{
  "schema_version": "chamgap-public-criteria-1.0",
  "title": "Steam-distilled garlic oil 4 mg four times daily × Helicobacter pylori eradication",
  "language": "en",
  "translation_date": "2026-10-26",
  "criteria_version": "1.0",
  "criteria_date": "2026-10-06",
  "condition_origin": "Chamgap's own application conditions",
  "method_sources": [
    {
      "id": "M03",
      "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03",
      "section": "§3.1, §3.2.1–3.2.3, MECIR C5/C7/C13",
      "official_principle": "Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.",
      "review_level": "Retained method-application records were reused. External originals were not reread and method content was not reassessed."
    },
    {
      "id": "M04",
      "version": "Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04",
      "section": "§4.5, §4.6.1–4.6.3, MECIR C42",
      "official_principle": "Distinguish studies from reports and link them; do not omit a study solely because results are unreported.",
      "review_level": "Retained method-application records were reused. External originals were not reread and method content was not reassessed."
    },
    {
      "id": "M08",
      "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08",
      "section": "§8.1–8.2.3, Table 8.2.a",
      "official_principle": "Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.",
      "review_level": "Retained method-application records were reused. External originals were not reread and method content was not reassessed."
    },
    {
      "id": "M15",
      "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15",
      "section": "§15.2.4, §15.3.1–15.3.3",
      "official_principle": "Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.",
      "review_level": "Retained method-application records were reused. External originals were not reread and method content was not reassessed."
    },
    {
      "id": "M19",
      "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19",
      "section": "§19.1.2, §19.2.1–19.2.4",
      "official_principle": "Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.",
      "review_level": "Retained method-application records were reused. External originals were not reread and method content was not reassessed."
    }
  ],
  "status_dictionary": {
    "Met": "The stated material, observation or boundary was checked within limits. Adverse observations are retained; this does not approve efficacy, safety or full-text reading.",
    "Partly verified": "Some retained information was checked, but material or conditions required by the criterion remain unverified.",
    "Unverified": "The criterion cannot be established in the retained record. This does not mean 0 studies, an effect of 0 or absence of harm.",
    "Not reported": "This is limited to a specific material or section actually read. It is not extended to nonreporting in an entire external paper.",
    "Inaccessible": "This is limited to an actual failed access attempt. It was not assigned to clinical materials in this conversion.",
    "Not applicable": "This is limited to a specific application exception. It does not substitute for unread material.",
    "Review incomplete": "Remaining comparison work and its reason are stated separately. This is distinguished from unverified material.",
    "Conflicting data": "This is limited to genuinely incompatible comparisons of the same question, time point and analysis."
  },
  "requirements": [
    {
      "item_id": "N01",
      "question_type": "Evidence condition",
      "question": "Which formulation, population and eradication question are being reviewed?",
      "needed": "Original locations for the claim, formulation, administration, population, eradication definition, comparison and timing",
      "role": "Required",
      "role_reason": "This prevents garlic as a whole or changes in UBT values from replacing the oil-monotherapy eradication question.",
      "application_exception": "Checking the question boundary does not verify efficacy. Raw garlic and combination antibiotic regimens are retained as excluded context.",
      "criterion": "Link the original verdict claim and claim conditions to eradication defined by two negative UBT assessments with steam-distilled oil monotherapy, and state the excluded formulations and endpoints.",
      "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These are Chamgap in-house application conditions for the steam-distilled garlic-oil monotherapy and H. pylori eradication question, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or independent clinical validation.",
      "proposed_research": "When a different formulation or antibiotic adjunct is considered as a new question, first establish its direct original material and comparison boundaries."
    },
    {
      "item_id": "N02",
      "question_type": "Evidence condition",
      "question": "Can the study families of the two reports and their restatements be distinguished?",
      "needed": "Identity links between reports, citations, registration and follow-up reports from the same study",
      "role": "Required",
      "role_reason": "This prevents Korean/English/synthesis texts and evidence/citation restatements from being added as independent replications.",
      "application_exception": "The two citations are clues to two reports; global unique-trial and participant counts remain unestablished.",
      "criterion": "Check citation, formulation and endpoint links for the McNulty oil report and Zardast raw-garlic report; verify follow-up reports from the same trial through original study identity.",
      "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These are Chamgap in-house application conditions for the steam-distilled garlic-oil monotherapy and H. pylori eradication question, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or independent clinical validation.",
      "proposed_research": "In an authorized update, link registrations, original trials and follow-up reports, and group recitations from the same family."
    },
    {
      "item_id": "N03",
      "question_type": "Evidence condition",
      "question": "Which summaries, citations and external materials were actually read?",
      "needed": "Acquisition, actual reading, original locations, dates, hashes and original-material gateways for each material",
      "role": "Required",
      "role_reason": "This prevents PubMed, DOI or PMCID links and historical verification wording from becoming current full-text reading.",
      "application_exception": "Access not attempted is not inaccessible. Reading in this conversion is limited to all fields of the retained summary.",
      "criterion": "Link the actual locations, values and identity of the retained summaries read, and separately record actual access to and reading of external abstracts, full texts, appendices and registrations.",
      "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These are Chamgap in-house application conditions for the steam-distilled garlic-oil monotherapy and H. pylori eradication question, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or independent clinical validation.",
      "proposed_research": "If full texts or appendices are read in a separately authorized update, add actual sections, dates and original identities."
    },
    {
      "item_id": "N04",
      "question_type": "Evidence condition",
      "question": "Which H. pylori-positive adult population do the 5 completers represent?",
      "needed": "Diagnosis, dyspepsia, age, eligibility, baseline status and recruitment route",
      "role": "Required",
      "role_reason": "This prevents observations in a very small completer group from being extended to all infected or asymptomatic people.",
      "application_exception": "Unverified recruitment information does not mean recruitment did not occur. The 15 people receiving raw garlic are not combined into the same sample.",
      "criterion": "Compare the original study’s H. pylori confirmation method, dyspepsia definition, eligibility, baseline characteristics and recruited population with the selected target population.",
      "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These are Chamgap in-house application conditions for the steam-distilled garlic-oil monotherapy and H. pylori eradication question, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or independent clinical validation.",
      "proposed_research": "Application to another population requires direct research with that population, the same formulation and an eradication endpoint."
    },
    {
      "item_id": "N05",
      "question_type": "Evidence condition",
      "question": "Are the ingredients and product identity of steam-distilled garlic-oil capsules established?",
      "needed": "Raw material, steam-distillation process, sulfur-compound specifications, manufacturing/batch and content testing",
      "role": "Required",
      "role_reason": "This prevents essential oil from being treated as equivalent to allicin, raw garlic or AGE.",
      "application_exception": "The name garlic oil alone does not establish sulfur-compound specifications or equivalence with other products.",
      "criterion": "Check steam-distilled essential oil, capsules, sulfur-compound specifications and batch/content of the actual administered product against original product records.",
      "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These are Chamgap in-house application conditions for the steam-distilled garlic-oil monotherapy and H. pylori eradication question, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or independent clinical validation.",
      "proposed_research": "Record product specifications and batches in subsequent comparisons and distinguish results from other formulations."
    },
    {
      "item_id": "N06",
      "question_type": "Evidence condition",
      "question": "Do 4 mg, 4 times daily for 14 days establish actual intake and adherence?",
      "needed": "Prescribed dose, actual administered dose, frequency, adherence, discontinuation and product content",
      "role": "Required",
      "role_reason": "This retains the original 16 mg/day while separating prescription from actual intake.",
      "application_exception": "16 mg/day is quoted from the retained record. No new dose calculation or equivalence conversion to grams of raw garlic is made.",
      "criterion": "Separately check the oil prescription of 4 mg, 4 times daily for 14 days and actual intake/adherence/discontinuation, without converting doses between formulations.",
      "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These are Chamgap in-house application conditions for the steam-distilled garlic-oil monotherapy and H. pylori eradication question, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or independent clinical validation.",
      "proposed_research": "An optimal-dose claim separately requires direct dose comparisons with the same specified product and eradication assessment."
    },
    {
      "item_id": "N07",
      "question_type": "Evidence condition",
      "question": "How far are concomitant and rescue treatments in the oil-monotherapy observation established?",
      "needed": "Antibiotics, acid suppressants, other treatments, intake changes, rescue treatment and adherence records",
      "role": "Required",
      "role_reason": "This prevents results from combination antibiotic regimens from being attributed to oil monotherapy.",
      "application_exception": "The retained monotherapy boundary does not establish every concomitant or rescue-treatment detail.",
      "criterion": "Check actual concomitant/rescue treatment, changes and analytical handling during observation, separating them from adjunct effects in an antibiotic 4-drug regimen.",
      "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These are Chamgap in-house application conditions for the steam-distilled garlic-oil monotherapy and H. pylori eradication question, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or independent clinical validation.",
      "proposed_research": "When comparing causal effects of oil, prospectively record background treatment, changes and rescue treatment."
    },
    {
      "item_id": "N08",
      "question_type": "Evidence condition",
      "question": "Is there a concurrent comparator, and which differences can be compared?",
      "needed": "Actual comparator, background treatment, time points, population and comparison of interest",
      "role": "Required for between-group efficacy; boundary for single-arm observation",
      "role_reason": "This prevents failure in 0/5 from becoming a placebo-adjusted null effect or noninferiority to antibiotics.",
      "application_exception": "The current uncontrolled observation is retained. Distinguish the absence of a comparator from a future comparative design.",
      "criterion": "Check the existence and content of a concurrent comparator for the eradication result; do not convert a single-arm observation into a between-group difference, RR or noninferiority result.",
      "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These are Chamgap in-house application conditions for the steam-distilled garlic-oil monotherapy and H. pylori eradication question, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or independent clinical validation.",
      "proposed_research": "Causal or replacement claims require an appropriate concurrent comparison with the same formulation and confirmed-eradication endpoint."
    },
    {
      "item_id": "N09",
      "question_type": "Evidence condition",
      "question": "When were the two UBT assessments performed after 14 days of treatment?",
      "needed": "Treatment end, the two test visits, intervals, concomitant-treatment withdrawal and follow-up schedule",
      "role": "Required",
      "role_reason": "This prevents 14 days of treatment from becoming the exact follow-up duration through eradication confirmation.",
      "application_exception": "Do not fill the retained two-test statement with particular dates or confirmed long-term persistence.",
      "criterion": "Link 14 days of treatment to the actual time points, intervals and pretest concomitant-treatment conditions of the two post-treatment UBT visits.",
      "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These are Chamgap in-house application conditions for the steam-distilled garlic-oil monotherapy and H. pylori eradication question, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or independent clinical validation.",
      "proposed_research": "Subsequent research should separately plan and report treatment end and eradication-confirmation time points."
    },
    {
      "item_id": "N10",
      "question_type": "Evidence condition",
      "question": "Are the two-negative-UBT eradication definition and test thresholds established?",
      "needed": "UBT type, negative threshold, assessment, testing conditions and the rule combining both tests",
      "role": "Required",
      "role_reason": "This prevents quantitative UBT decreases or suppression from replacing confirmed eradication.",
      "application_exception": "Both tests being negative is the selected endpoint. Diagnostic accuracy and symptom improvement are separate questions.",
      "criterion": "Check the original study’s two-negative-post-treatment-UBT definition, test method, thresholds and assessment/conditions, separating them from decreased values.",
      "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These are Chamgap in-house application conditions for the steam-distilled garlic-oil monotherapy and H. pylori eradication question, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or independent clinical validation.",
      "proposed_research": "Subsequent eradication research should state negative-result rules and testing conditions."
    },
    {
      "item_id": "N11",
      "question_type": "Evidence condition",
      "question": "What was observed in completer eradication 0/5 and no suppression?",
      "needed": "Two tests per participant, eradication/suppression results and endpoint-specific analysis tables",
      "role": "Required",
      "role_reason": "This prevents an adverse direct observation from being erased by positive raw-garlic values or promoted to a precise null effect.",
      "application_exception": "0/5 and no suppression are retained observations. Do not create a new proportion, RR, CI, P or replicated refutation.",
      "criterion": "Retain the original eradication 0/5 and no-suppression endpoint and completer denominator, distinguishing the single-arm failure observation from a between-group null effect or replicated refutation.",
      "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These are Chamgap in-house application conditions for the steam-distilled garlic-oil monotherapy and H. pylori eradication question, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or independent clinical validation.",
      "proposed_research": "Compare additional evidence using the same formulation and confirmed-eradication endpoint while retaining the earlier failure."
    },
    {
      "item_id": "N12",
      "question_type": "Evidence condition",
      "question": "Can the 5 completers be distinguished from original enrollment and analysis denominators?",
      "needed": "Participant counts and flow through recruitment, enrollment, exposure, testing, completion and analysis",
      "role": "Required",
      "role_reason": "This prevents 5 completers from becoming 5 initially recruited participants or an ITT denominator of 5.",
      "application_exception": "Do not combine participants with the 15 people receiving raw garlic. Unavailable denominators remain null or unverified.",
      "criterion": "Link the completer denominator of 0/5 with original recruitment, exposure, testing and analysis denominators and the original counts at each stage.",
      "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These are Chamgap in-house application conditions for the steam-distilled garlic-oil monotherapy and H. pylori eradication question, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or independent clinical validation.",
      "proposed_research": "Subsequent research should disclose participant flow from recruitment through both tests and analysis."
    },
    {
      "item_id": "N13",
      "question_type": "Evidence condition",
      "question": "Are losses, missed tests, missingness and completer selection established?",
      "needed": "Reasons for losses, missed tests, missingness, completion criteria, analytical handling and original participant flow",
      "role": "Required",
      "role_reason": "This prevents an unverified enrollment denominator from becoming 0 losses or an analysis without missing data.",
      "application_exception": "The term completer alone does not establish a PP or ITT analysis method.",
      "criterion": "Compare discontinuation, missed UBT assessments, reasons for losses and their eradication-analysis handling with original participant flow and the analysis plan.",
      "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These are Chamgap in-house application conditions for the steam-distilled garlic-oil monotherapy and H. pylori eradication question, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or independent clinical validation.",
      "proposed_research": "Subsequent research should prospectively define missing-data handling and analysis populations, separating them from completer-only results."
    },
    {
      "item_id": "N14",
      "question_type": "Evidence condition",
      "question": "What design governs recruitment and selection in the uncontrolled pilot?",
      "needed": "Single-arm design, recruitment/selection, baseline status, allocation status and original methods",
      "role": "Required for causal interpretation",
      "role_reason": "This prevents the pilot label from conferring random allocation or baseline balance.",
      "application_exception": "The retained study is uncontrolled; randomization/allocation is not verified. Parallel, crossover or cluster details are not inferred.",
      "criterion": "Check the actual single-arm recruitment and selection process in the original methods and state causal limitations of observation without randomization or a concurrent comparator.",
      "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These are Chamgap in-house application conditions for the steam-distilled garlic-oil monotherapy and H. pylori eradication question, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or independent clinical validation.",
      "proposed_research": "Research on causal effects should prospectively state an appropriate comparative design and the allocation/selection process."
    },
    {
      "item_id": "N15",
      "question_type": "Evidence condition",
      "question": "Are standardization and blinding of UBT measurement and assessment established?",
      "needed": "Consistent test method, sampling/testing conditions, assessors, blinding and error management",
      "role": "Required",
      "role_reason": "This prevents an objective test name from implying that measurement error or assessment bias is resolved.",
      "application_exception": "UBT use itself does not establish assessor blinding or matching conditions.",
      "criterion": "Check testing, sampling and assessment conditions and assessor blinding/error management for both UBT assessments against original procedures.",
      "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These are Chamgap in-house application conditions for the steam-distilled garlic-oil monotherapy and H. pylori eradication question, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or independent clinical validation.",
      "proposed_research": "Subsequent research should standardize testing and assessment, recording assessment blinding where it can be established."
    },
    {
      "item_id": "N16",
      "question_type": "Evidence condition",
      "question": "Which analysis and effect of interest do completer results answer?",
      "needed": "Analysis population, participant event tables, ITT/PP, within-/between-group distinctions and analysis plan",
      "role": "Required",
      "role_reason": "This prevents single-arm completer results from being transferred to randomized-assignment effects or placebo-adjusted estimates.",
      "application_exception": "No concurrent comparator is available to calculate between-group RR/CI. Do not fill an unverified analysis name.",
      "criterion": "Establish that the original 0/5 is a single-arm completer observation and link actual analysis rules and test-specific event tables with the original plan/results.",
      "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These are Chamgap in-house application conditions for the steam-distilled garlic-oil monotherapy and H. pylori eradication question, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or independent clinical validation.",
      "proposed_research": "A subsequent comparison should define its effect of interest, analysis population and missing-data handling before results are reported."
    },
    {
      "item_id": "N17",
      "question_type": "Evidence condition",
      "question": "Are the eradication observation’s precision and important-difference criterion established?",
      "needed": "Endpoint-specific events/denominators, originally reported intervals, justified important differences and concurrent comparison",
      "role": "Required for effect precision",
      "role_reason": "This prevents very small failure observations or significance alone from establishing confirmatory strength, equivalence or required sample size.",
      "application_exception": "Retain that between-group RR/CI cannot be calculated. Do not newly calculate single-arm CI or P; leave them unverified.",
      "criterion": "Compare originally reported eradication estimates, intervals, denominators and grounds for an important difference; do not attribute between-group precision or equivalence to uncontrolled results.",
      "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These are Chamgap in-house application conditions for the steam-distilled garlic-oil monotherapy and H. pylori eradication question, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or independent clinical validation.",
      "proposed_research": "Plan precision for future questions using a justified important difference and an appropriate design; do not invent a minimum n."
    },
    {
      "item_id": "N18",
      "question_type": "Evidence condition",
      "question": "Were planned endpoints compared with the registration, protocol and actual report?",
      "needed": "Registration ID, protocol, analysis plan, endpoint/time-point changes and results",
      "role": "Required",
      "role_reason": "This prevents could not confirm from becoming confirmed nonregistration or selective reporting.",
      "application_exception": "External registration and original plans remain unread in this conversion. The historical original-review date is not a plan-comparison date.",
      "criterion": "Compare original registration/plan definitions of eradication, the two tests and analysis populations with actual results by location, distinguishing portions that could not be compared.",
      "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These are Chamgap in-house application conditions for the steam-distilled garlic-oil monotherapy and H. pylori eradication question, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or independent clinical validation.",
      "proposed_research": "In a separate update, acquire registration, plans and change histories and review the linked results."
    },
    {
      "item_id": "N19",
      "question_type": "Evidence condition",
      "question": "Is the UBT decrease in 15 people receiving raw garlic replication of oil eradication?",
      "needed": "Links between the two reports’ formulations, doses, timing, denominators, endpoints and families",
      "role": "Required for directness and replication boundaries",
      "role_reason": "This prevents a quantitative decrease with raw garlic from being combined as oil-monotherapy eradication success.",
      "application_exception": "An ancillary report with another formulation and endpoint is retained. It is not classified as conflict within the same question or independent replication.",
      "criterion": "Compare S2’s raw garlic 3 g, 2 times daily for 3 days, 15 people and quantitative UBT change/unassessed eradication with S1’s oil, 14 days, 5 completers and eradication, to establish differences in directness.",
      "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These are Chamgap in-house application conditions for the steam-distilled garlic-oil monotherapy and H. pylori eradication question, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or independent clinical validation.",
      "proposed_research": "Independently identify replication of the same oil-eradication question using the same formulation, definition and time points."
    },
    {
      "item_id": "N20",
      "question_type": "Evidence condition",
      "question": "Does the record answer dose optimization, persistent eradication or other populations?",
      "needed": "Direct dose comparisons using the same formulation, post-discontinuation follow-up and subgroup/interaction evidence",
      "role": "Supplementary; required for the stated extension",
      "role_reason": "This prevents a short pilot at one dose from being extended to optimal dose or long-term persistence.",
      "application_exception": "Do not make all long-term and subgroup research mandatory for the narrow 14-day observation.",
      "criterion": "Check direct comparisons/follow-up and prespecified subgroup evidence using the same formulation for optimal-dose, persistent-eradication or other-population claims.",
      "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These are Chamgap in-house application conditions for the steam-distilled garlic-oil monotherapy and H. pylori eradication question, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or independent clinical validation.",
      "proposed_research": "When extension questions are requested, separate them into appropriate dose, follow-up and population designs."
    },
    {
      "item_id": "N21",
      "question_type": "Evidence condition",
      "question": "Do UBT and eradication observations also answer antibiotic replacement and clinical events?",
      "needed": "Separate comparisons for eradication versus symptoms, ulcers, bleeding, cancer and treatment replacement",
      "role": "Supplementary; required for clinical-event or replacement claims",
      "role_reason": "This prevents UBT values or antibacterial mechanisms from being extended to antibiotic replacement or ulcer/cancer prevention.",
      "application_exception": "Do not require every cancer-prevention trial for the selected eradication endpoint. Do not create a new report solely from the antibiotic 4-drug narrative.",
      "criterion": "Distinguish selected eradication from value changes, symptoms, clinical events and antibiotic replacement; require direct comparative evidence for each extension claim.",
      "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These are Chamgap in-house application conditions for the steam-distilled garlic-oil monotherapy and H. pylori eradication question, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or independent clinical validation.",
      "proposed_research": "Antibiotic replacement and clinical events require separate questions, appropriate direct comparisons and safety follow-up."
    },
    {
      "item_id": "N22",
      "question_type": "Evidence condition",
      "question": "What are the original review/correction dates and the scope of current reading/searching?",
      "needed": "Review/correction dates, input identities, actual reading and search/registration/retraction checks",
      "role": "Required",
      "role_reason": "This prevents a retained summary from being described as a current comprehensive literature review or a search returning 0 results.",
      "application_exception": "The original verdict-review date is neither the current access date nor a search cut-off.",
      "criterion": "Separate the 2026-09-08 original review, 09-14 correction record and current reading of retained summaries; accurately state the scope of searches and comprehensive registration/correction/retraction checks.",
      "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These are Chamgap in-house application conditions for the steam-distilled garlic-oil monotherapy and H. pylori eradication question, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or independent clinical validation.",
      "proposed_research": "In an authorized evidence update, record search scope, dates and unpublished/registration/correction status as a separate event."
    },
    {
      "item_id": "N23",
      "question_type": "Evidence condition",
      "question": "How far are funding, product provision and author interests established?",
      "needed": "Original-paper funding, product provision, employment/patents, interest declarations and institutions",
      "role": "Supplementary; required for independence claims",
      "role_reason": "This prevents historical I1 and generic English wording from being used as proof of independent funding or absence of interests.",
      "application_exception": "S2’s academic-research wording does not verify independent funding. Unverified interests do not establish absence of involvement.",
      "criterion": "Link each report’s funding, product provision and author/institution declarations to original sections; do not attribute unsupported independence claims.",
      "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These are Chamgap in-house application conditions for the steam-distilled garlic-oil monotherapy and H. pylori eradication question, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or independent clinical validation.",
      "proposed_research": "In a separate update, check funding, product and author relationships without automatically excluding results or approving them as unbiased."
    },
    {
      "item_id": "N24",
      "question_type": "Evidence condition",
      "question": "Are the original warning and actually collected adverse events distinguished?",
      "needed": "Event definitions, collection, severity and discontinuation for the same oil exposure, and the original warning",
      "role": "Supplementary; required for safety questions",
      "role_reason": "This prevents a warning about delayed management after replacing treatment from becoming bleeding or cancer events observed in the pilot.",
      "application_exception": "The original warning is retained. Absence of adverse-event counts in an efficacy summary does not mean no events.",
      "criterion": "Check actual adverse-event definitions, systematic/spontaneous collection, severity and discontinuation for oil exposure, separating them from the original treatment-replacement warning.",
      "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These are Chamgap in-house application conditions for the steam-distilled garlic-oil monotherapy and H. pylori eradication question, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or independent clinical validation.",
      "proposed_research": "When studying harms with the same formulation, separately design event definitions, collection and discontinuation procedures from efficacy endpoints."
    },
    {
      "item_id": "N25",
      "question_type": "Evidence condition",
      "question": "Are harm-exposure, onset/recovery timing and denominators available?",
      "needed": "Harms-assessed exposed people, affected people/event counts, observation periods, discontinuation/recovery and rechallenge",
      "role": "Supplementary; required for incidence or causal claims",
      "role_reason": "This prevents the 5 efficacy completers and 14-day treatment from automatically becoming harm denominators and follow-up.",
      "application_exception": "Unverified event-specific timing or denominators do not mean absence of harm in 0/5, recovery or rechallenge.",
      "criterion": "Link harm-exposure/event/recovery times with assessment denominators and follow-up in the same event material before interpreting frequency or temporal sequence.",
      "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These are Chamgap in-house application conditions for the steam-distilled garlic-oil monotherapy and H. pylori eradication question, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or independent clinical validation.",
      "proposed_research": "Collect exposure, events, follow-up and discontinuation information separately when observing harms with the same formulation."
    },
    {
      "item_id": "N26",
      "question_type": "Evidence condition",
      "question": "Can harm comparisons, concurrent treatments and alternative causes be established?",
      "needed": "Harms comparator, baseline events, simultaneous exposures, concurrent treatments, alternative explanations and adjustment",
      "role": "Supplementary; required for comparative or causal harms",
      "role_reason": "This prevents uncontrolled efficacy data or underlying-disease risk from becoming an oil-induced risk increase.",
      "application_exception": "Absent information on alternative causes does not mean none existed. Do not import external background incidence.",
      "criterion": "Check actual comparators and event-specific baseline/concurrent exposures and alternative explanations in original material, separating them from causal attribution to oil.",
      "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These are Chamgap in-house application conditions for the steam-distilled garlic-oil monotherapy and H. pylori eradication question, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or independent clinical validation.",
      "proposed_research": "Comparative-harm questions should record an appropriate comparator and event-specific baseline and simultaneous exposures."
    },
    {
      "item_id": "N27",
      "question_type": "Evidence condition",
      "question": "Is the scope of harm collection, omission, losses and disclosure established?",
      "needed": "Collection of all events, spontaneous reporting, detection, nonreporting, follow-up losses and exclusions",
      "role": "Supplementary; required for safety claims",
      "role_reason": "This prevents gaps in retained harm summaries from becoming whole-paper nonreporting or proof of safety.",
      "application_exception": "While external full texts remain unread, do not establish whole-paper failure of collection or disclosure.",
      "criterion": "Check harm collection/detection, omissions, follow-up losses and analysis exclusions by original sections actually read for the exposure.",
      "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These are Chamgap in-house application conditions for the steam-distilled garlic-oil monotherapy and H. pylori eradication question, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or independent clinical validation.",
      "proposed_research": "In a separate update, link harms tables, discontinuation reasons and collection plans and review the scope of missing information."
    },
    {
      "item_id": "N28",
      "question_type": "Evidence condition",
      "question": "What is the scope of independent harms material, long-term observation and vulnerable populations?",
      "needed": "Unique harms families, product matching, long-term/rare events and vulnerable-population follow-up",
      "role": "Supplementary; required for replication or expanded safety",
      "role_reason": "This prevents repeated warning wording from being counted as independent events or a short oil pilot from being extended to overall safety.",
      "application_exception": "Do not require all rare-harm research for the current narrow eradication observation. This condition concerns replication and population-extension claims.",
      "criterion": "Establish independent harms identity, exposure/product matching and long-term/vulnerable-population follow-up from actual material, distinguishing recitations and unestablished replication counts.",
      "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These are Chamgap in-house application conditions for the steam-distilled garlic-oil monotherapy and H. pylori eradication question, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or independent clinical validation.",
      "proposed_research": "Expanded safety questions require separate consideration of appropriate long-term and rare-event/vulnerable-population designs."
    },
    {
      "item_id": "N29",
      "question_type": "Evidence condition",
      "question": "Does the wording distinguish warning, signal, comparative risk and causality?",
      "needed": "Events, comparator, denominator, timing, alternative explanations and the level of the original warning for the same exposure",
      "role": "Supplementary; required for safety or causal harms",
      "role_reason": "This prevents the original warning from being converted to a new safety grade, confirmed causal harm or individual intake instruction.",
      "application_exception": "Distinguish checking interpretation boundaries permitted by the material from establishing actual harm information.",
      "criterion": "Link the nature of the original treatment-replacement warning with unverified actual harm material, distinguishing signals, comparative risk, causality and individual instructions.",
      "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These are Chamgap in-house application conditions for the steam-distilled garlic-oil monotherapy and H. pylori eradication question, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or independent clinical validation.",
      "proposed_research": "If direct harms material is added, review the level of wording within the same event, population and exposure boundaries."
    },
    {
      "item_id": "N30",
      "question_type": "Evidence condition",
      "question": "Are original C46, Warning, all axes, Korean/English text and correction separated from new states?",
      "needed": "Whole original summary, original data types, both languages/axes, correction, URLs and empty subclaims",
      "role": "Required",
      "role_reason": "This prevents existing grades/axes or generic English verification wording from automatically satisfying new conditions.",
      "application_exception": "The original verdict is a historical quotation; do not create a new clinical reassessment or efficacy/safety grade.",
      "criterion": "Retain C46, Warning, all axes, all Korean/English fields, correction, citations and empty subclaims as original typed content, separating them from condition states and current reading.",
      "basis": "Existing method principles distinguish population, formulation, dose, timing, endpoint, comparison, denominators, overlap, funding and harms in the retained reports. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These are Chamgap in-house application conditions for the steam-distilled garlic-oil monotherapy and H. pylori eradication question, developed with knowledge of the retained content. They do not establish blinding, trial preregistration, official-tool certification or independent clinical validation.",
      "proposed_research": "If a correction or update is separately requested, retain the whole original text and distinguish the event, condition version and verdict decision."
    }
  ]
}