batch, constituent and processing specifications. This records needed materials; no new research was executed." }, { "item_id": "N04", "question_type": "Evidence condition", "question": "Is the comparator a matched garlic-free sandwich placebo?", "needed": "The original food-placebo description and methods for food provision, energy/constituents and control treatment", "role": "Required", "role_reason": "The actual direction of the raw-garlic versus placebo comparison and the food-control content must be clear.", "application_exception": "Do not transfer raw-garlic food-placebo details unchanged to powder/AGE comparisons in the same 4-arm trial. An efficacy placebo alone does not certify a harm comparison.", "criterion": "Retain the original raw-garlic versus matched garlic-free sandwich-placebo contract and state the verified extent of actual composition and treatment 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 the raw-garlic food and 6-month LDL-C comparison. They do not establish blinding, clinical-trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: The original food-placebo description and methods for food provision, energy/constituents and control treatment. This records needed materials; no new research was executed." }, { "item_id": "N05", "question_type": "Evidence condition", "question": "Are the nominal about 4-g amount on 6 days weekly and actual intake/adherence distinct?", "needed": "The original about one average 4-g clove amount on 6 days weekly, plus batch amount, actual intake and adherence/discontinuation records", "role": "Required", "role_reason": "This is needed to avoid assuming that nominal food amount and actual exposure were identical.", "application_exception": "Do not calculate new daily active-constituent or cumulative amounts from 6 days weekly and 6 months. Do not fill powder/AGE doses with the raw-garlic amount.", "criterion": "Retain original nominal amount/frequency and separately state unverified actual intake and group-specific departures/changes.", "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 the raw-garlic food and 6-month LDL-C comparison. They do not establish blinding, clinical-trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: The original about one average 4-g clove amount on 6 days weekly, plus batch amount, actual intake and adherence/discontinuation records. This records needed materials; no new research was executed." }, { "item_id": "N06", "question_type": "Evidence condition", "question": "Are 6-month treatment, monthly measurements and the final 6-month endpoint distinct?", "needed": "6-month treatment, monthly lipid measurements, 6-month LDL-C change from baseline and visit/follow-up conditions", "role": "Required", "role_reason": "This is needed to avoid counting monthly measurements as independent trials or separate replications of the final endpoint.", "application_exception": "Do not create persistence effects, clinical events or new minimum-duration criteria beyond 6 months.", "criterion": "Attribute stated treatment duration, measurement frequency and the selected final time point to the original record, retaining unverified longer follow-up.", "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 the raw-garlic food and 6-month LDL-C comparison. They do not establish blinding, clinical-trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: 6-month treatment, monthly lipid measurements, 6-month LDL-C change from baseline and visit/follow-up conditions. This records needed materials; no new research was executed." }, { "item_id": "N07", "question_type": "Evidence condition", "question": "Are 4-arm reporting, bibliographies and the total 192 kept free of duplicate counting?", "needed": "Identity of the original Gardner report/bibliography, the 4-arm structure, total allocation of 192 and report-family/participant links", "role": "Required", "role_reason": "This is needed to avoid multiplying the three garlic arms and shared placebo into separate trials or repeated participants.", "application_exception": "Do not treat 192 as each arm's count, multiply participant counts by 3 or assume 48 per arm. Do not add the 25 Berthold completers from another report.", "criterion": "Link each evidence/bibliography pair, the four arms and Korean/English restatements within a local report context; keep unique trial and participant totals 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 the raw-garlic food and 6-month LDL-C comparison. They do not establish blinding, clinical-trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Identity of the original Gardner report/bibliography, the 4-arm structure, total allocation of 192 and report-family/participant links. This records needed materials; no new research was executed." }, { "item_id": "N08", "question_type": "Evidence condition", "question": "Are the local summaries actually read distinguished from external material remaining unread?", "needed": "Exact locations, data types, source-identity checks and actual review time in the current summary, with external URLs/access records for each report", "role": "Required", "role_reason": "This is needed to avoid converting PubMed, DOI, JAMA and NCT links into successful abstract/full-text/registration reading.", "application_exception": "Do not label unattempted external access as inaccessible. Reusing method-HTML identity and hashes does not establish complete full-text reading.", "criterion": "Link current local-summary reading to the original locations, and record actual non-attempt/non-reading separately for external abstracts, full texts, supplements and registrations.", "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 the raw-garlic food and 6-month LDL-C comparison. They do not establish blinding, clinical-trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Exact locations, data types, source-identity checks and actual review time in the current summary, with external URLs/access records for each report. This records needed materials; no new research was executed." }, { "item_id": "N09", "question_type": "Evidence condition", "question": "What are the verdict date, correction history, current review date and evidence-date scope?", "needed": "Original verdict date, corrections, Korean/English and synthesis text, and actual current review time", "role": "Required", "role_reason": "This is needed to avoid retroactively treating the original 2026-09-08 verdict and 9/14 English correction as a current comprehensive search or current full-text reading.", "application_exception": "Keep unavailable original search cutoffs and material-specific access dates/levels unverified. Generic English wording must not be promoted to new verification.", "criterion": "Preserve all original date/correction fields and both languages, distinguishing actual local reading and the absence of a new search.", "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 the raw-garlic food and 6-month LDL-C comparison. They do not establish blinding, clinical-trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Original verdict date, corrections, Korean/English and synthesis text, and actual current review time. This records needed materials; no new research was executed." }, { "item_id": "N10", "question_type": "Evidence condition", "question": "What is verified about NIH/NCCAM support, product donation and oil-report funding?", "needed": "Main-report NIH/NCCAM support/product donation, the oil report's German academic institution/unverified details, and COI, author and product-provision material", "role": "Supplementary; required for an independence claim", "role_reason": "This is needed to avoid certifying absence of conflicts, independent replication or absence of bias from the original independent-funding description alone.", "application_exception": "Do not automatically discard results because support or donation exists. Original I2/B1 assessments remain historical only.", "criterion": "Link actual retained support wording for each report separately from unverified declarations, employment, institutions and family relationships.", "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 the raw-garlic food and 6-month LDL-C comparison. They do not establish blinding, clinical-trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Main-report NIH/NCCAM support/product donation, the oil report's German academic institution/unverified details, and COI, author and product-provision material. This records needed materials; no new research was executed." }, { "item_id": "N11", "question_type": "Evidence condition", "question": "What actual 4-arm parallel randomized design does the main trial have?", "needed": "The original 4-arm randomized parallel design, arm composition, allocation methods and methods section", "role": "Required", "role_reason": "This is needed to avoid changing the original design into crossover, cluster randomization or three separate direct trials.", "application_exception": "The term randomized alone does not verify concealment, balance or elimination of bias. Preserve the oil crossover trial as another report.", "criterion": "Link Gardner's 4-arm parallel randomized design and the other report's crossover design separately, limiting claims to verified design descriptions.", "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 the raw-garlic food and 6-month LDL-C comparison. They do not establish blinding, clinical-trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: The original 4-arm randomized parallel design, arm composition, allocation methods and methods section. This records needed materials; no new research was executed." }, { "item_id": "N12", "question_type": "Evidence condition", "question": "Were allocation concealment, baseline balance and actual blinding implementation verified?", "needed": "Baseline tables by group, randomization/concealment, food/product blinding and assessor-handling material", "role": "Required", "role_reason": "This is needed to avoid inventing complete food-intake blinding or verified protection of RCT allocation.", "application_exception": "Do not automatically judge food blinding impossible. Objective LDL-C alone does not establish absence of measurement bias.", "criterion": "Verify actual implementation/differences at the original locations, or specifically state current limits of unverified 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 the raw-garlic food and 6-month LDL-C comparison. They do not establish blinding, clinical-trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Baseline tables by group, randomization/concealment, food/product blinding and assessor-handling material. This records needed materials; no new research was executed." }, { "item_id": "N13", "question_type": "Evidence condition", "question": "What changes in diet, concomitant medicine and rescue treatment occurred by group?", "needed": "Baseline absence of lipid-lowering medicine, common food provision, actual diet/medication/lifestyle changes and handling by group", "role": "Required", "role_reason": "This is needed to avoid attributing other treatment/diet changes to raw-garlic LDL-C changes.", "application_exception": "Baseline absence of lipid-lowering medicine does not establish absence of all concomitant use/changes over 6 months. Do not invent change values or assume balance.", "criterion": "Distinguish baseline conditions from actual concomitant use/changes during follow-up and analytical effects, retaining unverified group-specific 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 the raw-garlic food and 6-month LDL-C comparison. They do not establish blinding, clinical-trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Baseline absence of lipid-lowering medicine, common food provision, actual diet/medication/lifestyle changes and handling by group. This records needed materials; no new research was executed." }, { "item_id": "N14", "question_type": "Evidence condition", "question": "Were LDL-C methods, laboratory conditions and measurement procedures by group verified?", "needed": "LDL-C units in mg/dL, monthly measurements, sampling/calculation methods, laboratory, blinding and standardization material", "role": "Required", "role_reason": "The same LDL-C label does not establish identical testing conditions, measurement error or group differences.", "application_exception": "Do not substitute total cholesterol, TG or HDL for LDL-C or convert original values to another unit without authorization.", "criterion": "Link selected LDL-C results to measurement frequency and units, stating unverified actual testing conditions and assessment procedures.", "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 the raw-garlic food and 6-month LDL-C comparison. They do not establish blinding, clinical-trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: LDL-C units in mg/dL, monthly measurements, sampling/calculation methods, laboratory, blinding and standardization material. This records needed materials; no new research was executed." }, { "item_id": "N15", "question_type": "Evidence condition", "question": "Are 6-month LDL-C, other lipid endpoints and prespecified outcome hierarchy distinct?", "needed": "The original primary (1st) LDL-C description, 6-month change, total cholesterol/TG/HDL and registry/protocol endpoint tables", "role": "Required", "role_reason": "This is needed to avoid replacing the original LDL-C result with other lipids or a favorable time point.", "application_exception": "Preserve the original primary (1st) designation, while registry/selection-reporting comparison remains unverified because originals were not read. Do not create new values for other lipids.", "criterion": "Link retained principal LDL-C endpoint/time point and limits on substituting other lipids, separately stating the extent of comparison with 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 the raw-garlic food and 6-month LDL-C comparison. They do not establish blinding, clinical-trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: The original primary (1st) LDL-C description, 6-month change, total cholesterol/TG/HDL and registry/protocol endpoint tables. This records needed materials; no new research was executed." }, { "item_id": "N16", "question_type": "Evidence condition", "question": "What changes do +0.4, +3.2, +0.2 and −3.9 represent in the four groups?", "needed": "Original strings for 6-month raw-garlic/powder/AGE/placebo changes from baseline, the results table and analytical definitions", "role": "Required", "role_reason": "This is needed to avoid misreading within-group changes as between-group effects, positive efficacy or a garlic effect from placebo reduction.", "application_exception": "Do not subtract raw garlic and placebo to create a new effect estimate/CI. Do not interpret a plus sign as positive efficacy.", "criterion": "Retain each group's original change, units and time point, distinguishing the nonsignificant group-by-time narrative from the unverified direct contrast.", "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 the raw-garlic food and 6-month LDL-C comparison. They do not establish blinding, clinical-trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Original strings for 6-month raw-garlic/powder/AGE/placebo changes from baseline, the results table and analytical definitions. This records needed materials; no new research was executed." }, { "item_id": "N17", "question_type": "Evidence condition", "question": "How do mixed modeling and partial observations relate to ITT and the target effect?", "needed": "The mixed-model description including partial observations, analysis populations, missing-data handling and assignment/adherence-effect conditions", "role": "Required", "role_reason": "This is needed to avoid converting inclusion of partial data into verification of full ITT or a particular target effect.", "application_exception": "Do not infer absence of missing-data bias from retention alone or invent PP/ITT/model details.", "criterion": "Retain original analytical wording and explain unverified exact populations, model, target estimate, sensitivity and departure handling.", "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 the raw-garlic food and 6-month LDL-C comparison. They do not establish blinding, clinical-trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: The mixed-model description including partial observations, analysis populations, missing-data handling and assignment/adherence-effect conditions. This records needed materials; no new research was executed." }, { "item_id": "N18", "question_type": "Evidence condition", "question": "Are the total 192 and group retention of 87~90% distinct from analysis/completion denominators?", "needed": "Original total allocation of 192 and retention of 87~90%, with group allocation/analysis/completion, loss reasons and timing", "role": "Required", "role_reason": "This is needed to avoid converting the displayed sample size and retention range into the actual raw-garlic analysis denominator.", "application_exception": "Do not calculate completion/analysis counts from the retention range or assume 48 per group or ITT 192.", "criterion": "Retain the original overall denominator/retention range while separating unverified denominators and missingness in raw-garlic, powder, AGE and placebo arms.", "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 the raw-garlic food and 6-month LDL-C comparison. They do not establish blinding, clinical-trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Original total allocation of 192 and retention of 87~90%, with group allocation/analysis/completion, loss reasons and timing. This records needed materials; no new research was executed." }, { "item_id": "N19", "question_type": "Evidence condition", "question": "Does a nonsignificant group-by-time result establish a precise null effect or equivalence?", "needed": "Original nonsignificant group-by-time/null wording, with raw-garlic versus placebo difference, CI, exact P and variance", "role": "Required", "role_reason": "This is needed to avoid automatically promoting nonsignificance or an original null assessment into proof of an effect of 0 or equivalence.", "application_exception": "Original E0/RX labels are historical verdicts, without a new precision/exclusion-interval check. A plus change within a group is not positive efficacy.", "criterion": "Retain the original no-difference direction alongside unverified direct contrast/CI/exact P, without creating a new precise null effect or grade.", "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 the raw-garlic food and 6-month LDL-C comparison. They do not establish blinding, clinical-trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Original nonsignificant group-by-time/null wording, with raw-garlic versus placebo difference, CI, exact P and variance. This records needed materials; no new research was executed." }, { "item_id": "N20", "question_type": "Evidence condition", "question": "How are bibliography NCT00056511 and the evidence table's unverified registration status retained?", "needed": "NCT in the first report's bibliography and Korean research description, the first report's registration-status field, and original registration/protocol/SAP material", "role": "Required", "role_reason": "The identifier string must remain distinct from actual reading of the original registration or prespecified plans.", "application_exception": "Do not call unverified registration non-registration. An NCT string does not establish preregistration/plans or successful access.", "criterion": "Link both original fields separately; comparison with prespecified LDL-C, analysis and time plans remains externally unread.", "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 the raw-garlic food and 6-month LDL-C comparison. They do not establish blinding, clinical-trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: NCT in the first report's bibliography and Korean research description, the first report's registration-status field, and original registration/protocol/SAP material. This records needed materials; no new research was executed." }, { "item_id": "N21", "question_type": "Evidence condition", "question": "Are Garlicin powder and Kyolic AGE arms direct replications of raw garlic?", "needed": "Formulation-specific results and product names within the same 4-arm report, with dose, processing, active-constituent and administration details", "role": "Required; formulation extension requires a separate question", "role_reason": "This is needed to avoid counting no-difference results from other formulations within one report as independent replication of identical raw garlic.", "application_exception": "Powder/AGE doses remain unverified in the original material; do not transfer raw-garlic 4-g food/placebo conditions. Do not delete the other formulations' results.", "criterion": "Attribute powder +3.2 and AGE +0.2 mg/dL within the same report family as auxiliary comparisons of other formulations, limiting claims about raw-garlic effects and independence.", "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 the raw-garlic food and 6-month LDL-C comparison. They do not establish blinding, clinical-trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Formulation-specific results and product names within the same 4-arm report, with dose, processing, active-constituent and administration details. This records needed materials; no new research was executed." }, { "item_id": "N22", "question_type": "Evidence condition", "question": "What scope applies to 25 completers, 0.04 mg/dL and CI/P in the garlic-oil crossover trial?", "needed": "Original Berthold 1998 design, 25 completers, between-group LDL-C 0.04 mg/dL/95% CI −9.4~9.5/P=.99 and oil formulation/duration", "role": "Required; auxiliary context from another formulation", "role_reason": "This is needed to avoid treating a separate oil result as raw-garlic food, direct 6-month replication or an allocation result for all 25.", "application_exception": "Preserve original mg/dL, CI and P without unrequested correction/conversion because of suspected units. Retain unverified oil dose, duration, population, sequence, washout and carryover handling.", "criterion": "Link the separate report, crossover design, 25 completers and attribution of original between-group values, without transfer to raw-garlic formulation, duration or 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 the raw-garlic food and 6-month LDL-C comparison. They do not establish blinding, clinical-trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Original Berthold 1998 design, 25 completers, between-group LDL-C 0.04 mg/dL/95% CI −9.4~9.5/P=.99 and oil formulation/duration. This records needed materials; no new research was executed." }, { "item_id": "N23", "question_type": "Evidence condition", "question": "What status applies to older positive high-dose AGE/powder narratives and a separate powder-trial mention?", "needed": "Original Korean/English counterview and research narratives, with identifiable reports, products, doses, population and endpoint material", "role": "Required", "role_reason": "This is needed to preserve formulation/design differences between positive background and the current direct no-difference result without inventing unverified reports.", "application_exception": "There are currently 2 evidence entries/bibliographies. Unidentified positive AGE/powder or independent-powder-trial narratives must not generate S3, a new bibliography or independent-replication counts.", "criterion": "Link the existence of background narratives to unverified identity/values/access, without automatically labeling different questions as conflicting 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 the raw-garlic food and 6-month LDL-C comparison. They do not establish blinding, clinical-trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Original Korean/English counterview and research narratives, with identifiable reports, products, doses, population and endpoint material. This records needed materials; no new research was executed." }, { "item_id": "N24", "question_type": "Evidence condition", "question": "Were clinical-importance and precision criteria for the between-group LDL-C effect verified?", "needed": "Original raw-garlic versus placebo effect/CI, criteria/important difference, units, variance and denominators", "role": "Required", "role_reason": "192 participants, nonsignificance and original D30 alone cannot establish precision or exclusion of an important effect.", "application_exception": "Do not invent a minimum sample size, duration, MID, equivalence threshold or new score. Do not apply the oil CI to raw-garlic precision.", "criterion": "Distinguish availability of a selected raw-garlic CI and a justified importance criterion; if unavailable, explain that the range of important effects cannot be interpreted.", "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 the raw-garlic food and 6-month LDL-C comparison. They do not establish blinding, clinical-trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Original raw-garlic versus placebo effect/CI, criteria/important difference, units, variance and denominators. This records needed materials; no new research was executed." }, { "item_id": "N25", "question_type": "Evidence condition", "question": "Does the record answer other doses, subgroups and persistence after treatment?", "needed": "Direct dose comparisons, prespecified subgroup/interaction and post-treatment follow-up material beyond the stated 4 g on 6 days weekly for 6 months", "role": "Supplementary; required for an expanded claim", "role_reason": "This is needed to avoid extending an LDL-C result for one food amount/duration to an optimal dose, responder group or persistence effect.", "application_exception": "Do not require every extension trial to satisfy the narrow original main claim. An optimal amount, minimum duration and subgroup results absent from the original material remain unverified.", "criterion": "Limit the current direct scope and separately retain unverified extended questions and their estimates.", "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 the raw-garlic food and 6-month LDL-C comparison. They do not establish blinding, clinical-trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Direct dose comparisons, prespecified subgroup/interaction and post-treatment follow-up material beyond the stated 4 g on 6 days weekly for 6 months. This records needed materials; no new research was executed." }, { "item_id": "N26", "question_type": "Evidence condition", "question": "Does the LDL-C question answer cardiovascular-event prevention or replacement of statins?", "needed": "The original LDL-C endpoint and direct clinical-event, quality-of-life, death and standard-treatment comparison material", "role": "Supplementary; required for an event/replacement claim", "role_reason": "This is needed to avoid transferring retained lipid results to cardiovascular events or replacement of standard treatment.", "application_exception": "Do not require an event trial for the LDL-C-change question, but do not claim verified event/replacement effects.", "criterion": "Distinguish the direct LDL-C scope from separate clinical questions, retaining original statin-advertising limits and 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 the raw-garlic food and 6-month LDL-C comparison. They do not establish blinding, clinical-trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: The original LDL-C endpoint and direct clinical-event, quality-of-life, death and standard-treatment comparison material. This records needed materials; no new research was executed." }, { "item_id": "N27", "question_type": "Evidence condition", "question": "Are gastrointestinal, odor and allergy cautions observed events in the trial?", "needed": "Original caution/safety wording, individual-event definitions, collection/severity, group denominators and adverse-event tables", "role": "Supplementary; required for an observed-harm claim", "role_reason": "This is needed to avoid promoting general cautions into trial-observed event counts, causes or safety assessments.", "application_exception": "The lack of individual-harm results in the retained text must not be extended to non-reporting in the whole external paper or 0 adverse effects.", "criterion": "Separate a general caution from unverified trial-specific event counts, collection and causality; do not delete efficacy observations because of harm results.", "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 the raw-garlic food and 6-month LDL-C comparison. They do not establish blinding, clinical-trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Original caution/safety wording, individual-event definitions, collection/severity, group denominators and adverse-event tables. This records needed materials; no new research was executed." }, { "item_id": "N28", "question_type": "Evidence condition", "question": "Was the timeline of harm onset, stopping, recovery and re-exposure verified?", "needed": "Actual raw-garlic exposure, harm onset/recovery, discontinuation/re-exposure, latency and follow-up records", "role": "Supplementary; required for a temporal/causal harm claim", "role_reason": "This is needed to avoid treating 6-month exposure as the onset time or cause of individual symptoms.", "application_exception": "The original general caution has no individual timeline. Do not infer improvement after stopping, positive re-exposure or latency.", "criterion": "Distinguish exposure duration from individual-event timing, retaining unverified status when actual records are unavailable.", "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 the raw-garlic food and 6-month LDL-C comparison. They do not establish blinding, clinical-trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Actual raw-garlic exposure, harm onset/recovery, discontinuation/re-exposure, latency and follow-up records. This records needed materials; no new research was executed." }, { "item_id": "N29", "question_type": "Evidence condition", "question": "Were harm controls, affected people, exposure denominators and follow-up verified?", "needed": "Actual harm people/event counts by group, exposure/observation denominators, duration and comparison/follow-up material", "role": "Supplementary; required for harm incidence/comparison", "role_reason": "This is needed to avoid using the efficacy 4-arm placebo, 192 allocations or 25 oil completers as denominators for harm frequency/risk ratios.", "application_exception": "Do not fill proportions, RR or background incidence from general warnings without harm events/denominators. An efficacy control is distinct from a verified harm comparison.", "criterion": "Link the verified extent of harm-specific controls, events and exposure denominators/follow-up without inventing comparative estimates as original values.", "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 the raw-garlic food and 6-month LDL-C comparison. They do not establish blinding, clinical-trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Actual harm people/event counts by group, exposure/observation denominators, duration and comparison/follow-up material. This records needed materials; no new research was executed." }, { "item_id": "N30", "question_type": "Evidence condition", "question": "What are the high-intake, anticoagulant/antiplatelet cautions and alternative causes?", "needed": "Original high-intake/co-use bleeding caution and actual co-medication, baseline risk, exposure amount, events and alternative-cause material", "role": "Supplementary; required for interaction/causal harms", "role_reason": "This is needed to avoid converting caution wording into proof of co-use bleeding or a dose threshold in this raw-garlic 4-g trial.", "application_exception": "A numerical high-intake threshold, co-use events and baseline-risk balance remain unverified. Absence of lipid-lowering medicine does not mean no anticoagulant/antiplatelet use.", "criterion": "Distinguish original co-use cautions from unverified actual simultaneous exposure, alternatives and group risks, without personal dosing instructions or a new safety judgment.", "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 the raw-garlic food and 6-month LDL-C comparison. They do not establish blinding, clinical-trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Original high-intake/co-use bleeding caution and actual co-medication, baseline risk, exposure amount, events and alternative-cause material. This records needed materials; no new research was executed." }, { "item_id": "N31", "question_type": "Evidence condition", "question": "Are retention/efficacy missingness distinct from harm detection and reporting losses?", "needed": "Original retention of 87~90% and mixed modeling, with actual harm collection/loss, discontinuation/detection and disclosure-scope material", "role": "Supplementary; required for an absence/frequency-of-harm claim", "role_reason": "Efficacy retention/inclusion of partial observations alone cannot verify that all harms were followed and counted.", "application_exception": "Do not conversely infer harms occurred because of losses. Distinguish absence from the original summary from non-reporting in the entire paper.", "criterion": "Separate efficacy follow-up from verification of harm collection/reporting, retaining possible selection/detection limitations as 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 the raw-garlic food and 6-month LDL-C comparison. They do not establish blinding, clinical-trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Original retention of 87~90% and mixed modeling, with actual harm collection/loss, discontinuation/detection and disclosure-scope material. This records needed materials; no new research was executed." }, { "item_id": "N32", "question_type": "Evidence condition", "question": "Were independent cases and report families for the same harm verified?", "needed": "Original material linking unique cases/studies and related reports/re-citations with matching exposures and events", "role": "Supplementary; required for a repeated-harm claim", "role_reason": "This is needed to avoid counting repeated general cautions, two LDL reports or Korean/English/synthesis restatements as independent harm replication.", "application_exception": "The current material lacks unique harm-case/related-registration identity. Do not transfer original efficacy RX/I2 or the 2 reports to harm independence.", "criterion": "Link verified original cautions to unverified actual independent-harm material, retaining unknown case/participant/replication counts as 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 the raw-garlic food and 6-month LDL-C comparison. They do not establish blinding, clinical-trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Original material linking unique cases/studies and related reports/re-citations with matching exposures and events. This records needed materials; no new research was executed." }, { "item_id": "N33", "question_type": "Evidence condition", "question": "What is known about long-term/rare harms and vulnerable groups beyond 6-month LDL observation?", "needed": "Original general cautions and direct long-term/rare-event, other baseline-risk/age, special-exposure and co-use material", "role": "Supplementary; required for long-term/vulnerable-group safety", "role_reason": "This is needed to avoid generalizing a limited population and 6-month lipid result to overall safety.", "application_exception": "Do not require every rare-harm study for the current LDL question or invent a minimum follow-up duration or sample size.", "criterion": "Distinguish stated population/duration from unverified direct information for separate long-term/vulnerable-group harm questions.", "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 the raw-garlic food and 6-month LDL-C comparison. They do not establish blinding, clinical-trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Original general cautions and direct long-term/rare-event, other baseline-risk/age, special-exposure and co-use material. This records needed materials; no new research was executed." }, { "item_id": "N34", "question_type": "Evidence condition", "question": "What can current material say about harm, harmlessness and causality?", "needed": "Original cautions/warnings and event definitions/controls, denominators, timing, alternatives and collection material", "role": "Supplementary; required for a safety conclusion", "role_reason": "This is needed to avoid turning no-difference efficacy and general cautions into harmlessness, confirmed causality or a new safety grade.", "application_exception": "Preserve cautions without personal dosing/stopping instructions or clinical certification. Unverified harms must not erase the LDL result itself.", "criterion": "State the extent of caution, unverified trial-specific harms and inability to create new causality/incidence estimates.", "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 the raw-garlic food and 6-month LDL-C comparison. They do not establish blinding, clinical-trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: Original cautions/warnings and event definitions/controls, denominators, timing, alternatives and collection material. This records needed materials; no new research was executed." }, { "item_id": "N35", "question_type": "Evidence condition", "question": "Were original D30, RX/E0/I2/B1/C0, Korean/English wording, corrections and native values retained as historical text?", "needed": "The complete current original, score/axes, Korean/English verdict-decision/synthesis, empty values/dates and corrections, with typed original text/source-identity checks", "role": "Required; preservation of history", "role_reason": "This is needed to prevent original score, replication, null and independence labels from being inherited as new condition fulfillment, current full-text reading or precision certification.", "application_exception": "The original score is integer 30; subclaims remain empty, and false/empty strings and corrections retain their native types. No new grade, calculation or translation correction was performed.", "criterion": "Preserve the whole typed original and historical dates/values while distinguishing current observations, states, access and review.", "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 the raw-garlic food and 6-month LDL-C comparison. They do not establish blinding, clinical-trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Material needed: The complete current original, score/axes, Korean/English verdict-decision/synthesis, empty values/dates and corrections, with typed original text/source-identity checks. This records needed materials; no new research was executed." } ] }