{ "schema_version": "chamgap-public-evidence-check-1.0", "public_id": "v3058-main", "verdict_number": "3058", "title": "Chemically characterized raw garlic equivalent to about 4 g, six days per week × Reduction of LDL-C in adults with moderate hypercholesterolemia", "view_version": "1.0", "view_created_date": "2026-10-25", "criteria_version": "1.0", "criteria_date": "2026-10-06", "review_date": "2026-10-06", "legacy_evidence_date": "2026-09-08", "review_scope": { "materials_read": "Retained Korean/English summaries and case-specific condition/application records", "clinical_papers_directly_read": false, "new_clinical_search": false, "limitation": "Prepared from retained summaries and condition-application records. External abstracts, full texts, registration, protocols and analysis plans remain unread. Historical review records do not establish current independent clinical validation.", "date_meaning": "The material-check date distinguishes verification and reading status in the retained record. It is not a new external-original access date or a search cutoff." }, "claim_context": { "population": "Adults aged 30~65 with LDL-C 130~190 mg/dL who were not using lipid-lowering medicine. Recruitment, eligibility/exclusion criteria, sex, comorbidities, baseline balance and participant counts by group remain unverified.", "intervention": "Fresh Allium sativum L. cloves of California Early raw garlic were incorporated into sandwiches. The original chemical-characterization description is retained; actual constituent, batch, processing and storage specifications remain unverified. Powder, aged extract and oil remain distinct formulations.", "dose": "About one average 4-g clove, 6 days per week. This is the nominal food amount; actual intake, adherence, changes and active-constituent content remain unverified. It is not a personal dosing recommendation or the dose of another formulation.", "comparator": "A matched garlic-free sandwich placebo. Actual composition, energy content, provision procedures, changes in accompanying diet or medication and differences between groups remain unverified. Details of the food placebo are not automatically assigned to the powder or aged-extract arms of the same trial.", "endpoint": "The endpoint is change from baseline in LDL-C at 6 months. Retained values are raw garlic +0.4, powder +3.2, AGE +0.2 and placebo −3.9 mg/dL, with a reported nonsignificant group-by-time result. Changes within each group remain distinct from a direct between-group effect, and no new difference was calculated. The direct raw-garlic versus placebo contrast, CI, exact P and clinical-importance criterion remain unverified.", "duration": "6 months of treatment with monthly lipid measurements; the selected endpoint is the final 6-month measurement. Monthly observations are not independent trials. Persistence after treatment and long-term or rare harms remain unverified.", "excluded_extensions": [ "Treating powder, AGE, oil, black garlic, fermented garlic or isolated constituents as interchangeable with raw garlic", "Calculating a new between-group effect, CI, P or participant count by subtracting within-group changes", "Interpreting nonsignificance as proof of a precise null effect, equivalence or exclusion of an important effect", "Extension to an optimal dose, other doses, subgroups or persistence after treatment", "Extension to cardiovascular-event prevention, death, quality of life or replacement of statins", "Interpreting a general caution as a trial-observed harm, incidence, causality or overall safety", "Counting unidentified positive AGE/powder reports or a separate powder-trial narrative as new reports or independent replication" ] }, "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.", "current_reports": [ "S1", "S2" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The original outcome is LDL-C reduction in adults with moderate hypercholesterolemia. California Early raw garlic was supplied in sandwiches at about one average 4-g clove, 6 days weekly for 6 months, against matched garlic-free sandwich placebo. The endpoint is 6-month LDL-C change from baseline. Powder, AGE and oil provide formulation-specific auxiliary context.", "condition_status": "Met", "status_reason": "The current Korean claim, Korean/English descriptors and scope note are linked to the final raw-garlic main-question selection. This status verifies question identity and scope, without establishing raw-garlic efficacy.", "missingness": "The selected raw-garlic between-group estimate/CI, arm-specific denominators and external methods remain unverified. No separate questions or tables for other formulations were created here.", "uncertainty": "The selected raw-garlic between-group estimate/CI, arm-specific denominators and external methods remain unverified. No separate questions or tables for other formulations were created here.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "The current Korean claim, Korean/English intervention and population descriptors, scope note and selected question boundary" }, { "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.", "current_reports": [ "S1", "S2" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The main population is adults aged 30~65 with LDL-C 130~190 mg/dL who were not using lipid-lowering medicine. The total of 192 is the allocation denominator across all 4 arms. The oil report records only 25 completers; direct identity with the raw-garlic population is unverified.", "condition_status": "Partly verified", "status_reason": "Original raw-garlic population conditions are specific, but recruitment/eligibility, baseline tables, representativeness and arm-specific denominators are unavailable in the retained summary.", "missingness": "Detailed eligibility/exclusion criteria, baseline balance, comorbidities/sex and actual allocation, analysis and completion counts for raw garlic remain unverified.", "uncertainty": "Detailed eligibility/exclusion criteria, baseline balance, comorbidities/sex and actual allocation, analysis and completion counts for raw garlic remain unverified.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "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" }, { "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.", "current_reports": [ "S1" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The original formulation is California Early raw garlic from fresh Allium sativum L. cloves supplied in sandwiches as food. The Korean/English ingredient descriptions state chemically characterized material equivalent to about 4 g; product descriptions prohibit interchange with other garlic formulations.", "condition_status": "Partly verified", "status_reason": "Raw-garlic food/material identity is stated. Chemical-characterization wording is retained, but the actual analytical table and batch/specifications were not newly acquired.", "missingness": "Original constituent-content, batch, processing/storage and exposure-specification data remain unverified. About 4 g was not converted into allicin/SAC content.", "uncertainty": "Original constituent-content, batch, processing/storage and exposure-specification data remain unverified. About 4 g was not converted into allicin/SAC content.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Fresh cloves, sandwich provision and the original chemical-characterization description, with original batch, constituent and processing specifications" }, { "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.", "current_reports": [ "S1" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The original raw-garlic comparator is a matched garlic-free sandwich placebo. Powder, AGE and placebo changes are also reported in the same 4-arm trial, but actual placebo/treatment details for the other formulations remain separately unverified.", "condition_status": "Partly verified", "status_reason": "The original placebo contract for selected raw garlic was verified. Detailed food composition/energy, provision and treatments in other groups were not verified.", "missingness": "Food composition beyond garlic, provision/intake conditions by group and powder/AGE placebo details remain unverified because the original methods were not read.", "uncertainty": "Food composition beyond garlic, provision/intake conditions by group and powder/AGE placebo details remain unverified because the original methods were not read.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "The original food-placebo description and methods for food provision, energy/constituents and control treatment" }, { "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.", "current_reports": [ "S1" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The nominal intake is about one average 4-g clove on 6 days weekly. Actual batch amount, intake/adherence records and changes by group are not specified in the retained summary.", "condition_status": "Partly verified", "status_reason": "Nominal amount and frequency link to the original description, but actual-exposure, adherence and departure conditions could not be verified.", "missingness": "Actual intake, cumulative exposure, adherence by group, discontinuation/changes and doses of other formulations remain unverified. No new conversion was made.", "uncertainty": "Actual intake, cumulative exposure, adherence by group, discontinuation/changes and doses of other formulations remain unverified. No new conversion was made.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "The original about one average 4-g clove amount on 6 days weekly, plus batch amount, actual intake and adherence/discontinuation records" }, { "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.", "current_reports": [ "S1" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "Original descriptors separately record 6 months of treatment with monthly lipid measurements and 6-month LDL-C change from baseline. The selected result is the final 6-month endpoint; monthly observations are not independent trials.", "condition_status": "Met", "status_reason": "Stated treatment duration, measurement frequency and the selected time point are distinguished as originally recorded. Met concerns temporal attribution, without establishing longer-term persistence.", "missingness": "Exact visit windows/individual follow-up days and persistence after stopping or beyond 6 months remain unverified. The original duration was not adopted as a universal minimum.", "uncertainty": "Exact visit windows/individual follow-up days and persistence after stopping or beyond 6 months remain unverified. The original duration was not adopted as a universal minimum.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "6-month treatment, monthly lipid measurements, 6-month LDL-C change from baseline and visit/follow-up conditions" }, { "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.", "current_reports": [ "S1", "S2" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The main Gardner report is a 4-arm randomized parallel trial with 192 allocated in total. The first evidence entry, first bibliography and Korean/English descriptions are linked as restatements of the same report. The Berthold 1998 oil report/bibliography is separate auxiliary context from another formulation.", "condition_status": "Partly verified", "status_reason": "The 2 local reports and 2 bibliographies, and identity within each pair, are linked. Original registrations, related reports, recruitment identity and total independent-trial/participant counts were not newly verified.", "missingness": "The three garlic arms were not counted as 3 trials, and 192 was not treated as an arm count or multiplied by 3. Unique trial and participant totals across the reports remain unverified.", "uncertainty": "The three garlic arms were not counted as 3 trials, and 192 was not treated as an arm count or multiplied by 3. Unique trial and participant totals across the reports remain unverified.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Identity of the original Gardner report/bibliography, the 4-arm structure, total allocation of 192 and report-family/participant links" }, { "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.", "current_reports": [ "S1", "S2" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The entire current 3058 retained summary and byte-identical snapshot were read. Retained summaries/bibliographies for both reports and exact original locations, data types and source-identity checks were linked. PubMed, DOI, JAMA, NCT and supplements were not accessed or read; identity/source-identity checks for 5 method HTML files was reused.", "condition_status": "Met", "status_reason": "Actual current local-summary reading and external non-reading are separated by material. A link does not establish abstract/full-text access or acquisition.", "missingness": "Historical material-specific access dates, reading levels and original locations have no native keys. No external access failure occurred in this preparation, so material was not labeled inaccessible.", "uncertainty": "Historical material-specific access dates, reading levels and original locations have no native keys. No external access failure occurred in this preparation, so material was not labeled inaccessible.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Exact locations, data types, source-identity checks and actual review time in the current summary, with external URLs/access records for each report" }, { "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.", "current_reports": [ "S1", "S2" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The original verdict date is 2026-09-08. The 2026-09-14 English evidence-table placeholder correction is a historical event retaining grade D, without new research/reassessment. Current Korean/English wording, synthesis and generic evidence statements are preserved as originally stored. The current date denotes actual local review.", "condition_status": "Met", "status_reason": "Historical review/correction dates are distinct from actual current reading and search scope. Dates were not used as proof of a new comprehensive literature search or full-text access.", "missingness": "Historical access dates/levels by report and the evidence-search cutoff are unavailable and remain unverified. Generic verified/assessed wording is not independent verification in this preparation.", "uncertainty": "Historical access dates/levels by report and the evidence-search cutoff are unavailable and remain unverified. Generic verified/assessed wording is not independent verification in this preparation.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Original verdict date, corrections, Korean/English and synthesis text, and actual current review time" }, { "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.", "current_reports": [ "S1", "S2" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "NIH/NCCAM support and product donation are recorded for the main report. The oil report identifies a German academic institution, with funding details unverified. Original axis I2 and the original rationale's independent-funding assessment remain historical values.", "condition_status": "Partly verified", "status_reason": "Original support levels are separated by report, but complete COI, provision contracts/involvement, author employment/patents and institutional links were not read in this preparation.", "missingness": "Full COI declarations, donor/conditions, involvement in products/analysis, author details and family independence remain unverified.", "uncertainty": "Full COI declarations, donor/conditions, involvement in products/analysis, author details and family independence remain unverified.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Main-report NIH/NCCAM support/product donation, the oil report's German academic institution/unverified details, and COI, author and product-provision material" }, { "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.", "current_reports": [ "S1", "S2" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The original main-trial design is a 4-arm randomized parallel trial. The original central explanation describes separate analyses of raw garlic, Garlicin powder and Kyolic AGE. Auxiliary oil is a different randomized, double-blind, placebo-controlled crossover design.", "condition_status": "Partly verified", "status_reason": "Design names and the 4-arm composition are linked to the original record, but randomization/allocation and detailed original methods remain unverified. Parallel and crossover trials were not merged into one design.", "missingness": "Main-report allocation implementation, concealment/baseline and blinding remain unverified, as do crossover sequence, washout, period and carryover handling for oil.", "uncertainty": "Main-report allocation implementation, concealment/baseline and blinding remain unverified, as do crossover sequence, washout, period and carryover handling for oil.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "The original 4-arm randomized parallel design, arm composition, allocation methods and methods section" }, { "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.", "current_reports": [ "S1" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The retained summary identifies the main trial as randomized with 4 arms, but provides no random-sequence method, allocation concealment, baseline table by group, food/product blinding or assessor-handling details.", "condition_status": "Unverified", "status_reason": "The randomized label alone cannot establish allocation protection, balance or blinding. This is an information gap within current local reading.", "missingness": "Allocation/concealment, baseline balance and actual blinding/assessor procedures remain unverified. Neither impossibility of food blinding nor absence/confirmation of bias was inferred.", "uncertainty": "Allocation/concealment, baseline balance and actual blinding/assessor procedures remain unverified. Neither impossibility of food blinding nor absence/confirmation of bias was inferred.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Baseline tables by group, randomization/concealment, food/product blinding and assessor-handling material" }, { "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.", "current_reports": [ "S1" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "Participants were not using lipid-lowering medicine at baseline, and the comparison used a matched sandwich placebo. Diet, medication/rescue treatment and lifestyle changes during 6 months of follow-up, and their analytical treatment by group, are not specified in the retained summary.", "condition_status": "Partly verified", "status_reason": "Baseline and planned comparison content is verified, but actual accompanying changes during follow-up and differences by group remain unverified.", "missingness": "Do not assume there were no medication/diet changes throughout the trial or that groups remained balanced. Actual accompanying-change and target-effect handling records are needed.", "uncertainty": "Do not assume there were no medication/diet changes throughout the trial or that groups remained balanced. Actual accompanying-change and target-effect handling records are needed.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Baseline absence of lipid-lowering medicine, common food provision, actual diet/medication/lifestyle changes and handling by group" }, { "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.", "current_reports": [ "S1" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The endpoint is LDL-C in mg/dL, with monthly lipid measurements during 6 months of treatment. LDL testing/calculation methods, blood-sampling/laboratory standardization and assessor-blinding details are unavailable.", "condition_status": "Partly verified", "status_reason": "Endpoint, units and measurement frequency are linked, but actual measurement conditions and procedures by group could not be verified.", "missingness": "Testing methods, sampling conditions, measurement error/standardization, assessment procedures and group differences remain unverified. Original values were not converted to other units.", "uncertainty": "Testing methods, sampling conditions, measurement error/standardization, assessment procedures and group differences remain unverified. Original values were not converted to other units.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "LDL-C units in mg/dL, monthly measurements, sampling/calculation methods, laboratory, blinding and standardization material" }, { "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.", "current_reports": [ "S1" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The original reader answer and central explanation describe LDL-C as the primary (1st) endpoint; the descriptors specify 6-month change from baseline. The reasons distinguish total cholesterol, TG and HDL from LDL results. The bibliography contains an NCT identifier, but original plans were not read in this preparation.", "condition_status": "Partly verified", "status_reason": "The retained principal LDL endpoint/time point and separation from other lipids were verified. Actual comparison with prespecified registry endpoints, times and analyses remains unverified.", "missingness": "Original registry/protocol/SAP hierarchy, changes in plans and selection of analyses/time points remain unverified. The original primary (1st) label is not new confirmation of preregistration.", "uncertainty": "Original registry/protocol/SAP hierarchy, changes in plans and selection of analyses/time points remain unverified. The original primary (1st) label is not new confirmation of preregistration.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "The original primary (1st) LDL-C description, 6-month change, total cholesterol/TG/HDL and registry/protocol endpoint tables" }, { "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.", "current_reports": [ "S1" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "Original 6-month changes are raw garlic +0.4, powder +3.2, AGE +0.2 and placebo −3.9 mg/dL, with a nonsignificant group-by-time result. These are changes from baseline within each group; a new direct raw-garlic versus placebo estimate was not calculated.", "condition_status": "Met", "status_reason": "Values, time point, units and change definition for the four groups were attributed as originally recorded. Met concerns retention of values/analysis attribution, without establishing comparative efficacy.", "missingness": "The direct between-group effect, CI, exact P and variance remain separately unverified. A plus value is not positive efficacy, and placebo reduction is not a garlic effect.", "uncertainty": "The direct between-group effect, CI, exact P and variance remain separately unverified. A plus value is not positive efficacy, and placebo reduction is not a garlic effect.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Original strings for 6-month raw-garlic/powder/AGE/placebo changes from baseline, the results table and analytical definitions" }, { "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.", "current_reports": [ "S1" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The original reason describes retention of 87~90% and inclusion of partial observations in a mixed model. Exact ITT/PP, assignment/adherence effects, model/analysis population and missing-data sensitivity are not recorded.", "condition_status": "Partly verified", "status_reason": "The analytical narrative exists, but inclusion of partial observations was not promoted to complete ITT or verification of a particular target effect.", "missingness": "Analysis/target populations, fixed/repeated structures, missing-data assumptions/sensitivity and handling of departures by group remain unverified.", "uncertainty": "Analysis/target populations, fixed/repeated structures, missing-data assumptions/sensitivity and handling of departures by group remain unverified.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "The mixed-model description including partial observations, analysis populations, missing-data handling and assignment/adherence-effect conditions" }, { "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.", "current_reports": [ "S1" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The 192 participants are total allocations across 4 arms; retention is recorded as a range of 87~90% by group. Allocation, analysis and completion counts for raw garlic, powder, AGE and placebo, and missingness reasons/timing, are not specifically available in the retained summary.", "condition_status": "Partly verified", "status_reason": "The roles of total allocation, retention range and unverified arm denominators are distinct. Counts or ITT populations were not calculated to fill gaps.", "missingness": "Allocation, LDL measurement/analysis and completion denominators/loss reasons by group remain unverified. There was no assumption of 48 per group, conversion of completion rates or change to ITT 192.", "uncertainty": "Allocation, LDL measurement/analysis and completion denominators/loss reasons by group remain unverified. There was no assumption of 48 per group, conversion of completion rates or change to ITT 192.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Original total allocation of 192 and retention of 87~90%, with group allocation/analysis/completion, loss reasons and timing" }, { "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.", "current_reports": [ "S1" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The original result says the group-by-time comparison was nonsignificant; the original reader answer says all three formulations had no statistically or clinically significant effect. A direct raw-garlic versus placebo contrast, CI and exact P are absent from the retained summary.", "condition_status": "Partly verified", "status_reason": "The original no-difference direction is retained, but a precise null effect, equivalence or exclusion of an important effect was not newly established. Original E0/RX are historical verdict values.", "missingness": "The direct raw-garlic contrast/CI, variance/exact P and equivalence/important-difference conditions remain unverified. No subtraction of within-group values or new scoring was performed.", "uncertainty": "The direct raw-garlic contrast/CI, variance/exact P and equivalence/important-difference conditions remain unverified. No subtraction of within-group values or new scoring was performed.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Original nonsignificant group-by-time/null wording, with raw-garlic versus placebo difference, CI, exact P and variance" }, { "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.", "current_reports": [ "S1" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The first bibliography and Korean/English research descriptions retain NCT00056511. The first evidence entry's registration status is unverified. Registration, protocol and SAP access/reading were not attempted in this preparation.", "condition_status": "Partly verified", "status_reason": "The retained identifier and structured unverified status remain distinct. Wording at different levels was not converted into plan verification, non-registration or failed access.", "missingness": "Preregistration timing, protocol/SAP versions, original primary endpoint/analysis/time plans and comparison with actual reporting remain unverified.", "uncertainty": "Preregistration timing, protocol/SAP versions, original primary endpoint/analysis/time plans and comparison with actual reporting remain unverified.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "NCT in the first report's bibliography and Korean research description, the first report's registration-status field, and original registration/protocol/SAP material" }, { "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.", "current_reports": [ "S1" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "Within the same Gardner 4-arm report, Garlicin powder had a +3.2 and Kyolic AGE a +0.2 mg/dL 6-month change from baseline. The original central explanation says LDL-C results were null in separate analyses. These formulations differ from raw-garlic food.", "condition_status": "Partly verified", "status_reason": "Results for other formulations are retained and attributed as auxiliary comparisons within the same report. They are not independent replications of identical raw garlic or equal-dose comparisons.", "missingness": "Actual powder/AGE doses, processing/constituent specifications, dosing/placebo details and direct contrasts remain unverified. Raw-garlic 4-g food/placebo conditions were not transferred.", "uncertainty": "Actual powder/AGE doses, processing/constituent specifications, dosing/placebo details and direct contrasts remain unverified. Raw-garlic 4-g food/placebo conditions were not transferred.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Formulation-specific results and product names within the same 4-arm report, with dose, processing, active-constituent and administration details" }, { "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.", "current_reports": [ "S2" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "Berthold 1998 is a randomized, double-blind, placebo-controlled crossover trial of garlic oil with 25 completers. The original between-group LDL-C value is 0.04 mg/dL, 95% CI −9.4~9.5, P=.99, recorded as independent null evidence from another formulation. Original units/strings are retained.", "condition_status": "Partly verified", "status_reason": "The separate report's design, completion denominator and between-group value are linked. This is not replication of the same raw-garlic formulation/duration or a result from 25 initially allocated participants.", "missingness": "Oil specifications/dose, population, duration, allocation/analysis denominators, crossover order, washout, period and carryover handling remain unverified. No transfer to raw-garlic 6 months/4 g or unit conversion was made.", "uncertainty": "Oil specifications/dose, population, duration, allocation/analysis denominators, crossover order, washout, period and carryover handling remain unverified. No transfer to raw-garlic 6 months/4 g or unit conversion was made.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "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" }, { "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.", "current_reports": [ "S1", "S2" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "Korean/English counterviews describe LDL reductions in some older high-dose AGE/powder trials; the research description mentions independent oil and powder placebo trials. Only Gardner and Berthold pairs are explicitly present in current evidence/bibliographies.", "condition_status": "Partly verified", "status_reason": "Original positive/opposing background narratives remain, but unidentified high-dose AGE/powder reports or a separate powder trial were not created as new reports.", "missingness": "Names/identifiers, products/doses, denominators, estimates/CIs and access material for these background reports remain unverified. Differences in formulations are not automatically conflicting data for the same question.", "uncertainty": "Names/identifiers, products/doses, denominators, estimates/CIs and access material for these background reports remain unverified. Differences in formulations are not automatically conflicting data for the same question.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Original Korean/English counterview and research narratives, with identifiable reports, products, doses, population and endpoint material" }, { "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.", "current_reports": [ "S1", "S2" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The retained summary does not establish a direct raw-garlic versus placebo effect/CI or an LDL-C important-difference threshold. Original D30, nonsignificance, the total 192 and the oil CI for another formulation do not replace raw-garlic precision/clinical-importance conditions.", "condition_status": "Unverified", "status_reason": "Original material for comparing the selected raw-garlic reported interval against a justified clinical criterion is unavailable. No new judgment about permitted/excluded important effects was made.", "missingness": "The raw-garlic contrast/CI, variance and justified MID/equivalence threshold remain unverified. No arbitrary participant, duration or threshold criteria or new calculation were introduced.", "uncertainty": "The raw-garlic contrast/CI, variance and justified MID/equivalence threshold remain unverified. No arbitrary participant, duration or threshold criteria or new calculation were introduced.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Original raw-garlic versus placebo effect/CI, criteria/important difference, units, variance and denominators" }, { "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.", "current_reports": [ "S1" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The selected raw-garlic scope is about 4 g on 6 days weekly for 6 months. The retained summary has no direct raw-garlic dose comparison, prespecified effect-modification/subgroup estimate or post-discontinuation persistence value. Other formulations are not raw-garlic dose-response comparisons.", "condition_status": "Unverified", "status_reason": "Direct information for extended questions could not be established within the retained material. Every extension trial was not made mandatory for the narrow original claim.", "missingness": "Direct estimates for an optimal amount, other raw-garlic doses/durations, specific responder groups or persistence after stopping remain unverified. This does not establish absence of external research.", "uncertainty": "Direct estimates for an optimal amount, other raw-garlic doses/durations, specific responder groups or persistence after stopping remain unverified. This does not establish absence of external research.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct dose comparisons, prespecified subgroup/interaction and post-treatment follow-up material beyond the stated 4 g on 6 days weekly for 6 months" }, { "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.", "current_reports": [ "S1" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The original verdict selects 6-month LDL-C only and prohibits claims that one clove acts like a statin or use of pooled values from other formulations. Direct cardiovascular-event, death/quality-of-life or statin-replacement results are absent from the retained summary.", "condition_status": "Met", "status_reason": "The LDL-C question is distinct from event/standard-treatment replacement questions. Met concerns limits on interpretation, without establishing event effects.", "missingness": "Direct event/standard-treatment comparisons remain unverified within the retained material. No new claim was made that the entire original paper did not test or report them.", "uncertainty": "Direct event/standard-treatment comparisons remain unverified within the retained material. No new claim was made that the entire original paper did not test or report them.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "The original LDL-C endpoint and direct clinical-event, quality-of-life, death and standard-treatment comparison material" }, { "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.", "current_reports": [ "S1", "S2" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The original caution mentions possible gastrointestinal symptoms, odor and allergy from raw garlic, plus bleeding-risk review with high intake and anticoagulant/antiplatelet use. Event counts, collection/severity and group denominators in the trial are absent from the retained summary.", "condition_status": "Partly verified", "status_reason": "The general original caution is verified, but trial-specific observation, causality and incidence were not established.", "missingness": "Harm-event definitions, collection methods, individual occurrence, severity/discontinuation and denominators remain unverified. Absence from the retained summary does not establish non-reporting in the whole external paper or 0 adverse effects.", "uncertainty": "Harm-event definitions, collection methods, individual occurrence, severity/discontinuation and denominators remain unverified. Absence from the retained summary does not establish non-reporting in the whole external paper or 0 adverse effects.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Original caution/safety wording, individual-event definitions, collection/severity, group denominators and adverse-event tables" }, { "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.", "current_reports": [ "S1" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "6 months of raw-garlic efficacy treatment are recorded, but the original caution has no individual timeline of harm onset, latency, recovery, discontinuation or re-exposure.", "condition_status": "Unverified", "status_reason": "General cautions and treatment duration alone cannot establish individual-event temporal ordering or causality.", "missingness": "Event-specific timing, exposure changes, recovery after stopping, re-exposure and follow-up remain unverified. No cases were invented and temporal ordering was not treated as causation.", "uncertainty": "Event-specific timing, exposure changes, recovery after stopping, re-exposure and follow-up remain unverified. No cases were invented and temporal ordering was not treated as causation.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Actual raw-garlic exposure, harm onset/recovery, discontinuation/re-exposure, latency and follow-up records" }, { "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.", "current_reports": [ "S1", "S2" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "Efficacy information includes a 4-arm raw-garlic versus food-placebo design with 192 total allocations, and 25 completers for auxiliary oil. The retained summary has no harm people/event counts by group, harm-exposure denominators/follow-up or reported between-group harm estimate.", "condition_status": "Unverified", "status_reason": "Efficacy controls/sample sizes are distinguished from harm-specific comparisons and denominators. Warnings alone do not permit calculation of frequency or increased risk.", "missingness": "Harm-specific controls, events/affected people, exposure/follow-up denominators and time remain unverified. Neither 192 nor 25 was transferred to a harm denominator, and background incidence was not extrapolated.", "uncertainty": "Harm-specific controls, events/affected people, exposure/follow-up denominators and time remain unverified. Neither 192 nor 25 was transferred to a harm denominator, and background incidence was not extrapolated.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Actual harm people/event counts by group, exposure/observation denominators, duration and comparison/follow-up material" }, { "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.", "current_reports": [ "S1" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The original text cautions about bleeding-risk review with high intake and anticoagulant/antiplatelet use. Raw-garlic baseline conditions exclude lipid-lowering medicine, but anticoagulant/antiplatelet co-use, events and a numerical high-intake threshold are unavailable.", "condition_status": "Partly verified", "status_reason": "The co-use caution is verified, but this does not establish observed co-use bleeding or confirmed interaction in the raw-garlic 4-g trial.", "missingness": "Actual co-medication/baseline risk, events/timing, alternative causes and high-intake thresholds remain unverified. Absence of lipid-lowering medicine was not converted to absence of other medicine.", "uncertainty": "Actual co-medication/baseline risk, events/timing, alternative causes and high-intake thresholds remain unverified. Absence of lipid-lowering medicine was not converted to absence of other medicine.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Original high-intake/co-use bleeding caution and actual co-medication, baseline risk, exposure amount, events and alternative-cause material" }, { "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.", "current_reports": [ "S1", "S2" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "Original retention of 87~90% and the mixed model including partial observations concern LDL efficacy follow-up. Harm collection/detection, events in dropouts, discontinuation reasons and disclosure of all harms are not specified in the retained summary.", "condition_status": "Unverified", "status_reason": "Efficacy missing-data handling cannot verify complete harm follow-up or absence of harm. Losses were not treated as evidence of harm occurrence.", "missingness": "Harm-collection systems, differences in detection/spontaneous reporting, reasons for non-follow-up/discontinuation/dropout and full disclosure scope remain unverified.", "uncertainty": "Harm-collection systems, differences in detection/spontaneous reporting, reasons for non-follow-up/discontinuation/dropout and full disclosure scope remain unverified.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Original retention of 87~90% and mixed modeling, with actual harm collection/loss, discontinuation/detection and disclosure-scope material" }, { "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.", "current_reports": [ "S1", "S2" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The original material contains Korean/English/synthesis restatements of general cautions and two LDL reports. Identities of unique harm cases, related reports and re-citation families with matching exposure/events are not recorded.", "condition_status": "Unverified", "status_reason": "Two efficacy reports and original RX/I2 cannot be transferred to independent-harm replication counts. Original cautions remain and unique harm counts stay unverified.", "missingness": "Unique harm cases/families, independent studies, related registrations and re-citation links remain unverified. This does not claim their absence from all original papers or regulatory material.", "uncertainty": "Unique harm cases/families, independent studies, related registrations and re-citation links remain unverified. This does not claim their absence from all original papers or regulatory material.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Original material linking unique cases/studies and related reports/re-citations with matching exposures and events" }, { "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.", "current_reports": [ "S1" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "The selected raw-garlic scope concerns age 30~65, the stated LDL range and 6-month LDL-C, with general cautions. Direct results beyond this scope for long-term/rare harms, other baseline risks, vulnerable groups and combined exposures are not established in the retained summary.", "condition_status": "Unverified", "status_reason": "A restricted efficacy population/duration differs from overall safety. Every long-term/rare-event trial was not made a required condition for this LDL claim.", "missingness": "Direct long-term/rare-event and special-population exposure/interaction material remains unverified. No arbitrary minimum duration/sample size or overall harmlessness conclusion was introduced.", "uncertainty": "Direct long-term/rare-event and special-population exposure/interaction material remains unverified. No arbitrary minimum duration/sample size or overall harmlessness conclusion was introduced.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Original general cautions and direct long-term/rare-event, other baseline-risk/age, special-exposure and co-use material" }, { "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.", "current_reports": [ "S1", "S2" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "Current verified scope consists of original general cautions and LDL results limited by formulation, duration and denominators. Trial-specific harm counts, controls, denominators, timing and alternative-cause material are unavailable, so incidence, causality and harmlessness were not newly judged.", "condition_status": "Partly verified", "status_reason": "Caution level is distinct from unverified harm. No-difference efficacy and harm-verification status were not merged.", "missingness": "Trial-specific harm collection/comparison/denominators, causality and long-term safety remain unverified. No personal dosing/stopping instruction or safety grade was created.", "uncertainty": "Trial-specific harm collection/comparison/denominators, causality and long-term safety remain unverified. No personal dosing/stopping instruction or safety grade was created.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Original cautions/warnings and event definitions/controls, denominators, timing, alternatives and collection material" }, { "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.", "current_reports": [ "S1", "S2" ], "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific conditions/application records were read. Linked external abstracts, full texts, registration and planning material remain unread, with no access attempt.", "observation": "Original D, integer 30, all axes RX/I2/E0/B1/C0, false/empty strings, Korean/English verdict-decision and synthesis text, corrections, verdict date, empty subclaims and original URLs are retained through a whole typed original-record anchor. Current condition states remain distinct from historical verdict/access narratives.", "condition_status": "Met", "status_reason": "The complete current original/native types, values and events are retained, without transfer to a new score/grade, independent clinical certification or full-text reading.", "missingness": "Unavailable original access levels or evidence cutoffs were not inferred. This preparation involved no new clinical material, recalculation, reassessment or original-text correction.", "uncertainty": "Unavailable original access levels or evidence cutoffs were not inferred. This preparation involved no new clinical material, recalculation, reassessment or original-text correction.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "The complete current original, score/axes, Korean/English verdict-decision/synthesis, empty values/dates and corrections, with typed original text/source-identity checks" } ], "reports": [ { "report_id": "S1", "title": "Gardner CD et al. Arch Intern Med. 2007;167:346-353. PMID: 17325296. DOI: 10.1001/archinte.167.4.346. NCT00056511.", "url": "https://pubmed.ncbi.nlm.nih.gov/17325296/", "report_type": "Retained summary and bibliography for the raw-garlic/powder/AGE/placebo comparison", "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "Retained Korean/English summaries, conditions and application records were read. External PubMed, DOI, registration and supplement material remain unread, with access not attempted.", "study_family": "The 2 retained evidence summaries and 2 bibliographies identify the Gardner raw-garlic/powder/AGE/placebo comparison and the separate Berthold garlic-oil report. Korean/English restatements, other arms of the same trial and bibliography/DOI entries are not independent trials. Original-source identities, participant overlap, and unique trial and participant totals remain unverified.", "independent_replication": "The 2 retained evidence summaries and 2 bibliographies identify the Gardner raw-garlic/powder/AGE/placebo comparison and the separate Berthold garlic-oil report. Korean/English restatements, other arms of the same trial and bibliography/DOI entries are not independent trials. Original-source identities, participant overlap, and unique trial and participant totals remain unverified.", "observed_result": "192 participants were randomized across all 4 arms; retention by group was 87~90%. Retained 6-month changes from baseline are raw garlic +0.4, powder +3.2, AGE +0.2 and placebo −3.9 mg/dL, with a reported nonsignificant group-by-time result. Allocation, analysis and completion counts by arm, and the direct raw-garlic versus placebo contrast, CI and exact P remain unverified.", "result_level": "Changes from baseline within each group and the original no-difference description are retained. This does not establish a newly subtracted contrast, a precise null effect, equivalence, independent replication or full ITT status. NIH/NCCAM support and product donation remain distinct; author, donation-contract, involvement and conflict-of-interest details remain unverified.", "source_evidence_date": "2026-09-08", "materials": [ { "material_type": "Stored review summary", "public_status": "Locally retained summary", "access_status": "Acquired", "acquired": true, "actually_read": "Stored existing review summary read", "as_of": "2026-10-06", "qualification": "The retained evidence and bibliographic summaries were read. This does not mean the original paper file was acquired or its full text newly verified. This is the retained Gardner summary and bibliography. Powder and AGE in the same trial are other formulations, without establishing independent replication of raw garlic. External PubMed, DOI, registration and supplement material was not read or accessed in this preparation. The material-check date distinguishes verification and reading status in the retained record. It is not a new external-original access date or a search cutoff." }, { "material_type": "External bibliography/abstract or original-text entry", "public_status": "Unverified", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-06", "qualification": "The retained external address is provided. Current responses, public availability, abstract/full-text reading and successful access remain unverified. This is the retained Gardner summary and bibliography. Powder and AGE in the same trial are other formulations, without establishing independent replication of raw garlic. External PubMed, DOI, registration and supplement material was not read or accessed in this preparation. The material-check date distinguishes verification and reading status in the retained record. It is not a new external-original access date or a search cutoff." }, { "material_type": "DOI full-text entry", "public_status": "Unverified", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-06", "qualification": "This is the retained DOI entry for full text. It concerns the same report and is not an independent trial. Full-text existence, public availability, access, downloading and reading were not checked in this preparation. This is the retained Gardner summary and bibliography. Powder and AGE in the same trial are other formulations, without establishing independent replication of raw garlic. External PubMed, DOI, registration and supplement material was not read or accessed in this preparation. The material-check date distinguishes verification and reading status in the retained record. It is not a new external-original access date or a search cutoff." }, { "material_type": "Original-paper supplement", "public_status": "Unverified", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-06", "qualification": "The existence, exact location and original file of a supplement remain unverified. Non-reading does not establish absence of a supplement or a failed access attempt. This is the retained Gardner summary and bibliography. Powder and AGE in the same trial are other formulations, without establishing independent replication of raw garlic. External PubMed, DOI, registration and supplement material was not read or accessed in this preparation. The material-check date distinguishes verification and reading status in the retained record. It is not a new external-original access date or a search cutoff." }, { "material_type": "Registration, protocol and analysis plan", "public_status": "Unverified", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-06", "qualification": "The bibliography contains NCT00056511, while registration status in the original evidence table is not verified. Providing a registration entry does not establish preregistration, plans, current responses or reading of the original record. This is the retained Gardner summary and bibliography. Powder and AGE in the same trial are other formulations, without establishing independent replication of raw garlic. External PubMed, DOI, registration and supplement material was not read or accessed in this preparation. The material-check date distinguishes verification and reading status in the retained record. It is not a new external-original access date or a search cutoff." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/17325296/" } ] }, { "report_id": "S2", "title": "Berthold HK et al. JAMA. 1998;279:1900-1902. DOI: 10.1001/jama.279.23.1900.", "url": "https://jamanetwork.com/journals/jama/fullarticle/187635", "report_type": "Retained summary and bibliography for a crossover trial of another formulation, garlic oil", "existence": "Stored research/bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original manufacturing/support/harm material remain separately unverified.", "acquired_read": "Retained Korean/English summaries, conditions and application records were read. External JAMA, DOI, registration and supplement material remain unread, with access not attempted.", "study_family": "These are restatements of the Berthold garlic-oil report and bibliography. They are not counted as independent replication of raw-garlic food. Unique trial and participant totals remain unverified.", "independent_replication": "This is auxiliary context involving garlic oil, a formulation different from raw garlic. The original independent-null description is historical and does not establish a new check of institutional, author or participant independence.", "observed_result": "This is a randomized, double-blind, placebo-controlled crossover trial of garlic oil with 25 completers. The retained between-group LDL-C value is 0.04 mg/dL, 95% CI −9.4~9.5, P=.99. Original units and strings are retained without new correction or conversion. Oil specifications, dose, population, duration, allocation/analysis counts, crossover sequence, washout and carryover handling remain unverified.", "result_level": "These are auxiliary retained values from another formulation. They are not transferred to the dose, duration, precision or denominator for raw garlic. The original German academic-institution description remains distinct from unverified funding details.", "source_evidence_date": "2026-09-08", "materials": [ { "material_type": "Stored review summary", "public_status": "Locally retained summary", "access_status": "Acquired", "acquired": true, "actually_read": "Stored existing review summary read", "as_of": "2026-10-06", "qualification": "The retained evidence and bibliographic summaries were read. This does not mean the original paper file was acquired or its full text newly verified. This is the retained Berthold summary and bibliography. Garlic oil is auxiliary context from another formulation and is not counted as direct replication of raw garlic. External originals, registration and supplements were not read or accessed in this preparation. The material-check date distinguishes verification and reading status in the retained record. It is not a new external-original access date or a search cutoff." }, { "material_type": "External bibliography/abstract or original-text entry", "public_status": "Unverified", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-06", "qualification": "The retained external address is provided. Current responses, public availability, abstract/full-text reading and successful access remain unverified. This is the retained Berthold summary and bibliography. Garlic oil is auxiliary context from another formulation and is not counted as direct replication of raw garlic. External originals, registration and supplements were not read or accessed in this preparation. The material-check date distinguishes verification and reading status in the retained record. It is not a new external-original access date or a search cutoff." }, { "material_type": "DOI full-text entry", "public_status": "Unverified", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-06", "qualification": "This is the retained DOI entry for full text. It concerns the same report and is not an independent trial. Full-text existence, public availability, access, downloading and reading were not checked in this preparation. This is the retained Berthold summary and bibliography. Garlic oil is auxiliary context from another formulation and is not counted as direct replication of raw garlic. External originals, registration and supplements were not read or accessed in this preparation. The material-check date distinguishes verification and reading status in the retained record. It is not a new external-original access date or a search cutoff." }, { "material_type": "Original-paper supplement", "public_status": "Unverified", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-06", "qualification": "The existence, exact location and original file of a supplement remain unverified. Non-reading does not establish absence of a supplement or a failed access attempt. This is the retained Berthold summary and bibliography. Garlic oil is auxiliary context from another formulation and is not counted as direct replication of raw garlic. External originals, registration and supplements were not read or accessed in this preparation. The material-check date distinguishes verification and reading status in the retained record. It is not a new external-original access date or a search cutoff." }, { "material_type": "Registration, protocol and analysis plan", "public_status": "Unverified", "access_status": "Access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-06", "qualification": "The registration identifier, protocol and analysis plan remain unverified. This does not establish non-registration or a failed access attempt. This is the retained Berthold summary and bibliography. Garlic oil is auxiliary context from another formulation and is not counted as direct replication of raw garlic. External originals, registration and supplements were not read or accessed in this preparation. The material-check date distinguishes verification and reading status in the retained record. It is not a new external-original access date or a search cutoff." } ], "links": [ { "label": "Official source", "url": "https://jamanetwork.com/journals/jama/fullarticle/187635" } ] } ], "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." }, "study_overlap": { "state": "Unverified", "unique_trial_count": null, "unique_participant_count": null, "reason": "The 2 retained evidence summaries and 2 bibliographies identify the Gardner raw-garlic/powder/AGE/placebo comparison and the separate Berthold garlic-oil report. Korean/English restatements, other arms of the same trial and bibliography/DOI entries are not independent trials. Original-source identities, participant overlap, and unique trial and participant totals remain unverified." }, "history": [ { "date": "2026-10-25", "kind": "Separation of public-facing pages and materials", "view_version": "1.0", "change": "The public view and materials were prepared from the existing 35 items. No new clinical search, verification-state change or scoring was performed." } ], "language": "en", "translation_date": "2026-10-25" }