{ "schema_version": "chamgap-public-evidence-check-1.0", "public_id": "v2923-s0", "verdict_number": "2923", "title": "Amoxicillin-clavulanate × Acute odontogenic infection clinical-success evidence sheet", "view_version": "1.0", "view_created_date": "2026-10-10", "criteria_version": "1.0", "criteria_date": "2026-10-06", "review_date": null, "legacy_evidence_date": "2026-08-26", "review_scope": { "materials_read": "Existing review summaries and stored records of methodological application", "clinical_papers_directly_read": false, "new_clinical_search": false, "limitation": "Review of the existing content is incomplete. External abstracts, full texts, registration records, protocols and SAPs have not been read, and access has not been attempted.", "date_meaning": "This is the date the stored materials were checked, not the date of a new search of the clinical literature." }, "claim_context": { "population": "Acute odontogenic infection; 472 randomized (235/237). Actual eligibility, efficacy/safety analysis denominators and group labels are unverified", "intervention": "Historical trial exposure to amoxicillin-clavulanate 875/125 mg twice daily for 5~7 days; not dosing or treatment-selection guidance", "dose": null, "comparator": "Active control: clindamycin 150 mg four times daily; not the same drug BID versus TID or a placebo comparison", "endpoint": "End-of-treatment clinical success: composite of pain, swelling, fever and need for additional antibiotics; distinguished from cure/improvement and individual outcomes", "duration": "Original 5~7-day acute end-of-treatment assessment; later recurrence/long-term complications are unverified", "excluded_extensions": [ "Repurposing composite clinical success as complete cure alone, individual symptoms, or prevention of long-term recurrence/complications", "Extending passage of the 10% noninferiority margin/7.7% CI upper bound to equivalence, superiority or absence of all differences", "Calculating new differences, event counts/denominators, complete CIs, effects or rates from 88.2%/89.7% and 472/235/237", "Filling in explicit group labels, efficacy/safety analysis denominators or no dropouts from the original 235/237", "Changing the clindamycin active control to the same drug three times daily, placebo or no treatment", "Inheriting observer-blind wording as verified patient/administrator double blinding or allocation concealment", "Treating the original drainage/placebo ethics explanation as actual drainage or equivalent concurrent care for every participant", "Adding shared report, parent/subclaim, composite/component, safety or timepoint results as independent trials/participant totals", "Inheriting GSK/editorial support and employee stock/equity wording as current COI reading or independent certification", "Converting original adverse-event, caution and risk-population wording into safety event counts/rates, long-term/vulnerable-population certification or drug-selection/dosing/change guidance", "Upgrading an NCT number, bibliographic URL or historical cross-check/design-defect assessment to current registration/full-text reading or QA", "Filling absent subclaim score/status/axes with parent C50/axes, or creating new grades/reassessment", "New clinical searches/APIs, calculations, hypothetical numbers, effects/CIs, independent certification or treatment/dosing/suitability recommendations" ] }, "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.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The selected question is acute odontogenic infection clinical success. Subclaim grade C/note are retained; score, status and axes are unrecorded. Parent C50, caution and P/R1/I0/E+/B1 remain parent context.", "condition_status": "Partly verified", "status_reason": "This is a draft presentation of the stored summary. Some information exists, but Parent scores or axes are not inherited by the selected row, and no new verdict is created. Review of the table remains pending with the user.", "missingness": "Parent scores or axes are not inherited by the selected row, and no new verdict is created.", "uncertainty": "This presentation links stored wording. It does not constitute external full-text comparison, an efficacy judgment or completed QA.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original selected-subclaim/parent-verdict records or user-corrected copies" }, { "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. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant original material and analysis scope for Clinical composite definition of pain, swelling, fever and need for additional antibiotics 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 report material linking clinical success and each component separately; no new investigation, calculation or trial is performed here.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original endpoint is end-of-treatment clinical success, a composite of pain, swelling, fever and need for additional antibiotics. It is not changed into a laboratory surrogate.", "condition_status": "Partly verified", "status_reason": "This is a draft presentation of the stored summary. Some information exists, but Complete cure/improvement/failure classification, adjudication algorithms and component results are incomplete in the summary alone. Review of the table remains pending with the user.", "missingness": "Complete cure/improvement/failure classification, adjudication algorithms and component results are incomplete in the summary alone.", "uncertainty": "This presentation links stored wording. It does not constitute external full-text comparison, an efficacy judgment or completed QA.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Clinical-success adjudication tables, visit-specific classifications and complete original definitions" }, { "item_id": "N03", "question_type": "Efficacy comparison and presentation of stored material", "question": "Do complete cure and improvement use the same criteria?", "needed": "Distinguishing complete resolution from fever resolution and over 70% reduction in pain/swelling", "role": "Required", "role_reason": "This production item distinguishes Distinguishing complete resolution from fever resolution and over 70% reduction in pain/swelling 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 complete resolution from fever resolution and over 70% reduction in pain/swelling 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; M08 Table 8.2.a, M03 §3.2.4; internal application; M08 §8.2.2, M15 §15.3.1; 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 later material reporting separate effects for composite success and complete cure; no new investigation, calculation or trial is performed here.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Original cure means complete resolution of baseline infection signs/symptoms with no additional antibiotics needed. Improvement means fever resolution, over 70% reduction in pain/swelling and no additional antibiotics needed.", "condition_status": "Partly verified", "status_reason": "This is a draft presentation of the stored summary. Some information exists, but Cure-only and improvement-only proportions and composite aggregation rules are unverified. Review of the table remains pending with the user.", "missingness": "Cure-only and improvement-only proportions and composite aggregation rules are unverified.", "uncertainty": "This presentation links stored wording. It does not constitute external full-text comparison, an efficacy judgment or completed QA.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Cure/improvement/failure tables, VAS criteria and denominators" }, { "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. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant original material and analysis scope for Distinguishing between-group end-of-treatment clinical success from within-group change/complete-cure rates 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; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are internally designed; M08 §8.2.2, M15 §15.3.1; internal application; M15 §15.3.1–15.3.3; 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 between-group report material aligning clinical-success definitions and analysis populations; no new investigation, calculation or trial is performed here.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Original clinical success is 88.2% versus 89.7% for amoxicillin-clavulanate versus clindamycin. These values are not transferred to within-group change, complete cure alone or absolute effects versus placebo.", "condition_status": "Partly verified", "status_reason": "This is a draft presentation of the stored summary. Some information exists, but Actual successful-event counts/denominators, analysis populations and the exact two-sided interval are unverified. Review of the table remains pending with the user.", "missingness": "Actual successful-event counts/denominators, analysis populations and the exact two-sided interval are unverified.", "uncertainty": "This presentation links stored wording. It does not constitute external full-text comparison, an efficacy judgment or completed QA.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Group-specific events/denominators, analysis populations and original outcome tables" }, { "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. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant original material and analysis scope for Distinguishing the original protocol-specified margin/CI upper bound from the complete interval must be provided, with unverified matters distinguished. Stored wording is linked here; user review remains pending.", "basis": "M15 §15.3.1–15.3.3; internal application; 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 noninferiority report material specifying the contrast, sign and clinical margin rationale; no new investigation, calculation or trial is performed here.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The stored summary reports a prespecified 10% noninferiority margin and a 95% CI upper bound of 7.7% within it. No complete CI, difference or new verdict is calculated.", "condition_status": "Partly verified", "status_reason": "This is a draft presentation of the stored summary. Some information exists, but Difference sign/reference group, CI lower bound, calculation model and prespecified-margin rationale are unverified. Review of the table remains pending with the user.", "missingness": "Difference sign/reference group, CI lower bound, calculation model and prespecified-margin rationale are unverified.", "uncertainty": "This presentation links stored wording. It does not constitute external full-text comparison, an efficacy judgment or completed QA.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Protocol noninferiority specifications, complete original CI and analysis model" }, { "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. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant original material and analysis scope for Distinguishing the original noninferiority conclusion from identical/more effective conclusions 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; M15 §15.3.1–15.3.3; internal application; 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 question-specific linking when comparative material with separate hypotheses is provided; no new investigation, calculation or trial is performed here.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The existing note concludes noninferiority. Two success rates and passage of the margin are not extended to no differences, equivalence, superiority or guaranteed individual treatment effects.", "condition_status": "Partly verified", "status_reason": "This is a draft presentation of the stored summary. Some information exists, but Prespecified equivalence/superiority hypotheses, tests and direct results are absent from the summary. Review of the table remains pending with the user.", "missingness": "Prespecified equivalence/superiority hypotheses, tests and direct results are absent from the summary.", "uncertainty": "This presentation links stored wording. It does not constitute external full-text comparison, an efficacy judgment or completed QA.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original plans specifying trial hypotheses, margins and analysis direction" }, { "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. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant original material and analysis scope for Distinguishing clindamycin active control from same-ingredient BID/TID comparison 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 assessment adaptation are Chamgap design; M03 §3.2.3 and M08 §8.2.2–8.2.3; 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 material separately studying same-ingredient dosing frequency; no new investigation, calculation or trial is performed here.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original control is clindamycin 150 mg four times daily. It is not amoxicillin-clavulanate three times daily.", "condition_status": "Partly verified", "status_reason": "This is a draft presentation of the stored summary. Some information exists, but This trial has no direct results comparing dosing frequencies of the same ingredient. Review of the table remains pending with the user.", "missingness": "This trial has no direct results comparing dosing frequencies of the same ingredient.", "uncertainty": "This presentation links stored wording. It does not constitute external full-text comparison, an efficacy judgment or completed QA.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Active-control specifications, formulation/dose/duration and actual administration records" }, { "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. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant original material and analysis scope for Distinguishing 875/125 mg twice-daily short-term research exposure from use guidance 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; 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 later report separating trial conditions from actual deviations; no new investigation, calculation or trial is performed here.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original intervention is 875/125 mg twice daily under 5~7-day acute-infection research conditions. This is not written as dosing, selection, administration or change guidance.", "condition_status": "Partly verified", "status_reason": "This is a draft presentation of the stored summary. Some information exists, but Actual exposure/adherence, duration selection, crossover/discontinuation and formulation details are unverified. Review of the table remains pending with the user.", "missingness": "Actual exposure/adherence, duration selection, crossover/discontinuation and formulation details are unverified.", "uncertainty": "This presentation links stored wording. It does not constitute external full-text comparison, an efficacy judgment or completed QA.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Group-specific actual exposure, adherence, change and discontinuation records" }, { "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. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant original material and analysis scope for Acute odontogenic infection population, eligibility/baseline severity and recruitment scope must be provided, with unverified matters distinguished. Stored wording is linked here; user review remains pending.", "basis": "M03 §3.2.1; Detailed population conditions are Chamgap design; M03 §3.2.1–3.2.4; Dose, duration and effect-modifier details are Chamgap 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 distinguishing the original population from other infections/vulnerable populations; no new investigation, calculation or trial is performed here.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original trial included 472 people with acute odontogenic infection. Absent age, severity, fever/immune status, region or other conditions are not filled in, and results are not generalized to all dental infections.", "condition_status": "Partly verified", "status_reason": "This is a draft presentation of the stored summary. Some information exists, but Exact eligibility/exclusions, age, infection type/baseline symptoms, comorbidities and recruitment conditions are unverified. Review of the table remains pending with the user.", "missingness": "Exact eligibility/exclusions, age, infection type/baseline symptoms, comorbidities and recruitment conditions are unverified.", "uncertainty": "This presentation links stored wording. It does not constitute external full-text comparison, an efficacy judgment or completed QA.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Population eligibility, baseline tables and centre-specific recruitment material" }, { "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.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Original n is 472 randomized (235/237). Numbers and order are retained without calculating successful events, safety denominators or group dropout counts.", "condition_status": "Partly verified", "status_reason": "This is a draft presentation of the stored summary. Some information exists, but Explicit group labels for 235/237, actual assessed participants/successful events and analysis denominators are unverified. Review of the table remains pending with the user.", "missingness": "Explicit group labels for 235/237, actual assessed participants/successful events and analysis denominators are unverified.", "uncertainty": "This presentation links stored wording. It does not constitute external full-text comparison, an efficacy judgment or completed QA.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Group-specific flowcharts and randomized/treated/assessed/analyzed denominator tables" }, { "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. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant original material and analysis scope for Noninferiority analysis populations, missingness/discontinuation and sensitivity specifications 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, M19 §19.1.2–19.2.4; design-specific adaptations are internally designed; M08 §8.2.2, M15 §15.3.1; internal application; 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 later material disclosing analysis-population-specific noninferiority results and missingness assumptions; no new investigation, calculation or trial is performed here.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The stored summary provides a noninferiority conclusion and randomized counts. It does not establish concordant ITT/PP results or absence of missingness.", "condition_status": "Partly verified", "status_reason": "This is a draft presentation of the stored summary. Some information exists, but ITT/PP definitions, exclusions/missingness, dropout, sensitivity and group analysis counts are unverified. Review of the table remains pending with the user.", "missingness": "ITT/PP definitions, exclusions/missingness, dropout, sensitivity and group analysis counts are unverified.", "uncertainty": "This presentation links stored wording. It does not constitute external full-text comparison, an efficacy judgment or completed QA.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "SAP, ITT/PP outcome tables and missingness/follow-up flow material" }, { "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.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original is a randomized observer-blind phase 4 noninferiority trial. It is not changed into verified patient/administrator double blinding or allocation concealment.", "condition_status": "Partly verified", "status_reason": "This is a draft presentation of the stored summary. Some information exists, but Sequence generation/concealment, assessor/patient awareness, maintenance of blinding and breaches are unverified. Review of the table remains pending with the user.", "missingness": "Sequence generation/concealment, assessor/patient awareness, maintenance of blinding and breaches are unverified.", "uncertainty": "This presentation links stored wording. It does not constitute external full-text comparison, an efficacy judgment or completed QA.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Randomization, blinding, adjudication procedures and actual-deviation material" }, { "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.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The existing verdict rationale describes a patient-centred endpoint combining pain/swelling VAS, fever and rescue antibiotics. Individual between-group benefits for components are not invented.", "condition_status": "Partly verified", "status_reason": "This is a draft presentation of the stored summary. Some information exists, but VAS scale/baseline, fever definition, measurement timing, assessors and rescue-antibiotic criteria are unverified. Review of the table remains pending with the user.", "missingness": "VAS scale/baseline, fever definition, measurement timing, assessors and rescue-antibiotic criteria are unverified.", "uncertainty": "This presentation links stored wording. It does not constitute external full-text comparison, an efficacy judgment or completed QA.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Symptom scales, rescue-treatment criteria and component outcome tables" }, { "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.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Original treatment/observation wording specifies 5~7 days and does not answer long-term recurrence or complications. It is not extended to long-term cure or recurrence prevention.", "condition_status": "Partly verified", "status_reason": "This is a draft presentation of the stored summary. Some information exists, but Exact visit windows, extension decisions, later recurrence/complication definitions and denominators are unverified. Review of the table remains pending with the user.", "missingness": "Exact visit windows, extension decisions, later recurrence/complication definitions and denominators are unverified.", "uncertainty": "This presentation links stored wording. It does not constitute external full-text comparison, an efficacy judgment or completed QA.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Visit schedules, duration decisions and post-treatment follow-up results" }, { "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. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant original material and analysis scope for Original ethical-control explanation and actual shared/group-specific procedures 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 assessment adaptation are Chamgap design; M03 §3.2.3 and M08 §8.2.2–8.2.3; 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 distinguishing contributions of the antibiotic comparison and concurrent procedures; no new investigation, calculation or trial is performed here.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The existing research explanation about difficulty giving placebo alone instead of drainage/antibiotics is historical design commentary. It is not changed into actual drainage or equivalent care for every participant.", "condition_status": "Partly verified", "status_reason": "This is a draft presentation of the stored summary. Some information exists, but Group differences in actual drainage/surgery, analgesics, concurrent care and treatment deviations/rescue are unverified. Review of the table remains pending with the user.", "missingness": "Group differences in actual drainage/surgery, analgesics, concurrent care and treatment deviations/rescue are unverified.", "uncertainty": "This presentation links stored wording. It does not constitute external full-text comparison, an efficacy judgment or completed QA.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Shared/group-specific procedures, concomitant drugs, rescue and deviation material" }, { "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. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant original material and analysis scope for Distinguishing active-control noninferiority from effects versus placebo/no treatment 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 §3.2.2–3.2.3; reverse-direction labels and checking adaptations are internally designed; M08 §8.2.2, M15 §15.3.1; 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 separate material for comparison questions distinguishing ethical/research conditions; no new investigation, calculation or trial is performed here.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The existing counterargument says absolute efficacy versus placebo was not tested. Active-control success rates are not used to calculate improvement without treatment, absolute effects or individual need.", "condition_status": "Partly verified", "status_reason": "This is a draft presentation of the stored summary. Some information exists, but Direct results for placebo/no-treatment comparisons are absent. Review of the table remains pending with the user.", "missingness": "Direct results for placebo/no-treatment comparisons are absent.", "uncertainty": "This presentation links stored wording. It does not constitute external full-text comparison, an efficacy judgment or completed QA.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Current active-control results and original research material for separate comparisons" }, { "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. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant original material and analysis scope for Protocol-specified noninferiority specifications and hierarchy of other outcomes must be provided, with unverified matters distinguished. Stored wording is linked here; user review remains pending.", "basis": "Data collection/selection principles in M04 §4.5–4.6; Access/reading separation and hyperlink rules are Chamgap design; M08 Table 8.2.a and M04 §4.6.3; 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 material making prespecified plans and reported endpoints/timepoints comparable; no new investigation, calculation or trial is performed here.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original reports a prespecified noninferiority margin; this does not mean every symptom, visit or safety outcome was a prespecified primary endpoint.", "condition_status": "Partly verified", "status_reason": "This is a draft presentation of the stored summary. Some information exists, but Registration/protocol/SAP primary/secondary endpoints, visits, multiplicity and change histories remain unread. Review of the table remains pending with the user.", "missingness": "Registration/protocol/SAP primary/secondary endpoints, visits, multiplicity and change histories remain unread.", "uncertainty": "This presentation links stored wording. It does not constitute external full-text comparison, an efficacy judgment or completed QA.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original registration/protocol/SAP endpoint and analysis versions" }, { "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. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant original material and analysis scope for Corporate funding, DiagnoSearch editorial support and employee stock/equity COI must be provided, with unverified matters distinguished. Stored wording is linked here; user review remains pending.", "basis": "Chamgap independence/attribution conditions. The referenced official method sections do not certify every detail of these items; Data collection/selection principles in M04 §4.5–4.6; Access/reading separation and hyperlink rules are Chamgap 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 report disclosing support separately from research/manuscript control; no new investigation, calculation or trial is performed here.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Original funding information specifies GSK funding and DiagnoSearch editorial support, with stock/equity disclosures by four GSK employee authors. This is not current external COI reading or independence certification.", "condition_status": "Partly verified", "status_reason": "This is a draft presentation of the stored summary. Some information exists, but Funding/editorial-support details, product supply, design/analysis/manuscript contributions and complete COI remain unread. Review of the table remains pending with the user.", "missingness": "Funding/editorial-support details, product supply, design/analysis/manuscript contributions and complete COI remain unread.", "uncertainty": "This presentation links stored wording. It does not constitute external full-text comparison, an efficacy judgment or completed QA.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original funding, product-supply, author-role, COI and contractual material" }, { "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. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.", "criterion": "Relevant original material and analysis scope for One AUG117044 trial with shared bibliographic/subclaim/parent results must be provided, with unverified matters distinguished. Stored wording is linked here; user review remains pending.", "basis": "Study/report distinction in M04 §4.6.1–4.6.2; Cohort/outcome linkage is Chamgap application; M04 §4.6.1–4.6.2 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 linking that distinguishes trial-family and outcome relationships when new material is provided; no new investigation, calculation or trial is performed here.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Tancawan2015 AUG117044 and PMID26300919 link to the same stored report. Subclaim/parent, composite/component and safety results are not added as new independent trials or participant totals.", "condition_status": "Partly verified", "status_reason": "This is a draft presentation of the stored summary. Some information exists, but New unique trial/participant or independent-replication counts are not established and remain null. Review of the table remains pending with the user.", "missingness": "New unique trial/participant or independent-replication counts are not established and remain null.", "uncertainty": "This presentation links stored wording. It does not constitute external full-text comparison, an efficacy judgment or completed QA.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Report relationships within the same trial and identifying material for independent studies" }, { "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.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original identifier NCT02141217 is retained exactly. Its presence is not upgraded to registration-content verification, confirmed prespecified endpoints/analyses or successful access here.", "condition_status": "Partly verified", "status_reason": "This is a draft presentation of the stored summary. Some information exists, but Original registration/changes, protocol and SAP remain unread, with no access attempted. Review of the table remains pending with the user.", "missingness": "Original registration/changes, protocol and SAP remain unread, with no access attempted.", "uncertainty": "This presentation links stored wording. It does not constitute external full-text comparison, an efficacy judgment or completed QA.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "User-provided original registration/protocol/SAP copies" }, { "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.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The existing safety explanation reports diarrhea, elevated liver enzymes, headache and other events. Parent caution is an original value; no new event counts/rates, between-group harm differences or causal conclusions are created.", "condition_status": "Partly verified", "status_reason": "This is a draft presentation of the stored summary. Some information exists, but Group event counts/denominators, collection methods, severity, ascertainment/periods and CIs are unverified. Review of the table remains pending with the user.", "missingness": "Group event counts/denominators, collection methods, severity, ascertainment/periods and CIs are unverified.", "uncertainty": "This presentation links stored wording. It does not constitute external full-text comparison, an efficacy judgment or completed QA.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Adverse-event tables, collection criteria and exposure/safety denominators" }, { "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.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Original penicillin-allergy and liver-risk safety wording is preserved as historical text. It is not changed into drug-selection/change or suitability guidance, or long-term/vulnerable-population safety certification.", "condition_status": "Partly verified", "status_reason": "This is a draft presentation of the stored summary. Some information exists, but Risk-population inclusion/exclusion, occurrence/causality, long-term/delayed outcomes and missingness are unverified. Review of the table remains pending with the user.", "missingness": "Risk-population inclusion/exclusion, occurrence/causality, long-term/delayed outcomes and missingness are unverified.", "uncertainty": "This presentation links stored wording. It does not constitute external full-text comparison, an efficacy judgment or completed QA.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Risk-population eligibility, exposure time, long-term/delayed and discontinuation safety material" }, { "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.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The existing counterpoint says dosing convenience is not direct frequency-comparison evidence. Frequency is not used to calculate or recommend adherence rates, side-effect improvements or actual dosing behaviour.", "condition_status": "Partly verified", "status_reason": "This is a draft presentation of the stored summary. Some information exists, but Adherence, convenience scales and same-drug frequency-comparison results are unverified. Review of the table remains pending with the user.", "missingness": "Adherence, convenience scales and same-drug frequency-comparison results are unverified.", "uncertainty": "This presentation links stored wording. It does not constitute external full-text comparison, an efficacy judgment or completed QA.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Adherence/convenience tables and direct same-drug comparisons" }, { "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.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The existing research explanation says the under-200 criterion did not apply and that acute 5~7-day follow-up/active control were not counted as avoidable defects. This is not inherited as current reassessment, QA or certification of defect-free design.", "condition_status": "Partly verified", "status_reason": "This is a draft presentation of the stored summary. Some information exists, but No original-text comparison or new defect/grade application is performed here. Review of the table remains pending with the user.", "missingness": "No original-text comparison or new defect/grade application is performed here.", "uncertainty": "This presentation links stored wording. It does not constitute external full-text comparison, an efficacy judgment or completed QA.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original methods/verdict history or user-correction material" }, { "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.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Original Korean dental-prescribing/practicality wording is retained in the complete existing review summary. No current policy, approval, product-selection, frequency or treatment recommendations are added.", "condition_status": "Partly verified", "status_reason": "This is a draft presentation of the stored summary. Some information exists, but Current operational/recommendation updates or direct evidence for other formulations/populations/durations are outside this scope. Review of the table remains pending with the user.", "missingness": "Current operational/recommendation updates or direct evidence for other formulations/populations/durations are outside this scope.", "uncertainty": "This presentation links stored wording. It does not constitute external full-text comparison, an efficacy judgment or completed QA.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Separate policy/direct-research material provided if the scope expands" }, { "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.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The complete stored summary was read for production and marked as summary reading. Only the original PubMed URL is retained; paper/abstract/full text, registration, plans and COI remain unread.", "condition_status": "Partly verified", "status_reason": "This is a draft presentation of the stored summary. Some information exists, but External access, link/click tests and original-source identity/content comparisons were not performed. Review of the table remains pending with the user.", "missingness": "External access, link/click tests and original-source identity/content comparisons were not performed.", "uncertainty": "This presentation links stored wording. It does not constitute external full-text comparison, an efficacy judgment or completed QA.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "User-provided paper, registration, plan and COI copies" }, { "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.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Complete Korean/English articles, subclaim grade C, parent C50/caution, unrecorded precision/false flags, empty correction/deliberation values and reference date are preserved in their original form. Original cross-check wording is historical and does not mean completed review here.", "condition_status": "Partly verified", "status_reason": "This is a draft presentation of the stored summary. Some information exists, but No translation/content review, correction, new verdict or external update is performed here. Review of the table remains pending with the user.", "missingness": "No translation/content review, correction, new verdict or external update is performed here.", "uncertainty": "This presentation links stored wording. It does not constitute external full-text comparison, an efficacy judgment or completed QA.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Complete original copies, verdict history or user-corrected material" }, { "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.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "Condition preservation/application, case production and completed review are separate records. Review of the existing content is incomplete and is distinguished from production.", "condition_status": "Partly verified", "status_reason": "This is a draft presentation of the stored summary. Some information exists, but User review is incomplete; no post-storage rereading, review, checks/tests or link/screen verification is performed. Review of the table remains pending with the user.", "missingness": "User review is incomplete; no post-storage rereading, review, checks/tests or link/screen verification is performed.", "uncertainty": "This presentation links stored wording. It does not constitute external full-text comparison, an efficacy judgment or completed QA.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Separate event records when user comments or additional original material are provided" } ], "reports": [ { "report_id": "S01", "title": "Tancawan AL et al. 2015 AUG117044", "url": "https://pubmed.ncbi.nlm.nih.gov/26300919/", "report_type": "Randomized observer-blind phase 4 noninferiority trial", "existence": "Stored bibliography exists; external identity unverified", "acquired_read": "Summary read; external material unread", "study_family": "RG2923-AUG117044-TANCAWAN-2015", "independent_replication": null, "observed_result": "The original subclaim C/note describes noninferiority with 88.2% versus 89.7%. The end-of-treatment composite covers pain/swelling/fever/need for additional antibiotics, distinguishing cure from improvement with over 70% reduction. Original 10% margin/7.7% CI upper bound are retained without new differences/complete CIs or denominator calculations. GSK funding, DiagnoSearch editorial support, four employee authors with stock/equity and diarrhea/elevated liver enzymes/headache remain historical wording. Original parent C50/caution and cross-check/defect assessment are not inherited as new verdicts, QA or safety/independence certification.", "result_level": "Outcome wording in the stored summary", "source_evidence_date": "2026-08-26", "materials": [ { "material_type": "Stored evidence and bibliography summary", "public_status": "Stored file", "access_status": "Stored summary", "acquired": true, "actually_read": "Summary read", "as_of": "2026-08-26", "qualification": "Only the stored JSON summary and bibliography were used for production. This does not constitute external verification or completed content review." }, { "material_type": "Paper, abstract and full text", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Registration and change history", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Prespecified study protocol", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "SAP and prespecified analysis plan", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Original funding, product support, employee-author and conflict-of-interest disclosures", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/26300919/" } ] } ], "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." }, "study_overlap": { "state": "Unverified", "unique_trial_count": null, "unique_participant_count": null, "reason": "S01 Tancawan2015 AUG117044/PMID26300919/NCT02141217 is a stored report of the same randomized observer-blind phase 4 noninferiority trial with 472 people (235/237). Parent clinical cure, subclaim clinical success and component/safety results link to the same report/population and are not added as new independent trials/participants. Unique clinical totals remain null; entry counts are not independent totals." }, "history": [ { "date": "2026-10-10", "kind": "Separation of public-facing pages and materials", "view_version": "1.0", "change": "Public reader pages and material were prepared from the existing 28 items. No new clinical searches, verification-state changes or scoring were performed." } ], "language": "en", "translation_date": "2026-10-10" }