# Aged garlic extract liquid 2.4 mL/day × Prevention of colorectal-adenoma recurrence

Verdict 3061 · Evidence Check

Stored-material review date: 2026-10-06  
Original evidence cut-off: 2026-09-08  
Review-criteria version: 1.0  
Public page/material preparation date: 2026-10-26

Clinical papers were not read directly; existing review summaries were checked. No new clinical-literature search was performed. Unverified does not mean that research is absent or that there is no effect.

## Assessment scope

- 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.
- Ingredient, formulation and route: 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.
- Measured outcome: 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.
- Questions outside this scope: 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.

## Checklist items

### N01 · Which adenoma outcome is compared with what?

Verification status: Met  
Reading scope: 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.

- Current findings: 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.
- Why unverified: The retained question and excluded extensions were checked; recurrence or cancer-prevention efficacy was not confirmed.
- Reason for missing information: The retained question and excluded extensions were checked; recurrence or cancer-prevention efficacy was not confirmed.
- Required materials and conditions: Prior adenomas, extent of lesion removal, high-dose/active low-dose AGE and the 0~12-month participant endpoint
- Materials to obtain first: The trial's eligibility criteria, baseline lesion map and endpoint definition
- Further research: A separate study directly measuring the relevant population and endpoint for recurrence after complete removal or colorectal cancer
- Conditions for verification: Preserve the original claim and limit the selected question to the proportion with a new adenoma over 0~12 months versus active low dose.
- Why this condition is needed: Needed to avoid replacing the observed trial result with prevention after complete removal or cancer prevention
- Application exceptions: Adenoma count, size and colorectal cancer are separate endpoints and are not combined as required confirmation in this table.
- Remaining uncertainty: The retained question and excluded extensions were checked; recurrence or cancer-prevention efficacy was not confirmed.
- Referenced methods: 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.
- Related sources: S1

### N02 · Which adults with prior adenomas were included?

Verification status: Partly verified  
Reading scope: 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.

- Current findings: 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.
- Why unverified: The population label is checked, but detailed eligibility, representativeness and group characteristics remain unverified.
- Reason for missing information: The population label is checked, but detailed eligibility, representativeness and group characteristics remain unverified.
- Required materials and conditions: Diagnosis, age, baseline risk, eligibility/exclusions, care setting and group characteristics
- Materials to obtain first: The trial's eligibility criteria and group baseline table
- Further research: A prespecified comparison stratified by baseline lesions and risk; first check the existing selection table
- Conditions for verification: 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.
- Why this condition is needed: The prior-adenoma population must be distinguished from the general population and groups with complete removal
- Application exceptions: The whole-trial size of 51 randomized participants is not used as group baseline characteristics or representativeness.
- Remaining uncertainty: The population label is checked, but detailed eligibility, representativeness and group characteristics remain unverified.
- Referenced methods: 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.
- Related sources: S1

### N03 · Could smaller lesions have remained?

Verification status: Partly verified  
Reading scope: 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.

- Current findings: 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.
- Why unverified: The limitation in removal extent is checked, but new-versus-residual identification for individual lesions and complete removal remain unverified.
- Reason for missing information: The limitation in removal extent is checked, but new-versus-residual identification for individual lesions and complete removal remain unverified.
- Required materials and conditions: Initial removal size threshold, baseline lesion list, completeness of removal and identification of new lesions
- Materials to obtain first: Baseline/follow-up colonoscopy lesion maps, size thresholds and removal/new-lesion assessment records
- Further research: A recurrence study prespecifying confirmation of complete removal and lesion matching
- Conditions for verification: 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.
- Why this condition is needed: Residual lesions and new recurrence after complete removal are different conditions
- Application exceptions: Removal of lesions larger than 5 mm is not converted into removal of all lesions.
- Remaining uncertainty: The limitation in removal extent is checked, but new-versus-residual identification for individual lesions and complete removal remain unverified.
- Referenced methods: 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.
- Related sources: S1

### N04 · What were the specifications of the AGE capsules actually administered?

Verification status: Partly verified  
Reading scope: 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.

- Current findings: Liquid-equivalent AGE capsules and oral administration are stated. SAC and dry-matter equivalents are unverified in the original material.
- Why unverified: The formulation and route are named, but actual product specifications and component quantities remain unverified.
- Reason for missing information: The formulation and route are named, but actual product specifications and component quantities remain unverified.
- Required materials and conditions: Aged extract, liquid-equivalent capsules, manufacture/batch, SAC and dry-matter equivalents, and route
- Materials to obtain first: Trial-product specifications, content/batch analyses and the basis for liquid-to-capsule equivalence
- Further research: A replication using a specification-verified preparation; first obtain the existing product specifications
- Conditions for verification: Distinguish the name of the oral liquid-equivalent AGE capsules from verified or unverified actual specifications, component quantities and product matching.
- Why this condition is needed: Liquid-equivalent quantity cannot be arbitrarily converted into SAC or dry-matter mass
- Application exceptions: Raw garlic, powder, oil, black garlic and isolated SAC are not substituted as the same preparation.
- Remaining uncertainty: The formulation and route are named, but actual product specifications and component quantities remain unverified.
- Referenced methods: 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.
- Related sources: S1

### N05 · Were actual intakes of 2.4 mL and 0.16 mL checked?

Verification status: Partly verified  
Reading scope: 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.

- Current findings: High-dose 2.4 mL/day versus low-dose 0.16 mL/day is recorded. Frequency, actual intake and component quantities are unverified.
- Why unverified: A nominal dose comparison exists, but actual exposure and a general optimal dose remain unverified.
- Reason for missing information: A nominal dose comparison exists, but actual exposure and a general optimal dose remain unverified.
- Required materials and conditions: Group nominal liquid-equivalent quantities, frequency, adherence, actual intake and product content
- Materials to obtain first: Administration schedules, pill-return/intake records, adherence and component-content material
- Further research: A dose comparison prospectively tracking component quantities and adherence
- Conditions for verification: Distinguish nominal high-dose 2.4 mL/day versus low-dose 0.16 mL/day from unverified actual exposure and adherence.
- Why this condition is needed: Nominal high/low-dose comparisons must be separated from differences in actual exposure
- Application exceptions: Liquid-equivalent quantities are not converted to dry-matter mg or actual component quantities.
- Remaining uncertainty: A nominal dose comparison exists, but actual exposure and a general optimal dose remain unverified.
- Referenced methods: 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.
- Related sources: S1

### N06 · Was the comparator placebo or active low-dose AGE?

Verification status: Met  
Reading scope: 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.

- Current findings: The comparator was low-dose AGE 0.16 mL/day. The original text describes it as an active low-dose control.
- Why unverified: The actual comparison structure is preserved; this does not establish an effect versus placebo or inactivity of the low dose.
- Reason for missing information: The actual comparison structure is preserved; this does not establish an effect versus placebo or inactivity of the low dose.
- Required materials and conditions: Comparator preparation, components, dose, placebo/no-treatment status and comparison direction
- Materials to obtain first: Component, appearance, content and exposure specifications for the comparator capsules
- Further research: For a placebo question, a direct comparison of the same high-dose preparation with an appropriate placebo
- Conditions for verification: State the actual comparison of high dose versus active low-dose 0.16 mL/day and separately retain effects versus placebo as unverified.
- Why this condition is needed: Needed to avoid converting a result versus active low dose into an effect versus placebo
- Application exceptions: The low dose is not assumed to be biologically inactive or placebo.
- Remaining uncertainty: The actual comparison structure is preserved; this does not establish an effect versus placebo or inactivity of the low dose.
- Referenced methods: 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.
- Related sources: S1

### N07 · How are supplementation duration and colonoscopy visits distinguished?

Verification status: Partly verified  
Reading scope: 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.

- Current findings: 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.
- Why unverified: Supplementation and visit information exists, but intervals and persistence for all results cannot be established.
- Reason for missing information: Supplementation and visit information exists, but intervals and persistence for all results cannot be established.
- Required materials and conditions: 12 months of supplementation, colonoscopy at 6/12 months, observation windows and follow-up after stopping
- Materials to obtain first: Visit schedules, actual colonoscopy times and analysis-interval definitions
- Further research: A study prespecifying follow-up times and persistence after stopping
- Conditions for verification: 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.
- Why this condition is needed: Visit times must not be treated as the exact interval for each analysis
- Application exceptions: Recorded visits at 6 and 12 months do not establish the exact analysis interval for later P values.
- Remaining uncertainty: Supplementation and visit information exists, but intervals and persistence for all results cannot be established.
- Referenced methods: 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.
- Related sources: S1

### N08 · How were participants with new adenomas identified?

Verification status: Partly verified  
Reading scope: 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.

- Current findings: 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.
- Why unverified: The endpoint name and participant unit are checked, but details of measurement reproducibility and new-lesion identification remain unverified.
- Reason for missing information: The endpoint name and participant unit are checked, but details of measurement reproducibility and new-lesion identification remain unverified.
- Required materials and conditions: Participants with at least one new adenoma over 0~12 months, colonoscopy/histological assessment, assessors and lesion matching
- Materials to obtain first: The trial's endpoint definition, colonoscopy/histological assessment guidance and assessor-blinding material
- Further research: A comparison prespecifying identification of new lesions and central reading
- Conditions for verification: Link the participant-level endpoint definition to the scope of verified assessment methods, assessor blinding and measurement limitations.
- Why this condition is needed: Participant proportions, adenoma counts and sizes are different endpoints
- Application exceptions: Adenoma is not a directly measured colorectal-cancer event.
- Remaining uncertainty: The endpoint name and participant unit are checked, but details of measurement reproducibility and new-lesion identification remain unverified.
- Referenced methods: 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.
- Related sources: S1

### N09 · How were random allocation and concealment performed?

Verification status: Partly verified  
Reading scope: 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.

- Current findings: A randomized double-blind high-dose versus low-dose comparison is recorded. Details of allocation sequence, concealment and design unit are absent.
- Why unverified: The design is named, but material verifying the actual allocation process and concealment remains unverified.
- Reason for missing information: The design is named, but material verifying the actual allocation process and concealment remains unverified.
- Required materials and conditions: High/low-dose allocation, random sequence, concealment, design unit and group baseline balance
- Materials to obtain first: Allocation methods, concealment procedures, original protocol and group baseline table
- Further research: A replicated comparison clearly reporting the allocation sequence, concealment and design unit
- Conditions for verification: Distinguish the record of a randomized double-blind high/low-dose comparison from unverified sequence, concealment and design unit.
- Why this condition is needed: The summary label of randomization cannot establish adequacy of allocation methods
- Application exceptions: Unverified design details do not automatically establish nonapplication of crossover/cluster handling.
- Remaining uncertainty: The design is named, but material verifying the actual allocation process and concealment remains unverified.
- Referenced methods: 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.
- Related sources: S1

### N10 · Did double blinding cover both participants and outcome readers?

Verification status: Partly verified  
Reading scope: 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.

- Current findings: The bibliographic/design description says double blind. Methods for colonoscopy readers and analysts are absent from the current summary.
- Why unverified: Blinding is named, but actual blinding of outcome reading and analysis remains unverified.
- Reason for missing information: Blinding is named, but actual blinding of outcome reading and analysis remains unverified.
- Required materials and conditions: Blinding of participants, providers, colonoscopy readers and analysts, and how blinding was maintained
- Materials to obtain first: Blinding targets/maintenance procedures, reading guidance and unblinding records
- Further research: A study specifying assessor blinding and reading reproducibility
- Conditions for verification: Separately describe the recorded targets and methods of double blinding and uncertainties relevant to colonoscopy outcome measurement.
- Why this condition is needed: Supplementation blinding and outcome-reader blinding must be distinguished
- Application exceptions: The double-blind label is not used as confirmation that all assessors were blinded.
- Remaining uncertainty: Blinding is named, but actual blinding of outcome reading and analysis remains unverified.
- Referenced methods: 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.
- Related sources: S1

### N11 · Were prior adenomas and baseline lesions similar between groups?

Verification status: Unverified  
Reading scope: 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.

- Current findings: Overall prior adenomas and 51 randomized participants are recorded, but a group baseline table is absent from the retained material.
- Why unverified: Balance or differences in baseline lesions and risk between groups could not be checked.
- Reason for missing information: Balance or differences in baseline lesions and risk between groups could not be checked.
- Required materials and conditions: Group history, baseline adenoma count/size, age, concurrent exposures and baseline comparisons
- Materials to obtain first: Group baseline characteristics and baseline colonoscopy lesion tables
- Further research: A comparison prespecifying baseline-risk stratification and an adjustment plan
- Conditions for verification: State the scope of baseline group comparisons and identify unavailable items.
- Why this condition is needed: Baseline lesion differences in a small trial are relevant to interpretation
- Application exceptions: A randomization label does not automatically guarantee baseline balance.
- Remaining uncertainty: Balance or differences in baseline lesions and risk between groups could not be checked.
- Referenced methods: 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.
- Related sources: S1

### N12 · Are the 51 randomized and 37 efficacy-evaluable participants distinguished?

Verification status: Partly verified  
Reading scope: 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.

- Current findings: 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.
- Why unverified: Event denominators for the efficacy-evaluable population exist, but correspondence with group randomized/completed/whole-analysis populations remains unverified.
- Reason for missing information: Event denominators for the efficacy-evaluable population exist, but correspondence with group randomized/completed/whole-analysis populations remains unverified.
- Required materials and conditions: Whole-trial and group randomized/analyzed/completed/event denominators and analysis populations
- Materials to obtain first: Participant flow and group randomized/completed/analyzed/event tables
- Further research: A comparison specifying all randomized participants and each analysis population
- Conditions for verification: Link 51 randomized, 37 efficacy-evaluable and 9/19 versus 12/18 to their analysis, retaining unverified group randomized/completed denominators.
- Why this condition is needed: Event denominators in the efficacy-evaluable population must not be converted to randomized-group denominators
- Application exceptions: The 37 participants are not treated as ITT for all randomized participants or as the original recruitment denominator.
- Remaining uncertainty: Event denominators for the efficacy-evaluable population exist, but correspondence with group randomized/completed/whole-analysis populations remains unverified.
- Referenced methods: 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.
- Related sources: S1

### N13 · Does the efficacy-evaluable result estimate an ITT allocation effect?

Verification status: Unverified  
Reading scope: 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.

- Current findings: 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.
- Why unverified: The representative RR cannot be established as an ITT allocation effect.
- Reason for missing information: The representative RR cannot be established as an ITT allocation effect.
- Required materials and conditions: ITT/PP, efficacy-evaluable inclusion criteria, effect of interest and adjusted/unadjusted analyses
- Materials to obtain first: Analysis plan, efficacy-evaluable inclusion criteria and ITT/sensitivity analyses
- Further research: A comparison prespecifying and separately reporting allocation and adherence effects
- Conditions for verification: Preserve the recorded efficacy-evaluable population and explain definitions and uncertainties for allocation effects, adherence effects and adjustment.
- Why this condition is needed: The result for 37 efficacy-evaluable participants cannot be inherited as an allocation effect for 51 randomized participants
- Application exceptions: Unverified ITT and absence of an ITT result are described only within the retained scope.
- Remaining uncertainty: The representative RR cannot be established as an ITT allocation effect.
- Referenced methods: 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.
- Related sources: S1

### N14 · Who was excluded from the efficacy analysis and how was this handled?

Verification status: Partly verified  
Reading scope: 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.

- Current findings: The original text describes 27% efficacy-analysis exclusion. Group-specific reasons, handling and sensitivity results are absent from the current summary.
- Why unverified: The denominator difference and original exclusion statement are checked, but the structure and impact of missingness remain unverified.
- Reason for missing information: The denominator difference and original exclusion statement are checked, but the structure and impact of missingness remain unverified.
- Required materials and conditions: Group attrition/exclusions, reasons, missing-data handling, sensitivity analyses and analysis timing
- Materials to obtain first: Participant flow, group exclusion reasons, missing-data handling and sensitivity analyses
- Further research: A comparison tracking all outcomes and prespecifying missing-data handling
- Conditions for verification: Preserve the original randomized/evaluable distinction and historical 27% statement, leaving group reasons, handling and bias magnitude unverified.
- Why this condition is needed: The limitations of efficacy-analysis selection and missingness must be explained
- Application exceptions: Retain the original 27% efficacy-analysis exclusion without calculating a new excluded count or percentage.
- Remaining uncertainty: The denominator difference and original exclusion statement are checked, but the structure and impact of missingness remain unverified.
- Referenced methods: 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.
- Related sources: S1

### N15 · Which analysis and direction does RR0.71 represent?

Verification status: Partly verified  
Reading scope: 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.

- Current findings: 9/19 versus 12/18 and RR0.71 are retained. Adjustment status, model and absolute difference are unverified in this summary.
- Why unverified: The reported RR and direction are available, but the full effect-estimate definition and absolute effect remain unverified.
- Reason for missing information: The reported RR and direction are available, but the full effect-estimate definition and absolute effect remain unverified.
- Required materials and conditions: High dose versus low dose, participant event proportions, reported RR, adjustment status and model
- Materials to obtain first: The original outcome table, RR analysis/model, adjustment variables and analysis population
- Further research: A comparison prospectively reporting relative and absolute effects with their analysis definitions
- Conditions for verification: Link reported RR0.71 only to participants with a new adenoma over 0~12 months, marking adjustment, model and absolute-effect uncertainties.
- Why this condition is needed: RR, absolute difference, within-group change and adenoma-count decrease are different measures
- Application exceptions: Do not recalculate a new RR, absolute difference or percentage from 9/19 versus 12/18.
- Remaining uncertainty: The reported RR and direction are available, but the full effect-estimate definition and absolute effect remain unverified.
- Referenced methods: 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.
- Related sources: S1

### N16 · Can the interval and importance of the representative RR be interpreted?

Verification status: Unverified  
Reading scope: 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.

- Current findings: 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.
- Why unverified: Without a reported interval, the relationship between the range of possible effects and importance cannot be assessed.
- Reason for missing information: Without a reported interval, the relationship between the range of possible effects and importance cannot be assessed.
- Required materials and conditions: The selected comparison's 95%CI, denominators, P value and prespecified importance criterion
- Materials to obtain first: The representative outcome table's 95%CI, test definition and basis for importance
- Further research: A comparison prospectively justifying importance and precision planning for the clinical question
- Conditions for verification: Record the originally reported interval and importance criterion for the selected RR, or why these were not checked, without creating a new grade.
- Why this condition is needed: A point estimate alone cannot establish an effect range or importance
- Application exceptions: Do not invent a common minimum sample size, CI or importance threshold.
- Remaining uncertainty: Without a reported interval, the relationship between the range of possible effects and importance cannot be assessed.
- Referenced methods: 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.
- Related sources: S1

### N17 · Were later P=.02/.04 values attached to the representative recurrence result?

Verification status: Met  
Reading scope: 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.

- Current findings: P=.02 and .04 are retained as separate results for later adenoma decrease and total size. The exact later analysis interval remains unverified.
- Why unverified: Attribution of numbers and uncertainty boundaries is preserved; significance of the representative RR was not confirmed.
- Reason for missing information: Attribution of numbers and uncertainty boundaries is preserved; significance of the representative RR was not confirmed.
- Required materials and conditions: Endpoint/analysis-interval correspondence between later decrease, total size and the 0~12-month participant result
- Materials to obtain first: Endpoint-specific outcome tables, P-value targets and the later analysis-interval definition
- Further research: A report prespecifying analyses by endpoint/time and multiplicity
- Conditions for verification: Separate later-decrease/total-size P values from the selected participant result and retain the exact analysis interval as unverified.
- Why this condition is needed: P values from other endpoints must not be converted into significance for the representative RR
- Application exceptions: Colonoscopy visits at 6/12 months do not establish the later analysis interval as 6~12 months.
- Remaining uncertainty: Attribution of numbers and uncertainty boundaries is preserved; significance of the representative RR was not confirmed.
- Referenced methods: 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.
- Related sources: S1

### N18 · Were the selected endpoint, analysis and timing prespecified?

Verification status: Unverified  
Reading scope: 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.

- Current findings: 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.
- Why unverified: Agreement or differences between prior plans and actual reporting could not be compared.
- Reason for missing information: Agreement or differences between prior plans and actual reporting could not be compared.
- Required materials and conditions: Registration, protocol, SAP, primary/secondary endpoints, change history and actual reporting
- Materials to obtain first: The original registration number/timing, protocol, SAP and explanations of changes
- Further research: A comparison preregistering the question, endpoints, analyses and timing and publishing all results
- Conditions for verification: Distinguish acquisition/reading of registration/plans, the scope of comparisons with the selected endpoint/analysis/timing and items not compared.
- Why this condition is needed: The actual level of comparison between prior planning and selective reporting must be stated
- Application exceptions: Unverified registration is not converted into confirmed nonregistration or selective reporting.
- Remaining uncertainty: Agreement or differences between prior plans and actual reporting could not be compared.
- Referenced methods: 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.
- Related sources: S1

### N19 · How were other preventive interventions and adherence handled between groups?

Verification status: Unverified  
Reading scope: 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.

- Current findings: A high/low-dose comparison exists, but group-specific medicines, diet, additional intake and adherence data are absent from the current summary.
- Why unverified: The scope for checking concurrent interventions, actual exposure differences and handling is insufficient.
- Reason for missing information: The scope for checking concurrent interventions, actual exposure differences and handling is insufficient.
- Required materials and conditions: Concurrent medicines, diet, additional garlic, rescue treatment and group adherence/changes
- Materials to obtain first: Group concomitant-treatment, diet and adherence records and analysis handling
- Further research: A comparison prospectively tracking and analyzing concurrent exposures and adherence
- Conditions for verification: Explain verified and unverified group concomitant use, adherence and changes in relation to the effect of interest.
- Why this condition is needed: Differences other than high/low dose must be distinguished from the outcome
- Application exceptions: Do not require all changes to be identical between groups or treat missing records as equality.
- Remaining uncertainty: The scope for checking concurrent interventions, actual exposure differences and handling is insufficient.
- Referenced methods: 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.
- Related sources: S1

### N20 · Are a trial's summary and citation counted as separate replications?

Verification status: Partly verified  
Reading scope: 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.

- Current findings: The evidence and citation link Tanaka2004/PMID15726891. Korean/English/combined summaries are not counted as additional trials.
- Why unverified: Local report links exist, but the scope of all related reports and unique families/participants remains unverified.
- Reason for missing information: Local report links exist, but the scope of all related reports and unique families/participants remains unverified.
- Required materials and conditions: Tanaka2004, PMID15726891, evidence/citation and related registration/report families
- Materials to obtain first: Family comparison of the original report, registration, related reports and included-trial tables
- Further research: Independent replication matching product, population and endpoint; first organize existing related-report families
- Conditions for verification: Link the current 1 evidence summary/1 citation and bilingual restatements as the same report clue, leaving global unique-trial/participant counts undetermined.
- Why this condition is needed: Repeated citation of one report must not be counted as independent confirmation
- Application exceptions: A single current report clue does not establish a count of 1 unique trial across the entire literature.
- Remaining uncertainty: Local report links exist, but the scope of all related reports and unique families/participants remains unverified.
- Referenced methods: 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.
- Related sources: S1

### N21 · Can differences in results across unique trials be compared?

Verification status: Unverified  
Reading scope: 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.

- Current findings: 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.
- Why unverified: The historical statement of no independent confirmation is not converted into absence of all current studies or confirmed consistency.
- Reason for missing information: The historical statement of no independent confirmation is not converted into absence of all current studies or confirmed consistency.
- Required materials and conditions: Family-specific results for the same endpoint, formulation/population/timing differences and null/unfavorable results
- Materials to obtain first: Existing related-report lists, family-specific results/conditions and inclusion/exclusion records
- Further research: Replication of independent studies matching formulation, population and endpoint, with disclosure of the result distribution
- Conditions for verification: Distinguish endpoint differences within the retained report clue from unverified comparisons across unique studies.
- Why this condition is needed: Inter-study consistency requires identifying unique families first
- Application exceptions: Do not label later-endpoint differences as inter-study conflict or external non-search as absence of contrary results.
- Remaining uncertainty: The historical statement of no independent confirmation is not converted into absence of all current studies or confirmed consistency.
- Referenced methods: 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.
- Related sources: S1

### N22 · Were product supply, funding and author interests distinguished?

Verification status: Partly verified  
Reading scope: 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.

- Current findings: The original text describes product supply as I1, while the evidence funding entry says details of AGE-related commercial involvement are unverified.
- Why unverified: A historical product-related clue exists, but funding, supply, author employment/patents and declaration details remain unverified.
- Reason for missing information: A historical product-related clue exists, but funding, supply, author employment/patents and declaration details remain unverified.
- Required materials and conditions: AGE commercial involvement, product supply, funding, author employment/patents and declared COI
- Materials to obtain first: Original-paper funding/COI, product-supply and author-affiliation/patent material
- Further research: Independent replication and data disclosure specifying manufacturer roles and funding
- Conditions for verification: Link the original product-supply statement to unverified commercial details and distinguish the actual level of verification for funding and author relationships.
- Why this condition is needed: The original I1 axis or product-supply statement does not establish all funding information
- Application exceptions: Do not automatically exclude commercial involvement or treat unverified details as independent research.
- Remaining uncertainty: A historical product-related clue exists, but funding, supply, author employment/patents and declaration details remain unverified.
- Referenced methods: 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.
- Related sources: S1

### N23 · Was the material now read a summary or the original full paper?

Verification status: Met  
Reading scope: 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.

- Current findings: 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.
- Why unverified: The honest distinction in current reading level is checked; original-paper content verification is not established.
- Reason for missing information: The honest distinction in current reading level is checked; original-paper content verification is not established.
- Required materials and conditions: Retained summary, citation, external abstract/full text, acquisition/reading and original location/identity
- Materials to obtain first: Lawful access, acquisition and actual reading of the original paper/supplements, with table/section locations
- Further research: First obtain access records for existing originals; access alone does not establish a new effect
- Conditions for verification: Record actual reading of the retained summary separately from unread external material and link reading to exact locations, values and identity.
- Why this condition is needed: Needed to avoid presenting summary reading as full-text reading
- Application exceptions: External access not attempted does not mean failed access or absence of a publicly available full text.
- Remaining uncertainty: The honest distinction in current reading level is checked; original-paper content verification is not established.
- Referenced methods: 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.
- Related sources: S1

### N24 · What review date and search scope does this record represent?

Verification status: Partly verified  
Reading scope: 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.

- Current findings: 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.
- Why unverified: A review date and historical statement exist, but the current full-literature search/retraction status and individual access history remain unverified.
- Reason for missing information: A review date and historical statement exist, but the current full-literature search/retraction status and individual access history remain unverified.
- Required materials and conditions: Original verdict-review date, historical abstract-comparison statement, current local-review date and search/correction/retraction scope
- Materials to obtain first: Existing search expressions/scope, access receipts and correction/retraction comparison records
- Further research: If an update is requested, a literature update recording search scope/date and exclusion/selection reasons
- Conditions for verification: Separate the original review date 2026-09-08 from the local-conversion date and mark unverified historical access dates/levels and search cutoff.
- Why this condition is needed: The original review date must not be used as a current external-access date or search cutoff
- Application exceptions: A new search not performed is not described as 0 current studies or no retractions.
- Remaining uncertainty: A review date and historical statement exist, but the current full-literature search/retraction status and individual access history remain unverified.
- Referenced methods: 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.
- Related sources: S1

### N25 · Does the 12-month adenoma result answer persistence after stopping or cancer prevention?

Verification status: Partly verified  
Reading scope: 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.

- Current findings: 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.
- Why unverified: The current endpoint boundary is checked, but direct evidence for persistence after stopping or cancer events remains unverified in this retained scope.
- Reason for missing information: The current endpoint boundary is checked, but direct evidence for persistence after stopping or cancer events remains unverified in this retained scope.
- Required materials and conditions: The selected 12-month result, persistence after stopping, clinical cancer events and direct estimates
- Materials to obtain first: Follow-up after stopping and direct clinical events such as colorectal cancer
- Further research: Follow-up and direct clinical-endpoint research appropriate to long-term persistence/cancer-event questions
- Conditions for verification: Separate the 12-month participant endpoint from unverified extensions concerning persistence after stopping and colorectal-cancer prevention.
- Why this condition is needed: Needed to distinguish the original narrow participant endpoint from separate long-term/cancer-prevention questions
- Application exceptions: Cancer-event studies are not imposed as mandatory fulfillment conditions for the current adenoma-endpoint record.
- Remaining uncertainty: The current endpoint boundary is checked, but direct evidence for persistence after stopping or cancer events remains unverified in this retained scope.
- Referenced methods: 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.
- Related sources: S1

### N26 · What adverse events were collected and how?

Verification status: Unverified  
Reading scope: 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.

- Current findings: A caution label, unverified long-term safety and concomitant-use cautions are stated. Actual event definitions, collection methods and outcome tables are absent.
- Why unverified: A safety label exists, but actual adverse-event collection and occurrence for the selected exposure could not be checked.
- Reason for missing information: A safety label exists, but actual adverse-event collection and occurrence for the selected exposure could not be checked.
- Required materials and conditions: Event definitions, systematic/spontaneous collection, severity, incident/worsening events and stopping criteria
- Materials to obtain first: Trial adverse-event definitions, collection methods, group outcomes and stopping criteria
- Further research: Safety follow-up prespecifying event definitions, systematic collection, severity and stopping
- Conditions for verification: Link actual events, collection level and uncertainties for the same population/exposure, keeping efficacy and harm states separate.
- Why this condition is needed: A caution label cannot substitute for actual adverse-event collection results
- Application exceptions: Unreported harms do not justify deleting efficacy material or declaring absence of harm.
- Remaining uncertainty: A safety label exists, but actual adverse-event collection and occurrence for the selected exposure could not be checked.
- Referenced methods: 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.
- Related sources: S1

### N27 · Are the times of adverse-event onset, stopping and recovery known?

Verification status: Unverified  
Reading scope: 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.

- Current findings: 12 months of supplementation is checked, but event-onset, stopping, recovery and re-exposure timelines are absent from the retained material.
- Why unverified: Exposure duration cannot be converted into proof of the event's temporal relationship.
- Reason for missing information: Exposure duration cannot be converted into proof of the event's temporal relationship.
- Required materials and conditions: Exposure start/stop, event onset, recovery, re-exposure, latency and follow-up windows
- Materials to obtain first: Event timelines, stopping/recovery and exposure/follow-up records
- Further research: Safety research prospectively tracking exposure and event timelines
- Conditions for verification: Distinguish the 12-month supplementation record from verified/unverified event timelines without inferring recovery or re-exposure.
- Why this condition is needed: Temporal relationships and long-term windows require review when actual events are reported
- Application exceptions: 12 months of supplementation is not used as latency or complete follow-up for all harms.
- Remaining uncertainty: Exposure duration cannot be converted into proof of the event's temporal relationship.
- Referenced methods: 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.
- Related sources: S1

### N28 · Can high-dose and low-dose risks be compared?

Verification status: Unverified  
Reading scope: 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.

- Current findings: Efficacy concerns active high/low dose, but group harm events and comparative-risk estimates are absent from the current summary.
- Why unverified: The comparison design does not establish verified group safety.
- Reason for missing information: The comparison design does not establish verified group safety.
- Required materials and conditions: Group events, comparator, analysis population and actual comparative-risk estimates
- Materials to obtain first: Group harm outcomes, exposure/analysis denominators and risk comparisons
- Further research: A prespecified safety comparison of the same high/low-dose product; a nonexposure question requires a separate comparison
- Conditions for verification: Distinguish the active high/low-dose design from whether actual group harm comparisons are provided, retaining missing comparative estimates as unverified.
- Why this condition is needed: An efficacy comparator does not guarantee the existence of harm-comparison data
- Application exceptions: The low-dose control is not substituted for nonexposure or background incidence.
- Remaining uncertainty: The comparison design does not establish verified group safety.
- Referenced methods: 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.
- Related sources: S1

### N29 · Are event and exposure denominators available for harm frequency?

Verification status: Unverified  
Reading scope: 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.

- Current findings: Randomized/efficacy-evaluable denominators exist, but separate harm events, safety denominators and exposure time remain unverified in the summary.
- Why unverified: The event-denominator link needed to state harm frequency remains unverified.
- Reason for missing information: The event-denominator link needed to state harm frequency remains unverified.
- Required materials and conditions: Group exposed populations, affected people/event counts, exposure/follow-up time and collection scope
- Materials to obtain first: Group safety-analysis populations and event/exposure-time tables
- Further research: Follow-up publishing safety denominators, exposure time and all events together
- Conditions for verification: Present frequencies only from reported values linking harm events to their exposure/follow-up denominators, retaining unverified denominators.
- Why this condition is needed: The efficacy denominators of 51/37 participants must not substitute for safety-analysis denominators
- Application exceptions: Do not use efficacy events 9/19 versus 12/18 as adverse-event counts or calculate new incidence.
- Remaining uncertainty: The event-denominator link needed to state harm frequency remains unverified.
- Referenced methods: 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.
- Related sources: S1

### N30 · Were antithrombotic or procedure-related details checked?

Verification status: Partly verified  
Reading scope: 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.

- Current findings: The original text calls for checking anticoagulants, antiplatelet medicines and peri-procedural use. Actual concomitant-use/event records for trial participants are absent.
- Why unverified: The concomitant-use context needing review is recorded, but actual interactions and alternative causes remain unverified.
- Reason for missing information: The concomitant-use context needing review is recorded, but actual interactions and alternative causes remain unverified.
- Required materials and conditions: Actual concomitant medicines, procedures, baseline conditions, alternative causes and group exposure/adjustment
- Materials to obtain first: Actual concomitant medicines, procedure schedules, baseline events and group harm/adjustment data
- Further research: Appropriate safety observation for clinically relevant concomitant-use/procedural settings
- Conditions for verification: Distinguish the original concomitant-use/procedural caution from unverified actual co-exposures and alternative explanations.
- Why this condition is needed: Original cautions and actual participant concomitant-use records are different information
- Application exceptions: The caution is not treated as a finding that an interaction was observed in this trial.
- Remaining uncertainty: The concomitant-use context needing review is recorded, but actual interactions and alternative causes remain unverified.
- Referenced methods: 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.
- Related sources: S1

### N31 · Who was missing from safety follow-up?

Verification status: Unverified  
Reading scope: 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.

- Current findings: Efficacy-analysis exclusion is described, but safety follow-up losses and reasons for noncollection are not separately verified.
- Why unverified: Efficacy missingness is not inherited as safety missingness, and bias magnitude is not established.
- Reason for missing information: Efficacy missingness is not inherited as safety missingness, and bias magnitude is not established.
- Required materials and conditions: Safety collection/selection, follow-up losses, group noncollection and disclosure of all events
- Materials to obtain first: Safety participant flow, reasons for noncollection and disclosure records for all events
- Further research: Observation disclosing safety follow-up for all exposed participants and reasons for noncollection
- Conditions for verification: Separate efficacy-population exclusions from safety follow-up losses and retain unverified collection/selection/missingness.
- Why this condition is needed: Efficacy-analysis exclusion and safety noncollection may differ
- Application exceptions: The original 27% efficacy-analysis exclusion is not converted into a safety dropout rate.
- Remaining uncertainty: Efficacy missingness is not inherited as safety missingness, and bias magnitude is not established.
- Referenced methods: 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.
- Related sources: S1

### N32 · Are harms of the same preparation recorded in other independent material?

Verification status: Unverified  
Reading scope: 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.

- Current findings: The same caution is repeated across languages/summaries, but an independent harm-event list or family information is currently absent.
- Why unverified: Repeated wording is not summed as unique events, and the overall number of harm reports remains undetermined.
- Reason for missing information: Repeated wording is not summed as unique events, and the overall number of harm reports remains undetermined.
- Required materials and conditions: Unique event/study families, the same exposure/event, contrary records and distinctions from recitation/regulatory material
- Materials to obtain first: Original events, formulation/dose and family links in existing safety reports/regulatory documents
- Further research: Independent safety observation in appropriate populations using the same preparation, with disclosure of contrary records
- Conditions for verification: Distinguish sources of current harm statements, recitation and unverified relationships between unique events.
- Why this condition is needed: Repetition of the same caution is not an independent harm event
- Application exceptions: Korean/English/combined restatements or signals from other garlic formulations are not counted as independent events.
- Remaining uncertainty: Repeated wording is not summed as unique events, and the overall number of harm reports remains undetermined.
- Referenced methods: 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.
- Related sources: S1

### N33 · Can harms beyond the small 1-year dataset be described?

Verification status: Partly verified  
Reading scope: 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.

- Current findings: The original text says a small 1-year dataset cannot establish long-term safety of intake for cancer prevention.
- Why unverified: The current limitation is stated, but direct long-term, rare-event and vulnerable-group safety material remains unverified in this scope.
- Reason for missing information: The current limitation is stated, but direct long-term, rare-event and vulnerable-group safety material remains unverified in this scope.
- Required materials and conditions: Long-term and rare harms, vulnerable populations, baseline risk, exposures/interactions and appropriate follow-up
- Materials to obtain first: Exposure-event material on long-term follow-up, vulnerable groups, rare events and interactions
- Further research: Follow-up, registration and safety observation appropriate to long-term/special-population questions
- Conditions for verification: Distinguish the current supplementation/population scope from direct or unverified evidence on long-term, rare-event and vulnerable-group harms.
- Why this condition is needed: Long-term safety of intake for cancer prevention cannot be established from short, small datasets
- Application exceptions: All rare-event/vulnerable-group studies are not imposed as mandatory conditions for the narrow 12-month efficacy result.
- Remaining uncertainty: The current limitation is stated, but direct long-term, rare-event and vulnerable-group safety material remains unverified in this scope.
- Referenced methods: 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.
- Related sources: S1

### N34 · Is the caution a signal, comparative risk or causal statement?

Verification status: Partly verified  
Reading scope: 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.

- Current findings: 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.
- Why unverified: The original caution's scope is preserved; safety outcomes or individual safety are not confirmed.
- Reason for missing information: The original caution's scope is preserved; safety outcomes or individual safety are not confirmed.
- Required materials and conditions: Actual harm events, design/comparison, denominators, timing, alternatives and currently supportable wording
- Materials to obtain first: Original safety material linking events, comparisons, denominators, timing and alternatives
- Further research: Comparative safety research appropriate to the question; first check the basis of the original caution
- Conditions for verification: Separate the original safety caution from the level of verification for actual events/risks/causal material, retaining the limits of supportable wording.
- Why this condition is needed: General caution or insufficient material must not be converted into individual safety or causal results
- Application exceptions: Do not use the efficacy RR as a causal harm estimate or create personal dosing instructions.
- Remaining uncertainty: The original caution's scope is preserved; safety outcomes or individual safety are not confirmed.
- Referenced methods: 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.
- Related sources: S1

### N35 · Were original grade, score and axes inherited as new condition states?

Verification status: Met  
Reading scope: 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.

- Current findings: 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.
- Why unverified: Preservation of the original verdict and separation from new condition states are checked; the original grade is not recertified.
- Reason for missing information: Preservation of the original verdict and separation from new condition states are checked; the original grade is not recertified.
- Required materials and conditions: Native values for original C46, Caution, all axes, empty subclaims, Korean/English text, original URLs and corrections
- Materials to obtain first: Original canonical/revised versions, locations and original-byte preservation records
- Further research: Traceability of original text, versions and change events rather than a new research requirement
- Conditions for verification: Preserve all original bytes and source locations without creating new scores/grades, axis-derived fulfillment or independent clinical certification.
- Why this condition is needed: Original history and current item-specific condition states must remain separate
- Application exceptions: The original Codex independent-cross-check label is not promoted into current independent clinical certification.
- Remaining uncertainty: Preservation of the original verdict and separation from new condition states are checked; the original grade is not recertified.
- Referenced methods: 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.
- Related sources: S1

### N36 · Were generic English wording and historical correction statements preserved?

Verification status: Met  
Reading scope: 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.

- Current findings: The current English evidence/citation contains generic-principle wording, while corrections historically describe specific translation replacement. Both are preserved as original values.
- Why unverified: Original values and historical statements are preserved separately; specific English numerical verification or reconstruction of history is not established.
- Reason for missing information: Original values and historical statements are preserved separately; specific English numerical verification or reconstruction of history is not established.
- Required materials and conditions: Current original English evidence/citation values, corrections dated 2026-09-14 and historical versus current access levels
- Materials to obtain first: Canonical versions before/after correction and contemporary verification/access receipts
- Further research: Traceability of bilingual original values and change history rather than a new clinical research requirement
- Conditions for verification: Preserve current English wording and corrections as original values without presenting general-principle sentences as verification of specific denominators, results or funding.
- Why this condition is needed: A historical statement of specific translation replacement cannot establish numerical verification of current generic wording
- Application exceptions: Do not replace current original English values with new specific translations or reconstruct/judge the historical correction itself.
- Remaining uncertainty: Original values and historical statements are preserved separately; specific English numerical verification or reconstruction of history is not established.
- Referenced methods: 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.
- Related sources: S1

## Evidence and sources

### S1

Tanaka S et al. Hiroshima J Med Sci. 2004;53:39-45. PMID: 15726891.

[PubMed](https://pubmed.ncbi.nlm.nih.gov/15726891/)

Materials actually 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.  
Findings recorded in the summary: 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.  
Record 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.  
Independent replication: 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.

| Material | Public availability | Access status | Actually read | Notes |
|---|---|---|---|---|
| Retained verdict summary | Retained verdict summary read | Retained copy acquired; summary read | Stored existing review summary read | 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. |
| PubMed bibliographic/abstract gateway | Bibliographic link retained; external material unread | External access not attempted; not acquired | Not read | 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. |
| Original full text and supplements; location unverified | Full-text and supplement location unverified; unread | External access not attempted; not acquired | Not read | 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. |

## Review criteria and methods

These are Chamgap's own application conditions, informed by the relevant sections of official methodological guidance. They do not constitute official assessment-tool certification or a new efficacy score.

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

## What the statuses mean

- 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.

## Change history

2026-10-26 · Public page/materials 1.0. The public view and materials were prepared from the existing 36 items. No new clinical search, verification-state change or scoring was performed.
