{ "schema_version": "chamgap-public-criteria-1.0", "title": "Oral Nigella sativa seed powder plus omeprazole × Claimed equivalence to standard triple therapy for H. pylori eradication", "language": "en", "translation_date": "2026-10-24", "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": "Existing methodological links were reused for production. External originals were not reread and methodological 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": "Existing methodological links were reused for production. External originals were not reread and methodological 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": "Existing methodological links were reused for production. External originals were not reread and methodological 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": "Existing methodological links were reused for production. External originals were not reread and methodological 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": "Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed." } ], "status_dictionary": { "Partly verified": "Partial information from the stored summary is linked; detailed originals and content review remain incomplete.", "Unverified": "Required details cannot be established within the preserved scope. This does not establish absence of effects or studies, or safety.", "Review incomplete": "Review of existing content remains incomplete.", "Met": "This state is used only within the relevant conditions after material verification and content review. It was not automatically assigned in this work.", "Not reported": "Unreported within material actually read. Unread external material is not relabeled as unreported.", "Inaccessible": "This means actual access failure. External access was not attempted in this work, so this state was not assigned.", "Not applicable": "Used only with an application exception and reason based on the question scope.", "Conflicting data": "This requires actual comparison of materials; no new conflict judgment was made in this work.", "Insufficient evidence for the conditions": "This indicates gaps in additional material for the selected conditions. Unread material as a whole is not converted into an efficacy grade." }, "requirements": [ { "item_id": "N01", "question_type": "Evidence condition", "question": "What is the exact scope of the equivalence claim?", "needed": "The question of 2 g Nigella powder plus omeprazole, adults, eradication and equivalence to standard 3-drug therapy", "role": "Required", "role_reason": "Material on The question of 2 g Nigella powder plus omeprazole, adults, eradication and equivalence to standard 3-drug therapy is needed to connect the combination to its population, formulation, selected dose, comparison, eradication, timing, denominator, equivalence question or harms.", "application_exception": "The records of 110 assigned participants and 88 analyzed participants are not converted into randomization, initial arm allocations, ITT or safety denominators, and no new dropout count or rate is calculated. A nonsignificant comparison is not converted into equivalence, nor a historical reconstructed interval into a current calculation or trial-reported interval.", "criterion": "Original records on The question of 2 g Nigella powder plus omeprazole, adults, eradication and equivalence to standard 3-drug therapy must link to the relevant report, design, concomitant treatment, dose, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish the formulation, selected dose, population, active comparison, eradication test, allocation and analysis, equivalence question, report relationships, support and harms of the combination.", "condition_origin": "These existing conditions are linked to the eradication comparison of seed powder plus omeprazole with standard triple therapy. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original records defining the exact population, formulation, dose, comparison and equivalence question This records needed materials; no new research was executed." }, { "item_id": "N02", "question_type": "Evidence condition", "question": "Which materials were actually read?", "needed": "Separate reading records for the stored JSON summary, external article, registration and plans", "role": "Required", "role_reason": "Material on Separate reading records for the stored JSON summary, external article, registration and plans is needed to connect the combination to its population, formulation, selected dose, comparison, eradication, timing, denominator, equivalence question or harms.", "application_exception": "The records of 110 assigned participants and 88 analyzed participants are not converted into randomization, initial arm allocations, ITT or safety denominators, and no new dropout count or rate is calculated. A nonsignificant comparison is not converted into equivalence, nor a historical reconstructed interval into a current calculation or trial-reported interval.", "criterion": "Original records on Separate reading records for the stored JSON summary, external article, registration and plans must link to the relevant report, design, concomitant treatment, dose, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish the formulation, selected dose, population, active comparison, eradication test, allocation and analysis, equivalence question, report relationships, support and harms of the combination.", "condition_origin": "These existing conditions are linked to the eradication comparison of seed powder plus omeprazole with standard triple therapy. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original materials and access histories supplied by the user or acquired in subsequent work This records needed materials; no new research was executed." }, { "item_id": "N03", "question_type": "Evidence condition", "question": "What is the identity of the report?", "needed": "Link the authors, year, title, PMID/PMCID/DOI and report", "role": "Required", "role_reason": "Material on Link the authors, year, title, PMID/PMCID/DOI and report is needed to connect the combination to its population, formulation, selected dose, comparison, eradication, timing, denominator, equivalence question or harms.", "application_exception": "The records of 110 assigned participants and 88 analyzed participants are not converted into randomization, initial arm allocations, ITT or safety denominators, and no new dropout count or rate is calculated. A nonsignificant comparison is not converted into equivalence, nor a historical reconstructed interval into a current calculation or trial-reported interval.", "criterion": "Original records on Link the authors, year, title, PMID/PMCID/DOI and report must link to the relevant report, design, concomitant treatment, dose, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish the formulation, selected dose, population, active comparison, eradication test, allocation and analysis, equivalence question, report relationships, support and harms of the combination.", "condition_origin": "These existing conditions are linked to the eradication comparison of seed powder plus omeprazole with standard triple therapy. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Complete original bibliography, related reports and registration lists This records needed materials; no new research was executed." }, { "item_id": "N04", "question_type": "Evidence condition", "question": "How do the 4 arms relate within the comparison?", "needed": "3-drug therapy, 1/2/3 g arms, the shared comparison group and participant relationships", "role": "Required", "role_reason": "Material on 3-drug therapy, 1/2/3 g arms, the shared comparison group and participant relationships is needed to connect the combination to its population, formulation, selected dose, comparison, eradication, timing, denominator, equivalence question or harms.", "application_exception": "The records of 110 assigned participants and 88 analyzed participants are not converted into randomization, initial arm allocations, ITT or safety denominators, and no new dropout count or rate is calculated. A nonsignificant comparison is not converted into equivalence, nor a historical reconstructed interval into a current calculation or trial-reported interval.", "criterion": "Original records on 3-drug therapy, 1/2/3 g arms, the shared comparison group and participant relationships must link to the relevant report, design, concomitant treatment, dose, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish the formulation, selected dose, population, active comparison, eradication test, allocation and analysis, equivalence question, report relationships, support and harms of the combination.", "condition_origin": "These existing conditions are linked to the eradication comparison of seed powder plus omeprazole with standard triple therapy. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original arm structure, participant flow and lists of related reports This records needed materials; no new research was executed." }, { "item_id": "N05", "question_type": "Evidence condition", "question": "To which adults does the question apply?", "needed": "H. pylori-positive nonulcer dyspepsia, selection/exclusion and baseline status", "role": "Required", "role_reason": "Material on H. pylori-positive nonulcer dyspepsia, selection/exclusion and baseline status is needed to connect the combination to its population, formulation, selected dose, comparison, eradication, timing, denominator, equivalence question or harms.", "application_exception": "The records of 110 assigned participants and 88 analyzed participants are not converted into randomization, initial arm allocations, ITT or safety denominators, and no new dropout count or rate is calculated. A nonsignificant comparison is not converted into equivalence, nor a historical reconstructed interval into a current calculation or trial-reported interval.", "criterion": "Original records on H. pylori-positive nonulcer dyspepsia, selection/exclusion and baseline status must link to the relevant report, design, concomitant treatment, dose, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish the formulation, selected dose, population, active comparison, eradication test, allocation and analysis, equivalence question, report relationships, support and harms of the combination.", "condition_origin": "These existing conditions are linked to the eradication comparison of seed powder plus omeprazole with standard triple therapy. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Selection criteria, baseline characteristics and prior-treatment/resistance tables This records needed materials; no new research was executed." }, { "item_id": "N06", "question_type": "Evidence condition", "question": "What is the seed-powder preparation?", "needed": "Powder capsules, plant part, constituent content, quality and batch", "role": "Required", "role_reason": "Material on Powder capsules, plant part, constituent content, quality and batch is needed to connect the combination to its population, formulation, selected dose, comparison, eradication, timing, denominator, equivalence question or harms.", "application_exception": "The records of 110 assigned participants and 88 analyzed participants are not converted into randomization, initial arm allocations, ITT or safety denominators, and no new dropout count or rate is calculated. A nonsignificant comparison is not converted into equivalence, nor a historical reconstructed interval into a current calculation or trial-reported interval.", "criterion": "Original records on Powder capsules, plant part, constituent content, quality and batch must link to the relevant report, design, concomitant treatment, dose, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish the formulation, selected dose, population, active comparison, eradication test, allocation and analysis, equivalence question, report relationships, support and harms of the combination.", "condition_origin": "These existing conditions are linked to the eradication comparison of seed powder plus omeprazole with standard triple therapy. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Trial-product specifications and constituent/batch records This records needed materials; no new research was executed." }, { "item_id": "N07", "question_type": "Evidence condition", "question": "What combined dose was used in the selected 2 g arm?", "needed": "Nominal and actual powder and omeprazole doses, dosing frequency and adherence", "role": "Required", "role_reason": "Material on Nominal and actual powder and omeprazole doses, dosing frequency and adherence is needed to connect the combination to its population, formulation, selected dose, comparison, eradication, timing, denominator, equivalence question or harms.", "application_exception": "The records of 110 assigned participants and 88 analyzed participants are not converted into randomization, initial arm allocations, ITT or safety denominators, and no new dropout count or rate is calculated. A nonsignificant comparison is not converted into equivalence, nor a historical reconstructed interval into a current calculation or trial-reported interval.", "criterion": "Original records on Nominal and actual powder and omeprazole doses, dosing frequency and adherence must link to the relevant report, design, concomitant treatment, dose, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish the formulation, selected dose, population, active comparison, eradication test, allocation and analysis, equivalence question, report relationships, support and harms of the combination.", "condition_origin": "These existing conditions are linked to the eradication comparison of seed powder plus omeprazole with standard triple therapy. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Arm-specific dose, administration and adherence tables This records needed materials; no new research was executed." }, { "item_id": "N08", "question_type": "Evidence condition", "question": "Is the PPI used in every Nigella arm distinguished?", "needed": "Shared omeprazole, arm-specific concomitant treatment and limits on attributing effects to Nigella alone", "role": "Required", "role_reason": "Material on Shared omeprazole, arm-specific concomitant treatment and limits on attributing effects to Nigella alone is needed to connect the combination to its population, formulation, selected dose, comparison, eradication, timing, denominator, equivalence question or harms.", "application_exception": "The records of 110 assigned participants and 88 analyzed participants are not converted into randomization, initial arm allocations, ITT or safety denominators, and no new dropout count or rate is calculated. A nonsignificant comparison is not converted into equivalence, nor a historical reconstructed interval into a current calculation or trial-reported interval.", "criterion": "Original records on Shared omeprazole, arm-specific concomitant treatment and limits on attributing effects to Nigella alone must link to the relevant report, design, concomitant treatment, dose, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish the formulation, selected dose, population, active comparison, eradication test, allocation and analysis, equivalence question, report relationships, support and harms of the combination.", "condition_origin": "These existing conditions are linked to the eradication comparison of seed powder plus omeprazole with standard triple therapy. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Direct comparisons or factorial records separating PPI/Nigella alone and in combination This records needed materials; no new research was executed." }, { "item_id": "N09", "question_type": "Evidence condition", "question": "What treatment formed the standard 3-drug comparison?", "needed": "Doses, duration and adherence for clarithromycin, amoxicillin and omeprazole", "role": "Required", "role_reason": "Material on Doses, duration and adherence for clarithromycin, amoxicillin and omeprazole is needed to connect the combination to its population, formulation, selected dose, comparison, eradication, timing, denominator, equivalence question or harms.", "application_exception": "The records of 110 assigned participants and 88 analyzed participants are not converted into randomization, initial arm allocations, ITT or safety denominators, and no new dropout count or rate is calculated. A nonsignificant comparison is not converted into equivalence, nor a historical reconstructed interval into a current calculation or trial-reported interval.", "criterion": "Original records on Doses, duration and adherence for clarithromycin, amoxicillin and omeprazole must link to the relevant report, design, concomitant treatment, dose, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish the formulation, selected dose, population, active comparison, eradication test, allocation and analysis, equivalence question, report relationships, support and harms of the combination.", "condition_origin": "These existing conditions are linked to the eradication comparison of seed powder plus omeprazole with standard triple therapy. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Arm-specific drug doses/durations, adherence and treatment-setting specifications This records needed materials; no new research was executed." }, { "item_id": "N10", "question_type": "Evidence condition", "question": "Are treatment and test timing distinguished?", "needed": "4 weeks of treatment, testing 4 weeks after completion and arm-specific schedules", "role": "Required", "role_reason": "Material on 4 weeks of treatment, testing 4 weeks after completion and arm-specific schedules is needed to connect the combination to its population, formulation, selected dose, comparison, eradication, timing, denominator, equivalence question or harms.", "application_exception": "The records of 110 assigned participants and 88 analyzed participants are not converted into randomization, initial arm allocations, ITT or safety denominators, and no new dropout count or rate is calculated. A nonsignificant comparison is not converted into equivalence, nor a historical reconstructed interval into a current calculation or trial-reported interval.", "criterion": "Original records on 4 weeks of treatment, testing 4 weeks after completion and arm-specific schedules must link to the relevant report, design, concomitant treatment, dose, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish the formulation, selected dose, population, active comparison, eradication test, allocation and analysis, equivalence question, report relationships, support and harms of the combination.", "condition_origin": "These existing conditions are linked to the eradication comparison of seed powder plus omeprazole with standard triple therapy. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Treatment/test schedules and arm-specific visit records This records needed materials; no new research was executed." }, { "item_id": "N11", "question_type": "Evidence condition", "question": "Are alternate allocation and randomization distinguished?", "needed": "Actual allocation method, concealment and baseline balance", "role": "Required", "role_reason": "Material on Actual allocation method, concealment and baseline balance is needed to connect the combination to its population, formulation, selected dose, comparison, eradication, timing, denominator, equivalence question or harms.", "application_exception": "The records of 110 assigned participants and 88 analyzed participants are not converted into randomization, initial arm allocations, ITT or safety denominators, and no new dropout count or rate is calculated. A nonsignificant comparison is not converted into equivalence, nor a historical reconstructed interval into a current calculation or trial-reported interval.", "criterion": "Original records on Actual allocation method, concealment and baseline balance must link to the relevant report, design, concomitant treatment, dose, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish the formulation, selected dose, population, active comparison, eradication test, allocation and analysis, equivalence question, report relationships, support and harms of the combination.", "condition_origin": "These existing conditions are linked to the eradication comparison of seed powder plus omeprazole with standard triple therapy. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Allocation methods, baseline tables and adjustment plans This records needed materials; no new research was executed." }, { "item_id": "N12", "question_type": "Evidence condition", "question": "What measurement or behavioral differences may accompany open-label design?", "needed": "Masking of participants, treatment providers and test assessors, with arm-specific behavior/measurement", "role": "Required", "role_reason": "Material on Masking of participants, treatment providers and test assessors, with arm-specific behavior/measurement is needed to connect the combination to its population, formulation, selected dose, comparison, eradication, timing, denominator, equivalence question or harms.", "application_exception": "The records of 110 assigned participants and 88 analyzed participants are not converted into randomization, initial arm allocations, ITT or safety denominators, and no new dropout count or rate is calculated. A nonsignificant comparison is not converted into equivalence, nor a historical reconstructed interval into a current calculation or trial-reported interval.", "criterion": "Original records on Masking of participants, treatment providers and test assessors, with arm-specific behavior/measurement must link to the relevant report, design, concomitant treatment, dose, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish the formulation, selected dose, population, active comparison, eradication test, allocation and analysis, equivalence question, report relationships, support and harms of the combination.", "condition_origin": "These existing conditions are linked to the eradication comparison of seed powder plus omeprazole with standard triple therapy. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Records of masking, test conduct and additional treatment in each arm This records needed materials; no new research was executed." }, { "item_id": "N13", "question_type": "Evidence condition", "question": "What criteria identify eradication?", "needed": "Stool-antigen testing, negativity criteria, assay, test timing and medication conditions", "role": "Required", "role_reason": "Material on Stool-antigen testing, negativity criteria, assay, test timing and medication conditions is needed to connect the combination to its population, formulation, selected dose, comparison, eradication, timing, denominator, equivalence question or harms.", "application_exception": "The records of 110 assigned participants and 88 analyzed participants are not converted into randomization, initial arm allocations, ITT or safety denominators, and no new dropout count or rate is calculated. A nonsignificant comparison is not converted into equivalence, nor a historical reconstructed interval into a current calculation or trial-reported interval.", "criterion": "Original records on Stool-antigen testing, negativity criteria, assay, test timing and medication conditions must link to the relevant report, design, concomitant treatment, dose, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish the formulation, selected dose, population, active comparison, eradication test, allocation and analysis, equivalence question, report relationships, support and harms of the combination.", "condition_origin": "These existing conditions are linked to the eradication comparison of seed powder plus omeprazole with standard triple therapy. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Assay details, classification/medication-discontinuation rules and test records This records needed materials; no new research was executed." }, { "item_id": "N14", "question_type": "Evidence condition", "question": "How do 110 assigned participants relate to 88 analyzed participants?", "needed": "Allocation, completion, testing, analysis and arm-specific denominators", "role": "Required", "role_reason": "Material on Allocation, completion, testing, analysis and arm-specific denominators is needed to connect the combination to its population, formulation, selected dose, comparison, eradication, timing, denominator, equivalence question or harms.", "application_exception": "The records of 110 assigned participants and 88 analyzed participants are not converted into randomization, initial arm allocations, ITT or safety denominators, and no new dropout count or rate is calculated. A nonsignificant comparison is not converted into equivalence, nor a historical reconstructed interval into a current calculation or trial-reported interval.", "criterion": "Original records on Allocation, completion, testing, analysis and arm-specific denominators must link to the relevant report, design, concomitant treatment, dose, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish the formulation, selected dose, population, active comparison, eradication test, allocation and analysis, equivalence question, report relationships, support and harms of the combination.", "condition_origin": "These existing conditions are linked to the eradication comparison of seed powder plus omeprazole with standard triple therapy. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Participant-flow and arm-specific allocation/testing/analysis tables This records needed materials; no new research was executed." }, { "item_id": "N15", "question_type": "Evidence condition", "question": "How were attrition and missing data handled?", "needed": "Arm-specific attrition, reasons, denominators, missingness and completer/ITT/PP populations", "role": "Required", "role_reason": "Material on Arm-specific attrition, reasons, denominators, missingness and completer/ITT/PP populations is needed to connect the combination to its population, formulation, selected dose, comparison, eradication, timing, denominator, equivalence question or harms.", "application_exception": "The records of 110 assigned participants and 88 analyzed participants are not converted into randomization, initial arm allocations, ITT or safety denominators, and no new dropout count or rate is calculated. A nonsignificant comparison is not converted into equivalence, nor a historical reconstructed interval into a current calculation or trial-reported interval.", "criterion": "Original records on Arm-specific attrition, reasons, denominators, missingness and completer/ITT/PP populations must link to the relevant report, design, concomitant treatment, dose, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish the formulation, selected dose, population, active comparison, eradication test, allocation and analysis, equivalence question, report relationships, support and harms of the combination.", "condition_origin": "These existing conditions are linked to the eradication comparison of seed powder plus omeprazole with standard triple therapy. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Reasons for attrition/missingness, analysis populations and sensitivity analyses This records needed materials; no new research was executed." }, { "item_id": "N16", "question_type": "Evidence condition", "question": "Which denominators underlie the 2 g and 3-drug eradication results?", "needed": "Original eradication events/denominators, the completer population and comparison direction", "role": "Required", "role_reason": "Material on Original eradication events/denominators, the completer population and comparison direction is needed to connect the combination to its population, formulation, selected dose, comparison, eradication, timing, denominator, equivalence question or harms.", "application_exception": "The records of 110 assigned participants and 88 analyzed participants are not converted into randomization, initial arm allocations, ITT or safety denominators, and no new dropout count or rate is calculated. A nonsignificant comparison is not converted into equivalence, nor a historical reconstructed interval into a current calculation or trial-reported interval.", "criterion": "Original records on Original eradication events/denominators, the completer population and comparison direction must link to the relevant report, design, concomitant treatment, dose, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish the formulation, selected dose, population, active comparison, eradication test, allocation and analysis, equivalence question, report relationships, support and harms of the combination.", "condition_origin": "These existing conditions are linked to the eradication comparison of seed powder plus omeprazole with standard triple therapy. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Arm-specific eradication tables, assigned/completer analyses and original intervals This records needed materials; no new research was executed." }, { "item_id": "N17", "question_type": "Evidence condition", "question": "How are the 1 g and 3 g arm results kept separate?", "needed": "Eradication denominators/results for the other dose arms and direct dose comparisons", "role": "Required", "role_reason": "Material on Eradication denominators/results for the other dose arms and direct dose comparisons is needed to connect the combination to its population, formulation, selected dose, comparison, eradication, timing, denominator, equivalence question or harms.", "application_exception": "The records of 110 assigned participants and 88 analyzed participants are not converted into randomization, initial arm allocations, ITT or safety denominators, and no new dropout count or rate is calculated. A nonsignificant comparison is not converted into equivalence, nor a historical reconstructed interval into a current calculation or trial-reported interval.", "criterion": "Original records on Eradication denominators/results for the other dose arms and direct dose comparisons must link to the relevant report, design, concomitant treatment, dose, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish the formulation, selected dose, population, active comparison, eradication test, allocation and analysis, equivalence question, report relationships, support and harms of the combination.", "condition_origin": "These existing conditions are linked to the eradication comparison of seed powder plus omeprazole with standard triple therapy. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Arm-specific dose contrasts, intervals and prospective plans This records needed materials; no new research was executed." }, { "item_id": "N18", "question_type": "Evidence condition", "question": "Is a nonsignificant difference kept distinct from equivalence?", "needed": "Distinguish superiority P values from equivalence/noninferiority questions", "role": "Required", "role_reason": "Material on Distinguish superiority P values from equivalence/noninferiority questions is needed to connect the combination to its population, formulation, selected dose, comparison, eradication, timing, denominator, equivalence question or harms.", "application_exception": "The records of 110 assigned participants and 88 analyzed participants are not converted into randomization, initial arm allocations, ITT or safety denominators, and no new dropout count or rate is calculated. A nonsignificant comparison is not converted into equivalence, nor a historical reconstructed interval into a current calculation or trial-reported interval.", "criterion": "Original records on Distinguish superiority P values from equivalence/noninferiority questions must link to the relevant report, design, concomitant treatment, dose, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish the formulation, selected dose, population, active comparison, eradication test, allocation and analysis, equivalence question, report relationships, support and harms of the combination.", "condition_origin": "These existing conditions are linked to the eradication comparison of seed powder plus omeprazole with standard triple therapy. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original tests, hypotheses and equivalence plans This records needed materials; no new research was executed." }, { "item_id": "N19", "question_type": "Evidence condition", "question": "Was a noninferiority/equivalence margin prespecified?", "needed": "Clinically acceptable margins, one-/two-sided hypotheses, justification and testing plans", "role": "Required", "role_reason": "Material on Clinically acceptable margins, one-/two-sided hypotheses, justification and testing plans is needed to connect the combination to its population, formulation, selected dose, comparison, eradication, timing, denominator, equivalence question or harms.", "application_exception": "The records of 110 assigned participants and 88 analyzed participants are not converted into randomization, initial arm allocations, ITT or safety denominators, and no new dropout count or rate is calculated. A nonsignificant comparison is not converted into equivalence, nor a historical reconstructed interval into a current calculation or trial-reported interval.", "criterion": "Original records on Clinically acceptable margins, one-/two-sided hypotheses, justification and testing plans must link to the relevant report, design, concomitant treatment, dose, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish the formulation, selected dose, population, active comparison, eradication test, allocation and analysis, equivalence question, report relationships, support and harms of the combination.", "condition_origin": "These existing conditions are linked to the eradication comparison of seed powder plus omeprazole with standard triple therapy. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original protocol, SAP and margin justification This records needed materials; no new research was executed." }, { "item_id": "N20", "question_type": "Evidence condition", "question": "Were sample size and analysis adequate for the equivalence question?", "needed": "Prospective sample-size planning, ITT/PP, failure/missing-data assumptions and intervals against the margin", "role": "Required", "role_reason": "Material on Prospective sample-size planning, ITT/PP, failure/missing-data assumptions and intervals against the margin is needed to connect the combination to its population, formulation, selected dose, comparison, eradication, timing, denominator, equivalence question or harms.", "application_exception": "The records of 110 assigned participants and 88 analyzed participants are not converted into randomization, initial arm allocations, ITT or safety denominators, and no new dropout count or rate is calculated. A nonsignificant comparison is not converted into equivalence, nor a historical reconstructed interval into a current calculation or trial-reported interval.", "criterion": "Original records on Prospective sample-size planning, ITT/PP, failure/missing-data assumptions and intervals against the margin must link to the relevant report, design, concomitant treatment, dose, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish the formulation, selected dose, population, active comparison, eradication test, allocation and analysis, equivalence question, report relationships, support and harms of the combination.", "condition_origin": "These existing conditions are linked to the eradication comparison of seed powder plus omeprazole with standard triple therapy. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Sample-size plans, ITT/PP/SAP and missing-data sensitivity analyses This records needed materials; no new research was executed." }, { "item_id": "N21", "question_type": "Evidence condition", "question": "What historical event produced the risk difference and CI?", "needed": "Distinguish original article intervals from the historical Codex recalculation", "role": "Required", "role_reason": "Material on Distinguish original article intervals from the historical Codex recalculation is needed to connect the combination to its population, formulation, selected dose, comparison, eradication, timing, denominator, equivalence question or harms.", "application_exception": "The records of 110 assigned participants and 88 analyzed participants are not converted into randomization, initial arm allocations, ITT or safety denominators, and no new dropout count or rate is calculated. A nonsignificant comparison is not converted into equivalence, nor a historical reconstructed interval into a current calculation or trial-reported interval.", "criterion": "Original records on Distinguish original article intervals from the historical Codex recalculation must link to the relevant report, design, concomitant treatment, dose, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish the formulation, selected dose, population, active comparison, eradication test, allocation and analysis, equivalence question, report relationships, support and harms of the combination.", "condition_origin": "These existing conditions are linked to the eradication comparison of seed powder plus omeprazole with standard triple therapy. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Historical calculation records/methods, comparison with the original article and a separate change event This records needed materials; no new research was executed." }, { "item_id": "N22", "question_type": "Evidence condition", "question": "Were registration, prospective endpoints and plans actually verified?", "needed": "Registration identity/history, principal endpoints, analyses/timing and changes", "role": "Required", "role_reason": "Material on Registration identity/history, principal endpoints, analyses/timing and changes is needed to connect the combination to its population, formulation, selected dose, comparison, eradication, timing, denominator, equivalence question or harms.", "application_exception": "The records of 110 assigned participants and 88 analyzed participants are not converted into randomization, initial arm allocations, ITT or safety denominators, and no new dropout count or rate is calculated. A nonsignificant comparison is not converted into equivalence, nor a historical reconstructed interval into a current calculation or trial-reported interval.", "criterion": "Original records on Registration identity/history, principal endpoints, analyses/timing and changes must link to the relevant report, design, concomitant treatment, dose, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish the formulation, selected dose, population, active comparison, eradication test, allocation and analysis, equivalence question, report relationships, support and harms of the combination.", "condition_origin": "These existing conditions are linked to the eradication comparison of seed powder plus omeprazole with standard triple therapy. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Registration history, original plans and SAP This records needed materials; no new research was executed." }, { "item_id": "N23", "question_type": "Evidence condition", "question": "What reporting selection accompanies multiple doses and tests?", "needed": "1/2/3 g doses, the shared 3-drug comparison, timing, all results and multiplicity", "role": "Required", "role_reason": "Material on 1/2/3 g doses, the shared 3-drug comparison, timing, all results and multiplicity is needed to connect the combination to its population, formulation, selected dose, comparison, eradication, timing, denominator, equivalence question or harms.", "application_exception": "The records of 110 assigned participants and 88 analyzed participants are not converted into randomization, initial arm allocations, ITT or safety denominators, and no new dropout count or rate is calculated. A nonsignificant comparison is not converted into equivalence, nor a historical reconstructed interval into a current calculation or trial-reported interval.", "criterion": "Original records on 1/2/3 g doses, the shared 3-drug comparison, timing, all results and multiplicity must link to the relevant report, design, concomitant treatment, dose, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish the formulation, selected dose, population, active comparison, eradication test, allocation and analysis, equivalence question, report relationships, support and harms of the combination.", "condition_origin": "These existing conditions are linked to the eradication comparison of seed powder plus omeprazole with standard triple therapy. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Complete endpoint/dose tables, registration and SAP This records needed materials; no new research was executed." }, { "item_id": "N24", "question_type": "Evidence condition", "question": "Could adherence, additional drugs or resistance affect the comparison?", "needed": "Medication adherence, rescue/additional treatment, prior antibiotics, resistance and baseline differences", "role": "Required", "role_reason": "Material on Medication adherence, rescue/additional treatment, prior antibiotics, resistance and baseline differences is needed to connect the combination to its population, formulation, selected dose, comparison, eradication, timing, denominator, equivalence question or harms.", "application_exception": "The records of 110 assigned participants and 88 analyzed participants are not converted into randomization, initial arm allocations, ITT or safety denominators, and no new dropout count or rate is calculated. A nonsignificant comparison is not converted into equivalence, nor a historical reconstructed interval into a current calculation or trial-reported interval.", "criterion": "Original records on Medication adherence, rescue/additional treatment, prior antibiotics, resistance and baseline differences must link to the relevant report, design, concomitant treatment, dose, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish the formulation, selected dose, population, active comparison, eradication test, allocation and analysis, equivalence question, report relationships, support and harms of the combination.", "condition_origin": "These existing conditions are linked to the eradication comparison of seed powder plus omeprazole with standard triple therapy. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Adherence, additional-treatment and resistance/baseline records This records needed materials; no new research was executed." }, { "item_id": "N25", "question_type": "Evidence condition", "question": "What are the actual limits of funding and independence records?", "needed": "Funding sources, sponsor roles, study family and disclosure level", "role": "Required", "role_reason": "Material on Funding sources, sponsor roles, study family and disclosure level is needed to connect the combination to its population, formulation, selected dose, comparison, eradication, timing, denominator, equivalence question or harms.", "application_exception": "The records of 110 assigned participants and 88 analyzed participants are not converted into randomization, initial arm allocations, ITT or safety denominators, and no new dropout count or rate is calculated. A nonsignificant comparison is not converted into equivalence, nor a historical reconstructed interval into a current calculation or trial-reported interval.", "criterion": "Original records on Funding sources, sponsor roles, study family and disclosure level must link to the relevant report, design, concomitant treatment, dose, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish the formulation, selected dose, population, active comparison, eradication test, allocation and analysis, equivalence question, report relationships, support and harms of the combination.", "condition_origin": "These existing conditions are linked to the eradication comparison of seed powder plus omeprazole with standard triple therapy. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original support-role, funding and COI text This records needed materials; no new research was executed." }, { "item_id": "N26", "question_type": "Evidence condition", "question": "What is recorded about product provision, employee authorship and patents?", "needed": "Separate specifications of product provision/free support, author employment, patents and COI", "role": "Required", "role_reason": "Material on Separate specifications of product provision/free support, author employment, patents and COI is needed to connect the combination to its population, formulation, selected dose, comparison, eradication, timing, denominator, equivalence question or harms.", "application_exception": "The records of 110 assigned participants and 88 analyzed participants are not converted into randomization, initial arm allocations, ITT or safety denominators, and no new dropout count or rate is calculated. A nonsignificant comparison is not converted into equivalence, nor a historical reconstructed interval into a current calculation or trial-reported interval.", "criterion": "Original records on Separate specifications of product provision/free support, author employment, patents and COI must link to the relevant report, design, concomitant treatment, dose, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish the formulation, selected dose, population, active comparison, eradication test, allocation and analysis, equivalence question, report relationships, support and harms of the combination.", "condition_origin": "These existing conditions are linked to the eradication comparison of seed powder plus omeprazole with standard triple therapy. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Original product-provision, employment, patent and COI specifications This records needed materials; no new research was executed." }, { "item_id": "N27", "question_type": "Evidence condition", "question": "Is there independent replication of the same question?", "needed": "Unique families matching powder plus PPI, eradication, comparison with 3-drug therapy and an equivalence design", "role": "Required", "role_reason": "Material on Unique families matching powder plus PPI, eradication, comparison with 3-drug therapy and an equivalence design is needed to connect the combination to its population, formulation, selected dose, comparison, eradication, timing, denominator, equivalence question or harms.", "application_exception": "The records of 110 assigned participants and 88 analyzed participants are not converted into randomization, initial arm allocations, ITT or safety denominators, and no new dropout count or rate is calculated. A nonsignificant comparison is not converted into equivalence, nor a historical reconstructed interval into a current calculation or trial-reported interval.", "criterion": "Original records on Unique families matching powder plus PPI, eradication, comparison with 3-drug therapy and an equivalence design must link to the relevant report, design, concomitant treatment, dose, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish the formulation, selected dose, population, active comparison, eradication test, allocation and analysis, equivalence question, report relationships, support and harms of the combination.", "condition_origin": "These existing conditions are linked to the eradication comparison of seed powder plus omeprazole with standard triple therapy. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Related reports and lists of direct trials under the same conditions This records needed materials; no new research was executed." }, { "item_id": "N28", "question_type": "Evidence condition", "question": "Can the record be extended to other combinations or formulations?", "needed": "Distinguish powder plus omeprazole from honey, oil, aqueous extracts and purified constituents", "role": "Required", "role_reason": "Material on Distinguish powder plus omeprazole from honey, oil, aqueous extracts and purified constituents is needed to connect the combination to its population, formulation, selected dose, comparison, eradication, timing, denominator, equivalence question or harms.", "application_exception": "The records of 110 assigned participants and 88 analyzed participants are not converted into randomization, initial arm allocations, ITT or safety denominators, and no new dropout count or rate is calculated. A nonsignificant comparison is not converted into equivalence, nor a historical reconstructed interval into a current calculation or trial-reported interval.", "criterion": "Original records on Distinguish powder plus omeprazole from honey, oil, aqueous extracts and purified constituents must link to the relevant report, design, concomitant treatment, dose, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish the formulation, selected dose, population, active comparison, eradication test, allocation and analysis, equivalence question, report relationships, support and harms of the combination.", "condition_origin": "These existing conditions are linked to the eradication comparison of seed powder plus omeprazole with standard triple therapy. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Separate direct comparisons for each combination/formulation This records needed materials; no new research was executed." }, { "item_id": "N29", "question_type": "Evidence condition", "question": "What is known about sustained eradication and longer-term dose questions?", "needed": "Reinfection/relapse, sustained negativity, other doses and subgroups", "role": "Required", "role_reason": "Material on Reinfection/relapse, sustained negativity, other doses and subgroups is needed to connect the combination to its population, formulation, selected dose, comparison, eradication, timing, denominator, equivalence question or harms.", "application_exception": "The records of 110 assigned participants and 88 analyzed participants are not converted into randomization, initial arm allocations, ITT or safety denominators, and no new dropout count or rate is calculated. A nonsignificant comparison is not converted into equivalence, nor a historical reconstructed interval into a current calculation or trial-reported interval.", "criterion": "Original records on Reinfection/relapse, sustained negativity, other doses and subgroups must link to the relevant report, design, concomitant treatment, dose, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish the formulation, selected dose, population, active comparison, eradication test, allocation and analysis, equivalence question, report relationships, support and harms of the combination.", "condition_origin": "These existing conditions are linked to the eradication comparison of seed powder plus omeprazole with standard triple therapy. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Long-term eradication follow-up and direct dose/subgroup records This records needed materials; no new research was executed." }, { "item_id": "N30", "question_type": "Evidence condition", "question": "Does eradication negativity answer other clinical-outcome questions?", "needed": "Separate evidence for dyspepsia, ulcers, bleeding, cancer, quality of life and eradication", "role": "Required", "role_reason": "Material on Separate evidence for dyspepsia, ulcers, bleeding, cancer, quality of life and eradication is needed to connect the combination to its population, formulation, selected dose, comparison, eradication, timing, denominator, equivalence question or harms.", "application_exception": "The records of 110 assigned participants and 88 analyzed participants are not converted into randomization, initial arm allocations, ITT or safety denominators, and no new dropout count or rate is calculated. A nonsignificant comparison is not converted into equivalence, nor a historical reconstructed interval into a current calculation or trial-reported interval.", "criterion": "Original records on Separate evidence for dyspepsia, ulcers, bleeding, cancer, quality of life and eradication must link to the relevant report, design, concomitant treatment, dose, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish the formulation, selected dose, population, active comparison, eradication test, allocation and analysis, equivalence question, report relationships, support and harms of the combination.", "condition_origin": "These existing conditions are linked to the eradication comparison of seed powder plus omeprazole with standard triple therapy. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Separate clinical outcomes, durations, denominators and direct comparisons This records needed materials; no new research was executed." }, { "item_id": "N31", "question_type": "Evidence condition", "question": "How was safety information collected?", "needed": "Arm-specific adverse events, collection methods, severity, discontinuation and denominators", "role": "Supplementary", "role_reason": "Material on Arm-specific adverse events, collection methods, severity, discontinuation and denominators is needed to connect the combination to its population, formulation, selected dose, comparison, eradication, timing, denominator, equivalence question or harms.", "application_exception": "The records of 110 assigned participants and 88 analyzed participants are not converted into randomization, initial arm allocations, ITT or safety denominators, and no new dropout count or rate is calculated. A nonsignificant comparison is not converted into equivalence, nor a historical reconstructed interval into a current calculation or trial-reported interval.", "criterion": "Original records on Arm-specific adverse events, collection methods, severity, discontinuation and denominators must link to the relevant report, design, concomitant treatment, dose, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish the formulation, selected dose, population, active comparison, eradication test, allocation and analysis, equivalence question, report relationships, support and harms of the combination.", "condition_origin": "These existing conditions are linked to the eradication comparison of seed powder plus omeprazole with standard triple therapy. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Arm-specific harms, discontinuation and collection methods This records needed materials; no new research was executed." }, { "item_id": "N32", "question_type": "Evidence condition", "question": "What supports attribution of harms in the combination and concomitant drugs?", "needed": "Nigella, PPI, antibiotics, underlying conditions, timelines and alternative explanations", "role": "Supplementary", "role_reason": "Material on Nigella, PPI, antibiotics, underlying conditions, timelines and alternative explanations is needed to connect the combination to its population, formulation, selected dose, comparison, eradication, timing, denominator, equivalence question or harms.", "application_exception": "The records of 110 assigned participants and 88 analyzed participants are not converted into randomization, initial arm allocations, ITT or safety denominators, and no new dropout count or rate is calculated. A nonsignificant comparison is not converted into equivalence, nor a historical reconstructed interval into a current calculation or trial-reported interval.", "criterion": "Original records on Nigella, PPI, antibiotics, underlying conditions, timelines and alternative explanations must link to the relevant report, design, concomitant treatment, dose, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish the formulation, selected dose, population, active comparison, eradication test, allocation and analysis, equivalence question, report relationships, support and harms of the combination.", "condition_origin": "These existing conditions are linked to the eradication comparison of seed powder plus omeprazole with standard triple therapy. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Concomitant exposures, timelines, discontinuation/recovery and alternative-explanation records This records needed materials; no new research was executed." }, { "item_id": "N33", "question_type": "Evidence condition", "question": "What is known about long-term/rare harms and vulnerable populations?", "needed": "Direct safety data for long-term exposure, pregnancy/breastfeeding, children, liver/kidney conditions and other groups", "role": "Supplementary", "role_reason": "Material on Direct safety data for long-term exposure, pregnancy/breastfeeding, children, liver/kidney conditions and other groups is needed to connect the combination to its population, formulation, selected dose, comparison, eradication, timing, denominator, equivalence question or harms.", "application_exception": "The records of 110 assigned participants and 88 analyzed participants are not converted into randomization, initial arm allocations, ITT or safety denominators, and no new dropout count or rate is calculated. A nonsignificant comparison is not converted into equivalence, nor a historical reconstructed interval into a current calculation or trial-reported interval.", "criterion": "Original records on Direct safety data for long-term exposure, pregnancy/breastfeeding, children, liver/kidney conditions and other groups must link to the relevant report, design, concomitant treatment, dose, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish the formulation, selected dose, population, active comparison, eradication test, allocation and analysis, equivalence question, report relationships, support and harms of the combination.", "condition_origin": "These existing conditions are linked to the eradication comparison of seed powder plus omeprazole with standard triple therapy. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Long-term/population-specific exposure, harm and interaction records This records needed materials; no new research was executed." }, { "item_id": "N34", "question_type": "Evidence condition", "question": "How are D34, axes and historical cross-checking retained?", "needed": "Existing grade/score, E0/R1/I2 and other axis labels, inactive/empty records and verdict history", "role": "Required", "role_reason": "Material on Existing grade/score, E0/R1/I2 and other axis labels, inactive/empty records and verdict history is needed to connect the combination to its population, formulation, selected dose, comparison, eradication, timing, denominator, equivalence question or harms.", "application_exception": "The records of 110 assigned participants and 88 analyzed participants are not converted into randomization, initial arm allocations, ITT or safety denominators, and no new dropout count or rate is calculated. A nonsignificant comparison is not converted into equivalence, nor a historical reconstructed interval into a current calculation or trial-reported interval.", "criterion": "Original records on Existing grade/score, E0/R1/I2 and other axis labels, inactive/empty records and verdict history must link to the relevant report, design, concomitant treatment, dose, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish the formulation, selected dose, population, active comparison, eradication test, allocation and analysis, equivalence question, report relationships, support and harms of the combination.", "condition_origin": "These existing conditions are linked to the eradication comparison of seed powder plus omeprazole with standard triple therapy. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Separate histories of the verdict and correction events This records needed materials; no new research was executed." }, { "item_id": "N35", "question_type": "Evidence condition", "question": "What is the scope of the current English text, corrections and dates?", "needed": "Distinguish Korean/English text, the original evidence date and English corrections from preparation/reading here", "role": "Required", "role_reason": "Material on Distinguish Korean/English text, the original evidence date and English corrections from preparation/reading here is needed to connect the combination to its population, formulation, selected dose, comparison, eradication, timing, denominator, equivalence question or harms.", "application_exception": "The records of 110 assigned participants and 88 analyzed participants are not converted into randomization, initial arm allocations, ITT or safety denominators, and no new dropout count or rate is calculated. A nonsignificant comparison is not converted into equivalence, nor a historical reconstructed interval into a current calculation or trial-reported interval.", "criterion": "Original records on Distinguish Korean/English text, the original evidence date and English corrections from preparation/reading here must link to the relevant report, design, concomitant treatment, dose, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.", "basis": "Existing principles distinguish the formulation, selected dose, population, active comparison, eradication test, allocation and analysis, equivalence question, report relationships, support and harms of the combination.", "condition_origin": "These existing conditions are linked to the eradication comparison of seed powder plus omeprazole with standard triple therapy. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.", "proposed_research": "Material needed: Before/after correction records, user comments and subsequent original material This records needed materials; no new research was executed." } ] }