{
  "schema_version": "chamgap-public-criteria-1.0",
  "title": "Esomeprazole, amoxicillin, clarithromycin, and berberine hydrochloride × First-line Helicobacter pylori eradication",
  "language": "en",
  "translation_date": "2026-10-27",
  "criteria_version": "1.1",
  "criteria_date": "2026-10-05",
  "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; distinguish intervention variants.",
      "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": "Link studies and reports separately; do not omit studies 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": "Fix the result and effect of interest when examining randomization, deviations, missingness, 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.",
      "review_level": "Retained method-application records were reused. External originals were not reread and method content was not reassessed."
    }
  ],
  "status_dictionary": {
    "Met": "The row’s narrow record, attribution, boundary or actual fact was checked. This does not certify efficacy, precision or safety.",
    "Partly verified": "Some required information is available, but actual exposure, definitions, denominators or other necessary material remain missing.",
    "Unverified": "The criterion cannot be established within the retained scope. This does not mean 0 effect, 0 studies or failed access.",
    "Not applicable": "Separate optimal-dose, long-term and cancer-prevention extensions are not universally required for the selected eradication question 28 days after treatment.",
    "Review incomplete": "Original-material comparisons or searches were not performed within the authorized scope.",
    "Not reported": "A scope-limited status indicating that an item was not stated in a specific material or section actually read.",
    "Inaccessible": "Used only for material for which access was actually attempted and failed. Not assigned to clinical material in this work.",
    "Insufficient evidence matching the conditions": "Used only when related studies within a defined scope have been reviewed and evidence is insufficient to answer the condition. Not applied wholesale in this work.",
    "Conflicting data": "Used when incompatible material for the same question, time and analysis has actually been compared. Different review numbers alone do not establish this status."
  },
  "requirements": [
    {
      "item_id": "N01",
      "question_type": "Evidence condition",
      "question": "Which combination, population and eradication comparison are being examined?",
      "needed": "Original locations for the current claim, formulation, route, population, endpoint, comparator and timing",
      "role": "Required",
      "role_reason": "Needed to avoid combining different regimens or endpoints as the same eradication evidence.",
      "application_exception": "Limited to verification of retained summaries; external originals are not read, and no new calculations or reassessment are performed in this work.",
      "criterion": "Link the first-line eradication question for an oral berberine-containing antibiotic/PPI 4-drug regimen to the original record; distinguish the single-component question.",
      "basis": "Existing method principles distinguish population, formulation, combination therapy, active comparator, eradication endpoint, timing, noninferiority, denominators, analysis, study families, funding and harms. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These conditions concern first-line eradication with a berberine-containing combination and were developed with knowledge of the retained content. They were frozen before application, with historical criterion clarifications retained. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.",
      "proposed_research": "When the article is revised, cross-check formulation, endpoint and comparator, and record the independent question’s inclusions and exclusions again."
    },
    {
      "item_id": "N02",
      "question_type": "Evidence condition",
      "question": "Can the salt, source, specification and batch of the actual tablets be established?",
      "needed": "Product, content, batch and quality records for the trial’s berberine hydrochloride tablets",
      "role": "Required",
      "role_reason": "Needed to establish whether the actual trial product matches the advertised ingredient.",
      "application_exception": "Limited to verification of retained summaries; external originals are not read, and no new calculations or reassessment are performed in this work.",
      "criterion": "Link the nominal HCl to the actual administered product and its quality; retain the unverified plant source.",
      "basis": "Existing method principles distinguish population, formulation, combination therapy, active comparator, eradication endpoint, timing, noninferiority, denominators, analysis, study families, funding and harms. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These conditions concern first-line eradication with a berberine-containing combination and were developed with knowledge of the retained content. They were frozen before application, with historical criterion clarifications retained. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.",
      "proposed_research": "Obtain trial-product records, then compare the nominal ingredient with batch-test records to examine transferability to other extracts or derivatives."
    },
    {
      "item_id": "N03",
      "question_type": "Evidence condition",
      "question": "Is the nominal dose linked to actual medication use?",
      "needed": "Doses and medication records for berberine 500 mg 2 times daily and the 3 common medicines",
      "role": "Required",
      "role_reason": "Needed to avoid reducing differences in exposure to the entire 4-drug regimen to one ingredient’s nominal dose.",
      "application_exception": "Limited to verification of retained summaries; external originals are not read, and no new calculations or reassessment are performed in this work.",
      "criterion": "Distinguish each drug’s planned dose from actual use, changes and discontinuation.",
      "basis": "Existing method principles distinguish population, formulation, combination therapy, active comparator, eradication endpoint, timing, noninferiority, denominators, analysis, study families, funding and harms. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These conditions concern first-line eradication with a berberine-containing combination and were developed with knowledge of the retained content. They were frozen before application, with historical criterion clarifications retained. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.",
      "proposed_research": "Compare prescriptions and medication records by arm to assess differences between actual exposure and the planned regimen."
    },
    {
      "item_id": "N04",
      "question_type": "Evidence condition",
      "question": "Can the 14-day plan and actual treatment completion be established?",
      "needed": "Treatment start, end, discontinuation and medication-completion records by arm",
      "role": "Required",
      "role_reason": "Needed to establish whether exposure-duration differences are mixed into eradication analyses.",
      "application_exception": "Limited to verification of retained summaries; external originals are not read, and no new calculations or reassessment are performed in this work.",
      "criterion": "Link the 14-day plan to individual actual treatment duration and discontinuation.",
      "basis": "Existing method principles distinguish population, formulation, combination therapy, active comparator, eradication endpoint, timing, noninferiority, denominators, analysis, study families, funding and harms. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These conditions concern first-line eradication with a berberine-containing combination and were developed with knowledge of the retained content. They were frozen before application, with historical criterion clarifications retained. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.",
      "proposed_research": "Link timing and adherence records by arm to examine differences in actual treatment duration within analysis populations."
    },
    {
      "item_id": "N05",
      "question_type": "Evidence condition",
      "question": "Is the actual match between the bismuth comparator regimen and common medicines established?",
      "needed": "Bismuth tartrate regimen, common PPI/antibiotics and changes by arm",
      "role": "Required",
      "role_reason": "Needed to avoid attributing differences in common medicines or rescue treatment to berberine.",
      "application_exception": "Limited to verification of retained summaries; external originals are not read, and no new calculations or reassessment are performed in this work.",
      "criterion": "Distinguish the ingredient substitution in the active 4-drug comparison from actual differences in common treatment.",
      "basis": "Existing method principles distinguish population, formulation, combination therapy, active comparator, eradication endpoint, timing, noninferiority, denominators, analysis, study families, funding and harms. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These conditions concern first-line eradication with a berberine-containing combination and were developed with knowledge of the retained content. They were frozen before application, with historical criterion clarifications retained. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.",
      "proposed_research": "Compare prescriptions, rescue treatment and changes in both arms side by side to examine whether the intended comparison was maintained."
    },
    {
      "item_id": "N06",
      "question_type": "Evidence condition",
      "question": "Has the scope of attribution to the combination been distinguished?",
      "needed": "Composition of the 4-drug regimen and the original boundary on extensions to single-component efficacy",
      "role": "Required",
      "role_reason": "Needed to avoid confusing effects of the common antibiotics/PPI with effects of individual ingredients.",
      "application_exception": "Limited to verification of retained summaries; external originals are not read, and no new calculations or reassessment are performed in this work.",
      "criterion": "Do not elevate the comparison of the entire 4-drug regimen to berberine monotherapy or antibiotic replacement.",
      "basis": "Existing method principles distinguish population, formulation, combination therapy, active comparator, eradication endpoint, timing, noninferiority, denominators, analysis, study families, funding and harms. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These conditions concern first-line eradication with a berberine-containing combination and were developed with knowledge of the retained content. They were frozen before application, with historical criterion clarifications retained. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.",
      "proposed_research": "If individual contributions are newly asked about, define eligibility and design for a separate regimen comparison, apart from the current results."
    },
    {
      "item_id": "N07",
      "question_type": "Evidence condition",
      "question": "Are eligibility and baseline characteristics of the actual treatment-naive infected adults established?",
      "needed": "Infection diagnosis, treatment history, inclusion/exclusion, age and baseline-characteristic tables",
      "role": "Required",
      "role_reason": "Needed to establish differences between the first-line question’s population and actual recruitment.",
      "application_exception": "Limited to verification of retained summaries; external originals are not read, and no new calculations or reassessment are performed in this work.",
      "criterion": "Link the nominal population of treatment-naive adults with H. pylori infection to the actual selected population.",
      "basis": "Existing method principles distinguish population, formulation, combination therapy, active comparator, eradication endpoint, timing, noninferiority, denominators, analysis, study families, funding and harms. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These conditions concern first-line eradication with a berberine-containing combination and were developed with knowledge of the retained content. They were frozen before application, with historical criterion clarifications retained. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.",
      "proposed_research": "Compare eligibility criteria and baseline tables by arm to examine population match and differences in treatment history."
    },
    {
      "item_id": "N08",
      "question_type": "Evidence condition",
      "question": "Is the actual allocation process of the randomized noninferiority trial established?",
      "needed": "Random-sequence generation, allocation procedure, unit and baseline-balance material",
      "role": "Required",
      "role_reason": "Needed to distinguish an allocation label from review of actual group formation.",
      "application_exception": "Limited to verification of retained summaries; external originals are not read, and no new calculations or reassessment are performed in this work.",
      "criterion": "Establish actual material on random-sequence generation, allocation unit, implementation and baseline balance by arm. The RCT label cannot replace that material.",
      "basis": "Existing method principles distinguish population, formulation, combination therapy, active comparator, eradication endpoint, timing, noninferiority, denominators, analysis, study families, funding and harms. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These conditions concern first-line eradication with a berberine-containing combination and were developed with knowledge of the retained content. They were frozen before application, with historical criterion clarifications retained. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.",
      "proposed_research": "Compare methods, allocation records and baseline tables to examine allocation for this eradication comparison."
    },
    {
      "item_id": "N09",
      "question_type": "Evidence condition",
      "question": "Can allocation concealment during recruitment be established?",
      "needed": "Original material on concealment procedures, responsible staff and recruitment/allocation sequence",
      "role": "Required",
      "role_reason": "Needed to examine allocation concealment and post-treatment blinding as separate processes.",
      "application_exception": "Limited to verification of retained summaries; external originals are not read, and no new calculations or reassessment are performed in this work.",
      "criterion": "Establish actual concealment methods and implementation records; do not substitute the historical B2 axis.",
      "basis": "Existing method principles distinguish population, formulation, combination therapy, active comparator, eradication endpoint, timing, noninferiority, denominators, analysis, study families, funding and harms. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These conditions concern first-line eradication with a berberine-containing combination and were developed with knowledge of the retained content. They were frozen before application, with historical criterion clarifications retained. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.",
      "proposed_research": "Examine methods and operating records to determine whether recruiters could know the next allocation; record this separately from open-label conduct."
    },
    {
      "item_id": "N10",
      "question_type": "Evidence condition",
      "question": "Can differences between open-label conduct and UBT assessment conditions be established?",
      "needed": "Sample collection, testing, assessor blinding and measurement conditions by arm",
      "role": "Required",
      "role_reason": "Needed to examine treatment blinding and outcome-assessment limitations for this endpoint.",
      "application_exception": "Limited to verification of retained summaries; external originals are not read, and no new calculations or reassessment are performed in this work.",
      "criterion": "Separately from open-label conduct, establish actual material on UBT sample collection, testing, reading procedures and assessor blinding by arm.",
      "basis": "Existing method principles distinguish population, formulation, combination therapy, active comparator, eradication endpoint, timing, noninferiority, denominators, analysis, study families, funding and harms. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These conditions concern first-line eradication with a berberine-containing combination and were developed with knowledge of the retained content. They were frozen before application, with historical criterion clarifications retained. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.",
      "proposed_research": "Compare original testing procedures and reading information to examine whether knowledge of allocation or collection conditions could affect measurement."
    },
    {
      "item_id": "N11",
      "question_type": "Evidence condition",
      "question": "Can the ¹³C-UBT negative threshold and testing limitations be established?",
      "needed": "Negative threshold, testing conditions, validity and control of concomitant medicines",
      "role": "Required",
      "role_reason": "Needed to establish how reported events were defined and measured.",
      "application_exception": "Limited to verification of retained summaries; external originals are not read, and no new calculations or reassessment are performed in this work.",
      "criterion": "Link the original outcome’s negative definition to actual testing procedures and classification criteria.",
      "basis": "Existing method principles distinguish population, formulation, combination therapy, active comparator, eradication endpoint, timing, noninferiority, denominators, analysis, study families, funding and harms. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These conditions concern first-line eradication with a berberine-containing combination and were developed with knowledge of the retained content. They were frozen before application, with historical criterion clarifications retained. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.",
      "proposed_research": "Check testing methods, thresholds and valid-sample rules to compare definitions of reported eradication events."
    },
    {
      "item_id": "N12",
      "question_type": "Evidence condition",
      "question": "Is the result 28 days after treatment linked to actual follow-up timing?",
      "needed": "Treatment-end dates, UBT dates, permitted visit windows and missing-test records by arm",
      "role": "Required",
      "role_reason": "Needed to avoid combining measurements at different times as the same endpoint result.",
      "application_exception": "Limited to verification of retained summaries; external originals are not read, and no new calculations or reassessment are performed in this work.",
      "criterion": "Establish individual actual treatment-end dates, UBT visit dates, permitted windows, delays and missing tests linked to the planned measurement 28 days after treatment.",
      "basis": "Existing method principles distinguish population, formulation, combination therapy, active comparator, eradication endpoint, timing, noninferiority, denominators, analysis, study families, funding and harms. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These conditions concern first-line eradication with a berberine-containing combination and were developed with knowledge of the retained content. They were frozen before application, with historical criterion clarifications retained. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.",
      "proposed_research": "Compare visit records to examine how actual timing distributions and missing measurements were handled in analysis."
    },
    {
      "item_id": "N13",
      "question_type": "Evidence condition",
      "question": "Was the −10% margin prespecified and justified?",
      "needed": "Dated registration, protocol, margin rationale and analysis plan",
      "role": "Required",
      "role_reason": "Needed to link the allowable loss in noninferiority and result interpretation to prespecified plans.",
      "application_exception": "Limited to verification of retained summaries; external originals are not read, and no new calculations or reassessment are performed in this work.",
      "criterion": "Compare the reported −10% with prespecification, clinical rationale and the effect of interest.",
      "basis": "Existing method principles distinguish population, formulation, combination therapy, active comparator, eradication endpoint, timing, noninferiority, denominators, analysis, study families, funding and harms. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These conditions concern first-line eradication with a berberine-containing combination and were developed with knowledge of the retained content. They were frozen before application, with historical criterion clarifications retained. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.",
      "proposed_research": "Compare registration/protocol versions and dates with the paper to examine the margin, hypothesis and plan changes."
    },
    {
      "item_id": "N14",
      "question_type": "Evidence condition",
      "question": "Can the direction, interval and margin comparison for the between-arm difference be established?",
      "needed": "Noninferiority effect measure, difference direction, confidence interval and test definition for each ITT/PP analysis",
      "role": "Required",
      "role_reason": "The relationship between the estimated between-arm difference and allowable margin is central to this comparison.",
      "application_exception": "Limited to verification of retained summaries; external originals are not read, and no new calculations or reassessment are performed in this work.",
      "criterion": "Link the appropriate between-arm estimate and interval for each analysis to the −10% threshold; do not substitute a nonsignificant P value.",
      "basis": "Existing method principles distinguish population, formulation, combination therapy, active comparator, eradication endpoint, timing, noninferiority, denominators, analysis, study families, funding and harms. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These conditions concern first-line eradication with a berberine-containing combination and were developed with knowledge of the retained content. They were frozen before application, with historical criterion clarifications retained. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.",
      "proposed_research": "Compare original noninferiority analysis tables and the SAP to establish agreement in difference direction, interval, margin and ITT/PP interpretation."
    },
    {
      "item_id": "N15",
      "question_type": "Evidence condition",
      "question": "Can ITT event counts, denominators and arm attribution be linked?",
      "needed": "Original ITT tables, allocation flow, arm labels, inclusion rules and corrections",
      "role": "Required",
      "role_reason": "Needed to retain reported randomized-population results together with arm identity.",
      "application_exception": "Limited to verification of retained summaries; external originals are not read, and no new calculations or reassessment are performed in this work.",
      "criterion": "Retain ITT values unchanged while establishing the analysis population and exact arm attribution.",
      "basis": "Existing method principles distinguish population, formulation, combination therapy, active comparator, eradication endpoint, timing, noninferiority, denominators, analysis, study families, funding and harms. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These conditions concern first-line eradication with a berberine-containing combination and were developed with knowledge of the retained content. They were frozen before application, with historical criterion clarifications retained. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.",
      "proposed_research": "Compare methods, flow and original ITT tables in parallel; if author corrections exist, record the basis for arm-mapping changes by version."
    },
    {
      "item_id": "N16",
      "question_type": "Evidence condition",
      "question": "Can PP event counts, denominators and exclusion criteria be established?",
      "needed": "Original PP tables, arm labels, inclusion/exclusion criteria and flow material",
      "role": "Required",
      "role_reason": "Needed to avoid mixing adherent-population analyses with randomized-population results.",
      "application_exception": "Limited to verification of retained summaries; external originals are not read, and no new calculations or reassessment are performed in this work.",
      "criterion": "Link reported PP values to actual adherent-population inclusion rules and arm attribution.",
      "basis": "Existing method principles distinguish population, formulation, combination therapy, active comparator, eradication endpoint, timing, noninferiority, denominators, analysis, study families, funding and harms. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These conditions concern first-line eradication with a berberine-containing combination and were developed with knowledge of the retained content. They were frozen before application, with historical criterion clarifications retained. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.",
      "proposed_research": "Compare PP inclusion rules and flow with original tables to examine how population differences link to each event count/denominator."
    },
    {
      "item_id": "N17",
      "question_type": "Evidence condition",
      "question": "Is material available to resolve the 308/304 arm-label conflict?",
      "needed": "Exact arm labels, denominators and author corrections for methods, flow and ITT/PP tables",
      "role": "Required",
      "role_reason": "Arbitrarily changing arm identity could change effect direction and denominator attribution.",
      "application_exception": "Limited to verification of retained summaries; external originals are not read, and no new calculations or reassessment are performed in this work.",
      "criterion": "Compare conflicting original locations to establish which denominator belongs to which arm; do not swap values arbitrarily.",
      "basis": "Existing method principles distinguish population, formulation, combination therapy, active comparator, eradication endpoint, timing, noninferiority, denominators, analysis, study families, funding and harms. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These conditions concern first-line eradication with a berberine-containing combination and were developed with knowledge of the retained content. They were frozen before application, with historical criterion clarifications retained. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.",
      "proposed_research": "Compare relevant sections, tables, flow and author corrections; record agreement/conflict and retain original values from each version."
    },
    {
      "item_id": "N18",
      "question_type": "Evidence condition",
      "question": "Can appropriate eradication effect estimates and confidence intervals be established?",
      "needed": "Between-arm differences, effect measures, confidence intervals, dispersion and report locations for each analysis",
      "role": "Required",
      "role_reason": "Needed to avoid substituting sample size or significance for precision.",
      "application_exception": "Limited to verification of retained summaries; external originals are not read, and no new calculations or reassessment are performed in this work.",
      "criterion": "Establish actual between-arm effect measures, difference direction, denominators and reported confidence intervals for ITT and PP. Do not substitute arm rates or P values or back-calculate values in this work.",
      "basis": "Existing method principles distinguish population, formulation, combination therapy, active comparator, eradication endpoint, timing, noninferiority, denominators, analysis, study families, funding and harms. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These conditions concern first-line eradication with a berberine-containing combination and were developed with knowledge of the retained content. They were frozen before application, with historical criterion clarifications retained. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.",
      "proposed_research": "Check each effect measure, direction, denominator and interval in acquired analysis tables, together with the current arm-attribution conflict."
    },
    {
      "item_id": "N19",
      "question_type": "Evidence condition",
      "question": "Within what scope are the ITT and PP P values retained?",
      "needed": "Reported P values and test definitions for both analyses",
      "role": "Required",
      "role_reason": "Needed to avoid misreading nonsignificance as noninferiority or no effect.",
      "application_exception": "Limited to verification of retained summaries; external originals are not read, and no new calculations or reassessment are performed in this work.",
      "criterion": "Distinguish retained ITT P=.149 and PP P=.470; do not extend nonsignificance to proof of 0 effect, equivalence or noninferiority.",
      "basis": "Existing method principles distinguish population, formulation, combination therapy, active comparator, eradication endpoint, timing, noninferiority, denominators, analysis, study families, funding and harms. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These conditions concern first-line eradication with a berberine-containing combination and were developed with knowledge of the retained content. They were frozen before application, with historical criterion clarifications retained. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.",
      "proposed_research": "When test definitions from analysis plans and original tables become available, compare interpretation alongside hypotheses, effect measures and intervals."
    },
    {
      "item_id": "N20",
      "question_type": "Evidence condition",
      "question": "Is arm-specific flow from allocation through UBT, ITT and PP established?",
      "needed": "Allocation, nonuse, missing follow-up/tests, dropout reasons and missing-data handling by arm",
      "role": "Required",
      "role_reason": "Needed to distinguish allocated participants from actual observation and analysis denominators.",
      "application_exception": "Limited to verification of retained summaries; external originals are not read, and no new calculations or reassessment are performed in this work.",
      "criterion": "Link the reported 612 participants and each analysis denominator to actual flow and missing-data handling.",
      "basis": "Existing method principles distinguish population, formulation, combination therapy, active comparator, eradication endpoint, timing, noninferiority, denominators, analysis, study families, funding and harms. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These conditions concern first-line eradication with a berberine-containing combination and were developed with knowledge of the retained content. They were frozen before application, with historical criterion clarifications retained. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.",
      "proposed_research": "Compare flow with each analysis’s inclusion rules and examine robustness to missing-data handling using appropriate sensitivity analyses."
    },
    {
      "item_id": "N21",
      "question_type": "Evidence condition",
      "question": "Can adherence to common and trial medicines and rescue treatment be established?",
      "needed": "Drug-specific adherence, discontinuation, rescue treatment and analysis-handling records",
      "role": "Required",
      "role_reason": "Needed to avoid interpreting differences in actual implementation of the combination as one ingredient’s effect.",
      "application_exception": "Limited to verification of retained summaries; external originals are not read, and no new calculations or reassessment are performed in this work.",
      "criterion": "Establish how actual medication use and concurrent-treatment changes in each arm link to estimation of the effect of interest.",
      "basis": "Existing method principles distinguish population, formulation, combination therapy, active comparator, eradication endpoint, timing, noninferiority, denominators, analysis, study families, funding and harms. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These conditions concern first-line eradication with a berberine-containing combination and were developed with knowledge of the retained content. They were frozen before application, with historical criterion clarifications retained. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.",
      "proposed_research": "Compare drug-specific use, changes and discontinuation records with analysis plans to examine differences in the ITT/PP effects of interest."
    },
    {
      "item_id": "N22",
      "question_type": "Evidence condition",
      "question": "Can the bibliographic NCT number be linked to the unverified registration field?",
      "needed": "Original NCT02296021 registration and material linking paper, regimen and population",
      "role": "Required",
      "role_reason": "Needed to avoid automatically elevating a bibliographic number to verification of the registration full text.",
      "application_exception": "Limited to verification of retained summaries; external originals are not read, and no new calculations or reassessment are performed in this work.",
      "criterion": "Retain the bibliographic number and registration-field string unchanged and compare whether they refer to the same actual trial.",
      "basis": "Existing method principles distinguish population, formulation, combination therapy, active comparator, eradication endpoint, timing, noninferiority, denominators, analysis, study families, funding and harms. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These conditions concern first-line eradication with a berberine-containing combination and were developed with knowledge of the retained content. They were frozen before application, with historical criterion clarifications retained. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.",
      "proposed_research": "Compare regimen, population, institutions and timing in registration and paper; record identifier linkage and the basis for updating the structured field as a separate event."
    },
    {
      "item_id": "N23",
      "question_type": "Evidence condition",
      "question": "Were planned UBT endpoints, timing and analyses compared with results?",
      "needed": "Dated protocol, SAP, registration versions and reasons for changes",
      "role": "Required",
      "role_reason": "Needed to reveal the actual material-comparison scope for judging selective reporting.",
      "application_exception": "Limited to verification of retained summaries; external originals are not read, and no new calculations or reassessment are performed in this work.",
      "criterion": "Compare prespecified endpoints, timing, analysis populations and margin with reported ITT/PP results.",
      "basis": "Existing method principles distinguish population, formulation, combination therapy, active comparator, eradication endpoint, timing, noninferiority, denominators, analysis, study families, funding and harms. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These conditions concern first-line eradication with a berberine-containing combination and were developed with knowledge of the retained content. They were frozen before application, with historical criterion clarifications retained. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.",
      "proposed_research": "Compare plan/result versions, dates and content to record agreement in principal endpoints, analyses and changes."
    },
    {
      "item_id": "N24",
      "question_type": "Evidence condition",
      "question": "Are bibliography, registration and bilingual articles being counted as independent studies?",
      "needed": "Report, registration and cohort identities and study-family linkage material",
      "role": "Required",
      "role_reason": "Needed to avoid double-counting multiple records of the same trial as independent replication.",
      "application_exception": "Limited to verification of retained summaries; external originals are not read, and no new calculations or reassessment are performed in this work.",
      "criterion": "Distinguish repeat citations/registration links for the current single paper from unverified independent replication.",
      "basis": "Existing method principles distinguish population, formulation, combination therapy, active comparator, eradication endpoint, timing, noninferiority, denominators, analysis, study families, funding and harms. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These conditions concern first-line eradication with a berberine-containing combination and were developed with knowledge of the retained content. They were frozen before application, with historical criterion clarifications retained. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.",
      "proposed_research": "When related material is added, compare author, registration, recruitment and result identities to classify the same family versus independent trials."
    },
    {
      "item_id": "N25",
      "question_type": "Evidence condition",
      "question": "Does it apply in other regions and resistance settings?",
      "needed": "Recruitment region, antibiotic resistance, previous exposure and direct multicenter comparisons",
      "role": "Supplementary; required for generalization to other regions",
      "role_reason": "Needed to reveal applicability limits from differences in populations and settings of eradication regimens.",
      "application_exception": "Limited to verification of retained summaries; external originals are not read, and no new calculations or reassessment are performed in this work.",
      "criterion": "Establish direct comparisons of the same 4-drug regimen in other populations specifying recruitment region, antibiotic resistance and previous exposure. Retain the current single-center report’s generalizability limit.",
      "basis": "Existing method principles distinguish population, formulation, combination therapy, active comparator, eradication endpoint, timing, noninferiority, denominators, analysis, study families, funding and harms. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These conditions concern first-line eradication with a berberine-containing combination and were developed with knowledge of the retained content. They were frozen before application, with historical criterion clarifications retained. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.",
      "proposed_research": "Examine comparisons of the same regimen and prespecified effect-modification hypotheses in multicenter studies specifying population and resistance conditions."
    },
    {
      "item_id": "N26",
      "question_type": "Evidence condition",
      "question": "Can funding, drug support and author conflicts be established?",
      "needed": "Original funding, drug-provision, author-affiliation and conflict-disclosure material",
      "role": "Required",
      "role_reason": "Needed to avoid converting unverified product support into independent research funding.",
      "application_exception": "Limited to verification of retained summaries; external originals are not read, and no new calculations or reassessment are performed in this work.",
      "criterion": "In addition to retained academic/hospital support, establish actual funding details, drug providers and their roles, author affiliations and original conflict disclosures.",
      "basis": "Existing method principles distinguish population, formulation, combination therapy, active comparator, eradication endpoint, timing, noninferiority, denominators, analysis, study families, funding and harms. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These conditions concern first-line eradication with a berberine-containing combination and were developed with knowledge of the retained content. They were frozen before application, with historical criterion clarifications retained. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.",
      "proposed_research": "Compare funding, product support and author disclosures separately; record conflict scope and remaining uncertainties."
    },
    {
      "item_id": "N27",
      "question_type": "Evidence condition",
      "question": "Can actual adverse-event collection and denominators for the 4-drug regimen be established?",
      "needed": "Adverse events, definitions, collection, discontinuation and exposure/follow-up denominators by arm",
      "role": "Supplementary; required for harm-frequency and safety claims",
      "role_reason": "Needed to avoid automatically establishing safety of the same regimen from efficacy reports.",
      "application_exception": "Limited to verification of retained summaries; external originals are not read, and no new calculations or reassessment are performed in this work.",
      "criterion": "Establish actual arm-specific adverse-event definitions, collection methods, severity, discontinuation, exposure and safety-analysis denominators and follow-up. Do not substitute the original warning sentence for event-frequency data.",
      "basis": "Existing method principles distinguish population, formulation, combination therapy, active comparator, eradication endpoint, timing, noninferiority, denominators, analysis, study families, funding and harms. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These conditions concern first-line eradication with a berberine-containing combination and were developed with knowledge of the retained content. They were frozen before application, with historical criterion clarifications retained. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.",
      "proposed_research": "Examine safety tables, discontinuation records, event definitions and follow-up in both arms; link harm reporting for the same regimen separately from efficacy."
    },
    {
      "item_id": "N28",
      "question_type": "Evidence condition",
      "question": "How far can harms involving concomitant medicines, long-term exposure or vulnerable groups be described?",
      "needed": "Concomitant medicines, baseline disease, timing, vulnerable groups and rare/long-term events",
      "role": "Supplementary; required for ingredient-specific/long-term safety claims",
      "role_reason": "Needed to avoid extending harms of combined exposures to a single ingredient or overall safety.",
      "application_exception": "Limited to verification of retained summaries; external originals are not read, and no new calculations or reassessment are performed in this work.",
      "criterion": "Establish concomitant medicines, baseline risk, exposure/event timing needed for ingredient-specific attribution, and direct exposure/event and comparative material for long-term use and vulnerable groups. A combination 4-drug warning cannot replace ingredient-specific causation or overall safety.",
      "basis": "Existing method principles distinguish population, formulation, combination therapy, active comparator, eradication endpoint, timing, noninferiority, denominators, analysis, study families, funding and harms. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These conditions concern first-line eradication with a berberine-containing combination and were developed with knowledge of the retained content. They were frozen before application, with historical criterion clarifications retained. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.",
      "proposed_research": "Examine event collection and alternative explanations in suitable harm studies separating concomitant exposure and baseline risk."
    },
    {
      "item_id": "N29",
      "question_type": "Evidence condition",
      "question": "Are long-term maintenance, optimal dose and cancer prevention distinguished from current eradication conditions?",
      "needed": "Boundary between the current eradication endpoint and separate duration, dose and clinical-event questions",
      "role": "Supplementary; required for separate extension questions",
      "role_reason": "Needed to separate the scope of eradication results from long-term clinical and optimal-dose questions.",
      "application_exception": "Do not add all long-term, optimal-dose and cancer-prevention trials as requirements for the selected eradication question 28 days after treatment.",
      "criterion": "Do not impose separate extension trials as universally required for the narrow eradication question 28 days after treatment; distinguish unverified direct material.",
      "basis": "Existing method principles distinguish population, formulation, combination therapy, active comparator, eradication endpoint, timing, noninferiority, denominators, analysis, study families, funding and harms. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These conditions concern first-line eradication with a berberine-containing combination and were developed with knowledge of the retained content. They were frozen before application, with historical criterion clarifications retained. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.",
      "proposed_research": "If an extension is requested, define separate eligible populations, endpoints, duration and direct comparative designs, and use the current report separately."
    },
    {
      "item_id": "N30",
      "question_type": "Evidence condition",
      "question": "Has reading of the current summary been distinguished from reading external papers and registration?",
      "needed": "Current retained copy, exact original locations, SHA and access history for external abstract/full text/registration",
      "role": "Required",
      "role_reason": "Needed to distinguish existence of a summary link from actual full-text reading.",
      "application_exception": "Limited to verification of retained summaries; external originals are not read, and no new calculations or reassessment are performed in this work.",
      "criterion": "Link only the retained summary actually read as summary reading; record external links as unread.",
      "basis": "Existing method principles distinguish population, formulation, combination therapy, active comparator, eradication endpoint, timing, noninferiority, denominators, analysis, study families, funding and harms. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These conditions concern first-line eradication with a berberine-containing combination and were developed with knowledge of the retained content. They were frozen before application, with historical criterion clarifications retained. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.",
      "proposed_research": "When authorized material acquisition occurs, separately record material-specific dates, original locations, versions and copy SHA; review reading status for linked rows again."
    },
    {
      "item_id": "N31",
      "question_type": "Evidence condition",
      "question": "Are the original evidence date and current review/absence scope specified?",
      "needed": "Original verdict review date, current review date, inputs used and correction/search-checking scope",
      "role": "Required",
      "role_reason": "Needed to avoid exaggerating uncertainty within the retained scope as absence across all current literature.",
      "application_exception": "Limited to verification of retained summaries; external originals are not read, and no new calculations or reassessment are performed in this work.",
      "criterion": "Separate the historical evidence date from the retained-material review date; do not describe an unperformed search as 0 studies.",
      "basis": "Existing method principles distinguish population, formulation, combination therapy, active comparator, eradication endpoint, timing, noninferiority, denominators, analysis, study families, funding and harms. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These conditions concern first-line eradication with a berberine-containing combination and were developed with knowledge of the retained content. They were frozen before application, with historical criterion clarifications retained. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.",
      "proposed_research": "When search, correction or retraction material is updated, record search scope, retrieval date and versions, then compare affected conditions again."
    },
    {
      "item_id": "N32",
      "question_type": "Evidence condition",
      "question": "Have the original verdict, axes, corrections and data types been preserved unchanged?",
      "needed": "Copies of original C50, Warning, all axes, Korean/English values and corrections",
      "role": "Required",
      "role_reason": "Needed to distinguish the original judgment traceably from the current scoreless condition checklist.",
      "application_exception": "Limited to verification of retained summaries; external originals are not read, and no new calculations or reassessment are performed in this work.",
      "criterion": "Retain current original values and data types at exact locations; do not automatically inherit them as condition statuses or a new score.",
      "basis": "Existing method principles distinguish population, formulation, combination therapy, active comparator, eradication endpoint, timing, noninferiority, denominators, analysis, study families, funding and harms. Detailed conditions are Chamgap’s own application.",
      "condition_origin": "These conditions concern first-line eradication with a berberine-containing combination and were developed with knowledge of the retained content. They were frozen before application, with historical criterion clarifications retained. This does not establish clinical preregistration, blinded development, official-method certification or independent clinical validation.",
      "proposed_research": "When article correction or evidence updating occurs, retain the complete prior record and link original values, versions, reasons for change and condition review."
    }
  ]
}