{ "schema_version": "chamgap-public-criteria-1.0", "title": "Long-term factorial supplementation with garlic extract plus steam-distilled garlic oil × Reduction of gastric-cancer incidence", "language": "en", "translation_date": "2026-10-25", "criteria_version": "1.0", "criteria_date": "2026-10-06", "condition_origin": "Chamgap's own application conditions", "method_sources": [ { "id": "M03", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03", "section": "§3.1, §3.2.1–3.2.3, MECIR C5/C7/C13", "official_principle": "Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.", "review_level": "Retained method-application records were reused. External originals were not reread and method content was not reassessed." }, { "id": "M04", "version": "Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04", "section": "§4.5, §4.6.1–4.6.3, MECIR C42", "official_principle": "Distinguish studies from reports and link them; do not omit a study solely because results are unreported.", "review_level": "Retained method-application records were reused. External originals were not reread and method content was not reassessed." }, { "id": "M08", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08", "section": "§8.1–8.2.3, Table 8.2.a", "official_principle": "Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.", "review_level": "Retained method-application records were reused. External originals were not reread and method content was not reassessed." }, { "id": "M15", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15", "section": "§15.2.4, §15.3.1–15.3.3", "official_principle": "Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.", "review_level": "Retained method-application records were reused. External originals were not reread and method content was not reassessed." }, { "id": "M19", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19", "section": "§19.1.2, §19.2.1–19.2.4", "official_principle": "Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.", "review_level": "Retained method-application records were reused. External originals were not reread and method content was not reassessed." } ], "status_dictionary": { "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.", "Not applied": "An exception whose application premise is not met within the retained scope and selected question. It is limited to inter-study heterogeneity within the single retained report in N21, and a surrogate-to-incidence bridge for the clinical incidence endpoint in N23. It does not substitute for unread material, absence of evidence or confirmed efficacy, and requires review if its premise changes." }, "requirements": [ { "item_id": "N01", "question_type": "Evidence condition", "question": "Which garlic factor and which gastric-cancer outcome are compared?", "needed": "Combined garlic supplementation and its placebo, high-risk population, cumulative incidence, and supplementation and follow-up intervals", "role": "Required", "role_reason": "Needed to avoid combining incidence, mortality and other randomized factors from the same trial into a single efficacy claim.", "application_exception": "Mortality and H. pylori-treatment questions are retained as related background and do not replace this incidence comparison.", "criterion": "Specify cumulative gastric-cancer incidence for the combined garlic factor versus its placebo, with other factors and endpoints excluded.", "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 garlic-extract-plus-oil and gastric-cancer-incidence record. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "A product-specification-matched comparative study stating the incidence question separately" }, { "item_id": "N02", "question_type": "Evidence condition", "question": "What was the trial combination of garlic extract and oil?", "needed": "Ingredients, specifications, manufacture, content and formulation of the extract and steam-distilled oil combination", "role": "Required", "role_reason": "Needed to avoid transferring this result to garlic oil alone, raw garlic or AGE.", "application_exception": "Do not equate different extracted, aged or fermented formulations merely because they share a plant source.", "criterion": "Identify the actual trial specifications and combination of both components and record differences from other formulations.", "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 garlic-extract-plus-oil and gastric-cancer-incidence record. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "A direct formulation comparison with a fixed product-matched combination" }, { "item_id": "N03", "question_type": "Evidence condition", "question": "Are the exact daily dose and actual intake of the combination linked?", "needed": "Daily mg of each component, administration frequency, actual exposure and adherence", "role": "Required", "role_reason": "Needed to avoid filling the phrase trial specifications with an exact dose or actual intake.", "application_exception": "Do not import mg, mL or SAC content from other garlic studies into this trial.", "criterion": "Distinguish nominal amounts of each component from actual intake records; do not infer missing quantities.", "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 garlic-extract-plus-oil and gastric-cancer-incidence record. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "A product-matched dose study linking actual exposure" }, { "item_id": "N04", "question_type": "Evidence condition", "question": "What eligibility criteria defined the high-risk Linqu residents?", "needed": "Gastric-cancer risk, age, baseline lesions, infection status, inclusion/exclusion criteria and recruitment setting", "role": "Required", "role_reason": "Needed to avoid transferring a local high-risk-population result to preventive food effects for everyone.", "application_exception": "Preserve mixed infection status, baseline lesions, composition and differences.", "criterion": "Connect the actual composition of the selected high-risk population with the scope of the table.", "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 garlic-extract-plus-oil and gastric-cancer-incidence record. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "An external replication matched to the product in another risk group or setting" }, { "item_id": "N05", "question_type": "Evidence condition", "question": "How are the randomized factorial structure and actual allocation connected?", "needed": "The 2×2×2/2×2 allocation structure, factor application by infection status, concealment and baseline balance", "role": "Required", "role_reason": "Needed to avoid treating the randomized-factorial label as confirmation of all allocation procedures and detailed comparisons.", "application_exception": "Do not flatten the factorial design into an ordinary parallel 2-group comparison or label unknown allocation details as not applicable.", "criterion": "Link the factor-specific allocation structure and garlic comparison of interest to their original definitions.", "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 garlic-extract-plus-oil and gastric-cancer-incidence record. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "A product-matched randomized factorial trial disclosing allocation details" }, { "item_id": "N06", "question_type": "Evidence condition", "question": "What was the garlic-factor placebo and how were other factors handled?", "needed": "Placebo composition, blinding, and comparison/analysis handling of H. pylori and vitamin assignments", "role": "Required", "role_reason": "Needed to avoid mixing other factors’ effects into the garlic comparison.", "application_exception": "Do not delete garlic results because other factors exist; identify the comparison of interest and its handling.", "criterion": "Distinguish the actual garlic-placebo comparison from the scope of adjustment, stratification and interaction handling for other assigned factors.", "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 garlic-extract-plus-oil and gastric-cancer-incidence record. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "A study prespecifying the main-factor analysis and interaction reporting" }, { "item_id": "N07", "question_type": "Evidence condition", "question": "Are H. pylori-treatment results distinguished from garlic results?", "needed": "Allocation and results for the infection-treatment factor and its relationship to the garlic comparison", "role": "Required", "role_reason": "Needed to avoid attributing infection-treatment effects to garlic’s effect on gastric-cancer incidence.", "application_exception": "Do not add separate randomized-factor results; preserve the existence of related material.", "criterion": "Record incidence comparisons for the H. pylori-treatment factor and the garlic factor separately.", "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 garlic-extract-plus-oil and gastric-cancer-incidence record. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Prespecified effect-modification assessment by infection status and treatment" }, { "item_id": "N08", "question_type": "Evidence condition", "question": "Are vitamin-factor results also kept separate from garlic?", "needed": "Vitamin assignment, dose, concurrent exposure, results and interactions", "role": "Required", "role_reason": "Needed to avoid counting vitamin results from a multifactor trial as independent replication of garlic efficacy.", "application_exception": "Distinguish vitamin and garlic assignments without describing unverified interactions as absent.", "criterion": "Attribute vitamin-factor and garlic-factor results separately and record unverified concurrent 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 garlic-extract-plus-oil and gastric-cancer-incidence record. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "A study separating prespecified concurrent-factor interactions from standalone comparisons" }, { "item_id": "N09", "question_type": "Evidence condition", "question": "Are 7.3 years of supplementation distinguished from 22.3 years of follow-up?", "needed": "End of supplementation during 1995~2003, follow-up through 2017, post-discontinuation exposure and event timing", "role": "Required", "role_reason": "Needed to avoid converting long follow-up into equally long intake or confirmation of a sustained effect.", "application_exception": "Retain post-discontinuation follow-up without inferring actual intake after stopping or period-specific effects.", "criterion": "Link supplementation and follow-up separately; use only directly reported additional exposure and period-specific outcomes.", "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 garlic-extract-plus-oil and gastric-cancer-incidence record. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Long-term follow-up prespecifying actual post-discontinuation exposure and effects over time" }, { "item_id": "N10", "question_type": "Evidence condition", "question": "How were cumulative gastric-cancer incidence, diagnosis and detection collected?", "needed": "First-incidence definition, diagnostic criteria, detection/follow-up methods, assessor blinding and cumulative time point", "role": "Required", "role_reason": "Needed to avoid treating an event name alone as confirmation of diagnostic accuracy or equivalent detection.", "application_exception": "Incidence and mortality are both clinical events but do not substitute for the same event definition or analysis.", "criterion": "Link diagnosis, detection, cumulative interval and group-specific measurement conditions to the selected incidence outcome.", "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 garlic-extract-plus-oil and gastric-cancer-incidence record. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "A long-term study disclosing standard event adjudication and group-specific detection conditions" }, { "item_id": "N11", "question_type": "Evidence condition", "question": "Which set do the 3,365 participants and 151 incidence events describe?", "needed": "Whole-trial allocation, follow-up and incidence totals, and analysis denominators for the garlic groups", "role": "Required", "role_reason": "Needed to avoid converting whole-trial counts into each group’s analysis count or an incidence denominator.", "application_exception": "Distinguish events from people and do not double-count the same participants across factors or reports.", "criterion": "Keep supplied whole-trial counts at their original level; retain missing group denominators and events separately 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 garlic-extract-plus-oil and gastric-cancer-incidence record. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Reporting that discloses every group’s analysis denominator and event count" }, { "item_id": "N12", "question_type": "Evidence condition", "question": "What measure do the garlic-incidence OR and 95% CI represent?", "needed": "Incidence OR0.81, 95%CI0.57~1.13, model and comparison direction", "role": "Required", "role_reason": "Needed to avoid converting the OR into RR, HR, absolute risk or a mortality value.", "application_exception": "Preserve the original measure and interval without calculating new CI, P or effect values.", "criterion": "Link the incidence OR and interval to their endpoint, period and comparison, retaining unverified model details.", "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 garlic-extract-plus-oil and gastric-cancer-incidence record. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "A replication prespecifying the incidence estimand and its uncertainty" }, { "item_id": "N13", "question_type": "Evidence condition", "question": "Can group incidence and an absolute risk difference be checked directly?", "needed": "Group events, denominators and directly reported absolute differences for the same follow-up/analysis set", "role": "Supplementary; required for absolute preventive-effect claims", "role_reason": "Needed to avoid inventing prevention counts and absolute differences using the whole-trial 151 events or the OR.", "application_exception": "Do not back-calculate or extrapolate unverified absolute values, NNT or baseline risk.", "criterion": "Display an absolute preventive magnitude only when matching group denominators and directly reported absolute values are linked.", "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 garlic-extract-plus-oil and gastric-cancer-incidence record. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "A long-term study reporting group absolute risks with uncertainty" }, { "item_id": "N14", "question_type": "Evidence condition", "question": "Does the incidence OR describe assignment or adherence effects?", "needed": "ITT/PP, actual analysis sets, assignment/adherence comparison, adjustment variables and factor handling", "role": "Required", "role_reason": "Needed to avoid automatically filling ITT analysis from randomization.", "application_exception": "Do not choose ITT, PP or a model when the original material does not specify the analysis.", "criterion": "Connect the effect of interest to the original analysis set and adjustment definitions and state the unverified scope.", "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 garlic-extract-plus-oil and gastric-cancer-incidence record. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "A study prespecifying assignment and adherence effects separately" }, { "item_id": "N15", "question_type": "Evidence condition", "question": "How were long-term losses and deaths handled in the incidence analysis?", "needed": "Group losses/reasons, event detection, competing deaths/censoring and sensitivity analyses", "role": "Required", "role_reason": "Needed to avoid treating long follow-up and a total event count as confirmation of no missingness influence.", "application_exception": "Do not add deaths as incidence events or infer the competing-event method.", "criterion": "Connect actual handling of loss, censoring and competing deaths to its influence on analysis denominators and original results.", "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 garlic-extract-plus-oil and gastric-cancer-incidence record. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Follow-up prespecifying and disclosing long-term missingness and competing events" }, { "item_id": "N16", "question_type": "Evidence condition", "question": "Is citation identifier NCT00339768 linked to actual verification of prior registration?", "needed": "Registration identity, registration/change dates, recruitment start, registry versions, protocol/SAP", "role": "Required", "role_reason": "Needed to avoid promoting an identifier string into confirmation of prospective registration or a successful plan comparison.", "application_exception": "Preserve both the unverified structured registration field and citation identifier; lack of acquisition does not establish nonregistration.", "criterion": "Check original registry versions, dates and trial identity, distinguishing plans actually compared from parts 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 garlic-extract-plus-oil and gastric-cancer-incidence record. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "A study disclosing change history and the prior incidence analysis" }, { "item_id": "N17", "question_type": "Evidence condition", "question": "Were prespecified incidence/mortality endpoints and analysis hierarchy compared?", "needed": "Planned incidence/mortality endpoints and models, time points, changes and multiplicity rationale", "role": "Required", "role_reason": "Needed to avoid substituting a favorable other endpoint for the selected incidence analysis.", "application_exception": "Record the manuscript’s main question separately from verification of the trial’s prespecified primary/secondary endpoints.", "criterion": "Compare original plans with actual incidence and mortality analyses separately, retaining unavailable parts.", "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 garlic-extract-plus-oil and gastric-cancer-incidence record. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "A long-term confirmatory study prespecifying incidence and mortality separately" }, { "item_id": "N18", "question_type": "Evidence condition", "question": "Is the gastric-cancer-mortality HR substituted for the incidence OR?", "needed": "Separate endpoints, models and interpretation for incidence 151 events/OR and mortality 94 deaths/HR", "role": "Required", "role_reason": "Needed to avoid transferring a borderline signal in another endpoint into confirmed prevention of incidence.", "application_exception": "Retain mortality values as originally reported without merging their events, intervals or measure into incidence.", "criterion": "Attribute incidence OR0.81(0.57~1.13) and mortality HR0.66(0.43~1.00) to their respective endpoints.", "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 garlic-extract-plus-oil and gastric-cancer-incidence record. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "A study defining and reporting each endpoint as a separate question in advance" }, { "item_id": "N19", "question_type": "Evidence condition", "question": "Was nonsignificant incidence converted into an effect of 0 or equivalence?", "needed": "Original OR/CI, reported wording and equivalence/important-difference criteria", "role": "Required", "role_reason": "Needed to retain original null/nonsignificant wording without newly concluding an exact effect of 0 or equivalence.", "application_exception": "Retain original D34/E0 and null wording as a historical verdict; this is not a new clinical grade.", "criterion": "Preserve original observations and intervals without adding unreported equivalence, effect of 0 or importance criteria.", "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 garlic-extract-plus-oil and gastric-cancer-incidence record. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "An incidence study prespecifying the effect magnitude of interest and precision" }, { "item_id": "N20", "question_type": "Evidence condition", "question": "Are a trial’s factors, languages and follow-up reports counted as independent replications?", "needed": "Shared-participant relationships among reports, factors and time points of the Shandong trial", "role": "Required", "role_reason": "Needed to avoid adding the same participants’ results or Korean/English/combined summaries as independent studies or patients.", "application_exception": "Linking a family in the retained 1 report is separate from establishing a unique-trial count across the literature.", "criterion": "Identify currently linked reports/families; leave unestablished global unique-study and participant counts null.", "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 garlic-extract-plus-oil and gastric-cancer-incidence record. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "A separate product-matched replication with independent funding and investigators" }, { "item_id": "N21", "question_type": "Evidence condition", "question": "Should inter-study heterogeneity be calculated within the one retained family?", "needed": "Actually distinct study families and condition-specific results", "role": "Not applied; claims across multiple families are separate", "role_reason": "Needed to avoid turning factors, languages or endpoints within a retained report into multiple studies and inventing heterogeneity.", "application_exception": "Inter-study statistical comparison is not applied to this within-family question; independent replication across the literature remains unverified.", "criterion": "Do not create inter-study heterogeneity values within the current single-report clue; distinguish unverified separate families.", "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 garlic-extract-plus-oil and gastric-cancer-incidence record. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Review of independent-family result distributions for the same incidence question" }, { "item_id": "N22", "question_type": "Evidence condition", "question": "Does the record directly answer dose, infection-status and post-discontinuation questions?", "needed": "Direct dose comparisons, prespecified subgroups/interactions and period-specific estimates", "role": "Supplementary; required for the stated extensions", "role_reason": "Needed to avoid extending the overall incidence comparison to optimal dose, specific groups or persistence after stopping.", "application_exception": "Do not require every extension study for the narrow incidence question; retain each extension separately as unverified.", "criterion": "Connect an extension only when its direct comparison, prior plan, denominator and interval are available.", "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 garlic-extract-plus-oil and gastric-cancer-incidence record. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "A study separating prespecified effect modification, dose and post-discontinuation follow-up" }, { "item_id": "N23", "question_type": "Evidence condition", "question": "Does an incidence question need a bridge from surrogates to events?", "needed": "Distinction between selected cumulative gastric-cancer incidence and surrogate/mortality questions", "role": "Not applied; boundary for extensions to mortality or other events", "role_reason": "Needed to avoid imposing a surrogate bridge on a question already concerning clinical incidence.", "application_exception": "A surrogate-to-incidence bridge is unnecessary for incidence itself, but incidence results do not guarantee reduced mortality.", "criterion": "Keep incidence as the directly selected endpoint without extending it to mortality or other 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 garlic-extract-plus-oil and gastric-cancer-incidence record. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "A study independently verifying any clinical endpoint to which the claim is extended" }, { "item_id": "N24", "question_type": "Evidence condition", "question": "Is public funding the same as checking product/author conflicts?", "needed": "NCI and Chinese public funding, product provision, employment/patents and declared conflicts", "role": "Supplementary; required for independence claims", "role_reason": "Needed to avoid converting public funding into proof of no conflicts or independent replication.", "application_exception": "Retain original I2 and independent-funding wording without newly certifying all disclosures or product provision.", "criterion": "Explain identified funding statements and unverified product/author relationships at their respective original locations.", "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 garlic-extract-plus-oil and gastric-cancer-incidence record. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "A product-specification-matched replication with separate funding and investigators" }, { "item_id": "N25", "question_type": "Evidence condition", "question": "What are the actual reading levels for summaries, citations, full text and registration?", "needed": "Existence, public availability, access, acquisition, actual reading, dates and original locations/links for each material", "role": "Required", "role_reason": "Needed to avoid converting the presence of PMID, PMCID, DOI, NCT or URLs into actual reading of the material.", "application_exception": "Do not describe unattempted access as failure or nonpublic status; separate the retained summary from external material.", "criterion": "Link the summary-reading label to current retained-summary citation locations; keep external full text and registration unread according to actual actions.", "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 garlic-extract-plus-oil and gastric-cancer-incidence record. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Compare subsequently acquired material with each condition and link update history" }, { "item_id": "N26", "question_type": "Evidence condition", "question": "Were specific Korean/English values and remaining generic wording preserved?", "needed": "Original Korean/English/combined-summary/evidence/citation values and the English-placeholder correction event", "role": "Required", "role_reason": "Needed to avoid filling generic confirmation wording with missing specific values or verification actions.", "application_exception": "Preserve both the historical correction of 1 field and remaining generic English wording; do not newly revise the original.", "criterion": "Preserve every original literal, type and correction event and link specific observations to their actual original locations.", "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 garlic-extract-plus-oil and gastric-cancer-incidence record. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "When new material is authorized, distinguish evidence updates from language corrections" }, { "item_id": "N27", "question_type": "Evidence condition", "question": "Are original review date, reading date and search scope distinguished?", "needed": "Original review date 2026-09-08, actual reading date, inputs used, and search/correction/retraction-check scope", "role": "Required", "role_reason": "Needed to avoid backdating the original review date as a current access date or search cut-off.", "application_exception": "No new clinical search was conducted, so do not claim absence of new papers or a complete current literature check.", "criterion": "Link every absence/unverified statement to the retained scope and date; do not convert no search into 0 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 garlic-extract-plus-oil and gastric-cancer-incidence record. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Compare the existing question with new evidence within an authorized follow-up scope" }, { "item_id": "N28", "question_type": "Evidence condition", "question": "Are original D34/E0 and current item states distinguished?", "needed": "Original grade, score, axes, historical Codex cross-check and the scope of current rows", "role": "Required", "role_reason": "Needed to avoid inheriting historical scores/axes as automatic fulfillment, probability or clinical certification.", "application_exception": "Preserve original D34/Caution/B-H-R1-I2-E0-B0-C0 and wording without new grading or calculation.", "criterion": "Preserve historical values separately; explain row states from their observations and reasons for uncertainty.", "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 garlic-extract-plus-oil and gastric-cancer-incidence record. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Link only affected conditions to a separate version when an evidence-update event arises" }, { "item_id": "N29", "question_type": "Evidence condition", "question": "How were actual harms collected for this long-term combined exposure?", "needed": "Definitions, systematic collection, severity and discontinuation for bleeding, gastrointestinal discomfort and interactions", "role": "Supplementary; required for safety", "role_reason": "Needed to avoid turning caution wording into an event frequency or confirmed causal events.", "application_exception": "Do not erase incidence results because harms are unreported or equate the combination with ordinary-food-intake safety.", "criterion": "Distinguish actual event definitions, collection and discontinuation from the level of the original caution narrative.", "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 garlic-extract-plus-oil and gastric-cancer-incidence record. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "A study systematically collecting harms for the same combined exposure" }, { "item_id": "N30", "question_type": "Evidence condition", "question": "Are harm timing, stopping, recovery and re-exposure known?", "needed": "Actual exposure start/stop, harm onset/recovery, re-exposure and observation intervals", "role": "Supplementary; required for timing or causal claims", "role_reason": "Needed to avoid treating trial periods alone as confirmation of temporal harm causality.", "application_exception": "Do not require personal re-exposure for this incidence-efficacy question or infer absent original event records.", "criterion": "Distinguish periods from event timelines; do not fill unverified stopping, improvement 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 garlic-extract-plus-oil and gastric-cancer-incidence record. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Long-term safety-event follow-up without requiring re-exposure" }, { "item_id": "N31", "question_type": "Evidence condition", "question": "Were harm frequency versus placebo and its denominator checked directly?", "needed": "Group harm-person/event counts, exposure/observation denominators, placebo comparisons and intervals", "role": "Supplementary; required for comparative risk or frequency", "role_reason": "Needed to avoid using the whole-trial 3,365 participants as every harm denominator.", "application_exception": "Caution wording is not a comparative-risk value; do not extrapolate background incidence.", "criterion": "Display comparisons/frequencies only from direct reports linking harm events, group denominators and observation time.", "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 garlic-extract-plus-oil and gastric-cancer-incidence record. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "A product-matched comparative study disclosing safety denominators and events" }, { "item_id": "N32", "question_type": "Evidence condition", "question": "Could concurrent exposure, selection or omissions change harm attribution?", "needed": "Other randomized factors, concomitant drugs, baseline conditions, event reporting/detection and follow-up losses", "role": "Supplementary; required for causal or comparative harm", "role_reason": "Needed to avoid treating missing concurrent-exposure and omission information as no alternative cause or no harm.", "application_exception": "Do not newly establish H. pylori or vitamin factors as harm causes; record only identified concurrent exposure.", "criterion": "Explain the verified scope of alternative/concurrent exposures, event collection and losses, with attribution limits.", "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 garlic-extract-plus-oil and gastric-cancer-incidence record. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "A safety study jointly addressing exposure, alternative explanations and event omissions" }, { "item_id": "N33", "question_type": "Evidence condition", "question": "What is known about independent harm records and long-term/special-population safety?", "needed": "Distinct safety events/study families, rare/long-term harms, vulnerable populations and concurrent-drug exposure", "role": "Supplementary; required for the stated safety extensions", "role_reason": "Needed to avoid extending a long-follow-up incidence study to safety for every rare event and population.", "application_exception": "Requoting a summary is not an independent event; do not require every safety study for this narrow incidence question.", "criterion": "Keep the family, period and population scope of direct safety material separate from unverified replication/vulnerable-group information.", "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 garlic-extract-plus-oil and gastric-cancer-incidence record. They do not establish blinding, trial preregistration, official-tool certification or new independent clinical validation.", "proposed_research": "Long-term/special-population safety follow-up linking product specifications and exposure" } ] }