{ "schema_version": "chamgap-public-evidence-check-1.0", "public_id": "v3061-main", "verdict_number": "3061", "title": "Aged garlic extract liquid 2.4 mL/day × Prevention of colorectal-adenoma recurrence", "view_version": "1.0", "view_created_date": "2026-10-26", "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 is the original date retained in the summary and condition records. The original verdict-review date does not establish a search cut-off or historical access dates for individual materials; external access was not attempted in this conversion." }, "claim_context": { "population": "51 adults with prior adenomas. Lesions larger than 5 mm were removed, and smaller lesions could remain. Group baseline characteristics and complete removal remain unverified.", "intervention": "Oral capsules equivalent to liquid AGE. Product, manufacturing and batch specifications, and SAC and dry-matter equivalents remain unverified.", "dose": "Nominal high dose 2.4 mL/day versus low dose 0.16 mL/day. Frequency, actual intake, component content and adherence remain unverified.", "comparator": "Active low-dose AGE 0.16 mL/day. The low dose is not treated as an inactive placebo or an unexposed control.", "endpoint": "Proportion with at least one new adenoma over 0~12 months. Among 37 efficacy-evaluable participants, high-dose 9/19 versus low-dose 12/18 and reported RR0.71 are retained; the exact CI, P value and ITT result for this comparison remain unverified.", "duration": "12 months of supplementation and colonoscopy at 6 and 12 months. The exact analysis interval for later results and follow-up after stopping remain unverified.", "excluded_extensions": [ "Results from a trial in which smaller lesions could remain are not extended to confirmed prevention of recurrence after complete removal or colorectal-cancer prevention.", "P=.02 and .04 for later adenoma decrease and total size are not attached to the selected 0~12-month participant result. The exact later analysis interval remains unverified.", "51 randomized participants, 37 efficacy-evaluable participants and the original 27% efficacy-analysis exclusion are kept distinct. No new RR, CI, absolute difference or percentage is calculated.", "Raw garlic, powder, garlic oil, stabilized allicin, black garlic, fermented garlic and isolated SAC are not treated as the same aged-garlic-extract formulation.", "The original caution statement does not establish observed harm incidence or individual safety. Long-term, rare-event, vulnerable-group, concomitant-use and peri-procedural safety and a general optimal dose are separate questions." ] }, "requirements": [ { "item_id": "N01", "question_type": "Evidence condition", "question": "Which adenoma outcome is compared with what?", "needed": "Prior adenomas, extent of lesion removal, high-dose/active low-dose AGE and the 0~12-month participant endpoint", "role": "Required", "role_reason": "Needed to avoid replacing the observed trial result with prevention after complete removal or cancer prevention", "application_exception": "Adenoma count, size and colorectal cancer are separate endpoints and are not combined as required confirmation in this table.", "criterion": "Preserve the original claim and limit the selected question to the proportion with a new adenoma over 0~12 months versus active low dose.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are Chamgap in-house application conditions developed with knowledge of the retained comparison of high-dose and active low-dose aged garlic extract and participants with new adenomas. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "A separate study directly measuring the relevant population and endpoint for recurrence after complete removal or colorectal cancer", "current_reports": [ "S1" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "The original claim is prevention of colorectal-adenoma recurrence, but the retained material concerns only participants with new adenomas in a trial in which smaller lesions could remain.", "condition_status": "Met", "status_reason": "The retained question and excluded extensions were checked; recurrence or cancer-prevention efficacy was not confirmed.", "missingness": "The retained question and excluded extensions were checked; recurrence or cancer-prevention efficacy was not confirmed.", "uncertainty": "The retained question and excluded extensions were checked; recurrence or cancer-prevention efficacy was not confirmed.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "The trial's eligibility criteria, baseline lesion map and endpoint definition" }, { "item_id": "N02", "question_type": "Evidence condition", "question": "Which adults with prior adenomas were included?", "needed": "Diagnosis, age, baseline risk, eligibility/exclusions, care setting and group characteristics", "role": "Required", "role_reason": "The prior-adenoma population must be distinguished from the general population and groups with complete removal", "application_exception": "The whole-trial size of 51 randomized participants is not used as group baseline characteristics or representativeness.", "criterion": "Link the record of adults with prior adenomas to the scope of verified eligibility and baseline characteristics, including matches or differences from the question's population.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are Chamgap in-house application conditions developed with knowledge of the retained comparison of high-dose and active low-dose aged garlic extract and participants with new adenomas. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "A prespecified comparison stratified by baseline lesions and risk; first check the existing selection table", "current_reports": [ "S1" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "A record of 51 adults with prior adenomas exists. Age, baseline risk, setting and group-specific selection characteristics are not established in the current summary.", "condition_status": "Partly verified", "status_reason": "The population label is checked, but detailed eligibility, representativeness and group characteristics remain unverified.", "missingness": "The population label is checked, but detailed eligibility, representativeness and group characteristics remain unverified.", "uncertainty": "The population label is checked, but detailed eligibility, representativeness and group characteristics remain unverified.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "The trial's eligibility criteria and group baseline table" }, { "item_id": "N03", "question_type": "Evidence condition", "question": "Could smaller lesions have remained?", "needed": "Initial removal size threshold, baseline lesion list, completeness of removal and identification of new lesions", "role": "Required", "role_reason": "Residual lesions and new recurrence after complete removal are different conditions", "application_exception": "Removal of lesions larger than 5 mm is not converted into removal of all lesions.", "criterion": "State removal of lesions larger than 5 mm and the possibility of smaller residual lesions, retaining uncertainty about identification of new lesions and complete removal.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are Chamgap in-house application conditions developed with knowledge of the retained comparison of high-dose and active low-dose aged garlic extract and participants with new adenomas. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "A recurrence study prespecifying confirmation of complete removal and lesion matching", "current_reports": [ "S1" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "The record states that only lesions larger than 5 mm were removed and smaller lesions could remain. A matching table of baseline and follow-up lesions is absent.", "condition_status": "Partly verified", "status_reason": "The limitation in removal extent is checked, but new-versus-residual identification for individual lesions and complete removal remain unverified.", "missingness": "The limitation in removal extent is checked, but new-versus-residual identification for individual lesions and complete removal remain unverified.", "uncertainty": "The limitation in removal extent is checked, but new-versus-residual identification for individual lesions and complete removal remain unverified.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Baseline/follow-up colonoscopy lesion maps, size thresholds and removal/new-lesion assessment records" }, { "item_id": "N04", "question_type": "Evidence condition", "question": "What were the specifications of the AGE capsules actually administered?", "needed": "Aged extract, liquid-equivalent capsules, manufacture/batch, SAC and dry-matter equivalents, and route", "role": "Required", "role_reason": "Liquid-equivalent quantity cannot be arbitrarily converted into SAC or dry-matter mass", "application_exception": "Raw garlic, powder, oil, black garlic and isolated SAC are not substituted as the same preparation.", "criterion": "Distinguish the name of the oral liquid-equivalent AGE capsules from verified or unverified actual specifications, component quantities and product matching.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are Chamgap in-house application conditions developed with knowledge of the retained comparison of high-dose and active low-dose aged garlic extract and participants with new adenomas. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "A replication using a specification-verified preparation; first obtain the existing product specifications", "current_reports": [ "S1" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "Liquid-equivalent AGE capsules and oral administration are stated. SAC and dry-matter equivalents are unverified in the original material.", "condition_status": "Partly verified", "status_reason": "The formulation and route are named, but actual product specifications and component quantities remain unverified.", "missingness": "The formulation and route are named, but actual product specifications and component quantities remain unverified.", "uncertainty": "The formulation and route are named, but actual product specifications and component quantities remain unverified.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Trial-product specifications, content/batch analyses and the basis for liquid-to-capsule equivalence" }, { "item_id": "N05", "question_type": "Evidence condition", "question": "Were actual intakes of 2.4 mL and 0.16 mL checked?", "needed": "Group nominal liquid-equivalent quantities, frequency, adherence, actual intake and product content", "role": "Required", "role_reason": "Nominal high/low-dose comparisons must be separated from differences in actual exposure", "application_exception": "Liquid-equivalent quantities are not converted to dry-matter mg or actual component quantities.", "criterion": "Distinguish nominal high-dose 2.4 mL/day versus low-dose 0.16 mL/day from unverified actual exposure and adherence.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are Chamgap in-house application conditions developed with knowledge of the retained comparison of high-dose and active low-dose aged garlic extract and participants with new adenomas. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "A dose comparison prospectively tracking component quantities and adherence", "current_reports": [ "S1" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "High-dose 2.4 mL/day versus low-dose 0.16 mL/day is recorded. Frequency, actual intake and component quantities are unverified.", "condition_status": "Partly verified", "status_reason": "A nominal dose comparison exists, but actual exposure and a general optimal dose remain unverified.", "missingness": "A nominal dose comparison exists, but actual exposure and a general optimal dose remain unverified.", "uncertainty": "A nominal dose comparison exists, but actual exposure and a general optimal dose remain unverified.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Administration schedules, pill-return/intake records, adherence and component-content material" }, { "item_id": "N06", "question_type": "Evidence condition", "question": "Was the comparator placebo or active low-dose AGE?", "needed": "Comparator preparation, components, dose, placebo/no-treatment status and comparison direction", "role": "Required", "role_reason": "Needed to avoid converting a result versus active low dose into an effect versus placebo", "application_exception": "The low dose is not assumed to be biologically inactive or placebo.", "criterion": "State the actual comparison of high dose versus active low-dose 0.16 mL/day and separately retain effects versus placebo as unverified.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are Chamgap in-house application conditions developed with knowledge of the retained comparison of high-dose and active low-dose aged garlic extract and participants with new adenomas. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "For a placebo question, a direct comparison of the same high-dose preparation with an appropriate placebo", "current_reports": [ "S1" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "The comparator was low-dose AGE 0.16 mL/day. The original text describes it as an active low-dose control.", "condition_status": "Met", "status_reason": "The actual comparison structure is preserved; this does not establish an effect versus placebo or inactivity of the low dose.", "missingness": "The actual comparison structure is preserved; this does not establish an effect versus placebo or inactivity of the low dose.", "uncertainty": "The actual comparison structure is preserved; this does not establish an effect versus placebo or inactivity of the low dose.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Component, appearance, content and exposure specifications for the comparator capsules" }, { "item_id": "N07", "question_type": "Evidence condition", "question": "How are supplementation duration and colonoscopy visits distinguished?", "needed": "12 months of supplementation, colonoscopy at 6/12 months, observation windows and follow-up after stopping", "role": "Required", "role_reason": "Visit times must not be treated as the exact interval for each analysis", "application_exception": "Recorded visits at 6 and 12 months do not establish the exact analysis interval for later P values.", "criterion": "Cite the record of 12 months of supplementation and colonoscopy at 6/12 months, distinguishing unverified analysis windows, visit allowances and follow-up after stopping.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are Chamgap in-house application conditions developed with knowledge of the retained comparison of high-dose and active low-dose aged garlic extract and participants with new adenomas. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "A study prespecifying follow-up times and persistence after stopping", "current_reports": [ "S1" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "12 months of supplementation and colonoscopy at 6 and 12 months are recorded. The exact analysis interval for later P values and follow-up after stopping remain unverified.", "condition_status": "Partly verified", "status_reason": "Supplementation and visit information exists, but intervals and persistence for all results cannot be established.", "missingness": "Supplementation and visit information exists, but intervals and persistence for all results cannot be established.", "uncertainty": "Supplementation and visit information exists, but intervals and persistence for all results cannot be established.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Visit schedules, actual colonoscopy times and analysis-interval definitions" }, { "item_id": "N08", "question_type": "Evidence condition", "question": "How were participants with new adenomas identified?", "needed": "Participants with at least one new adenoma over 0~12 months, colonoscopy/histological assessment, assessors and lesion matching", "role": "Required", "role_reason": "Participant proportions, adenoma counts and sizes are different endpoints", "application_exception": "Adenoma is not a directly measured colorectal-cancer event.", "criterion": "Link the participant-level endpoint definition to the scope of verified assessment methods, assessor blinding and measurement limitations.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are Chamgap in-house application conditions developed with knowledge of the retained comparison of high-dose and active low-dose aged garlic extract and participants with new adenomas. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "A comparison prespecifying identification of new lesions and central reading", "current_reports": [ "S1" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "The endpoint is the proportion with at least one new adenoma over 0~12 months. Details of histological assessment, assessor blinding and lesion matching are absent.", "condition_status": "Partly verified", "status_reason": "The endpoint name and participant unit are checked, but details of measurement reproducibility and new-lesion identification remain unverified.", "missingness": "The endpoint name and participant unit are checked, but details of measurement reproducibility and new-lesion identification remain unverified.", "uncertainty": "The endpoint name and participant unit are checked, but details of measurement reproducibility and new-lesion identification remain unverified.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "The trial's endpoint definition, colonoscopy/histological assessment guidance and assessor-blinding material" }, { "item_id": "N09", "question_type": "Evidence condition", "question": "How were random allocation and concealment performed?", "needed": "High/low-dose allocation, random sequence, concealment, design unit and group baseline balance", "role": "Required", "role_reason": "The summary label of randomization cannot establish adequacy of allocation methods", "application_exception": "Unverified design details do not automatically establish nonapplication of crossover/cluster handling.", "criterion": "Distinguish the record of a randomized double-blind high/low-dose comparison from unverified sequence, concealment and design unit.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are Chamgap in-house application conditions developed with knowledge of the retained comparison of high-dose and active low-dose aged garlic extract and participants with new adenomas. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "A replicated comparison clearly reporting the allocation sequence, concealment and design unit", "current_reports": [ "S1" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "A randomized double-blind high-dose versus low-dose comparison is recorded. Details of allocation sequence, concealment and design unit are absent.", "condition_status": "Partly verified", "status_reason": "The design is named, but material verifying the actual allocation process and concealment remains unverified.", "missingness": "The design is named, but material verifying the actual allocation process and concealment remains unverified.", "uncertainty": "The design is named, but material verifying the actual allocation process and concealment remains unverified.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Allocation methods, concealment procedures, original protocol and group baseline table" }, { "item_id": "N10", "question_type": "Evidence condition", "question": "Did double blinding cover both participants and outcome readers?", "needed": "Blinding of participants, providers, colonoscopy readers and analysts, and how blinding was maintained", "role": "Required", "role_reason": "Supplementation blinding and outcome-reader blinding must be distinguished", "application_exception": "The double-blind label is not used as confirmation that all assessors were blinded.", "criterion": "Separately describe the recorded targets and methods of double blinding and uncertainties relevant to colonoscopy outcome measurement.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are Chamgap in-house application conditions developed with knowledge of the retained comparison of high-dose and active low-dose aged garlic extract and participants with new adenomas. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "A study specifying assessor blinding and reading reproducibility", "current_reports": [ "S1" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "The bibliographic/design description says double blind. Methods for colonoscopy readers and analysts are absent from the current summary.", "condition_status": "Partly verified", "status_reason": "Blinding is named, but actual blinding of outcome reading and analysis remains unverified.", "missingness": "Blinding is named, but actual blinding of outcome reading and analysis remains unverified.", "uncertainty": "Blinding is named, but actual blinding of outcome reading and analysis remains unverified.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Blinding targets/maintenance procedures, reading guidance and unblinding records" }, { "item_id": "N11", "question_type": "Evidence condition", "question": "Were prior adenomas and baseline lesions similar between groups?", "needed": "Group history, baseline adenoma count/size, age, concurrent exposures and baseline comparisons", "role": "Required", "role_reason": "Baseline lesion differences in a small trial are relevant to interpretation", "application_exception": "A randomization label does not automatically guarantee baseline balance.", "criterion": "State the scope of baseline group comparisons and identify unavailable items.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are Chamgap in-house application conditions developed with knowledge of the retained comparison of high-dose and active low-dose aged garlic extract and participants with new adenomas. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "A comparison prespecifying baseline-risk stratification and an adjustment plan", "current_reports": [ "S1" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "Overall prior adenomas and 51 randomized participants are recorded, but a group baseline table is absent from the retained material.", "condition_status": "Unverified", "status_reason": "Balance or differences in baseline lesions and risk between groups could not be checked.", "missingness": "Balance or differences in baseline lesions and risk between groups could not be checked.", "uncertainty": "Balance or differences in baseline lesions and risk between groups could not be checked.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Group baseline characteristics and baseline colonoscopy lesion tables" }, { "item_id": "N12", "question_type": "Evidence condition", "question": "Are the 51 randomized and 37 efficacy-evaluable participants distinguished?", "needed": "Whole-trial and group randomized/analyzed/completed/event denominators and analysis populations", "role": "Required", "role_reason": "Event denominators in the efficacy-evaluable population must not be converted to randomized-group denominators", "application_exception": "The 37 participants are not treated as ITT for all randomized participants or as the original recruitment denominator.", "criterion": "Link 51 randomized, 37 efficacy-evaluable and 9/19 versus 12/18 to their analysis, retaining unverified group randomized/completed denominators.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are Chamgap in-house application conditions developed with knowledge of the retained comparison of high-dose and active low-dose aged garlic extract and participants with new adenomas. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "A comparison specifying all randomized participants and each analysis population", "current_reports": [ "S1" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "51 randomized and 37 efficacy-evaluable participants are recorded, with participants with new adenomas at 9/19 versus 12/18. Group randomized/completed denominators are absent.", "condition_status": "Partly verified", "status_reason": "Event denominators for the efficacy-evaluable population exist, but correspondence with group randomized/completed/whole-analysis populations remains unverified.", "missingness": "Event denominators for the efficacy-evaluable population exist, but correspondence with group randomized/completed/whole-analysis populations remains unverified.", "uncertainty": "Event denominators for the efficacy-evaluable population exist, but correspondence with group randomized/completed/whole-analysis populations remains unverified.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Participant flow and group randomized/completed/analyzed/event tables" }, { "item_id": "N13", "question_type": "Evidence condition", "question": "Does the efficacy-evaluable result estimate an ITT allocation effect?", "needed": "ITT/PP, efficacy-evaluable inclusion criteria, effect of interest and adjusted/unadjusted analyses", "role": "Required", "role_reason": "The result for 37 efficacy-evaluable participants cannot be inherited as an allocation effect for 51 randomized participants", "application_exception": "Unverified ITT and absence of an ITT result are described only within the retained scope.", "criterion": "Preserve the recorded efficacy-evaluable population and explain definitions and uncertainties for allocation effects, adherence effects and adjustment.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are Chamgap in-house application conditions developed with knowledge of the retained comparison of high-dose and active low-dose aged garlic extract and participants with new adenomas. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "A comparison prespecifying and separately reporting allocation and adherence effects", "current_reports": [ "S1" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "The original material describes 37 efficacy-evaluable participants and unverified ITT. The representative result for all 51 participants and the effect definition were not acquired.", "condition_status": "Unverified", "status_reason": "The representative RR cannot be established as an ITT allocation effect.", "missingness": "The representative RR cannot be established as an ITT allocation effect.", "uncertainty": "The representative RR cannot be established as an ITT allocation effect.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Analysis plan, efficacy-evaluable inclusion criteria and ITT/sensitivity analyses" }, { "item_id": "N14", "question_type": "Evidence condition", "question": "Who was excluded from the efficacy analysis and how was this handled?", "needed": "Group attrition/exclusions, reasons, missing-data handling, sensitivity analyses and analysis timing", "role": "Required", "role_reason": "The limitations of efficacy-analysis selection and missingness must be explained", "application_exception": "Retain the original 27% efficacy-analysis exclusion without calculating a new excluded count or percentage.", "criterion": "Preserve the original randomized/evaluable distinction and historical 27% statement, leaving group reasons, handling and bias magnitude unverified.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are Chamgap in-house application conditions developed with knowledge of the retained comparison of high-dose and active low-dose aged garlic extract and participants with new adenomas. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "A comparison tracking all outcomes and prespecifying missing-data handling", "current_reports": [ "S1" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "The original text describes 27% efficacy-analysis exclusion. Group-specific reasons, handling and sensitivity results are absent from the current summary.", "condition_status": "Partly verified", "status_reason": "The denominator difference and original exclusion statement are checked, but the structure and impact of missingness remain unverified.", "missingness": "The denominator difference and original exclusion statement are checked, but the structure and impact of missingness remain unverified.", "uncertainty": "The denominator difference and original exclusion statement are checked, but the structure and impact of missingness remain unverified.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Participant flow, group exclusion reasons, missing-data handling and sensitivity analyses" }, { "item_id": "N15", "question_type": "Evidence condition", "question": "Which analysis and direction does RR0.71 represent?", "needed": "High dose versus low dose, participant event proportions, reported RR, adjustment status and model", "role": "Required", "role_reason": "RR, absolute difference, within-group change and adenoma-count decrease are different measures", "application_exception": "Do not recalculate a new RR, absolute difference or percentage from 9/19 versus 12/18.", "criterion": "Link reported RR0.71 only to participants with a new adenoma over 0~12 months, marking adjustment, model and absolute-effect uncertainties.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are Chamgap in-house application conditions developed with knowledge of the retained comparison of high-dose and active low-dose aged garlic extract and participants with new adenomas. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "A comparison prospectively reporting relative and absolute effects with their analysis definitions", "current_reports": [ "S1" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "9/19 versus 12/18 and RR0.71 are retained. Adjustment status, model and absolute difference are unverified in this summary.", "condition_status": "Partly verified", "status_reason": "The reported RR and direction are available, but the full effect-estimate definition and absolute effect remain unverified.", "missingness": "The reported RR and direction are available, but the full effect-estimate definition and absolute effect remain unverified.", "uncertainty": "The reported RR and direction are available, but the full effect-estimate definition and absolute effect remain unverified.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "The original outcome table, RR analysis/model, adjustment variables and analysis population" }, { "item_id": "N16", "question_type": "Evidence condition", "question": "Can the interval and importance of the representative RR be interpreted?", "needed": "The selected comparison's 95%CI, denominators, P value and prespecified importance criterion", "role": "Required", "role_reason": "A point estimate alone cannot establish an effect range or importance", "application_exception": "Do not invent a common minimum sample size, CI or importance threshold.", "criterion": "Record the originally reported interval and importance criterion for the selected RR, or why these were not checked, without creating a new grade.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are Chamgap in-house application conditions developed with knowledge of the retained comparison of high-dose and active low-dose aged garlic extract and participants with new adenomas. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "A comparison prospectively justifying importance and precision planning for the clinical question", "current_reports": [ "S1" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "The original material explicitly states that the exact 95%CI and P value for the representative comparison are unverified. An importance criterion is also unverified.", "condition_status": "Unverified", "status_reason": "Without a reported interval, the relationship between the range of possible effects and importance cannot be assessed.", "missingness": "Without a reported interval, the relationship between the range of possible effects and importance cannot be assessed.", "uncertainty": "Without a reported interval, the relationship between the range of possible effects and importance cannot be assessed.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "The representative outcome table's 95%CI, test definition and basis for importance" }, { "item_id": "N17", "question_type": "Evidence condition", "question": "Were later P=.02/.04 values attached to the representative recurrence result?", "needed": "Endpoint/analysis-interval correspondence between later decrease, total size and the 0~12-month participant result", "role": "Required", "role_reason": "P values from other endpoints must not be converted into significance for the representative RR", "application_exception": "Colonoscopy visits at 6/12 months do not establish the later analysis interval as 6~12 months.", "criterion": "Separate later-decrease/total-size P values from the selected participant result and retain the exact analysis interval as unverified.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are Chamgap in-house application conditions developed with knowledge of the retained comparison of high-dose and active low-dose aged garlic extract and participants with new adenomas. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "A report prespecifying analyses by endpoint/time and multiplicity", "current_reports": [ "S1" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "P=.02 and .04 are retained as separate results for later adenoma decrease and total size. The exact later analysis interval remains unverified.", "condition_status": "Met", "status_reason": "Attribution of numbers and uncertainty boundaries is preserved; significance of the representative RR was not confirmed.", "missingness": "Attribution of numbers and uncertainty boundaries is preserved; significance of the representative RR was not confirmed.", "uncertainty": "Attribution of numbers and uncertainty boundaries is preserved; significance of the representative RR was not confirmed.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Endpoint-specific outcome tables, P-value targets and the later analysis-interval definition" }, { "item_id": "N18", "question_type": "Evidence condition", "question": "Were the selected endpoint, analysis and timing prespecified?", "needed": "Registration, protocol, SAP, primary/secondary endpoints, change history and actual reporting", "role": "Required", "role_reason": "The actual level of comparison between prior planning and selective reporting must be stated", "application_exception": "Unverified registration is not converted into confirmed nonregistration or selective reporting.", "criterion": "Distinguish acquisition/reading of registration/plans, the scope of comparisons with the selected endpoint/analysis/timing and items not compared.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are Chamgap in-house application conditions developed with knowledge of the retained comparison of high-dose and active low-dose aged garlic extract and participants with new adenomas. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "A comparison preregistering the question, endpoints, analyses and timing and publishing all results", "current_reports": [ "S1" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "The registration field is unverified, and the original material also describes unverified prospective registration. The original protocol and SAP were not read in this conversion.", "condition_status": "Unverified", "status_reason": "Agreement or differences between prior plans and actual reporting could not be compared.", "missingness": "Agreement or differences between prior plans and actual reporting could not be compared.", "uncertainty": "Agreement or differences between prior plans and actual reporting could not be compared.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "The original registration number/timing, protocol, SAP and explanations of changes" }, { "item_id": "N19", "question_type": "Evidence condition", "question": "How were other preventive interventions and adherence handled between groups?", "needed": "Concurrent medicines, diet, additional garlic, rescue treatment and group adherence/changes", "role": "Required", "role_reason": "Differences other than high/low dose must be distinguished from the outcome", "application_exception": "Do not require all changes to be identical between groups or treat missing records as equality.", "criterion": "Explain verified and unverified group concomitant use, adherence and changes in relation to the effect of interest.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are Chamgap in-house application conditions developed with knowledge of the retained comparison of high-dose and active low-dose aged garlic extract and participants with new adenomas. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "A comparison prospectively tracking and analyzing concurrent exposures and adherence", "current_reports": [ "S1" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "A high/low-dose comparison exists, but group-specific medicines, diet, additional intake and adherence data are absent from the current summary.", "condition_status": "Unverified", "status_reason": "The scope for checking concurrent interventions, actual exposure differences and handling is insufficient.", "missingness": "The scope for checking concurrent interventions, actual exposure differences and handling is insufficient.", "uncertainty": "The scope for checking concurrent interventions, actual exposure differences and handling is insufficient.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Group concomitant-treatment, diet and adherence records and analysis handling" }, { "item_id": "N20", "question_type": "Evidence condition", "question": "Are a trial's summary and citation counted as separate replications?", "needed": "Tanaka2004, PMID15726891, evidence/citation and related registration/report families", "role": "Required", "role_reason": "Repeated citation of one report must not be counted as independent confirmation", "application_exception": "A single current report clue does not establish a count of 1 unique trial across the entire literature.", "criterion": "Link the current 1 evidence summary/1 citation and bilingual restatements as the same report clue, leaving global unique-trial/participant counts undetermined.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are Chamgap in-house application conditions developed with knowledge of the retained comparison of high-dose and active low-dose aged garlic extract and participants with new adenomas. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Independent replication matching product, population and endpoint; first organize existing related-report families", "current_reports": [ "S1" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "The evidence and citation link Tanaka2004/PMID15726891. Korean/English/combined summaries are not counted as additional trials.", "condition_status": "Partly verified", "status_reason": "Local report links exist, but the scope of all related reports and unique families/participants remains unverified.", "missingness": "Local report links exist, but the scope of all related reports and unique families/participants remains unverified.", "uncertainty": "Local report links exist, but the scope of all related reports and unique families/participants remains unverified.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Family comparison of the original report, registration, related reports and included-trial tables" }, { "item_id": "N21", "question_type": "Evidence condition", "question": "Can differences in results across unique trials be compared?", "needed": "Family-specific results for the same endpoint, formulation/population/timing differences and null/unfavorable results", "role": "Conditional", "role_reason": "Inter-study consistency requires identifying unique families first", "application_exception": "Do not label later-endpoint differences as inter-study conflict or external non-search as absence of contrary results.", "criterion": "Distinguish endpoint differences within the retained report clue from unverified comparisons across unique studies.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are Chamgap in-house application conditions developed with knowledge of the retained comparison of high-dose and active low-dose aged garlic extract and participants with new adenomas. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Replication of independent studies matching formulation, population and endpoint, with disclosure of the result distribution", "current_reports": [ "S1" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "The current retained record historically describes no independent confirmation and provides one report clue. A comparison across the full external literature was not performed in this conversion.", "condition_status": "Unverified", "status_reason": "The historical statement of no independent confirmation is not converted into absence of all current studies or confirmed consistency.", "missingness": "The historical statement of no independent confirmation is not converted into absence of all current studies or confirmed consistency.", "uncertainty": "The historical statement of no independent confirmation is not converted into absence of all current studies or confirmed consistency.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Existing related-report lists, family-specific results/conditions and inclusion/exclusion records" }, { "item_id": "N22", "question_type": "Evidence condition", "question": "Were product supply, funding and author interests distinguished?", "needed": "AGE commercial involvement, product supply, funding, author employment/patents and declared COI", "role": "Required", "role_reason": "The original I1 axis or product-supply statement does not establish all funding information", "application_exception": "Do not automatically exclude commercial involvement or treat unverified details as independent research.", "criterion": "Link the original product-supply statement to unverified commercial details and distinguish the actual level of verification for funding and author relationships.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are Chamgap in-house application conditions developed with knowledge of the retained comparison of high-dose and active low-dose aged garlic extract and participants with new adenomas. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Independent replication and data disclosure specifying manufacturer roles and funding", "current_reports": [ "S1" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "The original text describes product supply as I1, while the evidence funding entry says details of AGE-related commercial involvement are unverified.", "condition_status": "Partly verified", "status_reason": "A historical product-related clue exists, but funding, supply, author employment/patents and declaration details remain unverified.", "missingness": "A historical product-related clue exists, but funding, supply, author employment/patents and declaration details remain unverified.", "uncertainty": "A historical product-related clue exists, but funding, supply, author employment/patents and declaration details remain unverified.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Original-paper funding/COI, product-supply and author-affiliation/patent material" }, { "item_id": "N23", "question_type": "Evidence condition", "question": "Was the material now read a summary or the original full paper?", "needed": "Retained summary, citation, external abstract/full text, acquisition/reading and original location/identity", "role": "Required", "role_reason": "Needed to avoid presenting summary reading as full-text reading", "application_exception": "External access not attempted does not mean failed access or absence of a publicly available full text.", "criterion": "Record actual reading of the retained summary separately from unread external material and link reading to exact locations, values and identity.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are Chamgap in-house application conditions developed with knowledge of the retained comparison of high-dose and active low-dose aged garlic extract and participants with new adenomas. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "First obtain access records for existing originals; access alone does not establish a new effect", "current_reports": [ "S1" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "The whole retained summary, evidence and citation were read. A PubMed link exists, but external abstracts, full text and registration were not read in this conversion.", "condition_status": "Met", "status_reason": "The honest distinction in current reading level is checked; original-paper content verification is not established.", "missingness": "The honest distinction in current reading level is checked; original-paper content verification is not established.", "uncertainty": "The honest distinction in current reading level is checked; original-paper content verification is not established.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Lawful access, acquisition and actual reading of the original paper/supplements, with table/section locations" }, { "item_id": "N24", "question_type": "Evidence condition", "question": "What review date and search scope does this record represent?", "needed": "Original verdict-review date, historical abstract-comparison statement, current local-review date and search/correction/retraction scope", "role": "Required", "role_reason": "The original review date must not be used as a current external-access date or search cutoff", "application_exception": "A new search not performed is not described as 0 current studies or no retractions.", "criterion": "Separate the original review date 2026-09-08 from the local-conversion date and mark unverified historical access dates/levels and search cutoff.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are Chamgap in-house application conditions developed with knowledge of the retained comparison of high-dose and active low-dose aged garlic extract and participants with new adenomas. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "If an update is requested, a literature update recording search scope/date and exclusion/selection reasons", "current_reports": [ "S1" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "The original verdict-review date is 2026-09-08, and abstract comparison is a historical statement. Report-specific access date/level and search-cutoff fields are absent.", "condition_status": "Partly verified", "status_reason": "A review date and historical statement exist, but the current full-literature search/retraction status and individual access history remain unverified.", "missingness": "A review date and historical statement exist, but the current full-literature search/retraction status and individual access history remain unverified.", "uncertainty": "A review date and historical statement exist, but the current full-literature search/retraction status and individual access history remain unverified.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Existing search expressions/scope, access receipts and correction/retraction comparison records" }, { "item_id": "N25", "question_type": "Evidence condition", "question": "Does the 12-month adenoma result answer persistence after stopping or cancer prevention?", "needed": "The selected 12-month result, persistence after stopping, clinical cancer events and direct estimates", "role": "Recommended", "role_reason": "Needed to distinguish the original narrow participant endpoint from separate long-term/cancer-prevention questions", "application_exception": "Cancer-event studies are not imposed as mandatory fulfillment conditions for the current adenoma-endpoint record.", "criterion": "Separate the 12-month participant endpoint from unverified extensions concerning persistence after stopping and colorectal-cancer prevention.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are Chamgap in-house application conditions developed with knowledge of the retained comparison of high-dose and active low-dose aged garlic extract and participants with new adenomas. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Follow-up and direct clinical-endpoint research appropriate to long-term persistence/cancer-event questions", "current_reports": [ "S1" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "The selected result concerns participants with adenomas over 12 months; the original text says it cannot be extended to colorectal-cancer prevention or complete polyp prevention.", "condition_status": "Partly verified", "status_reason": "The current endpoint boundary is checked, but direct evidence for persistence after stopping or cancer events remains unverified in this retained scope.", "missingness": "The current endpoint boundary is checked, but direct evidence for persistence after stopping or cancer events remains unverified in this retained scope.", "uncertainty": "The current endpoint boundary is checked, but direct evidence for persistence after stopping or cancer events remains unverified in this retained scope.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Follow-up after stopping and direct clinical events such as colorectal cancer" }, { "item_id": "N26", "question_type": "Evidence condition", "question": "What adverse events were collected and how?", "needed": "Event definitions, systematic/spontaneous collection, severity, incident/worsening events and stopping criteria", "role": "Required", "role_reason": "A caution label cannot substitute for actual adverse-event collection results", "application_exception": "Unreported harms do not justify deleting efficacy material or declaring absence of harm.", "criterion": "Link actual events, collection level and uncertainties for the same population/exposure, keeping efficacy and harm states separate.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are Chamgap in-house application conditions developed with knowledge of the retained comparison of high-dose and active low-dose aged garlic extract and participants with new adenomas. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Safety follow-up prespecifying event definitions, systematic collection, severity and stopping", "current_reports": [ "S1" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "A caution label, unverified long-term safety and concomitant-use cautions are stated. Actual event definitions, collection methods and outcome tables are absent.", "condition_status": "Unverified", "status_reason": "A safety label exists, but actual adverse-event collection and occurrence for the selected exposure could not be checked.", "missingness": "A safety label exists, but actual adverse-event collection and occurrence for the selected exposure could not be checked.", "uncertainty": "A safety label exists, but actual adverse-event collection and occurrence for the selected exposure could not be checked.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Trial adverse-event definitions, collection methods, group outcomes and stopping criteria" }, { "item_id": "N27", "question_type": "Evidence condition", "question": "Are the times of adverse-event onset, stopping and recovery known?", "needed": "Exposure start/stop, event onset, recovery, re-exposure, latency and follow-up windows", "role": "Conditional", "role_reason": "Temporal relationships and long-term windows require review when actual events are reported", "application_exception": "12 months of supplementation is not used as latency or complete follow-up for all harms.", "criterion": "Distinguish the 12-month supplementation record from verified/unverified event timelines without inferring recovery or re-exposure.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are Chamgap in-house application conditions developed with knowledge of the retained comparison of high-dose and active low-dose aged garlic extract and participants with new adenomas. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Safety research prospectively tracking exposure and event timelines", "current_reports": [ "S1" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "12 months of supplementation is checked, but event-onset, stopping, recovery and re-exposure timelines are absent from the retained material.", "condition_status": "Unverified", "status_reason": "Exposure duration cannot be converted into proof of the event's temporal relationship.", "missingness": "Exposure duration cannot be converted into proof of the event's temporal relationship.", "uncertainty": "Exposure duration cannot be converted into proof of the event's temporal relationship.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Event timelines, stopping/recovery and exposure/follow-up records" }, { "item_id": "N28", "question_type": "Evidence condition", "question": "Can high-dose and low-dose risks be compared?", "needed": "Group events, comparator, analysis population and actual comparative-risk estimates", "role": "Conditional", "role_reason": "An efficacy comparator does not guarantee the existence of harm-comparison data", "application_exception": "The low-dose control is not substituted for nonexposure or background incidence.", "criterion": "Distinguish the active high/low-dose design from whether actual group harm comparisons are provided, retaining missing comparative estimates as unverified.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are Chamgap in-house application conditions developed with knowledge of the retained comparison of high-dose and active low-dose aged garlic extract and participants with new adenomas. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "A prespecified safety comparison of the same high/low-dose product; a nonexposure question requires a separate comparison", "current_reports": [ "S1" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "Efficacy concerns active high/low dose, but group harm events and comparative-risk estimates are absent from the current summary.", "condition_status": "Unverified", "status_reason": "The comparison design does not establish verified group safety.", "missingness": "The comparison design does not establish verified group safety.", "uncertainty": "The comparison design does not establish verified group safety.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Group harm outcomes, exposure/analysis denominators and risk comparisons" }, { "item_id": "N29", "question_type": "Evidence condition", "question": "Are event and exposure denominators available for harm frequency?", "needed": "Group exposed populations, affected people/event counts, exposure/follow-up time and collection scope", "role": "Required", "role_reason": "The efficacy denominators of 51/37 participants must not substitute for safety-analysis denominators", "application_exception": "Do not use efficacy events 9/19 versus 12/18 as adverse-event counts or calculate new incidence.", "criterion": "Present frequencies only from reported values linking harm events to their exposure/follow-up denominators, retaining unverified denominators.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are Chamgap in-house application conditions developed with knowledge of the retained comparison of high-dose and active low-dose aged garlic extract and participants with new adenomas. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Follow-up publishing safety denominators, exposure time and all events together", "current_reports": [ "S1" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "Randomized/efficacy-evaluable denominators exist, but separate harm events, safety denominators and exposure time remain unverified in the summary.", "condition_status": "Unverified", "status_reason": "The event-denominator link needed to state harm frequency remains unverified.", "missingness": "The event-denominator link needed to state harm frequency remains unverified.", "uncertainty": "The event-denominator link needed to state harm frequency remains unverified.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Group safety-analysis populations and event/exposure-time tables" }, { "item_id": "N30", "question_type": "Evidence condition", "question": "Were antithrombotic or procedure-related details checked?", "needed": "Actual concomitant medicines, procedures, baseline conditions, alternative causes and group exposure/adjustment", "role": "Conditional", "role_reason": "Original cautions and actual participant concomitant-use records are different information", "application_exception": "The caution is not treated as a finding that an interaction was observed in this trial.", "criterion": "Distinguish the original concomitant-use/procedural caution from unverified actual co-exposures and alternative explanations.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are Chamgap in-house application conditions developed with knowledge of the retained comparison of high-dose and active low-dose aged garlic extract and participants with new adenomas. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Appropriate safety observation for clinically relevant concomitant-use/procedural settings", "current_reports": [ "S1" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "The original text calls for checking anticoagulants, antiplatelet medicines and peri-procedural use. Actual concomitant-use/event records for trial participants are absent.", "condition_status": "Partly verified", "status_reason": "The concomitant-use context needing review is recorded, but actual interactions and alternative causes remain unverified.", "missingness": "The concomitant-use context needing review is recorded, but actual interactions and alternative causes remain unverified.", "uncertainty": "The concomitant-use context needing review is recorded, but actual interactions and alternative causes remain unverified.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Actual concomitant medicines, procedure schedules, baseline events and group harm/adjustment data" }, { "item_id": "N31", "question_type": "Evidence condition", "question": "Who was missing from safety follow-up?", "needed": "Safety collection/selection, follow-up losses, group noncollection and disclosure of all events", "role": "Conditional", "role_reason": "Efficacy-analysis exclusion and safety noncollection may differ", "application_exception": "The original 27% efficacy-analysis exclusion is not converted into a safety dropout rate.", "criterion": "Separate efficacy-population exclusions from safety follow-up losses and retain unverified collection/selection/missingness.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are Chamgap in-house application conditions developed with knowledge of the retained comparison of high-dose and active low-dose aged garlic extract and participants with new adenomas. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Observation disclosing safety follow-up for all exposed participants and reasons for noncollection", "current_reports": [ "S1" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "Efficacy-analysis exclusion is described, but safety follow-up losses and reasons for noncollection are not separately verified.", "condition_status": "Unverified", "status_reason": "Efficacy missingness is not inherited as safety missingness, and bias magnitude is not established.", "missingness": "Efficacy missingness is not inherited as safety missingness, and bias magnitude is not established.", "uncertainty": "Efficacy missingness is not inherited as safety missingness, and bias magnitude is not established.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Safety participant flow, reasons for noncollection and disclosure records for all events" }, { "item_id": "N32", "question_type": "Evidence condition", "question": "Are harms of the same preparation recorded in other independent material?", "needed": "Unique event/study families, the same exposure/event, contrary records and distinctions from recitation/regulatory material", "role": "Conditional", "role_reason": "Repetition of the same caution is not an independent harm event", "application_exception": "Korean/English/combined restatements or signals from other garlic formulations are not counted as independent events.", "criterion": "Distinguish sources of current harm statements, recitation and unverified relationships between unique events.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are Chamgap in-house application conditions developed with knowledge of the retained comparison of high-dose and active low-dose aged garlic extract and participants with new adenomas. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Independent safety observation in appropriate populations using the same preparation, with disclosure of contrary records", "current_reports": [ "S1" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "The same caution is repeated across languages/summaries, but an independent harm-event list or family information is currently absent.", "condition_status": "Unverified", "status_reason": "Repeated wording is not summed as unique events, and the overall number of harm reports remains undetermined.", "missingness": "Repeated wording is not summed as unique events, and the overall number of harm reports remains undetermined.", "uncertainty": "Repeated wording is not summed as unique events, and the overall number of harm reports remains undetermined.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Original events, formulation/dose and family links in existing safety reports/regulatory documents" }, { "item_id": "N33", "question_type": "Evidence condition", "question": "Can harms beyond the small 1-year dataset be described?", "needed": "Long-term and rare harms, vulnerable populations, baseline risk, exposures/interactions and appropriate follow-up", "role": "Recommended", "role_reason": "Long-term safety of intake for cancer prevention cannot be established from short, small datasets", "application_exception": "All rare-event/vulnerable-group studies are not imposed as mandatory conditions for the narrow 12-month efficacy result.", "criterion": "Distinguish the current supplementation/population scope from direct or unverified evidence on long-term, rare-event and vulnerable-group harms.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are Chamgap in-house application conditions developed with knowledge of the retained comparison of high-dose and active low-dose aged garlic extract and participants with new adenomas. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Follow-up, registration and safety observation appropriate to long-term/special-population questions", "current_reports": [ "S1" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "The original text says a small 1-year dataset cannot establish long-term safety of intake for cancer prevention.", "condition_status": "Partly verified", "status_reason": "The current limitation is stated, but direct long-term, rare-event and vulnerable-group safety material remains unverified in this scope.", "missingness": "The current limitation is stated, but direct long-term, rare-event and vulnerable-group safety material remains unverified in this scope.", "uncertainty": "The current limitation is stated, but direct long-term, rare-event and vulnerable-group safety material remains unverified in this scope.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Exposure-event material on long-term follow-up, vulnerable groups, rare events and interactions" }, { "item_id": "N34", "question_type": "Evidence condition", "question": "Is the caution a signal, comparative risk or causal statement?", "needed": "Actual harm events, design/comparison, denominators, timing, alternatives and currently supportable wording", "role": "Required", "role_reason": "General caution or insufficient material must not be converted into individual safety or causal results", "application_exception": "Do not use the efficacy RR as a causal harm estimate or create personal dosing instructions.", "criterion": "Separate the original safety caution from the level of verification for actual events/risks/causal material, retaining the limits of supportable wording.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are Chamgap in-house application conditions developed with knowledge of the retained comparison of high-dose and active low-dose aged garlic extract and participants with new adenomas. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Comparative safety research appropriate to the question; first check the basis of the original caution", "current_reports": [ "S1" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "The current record contains caution, unverified long-term safety and a need to check concomitant use. Actual harm events, comparative risk and causal estimates remain unverified.", "condition_status": "Partly verified", "status_reason": "The original caution's scope is preserved; safety outcomes or individual safety are not confirmed.", "missingness": "The original caution's scope is preserved; safety outcomes or individual safety are not confirmed.", "uncertainty": "The original caution's scope is preserved; safety outcomes or individual safety are not confirmed.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Original safety material linking events, comparisons, denominators, timing and alternatives" }, { "item_id": "N35", "question_type": "Evidence condition", "question": "Were original grade, score and axes inherited as new condition states?", "needed": "Native values for original C46, Caution, all axes, empty subclaims, Korean/English text, original URLs and corrections", "role": "Required", "role_reason": "Original history and current item-specific condition states must remain separate", "application_exception": "The original Codex independent-cross-check label is not promoted into current independent clinical certification.", "criterion": "Preserve all original bytes and source locations without creating new scores/grades, axis-derived fulfillment or independent clinical certification.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are Chamgap in-house application conditions developed with knowledge of the retained comparison of high-dose and active low-dose aged garlic extract and participants with new adenomas. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Traceability of original text, versions and change events rather than a new research requirement", "current_reports": [ "S1" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "Original C46, Caution, all axes/booleans, Korean/English text, empty arrays, URLs and corrections are preserved as native values in the retained summary. No new clinical judgment is made.", "condition_status": "Met", "status_reason": "Preservation of the original verdict and separation from new condition states are checked; the original grade is not recertified.", "missingness": "Preservation of the original verdict and separation from new condition states are checked; the original grade is not recertified.", "uncertainty": "Preservation of the original verdict and separation from new condition states are checked; the original grade is not recertified.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Original canonical/revised versions, locations and original-byte preservation records" }, { "item_id": "N36", "question_type": "Evidence condition", "question": "Were generic English wording and historical correction statements preserved?", "needed": "Current original English evidence/citation values, corrections dated 2026-09-14 and historical versus current access levels", "role": "Required", "role_reason": "A historical statement of specific translation replacement cannot establish numerical verification of current generic wording", "application_exception": "Do not replace current original English values with new specific translations or reconstruct/judge the historical correction itself.", "criterion": "Preserve current English wording and corrections as original values without presenting general-principle sentences as verification of specific denominators, results or funding.", "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.", "condition_origin": "These are Chamgap in-house application conditions developed with knowledge of the retained comparison of high-dose and active low-dose aged garlic extract and participants with new adenomas. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Traceability of bilingual original values and change history rather than a new clinical research requirement", "current_reports": [ "S1" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "observation": "The current English evidence/citation contains generic-principle wording, while corrections historically describe specific translation replacement. Both are preserved as original values.", "condition_status": "Met", "status_reason": "Original values and historical statements are preserved separately; specific English numerical verification or reconstruction of history is not established.", "missingness": "Original values and historical statements are preserved separately; specific English numerical verification or reconstruction of history is not established.", "uncertainty": "Original values and historical statements are preserved separately; specific English numerical verification or reconstruction of history is not established.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Canonical versions before/after correction and contemporary verification/access receipts" } ], "reports": [ { "report_id": "S1", "title": "Tanaka S et al. Hiroshima J Med Sci. 2004;53:39-45. PMID: 15726891.", "url": "https://pubmed.ncbi.nlm.nih.gov/15726891/", "report_type": "Retained record: a randomized double-blind comparison of high dose versus active low dose. Details of allocation, concealment, design unit and outcome reading remain unverified.", "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread, with access not attempted.", "study_family": "One report clue for Tanaka2004/PMID15726891. Endpoints and language summaries from the same 51 randomized and 37 efficacy-evaluable participants are not independent replications.", "independent_replication": "One currently retained report is distinct from a count of unique trials across the literature. No complete search for other reports or product-matched replications was conducted, and participant totals were not established.", "observed_result": "Among 37 efficacy-evaluable participants from 51 randomized, participants with new adenomas were high-dose 9/19 versus active low-dose 12/18, with reported RR0.71.", "result_level": "The selected result is the 0~12-month participant proportion. The exact 95%CI, P value and ITT result for the selected comparison remain unverified. P=.02 and .04 for later adenoma decrease and total size are separate results, with the exact analysis interval unverified.", "source_evidence_date": "2026-09-08", "materials": [ { "material_type": "Retained verdict summary", "public_status": "Retained verdict summary read", "access_status": "Retained copy acquired; summary read", "acquired": true, "actually_read": "Stored existing review summary read", "as_of": "2026-10-06", "qualification": "Relevant content in the retained Korean/English summary, evidence and citation was read. This does not establish acquisition or reading of the original clinical paper. The 2004 report by Tanaka and colleagues is a citation linked in the retained summary. External abstracts, full texts, registration, protocols and analysis plans were not read in this conversion, and independent clinical validation was not performed. The material check date is the original date retained in the summary and condition records. The original verdict-review date does not establish a search cut-off or historical access dates for individual materials; external access was not attempted in this conversion." }, { "material_type": "PubMed bibliographic/abstract gateway", "public_status": "Bibliographic link retained; external material unread", "access_status": "External access not attempted; not acquired", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-06", "qualification": "This is the PubMed link from the retained citation. The current response, bibliographic identity, abstract content and public access were not checked. The 2004 report by Tanaka and colleagues is a citation linked in the retained summary. External abstracts, full texts, registration, protocols and analysis plans were not read in this conversion, and independent clinical validation was not performed. The material check date is the original date retained in the summary and condition records. The original verdict-review date does not establish a search cut-off or historical access dates for individual materials; external access was not attempted in this conversion." }, { "material_type": "Original full text and supplements; location unverified", "public_status": "Full-text and supplement location unverified; unread", "access_status": "External access not attempted; not acquired", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-06", "qualification": "The DOI, PMCID, and identity and location of the full text and supplements remain unverified. Access was not attempted; this does not establish absence of a publicly available full text. The 2004 report by Tanaka and colleagues is a citation linked in the retained summary. External abstracts, full texts, registration, protocols and analysis plans were not read in this conversion, and independent clinical validation was not performed. The material check date is the original date retained in the summary and condition records. The original verdict-review date does not establish a search cut-off or historical access dates for individual materials; external access was not attempted in this conversion." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/15726891/" } ] } ], "method_sources": [ { "id": "M03", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03", "section": "§3.1, §3.2.1–3.2.3, MECIR C5/C7/C13", "official_principle": "Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.", "review_level": "Retained method-application records were reused. External originals were not reread and method content was not reassessed." }, { "id": "M04", "version": "Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04", "section": "§4.5, §4.6.1–4.6.3, MECIR C42", "official_principle": "Distinguish studies from reports and link them; do not omit a study solely because results are unreported.", "review_level": "Retained method-application records were reused. External originals were not reread and method content was not reassessed." }, { "id": "M08", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08", "section": "§8.1–8.2.3, Table 8.2.a", "official_principle": "Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.", "review_level": "Retained method-application records were reused. External originals were not reread and method content was not reassessed." }, { "id": "M15", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15", "section": "§15.2.4, §15.3.1–15.3.3", "official_principle": "Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.", "review_level": "Retained method-application records were reused. External originals were not reread and method content was not reassessed." }, { "id": "M19", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19", "section": "§19.1.2, §19.2.1–19.2.4", "official_principle": "Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.", "review_level": "Retained method-application records were reused. External originals were not reread and method content was not reassessed." } ], "status_dictionary": { "Partly verified": "Some required facts are known, but the stated conditions involving analyses, populations, formulation or denominators remain unverified.", "Unverified": "Direct information is unverified in the retained record. This does not establish an effect of 0, no studies or absence of harm.", "Review incomplete": "Reading of the material or review of a condition is incomplete. This does not establish absence of studies or efficacy.", "Not reported": "The needed information was not found in material actually read. This is distinguished from unread material.", "Inaccessible": "Access was actually attempted but the material was not acquired. This is distinguished from access not attempted.", "Insufficient evidence matching the conditions": "Evidence directly matching the defined question and conditions is insufficient. This does not establish absence of all research.", "Not applicable": "A specific condition does not apply to the question. This does not substitute for unread or unverified material.", "Conflicting data": "This covers discrepancies in material about the same question, denominator and timing. Differences between separate questions are not automatically treated as conflicts.", "Met": "The retained identity, observation or scope required by this item was checked within stated limits. This does not establish preventive efficacy or full-text certification." }, "study_overlap": { "state": "Unverified", "unique_trial_count": null, "unique_participant_count": null, "reason": "The retained evidence and citation link to Tanaka2004/PMID15726891. The same trial’s 51 randomized and 37 efficacy-evaluable participants, endpoints, time points and Korean/English summaries are not double-counted as independent trials or participants. Global unique-trial counts, participant totals and independent replication remain unverified." }, "history": [ { "date": "2026-10-26", "kind": "Separation of public-facing pages and materials", "view_version": "1.0", "change": "The public view and materials were prepared from the existing 36 items. No new clinical search, verification-state change or scoring was performed." } ], "language": "en", "translation_date": "2026-10-26" }