{
  "schema_version": "chamgap-public-criteria-1.0",
  "title": "Aged garlic extract liquid 2.4 mL/day × Prevention of colorectal-adenoma recurrence",
  "language": "en",
  "translation_date": "2026-10-26",
  "criteria_version": "1.0",
  "criteria_date": "2026-10-06",
  "condition_origin": "Chamgap's own application conditions",
  "method_sources": [
    {
      "id": "M03",
      "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03",
      "section": "§3.1, §3.2.1–3.2.3, MECIR C5/C7/C13",
      "official_principle": "Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.",
      "review_level": "Retained method-application records were reused. External originals were not reread and method content was not reassessed."
    },
    {
      "id": "M04",
      "version": "Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04",
      "section": "§4.5, §4.6.1–4.6.3, MECIR C42",
      "official_principle": "Distinguish studies from reports and link them; do not omit a study solely because results are unreported.",
      "review_level": "Retained method-application records were reused. External originals were not reread and method content was not reassessed."
    },
    {
      "id": "M08",
      "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08",
      "section": "§8.1–8.2.3, Table 8.2.a",
      "official_principle": "Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.",
      "review_level": "Retained method-application records were reused. External originals were not reread and method content was not reassessed."
    },
    {
      "id": "M15",
      "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15",
      "section": "§15.2.4, §15.3.1–15.3.3",
      "official_principle": "Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.",
      "review_level": "Retained method-application records were reused. External originals were not reread and method content was not reassessed."
    },
    {
      "id": "M19",
      "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19",
      "section": "§19.1.2, §19.2.1–19.2.4",
      "official_principle": "Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.",
      "review_level": "Retained method-application records were reused. External originals were not reread and method content was not reassessed."
    }
  ],
  "status_dictionary": {
    "Partly verified": "Some 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."
  },
  "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"
    },
    {
      "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"
    },
    {
      "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"
    },
    {
      "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"
    },
    {
      "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"
    },
    {
      "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"
    },
    {
      "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"
    },
    {
      "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"
    },
    {
      "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"
    },
    {
      "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"
    },
    {
      "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"
    },
    {
      "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"
    },
    {
      "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"
    },
    {
      "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"
    },
    {
      "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"
    },
    {
      "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"
    },
    {
      "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"
    },
    {
      "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"
    },
    {
      "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"
    },
    {
      "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"
    },
    {
      "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"
    },
    {
      "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"
    },
    {
      "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"
    },
    {
      "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"
    },
    {
      "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"
    },
    {
      "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"
    },
    {
      "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"
    },
    {
      "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"
    },
    {
      "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"
    },
    {
      "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"
    },
    {
      "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"
    },
    {
      "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"
    },
    {
      "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"
    },
    {
      "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"
    },
    {
      "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"
    },
    {
      "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"
    }
  ]
}