{ "schema_version": "chamgap-public-criteria-1.0", "title": "Amoxicillin-clavulanate × Acute odontogenic infection clinical-success evidence sheet", "language": "en", "translation_date": "2026-10-10", "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": "Preserved method HTML copies; no current method-content re-review or official tool execution" }, { "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": "Preserved method HTML copies; no current method-content re-review or official tool execution" }, { "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": "Preserved method HTML copies; no current method-content re-review or official tool execution" }, { "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": "Preserved method HTML copies; no current method-content re-review or official tool execution" }, { "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": "Preserved method HTML copies; no current method-content re-review or official tool execution" } ], "status_dictionary": { "Met": "A state used when required evidence is confirmed after user review. This production does not declare that review complete.", "Partly verified": "Some information in the stored summary is linked into the table. External comparison/content review is not complete.", "Unverified": "The article leaves this unverified, or required material is absent from the current stored summary. This is distinct from zero, absence or safety.", "Review incomplete": "User review pending.", "Not reported": "Not reported within the stored material actually read; not extended to the entire primary paper.", "Inaccessible": "Means an actual access failure. Access not attempted here is not assigned this state.", "Not applicable": "Not used as a substitute for an evidence gap.", "Conflicting data": "Requires an observed disagreement under the same comparison criteria; not automatically judged in this production.", "Insufficient evidence for the conditions": "Marks a gap in additional material required by the selected conditions; not a new efficacy grade." }, "requirements": [ { "item_id": "N01", "question_type": "Efficacy comparison and presentation of stored material", "question": "What are the selected clinical-success question and existing verdict record?", "needed": "Distinguishing subclaim grade C/note, parent C50/axes and absent score", "role": "Required", "role_reason": "This production item distinguishes Distinguishing subclaim grade C/note, parent C50/axes and absent score to connect material needed for the selected question with current material.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant original material and analysis scope for Distinguishing subclaim grade C/note, parent C50/axes and absent score must be provided, with unverified matters distinguished. Stored wording is linked here; user review remains pending.", "basis": "M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design", "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run", "proposed_research": "Proposed later production record separating the subclaim question from parent clinical-cure context; no new investigation, calculation or trial is performed here." }, { "item_id": "N02", "question_type": "Efficacy comparison and presentation of stored material", "question": "What outcomes make up end-of-treatment clinical success?", "needed": "Clinical composite definition of pain, swelling, fever and need for additional antibiotics", "role": "Required", "role_reason": "This production item distinguishes Clinical composite definition of pain, swelling, fever and need for additional antibiotics to connect material needed for the selected question with current material.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. 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No official assessment tool or QA was run", "proposed_research": "Proposed later material reporting separate effects for composite success and complete cure; no new investigation, calculation or trial is performed here." }, { "item_id": "N04", "question_type": "Efficacy comparison and presentation of stored material", "question": "Which comparison do the 88.2% versus 89.7% success rates describe?", "needed": "Distinguishing between-group end-of-treatment clinical success from within-group change/complete-cure rates", "role": "Required", "role_reason": "This production item distinguishes Distinguishing between-group end-of-treatment clinical success from within-group change/complete-cure rates to connect material needed for the selected question with current material.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. 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No official assessment tool or QA was run", "proposed_research": "Proposed between-group report material aligning clinical-success definitions and analysis populations; no new investigation, calculation or trial is performed here." }, { "item_id": "N05", "question_type": "Efficacy comparison and presentation of stored material", "question": "What are the prespecified 10% noninferiority margin and 7.7% CI upper bound?", "needed": "Distinguishing the original protocol-specified margin/CI upper bound from the complete interval", "role": "Required", "role_reason": "This production item distinguishes Distinguishing the original protocol-specified margin/CI upper bound from the complete interval to connect material needed for the selected question with current material.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. 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No official assessment tool or QA was run", "proposed_research": "Proposed noninferiority report material specifying the contrast, sign and clinical margin rationale; no new investigation, calculation or trial is performed here." }, { "item_id": "N06", "question_type": "Efficacy comparison and presentation of stored material", "question": "Does noninferiority imply equivalence or superiority?", "needed": "Distinguishing the original noninferiority conclusion from identical/more effective conclusions", "role": "Required", "role_reason": "This production item distinguishes Distinguishing the original noninferiority conclusion from identical/more effective conclusions to connect material needed for the selected question with current material.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. 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No official assessment tool or QA was run", "proposed_research": "Proposed question-specific linking when comparative material with separate hypotheses is provided; no new investigation, calculation or trial is performed here." }, { "item_id": "N07", "question_type": "Efficacy comparison and presentation of stored material", "question": "Is the control a three-times-daily regimen of the same drug?", "needed": "Distinguishing clindamycin active control from same-ingredient BID/TID comparison", "role": "Required", "role_reason": "This production item distinguishes Distinguishing clindamycin active control from same-ingredient BID/TID comparison to connect material needed for the selected question with current material.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. 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No official assessment tool or QA was run", "proposed_research": "Proposed material separately studying same-ingredient dosing frequency; no new investigation, calculation or trial is performed here." }, { "item_id": "N08", "question_type": "Efficacy comparison and presentation of stored material", "question": "What research conditions describe the original amoxicillin-clavulanate exposure?", "needed": "Distinguishing 875/125 mg twice-daily short-term research exposure from use guidance", "role": "Required", "role_reason": "This production item distinguishes Distinguishing 875/125 mg twice-daily short-term research exposure from use guidance to connect material needed for the selected question with current material.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. 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No official assessment tool or QA was run", "proposed_research": "Proposed later report separating trial conditions from actual deviations; no new investigation, calculation or trial is performed here." }, { "item_id": "N09", "question_type": "Efficacy comparison and presentation of stored material", "question": "What are the actual population and infection scope?", "needed": "Acute odontogenic infection population, eligibility/baseline severity and recruitment scope", "role": "Required", "role_reason": "This production item distinguishes Acute odontogenic infection population, eligibility/baseline severity and recruitment scope to connect material needed for the selected question with current material.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. 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No official assessment tool or QA was run", "proposed_research": "Proposed later material distinguishing the original population from other infections/vulnerable populations; no new investigation, calculation or trial is performed here." }, { "item_id": "N10", "question_type": "Efficacy comparison and presentation of stored material", "question": "What denominators do 472 randomized and 235/237 represent?", "needed": "Distinguishing randomized counts/original group array from clinical-success analysis denominators", "role": "Required", "role_reason": "This production item distinguishes Distinguishing randomized counts/original group array from clinical-success analysis denominators to connect material needed for the selected question with current material.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant original material and analysis scope for Distinguishing randomized counts/original group array from clinical-success analysis denominators must be provided, with unverified matters distinguished. Stored wording is linked here; user review remains pending.", "basis": "M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; Design-specific adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap application", "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run", "proposed_research": "Proposed report material linking separate denominators to clinical-success and safety results; no new investigation, calculation or trial is performed here." }, { "item_id": "N11", "question_type": "Efficacy comparison and presentation of stored material", "question": "Are ITT, PP, missingness and noninferiority analyses distinguished?", "needed": "Noninferiority analysis populations, missingness/discontinuation and sensitivity specifications", "role": "Required", "role_reason": "This production item distinguishes Noninferiority analysis populations, missingness/discontinuation and sensitivity specifications to connect material needed for the selected question with current material.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. 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No official assessment tool or QA was run", "proposed_research": "Proposed later material disclosing analysis-population-specific noninferiority results and missingness assumptions; no new investigation, calculation or trial is performed here." }, { "item_id": "N12", "question_type": "Efficacy comparison and presentation of stored material", "question": "What does observer blinding cover?", "needed": "Distinguishing observer blinding from patient/administrator/analyst blinding", "role": "Required", "role_reason": "This production item distinguishes Distinguishing observer blinding from patient/administrator/analyst blinding to connect material needed for the selected question with current material.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant original material and analysis scope for Distinguishing observer blinding from patient/administrator/analyst blinding must be provided, with unverified matters distinguished. Stored wording is linked here; user review remains pending.", "basis": "M08 §8.1–8.2.3; internal application; M08 Table 8.2.a, M03 §3.2.4; internal application", "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run", "proposed_research": "Proposed report linking the scope of blinding to composite clinical-success adjudication; no new investigation, calculation or trial is performed here." }, { "item_id": "N13", "question_type": "Efficacy comparison and presentation of stored material", "question": "How were VAS, fever and rescue antibiotics assessed?", "needed": "Symptom measurement, assessors, composite adjudication and rescue treatment", "role": "Required", "role_reason": "This production item distinguishes Symptom measurement, assessors, composite adjudication and rescue treatment to connect material needed for the selected question with current material.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant original material and analysis scope for Symptom measurement, assessors, composite adjudication and rescue treatment must be provided, with unverified matters distinguished. Stored wording is linked here; user review remains pending.", "basis": "M03 §3.2.4 and M15 §15.3.1–15.3.3; Question-specific outcome adaptation is Chamgap design; M08 Table 8.2.a and M03 §3.2.4; Chamgap application; M03 §3.2.4; Chamgap interpretation boundary", "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run", "proposed_research": "Proposed outcome report separating symptoms from need for additional treatment; no new investigation, calculation or trial is performed here." }, { "item_id": "N14", "question_type": "Efficacy comparison and presentation of stored material", "question": "Are the 5~7-day end of treatment and later recurrence the same window?", "needed": "Acute end-of-treatment visits, duration variation and long-term follow-up", "role": "Required", "role_reason": "This production item distinguishes Acute end-of-treatment visits, duration variation and long-term follow-up to connect material needed for the selected question with current material.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant original material and analysis scope for Acute end-of-treatment visits, duration variation and long-term follow-up must be provided, with unverified matters distinguished. Stored wording is linked here; user review remains pending.", "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed; M03 §3.2.1–3.2.4; dose, duration and effect-modification details are internally designed", "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run", "proposed_research": "Proposed material assessing acute success and later recurrence/complications separately; no new investigation, calculation or trial is performed here." }, { "item_id": "N15", "question_type": "Efficacy comparison and presentation of stored material", "question": "How do drainage, dental procedures and concurrent exposure relate to results?", "needed": "Original ethical-control explanation and actual shared/group-specific procedures", "role": "Required", "role_reason": "This production item distinguishes Original ethical-control explanation and actual shared/group-specific procedures to connect material needed for the selected question with current material.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. 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No official assessment tool or QA was run", "proposed_research": "Proposed report distinguishing contributions of the antibiotic comparison and concurrent procedures; no new investigation, calculation or trial is performed here." }, { "item_id": "N16", "question_type": "Efficacy comparison and presentation of stored material", "question": "Can this comparison establish absolute efficacy versus placebo?", "needed": "Distinguishing active-control noninferiority from effects versus placebo/no treatment", "role": "Required", "role_reason": "This production item distinguishes Distinguishing active-control noninferiority from effects versus placebo/no treatment to connect material needed for the selected question with current material.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. 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No official assessment tool or QA was run", "proposed_research": "Proposed separate material for comparison questions distinguishing ethical/research conditions; no new investigation, calculation or trial is performed here." }, { "item_id": "N17", "question_type": "Efficacy comparison and presentation of stored material", "question": "What are the prespecified clinical-success endpoint/timepoint and multiplicity?", "needed": "Protocol-specified noninferiority specifications and hierarchy of other outcomes", "role": "Required", "role_reason": "This production item distinguishes Protocol-specified noninferiority specifications and hierarchy of other outcomes to connect material needed for the selected question with current material.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. 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No official assessment tool or QA was run", "proposed_research": "Proposed material making prespecified plans and reported endpoints/timepoints comparable; no new investigation, calculation or trial is performed here." }, { "item_id": "N18", "question_type": "Efficacy comparison and presentation of stored material", "question": "How are GSK funding, editorial support and employee authors distinguished?", "needed": "Corporate funding, DiagnoSearch editorial support and employee stock/equity COI", "role": "Required", "role_reason": "This production item distinguishes Corporate funding, DiagnoSearch editorial support and employee stock/equity COI to connect material needed for the selected question with current material.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. 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No official assessment tool or QA was run", "proposed_research": "Proposed report disclosing support separately from research/manuscript control; no new investigation, calculation or trial is performed here." }, { "item_id": "N19", "question_type": "Efficacy comparison and presentation of stored material", "question": "How are manufacturer-sponsored trials and independent replication recorded?", "needed": "One AUG117044 trial with shared bibliographic/subclaim/parent results", "role": "Required", "role_reason": "This production item distinguishes One AUG117044 trial with shared bibliographic/subclaim/parent results to connect material needed for the selected question with current material.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. 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No official assessment tool or QA was run", "proposed_research": "Proposed linking that distinguishes trial-family and outcome relationships when new material is provided; no new investigation, calculation or trial is performed here." }, { "item_id": "N20", "question_type": "Efficacy comparison and presentation of stored material", "question": "Does NCT02141217 mean registration was read here?", "needed": "Distinguishing a literal registration number from actual reading of registration/changes/plans", "role": "Required", "role_reason": "This production item distinguishes Distinguishing a literal registration number from actual reading of registration/changes/plans to connect material needed for the selected question with current material.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant original material and analysis scope for Distinguishing a literal registration number from actual reading of registration/changes/plans must be provided, with unverified matters distinguished. Stored wording is linked here; user review remains pending.", "basis": "M04 §4.5–4.6 material collection/selection principles; acquisition/reading separation and hyperlink specifications are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design; M08 Table 8.2.a, M04 §4.6.3; internal application", "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run", "proposed_research": "Proposed material providing report-plan links and change histories; no new investigation, calculation or trial is performed here." }, { "item_id": "N21", "question_type": "Harm-information gaps supplementing the efficacy table", "question": "What safety outcomes do diarrhea, elevated liver enzymes and headache represent?", "needed": "Originally reported adverse events and safety-event definitions/denominators", "role": "Supplementary", "role_reason": "This production item distinguishes Originally reported adverse events and safety-event definitions/denominators to connect material needed for the selected question with current material.", "application_exception": "This addresses harm-evidence gaps for the selected acute odontogenic infection clinical-success question. Original adverse-event/caution wording is not extended to overall safety or causal harm/rates, and no antibiotic-selection, dosing, administration/change or suitability guidance is created.", "criterion": "Relevant original material and analysis scope for Originally reported adverse events and safety-event definitions/denominators must be provided, with unverified matters distinguished. Stored wording is linked here; user review remains pending.", "basis": "M19 §19.1.2–19.2.4; Chamgap application; M19 §19.1.2–19.2.4; Detailed distinctions are Chamgap design; M19 §19.1.2–19.2.4; Chamgap application; Chamgap interpretation boundary. M19 principles are referenced; no official causality tool was run", "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run", "proposed_research": "Proposed safety report distinguishing symptoms, laboratory abnormalities and discontinuation; no new investigation, calculation or trial is performed here." }, { "item_id": "N22", "question_type": "Harm-information gaps supplementing the efficacy table", "question": "What is known about allergy/liver risk, vulnerable populations and long-term outcomes?", "needed": "Original safety history and directly studied risk/follow-up scope", "role": "Supplementary", "role_reason": "This production item distinguishes Original safety history and directly studied risk/follow-up scope to connect material needed for the selected question with current material.", "application_exception": "This addresses harm-evidence gaps for the selected acute odontogenic infection clinical-success question. Original adverse-event/caution wording is not extended to overall safety or causal harm/rates, and no antibiotic-selection, dosing, administration/change or suitability guidance is created.", "criterion": "Relevant original material and analysis scope for Original safety history and directly studied risk/follow-up scope must be provided, with unverified matters distinguished. Stored wording is linked here; user review remains pending.", "basis": "M19 §19.1.2–19.2.4; internal application; M19 §19.2 design-specific harm questions; temporal-relationship details are internally designed; M19 §19.2.2–19.2.4 design considerations; detailed confounding records are internally designed; M19 §19.1.2–19.2.4, M04 §4.6.3; internal application; M19 §19.1.2–19.2.4; internal application; Chamgap interpretation limits, informed by M19 principles without running an official causality tool", "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run", "proposed_research": "Proposed safety material distinguishing the original population from vulnerable populations; no new investigation, calculation or trial is performed here." }, { "item_id": "N23", "question_type": "Harm-information gaps supplementing the efficacy table", "question": "Can adherence benefits be inferred from safety or convenience?", "needed": "BID convenience wording and direct adherence/harm/frequency comparisons", "role": "Supplementary", "role_reason": "This production item distinguishes BID convenience wording and direct adherence/harm/frequency comparisons to connect material needed for the selected question with current material.", "application_exception": "This addresses harm-evidence gaps for the selected acute odontogenic infection clinical-success question. Original adverse-event/caution wording is not extended to overall safety or causal harm/rates, and no antibiotic-selection, dosing, administration/change or suitability guidance is created.", "criterion": "Relevant original material and analysis scope for BID convenience wording and direct adherence/harm/frequency comparisons must be provided, with unverified matters distinguished. Stored wording is linked here; user review remains pending.", "basis": "M03 §3.2.2–3.2.3; reverse-direction labels and checking adaptations are internally designed; M03 §3.2.3, M08 §8.2.2–8.2.3; internal application; M19 §19.1.2–19.2.4; internal application", "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run", "proposed_research": "Proposed material reporting clinical success, adherence and harms separately; no new investigation, calculation or trial is performed here." }, { "item_id": "N24", "question_type": "Efficacy comparison and presentation of stored material", "question": "What is the historical defect assessment for short follow-up, sample size and control?", "needed": "Original historical assessment of 472 people, 5~7 days and active control", "role": "Required", "role_reason": "This production item distinguishes Original historical assessment of 472 people, 5~7 days and active control to connect material needed for the selected question with current material.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant original material and analysis scope for Original historical assessment of 472 people, 5~7 days and active control must be provided, with unverified matters distinguished. Stored wording is linked here; user review remains pending.", "basis": "M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design; M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are internally designed", "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run", "proposed_research": "Proposed later record separating the original design assessment from new evidence-update events; no new investigation, calculation or trial is performed here." }, { "item_id": "N25", "question_type": "Efficacy comparison and presentation of stored material", "question": "Can Korean prescribing/practicality wording be used as current recommendations?", "needed": "Distinguishing original advertising-interpretation history from current policy/product/dosing verification", "role": "Required", "role_reason": "This production item distinguishes Distinguishing original advertising-interpretation history from current policy/product/dosing verification to connect material needed for the selected question with current material.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant original material and analysis scope for Distinguishing original advertising-interpretation history from current policy/product/dosing verification must be provided, with unverified matters distinguished. Stored wording is linked here; user review remains pending.", "basis": "M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are internally designed; M03 §3.2.1; detailed population conditions are internally designed; M03 §3.2.2–3.2.3; reverse-direction labels and checking adaptations are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design", "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run", "proposed_research": "Proposed later material record distinguishing historical wording from current material; no new investigation, calculation or trial is performed here." }, { "item_id": "N26", "question_type": "Efficacy comparison and presentation of stored material", "question": "At what level were the stored summary, external papers and source links read?", "needed": "Complete original stored summary; PMID26300919, registration/plans/COI remain unread", "role": "Required", "role_reason": "This production item distinguishes Complete original stored summary; PMID26300919, registration/plans/COI remain unread to connect material needed for the selected question with current material.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant original material and analysis scope for Complete original stored summary; PMID26300919, registration/plans/COI remain unread must be provided, with unverified matters distinguished. Stored wording is linked here; user review remains pending.", "basis": "M04 §4.5–4.6 material collection/selection principles; acquisition/reading separation and hyperlink specifications are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design", "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run", "proposed_research": "Proposed later record separating actual acquisition/reading scope for each material; no new investigation, calculation or trial is performed here." }, { "item_id": "N27", "question_type": "Efficacy comparison and presentation of stored material", "question": "How are Korean/English, dates, corrections, empty values and cross-check history retained?", "needed": "Subclaim C/note, parent C50/caution, 2026-08-26 and original false/null/empty values", "role": "Required", "role_reason": "This production item distinguishes Subclaim C/note, parent C50/caution, 2026-08-26 and original false/null/empty values to connect material needed for the selected question with current material.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant original material and analysis scope for Subclaim C/note, parent C50/caution, 2026-08-26 and original false/null/empty values must be provided, with unverified matters distinguished. Stored wording is linked here; user review remains pending.", "basis": "M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design", "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run", "proposed_research": "Proposed later production record separating original preservation from correction/update events; no new investigation, calculation or trial is performed here." }, { "item_id": "N28", "question_type": "Efficacy comparison and presentation of stored material", "question": "Are condition freezing/application, case storage and user review separate events?", "needed": "Prior condition storage, freezing, separate application/case and incomplete-review flags", "role": "Required", "role_reason": "This production item distinguishes Prior condition storage, freezing, separate application/case and incomplete-review flags to connect material needed for the selected question with current material.", "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant original material and analysis scope for Prior condition storage, freezing, separate application/case and incomplete-review flags must be provided, with unverified matters distinguished. Stored wording is linked here; user review remains pending.", "basis": "M04 §4.5–4.6 material collection/selection principles; acquisition/reading separation and hyperlink specifications are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design", "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run", "proposed_research": "Proposed later work recording production separately from user correction/review events; no new investigation, calculation or trial is performed here." } ] }