CHAMGAP

Long-term factorial supplementation with garlic extract plus steam-distilled garlic oil × Reduction of gastric-cancer incidence

Select a review item to see its details.
Required evidence, verification status and materials actually read
ItemAVerification statusBReading scopeCReview itemDCurrent findingsEWhy unverifiedFRequired materials and conditionsGFurther research
1 Met Full text not readStored summary read N01 · Evidence conditionWhich garlic factor and which gastric-cancer outcome are compared?Required
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.
The claim boundary is checked; this does not establish preventive efficacy or full-text verification.
Combined garlic supplementation and its placebo, high-risk population, cumulative incidence, and supplementation and follow-up intervals
A product-specification-matched comparative study stating the incidence question separately
2 Partly verified Full text not readStored summary read N02 · Evidence conditionWhat was the trial combination of garlic extract and oil?Required
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.
The combination is identified, but product, manufacturing and component specifications remain unverified.
Ingredients, specifications, manufacture, content and formulation of the extract and steam-distilled oil combination
A direct formulation comparison with a fixed product-matched combination
3 Unverified Full text not readStored summary read N03 · Evidence conditionAre the exact daily dose and actual intake of the combination linked?Required
The original Korean/English wording that exact daily mg require checking in the original source is retained. Actual intake also remains unverified.
Exact mg, frequency and adherence information are absent from this retained scope.
Daily mg of each component, administration frequency, actual exposure and adherence
A product-matched dose study linking actual exposure
4 Partly verified Full text not readStored summary read N04 · Evidence conditionWhat eligibility criteria defined the high-risk Linqu residents?Required
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.
The region and high-risk population are retained, but specific eligibility and composition remain unverified.
Gastric-cancer risk, age, baseline lesions, infection status, inclusion/exclusion criteria and recruitment setting
An external replication matched to the product in another risk group or setting
5 Partly verified Full text not readStored summary read N05 · Evidence conditionHow are the randomized factorial structure and actual allocation connected?Required
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.
The structure is stated, but the actual factor-allocation procedure has not been compared with the full text.
The 2×2×2/2×2 allocation structure, factor application by infection status, concealment and baseline balance
A product-matched randomized factorial trial disclosing allocation details
6 Partly verified Full text not readStored summary read N06 · Evidence conditionWhat was the garlic-factor placebo and how were other factors handled?Required
The comparator is placebo for the garlic factor, with separate H. pylori-treatment and vitamin assignments. Detailed adjustment and interactions remain unverified.
The comparison direction is identified, but placebo details and the full factor analysis are unavailable.
Placebo composition, blinding, and comparison/analysis handling of H. pylori and vitamin assignments
A study prespecifying the main-factor analysis and interaction reporting
7 Met Full text not readStored summary read N07 · Evidence conditionAre H. pylori-treatment results distinguished from garlic results?Required
The retained text identifies H. pylori treatment as a separate randomized factor and does not merge it with garlic’s incidence effect.
This checks the attribution boundary. It is not new verification of infection-treatment or interaction effects.
Allocation and results for the infection-treatment factor and its relationship to the garlic comparison
Prespecified effect-modification assessment by infection status and treatment
8 Partly verified Full text not readStored summary read N08 · Evidence conditionAre vitamin-factor results also kept separate from garlic?Required
The original Korean/English description is retained: vitamins were a separate randomized factor. Numerical interactions with the garlic comparison remain unverified.
Separate attribution is identified, but concurrent-exposure and interaction material is unavailable.
Vitamin assignment, dose, concurrent exposure, results and interactions
A study separating prespecified concurrent-factor interactions from standalone comparisons
9 Partly verified Full text not readStored summary read N09 · Evidence conditionAre 7.3 years of supplementation distinguished from 22.3 years of follow-up?Required
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.
The two periods are identified, but post-discontinuation exposure and period-specific estimates remain unverified.
End of supplementation during 1995~2003, follow-up through 2017, post-discontinuation exposure and event timing
Long-term follow-up prespecifying actual post-discontinuation exposure and effects over time
10 Partly verified Full text not readStored summary read N10 · Evidence conditionHow were cumulative gastric-cancer incidence, diagnosis and detection collected?Required
The cumulative gastric-cancer-incidence endpoint is identified, but diagnostic/detection procedures and assessor-blinding details are absent from the retained summary.
A clinical-event name is available, but the full definition and detection conditions remain unverified.
First-incidence definition, diagnostic criteria, detection/follow-up methods, assessor blinding and cumulative time point
A long-term study disclosing standard event adjudication and group-specific detection conditions
11 Partly verified Full text not readStored summary read N11 · Evidence conditionWhich set do the 3,365 participants and 151 incidence events describe?Required
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.
Whole-trial totals are identified, but group totals for this comparison are unavailable.
Whole-trial allocation, follow-up and incidence totals, and analysis denominators for the garlic groups
Reporting that discloses every group’s analysis denominator and event count
12 Partly verified Full text not readStored summary read N12 · Evidence conditionWhat measure do the garlic-incidence OR and 95% CI represent?Required
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.
The measure and interval are available, but the exact model/adjustment and original result table have not been compared.
Incidence OR0.81, 95%CI0.57~1.13, model and comparison direction
A replication prespecifying the incidence estimand and its uncertainty
13 Unverified Full text not readStored summary read N13 · Evidence conditionCan group incidence and an absolute risk difference be checked directly?Supplementary; required for absolute preventive-effect claims
Incidence, denominators, absolute risk differences and NNT for each garlic group are absent from the retained summary.
Absolute risk is not newly calculated from the OR and whole-trial counts alone.
Group events, denominators and directly reported absolute differences for the same follow-up/analysis set
A long-term study reporting group absolute risks with uncertainty
14 Unverified Full text not readStored summary read N14 · Evidence conditionDoes the incidence OR describe assignment or adherence effects?Required
The retained record provides a randomized factorial design and an OR, but ITT/PP, group analysis sets and adjustment variables remain unverified.
The allocation description is not connected to the analysis definition for the outcome of interest in this material.
ITT/PP, actual analysis sets, assignment/adherence comparison, adjustment variables and factor handling
A study prespecifying assignment and adherence effects separately
15 Unverified Full text not readStored summary read N15 · Evidence conditionHow were long-term losses and deaths handled in the incidence analysis?Required
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.
The retained scope does not establish how losses and deaths were handled.
Group losses/reasons, event detection, competing deaths/censoring and sensitivity analyses
Follow-up prespecifying and disclosing long-term missingness and competing events
16 Partly verified Full text not readStored summary read N16 · Evidence conditionIs citation identifier NCT00339768 linked to actual verification of prior registration?Required
The citation lists NCT00339768, but the structured registration field says unverified. The original registration was not read in this conversion.
An identifier clue exists, but prospective dates, trial identity and prior plans remain unverified.
Registration identity, registration/change dates, recruitment start, registry versions, protocol/SAP
A study disclosing change history and the prior incidence analysis
17 Partly verified Full text not readStored summary read N17 · Evidence conditionWere prespecified incidence/mortality endpoints and analysis hierarchy compared?Required
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.
The manuscript boundary is identified, but actual agreement with prior plans remains unverified.
Planned incidence/mortality endpoints and models, time points, changes and multiplicity rationale
A long-term confirmatory study prespecifying incidence and mortality separately
18 Met Full text not readStored summary read N18 · Evidence conditionIs the gastric-cancer-mortality HR substituted for the incidence OR?Required
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.
This checks endpoint separation. It does not newly confirm reduced mortality or prevention of incidence.
Separate endpoints, models and interpretation for incidence 151 events/OR and mortality 94 deaths/HR
A study defining and reporting each endpoint as a separate question in advance
19 Partly verified Full text not readStored summary read N19 · Evidence conditionWas nonsignificant incidence converted into an effect of 0 or equivalence?Required
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.
The original report is retained, but prior importance/equivalence hypotheses remain unverified.
Original OR/CI, reported wording and equivalence/important-difference criteria
An incidence study prespecifying the effect magnitude of interest and precision
20 Partly verified Full text not readStored summary read N20 · Evidence conditionAre a trial’s factors, languages and follow-up reports counted as independent replications?Required
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.
Current family clues exist, but a complete search for other reports and independent replication was not performed in this conversion.
Shared-participant relationships among reports, factors and time points of the Shandong trial
A separate product-matched replication with independent funding and investigators
21 Not applied Full text not readStored summary read N21 · Evidence conditionShould inter-study heterogeneity be calculated within the one retained family?Not applied; claims across multiple families are separate
Only one report is directly retained. Its factors, incidence/mortality and Korean/English descriptions are not independent units for inter-study heterogeneity.
Not applied only to inter-study comparison within this retained single-family question; this does not establish 0 studies or absence of replication.
Actually distinct study families and condition-specific results
Review of independent-family result distributions for the same incidence question
22 Unverified Full text not readStored summary read N22 · Evidence conditionDoes the record directly answer dose, infection-status and post-discontinuation questions?Supplementary; required for the stated extensions
Exact daily dose, direct dose comparisons, prespecified subgroups and period-specific effects after stopping remain unverified in the retained summary.
The main incidence comparison does not fill extension questions.
Direct dose comparisons, prespecified subgroups/interactions and period-specific estimates
A study separating prespecified effect modification, dose and post-discontinuation follow-up
23 Not applied Full text not readStored summary read N23 · Evidence conditionDoes an incidence question need a bridge from surrogates to events?Not applied; boundary for extensions to mortality or other events
The selected outcome is cumulative gastric-cancer incidence, a clinical event. Mortality is separate.
This limited nonapplication concerns a surrogate-to-incidence bridge for incidence itself; it does not establish preventive efficacy.
Distinction between selected cumulative gastric-cancer incidence and surrogate/mortality questions
A study independently verifying any clinical endpoint to which the claim is extended
24 Partly verified Full text not readStored summary read N24 · Evidence conditionIs public funding the same as checking product/author conflicts?Supplementary; required for independence claims
The retained record states NCI and Chinese public funding and original I2. Product provision, author employment/patents and disclosure details remain unverified.
Funding names alone do not newly establish overall independence or replication.
NCI and Chinese public funding, product provision, employment/patents and declared conflicts
A product-specification-matched replication with separate funding and investigators
25 Met Full text not readStored summary read N25 · Evidence conditionWhat are the actual reading levels for summaries, citations, full text and registration?Required
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.
Reading-state separation is met; this does not mean external-material conditions are met.
Existence, public availability, access, acquisition, actual reading, dates and original locations/links for each material
Compare subsequently acquired material with each condition and link update history
26 Met Full text not readStored summary read N26 · Evidence conditionWere specific Korean/English values and remaining generic wording preserved?Required
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.
Original preservation is met; this does not claim all original English fields were corrected in this conversion.
Original Korean/English/combined-summary/evidence/citation values and the English-placeholder correction event
When new material is authorized, distinguish evidence updates from language corrections
27 Partly verified Full text not readStored summary read N27 · Evidence conditionAre original review date, reading date and search scope distinguished?Required
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.
The original date is present, but historical search cut-off and material-specific access records remain unverified.
Original review date 2026-09-08, actual reading date, inputs used, and search/correction/retraction-check scope
Compare the existing question with new evidence within an authorized follow-up scope
28 Met Full text not readStored summary read N28 · Evidence conditionAre original D34/E0 and current item states distinguished?Required
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.
Separation of historical and current states is met; this is not independent recertification of the original verdict.
Original grade, score, axes, historical Codex cross-check and the scope of current rows
Link only affected conditions to a separate version when an evidence-update event arises
29 Partly verified Full text not readStored summary read N29 · Evidence conditionHow were actual harms collected for this long-term combined exposure?Supplementary; required for safety
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.
Caution wording is retained, but direct harm-event definitions and totals remain unverified.
Definitions, systematic collection, severity and discontinuation for bleeding, gastrointestinal discomfort and interactions
A study systematically collecting harms for the same combined exposure
30 Unverified Full text not readStored summary read N30 · Evidence conditionAre harm timing, stopping, recovery and re-exposure known?Supplementary; required for timing or causal claims
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.
Trial periods cannot be converted into a harm-onset/recovery timeline.
Actual exposure start/stop, harm onset/recovery, re-exposure and observation intervals
Long-term safety-event follow-up without requiring re-exposure
31 Unverified Full text not readStored summary read N31 · Evidence conditionWere harm frequency versus placebo and its denominator checked directly?Supplementary; required for comparative risk or frequency
Garlic-factor placebo is the comparator for incidence. Group harm events, safety-analysis denominators and observation time remain unverified.
Neither an incidence comparator nor the whole-trial N is used to invent harm frequency.
Group harm-person/event counts, exposure/observation denominators, placebo comparisons and intervals
A product-matched comparative study disclosing safety denominators and events
32 Unverified Full text not readStored summary read N32 · Evidence conditionCould concurrent exposure, selection or omissions change harm attribution?Supplementary; required for causal or comparative harm
Other randomized factors are identified, but concomitant drugs, baseline harm risks, differential event omissions/detection and adjustment information are unavailable.
Do not establish harm causality or absence of harm without checking alternative explanations and reporting limits.
Other randomized factors, concomitant drugs, baseline conditions, event reporting/detection and follow-up losses
A safety study jointly addressing exposure, alternative explanations and event omissions
33 Unverified Full text not readStored summary read N33 · Evidence conditionWhat is known about independent harm records and long-term/special-population safety?Supplementary; required for the stated safety extensions
Direct safety families, group events/denominators and rare/special-population results remain unverified. Only existing caution wording is retained.
Long-term incidence follow-up and safety of other formulations or food intakes do not substitute for safety certification of this combination.
Distinct safety events/study families, rare/long-term harms, vulnerable populations and concurrent-drug exposure
Long-term/special-population safety follow-up linking product specifications and exposure
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33 itemsWhat the statuses mean

Assessment scope

Stored-material review date
2026-10-06
Original evidence cut-off
2026-09-08
Scope actually checked
Retained Korean/English summaries and case-specific condition/application records. Full papers, supplements, registrations, plans and original data were not read.
What the dates mean
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.
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.
Ingredient, formulation and route
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.
Measured outcome
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.
Questions outside this scope
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.

Evidence and sources

The links below lead to the sources. A link alone does not mean the original source was read or its latest publication status verified.

S1 · Li WQ et al. BMJ. 2019;366:l5016. PMID: 31511230. PMCID: PMC6737461. DOI: 10.1136/bmj.l5016. NCT00339768.

PubMed

Material 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.
Materials actually 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.
Findings recorded in the stored summary
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.
Record 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.
Study overlap and independent replication
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.
Public availability, access and reading status by material
MaterialPublic availabilityAccess statusActually readNotes
Retained verdict summaryRetained verdict summary readRetained copy acquired; summary readStored existing review summary readRelevant 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.
PubMed bibliographic/abstract gatewayBibliographic link retained; external material unreadExternal access not attempted; not acquiredNot readThis 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.
PMC full-text gatewayFull-text gateway; external material unreadExternal access not attempted; not acquiredNot readThis 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.
Trial registration identifier gatewayRegistration identifier gateway; original registration unreadExternal access not attempted; not acquiredNot readThis 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.
Protocol and statistical analysis planExistence, public availability and location unverified; unreadExternal access not attempted; not acquiredNot readExistence, 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.

Report counts versus independent study counts

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.

Review criteria

Version 1.0 · Criteria record date 2026-10-06. These are Chamgap's own application conditions, informed by the referenced methods. They do not constitute official assessment-tool certification or a new efficacy score.

N01 · Which garlic factor and which gastric-cancer outcome are compared?
Required materials and conditions
Combined garlic supplementation and its placebo, high-risk population, cumulative incidence, and supplementation and follow-up intervals
Conditions for verification
Specify cumulative gastric-cancer incidence for the combined garlic factor versus its placebo, with other factors and endpoints excluded.
Requirement and applicability
Required
Application exceptions
Mortality and H. pylori-treatment questions are retained as related background and do not replace this incidence comparison.
Why this condition is needed
Needed to avoid combining incidence, mortality and other randomized factors from the same trial into a single efficacy claim.
Referenced methods
Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.
N02 · What was the trial combination of garlic extract and oil?
Required materials and conditions
Ingredients, specifications, manufacture, content and formulation of the extract and steam-distilled oil combination
Conditions for verification
Identify the actual trial specifications and combination of both components and record differences from other formulations.
Requirement and applicability
Required
Application exceptions
Do not equate different extracted, aged or fermented formulations merely because they share a plant source.
Why this condition is needed
Needed to avoid transferring this result to garlic oil alone, raw garlic or AGE.
Referenced methods
Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.
N03 · Are the exact daily dose and actual intake of the combination linked?
Required materials and conditions
Daily mg of each component, administration frequency, actual exposure and adherence
Conditions for verification
Distinguish nominal amounts of each component from actual intake records; do not infer missing quantities.
Requirement and applicability
Required
Application exceptions
Do not import mg, mL or SAC content from other garlic studies into this trial.
Why this condition is needed
Needed to avoid filling the phrase trial specifications with an exact dose or actual intake.
Referenced methods
Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.
N04 · What eligibility criteria defined the high-risk Linqu residents?
Required materials and conditions
Gastric-cancer risk, age, baseline lesions, infection status, inclusion/exclusion criteria and recruitment setting
Conditions for verification
Connect the actual composition of the selected high-risk population with the scope of the table.
Requirement and applicability
Required
Application exceptions
Preserve mixed infection status, baseline lesions, composition and differences.
Why this condition is needed
Needed to avoid transferring a local high-risk-population result to preventive food effects for everyone.
Referenced methods
Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.
N05 · How are the randomized factorial structure and actual allocation connected?
Required materials and conditions
The 2×2×2/2×2 allocation structure, factor application by infection status, concealment and baseline balance
Conditions for verification
Link the factor-specific allocation structure and garlic comparison of interest to their original definitions.
Requirement and applicability
Required
Application exceptions
Do not flatten the factorial design into an ordinary parallel 2-group comparison or label unknown allocation details as not applicable.
Why this condition is needed
Needed to avoid treating the randomized-factorial label as confirmation of all allocation procedures and detailed comparisons.
Referenced methods
Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.
N06 · What was the garlic-factor placebo and how were other factors handled?
Required materials and conditions
Placebo composition, blinding, and comparison/analysis handling of H. pylori and vitamin assignments
Conditions for verification
Distinguish the actual garlic-placebo comparison from the scope of adjustment, stratification and interaction handling for other assigned factors.
Requirement and applicability
Required
Application exceptions
Do not delete garlic results because other factors exist; identify the comparison of interest and its handling.
Why this condition is needed
Needed to avoid mixing other factors’ effects into the garlic comparison.
Referenced methods
Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.
N07 · Are H. pylori-treatment results distinguished from garlic results?
Required materials and conditions
Allocation and results for the infection-treatment factor and its relationship to the garlic comparison
Conditions for verification
Record incidence comparisons for the H. pylori-treatment factor and the garlic factor separately.
Requirement and applicability
Required
Application exceptions
Do not add separate randomized-factor results; preserve the existence of related material.
Why this condition is needed
Needed to avoid attributing infection-treatment effects to garlic’s effect on gastric-cancer incidence.
Referenced methods
Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.
N08 · Are vitamin-factor results also kept separate from garlic?
Required materials and conditions
Vitamin assignment, dose, concurrent exposure, results and interactions
Conditions for verification
Attribute vitamin-factor and garlic-factor results separately and record unverified concurrent exposure.
Requirement and applicability
Required
Application exceptions
Distinguish vitamin and garlic assignments without describing unverified interactions as absent.
Why this condition is needed
Needed to avoid counting vitamin results from a multifactor trial as independent replication of garlic efficacy.
Referenced methods
Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.
N09 · Are 7.3 years of supplementation distinguished from 22.3 years of follow-up?
Required materials and conditions
End of supplementation during 1995~2003, follow-up through 2017, post-discontinuation exposure and event timing
Conditions for verification
Link supplementation and follow-up separately; use only directly reported additional exposure and period-specific outcomes.
Requirement and applicability
Required
Application exceptions
Retain post-discontinuation follow-up without inferring actual intake after stopping or period-specific effects.
Why this condition is needed
Needed to avoid converting long follow-up into equally long intake or confirmation of a sustained effect.
Referenced methods
Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.
N10 · How were cumulative gastric-cancer incidence, diagnosis and detection collected?
Required materials and conditions
First-incidence definition, diagnostic criteria, detection/follow-up methods, assessor blinding and cumulative time point
Conditions for verification
Link diagnosis, detection, cumulative interval and group-specific measurement conditions to the selected incidence outcome.
Requirement and applicability
Required
Application exceptions
Incidence and mortality are both clinical events but do not substitute for the same event definition or analysis.
Why this condition is needed
Needed to avoid treating an event name alone as confirmation of diagnostic accuracy or equivalent detection.
Referenced methods
Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.
N11 · Which set do the 3,365 participants and 151 incidence events describe?
Required materials and conditions
Whole-trial allocation, follow-up and incidence totals, and analysis denominators for the garlic groups
Conditions for verification
Keep supplied whole-trial counts at their original level; retain missing group denominators and events separately as unverified.
Requirement and applicability
Required
Application exceptions
Distinguish events from people and do not double-count the same participants across factors or reports.
Why this condition is needed
Needed to avoid converting whole-trial counts into each group’s analysis count or an incidence denominator.
Referenced methods
Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.
N12 · What measure do the garlic-incidence OR and 95% CI represent?
Required materials and conditions
Incidence OR0.81, 95%CI0.57~1.13, model and comparison direction
Conditions for verification
Link the incidence OR and interval to their endpoint, period and comparison, retaining unverified model details.
Requirement and applicability
Required
Application exceptions
Preserve the original measure and interval without calculating new CI, P or effect values.
Why this condition is needed
Needed to avoid converting the OR into RR, HR, absolute risk or a mortality value.
Referenced methods
Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.
N13 · Can group incidence and an absolute risk difference be checked directly?
Required materials and conditions
Group events, denominators and directly reported absolute differences for the same follow-up/analysis set
Conditions for verification
Display an absolute preventive magnitude only when matching group denominators and directly reported absolute values are linked.
Requirement and applicability
Supplementary; required for absolute preventive-effect claims
Application exceptions
Do not back-calculate or extrapolate unverified absolute values, NNT or baseline risk.
Why this condition is needed
Needed to avoid inventing prevention counts and absolute differences using the whole-trial 151 events or the OR.
Referenced methods
Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.
N14 · Does the incidence OR describe assignment or adherence effects?
Required materials and conditions
ITT/PP, actual analysis sets, assignment/adherence comparison, adjustment variables and factor handling
Conditions for verification
Connect the effect of interest to the original analysis set and adjustment definitions and state the unverified scope.
Requirement and applicability
Required
Application exceptions
Do not choose ITT, PP or a model when the original material does not specify the analysis.
Why this condition is needed
Needed to avoid automatically filling ITT analysis from randomization.
Referenced methods
Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.
N15 · How were long-term losses and deaths handled in the incidence analysis?
Required materials and conditions
Group losses/reasons, event detection, competing deaths/censoring and sensitivity analyses
Conditions for verification
Connect actual handling of loss, censoring and competing deaths to its influence on analysis denominators and original results.
Requirement and applicability
Required
Application exceptions
Do not add deaths as incidence events or infer the competing-event method.
Why this condition is needed
Needed to avoid treating long follow-up and a total event count as confirmation of no missingness influence.
Referenced methods
Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.
N16 · Is citation identifier NCT00339768 linked to actual verification of prior registration?
Required materials and conditions
Registration identity, registration/change dates, recruitment start, registry versions, protocol/SAP
Conditions for verification
Check original registry versions, dates and trial identity, distinguishing plans actually compared from parts not compared.
Requirement and applicability
Required
Application exceptions
Preserve both the unverified structured registration field and citation identifier; lack of acquisition does not establish nonregistration.
Why this condition is needed
Needed to avoid promoting an identifier string into confirmation of prospective registration or a successful plan comparison.
Referenced methods
Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.
N17 · Were prespecified incidence/mortality endpoints and analysis hierarchy compared?
Required materials and conditions
Planned incidence/mortality endpoints and models, time points, changes and multiplicity rationale
Conditions for verification
Compare original plans with actual incidence and mortality analyses separately, retaining unavailable parts.
Requirement and applicability
Required
Application exceptions
Record the manuscript’s main question separately from verification of the trial’s prespecified primary/secondary endpoints.
Why this condition is needed
Needed to avoid substituting a favorable other endpoint for the selected incidence analysis.
Referenced methods
Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.
N18 · Is the gastric-cancer-mortality HR substituted for the incidence OR?
Required materials and conditions
Separate endpoints, models and interpretation for incidence 151 events/OR and mortality 94 deaths/HR
Conditions for verification
Attribute incidence OR0.81(0.57~1.13) and mortality HR0.66(0.43~1.00) to their respective endpoints.
Requirement and applicability
Required
Application exceptions
Retain mortality values as originally reported without merging their events, intervals or measure into incidence.
Why this condition is needed
Needed to avoid transferring a borderline signal in another endpoint into confirmed prevention of incidence.
Referenced methods
Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.
N19 · Was nonsignificant incidence converted into an effect of 0 or equivalence?
Required materials and conditions
Original OR/CI, reported wording and equivalence/important-difference criteria
Conditions for verification
Preserve original observations and intervals without adding unreported equivalence, effect of 0 or importance criteria.
Requirement and applicability
Required
Application exceptions
Retain original D34/E0 and null wording as a historical verdict; this is not a new clinical grade.
Why this condition is needed
Needed to retain original null/nonsignificant wording without newly concluding an exact effect of 0 or equivalence.
Referenced methods
Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.
N20 · Are a trial’s factors, languages and follow-up reports counted as independent replications?
Required materials and conditions
Shared-participant relationships among reports, factors and time points of the Shandong trial
Conditions for verification
Identify currently linked reports/families; leave unestablished global unique-study and participant counts null.
Requirement and applicability
Required
Application exceptions
Linking a family in the retained 1 report is separate from establishing a unique-trial count across the literature.
Why this condition is needed
Needed to avoid adding the same participants’ results or Korean/English/combined summaries as independent studies or patients.
Referenced methods
Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.
N21 · Should inter-study heterogeneity be calculated within the one retained family?
Required materials and conditions
Actually distinct study families and condition-specific results
Conditions for verification
Do not create inter-study heterogeneity values within the current single-report clue; distinguish unverified separate families.
Requirement and applicability
Not applied; claims across multiple families are separate
Application exceptions
Inter-study statistical comparison is not applied to this within-family question; independent replication across the literature remains unverified.
Why this condition is needed
Needed to avoid turning factors, languages or endpoints within a retained report into multiple studies and inventing heterogeneity.
Referenced methods
Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.
N22 · Does the record directly answer dose, infection-status and post-discontinuation questions?
Required materials and conditions
Direct dose comparisons, prespecified subgroups/interactions and period-specific estimates
Conditions for verification
Connect an extension only when its direct comparison, prior plan, denominator and interval are available.
Requirement and applicability
Supplementary; required for the stated extensions
Application exceptions
Do not require every extension study for the narrow incidence question; retain each extension separately as unverified.
Why this condition is needed
Needed to avoid extending the overall incidence comparison to optimal dose, specific groups or persistence after stopping.
Referenced methods
Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.
N23 · Does an incidence question need a bridge from surrogates to events?
Required materials and conditions
Distinction between selected cumulative gastric-cancer incidence and surrogate/mortality questions
Conditions for verification
Keep incidence as the directly selected endpoint without extending it to mortality or other events.
Requirement and applicability
Not applied; boundary for extensions to mortality or other events
Application exceptions
A surrogate-to-incidence bridge is unnecessary for incidence itself, but incidence results do not guarantee reduced mortality.
Why this condition is needed
Needed to avoid imposing a surrogate bridge on a question already concerning clinical incidence.
Referenced methods
Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.
N24 · Is public funding the same as checking product/author conflicts?
Required materials and conditions
NCI and Chinese public funding, product provision, employment/patents and declared conflicts
Conditions for verification
Explain identified funding statements and unverified product/author relationships at their respective original locations.
Requirement and applicability
Supplementary; required for independence claims
Application exceptions
Retain original I2 and independent-funding wording without newly certifying all disclosures or product provision.
Why this condition is needed
Needed to avoid converting public funding into proof of no conflicts or independent replication.
Referenced methods
Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.
N25 · What are the actual reading levels for summaries, citations, full text and registration?
Required materials and conditions
Existence, public availability, access, acquisition, actual reading, dates and original locations/links for each material
Conditions for verification
Link the summary-reading label to current retained-summary citation locations; keep external full text and registration unread according to actual actions.
Requirement and applicability
Required
Application exceptions
Do not describe unattempted access as failure or nonpublic status; separate the retained summary from external material.
Why this condition is needed
Needed to avoid converting the presence of PMID, PMCID, DOI, NCT or URLs into actual reading of the material.
Referenced methods
Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.
N26 · Were specific Korean/English values and remaining generic wording preserved?
Required materials and conditions
Original Korean/English/combined-summary/evidence/citation values and the English-placeholder correction event
Conditions for verification
Preserve every original literal, type and correction event and link specific observations to their actual original locations.
Requirement and applicability
Required
Application exceptions
Preserve both the historical correction of 1 field and remaining generic English wording; do not newly revise the original.
Why this condition is needed
Needed to avoid filling generic confirmation wording with missing specific values or verification actions.
Referenced methods
Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.
N27 · Are original review date, reading date and search scope distinguished?
Required materials and conditions
Original review date 2026-09-08, actual reading date, inputs used, and search/correction/retraction-check scope
Conditions for verification
Link every absence/unverified statement to the retained scope and date; do not convert no search into 0 studies.
Requirement and applicability
Required
Application exceptions
No new clinical search was conducted, so do not claim absence of new papers or a complete current literature check.
Why this condition is needed
Needed to avoid backdating the original review date as a current access date or search cut-off.
Referenced methods
Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.
N28 · Are original D34/E0 and current item states distinguished?
Required materials and conditions
Original grade, score, axes, historical Codex cross-check and the scope of current rows
Conditions for verification
Preserve historical values separately; explain row states from their observations and reasons for uncertainty.
Requirement and applicability
Required
Application exceptions
Preserve original D34/Caution/B-H-R1-I2-E0-B0-C0 and wording without new grading or calculation.
Why this condition is needed
Needed to avoid inheriting historical scores/axes as automatic fulfillment, probability or clinical certification.
Referenced methods
Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.
N29 · How were actual harms collected for this long-term combined exposure?
Required materials and conditions
Definitions, systematic collection, severity and discontinuation for bleeding, gastrointestinal discomfort and interactions
Conditions for verification
Distinguish actual event definitions, collection and discontinuation from the level of the original caution narrative.
Requirement and applicability
Supplementary; required for safety
Application exceptions
Do not erase incidence results because harms are unreported or equate the combination with ordinary-food-intake safety.
Why this condition is needed
Needed to avoid turning caution wording into an event frequency or confirmed causal events.
Referenced methods
Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.
N30 · Are harm timing, stopping, recovery and re-exposure known?
Required materials and conditions
Actual exposure start/stop, harm onset/recovery, re-exposure and observation intervals
Conditions for verification
Distinguish periods from event timelines; do not fill unverified stopping, improvement or re-exposure.
Requirement and applicability
Supplementary; required for timing or causal claims
Application exceptions
Do not require personal re-exposure for this incidence-efficacy question or infer absent original event records.
Why this condition is needed
Needed to avoid treating trial periods alone as confirmation of temporal harm causality.
Referenced methods
Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.
N31 · Were harm frequency versus placebo and its denominator checked directly?
Required materials and conditions
Group harm-person/event counts, exposure/observation denominators, placebo comparisons and intervals
Conditions for verification
Display comparisons/frequencies only from direct reports linking harm events, group denominators and observation time.
Requirement and applicability
Supplementary; required for comparative risk or frequency
Application exceptions
Caution wording is not a comparative-risk value; do not extrapolate background incidence.
Why this condition is needed
Needed to avoid using the whole-trial 3,365 participants as every harm denominator.
Referenced methods
Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.
N32 · Could concurrent exposure, selection or omissions change harm attribution?
Required materials and conditions
Other randomized factors, concomitant drugs, baseline conditions, event reporting/detection and follow-up losses
Conditions for verification
Explain the verified scope of alternative/concurrent exposures, event collection and losses, with attribution limits.
Requirement and applicability
Supplementary; required for causal or comparative harm
Application exceptions
Do not newly establish H. pylori or vitamin factors as harm causes; record only identified concurrent exposure.
Why this condition is needed
Needed to avoid treating missing concurrent-exposure and omission information as no alternative cause or no harm.
Referenced methods
Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.
N33 · What is known about independent harm records and long-term/special-population safety?
Required materials and conditions
Distinct safety events/study families, rare/long-term harms, vulnerable populations and concurrent-drug exposure
Conditions for verification
Keep the family, period and population scope of direct safety material separate from unverified replication/vulnerable-group information.
Requirement and applicability
Supplementary; required for the stated safety extensions
Application exceptions
Requoting a summary is not an independent event; do not require every safety study for this narrow incidence question.
Why this condition is needed
Needed to avoid extending a long-follow-up incidence study to safety for every rare event and population.
Referenced methods
Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.
Referenced methods and the sections actually reviewed

M03 · Cochrane Handbook 6.5 (2024), chapter updated 2023-08

Official methodology · §3.1, §3.2.1–3.2.3, MECIR C5/C7/C13

Referenced principle
Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.
Extent of review
Retained method-application records were reused. External originals were not reread and method content was not reassessed.

M04 · Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03

Official methodology · §4.5, §4.6.1–4.6.3, MECIR C42

Referenced principle
Distinguish studies from reports and link them; do not omit a study solely because results are unreported.
Extent of review
Retained method-application records were reused. External originals were not reread and method content was not reassessed.

M08 · Cochrane Handbook 6.5 (2024), chapter updated 2019-10

Official methodology · §8.1–8.2.3, Table 8.2.a

Referenced principle
Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.
Extent of review
Retained method-application records were reused. External originals were not reread and method content was not reassessed.

M15 · Cochrane Handbook 6.5 (2024), chapter updated 2023-08

Official methodology · §15.2.4, §15.3.1–15.3.3

Referenced principle
Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.
Extent of review
Retained method-application records were reused. External originals were not reread and method content was not reassessed.

M19 · Cochrane Handbook 6.5 (2024), chapter updated 2019-10

Official methodology · §19.1.2, §19.2.1–19.2.4

Referenced principle
Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.
Extent of review
Retained method-application records were reused. External originals were not reread and method content was not reassessed.
What the statuses mean
Partly verified
Some required facts are known, but the stated conditions involving analyses, populations, formulation or denominators remain unverified.
Unverified
Direct information is unverified in the retained record. This does not establish an effect of 0, no studies or absence of harm.
Review incomplete
Reading of the material or review of a condition is incomplete. This does not establish absence of studies or efficacy.
Not reported
The needed information was not found in material actually read. This is distinguished from unread material.
Inaccessible
Access was actually attempted but the material was not acquired. This is distinguished from access not attempted.
Insufficient evidence matching the conditions
Evidence directly matching the defined question and conditions is insufficient. This does not establish absence of all research.
Not applicable
A specific condition does not apply to the question. This does not substitute for unread or unverified material.
Conflicting data
This covers discrepancies in material about the same question, denominator and timing. Differences between separate questions are not automatically treated as conflicts.
Met
The retained identity, observation or scope required by this item was checked within stated limits. This does not establish preventive efficacy or full-text certification.
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.

Change history

2026-10-25 · Public page/material version 1.0

The public view and materials were prepared from the existing 33 items. No new clinical search, verification-state change or scoring was performed.

The stored-material review date (2026-10-06) and original evidence cut-off (2026-09-08) were retained unchanged.

Researcher downloads

These materials provide the same evidence, scope and verification status as this page.

View all item details

N01 · Which garlic factor and which gastric-cancer outcome are compared?

Current findings
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.
Verification status
Met
Materials actually 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.
Why unverified
The claim boundary is checked; this does not establish preventive efficacy or full-text verification.
Reason for missing information
The claim boundary is checked; this does not establish preventive efficacy or full-text verification.
Required materials and conditions
Combined garlic supplementation and its placebo, high-risk population, cumulative incidence, and supplementation and follow-up intervals
Materials to obtain first
The original protocol and report specifying the trial question, factor-specific comparisons and incidence definition
Further research
A product-specification-matched comparative study stating the incidence question separately
Remaining uncertainty
The claim boundary is checked; this does not establish preventive efficacy or full-text verification.
Conditions for verification
Specify cumulative gastric-cancer incidence for the combined garlic factor versus its placebo, with other factors and endpoints excluded.
Why this condition is needed
Needed to avoid combining incidence, mortality and other randomized factors from the same trial into a single efficacy claim.
Application exceptions
Mortality and H. pylori-treatment questions are retained as related background and do not replace this incidence comparison.
Referenced methods
Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.

Related sources S1

N02 · What was the trial combination of garlic extract and oil?

Current findings
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.
Verification status
Partly verified
Materials actually 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.
Why unverified
The combination is identified, but product, manufacturing and component specifications remain unverified.
Reason for missing information
The combination is identified, but product, manufacturing and component specifications remain unverified.
Required materials and conditions
Ingredients, specifications, manufacture, content and formulation of the extract and steam-distilled oil combination
Materials to obtain first
Manufacturing, component quality and supply material for the trial product
Further research
A direct formulation comparison with a fixed product-matched combination
Remaining uncertainty
The combination is identified, but product, manufacturing and component specifications remain unverified.
Conditions for verification
Identify the actual trial specifications and combination of both components and record differences from other formulations.
Why this condition is needed
Needed to avoid transferring this result to garlic oil alone, raw garlic or AGE.
Application exceptions
Do not equate different extracted, aged or fermented formulations merely because they share a plant source.
Referenced methods
Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.

Related sources S1

N03 · Are the exact daily dose and actual intake of the combination linked?

Current findings
The original Korean/English wording that exact daily mg require checking in the original source is retained. Actual intake also remains unverified.
Verification status
Unverified
Materials actually 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.
Why unverified
Exact mg, frequency and adherence information are absent from this retained scope.
Reason for missing information
Exact mg, frequency and adherence information are absent from this retained scope.
Required materials and conditions
Daily mg of each component, administration frequency, actual exposure and adherence
Materials to obtain first
The trial-product label, dosing schedule, and group adherence and discontinuation material
Further research
A product-matched dose study linking actual exposure
Remaining uncertainty
Exact mg, frequency and adherence information are absent from this retained scope.
Conditions for verification
Distinguish nominal amounts of each component from actual intake records; do not infer missing quantities.
Why this condition is needed
Needed to avoid filling the phrase trial specifications with an exact dose or actual intake.
Application exceptions
Do not import mg, mL or SAC content from other garlic studies into this trial.
Referenced methods
Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.

Related sources S1

N04 · What eligibility criteria defined the high-risk Linqu residents?

Current findings
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.
Verification status
Partly verified
Materials actually 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.
Why unverified
The region and high-risk population are retained, but specific eligibility and composition remain unverified.
Reason for missing information
The region and high-risk population are retained, but specific eligibility and composition remain unverified.
Required materials and conditions
Gastric-cancer risk, age, baseline lesions, infection status, inclusion/exclusion criteria and recruitment setting
Materials to obtain first
Baseline tables, infection and lesion composition, and group balance
Further research
An external replication matched to the product in another risk group or setting
Remaining uncertainty
The region and high-risk population are retained, but specific eligibility and composition remain unverified.
Conditions for verification
Connect the actual composition of the selected high-risk population with the scope of the table.
Why this condition is needed
Needed to avoid transferring a local high-risk-population result to preventive food effects for everyone.
Application exceptions
Preserve mixed infection status, baseline lesions, composition and differences.
Referenced methods
Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.

Related sources S1

N05 · How are the randomized factorial structure and actual allocation connected?

Current findings
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.
Verification status
Partly verified
Materials actually 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.
Why unverified
The structure is stated, but the actual factor-allocation procedure has not been compared with the full text.
Reason for missing information
The structure is stated, but the actual factor-allocation procedure has not been compared with the full text.
Required materials and conditions
The 2×2×2/2×2 allocation structure, factor application by infection status, concealment and baseline balance
Materials to obtain first
The protocol, allocation flow, methods and baseline tables
Further research
A product-matched randomized factorial trial disclosing allocation details
Remaining uncertainty
The structure is stated, but the actual factor-allocation procedure has not been compared with the full text.
Conditions for verification
Link the factor-specific allocation structure and garlic comparison of interest to their original definitions.
Why this condition is needed
Needed to avoid treating the randomized-factorial label as confirmation of all allocation procedures and detailed comparisons.
Application exceptions
Do not flatten the factorial design into an ordinary parallel 2-group comparison or label unknown allocation details as not applicable.
Referenced methods
Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.

Related sources S1

N06 · What was the garlic-factor placebo and how were other factors handled?

Current findings
The comparator is placebo for the garlic factor, with separate H. pylori-treatment and vitamin assignments. Detailed adjustment and interactions remain unverified.
Verification status
Partly verified
Materials actually 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.
Why unverified
The comparison direction is identified, but placebo details and the full factor analysis are unavailable.
Reason for missing information
The comparison direction is identified, but placebo details and the full factor analysis are unavailable.
Required materials and conditions
Placebo composition, blinding, and comparison/analysis handling of H. pylori and vitamin assignments
Materials to obtain first
Placebo specifications, factor layout, and analysis and interaction plans
Further research
A study prespecifying the main-factor analysis and interaction reporting
Remaining uncertainty
The comparison direction is identified, but placebo details and the full factor analysis are unavailable.
Conditions for verification
Distinguish the actual garlic-placebo comparison from the scope of adjustment, stratification and interaction handling for other assigned factors.
Why this condition is needed
Needed to avoid mixing other factors’ effects into the garlic comparison.
Application exceptions
Do not delete garlic results because other factors exist; identify the comparison of interest and its handling.
Referenced methods
Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.

Related sources S1

N07 · Are H. pylori-treatment results distinguished from garlic results?

Current findings
The retained text identifies H. pylori treatment as a separate randomized factor and does not merge it with garlic’s incidence effect.
Verification status
Met
Materials actually 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.
Why unverified
This checks the attribution boundary. It is not new verification of infection-treatment or interaction effects.
Reason for missing information
This checks the attribution boundary. It is not new verification of infection-treatment or interaction effects.
Required materials and conditions
Allocation and results for the infection-treatment factor and its relationship to the garlic comparison
Materials to obtain first
Infection status, treatment-factor results, factor-specific estimates and interaction tables
Further research
Prespecified effect-modification assessment by infection status and treatment
Remaining uncertainty
This checks the attribution boundary. It is not new verification of infection-treatment or interaction effects.
Conditions for verification
Record incidence comparisons for the H. pylori-treatment factor and the garlic factor separately.
Why this condition is needed
Needed to avoid attributing infection-treatment effects to garlic’s effect on gastric-cancer incidence.
Application exceptions
Do not add separate randomized-factor results; preserve the existence of related material.
Referenced methods
Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.

Related sources S1

N08 · Are vitamin-factor results also kept separate from garlic?

Current findings
The original Korean/English description is retained: vitamins were a separate randomized factor. Numerical interactions with the garlic comparison remain unverified.
Verification status
Partly verified
Materials actually 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.
Why unverified
Separate attribution is identified, but concurrent-exposure and interaction material is unavailable.
Reason for missing information
Separate attribution is identified, but concurrent-exposure and interaction material is unavailable.
Required materials and conditions
Vitamin assignment, dose, concurrent exposure, results and interactions
Materials to obtain first
Vitamin specifications, factor layout, adherence, and interaction plans/results
Further research
A study separating prespecified concurrent-factor interactions from standalone comparisons
Remaining uncertainty
Separate attribution is identified, but concurrent-exposure and interaction material is unavailable.
Conditions for verification
Attribute vitamin-factor and garlic-factor results separately and record unverified concurrent exposure.
Why this condition is needed
Needed to avoid counting vitamin results from a multifactor trial as independent replication of garlic efficacy.
Application exceptions
Distinguish vitamin and garlic assignments without describing unverified interactions as absent.
Referenced methods
Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.

Related sources S1

N09 · Are 7.3 years of supplementation distinguished from 22.3 years of follow-up?

Current findings
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.
Verification status
Partly verified
Materials actually 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.
Why unverified
The two periods are identified, but post-discontinuation exposure and period-specific estimates remain unverified.
Reason for missing information
The two periods are identified, but post-discontinuation exposure and period-specific estimates remain unverified.
Required materials and conditions
End of supplementation during 1995~2003, follow-up through 2017, post-discontinuation exposure and event timing
Materials to obtain first
Supplementation, discontinuation and follow-up schedules, with period-specific exposure/analysis tables
Further research
Long-term follow-up prespecifying actual post-discontinuation exposure and effects over time
Remaining uncertainty
The two periods are identified, but post-discontinuation exposure and period-specific estimates remain unverified.
Conditions for verification
Link supplementation and follow-up separately; use only directly reported additional exposure and period-specific outcomes.
Why this condition is needed
Needed to avoid converting long follow-up into equally long intake or confirmation of a sustained effect.
Application exceptions
Retain post-discontinuation follow-up without inferring actual intake after stopping or period-specific effects.
Referenced methods
Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.

Related sources S1

N10 · How were cumulative gastric-cancer incidence, diagnosis and detection collected?

Current findings
The cumulative gastric-cancer-incidence endpoint is identified, but diagnostic/detection procedures and assessor-blinding details are absent from the retained summary.
Verification status
Partly verified
Materials actually 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.
Why unverified
A clinical-event name is available, but the full definition and detection conditions remain unverified.
Reason for missing information
A clinical-event name is available, but the full definition and detection conditions remain unverified.
Required materials and conditions
First-incidence definition, diagnostic criteria, detection/follow-up methods, assessor blinding and cumulative time point
Materials to obtain first
Diagnostic/event-adjudication criteria, endoscopy/pathology, detection schedules and blinding material
Further research
A long-term study disclosing standard event adjudication and group-specific detection conditions
Remaining uncertainty
A clinical-event name is available, but the full definition and detection conditions remain unverified.
Conditions for verification
Link diagnosis, detection, cumulative interval and group-specific measurement conditions to the selected incidence outcome.
Why this condition is needed
Needed to avoid treating an event name alone as confirmation of diagnostic accuracy or equivalent detection.
Application exceptions
Incidence and mortality are both clinical events but do not substitute for the same event definition or analysis.
Referenced methods
Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.

Related sources S1

N11 · Which set do the 3,365 participants and 151 incidence events describe?

Current findings
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.
Verification status
Partly verified
Materials actually 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.
Why unverified
Whole-trial totals are identified, but group totals for this comparison are unavailable.
Reason for missing information
Whole-trial totals are identified, but group totals for this comparison are unavailable.
Required materials and conditions
Whole-trial allocation, follow-up and incidence totals, and analysis denominators for the garlic groups
Materials to obtain first
Factor-specific allocation, completion, analysis and incidence flow tables
Further research
Reporting that discloses every group’s analysis denominator and event count
Remaining uncertainty
Whole-trial totals are identified, but group totals for this comparison are unavailable.
Conditions for verification
Keep supplied whole-trial counts at their original level; retain missing group denominators and events separately as unverified.
Why this condition is needed
Needed to avoid converting whole-trial counts into each group’s analysis count or an incidence denominator.
Application exceptions
Distinguish events from people and do not double-count the same participants across factors or reports.
Referenced methods
Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.

Related sources S1

N12 · What measure do the garlic-incidence OR and 95% CI represent?

Current findings
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.
Verification status
Partly verified
Materials actually 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.
Why unverified
The measure and interval are available, but the exact model/adjustment and original result table have not been compared.
Reason for missing information
The measure and interval are available, but the exact model/adjustment and original result table have not been compared.
Required materials and conditions
Incidence OR0.81, 95%CI0.57~1.13, model and comparison direction
Materials to obtain first
Original incidence result tables, model/adjustment definitions and group totals
Further research
A replication prespecifying the incidence estimand and its uncertainty
Remaining uncertainty
The measure and interval are available, but the exact model/adjustment and original result table have not been compared.
Conditions for verification
Link the incidence OR and interval to their endpoint, period and comparison, retaining unverified model details.
Why this condition is needed
Needed to avoid converting the OR into RR, HR, absolute risk or a mortality value.
Application exceptions
Preserve the original measure and interval without calculating new CI, P or effect values.
Referenced methods
Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.

Related sources S1

N13 · Can group incidence and an absolute risk difference be checked directly?

Current findings
Incidence, denominators, absolute risk differences and NNT for each garlic group are absent from the retained summary.
Verification status
Unverified
Materials actually 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.
Why unverified
Absolute risk is not newly calculated from the OR and whole-trial counts alone.
Reason for missing information
Absolute risk is not newly calculated from the OR and whole-trial counts alone.
Required materials and conditions
Group events, denominators and directly reported absolute differences for the same follow-up/analysis set
Materials to obtain first
Group events, follow-up denominators, and direct absolute differences and intervals
Further research
A long-term study reporting group absolute risks with uncertainty
Remaining uncertainty
Absolute risk is not newly calculated from the OR and whole-trial counts alone.
Conditions for verification
Display an absolute preventive magnitude only when matching group denominators and directly reported absolute values are linked.
Why this condition is needed
Needed to avoid inventing prevention counts and absolute differences using the whole-trial 151 events or the OR.
Application exceptions
Do not back-calculate or extrapolate unverified absolute values, NNT or baseline risk.
Referenced methods
Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.

Related sources S1

N14 · Does the incidence OR describe assignment or adherence effects?

Current findings
The retained record provides a randomized factorial design and an OR, but ITT/PP, group analysis sets and adjustment variables remain unverified.
Verification status
Unverified
Materials actually 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.
Why unverified
The allocation description is not connected to the analysis definition for the outcome of interest in this material.
Reason for missing information
The allocation description is not connected to the analysis definition for the outcome of interest in this material.
Required materials and conditions
ITT/PP, actual analysis sets, assignment/adherence comparison, adjustment variables and factor handling
Materials to obtain first
SAP, analysis sets/exclusions, adjustment methods and the actual incidence model
Further research
A study prespecifying assignment and adherence effects separately
Remaining uncertainty
The allocation description is not connected to the analysis definition for the outcome of interest in this material.
Conditions for verification
Connect the effect of interest to the original analysis set and adjustment definitions and state the unverified scope.
Why this condition is needed
Needed to avoid automatically filling ITT analysis from randomization.
Application exceptions
Do not choose ITT, PP or a model when the original material does not specify the analysis.
Referenced methods
Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.

Related sources S1

N15 · How were long-term losses and deaths handled in the incidence analysis?

Current findings
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.
Verification status
Unverified
Materials actually 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.
Why unverified
The retained scope does not establish how losses and deaths were handled.
Reason for missing information
The retained scope does not establish how losses and deaths were handled.
Required materials and conditions
Group losses/reasons, event detection, competing deaths/censoring and sensitivity analyses
Materials to obtain first
Group follow-up flow, death/censoring handling and sensitivity analyses
Further research
Follow-up prespecifying and disclosing long-term missingness and competing events
Remaining uncertainty
The retained scope does not establish how losses and deaths were handled.
Conditions for verification
Connect actual handling of loss, censoring and competing deaths to its influence on analysis denominators and original results.
Why this condition is needed
Needed to avoid treating long follow-up and a total event count as confirmation of no missingness influence.
Application exceptions
Do not add deaths as incidence events or infer the competing-event method.
Referenced methods
Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.

Related sources S1

N16 · Is citation identifier NCT00339768 linked to actual verification of prior registration?

Current findings
The citation lists NCT00339768, but the structured registration field says unverified. The original registration was not read in this conversion.
Verification status
Partly verified
Materials actually 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.
Why unverified
An identifier clue exists, but prospective dates, trial identity and prior plans remain unverified.
Reason for missing information
An identifier clue exists, but prospective dates, trial identity and prior plans remain unverified.
Required materials and conditions
Registration identity, registration/change dates, recruitment start, registry versions, protocol/SAP
Materials to obtain first
Original NCT00339768 registration history, protocol and incidence/mortality SAP
Further research
A study disclosing change history and the prior incidence analysis
Remaining uncertainty
An identifier clue exists, but prospective dates, trial identity and prior plans remain unverified.
Conditions for verification
Check original registry versions, dates and trial identity, distinguishing plans actually compared from parts not compared.
Why this condition is needed
Needed to avoid promoting an identifier string into confirmation of prospective registration or a successful plan comparison.
Application exceptions
Preserve both the unverified structured registration field and citation identifier; lack of acquisition does not establish nonregistration.
Referenced methods
Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.

Related sources S1

N17 · Were prespecified incidence/mortality endpoints and analysis hierarchy compared?

Current findings
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.
Verification status
Partly verified
Materials actually 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.
Why unverified
The manuscript boundary is identified, but actual agreement with prior plans remains unverified.
Reason for missing information
The manuscript boundary is identified, but actual agreement with prior plans remains unverified.
Required materials and conditions
Planned incidence/mortality endpoints and models, time points, changes and multiplicity rationale
Materials to obtain first
Endpoints, timing, multiplicity and change history in registration/protocol/SAP
Further research
A long-term confirmatory study prespecifying incidence and mortality separately
Remaining uncertainty
The manuscript boundary is identified, but actual agreement with prior plans remains unverified.
Conditions for verification
Compare original plans with actual incidence and mortality analyses separately, retaining unavailable parts.
Why this condition is needed
Needed to avoid substituting a favorable other endpoint for the selected incidence analysis.
Application exceptions
Record the manuscript’s main question separately from verification of the trial’s prespecified primary/secondary endpoints.
Referenced methods
Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.

Related sources S1

N18 · Is the gastric-cancer-mortality HR substituted for the incidence OR?

Current findings
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.
Verification status
Met
Materials actually 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.
Why unverified
This checks endpoint separation. It does not newly confirm reduced mortality or prevention of incidence.
Reason for missing information
This checks endpoint separation. It does not newly confirm reduced mortality or prevention of incidence.
Required materials and conditions
Separate endpoints, models and interpretation for incidence 151 events/OR and mortality 94 deaths/HR
Materials to obtain first
Original incidence/mortality result tables, models and prior plans
Further research
A study defining and reporting each endpoint as a separate question in advance
Remaining uncertainty
This checks endpoint separation. It does not newly confirm reduced mortality or prevention of incidence.
Conditions for verification
Attribute incidence OR0.81(0.57~1.13) and mortality HR0.66(0.43~1.00) to their respective endpoints.
Why this condition is needed
Needed to avoid transferring a borderline signal in another endpoint into confirmed prevention of incidence.
Application exceptions
Retain mortality values as originally reported without merging their events, intervals or measure into incidence.
Referenced methods
Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.

Related sources S1

N19 · Was nonsignificant incidence converted into an effect of 0 or equivalence?

Current findings
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.
Verification status
Partly verified
Materials actually 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.
Why unverified
The original report is retained, but prior importance/equivalence hypotheses remain unverified.
Reason for missing information
The original report is retained, but prior importance/equivalence hypotheses remain unverified.
Required materials and conditions
Original OR/CI, reported wording and equivalence/important-difference criteria
Materials to obtain first
Prespecified important differences, equivalence hypotheses/interval criteria and original result tables
Further research
An incidence study prespecifying the effect magnitude of interest and precision
Remaining uncertainty
The original report is retained, but prior importance/equivalence hypotheses remain unverified.
Conditions for verification
Preserve original observations and intervals without adding unreported equivalence, effect of 0 or importance criteria.
Why this condition is needed
Needed to retain original null/nonsignificant wording without newly concluding an exact effect of 0 or equivalence.
Application exceptions
Retain original D34/E0 and null wording as a historical verdict; this is not a new clinical grade.
Referenced methods
Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.

Related sources S1

N20 · Are a trial’s factors, languages and follow-up reports counted as independent replications?

Current findings
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.
Verification status
Partly verified
Materials actually 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.
Why unverified
Current family clues exist, but a complete search for other reports and independent replication was not performed in this conversion.
Reason for missing information
Current family clues exist, but a complete search for other reports and independent replication was not performed in this conversion.
Required materials and conditions
Shared-participant relationships among reports, factors and time points of the Shandong trial
Materials to obtain first
A study-family crosswalk connecting registration, reports and subsequent follow-up
Further research
A separate product-matched replication with independent funding and investigators
Remaining uncertainty
Current family clues exist, but a complete search for other reports and independent replication was not performed in this conversion.
Conditions for verification
Identify currently linked reports/families; leave unestablished global unique-study and participant counts null.
Why this condition is needed
Needed to avoid adding the same participants’ results or Korean/English/combined summaries as independent studies or patients.
Application exceptions
Linking a family in the retained 1 report is separate from establishing a unique-trial count across the literature.
Referenced methods
Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.

Related sources S1

N21 · Should inter-study heterogeneity be calculated within the one retained family?

Current findings
Only one report is directly retained. Its factors, incidence/mortality and Korean/English descriptions are not independent units for inter-study heterogeneity.
Verification status
Not applied
Materials actually 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.
Why unverified
Not applied only to inter-study comparison within this retained single-family question; this does not establish 0 studies or absence of replication.
Reason for missing information
Not applied only to inter-study comparison within this retained single-family question; this does not establish 0 studies or absence of replication.
Required materials and conditions
Actually distinct study families and condition-specific results
Materials to obtain first
Other distinct product-matched studies/reports and comparisons of their conditions
Further research
Review of independent-family result distributions for the same incidence question
Remaining uncertainty
Not applied only to inter-study comparison within this retained single-family question; this does not establish 0 studies or absence of replication.
Conditions for verification
Do not create inter-study heterogeneity values within the current single-report clue; distinguish unverified separate families.
Why this condition is needed
Needed to avoid turning factors, languages or endpoints within a retained report into multiple studies and inventing heterogeneity.
Application exceptions
Inter-study statistical comparison is not applied to this within-family question; independent replication across the literature remains unverified.
Referenced methods
Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.

Related sources S1

N22 · Does the record directly answer dose, infection-status and post-discontinuation questions?

Current findings
Exact daily dose, direct dose comparisons, prespecified subgroups and period-specific effects after stopping remain unverified in the retained summary.
Verification status
Unverified
Materials actually 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.
Why unverified
The main incidence comparison does not fill extension questions.
Reason for missing information
The main incidence comparison does not fill extension questions.
Required materials and conditions
Direct dose comparisons, prespecified subgroups/interactions and period-specific estimates
Materials to obtain first
Direct dose comparisons, infection/lesion plans and interactions, and period-specific estimates
Further research
A study separating prespecified effect modification, dose and post-discontinuation follow-up
Remaining uncertainty
The main incidence comparison does not fill extension questions.
Conditions for verification
Connect an extension only when its direct comparison, prior plan, denominator and interval are available.
Why this condition is needed
Needed to avoid extending the overall incidence comparison to optimal dose, specific groups or persistence after stopping.
Application exceptions
Do not require every extension study for the narrow incidence question; retain each extension separately as unverified.
Referenced methods
Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.

Related sources S1

N23 · Does an incidence question need a bridge from surrogates to events?

Current findings
The selected outcome is cumulative gastric-cancer incidence, a clinical event. Mortality is separate.
Verification status
Not applied
Materials actually 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.
Why unverified
This limited nonapplication concerns a surrogate-to-incidence bridge for incidence itself; it does not establish preventive efficacy.
Reason for missing information
This limited nonapplication concerns a surrogate-to-incidence bridge for incidence itself; it does not establish preventive efficacy.
Required materials and conditions
Distinction between selected cumulative gastric-cancer incidence and surrogate/mortality questions
Materials to obtain first
Direct material and original plans for separate mortality/other-event questions
Further research
A study independently verifying any clinical endpoint to which the claim is extended
Remaining uncertainty
This limited nonapplication concerns a surrogate-to-incidence bridge for incidence itself; it does not establish preventive efficacy.
Conditions for verification
Keep incidence as the directly selected endpoint without extending it to mortality or other events.
Why this condition is needed
Needed to avoid imposing a surrogate bridge on a question already concerning clinical incidence.
Application exceptions
A surrogate-to-incidence bridge is unnecessary for incidence itself, but incidence results do not guarantee reduced mortality.
Referenced methods
Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.

Related sources S1

N24 · Is public funding the same as checking product/author conflicts?

Current findings
The retained record states NCI and Chinese public funding and original I2. Product provision, author employment/patents and disclosure details remain unverified.
Verification status
Partly verified
Materials actually 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.
Why unverified
Funding names alone do not newly establish overall independence or replication.
Reason for missing information
Funding names alone do not newly establish overall independence or replication.
Required materials and conditions
NCI and Chinese public funding, product provision, employment/patents and declared conflicts
Materials to obtain first
Original funding, product provision, author employment/patents and COI disclosures
Further research
A product-specification-matched replication with separate funding and investigators
Remaining uncertainty
Funding names alone do not newly establish overall independence or replication.
Conditions for verification
Explain identified funding statements and unverified product/author relationships at their respective original locations.
Why this condition is needed
Needed to avoid converting public funding into proof of no conflicts or independent replication.
Application exceptions
Retain original I2 and independent-funding wording without newly certifying all disclosures or product provision.
Referenced methods
Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.

Related sources S1

N25 · What are the actual reading levels for summaries, citations, full text and registration?

Current findings
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.
Verification status
Met
Materials actually 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.
Why unverified
Reading-state separation is met; this does not mean external-material conditions are met.
Reason for missing information
Reading-state separation is met; this does not mean external-material conditions are met.
Required materials and conditions
Existence, public availability, access, acquisition, actual reading, dates and original locations/links for each material
Materials to obtain first
Actual acquisition/reading receipts and original locations for the paper, supplements, registration and SAP
Further research
Compare subsequently acquired material with each condition and link update history
Remaining uncertainty
Reading-state separation is met; this does not mean external-material conditions are met.
Conditions for verification
Link the summary-reading label to current retained-summary citation locations; keep external full text and registration unread according to actual actions.
Why this condition is needed
Needed to avoid converting the presence of PMID, PMCID, DOI, NCT or URLs into actual reading of the material.
Application exceptions
Do not describe unattempted access as failure or nonpublic status; separate the retained summary from external material.
Referenced methods
Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.

Related sources S1

N26 · Were specific Korean/English values and remaining generic wording preserved?

Current findings
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.
Verification status
Met
Materials actually 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.
Why unverified
Original preservation is met; this does not claim all original English fields were corrected in this conversion.
Reason for missing information
Original preservation is met; this does not claim all original English fields were corrected in this conversion.
Required materials and conditions
Original Korean/English/combined-summary/evidence/citation values and the English-placeholder correction event
Materials to obtain first
Original text before/after the historical correction and report-specific English evidence fields
Further research
When new material is authorized, distinguish evidence updates from language corrections
Remaining uncertainty
Original preservation is met; this does not claim all original English fields were corrected in this conversion.
Conditions for verification
Preserve every original literal, type and correction event and link specific observations to their actual original locations.
Why this condition is needed
Needed to avoid filling generic confirmation wording with missing specific values or verification actions.
Application exceptions
Preserve both the historical correction of 1 field and remaining generic English wording; do not newly revise the original.
Referenced methods
Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.

Related sources S1

N27 · Are original review date, reading date and search scope distinguished?

Current findings
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.
Verification status
Partly verified
Materials actually 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.
Why unverified
The original date is present, but historical search cut-off and material-specific access records remain unverified.
Reason for missing information
The original date is present, but historical search cut-off and material-specific access records remain unverified.
Required materials and conditions
Original review date 2026-09-08, actual reading date, inputs used, and search/correction/retraction-check scope
Materials to obtain first
Existing search records, report-specific access records and correction/retraction history
Further research
Compare the existing question with new evidence within an authorized follow-up scope
Remaining uncertainty
The original date is present, but historical search cut-off and material-specific access records remain unverified.
Conditions for verification
Link every absence/unverified statement to the retained scope and date; do not convert no search into 0 studies.
Why this condition is needed
Needed to avoid backdating the original review date as a current access date or search cut-off.
Application exceptions
No new clinical search was conducted, so do not claim absence of new papers or a complete current literature check.
Referenced methods
Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.

Related sources S1

N28 · Are original D34/E0 and current item states distinguished?

Current findings
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.
Verification status
Met
Materials actually 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.
Why unverified
Separation of historical and current states is met; this is not independent recertification of the original verdict.
Reason for missing information
Separation of historical and current states is met; this is not independent recertification of the original verdict.
Required materials and conditions
Original grade, score, axes, historical Codex cross-check and the scope of current rows
Materials to obtain first
Versions, original text and decisions for the original verdict, axes and corrections
Further research
Link only affected conditions to a separate version when an evidence-update event arises
Remaining uncertainty
Separation of historical and current states is met; this is not independent recertification of the original verdict.
Conditions for verification
Preserve historical values separately; explain row states from their observations and reasons for uncertainty.
Why this condition is needed
Needed to avoid inheriting historical scores/axes as automatic fulfillment, probability or clinical certification.
Application exceptions
Preserve original D34/Caution/B-H-R1-I2-E0-B0-C0 and wording without new grading or calculation.
Referenced methods
Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.

Related sources S1

N29 · How were actual harms collected for this long-term combined exposure?

Current findings
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.
Verification status
Partly verified
Materials actually 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.
Why unverified
Caution wording is retained, but direct harm-event definitions and totals remain unverified.
Reason for missing information
Caution wording is retained, but direct harm-event definitions and totals remain unverified.
Required materials and conditions
Definitions, systematic collection, severity and discontinuation for bleeding, gastrointestinal discomfort and interactions
Materials to obtain first
Original-trial harm-collection tables, severity, discontinuation and event definitions
Further research
A study systematically collecting harms for the same combined exposure
Remaining uncertainty
Caution wording is retained, but direct harm-event definitions and totals remain unverified.
Conditions for verification
Distinguish actual event definitions, collection and discontinuation from the level of the original caution narrative.
Why this condition is needed
Needed to avoid turning caution wording into an event frequency or confirmed causal events.
Application exceptions
Do not erase incidence results because harms are unreported or equate the combination with ordinary-food-intake safety.
Referenced methods
Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.

Related sources S1

N30 · Are harm timing, stopping, recovery and re-exposure known?

Current findings
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.
Verification status
Unverified
Materials actually 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.
Why unverified
Trial periods cannot be converted into a harm-onset/recovery timeline.
Reason for missing information
Trial periods cannot be converted into a harm-onset/recovery timeline.
Required materials and conditions
Actual exposure start/stop, harm onset/recovery, re-exposure and observation intervals
Materials to obtain first
Exposure, onset, stopping and recovery dates for individual safety events
Further research
Long-term safety-event follow-up without requiring re-exposure
Remaining uncertainty
Trial periods cannot be converted into a harm-onset/recovery timeline.
Conditions for verification
Distinguish periods from event timelines; do not fill unverified stopping, improvement or re-exposure.
Why this condition is needed
Needed to avoid treating trial periods alone as confirmation of temporal harm causality.
Application exceptions
Do not require personal re-exposure for this incidence-efficacy question or infer absent original event records.
Referenced methods
Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.

Related sources S1

N31 · Were harm frequency versus placebo and its denominator checked directly?

Current findings
Garlic-factor placebo is the comparator for incidence. Group harm events, safety-analysis denominators and observation time remain unverified.
Verification status
Unverified
Materials actually 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.
Why unverified
Neither an incidence comparator nor the whole-trial N is used to invent harm frequency.
Reason for missing information
Neither an incidence comparator nor the whole-trial N is used to invent harm frequency.
Required materials and conditions
Group harm-person/event counts, exposure/observation denominators, placebo comparisons and intervals
Materials to obtain first
Group harm/discontinuation people and event counts, exposure time and direct comparison values
Further research
A product-matched comparative study disclosing safety denominators and events
Remaining uncertainty
Neither an incidence comparator nor the whole-trial N is used to invent harm frequency.
Conditions for verification
Display comparisons/frequencies only from direct reports linking harm events, group denominators and observation time.
Why this condition is needed
Needed to avoid using the whole-trial 3,365 participants as every harm denominator.
Application exceptions
Caution wording is not a comparative-risk value; do not extrapolate background incidence.
Referenced methods
Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.

Related sources S1

N32 · Could concurrent exposure, selection or omissions change harm attribution?

Current findings
Other randomized factors are identified, but concomitant drugs, baseline harm risks, differential event omissions/detection and adjustment information are unavailable.
Verification status
Unverified
Materials actually 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.
Why unverified
Do not establish harm causality or absence of harm without checking alternative explanations and reporting limits.
Reason for missing information
Do not establish harm causality or absence of harm without checking alternative explanations and reporting limits.
Required materials and conditions
Other randomized factors, concomitant drugs, baseline conditions, event reporting/detection and follow-up losses
Materials to obtain first
Concomitant exposure, baseline conditions, group reporting/omissions and factor-specific harm handling
Further research
A safety study jointly addressing exposure, alternative explanations and event omissions
Remaining uncertainty
Do not establish harm causality or absence of harm without checking alternative explanations and reporting limits.
Conditions for verification
Explain the verified scope of alternative/concurrent exposures, event collection and losses, with attribution limits.
Why this condition is needed
Needed to avoid treating missing concurrent-exposure and omission information as no alternative cause or no harm.
Application exceptions
Do not newly establish H. pylori or vitamin factors as harm causes; record only identified concurrent exposure.
Referenced methods
Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.

Related sources S1

N33 · What is known about independent harm records and long-term/special-population safety?

Current findings
Direct safety families, group events/denominators and rare/special-population results remain unverified. Only existing caution wording is retained.
Verification status
Unverified
Materials actually 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.
Why unverified
Long-term incidence follow-up and safety of other formulations or food intakes do not substitute for safety certification of this combination.
Reason for missing information
Long-term incidence follow-up and safety of other formulations or food intakes do not substitute for safety certification of this combination.
Required materials and conditions
Distinct safety events/study families, rare/long-term harms, vulnerable populations and concurrent-drug exposure
Materials to obtain first
Independent safety reports for this combination, long-term/rare events, special populations and concurrent-exposure material
Further research
Long-term/special-population safety follow-up linking product specifications and exposure
Remaining uncertainty
Long-term incidence follow-up and safety of other formulations or food intakes do not substitute for safety certification of this combination.
Conditions for verification
Keep the family, period and population scope of direct safety material separate from unverified replication/vulnerable-group information.
Why this condition is needed
Needed to avoid extending a long-follow-up incidence study to safety for every rare event and population.
Application exceptions
Requoting a summary is not an independent event; do not require every safety study for this narrow incidence question.
Referenced methods
Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained report. Detailed conditions are Chamgap’s own application.

Related sources S1