{ "schema_version": "chamgap-public-evidence-check-1.0", "public_id": "v3060-main", "verdict_number": "3060", "title": "Long-term factorial supplementation with garlic extract plus steam-distilled garlic oil × Reduction of gastric-cancer incidence", "view_version": "1.0", "view_created_date": "2026-10-25", "criteria_version": "1.0", "criteria_date": "2026-10-06", "review_date": "2026-10-06", "legacy_evidence_date": "2026-09-08", "review_scope": { "materials_read": "Retained Korean/English summaries and case-specific condition/application records", "clinical_papers_directly_read": false, "new_clinical_search": false, "limitation": "Prepared from retained summaries and condition-application records. External abstracts, full texts, registration, protocols and analysis plans remain unread. Historical review records do not establish current independent clinical validation.", "date_meaning": "The material check date is the original date retained in the summary and condition records. The original verdict-review date does not establish a search cut-off or historical access dates for individual materials; external access was not attempted in this conversion." }, "claim_context": { "population": "Residents at high risk of gastric cancer in Linqu, Shandong, China. The whole trial included 3,365 people; analysis denominators for the garlic groups remain unverified.", "intervention": "Oral combined supplementation with clove-derived garlic extract and steam-distilled garlic oil. Exact product, manufacturing and component specifications remain unverified.", "dose": "Exact daily mg, administration frequency, actual intake and adherence remain unverified.", "comparator": "Placebo for the garlic factor. H. pylori treatment and vitamins are separate randomized factors; detailed adjustment and interactions remain unverified.", "endpoint": "Cumulative gastric-cancer incidence during follow-up. Gastric-cancer mortality is a separate endpoint; the incidence OR and mortality HR are not interchangeable.", "duration": "Supplementation during 1995~2003 for 7.3 years; follow-up through 2017 for 22.3 years. The full follow-up is not treated as the duration of intake.", "excluded_extensions": [ "Gastric-cancer mortality is not substituted for incidence, and their event counts are not added.", "Results of the H. pylori-treatment or vitamin factors are not attributed to garlic.", "Raw garlic, powder, oil alone, aged garlic extract, black garlic, fermented garlic and isolated SAC are not treated as this combination.", "Whole-trial counts and the OR are not used to calculate group denominators, absolute risks or NNT.", "Exact dose, optimal dose, subgroups, persistence after stopping and safety at ordinary food intakes are separate questions." ] }, "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", "current_reports": [ "S1" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External PubMed, DOI, full-text and registration material remain unread, with access not attempted.", "observation": "The original claim is reduced gastric-cancer incidence; the main endpoint is cumulative gastric-cancer incidence during follow-up. This concerns the retained summary comparing the combined garlic factor with its placebo.", "condition_status": "Met", "status_reason": "The claim boundary is checked; this does not establish preventive efficacy or full-text verification.", "missingness": "The claim boundary is checked; this does not establish preventive efficacy or full-text verification.", "uncertainty": "The claim boundary is checked; this does not establish preventive efficacy or full-text verification.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "The original protocol and report specifying the trial question, factor-specific comparisons and incidence definition" }, { "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", "current_reports": [ "S1" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External PubMed, DOI, full-text and registration material remain unread, with access not attempted.", "observation": "This is oral combined supplementation with Allium sativum clove-derived extract and steam-distilled garlic oil. Detailed specifications and equivalence to other formulations are absent from the retained summary.", "condition_status": "Partly verified", "status_reason": "The combination is identified, but product, manufacturing and component specifications remain unverified.", "missingness": "The combination is identified, but product, manufacturing and component specifications remain unverified.", "uncertainty": "The combination is identified, but product, manufacturing and component specifications remain unverified.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Manufacturing, component quality and supply material for the trial product" }, { "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", "current_reports": [ "S1" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External PubMed, DOI, full-text and registration material remain unread, with access not attempted.", "observation": "The original Korean/English wording that exact daily mg require checking in the original source is retained. Actual intake also remains unverified.", "condition_status": "Unverified", "status_reason": "Exact mg, frequency and adherence information are absent from this retained scope.", "missingness": "Exact mg, frequency and adherence information are absent from this retained scope.", "uncertainty": "Exact mg, frequency and adherence information are absent from this retained scope.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "The trial-product label, dosing schedule, and group adherence and discontinuation material" }, { "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", "current_reports": [ "S1" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External PubMed, DOI, full-text and registration material remain unread, with access not attempted.", "observation": "This describes the whole-trial 3,365 residents at high risk of gastric cancer in Linqu, Shandong, China. Composition by age, lesions and infection remains unverified.", "condition_status": "Partly verified", "status_reason": "The region and high-risk population are retained, but specific eligibility and composition remain unverified.", "missingness": "The region and high-risk population are retained, but specific eligibility and composition remain unverified.", "uncertainty": "The region and high-risk population are retained, but specific eligibility and composition remain unverified.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Baseline tables, infection and lesion composition, and group balance" }, { "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", "current_reports": [ "S1" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External PubMed, DOI, full-text and registration material remain unread, with access not attempted.", "observation": "The original record describes long-term follow-up of a blinded randomized factorial trial with a 2×2×2/2×2 structure. Sequence generation, concealment and detailed baseline balance remain unverified.", "condition_status": "Partly verified", "status_reason": "The structure is stated, but the actual factor-allocation procedure has not been compared with the full text.", "missingness": "The structure is stated, but the actual factor-allocation procedure has not been compared with the full text.", "uncertainty": "The structure is stated, but the actual factor-allocation procedure has not been compared with the full text.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "The protocol, allocation flow, methods and baseline tables" }, { "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", "current_reports": [ "S1" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External PubMed, DOI, full-text and registration material remain unread, with access not attempted.", "observation": "The comparator is placebo for the garlic factor, with separate H. pylori-treatment and vitamin assignments. Detailed adjustment and interactions remain unverified.", "condition_status": "Partly verified", "status_reason": "The comparison direction is identified, but placebo details and the full factor analysis are unavailable.", "missingness": "The comparison direction is identified, but placebo details and the full factor analysis are unavailable.", "uncertainty": "The comparison direction is identified, but placebo details and the full factor analysis are unavailable.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Placebo specifications, factor layout, and analysis and interaction plans" }, { "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", "current_reports": [ "S1" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External PubMed, DOI, full-text and registration material remain unread, with access not attempted.", "observation": "The retained text identifies H. pylori treatment as a separate randomized factor and does not merge it with garlic’s incidence effect.", "condition_status": "Met", "status_reason": "This checks the attribution boundary. It is not new verification of infection-treatment or interaction effects.", "missingness": "This checks the attribution boundary. It is not new verification of infection-treatment or interaction effects.", "uncertainty": "This checks the attribution boundary. It is not new verification of infection-treatment or interaction effects.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Infection status, treatment-factor results, factor-specific estimates and interaction tables" }, { "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", "current_reports": [ "S1" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External PubMed, DOI, full-text and registration material remain unread, with access not attempted.", "observation": "The original Korean/English description is retained: vitamins were a separate randomized factor. Numerical interactions with the garlic comparison remain unverified.", "condition_status": "Partly verified", "status_reason": "Separate attribution is identified, but concurrent-exposure and interaction material is unavailable.", "missingness": "Separate attribution is identified, but concurrent-exposure and interaction material is unavailable.", "uncertainty": "Separate attribution is identified, but concurrent-exposure and interaction material is unavailable.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Vitamin specifications, factor layout, adherence, and interaction plans/results" }, { "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", "current_reports": [ "S1" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External PubMed, DOI, full-text and registration material remain unread, with access not attempted.", "observation": "Supplementation lasted 7.3 years during 1995~2003, with 22.3 years of follow-up through 2017. The whole follow-up is not converted into the supplementation period.", "condition_status": "Partly verified", "status_reason": "The two periods are identified, but post-discontinuation exposure and period-specific estimates remain unverified.", "missingness": "The two periods are identified, but post-discontinuation exposure and period-specific estimates remain unverified.", "uncertainty": "The two periods are identified, but post-discontinuation exposure and period-specific estimates remain unverified.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Supplementation, discontinuation and follow-up schedules, with period-specific exposure/analysis tables" }, { "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", "current_reports": [ "S1" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External PubMed, DOI, full-text and registration material remain unread, with access not attempted.", "observation": "The cumulative gastric-cancer-incidence endpoint is identified, but diagnostic/detection procedures and assessor-blinding details are absent from the retained summary.", "condition_status": "Partly verified", "status_reason": "A clinical-event name is available, but the full definition and detection conditions remain unverified.", "missingness": "A clinical-event name is available, but the full definition and detection conditions remain unverified.", "uncertainty": "A clinical-event name is available, but the full definition and detection conditions remain unverified.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Diagnostic/event-adjudication criteria, endoscopy/pathology, detection schedules and blinding material" }, { "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", "current_reports": [ "S1" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External PubMed, DOI, full-text and registration material remain unread, with access not attempted.", "observation": "The original record gives a whole-trial 3,365 participants and 151 incidence events. Allocation/analysis counts and event counts for each garlic group remain unverified.", "condition_status": "Partly verified", "status_reason": "Whole-trial totals are identified, but group totals for this comparison are unavailable.", "missingness": "Whole-trial totals are identified, but group totals for this comparison are unavailable.", "uncertainty": "Whole-trial totals are identified, but group totals for this comparison are unavailable.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Factor-specific allocation, completion, analysis and incidence flow tables" }, { "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", "current_reports": [ "S1" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External PubMed, DOI, full-text and registration material remain unread, with access not attempted.", "observation": "The original incidence OR0.81 and 95%CI0.57~1.13 are retained. The detailed incidence model and P value remain unverified in the current material.", "condition_status": "Partly verified", "status_reason": "The measure and interval are available, but the exact model/adjustment and original result table have not been compared.", "missingness": "The measure and interval are available, but the exact model/adjustment and original result table have not been compared.", "uncertainty": "The measure and interval are available, but the exact model/adjustment and original result table have not been compared.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Original incidence result tables, model/adjustment definitions and group totals" }, { "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", "current_reports": [ "S1" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External PubMed, DOI, full-text and registration material remain unread, with access not attempted.", "observation": "Incidence, denominators, absolute risk differences and NNT for each garlic group are absent from the retained summary.", "condition_status": "Unverified", "status_reason": "Absolute risk is not newly calculated from the OR and whole-trial counts alone.", "missingness": "Absolute risk is not newly calculated from the OR and whole-trial counts alone.", "uncertainty": "Absolute risk is not newly calculated from the OR and whole-trial counts alone.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Group events, follow-up denominators, and direct absolute differences and intervals" }, { "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", "current_reports": [ "S1" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External PubMed, DOI, full-text and registration material remain unread, with access not attempted.", "observation": "The retained record provides a randomized factorial design and an OR, but ITT/PP, group analysis sets and adjustment variables remain unverified.", "condition_status": "Unverified", "status_reason": "The allocation description is not connected to the analysis definition for the outcome of interest in this material.", "missingness": "The allocation description is not connected to the analysis definition for the outcome of interest in this material.", "uncertainty": "The allocation description is not connected to the analysis definition for the outcome of interest in this material.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "SAP, analysis sets/exclusions, adjustment methods and the actual incidence model" }, { "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", "current_reports": [ "S1" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External PubMed, DOI, full-text and registration material remain unread, with access not attempted.", "observation": "Long follow-up and a separate 94 gastric-cancer deaths are mentioned, but incidence-analysis material on loss, censoring and competing-event handling is unavailable.", "condition_status": "Unverified", "status_reason": "The retained scope does not establish how losses and deaths were handled.", "missingness": "The retained scope does not establish how losses and deaths were handled.", "uncertainty": "The retained scope does not establish how losses and deaths were handled.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Group follow-up flow, death/censoring handling and sensitivity analyses" }, { "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", "current_reports": [ "S1" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External PubMed, DOI, full-text and registration material remain unread, with access not attempted.", "observation": "The citation lists NCT00339768, but the structured registration field says unverified. The original registration was not read in this conversion.", "condition_status": "Partly verified", "status_reason": "An identifier clue exists, but prospective dates, trial identity and prior plans remain unverified.", "missingness": "An identifier clue exists, but prospective dates, trial identity and prior plans remain unverified.", "uncertainty": "An identifier clue exists, but prospective dates, trial identity and prior plans remain unverified.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Original NCT00339768 registration history, protocol and incidence/mortality SAP" }, { "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", "current_reports": [ "S1" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External PubMed, DOI, full-text and registration material remain unread, with access not attempted.", "observation": "This original verdict selects incidence as its main question and specifies mortality separately. The trial’s prespecified endpoint hierarchy/models were not compared in this conversion.", "condition_status": "Partly verified", "status_reason": "The manuscript boundary is identified, but actual agreement with prior plans remains unverified.", "missingness": "The manuscript boundary is identified, but actual agreement with prior plans remains unverified.", "uncertainty": "The manuscript boundary is identified, but actual agreement with prior plans remains unverified.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Endpoints, timing, multiplicity and change history in registration/protocol/SAP" }, { "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", "current_reports": [ "S1" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External PubMed, DOI, full-text and registration material remain unread, with access not attempted.", "observation": "Incidence OR0.81/95%CI0.57~1.13 and mortality HR0.66/0.43~1.00 are different endpoints in the same retained report. The 151 incidence events and 94 deaths are not added.", "condition_status": "Met", "status_reason": "This checks endpoint separation. It does not newly confirm reduced mortality or prevention of incidence.", "missingness": "This checks endpoint separation. It does not newly confirm reduced mortality or prevention of incidence.", "uncertainty": "This checks endpoint separation. It does not newly confirm reduced mortality or prevention of incidence.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Original incidence/mortality result tables, models and prior plans" }, { "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", "current_reports": [ "S1" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External PubMed, DOI, full-text and registration material remain unread, with access not attempted.", "observation": "The original record contains OR0.81 with 95%CI0.57~1.13 and nonsignificant/null wording. No new effect of 0, equivalence or important-difference criterion is created.", "condition_status": "Partly verified", "status_reason": "The original report is retained, but prior importance/equivalence hypotheses remain unverified.", "missingness": "The original report is retained, but prior importance/equivalence hypotheses remain unverified.", "uncertainty": "The original report is retained, but prior importance/equivalence hypotheses remain unverified.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Prespecified important differences, equivalence hypotheses/interval criteria and original result tables" }, { "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", "current_reports": [ "S1" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External PubMed, DOI, full-text and registration material remain unread, with access not attempted.", "observation": "The retained 1 evidence summary and 1 citation for Li WQ et al.BMJ2019/PMID31511230·PMC6737461·DOI10.1136/bmj.l5016 are linked as clues to the same report. No global unique-trial count is established.", "condition_status": "Partly verified", "status_reason": "Current family clues exist, but a complete search for other reports and independent replication was not performed in this conversion.", "missingness": "Current family clues exist, but a complete search for other reports and independent replication was not performed in this conversion.", "uncertainty": "Current family clues exist, but a complete search for other reports and independent replication was not performed in this conversion.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "A study-family crosswalk connecting registration, reports and subsequent follow-up" }, { "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", "current_reports": [ "S1" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External PubMed, DOI, full-text and registration material remain unread, with access not attempted.", "observation": "Only one report is directly retained. Its factors, incidence/mortality and Korean/English descriptions are not independent units for inter-study heterogeneity.", "condition_status": "Not applied", "status_reason": "Not applied only to inter-study comparison within this retained single-family question; this does not establish 0 studies or absence of replication.", "missingness": "Not applied only to inter-study comparison within this retained single-family question; this does not establish 0 studies or absence of replication.", "uncertainty": "Not applied only to inter-study comparison within this retained single-family question; this does not establish 0 studies or absence of replication.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Other distinct product-matched studies/reports and comparisons of their conditions" }, { "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", "current_reports": [ "S1" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External PubMed, DOI, full-text and registration material remain unread, with access not attempted.", "observation": "Exact daily dose, direct dose comparisons, prespecified subgroups and period-specific effects after stopping remain unverified in the retained summary.", "condition_status": "Unverified", "status_reason": "The main incidence comparison does not fill extension questions.", "missingness": "The main incidence comparison does not fill extension questions.", "uncertainty": "The main incidence comparison does not fill extension questions.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct dose comparisons, infection/lesion plans and interactions, and period-specific estimates" }, { "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", "current_reports": [ "S1" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External PubMed, DOI, full-text and registration material remain unread, with access not attempted.", "observation": "The selected outcome is cumulative gastric-cancer incidence, a clinical event. Mortality is separate.", "condition_status": "Not applied", "status_reason": "This limited nonapplication concerns a surrogate-to-incidence bridge for incidence itself; it does not establish preventive efficacy.", "missingness": "This limited nonapplication concerns a surrogate-to-incidence bridge for incidence itself; it does not establish preventive efficacy.", "uncertainty": "This limited nonapplication concerns a surrogate-to-incidence bridge for incidence itself; it does not establish preventive efficacy.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct material and original plans for separate mortality/other-event questions" }, { "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", "current_reports": [ "S1" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External PubMed, DOI, full-text and registration material remain unread, with access not attempted.", "observation": "The retained record states NCI and Chinese public funding and original I2. Product provision, author employment/patents and disclosure details remain unverified.", "condition_status": "Partly verified", "status_reason": "Funding names alone do not newly establish overall independence or replication.", "missingness": "Funding names alone do not newly establish overall independence or replication.", "uncertainty": "Funding names alone do not newly establish overall independence or replication.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Original funding, product provision, author employment/patents and COI disclosures" }, { "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", "current_reports": [ "S1" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External PubMed, DOI, full-text and registration material remain unread, with access not attempted.", "observation": "This conversion reads the retained summary and an identical copy. Bibliographic identifiers/URLs exist, but external abstracts, full texts, registration and supplements were not accessed.", "condition_status": "Met", "status_reason": "Reading-state separation is met; this does not mean external-material conditions are met.", "missingness": "Reading-state separation is met; this does not mean external-material conditions are met.", "uncertainty": "Reading-state separation is met; this does not mean external-material conditions are met.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Actual acquisition/reading receipts and original locations for the paper, supplements, registration and SAP" }, { "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", "current_reports": [ "S1" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External PubMed, DOI, full-text and registration material remain unread, with access not attempted.", "observation": "Specific Korean incidence/mortality values, the generic English evidence table and the historical 1 correction record are all retained unchanged. Generic English wording is not interpreted as successful full-text verification.", "condition_status": "Met", "status_reason": "Original preservation is met; this does not claim all original English fields were corrected in this conversion.", "missingness": "Original preservation is met; this does not claim all original English fields were corrected in this conversion.", "uncertainty": "Original preservation is met; this does not claim all original English fields were corrected in this conversion.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Original text before/after the historical correction and report-specific English evidence fields" }, { "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", "current_reports": [ "S1" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External PubMed, DOI, full-text and registration material remain unread, with access not attempted.", "observation": "The original verdict-review date is 2026-09-08. The retained summary has no separate evidence cut-off or material-specific access dates; no new search was performed in this conversion.", "condition_status": "Partly verified", "status_reason": "The original date is present, but historical search cut-off and material-specific access records remain unverified.", "missingness": "The original date is present, but historical search cut-off and material-specific access records remain unverified.", "uncertainty": "The original date is present, but historical search cut-off and material-specific access records remain unverified.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Existing search records, report-specific access records and correction/retraction history" }, { "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", "current_reports": [ "S1" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External PubMed, DOI, full-text and registration material remain unread, with access not attempted.", "observation": "Original D34, Caution, all axes and the Codex independent-cross-check wording are preserved as history. No full-text verification, new clinical score or probability is created in this conversion.", "condition_status": "Met", "status_reason": "Separation of historical and current states is met; this is not independent recertification of the original verdict.", "missingness": "Separation of historical and current states is met; this is not independent recertification of the original verdict.", "uncertainty": "Separation of historical and current states is met; this is not independent recertification of the original verdict.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Versions, original text and decisions for the original verdict, axes and corrections" }, { "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", "current_reports": [ "S1" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External PubMed, DOI, full-text and registration material remain unread, with access not attempted.", "observation": "The retained narrative cautions about bleeding, gastrointestinal discomfort and interactions from concentrated extract plus oil over years. Specific event counts, collection systems and discontinuation totals are unavailable.", "condition_status": "Partly verified", "status_reason": "Caution wording is retained, but direct harm-event definitions and totals remain unverified.", "missingness": "Caution wording is retained, but direct harm-event definitions and totals remain unverified.", "uncertainty": "Caution wording is retained, but direct harm-event definitions and totals remain unverified.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Original-trial harm-collection tables, severity, discontinuation and event definitions" }, { "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", "current_reports": [ "S1" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External PubMed, DOI, full-text and registration material remain unread, with access not attempted.", "observation": "Only 7.3 years of supplementation and 22.3 years of follow-up are provided; individual harm-event timelines, recovery and re-exposure information are unavailable.", "condition_status": "Unverified", "status_reason": "Trial periods cannot be converted into a harm-onset/recovery timeline.", "missingness": "Trial periods cannot be converted into a harm-onset/recovery timeline.", "uncertainty": "Trial periods cannot be converted into a harm-onset/recovery timeline.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Exposure, onset, stopping and recovery dates for individual safety events" }, { "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", "current_reports": [ "S1" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External PubMed, DOI, full-text and registration material remain unread, with access not attempted.", "observation": "Garlic-factor placebo is the comparator for incidence. Group harm events, safety-analysis denominators and observation time remain unverified.", "condition_status": "Unverified", "status_reason": "Neither an incidence comparator nor the whole-trial N is used to invent harm frequency.", "missingness": "Neither an incidence comparator nor the whole-trial N is used to invent harm frequency.", "uncertainty": "Neither an incidence comparator nor the whole-trial N is used to invent harm frequency.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Group harm/discontinuation people and event counts, exposure time and direct comparison values" }, { "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", "current_reports": [ "S1" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External PubMed, DOI, full-text and registration material remain unread, with access not attempted.", "observation": "Other randomized factors are identified, but concomitant drugs, baseline harm risks, differential event omissions/detection and adjustment information are unavailable.", "condition_status": "Unverified", "status_reason": "Do not establish harm causality or absence of harm without checking alternative explanations and reporting limits.", "missingness": "Do not establish harm causality or absence of harm without checking alternative explanations and reporting limits.", "uncertainty": "Do not establish harm causality or absence of harm without checking alternative explanations and reporting limits.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Concomitant exposure, baseline conditions, group reporting/omissions and factor-specific harm handling" }, { "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", "current_reports": [ "S1" ], "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External PubMed, DOI, full-text and registration material remain unread, with access not attempted.", "observation": "Direct safety families, group events/denominators and rare/special-population results remain unverified. Only existing caution wording is retained.", "condition_status": "Unverified", "status_reason": "Long-term incidence follow-up and safety of other formulations or food intakes do not substitute for safety certification of this combination.", "missingness": "Long-term incidence follow-up and safety of other formulations or food intakes do not substitute for safety certification of this combination.", "uncertainty": "Long-term incidence follow-up and safety of other formulations or food intakes do not substitute for safety certification of this combination.", "review_date": "2026-10-06", "reading_status": "Full text not read · Stored summary read", "additional_material": "Independent safety reports for this combination, long-term/rare events, special populations and concurrent-exposure material" } ], "reports": [ { "report_id": "S1", "title": "Li WQ et al. BMJ. 2019;366:l5016. PMID: 31511230. PMCID: PMC6737461. DOI: 10.1136/bmj.l5016. NCT00339768.", "url": "https://pubmed.ncbi.nlm.nih.gov/31511230/", "report_type": "Retained record: long-term follow-up of a blinded randomized factorial trial. The structure is 2×2×2/2×2; details of allocation, concealment and incidence analysis remain unverified.", "existence": "Stored research and bibliographic summaries exist. Existence, public availability, acquisition and reading of external abstracts, full texts, registration, protocols, analysis plans and original product, funding and harm material remain separately unverified.", "acquired_read": "The retained Korean/English summaries and case-specific condition/application records were read. External PubMed, DOI, full-text and registration material remain unread, with access not attempted.", "study_family": "A long-term-report clue for the Shandong Intervention Trial. Factors, endpoints and language summaries from the same trial are not independent replications.", "independent_replication": "One currently retained report is distinct from a count of unique trials across the literature. No complete search for other reports or product-matched replications was conducted, and participant totals were not established.", "observed_result": "The retained incidence result is OR0.81, 95%CI0.57~1.13. The separate mortality result is HR0.66 (0.43~1.00). The whole-trial 3,365 participants, 151 gastric-cancer incidence events and 94 gastric-cancer deaths are preserved at their respective levels.", "result_level": "The incidence OR and mortality HR are separate reported values. The nonsignificant incidence description is not converted into an effect of 0 or equivalence. Group denominators and events, exact models, ITT/PP and the prespecified endpoint hierarchy remain unverified.", "source_evidence_date": "2026-09-08", "materials": [ { "material_type": "Retained verdict summary", "public_status": "Retained verdict summary read", "access_status": "Retained copy acquired; summary read", "acquired": true, "actually_read": "Stored existing review summary read", "as_of": "2026-10-06", "qualification": "Relevant content in the retained Korean/English summary, evidence and citation was read. This does not establish acquisition or reading of the original clinical paper. BMJ2019 by Li WQ and colleagues is a report linked in the retained summary. External abstracts, full texts, registration, protocols and analysis plans were not read in this conversion, and independent clinical validation was not performed. The material check date is the original date retained in the summary and condition records. The original verdict-review date does not establish a search cut-off or historical access dates for individual materials; external access was not attempted in this conversion." }, { "material_type": "PubMed bibliographic/abstract gateway", "public_status": "Bibliographic link retained; external material unread", "access_status": "External access not attempted; not acquired", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-06", "qualification": "This is the PubMed link from the retained citation. The current response, bibliographic identity, abstract content and public access were not checked. BMJ2019 by Li WQ and colleagues is a report linked in the retained summary. External abstracts, full texts, registration, protocols and analysis plans were not read in this conversion, and independent clinical validation was not performed. The material check date is the original date retained in the summary and condition records. The original verdict-review date does not establish a search cut-off or historical access dates for individual materials; external access was not attempted in this conversion." }, { "material_type": "PMC full-text gateway", "public_status": "Full-text gateway; external material unread", "access_status": "External access not attempted; not acquired", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-06", "qualification": "This gateway was constructed from retained citation identifier PMC6737461. The current response, full-text and supplement identity, and reading remain unverified. BMJ2019 by Li WQ and colleagues is a report linked in the retained summary. External abstracts, full texts, registration, protocols and analysis plans were not read in this conversion, and independent clinical validation was not performed. The material check date is the original date retained in the summary and condition records. The original verdict-review date does not establish a search cut-off or historical access dates for individual materials; external access was not attempted in this conversion." }, { "material_type": "Trial registration identifier gateway", "public_status": "Registration identifier gateway; original registration unread", "access_status": "External access not attempted; not acquired", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-06", "qualification": "This gateway was constructed from retained citation identifier NCT00339768. The original registration field remains unverified, as do registration dates, versions, trial identity and prior plans. BMJ2019 by Li WQ and colleagues is a report linked in the retained summary. External abstracts, full texts, registration, protocols and analysis plans were not read in this conversion, and independent clinical validation was not performed. The material check date is the original date retained in the summary and condition records. The original verdict-review date does not establish a search cut-off or historical access dates for individual materials; external access was not attempted in this conversion." }, { "material_type": "Protocol and statistical analysis plan", "public_status": "Existence, public availability and location unverified; unread", "access_status": "External access not attempted; not acquired", "acquired": false, "actually_read": "Not read", "as_of": "2026-10-06", "qualification": "Existence, public availability, location, prior endpoints, analysis models and change history for the protocol and SAP remain unverified. Access was not attempted; this does not establish absence of registration or nonpublic status. BMJ2019 by Li WQ and colleagues is a report linked in the retained summary. External abstracts, full texts, registration, protocols and analysis plans were not read in this conversion, and independent clinical validation was not performed. The material check date is the original date retained in the summary and condition records. The original verdict-review date does not establish a search cut-off or historical access dates for individual materials; external access was not attempted in this conversion." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/31511230/" } ] } ], "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." }, "study_overlap": { "state": "Unverified", "unique_trial_count": null, "unique_participant_count": null, "reason": "The retained evidence and citation link to the BMJ2019 report by Li WQ and colleagues. Factors, incidence/mortality, time points and Korean/English summaries are not double-counted as independent studies or participants. Global unique-trial counts, participant totals and independent replication remain unverified." }, "history": [ { "date": "2026-10-25", "kind": "Separation of public-facing pages and materials", "view_version": "1.0", "change": "The public view and materials were prepared from the existing 33 items. No new clinical search, verification-state change or scoring was performed." } ], "language": "en", "translation_date": "2026-10-25" }