{ "schema_version": "chamgap-public-evidence-check-1.0", "public_id": "v2930-s0", "verdict_number": "2930", "title": "7 versus 14 days of antibiotics · Afebrile men with UTI · Symptom-resolution noninferiority evidence checklist", "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": "Prepared from the designated stored summary. External abstracts, full texts, registration and related judgments in women have not been read, and access was not attempted. Review of existing content remains incomplete.", "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": "Afebrile men with UTI at two US VA centers; age/diagnosis/baseline/culture and inclusion/exclusion details remain unverified", "intervention": "A 7-day duration strategy under the original ciprofloxacin or trimethoprim-sulfamethoxazole conditions", "dose": "7 days/14 days; the primary adherence criterion of at least 26 of 28 doses and no more than 2 consecutive doses missed is a historical exposure/population definition; no conversion to individual dose, drug, duration or dosing-frequency instructions", "comparator": "A 14-day duration strategy under the same original antibiotic conditions; double-blind placebo control; actual placebo/active-drug periods, drug composition and concomitant treatment remain unverified", "endpoint": "Patient-reported UTI symptom resolution within 14 days after therapy; noninferiority of the 7-day−14-day proportion difference; primary as-treated 254/all-randomized 272 consistency, 28-day recurrence and AEs kept separate", "duration": "Distinguishes 7-day/14-day exposure, assessment within 14 days after therapy and the 28-day recurrence question; calendar/collection-window details by group remain unverified", "excluded_extensions": [ "Extending noninferiority to exact equivalence/superiority, safety or reduced resistance", "Applying the original one-sided 97.5% CI/−10%p margin to other outcomes, or calculating new CIs/effects", "Recalculating/correcting durations, assessment dates, dosing frequency/active-drug amounts or primary/all-randomized/recurrence fractions/proportions", "Extension to febrile UTI, prostatitis, other antibiotics or uncomplicated cystitis in women", "Individual recommendations on antibiotics, dose, duration, suitability, stopping or substitution; adding independent trials/participants" ] }, "requirements": [ { "item_id": "N01", "question_type": "Evidence condition", "question": "What are the existing question, record and parent/sibling contexts?", "needed": "Linkage of the existing question, record and parent/sibling boundaries", "role": "Required", "role_reason": "Required to address 'What are the existing question, record and parent/sibling contexts?' separately for the selected question of 7-day symptom-resolution noninferiority.", "application_exception": "The existing candidate's pending boundary review is historical; review of existing content and the question boundary remains incomplete. Empty values are not filled with new calculations, numerical examples or judgments; the original scope is retained.", "criterion": "Link original values, definitions, denominators, times, margins/direction and unverified matters for 'What are the existing question, record and parent/sibling contexts?' to the corresponding original records. The existing candidate's pending boundary review is historical; review of existing content and the question boundary remains incomplete.", "basis": "Internally designed question conditions referring to the corresponding stored-summary records and family application conditions C01", "condition_origin": "Case-specific question conditions; review of the existing content incomplete", "proposed_research": "Follow-up materials linking new information for the same question while retaining the original question and judgment record", "current_reports": [ "R01" ], "existence": "Relevant accounts in the stored summary; existence/acquisition of direct original materials remains unverified", "acquired_read": "Summary read; external materials not read", "observation": "The selected question is 'Noninferior symptom resolution with seven days'; the question and existing judgment record are distinguished. The parent concerns noninferiority versus 14 days in afebrile men with UTI, and the sibling concerns symptom recurrence by 28 days.", "condition_status": "Partly verified", "status_reason": "Some information in the stored summary was linked for preparation. The existing candidate's pending boundary review is historical; review of existing content and the question boundary remains incomplete. Review of existing content remains incomplete; this is not verification of clinical condition fulfillment, an effect of 0 or absence of materials.", "missingness": "The existing candidate's pending boundary review is historical; review of existing content and the question boundary remains incomplete.", "uncertainty": "The existing candidate's pending boundary review is historical; review of existing content and the question boundary remains incomplete.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Linkage of the existing question, record and parent/sibling boundaries" }, { "item_id": "N02", "question_type": "Evidence condition", "question": "Are subclaim B/note and parent B70 different from absent subclaim scores/axes?", "needed": "Separate preservation of subclaim/parent judgments and absent scores/axes", "role": "Required", "role_reason": "Required to address 'Are subclaim B/note and parent B70 different from absent subclaim scores/axes?' separately for the selected question of 7-day symptom-resolution noninferiority.", "application_exception": "No uniform D, parent 70 points, B1/I2 or precision null is copied to the subclaim, and no reassessment is performed.", "criterion": "Link original values, definitions, denominators, times, margins/direction and unverified matters for 'Are subclaim B/note and parent B70 different from absent subclaim scores/axes?' to the corresponding original records. No direct original subclaim score, status or axis values exist.", "basis": "Internally designed question conditions referring to the corresponding stored-summary records and family application conditions C01, C09", "condition_origin": "Case-specific question conditions; review of the existing content incomplete", "proposed_research": "If a correction is actually provided, a record separating the full original text, event/version and change decision", "current_reports": [ "R01" ], "existence": "Relevant accounts in the stored summary; existence/acquisition of direct original materials remains unverified", "acquired_read": "Summary read; external materials not read", "observation": "Retains subclaim B grade and the note 'The prespecified margin was met.' The subclaim has no score, status or axes; parent B70, Caution and axes are parent history.", "condition_status": "Partly verified", "status_reason": "Some information in the stored summary was linked for preparation. No direct original subclaim score, status or axis values exist. Review of existing content remains incomplete; this is not verification of clinical condition fulfillment, an effect of 0 or absence of materials.", "missingness": "No direct original subclaim score, status or axis values exist.", "uncertainty": "No direct original subclaim score, status or axis values exist.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Separate preservation of subclaim/parent judgments and absent scores/axes" }, { "item_id": "N03", "question_type": "Evidence condition", "question": "How are the same trial, report and recurrence/safety populations linked?", "needed": "Relationships among bibliography/registration, report/trial families, populations/outcomes and related materials", "role": "Required", "role_reason": "Required to address 'How are the same trial, report and recurrence/safety populations linked?' separately for the selected question of 7-day symptom-resolution noninferiority.", "application_exception": "The two subclaim rows, 131/123, 272, 136/136 and related-judgment links are not added as independent replications or new participants.", "criterion": "Link original values, definitions, denominators, times, margins/direction and unverified matters for 'How are the same trial, report and recurrence/safety populations linked?' to the corresponding original records. Subsequent/other paper versions, overlapping people/reports and current unique trial/participant totals remain undetermined.", "basis": "Internally designed question conditions referring to the corresponding stored-summary records and family application conditions C02, E07, H07", "condition_origin": "Case-specific question conditions; review of the existing content incomplete", "proposed_research": "A list distinguishing the same, separate or unidentified reports and outcome populations when additional materials are provided", "current_reports": [ "R01" ], "existence": "Relevant accounts in the stored summary; existence/acquisition of direct original materials remains unverified", "acquired_read": "Summary read; external materials not read", "observation": "The one evidence report, Drekonja2021, PMID34313686 and NCT01994538, shares symptom resolution/recurrence, the all-randomized consistency analysis and adverse events. The other 2 of 3 citations concern related judgments on different questions in women.", "condition_status": "Partly verified", "status_reason": "Some information in the stored summary was linked for preparation. Subsequent/other paper versions, overlapping people/reports and current unique trial/participant totals remain undetermined. Review of existing content remains incomplete; this is not verification of clinical condition fulfillment, an effect of 0 or absence of materials.", "missingness": "Subsequent/other paper versions, overlapping people/reports and current unique trial/participant totals remain undetermined.", "uncertainty": "Subsequent/other paper versions, overlapping people/reports and current unique trial/participant totals remain undetermined.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Relationships among bibliography/registration, report/trial families, populations/outcomes and related materials" }, { "item_id": "N04", "question_type": "Evidence condition", "question": "How do reading the stored summary and not reading original papers/links differ?", "needed": "Status/reading level and original locations of the preserved summary and each external original material", "role": "Required", "role_reason": "Required to address 'How do reading the stored summary and not reading original papers/links differ?' separately for the selected question of 7-day symptom-resolution noninferiority.", "application_exception": "Summary reading is not promoted to verification of full texts, registration or related judgments; unattempted access is not changed to failure or zero existence.", "criterion": "Link original values, definitions, denominators, times, margins/direction and unverified matters for 'How do reading the stored summary and not reading original papers/links differ?' to the corresponding original records. Current public availability/acquisition, access/content and URL operation have not been verified.", "basis": "Internally designed question conditions referring to the corresponding stored-summary records and family application conditions C03", "condition_origin": "Case-specific question conditions; review of the existing content incomplete", "proposed_research": "Records separating actual access attempts, reading and dates when acquiring materials is allowed", "current_reports": [ "R01" ], "existence": "Relevant accounts in the stored summary; existence/acquisition of direct original materials remains unverified", "acquired_read": "Summary read; external materials not read", "observation": "The designated full stored summary was read for preparation and the original was preserved. Original PubMed and related-judgment URLs are linked only; abstracts, full texts, registration and related judgments have not been read.", "condition_status": "Partly verified", "status_reason": "Some information in the stored summary was linked for preparation. Current public availability/acquisition, access/content and URL operation have not been verified. Review of existing content remains incomplete; this is not verification of clinical condition fulfillment, an effect of 0 or absence of materials.", "missingness": "Current public availability/acquisition, access/content and URL operation have not been verified.", "uncertainty": "Current public availability/acquisition, access/content and URL operation have not been verified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Status/reading level and original locations of the preserved summary and each external original material" }, { "item_id": "N05", "question_type": "Evidence condition", "question": "What is the actual selection boundary for afebrile men with UTI?", "needed": "Original inclusion/exclusion, baseline/culture and diagnostic/afebrile definition tables", "role": "Required", "role_reason": "Required to address 'What is the actual selection boundary for afebrile men with UTI?' separately for the selected question of 7-day symptom-resolution noninferiority.", "application_exception": "Original details of age, diagnosis/symptoms, underlying conditions, culture positivity/susceptibility, inclusion/exclusion and infection site remain unverified. Empty values are not filled with new calculations, numerical examples or judgments; the original scope is retained.", "criterion": "Link original values, definitions, denominators, times, margins/direction and unverified matters for 'What is the actual selection boundary for afebrile men with UTI?' to the corresponding original records. Original details of age, diagnosis/symptoms, underlying conditions, culture positivity/susceptibility, inclusion/exclusion and infection site remain unverified.", "basis": "Internally designed question conditions referring to the corresponding stored-summary records and family application conditions C04, E08", "condition_origin": "Case-specific question conditions; review of the existing content incomplete", "proposed_research": "Materials from the same trial or appropriate separate materials that directly specify the selected population/drug conditions", "current_reports": [ "R01" ], "existence": "Relevant accounts in the stored summary; existence/acquisition of direct original materials remains unverified", "acquired_read": "Summary read; external materials not read", "observation": "The original population is afebrile men with UTI; preserves the existing research-condition description that it does not apply to febrile men. Prostatitis, other antibiotics and uncomplicated cystitis in women are separate scopes.", "condition_status": "Partly verified", "status_reason": "Some information in the stored summary was linked for preparation. Original details of age, diagnosis/symptoms, underlying conditions, culture positivity/susceptibility, inclusion/exclusion and infection site remain unverified. Review of existing content remains incomplete; this is not verification of clinical condition fulfillment, an effect of 0 or absence of materials.", "missingness": "Original details of age, diagnosis/symptoms, underlying conditions, culture positivity/susceptibility, inclusion/exclusion and infection site remain unverified.", "uncertainty": "Original details of age, diagnosis/symptoms, underlying conditions, culture positivity/susceptibility, inclusion/exclusion and infection site remain unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original inclusion/exclusion, baseline/culture and diagnostic/afebrile definition tables" }, { "item_id": "N06", "question_type": "Evidence condition", "question": "What are the representativeness and participant distributions at the two US VA centers?", "needed": "Center/recruitment, baseline tables and actual population/setting materials", "role": "Required", "role_reason": "Required to address 'What are the representativeness and participant distributions at the two US VA centers?' separately for the selected question of 7-day symptom-resolution noninferiority.", "application_exception": "The selected VA sample is not presented as having the same effect in all men/women with UTI or as independent replication at two institutions.", "criterion": "Link original values, definitions, denominators, times, margins/direction and unverified matters for 'What are the representativeness and participant distributions at the two US VA centers?' to the corresponding original records. Recruitment/composition by center, baseline balance and direct outcomes in populations outside the VA or other settings remain unverified.", "basis": "Internally designed question conditions referring to the corresponding stored-summary records and family application conditions C04, E07", "condition_origin": "Case-specific question conditions; review of the existing content incomplete", "proposed_research": "Additional materials distinguishing conditions at each center of the same trial or populations for extension", "current_reports": [ "R01" ], "existence": "Relevant accounts in the stored summary; existence/acquisition of direct original materials remains unverified", "acquired_read": "Summary read; external materials not read", "observation": "The original record describes a 272-participant trial at two US VA centers. The two centers are not two independent trials.", "condition_status": "Partly verified", "status_reason": "Some information in the stored summary was linked for preparation. Recruitment/composition by center, baseline balance and direct outcomes in populations outside the VA or other settings remain unverified. Review of existing content remains incomplete; this is not verification of clinical condition fulfillment, an effect of 0 or absence of materials.", "missingness": "Recruitment/composition by center, baseline balance and direct outcomes in populations outside the VA or other settings remain unverified.", "uncertainty": "Recruitment/composition by center, baseline balance and direct outcomes in populations outside the VA or other settings remain unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Center/recruitment, baseline tables and actual population/setting materials" }, { "item_id": "N07", "question_type": "Evidence condition", "question": "What finished-product/drug scope applies to the study antibiotics?", "needed": "Drug selection, group composition, nominal/actual exposure and drug-specific original materials", "role": "Required", "role_reason": "Required to address 'What finished-product/drug scope applies to the study antibiotics?' separately for the selected question of 7-day symptom-resolution noninferiority.", "application_exception": "The two drugs are not changed to simultaneous combination treatment or extended to other antibiotics or individual drug-selection/dose recommendations.", "criterion": "Link original values, definitions, denominators, times, margins/direction and unverified matters for 'What finished-product/drug scope applies to the study antibiotics?' to the corresponding original records. Numbers by drug, selection/allocation, dose/formulation/route, actual exposure and drug-specific outcomes/interactions remain unverified.", "basis": "Internally designed question conditions referring to the corresponding stored-summary records and family application conditions C05, E08", "condition_origin": "Case-specific question conditions; review of the existing content incomplete", "proposed_research": "Original reports separating the applicable drug/population conditions and effects", "current_reports": [ "R01" ], "existence": "Relevant accounts in the stored summary; existence/acquisition of direct original materials remains unverified", "acquired_read": "Summary read; external materials not read", "observation": "The original drugs are ciprofloxacin or trimethoprim-sulfamethoxazole. Retains the original scope of exposure to one of these two drugs in the trial.", "condition_status": "Partly verified", "status_reason": "Some information in the stored summary was linked for preparation. Numbers by drug, selection/allocation, dose/formulation/route, actual exposure and drug-specific outcomes/interactions remain unverified. Review of existing content remains incomplete; this is not verification of clinical condition fulfillment, an effect of 0 or absence of materials.", "missingness": "Numbers by drug, selection/allocation, dose/formulation/route, actual exposure and drug-specific outcomes/interactions remain unverified.", "uncertainty": "Numbers by drug, selection/allocation, dose/formulation/route, actual exposure and drug-specific outcomes/interactions remain unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Drug selection, group composition, nominal/actual exposure and drug-specific original materials" }, { "item_id": "N08", "question_type": "Evidence condition", "question": "Do 7 versus 14 days of exposure differ from actual dose/adherence?", "needed": "Original treatment durations, active-drug/placebo schedules and actual adherence/change materials", "role": "Required", "role_reason": "Required to address 'Do 7 versus 14 days of exposure differ from actual dose/adherence?' separately for the selected question of 7-day symptom-resolution noninferiority.", "application_exception": "The halving statement is not changed to a new dose conversion, instructions on individual duration or stopping medication, or actual cumulative drug amount.", "criterion": "Link original values, definitions, denominators, times, margins/direction and unverified matters for 'Do 7 versus 14 days of exposure differ from actual dose/adherence?' to the corresponding original records. Nominal/actual amounts by drug, discontinuation/changes, adverse effects/rescue, medication schedules and total exposure details remain unverified.", "basis": "Internally designed question conditions referring to the corresponding stored-summary records and family application conditions C05, E02", "condition_origin": "Case-specific question conditions; review of the existing content incomplete", "proposed_research": "Materials from the same trial separating exposure strategy and actual adherence", "current_reports": [ "R01" ], "existence": "Relevant accounts in the stored summary; existence/acquisition of direct original materials remains unverified", "acquired_read": "Summary read; external materials not read", "observation": "The original comparison is 7 versus 14 days of antibiotics; wording about halved exposure in the existing central summary is already present in the stored summary. Actual medication/placebo amounts and dose intensity are separate.", "condition_status": "Partly verified", "status_reason": "Some information in the stored summary was linked for preparation. Nominal/actual amounts by drug, discontinuation/changes, adverse effects/rescue, medication schedules and total exposure details remain unverified. Review of existing content remains incomplete; this is not verification of clinical condition fulfillment, an effect of 0 or absence of materials.", "missingness": "Nominal/actual amounts by drug, discontinuation/changes, adverse effects/rescue, medication schedules and total exposure details remain unverified.", "uncertainty": "Nominal/actual amounts by drug, discontinuation/changes, adverse effects/rescue, medication schedules and total exposure details remain unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original treatment durations, active-drug/placebo schedules and actual adherence/change materials" }, { "item_id": "N09", "question_type": "Evidence condition", "question": "What actually occurred during placebo control and blinding periods?", "needed": "Methods/appendices for original placebo/blinding, drug schedules and assessment procedures", "role": "Required", "role_reason": "Required to address 'What actually occurred during placebo control and blinding periods?' separately for the selected question of 7-day symptom-resolution noninferiority.", "application_exception": "Periods or replacement-drug/placebo allocation dates absent from the review summary are not created, and the double-blind label does not certify completion of current measurement/bias review.", "criterion": "Link original values, definitions, denominators, times, margins/direction and unverified matters for 'What actually occurred during placebo control and blinding periods?' to the corresponding original records. Active-drug/placebo periods, packaging/matching, blinding targets/maintenance, unblinding/success and assessor roles remain unverified.", "basis": "Internally designed question conditions referring to the corresponding stored-summary records and family application conditions E01, E03, E02", "condition_origin": "Case-specific question conditions; review of the existing content incomplete", "proposed_research": "Materials linking actual blinding and medication operation in the report/protocol", "current_reports": [ "R01" ], "existence": "Relevant accounts in the stored summary; existence/acquisition of direct original materials remains unverified", "acquired_read": "Summary read; external materials not read", "observation": "The existing evidence list describes a double-blind, placebo-controlled noninferiority RCT; the existing synthesis records double blinding in 272 participants. Details of placebo operation are absent from the stored summary.", "condition_status": "Partly verified", "status_reason": "Some information in the stored summary was linked for preparation. Active-drug/placebo periods, packaging/matching, blinding targets/maintenance, unblinding/success and assessor roles remain unverified. Review of existing content remains incomplete; this is not verification of clinical condition fulfillment, an effect of 0 or absence of materials.", "missingness": "Active-drug/placebo periods, packaging/matching, blinding targets/maintenance, unblinding/success and assessor roles remain unverified.", "uncertainty": "Active-drug/placebo periods, packaging/matching, blinding targets/maintenance, unblinding/success and assessor roles remain unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Methods/appendices for original placebo/blinding, drug schedules and assessment procedures" }, { "item_id": "N10", "question_type": "Evidence condition", "question": "What are the 272 allocated participants, primary-analysis population of 254 and group denominators?", "needed": "Original flow from allocation to primary/consistency analysis and assessment/safety", "role": "Required", "role_reason": "Required to address 'What are the 272 allocated participants, primary-analysis population of 254 and group denominators?' separately for the selected question of 7-day symptom-resolution noninferiority.", "application_exception": "272−254 is not calculated as a new dropout count, and safety denominators 136/136 are not transferred as verified primary-analysis denominators.", "criterion": "Link original values, definitions, denominators, times, margins/direction and unverified matters for 'What are the 272 allocated participants, primary-analysis population of 254 and group denominators?' to the corresponding original records. Original flow by randomized group, counts for each exclusion/nonadherence reason, drug composition and detailed endpoint-specific assessment/safety denominators remain unverified.", "basis": "Internally designed question conditions referring to the corresponding stored-summary records and family application conditions C07, E04", "condition_origin": "Case-specific question conditions; review of the existing content incomplete", "proposed_research": "Materials from the same trial linking inclusion/exclusion and outcomes in each population", "current_reports": [ "R01" ], "existence": "Relevant accounts in the stored summary; existence/acquisition of direct original materials remains unverified", "acquired_read": "Summary read; external materials not read", "observation": "The original participant counts are 272 randomized and 254 in the prespecified primary analysis. The primary as-treated groups are 131/123, while adverse events separately use 136/136.", "condition_status": "Partly verified", "status_reason": "Some information in the stored summary was linked for preparation. Original flow by randomized group, counts for each exclusion/nonadherence reason, drug composition and detailed endpoint-specific assessment/safety denominators remain unverified. Review of existing content remains incomplete; this is not verification of clinical condition fulfillment, an effect of 0 or absence of materials.", "missingness": "Original flow by randomized group, counts for each exclusion/nonadherence reason, drug composition and detailed endpoint-specific assessment/safety denominators remain unverified.", "uncertainty": "Original flow by randomized group, counts for each exclusion/nonadherence reason, drug composition and detailed endpoint-specific assessment/safety denominators remain unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original flow from allocation to primary/consistency analysis and assessment/safety" }, { "item_id": "N11", "question_type": "Evidence condition", "question": "What is the original medication-adherence criterion?", "needed": "Adherence definitions/measurement and original medication, exclusion and SAP materials", "role": "Required", "role_reason": "Required to address 'What is the original medication-adherence criterion?' separately for the selected question of 7-day symptom-resolution noninferiority.", "application_exception": "28/26 doses are not converted to individual instructions, daily frequency or active-drug dose, and the adherence criterion is not presented as a treatment recommendation.", "criterion": "Link original values, definitions, denominators, times, margins/direction and unverified matters for 'What is the original medication-adherence criterion?' to the corresponding original records. Total active-drug/placebo doses, drug-specific dosing intervals, recording/verification, criterion changes/exclusion reasons and selection effects remain unverified.", "basis": "Internally designed question conditions referring to the corresponding stored-summary records and family application conditions E04, E02", "condition_origin": "Case-specific question conditions; review of the existing content incomplete", "proposed_research": "Materials distinguishing original criteria, inclusion/exclusion and missing data/changes", "current_reports": [ "R01" ], "existence": "Relevant accounts in the stored summary; existence/acquisition of direct original materials remains unverified", "acquired_read": "Summary read; external materials not read", "observation": "The original primary-analysis criterion is at least 26 of 28 doses taken, with no more than 2 consecutive doses missed, in an as-treated population of 254 (131/123). This is recorded as the original participant-population definition.", "condition_status": "Partly verified", "status_reason": "Some information in the stored summary was linked for preparation. Total active-drug/placebo doses, drug-specific dosing intervals, recording/verification, criterion changes/exclusion reasons and selection effects remain unverified. Review of existing content remains incomplete; this is not verification of clinical condition fulfillment, an effect of 0 or absence of materials.", "missingness": "Total active-drug/placebo doses, drug-specific dosing intervals, recording/verification, criterion changes/exclusion reasons and selection effects remain unverified.", "uncertainty": "Total active-drug/placebo doses, drug-specific dosing intervals, recording/verification, criterion changes/exclusion reasons and selection effects remain unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Adherence definitions/measurement and original medication, exclusion and SAP materials" }, { "item_id": "N12", "question_type": "Evidence condition", "question": "What original record describes the prespecified primary as-treated and per-protocol-type population?", "needed": "SAP/protocol and original rules for analysis populations/per-protocol characteristics", "role": "Required", "role_reason": "Required to address 'What original record describes the prespecified primary as-treated and per-protocol-type population?' separately for the selected question of 7-day symptom-resolution noninferiority.", "application_exception": "The primary analysis is not renamed as an all-randomized ITT analysis, and per-protocol characteristics are not substituted for complete observation or successful current review.", "criterion": "Link original values, definitions, denominators, times, margins/direction and unverified matters for 'What original record describes the prespecified primary as-treated and per-protocol-type population?' to the corresponding original records. The full original analysis-population definition, prespecification/changes, selection/deviations and sensitivity analyses including nonadherence have not been read externally.", "basis": "Internally designed question conditions referring to the corresponding stored-summary records and family application conditions E04, E06", "condition_origin": "Case-specific question conditions; review of the existing content incomplete", "proposed_research": "Materials from the same trial disclosing planned and actual analysis-population inclusion/exclusion", "current_reports": [ "R01" ], "existence": "Relevant accounts in the stored summary; existence/acquisition of direct original materials remains unverified", "acquired_read": "Summary read; external materials not read", "observation": "The existing research description places the prespecified primary analysis in the adherent as-treated population and describes it as a per-protocol-type population. Retains that original name/level.", "condition_status": "Partly verified", "status_reason": "Some information in the stored summary was linked for preparation. The full original analysis-population definition, prespecification/changes, selection/deviations and sensitivity analyses including nonadherence have not been read externally. Review of existing content remains incomplete; this is not verification of clinical condition fulfillment, an effect of 0 or absence of materials.", "missingness": "The full original analysis-population definition, prespecification/changes, selection/deviations and sensitivity analyses including nonadherence have not been read externally.", "uncertainty": "The full original analysis-population definition, prespecification/changes, selection/deviations and sensitivity analyses including nonadherence have not been read externally.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "SAP/protocol and original rules for analysis populations/per-protocol characteristics" }, { "item_id": "N13", "question_type": "Evidence condition", "question": "Does complete follow-up of everyone differ from primary-analysis exclusion/missing data?", "needed": "Follow-up, assessment, medication and analysis flow, with exclusion/missing-data tables", "role": "Required", "role_reason": "Required to address 'Does complete follow-up of everyone differ from primary-analysis exclusion/missing data?' separately for the selected question of 7-day symptom-resolution noninferiority.", "application_exception": "Participants outside the 254 are not calculated as dropouts, and completion records are not expanded to complete collection of all primary, secondary or safety data.", "criterion": "Link original values, definitions, denominators, times, margins/direction and unverified matters for 'Does complete follow-up of everyone differ from primary-analysis exclusion/missing data?' to the corresponding original records. Completion definitions/methods, omissions by assessment, reasons/counts by group outside the primary analysis and missing data at later time points remain unverified.", "basis": "Internally designed question conditions referring to the corresponding stored-summary records and family application conditions C07, E04", "condition_origin": "Case-specific question conditions; review of the existing content incomplete", "proposed_research": "Materials linking original completion records with each analysis/measurement scope", "current_reports": [ "R01" ], "existence": "Relevant accounts in the stored summary; existence/acquisition of direct original materials remains unverified", "acquired_read": "Summary read; external materials not read", "observation": "The original states that all 272 completed follow-up, while the primary analysis includes 254. Follow-up completion, adherence criteria and analysis inclusion are different flows.", "condition_status": "Partly verified", "status_reason": "Some information in the stored summary was linked for preparation. Completion definitions/methods, omissions by assessment, reasons/counts by group outside the primary analysis and missing data at later time points remain unverified. Review of existing content remains incomplete; this is not verification of clinical condition fulfillment, an effect of 0 or absence of materials.", "missingness": "Completion definitions/methods, omissions by assessment, reasons/counts by group outside the primary analysis and missing data at later time points remain unverified.", "uncertainty": "Completion definitions/methods, omissions by assessment, reasons/counts by group outside the primary analysis and missing data at later time points remain unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Follow-up, assessment, medication and analysis flow, with exclusion/missing-data tables" }, { "item_id": "N14", "question_type": "Evidence condition", "question": "What people, denominators and proportions describe primary-analysis symptom resolution?", "needed": "Original primary symptom-resolution tables, counts/definitions and population/time materials", "role": "Required", "role_reason": "Required to address 'What people, denominators and proportions describe primary-analysis symptom resolution?' separately for the selected question of 7-day symptom-resolution noninferiority.", "application_exception": "Rounded proportions are not used to calculate new values/CIs, unresolved cases or participant totals, or transferred to recurrence denominators/events.", "criterion": "Link original values, definitions, denominators, times, margins/direction and unverified matters for 'What people, denominators and proportions describe primary-analysis symptom resolution?' to the corresponding original records. Original symptom definitions, criteria/assessment schedules, individual omissions and distributions by drug remain unverified.", "basis": "Internally designed question conditions referring to the corresponding stored-summary records and family application conditions C06, C07", "condition_origin": "Case-specific question conditions; review of the existing content incomplete", "proposed_research": "Reports/appendices linking resolution events, original denominators and measurement rules", "current_reports": [ "R01" ], "existence": "Relevant accounts in the stored summary; existence/acquisition of direct original materials remains unverified", "acquired_read": "Summary read; external materials not read", "observation": "Preserves the original events/denominators/proportions together: 122/131 (93.1%) versus 111/123 (90.2%) in the primary analysis. These are group-specific resolution results in 7-day versus 14-day order.", "condition_status": "Partly verified", "status_reason": "Some information in the stored summary was linked for preparation. Original symptom definitions, criteria/assessment schedules, individual omissions and distributions by drug remain unverified. Review of existing content remains incomplete; this is not verification of clinical condition fulfillment, an effect of 0 or absence of materials.", "missingness": "Original symptom definitions, criteria/assessment schedules, individual omissions and distributions by drug remain unverified.", "uncertainty": "Original symptom definitions, criteria/assessment schedules, individual omissions and distributions by drug remain unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original primary symptom-resolution tables, counts/definitions and population/time materials" }, { "item_id": "N15", "question_type": "Evidence condition", "question": "What defines difference +2.9%p and the favorable direction?", "needed": "Direction/unit of the original difference, estimation model and original tables", "role": "Required", "role_reason": "Required to address 'What defines difference +2.9%p and the favorable direction?' separately for the selected question of 7-day symptom-resolution noninferiority.", "application_exception": "No new risk ratio/difference or improvement duration is calculated, and +2.9 is not changed to statistical superiority or individual benefit.", "criterion": "Link original values, definitions, denominators, times, margins/direction and unverified matters for 'What defines difference +2.9%p and the favorable direction?' to the corresponding original records. Direct original details of difference estimation/adjustment, stratification, interval methods, within-group change and absolute durations remain unverified.", "basis": "Internally designed question conditions referring to the corresponding stored-summary records and family application conditions C06, E04, E05", "condition_origin": "Case-specific question conditions; review of the existing content incomplete", "proposed_research": "Statistical materials specifying difference, adjustment and interval definitions", "current_reports": [ "R01" ], "existence": "Relevant accounts in the stored summary; existence/acquisition of direct original materials remains unverified", "acquired_read": "Summary read; external materials not read", "observation": "The original symptom-resolution proportion difference is +2.9%p for 7 days−14 days. Higher resolution is favorable; a negative value represents lower resolution with 7 days in the noninferiority comparison.", "condition_status": "Partly verified", "status_reason": "Some information in the stored summary was linked for preparation. Direct original details of difference estimation/adjustment, stratification, interval methods, within-group change and absolute durations remain unverified. Review of existing content remains incomplete; this is not verification of clinical condition fulfillment, an effect of 0 or absence of materials.", "missingness": "Direct original details of difference estimation/adjustment, stratification, interval methods, within-group change and absolute durations remain unverified.", "uncertainty": "Direct original details of difference estimation/adjustment, stratification, interval methods, within-group change and absolute durations remain unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Direction/unit of the original difference, estimation model and original tables" }, { "item_id": "N16", "question_type": "Evidence condition", "question": "What are the lower bound and infinite upper end of the one-sided 97.5% CI?", "needed": "One-sided interval/SAP, statistical methods and original result tables", "role": "Required", "role_reason": "Required to address 'What are the lower bound and infinite upper end of the one-sided 97.5% CI?' separately for the selected question of 7-day symptom-resolution noninferiority.", "application_exception": "The infinite upper end is not filled with the JSON number Infinity or a confirmed upper bound, and one-sided 97.5% is not changed to two-sided 95%.", "criterion": "Link original values, definitions, denominators, times, margins/direction and unverified matters for 'What are the lower bound and infinite upper end of the one-sided 97.5% CI?' to the corresponding original records. Original interval calculation, adjustment, model/stratification, alternative intervals and two-sided intervals remain unverified.", "basis": "Internally designed question conditions referring to the corresponding stored-summary records and family application conditions C07, E05", "condition_origin": "Case-specific question conditions; review of the existing content incomplete", "proposed_research": "Materials disclosing intervals/models according to the original methods", "current_reports": [ "R01" ], "existence": "Relevant accounts in the stored summary; existence/acquisition of direct original materials remains unverified", "acquired_read": "Summary read; external materials not read", "observation": "The original primary result has a one-sided 97.5% CI lower bound of −5.2%p; the existing evidence list records −5.2%p~infinity. Interval form, confidence level and units are preserved as original strings.", "condition_status": "Partly verified", "status_reason": "Some information in the stored summary was linked for preparation. Original interval calculation, adjustment, model/stratification, alternative intervals and two-sided intervals remain unverified. Review of existing content remains incomplete; this is not verification of clinical condition fulfillment, an effect of 0 or absence of materials.", "missingness": "Original interval calculation, adjustment, model/stratification, alternative intervals and two-sided intervals remain unverified.", "uncertainty": "Original interval calculation, adjustment, model/stratification, alternative intervals and two-sided intervals remain unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "One-sided interval/SAP, statistical methods and original result tables" }, { "item_id": "N17", "question_type": "Evidence condition", "question": "What is the comparison scope for the prespecified margin −10%p and lower bound?", "needed": "Noninferiority-margin justification, SAP/registration and original estimation/testing plans", "role": "Required", "role_reason": "Required to address 'What is the comparison scope for the prespecified margin −10%p and lower bound?' separately for the selected question of 7-day symptom-resolution noninferiority.", "application_exception": "The margin is not inherited as a universal MCID or exact-equivalence limit, and no new value between the lower bound and margin is calculated.", "criterion": "Link original values, definitions, denominators, times, margins/direction and unverified matters for 'What is the comparison scope for the prespecified margin −10%p and lower bound?' to the corresponding original records. Margin rationale, historical control effect/preservation, patient values, original alpha/power and comparison of versions remain unverified.", "basis": "Internally designed question conditions referring to the corresponding stored-summary records and family application conditions E05, E06", "condition_origin": "Case-specific question conditions; review of the existing content incomplete", "proposed_research": "Materials disclosing the relationship between original margin justification/plans and results", "current_reports": [ "R01" ], "existence": "Relevant accounts in the stored summary; existence/acquisition of direct original materials remains unverified", "acquired_read": "Summary read; external materials not read", "observation": "The original describes the relationship between prespecified noninferiority margin −10%p and primary-analysis lower bound −5.2%p as meeting the margin. The existing English manuscript states that the lower bound is above the prespecified −10 margin.", "condition_status": "Partly verified", "status_reason": "Some information in the stored summary was linked for preparation. Margin rationale, historical control effect/preservation, patient values, original alpha/power and comparison of versions remain unverified. Review of existing content remains incomplete; this is not verification of clinical condition fulfillment, an effect of 0 or absence of materials.", "missingness": "Margin rationale, historical control effect/preservation, patient values, original alpha/power and comparison of versions remain unverified.", "uncertainty": "Margin rationale, historical control effect/preservation, patient values, original alpha/power and comparison of versions remain unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Noninferiority-margin justification, SAP/registration and original estimation/testing plans" }, { "item_id": "N18", "question_type": "Evidence condition", "question": "How are noninferiority, equivalence and superiority distinguished?", "needed": "Testing objective/limits, intervals and original judgment scope", "role": "Required", "role_reason": "Required to address 'How are noninferiority, equivalence and superiority distinguished?' separately for the selected question of 7-day symptom-resolution noninferiority.", "application_exception": "The existing advertising interpretation's wording 'same'/equal is not newly confirmed as exact equivalence, superiority or absence of harm.", "criterion": "Link original values, definitions, denominators, times, margins/direction and unverified matters for 'How are noninferiority, equivalence and superiority distinguished?' to the corresponding original records. Superiority/equivalence plans, two-sided equivalence intervals, individual importance and superiority for safety/resistance have not been verified.", "basis": "Internally designed question conditions referring to the corresponding stored-summary records and family application conditions C08, E05, E09", "condition_origin": "Case-specific question conditions; review of the existing content incomplete", "proposed_research": "Additional materials separately distinguishing original testing objectives, patient outcomes and safety", "current_reports": [ "R01" ], "existence": "Relevant accounts in the stored summary; existence/acquisition of direct original materials remains unverified", "acquired_read": "Summary read; external materials not read", "observation": "The original selection is noninferiority to 14 days for symptom resolution. The positive primary difference and reduced exposure remain original accounts, without confirming exactly equal or superior resolution.", "condition_status": "Partly verified", "status_reason": "Some information in the stored summary was linked for preparation. Superiority/equivalence plans, two-sided equivalence intervals, individual importance and superiority for safety/resistance have not been verified. Review of existing content remains incomplete; this is not verification of clinical condition fulfillment, an effect of 0 or absence of materials.", "missingness": "Superiority/equivalence plans, two-sided equivalence intervals, individual importance and superiority for safety/resistance have not been verified.", "uncertainty": "Superiority/equivalence plans, two-sided equivalence intervals, individual importance and superiority for safety/resistance have not been verified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Testing objective/limits, intervals and original judgment scope" }, { "item_id": "N19", "question_type": "Evidence condition", "question": "What are the original values in the all-randomized consistency analysis of 272?", "needed": "Original all-randomized analysis tables, definitions/missing data/SAP and intervals", "role": "Required", "role_reason": "Required to address 'What are the original values in the all-randomized consistency analysis of 272?' separately for the selected question of 7-day symptom-resolution noninferiority.", "application_exception": "Original event counts are not reconstructed, and all-randomized results/lower bounds are not copied as primary-analysis results for 254.", "criterion": "Link original values, definitions, denominators, times, margins/direction and unverified matters for 'What are the original values in the all-randomized consistency analysis of 272?' to the corresponding original records. Original events/denominators by group, the consistency-analysis definition, missing-data/adherence handling and original models remain unverified.", "basis": "Internally designed question conditions referring to the corresponding stored-summary records and family application conditions E04, E05, C07", "condition_origin": "Case-specific question conditions; review of the existing content incomplete", "proposed_research": "Materials separately disclosing original denominators and results of the primary/all-randomized consistency populations", "current_reports": [ "R01" ], "existence": "Relevant accounts in the stored summary; existence/acquisition of direct original materials remains unverified", "acquired_read": "Summary read; external materials not read", "observation": "The existing Korean manuscript describes the all-randomized consistency analysis of 272 as 91.9% versus 90.4%, difference +1.5%p and one-sided 97.5% CI lower bound −5.8%p. The existing English manuscript retains lower bound −5.8.", "condition_status": "Partly verified", "status_reason": "Some information in the stored summary was linked for preparation. Original events/denominators by group, the consistency-analysis definition, missing-data/adherence handling and original models remain unverified. Review of existing content remains incomplete; this is not verification of clinical condition fulfillment, an effect of 0 or absence of materials.", "missingness": "Original events/denominators by group, the consistency-analysis definition, missing-data/adherence handling and original models remain unverified.", "uncertainty": "Original events/denominators by group, the consistency-analysis definition, missing-data/adherence handling and original models remain unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original all-randomized analysis tables, definitions/missing data/SAP and intervals" }, { "item_id": "N20", "question_type": "Evidence condition", "question": "What differs between the primary and all-randomized populations, and what establishes robustness?", "needed": "Analysis-population inclusion/exclusion, sensitivity analyses and original plans/result tables", "role": "Required", "role_reason": "Required to address 'What differs between the primary and all-randomized populations, and what establishes robustness?' separately for the selected question of 7-day symptom-resolution noninferiority.", "application_exception": "Consistency wording alone does not certify robustness across every analysis/population, and the two populations are not added as independent confirmations.", "criterion": "Link original values, definitions, denominators, times, margins/direction and unverified matters for 'What differs between the primary and all-randomized populations, and what establishes robustness?' to the corresponding original records. Nonadherence/drug changes by group, relationships between people in the two populations, sensitivity analyses and magnitudes/assumptions of selection bias remain unverified.", "basis": "Internally designed question conditions referring to the corresponding stored-summary records and family application conditions E04, E05, C02", "condition_origin": "Case-specific question conditions; review of the existing content incomplete", "proposed_research": "Materials specifying the scope and outcomes of differing populations/handling using the original methods", "current_reports": [ "R01" ], "existence": "Relevant accounts in the stored summary; existence/acquisition of direct original materials remains unverified", "acquired_read": "Summary read; external materials not read", "observation": "Primary 122/131 versus 111/123 and all-randomized consistency proportions 91.9/90.4% are different analysis populations of the same trial. Each difference/lower bound is preserved separately.", "condition_status": "Partly verified", "status_reason": "Some information in the stored summary was linked for preparation. Nonadherence/drug changes by group, relationships between people in the two populations, sensitivity analyses and magnitudes/assumptions of selection bias remain unverified. Review of existing content remains incomplete; this is not verification of clinical condition fulfillment, an effect of 0 or absence of materials.", "missingness": "Nonadherence/drug changes by group, relationships between people in the two populations, sensitivity analyses and magnitudes/assumptions of selection bias remain unverified.", "uncertainty": "Nonadherence/drug changes by group, relationships between people in the two populations, sensitivity analyses and magnitudes/assumptions of selection bias remain unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Analysis-population inclusion/exclusion, sensitivity analyses and original plans/result tables" }, { "item_id": "N21", "question_type": "Evidence condition", "question": "How were patient-reported symptom resolution and scales defined?", "needed": "Original symptom lists/resolution judgments, patient reports and collection/measurement methods", "role": "Required", "role_reason": "Required to address 'How were patient-reported symptom resolution and scales defined?' separately for the selected question of 7-day symptom-resolution noninferiority.", "application_exception": "Symptom resolution is not changed to microbiological clearance, complication prevention or all long-term cure without original materials.", "criterion": "Link original values, definitions, denominators, times, margins/direction and unverified matters for 'How were patient-reported symptom resolution and scales defined?' to the corresponding original records. Symptom lists, definitions/scales, assessors/records, resolution judgments and agreement with culture results remain unverified.", "basis": "Internally designed question conditions referring to the corresponding stored-summary records and family application conditions C06, E03, E09", "condition_origin": "Case-specific question conditions; review of the existing content incomplete", "proposed_research": "Materials from the same trial disclosing actual definitions and measurement limits of patient-reported outcomes", "current_reports": [ "R01" ], "existence": "Relevant accounts in the stored summary; existence/acquisition of direct original materials remains unverified", "acquired_read": "Summary read; external materials not read", "observation": "The existing judgment rationale records patient-reported symptom resolution as a patient-centered endpoint. It is not automatically the same as clinical/microbiological cure or culture clearance.", "condition_status": "Partly verified", "status_reason": "Some information in the stored summary was linked for preparation. Symptom lists, definitions/scales, assessors/records, resolution judgments and agreement with culture results remain unverified. Review of existing content remains incomplete; this is not verification of clinical condition fulfillment, an effect of 0 or absence of materials.", "missingness": "Symptom lists, definitions/scales, assessors/records, resolution judgments and agreement with culture results remain unverified.", "uncertainty": "Symptom lists, definitions/scales, assessors/records, resolution judgments and agreement with culture results remain unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original symptom lists/resolution judgments, patient reports and collection/measurement methods" }, { "item_id": "N22", "question_type": "Evidence condition", "question": "Are 7 days of treatment and assessment within 14 days after therapy the same window?", "needed": "Original schedules, exposure/end/assessment times by group and counting rules", "role": "Required", "role_reason": "Required to address 'Are 7 days of treatment and assessment within 14 days after therapy the same window?' separately for the selected question of 7-day symptom-resolution noninferiority.", "application_exception": "7 days in the existing question is not changed to assessment of resolution on day 7, and no total calendar duration absent from original materials is calculated.", "criterion": "Link original values, definitions, denominators, times, margins/direction and unverified matters for 'Are 7 days of treatment and assessment within 14 days after therapy the same window?' to the corresponding original records. Original assessment days, time origins/synchronization by group, allowed windows, repeated measurements and closure/omissions remain unverified.", "basis": "Internally designed question conditions referring to the corresponding stored-summary records and family application conditions C06, E03", "condition_origin": "Case-specific question conditions; review of the existing content incomplete", "proposed_research": "Reports/protocols linking actual assessment windows with each group's treatment schedule", "current_reports": [ "R01" ], "existence": "Relevant accounts in the stored summary; existence/acquisition of direct original materials remains unverified", "acquired_read": "Summary read; external materials not read", "observation": "The original endpoint is 'Resolution of UTI symptoms within 14 days after therapy'. The 7-day/14-day exposure strategies and the assessment window after therapy ends are recorded separately.", "condition_status": "Partly verified", "status_reason": "Some information in the stored summary was linked for preparation. Original assessment days, time origins/synchronization by group, allowed windows, repeated measurements and closure/omissions remain unverified. Review of existing content remains incomplete; this is not verification of clinical condition fulfillment, an effect of 0 or absence of materials.", "missingness": "Original assessment days, time origins/synchronization by group, allowed windows, repeated measurements and closure/omissions remain unverified.", "uncertainty": "Original assessment days, time origins/synchronization by group, allowed windows, repeated measurements and closure/omissions remain unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original schedules, exposure/end/assessment times by group and counting rules" }, { "item_id": "N23", "question_type": "Evidence condition", "question": "How do blinding and medication schedules affect patient-reported measurement?", "needed": "Blinding/unblinding, patient-report collection and assessment times/tools", "role": "Required", "role_reason": "Required to address 'How do blinding and medication schedules affect patient-reported measurement?' separately for the selected question of 7-day symptom-resolution noninferiority.", "application_exception": "Double-blind wording is not automatically promoted to absence of measurement limitations or fulfillment of all conditions.", "criterion": "Link original values, definitions, denominators, times, margins/direction and unverified matters for 'How do blinding and medication schedules affect patient-reported measurement?' to the corresponding original records. Assessor/participant information, blinding success/unblinding, measurement tools/differences, omissions and group-specific assessment methods remain unverified.", "basis": "Internally designed question conditions referring to the corresponding stored-summary records and family application conditions E03, E01", "condition_origin": "Case-specific question conditions; review of the existing content incomplete", "proposed_research": "Original materials linking actual symptom measurement and blinding to each endpoint", "current_reports": [ "R01" ], "existence": "Relevant accounts in the stored summary; existence/acquisition of direct original materials remains unverified", "acquired_read": "Summary read; external materials not read", "observation": "The original design is double-blind/placebo-controlled, and the endpoint is patient-reported symptoms. Actual assessment blinding/schedules and medication conditions are described separately for the outcome.", "condition_status": "Partly verified", "status_reason": "Some information in the stored summary was linked for preparation. Assessor/participant information, blinding success/unblinding, measurement tools/differences, omissions and group-specific assessment methods remain unverified. Review of existing content remains incomplete; this is not verification of clinical condition fulfillment, an effect of 0 or absence of materials.", "missingness": "Assessor/participant information, blinding success/unblinding, measurement tools/differences, omissions and group-specific assessment methods remain unverified.", "uncertainty": "Assessor/participant information, blinding success/unblinding, measurement tools/differences, omissions and group-specific assessment methods remain unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Blinding/unblinding, patient-report collection and assessment times/tools" }, { "item_id": "N24", "question_type": "Evidence condition", "question": "What models, between-/within-group comparisons, adjustments and missing-data handling define the difference?", "needed": "Statistical methods/SAP, original models, analysis/missing data and result tables", "role": "Required", "role_reason": "Required to address 'What models, between-/within-group comparisons, adjustments and missing-data handling define the difference?' separately for the selected question of 7-day symptom-resolution noninferiority.", "application_exception": "Models/adjustments or ITT/PP levels are not filled by inference, and superiority between drugs is not created.", "criterion": "Link original values, definitions, denominators, times, margins/direction and unverified matters for 'What models, between-/within-group comparisons, adjustments and missing-data handling define the difference?' to the corresponding original records. Difference/interval models, adjustment/stratification, contributions by drug, missing data/deviations and original SAP details remain unverified.", "basis": "Internally designed question conditions referring to the corresponding stored-summary records and family application conditions E04, E05", "condition_origin": "Case-specific question conditions; review of the existing content incomplete", "proposed_research": "Materials specifying between-group differences, models and populations using the original methods", "current_reports": [ "R01" ], "existence": "Relevant accounts in the stored summary; existence/acquisition of direct original materials remains unverified", "acquired_read": "Summary read; external materials not read", "observation": "The originally reported values are between-group symptom-resolution proportion differences, one-sided intervals and each group's proportions. They are not within-group changes from baseline or self-controlled comparisons in the same people.", "condition_status": "Partly verified", "status_reason": "Some information in the stored summary was linked for preparation. Difference/interval models, adjustment/stratification, contributions by drug, missing data/deviations and original SAP details remain unverified. Review of existing content remains incomplete; this is not verification of clinical condition fulfillment, an effect of 0 or absence of materials.", "missingness": "Difference/interval models, adjustment/stratification, contributions by drug, missing data/deviations and original SAP details remain unverified.", "uncertainty": "Difference/interval models, adjustment/stratification, contributions by drug, missing data/deviations and original SAP details remain unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Statistical methods/SAP, original models, analysis/missing data and result tables" }, { "item_id": "N25", "question_type": "Evidence condition", "question": "What records describe the primary endpoint/analysis, margin and registration?", "needed": "Registration/plan/analysis versions, margins/endpoints/populations and change materials", "role": "Required", "role_reason": "Required to address 'What records describe the primary endpoint/analysis, margin and registration?' separately for the selected question of 7-day symptom-resolution noninferiority.", "application_exception": "The registration ID or original 'prespecified' wording does not certify completed current registration/plan review or absence of all selective reporting.", "criterion": "Link original values, definitions, denominators, times, margins/direction and unverified matters for 'What records describe the primary endpoint/analysis, margin and registration?' to the corresponding original records. Original comparison of registration/protocol/SAP versions, change dates and prespecified endpoints/analyses/time points has not been read.", "basis": "Internally designed question conditions referring to the corresponding stored-summary records and family application conditions E06, C09", "condition_origin": "Case-specific question conditions; review of the existing content incomplete", "proposed_research": "Records separating verified comparison scope from unexamined matters and changes when actual plans are provided", "current_reports": [ "R01" ], "existence": "Relevant accounts in the stored summary; existence/acquisition of direct original materials remains unverified", "acquired_read": "Summary read; external materials not read", "observation": "The original describes a prespecified primary analysis and −10%p margin, and records NCT01994538 in the existing evidence list. No original registration URL exists; current access/comparison is not performed.", "condition_status": "Partly verified", "status_reason": "Some information in the stored summary was linked for preparation. Original comparison of registration/protocol/SAP versions, change dates and prespecified endpoints/analyses/time points has not been read. Review of existing content remains incomplete; this is not verification of clinical condition fulfillment, an effect of 0 or absence of materials.", "missingness": "Original comparison of registration/protocol/SAP versions, change dates and prespecified endpoints/analyses/time points has not been read.", "uncertainty": "Original comparison of registration/protocol/SAP versions, change dates and prespecified endpoints/analyses/time points has not been read.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Registration/plan/analysis versions, margins/endpoints/populations and change materials" }, { "item_id": "N26", "question_type": "Evidence condition", "question": "What supports the importance and preserved effect of the −10%p margin?", "needed": "Noninferiority-margin rationale, original design/historical materials and testing assumptions", "role": "Required", "role_reason": "Required to address 'What supports the importance and preserved effect of the −10%p margin?' separately for the selected question of 7-day symptom-resolution noninferiority.", "application_exception": "−10%p is not used as a common importance threshold for every symptom, infection or safety result, and no new margin/grade is selected.", "criterion": "Link original values, definitions, denominators, times, margins/direction and unverified matters for 'What supports the importance and preserved effect of the −10%p margin?' to the corresponding original records. Margin selection, historical effects/constancy, acceptable differences and power/SAP criteria remain unverified.", "basis": "Internally designed question conditions referring to the corresponding stored-summary records and family application conditions E05, E06", "condition_origin": "Case-specific question conditions; review of the existing content incomplete", "proposed_research": "A manuscript specifying the margin and current interval/population when actual justification materials are provided", "current_reports": [ "R01" ], "existence": "Relevant accounts in the stored summary; existence/acquisition of direct original materials remains unverified", "acquired_read": "Summary read; external materials not read", "observation": "The original presents fulfillment of the prespecified −10%p margin. Patient/historical-control-effect and absolute-importance justification for that margin is absent from the summary.", "condition_status": "Unverified", "status_reason": "Required direct details could not be verified within the preserved-summary/unread-external-material scope. Margin selection, historical effects/constancy, acceptable differences and power/SAP criteria remain unverified. Review of existing content remains incomplete; this is not verification of clinical condition fulfillment, an effect of 0 or absence of materials.", "missingness": "Margin selection, historical effects/constancy, acceptable differences and power/SAP criteria remain unverified.", "uncertainty": "Margin selection, historical effects/constancy, acceptable differences and power/SAP criteria remain unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Noninferiority-margin rationale, original design/historical materials and testing assumptions" }, { "item_id": "N27", "question_type": "Evidence condition", "question": "What are the effects of per-protocol-type selection, adherence/rescue treatment and the effect of interest?", "needed": "Concomitant/rescue treatment, medication/changes and analysis-inclusion/SAP materials", "role": "Required", "role_reason": "Required to address 'What are the effects of per-protocol-type selection, adherence/rescue treatment and the effect of interest?' separately for the selected question of 7-day symptom-resolution noninferiority.", "application_exception": "SAP details for nonadherence/concomitant treatment, drug switching, rescue/retreatment, subsequent exposure and allocation/adherence effects remain unverified. Empty values are not filled with new calculations, numerical examples or judgments; the original scope is retained.", "criterion": "Link original values, definitions, denominators, times, margins/direction and unverified matters for 'What are the effects of per-protocol-type selection, adherence/rescue treatment and the effect of interest?' to the corresponding original records. SAP details for nonadherence/concomitant treatment, drug switching, rescue/retreatment, subsequent exposure and allocation/adherence effects remain unverified.", "basis": "Internally designed question conditions referring to the corresponding stored-summary records and family application conditions E02, E04", "condition_origin": "Case-specific question conditions; review of the existing content incomplete", "proposed_research": "Materials linking strategy, actual implementation and conditional selection to original populations/outcomes", "current_reports": [ "R01" ], "existence": "Relevant accounts in the stored summary; existence/acquisition of direct original materials remains unverified", "acquired_read": "Summary read; external materials not read", "observation": "The primary analysis is adherent as-treated, while the all-randomized analysis examines consistency. The 7-day strategy and effects of actual adherence, changes or rescue treatment are distinguished.", "condition_status": "Partly verified", "status_reason": "Some information in the stored summary was linked for preparation. SAP details for nonadherence/concomitant treatment, drug switching, rescue/retreatment, subsequent exposure and allocation/adherence effects remain unverified. Review of existing content remains incomplete; this is not verification of clinical condition fulfillment, an effect of 0 or absence of materials.", "missingness": "SAP details for nonadherence/concomitant treatment, drug switching, rescue/retreatment, subsequent exposure and allocation/adherence effects remain unverified.", "uncertainty": "SAP details for nonadherence/concomitant treatment, drug switching, rescue/retreatment, subsequent exposure and allocation/adherence effects remain unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Concomitant/rescue treatment, medication/changes and analysis-inclusion/SAP materials" }, { "item_id": "N28", "question_type": "Evidence condition", "question": "What time origin and definition apply to the sibling 28-day recurrence outcome?", "needed": "Recurrence definitions/times, conditional populations and counting/assessment materials", "role": "Required", "role_reason": "Required to address 'What time origin and definition apply to the sibling 28-day recurrence outcome?' separately for the selected question of 7-day symptom-resolution noninferiority.", "application_exception": "28 days is not asserted to be after treatment ends or begins without original materials, and recurrence is not transferred to the original primary-resolution result.", "criterion": "Link original values, definitions, denominators, times, margins/direction and unverified matters for 'What time origin and definition apply to the sibling 28-day recurrence outcome?' to the corresponding original records. The 28-day time origin, recurrence/reinfection, selection after resolution, records/culture/retreatment and original assessment window remain unverified.", "basis": "Internally designed question conditions referring to the corresponding stored-summary records and family application conditions C06, E03, E09", "condition_origin": "Case-specific question conditions; review of the existing content incomplete", "proposed_research": "Materials disclosing symptom resolution and recurrence in the same trial according to their respective original definitions/time points", "current_reports": [ "R01" ], "existence": "Relevant accounts in the stored summary; existence/acquisition of direct original materials remains unverified", "acquired_read": "Summary read; external materials not read", "observation": "The recurrence sheet is 'Symptom recurrence by 28 days', D, with the note 9.9% versus 12.9% and a wide CI. It is an outcome from the same trial with a different time/definition from the original primary symptom-resolution outcome.", "condition_status": "Partly verified", "status_reason": "Some information in the stored summary was linked for preparation. The 28-day time origin, recurrence/reinfection, selection after resolution, records/culture/retreatment and original assessment window remain unverified. Review of existing content remains incomplete; this is not verification of clinical condition fulfillment, an effect of 0 or absence of materials.", "missingness": "The 28-day time origin, recurrence/reinfection, selection after resolution, records/culture/retreatment and original assessment window remain unverified.", "uncertainty": "The 28-day time origin, recurrence/reinfection, selection after resolution, records/culture/retreatment and original assessment window remain unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Recurrence definitions/times, conditional populations and counting/assessment materials" }, { "item_id": "N29", "question_type": "Evidence condition", "question": "What are the recorded recurrence numerators, denominators, proportions and difference?", "needed": "Original recurrence tables, numerators/denominators/counting, conditions/assessment and versions", "role": "Required", "role_reason": "Required to address 'What are the recorded recurrence numerators, denominators, proportions and difference?' separately for the selected question of 7-day symptom-resolution noninferiority.", "application_exception": "Original fractions/proportions are not recalculated, rounded differently or corrected without checking original tables, and no new recurrence differences or summed participants are created.", "criterion": "Link original values, definitions, denominators, times, margins/direction and unverified matters for 'What are the recorded recurrence numerators, denominators, proportions and difference?' to the corresponding original records. Original recurrence counting rules, assessability, conditional populations, recurrence/missing data and numerical/version details remain unverified.", "basis": "Internally designed question conditions referring to the corresponding stored-summary records and family application conditions C07, C08, E04", "condition_origin": "Case-specific question conditions; review of the existing content incomplete", "proposed_research": "Linkage separating the full before/after original text and events when original result tables/corrections are provided", "current_reports": [ "R01" ], "existence": "Relevant accounts in the stored summary; existence/acquisition of direct original materials remains unverified", "acquired_read": "Summary read; external materials not read", "observation": "The existing Korean counterview records 13/131 (9.9%) versus 15/123 (12.9%), difference −3.0%p. The existing English manuscript preserves 9.9% versus 12.9% and −3.0. Each existing record is retained unchanged.", "condition_status": "Partly verified", "status_reason": "Some information in the stored summary was linked for preparation. Original recurrence counting rules, assessability, conditional populations, recurrence/missing data and numerical/version details remain unverified. Review of existing content remains incomplete; this is not verification of clinical condition fulfillment, an effect of 0 or absence of materials.", "missingness": "Original recurrence counting rules, assessability, conditional populations, recurrence/missing data and numerical/version details remain unverified.", "uncertainty": "Original recurrence counting rules, assessability, conditional populations, recurrence/missing data and numerical/version details remain unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original recurrence tables, numerators/denominators/counting, conditions/assessment and versions" }, { "item_id": "N30", "question_type": "Evidence condition", "question": "What does the recurrence 95% CI −10.8~6.2 cover?", "needed": "Original recurrence intervals, statistics/plans, hierarchy and testing objectives", "role": "Required", "role_reason": "Required to address 'What does the recurrence 95% CI −10.8~6.2 cover?' separately for the selected question of 7-day symptom-resolution noninferiority.", "application_exception": "The primary −10%p margin is not applied to the recurrence CI to make a new noninferiority, equivalence or significant-reduction judgment.", "criterion": "Link original values, definitions, denominators, times, margins/direction and unverified matters for 'What does the recurrence 95% CI −10.8~6.2 cover?' to the corresponding original records. Recurrence CI calculation/models, P value, prespecified margins/hierarchy, importance and power remain unverified.", "basis": "Internally designed question conditions referring to the corresponding stored-summary records and family application conditions E05, C08, E06", "condition_origin": "Case-specific question conditions; review of the existing content incomplete", "proposed_research": "Materials separately disclosing recurrence estimates/intervals and plans", "current_reports": [ "R01" ], "existence": "Relevant accounts in the stored summary; existence/acquisition of direct original materials remains unverified", "acquired_read": "Summary read; external materials not read", "observation": "Preserves original recurrence difference −3.0%p (95% CI −10.8~6.2) and the wide-CI account. This differs from symptom resolution's one-sided 97.5% CI/noninferiority margin.", "condition_status": "Partly verified", "status_reason": "Some information in the stored summary was linked for preparation. Recurrence CI calculation/models, P value, prespecified margins/hierarchy, importance and power remain unverified. Review of existing content remains incomplete; this is not verification of clinical condition fulfillment, an effect of 0 or absence of materials.", "missingness": "Recurrence CI calculation/models, P value, prespecified margins/hierarchy, importance and power remain unverified.", "uncertainty": "Recurrence CI calculation/models, P value, prespecified margins/hierarchy, importance and power remain unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original recurrence intervals, statistics/plans, hierarchy and testing objectives" }, { "item_id": "N31", "question_type": "Evidence condition", "question": "How is sharing of the same people among recurrence, primary and all-randomized populations distinguished?", "needed": "Endpoint/analysis-specific flow and original relationships among people, repeated events and time points", "role": "Required", "role_reason": "Required to address 'How is sharing of the same people among recurrence, primary and all-randomized populations distinguished?' separately for the selected question of 7-day symptom-resolution noninferiority.", "application_exception": "Resolution/recurrence and primary/all-randomized denominators are not added to create new participants or independent replications.", "criterion": "Link original values, definitions, denominators, times, margins/direction and unverified matters for 'How is sharing of the same people among recurrence, primary and all-randomized populations distinguished?' to the corresponding original records. Original inclusion/omission in each population, resolution conditions/recurrence selection, repeated events and relationships among people at each time point remain unverified.", "basis": "Internally designed question conditions referring to the corresponding stored-summary records and family application conditions C02, C07, E04", "condition_origin": "Case-specific question conditions; review of the existing content incomplete", "proposed_research": "Original materials linking the same populations/different conditions to each denominator", "current_reports": [ "R01" ], "existence": "Relevant accounts in the stored summary; existence/acquisition of direct original materials remains unverified", "acquired_read": "Summary read; external materials not read", "observation": "Primary 131/123, original recurrence denominators 131/123 and all 272 participants are outcome/analysis-population scopes of the same trial. Identical numbers alone do not confirm identical recurrence conditions/observations.", "condition_status": "Partly verified", "status_reason": "Some information in the stored summary was linked for preparation. Original inclusion/omission in each population, resolution conditions/recurrence selection, repeated events and relationships among people at each time point remain unverified. Review of existing content remains incomplete; this is not verification of clinical condition fulfillment, an effect of 0 or absence of materials.", "missingness": "Original inclusion/omission in each population, resolution conditions/recurrence selection, repeated events and relationships among people at each time point remain unverified.", "uncertainty": "Original inclusion/omission in each population, resolution conditions/recurrence selection, repeated events and relationships among people at each time point remain unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Endpoint/analysis-specific flow and original relationships among people, repeated events and time points" }, { "item_id": "N32", "question_type": "Evidence condition", "question": "What are the original people, denominators, proportions and difference for adverse events?", "needed": "Original AE tables, people/event counts, populations/times and classification/collection", "role": "Required", "role_reason": "Required to address 'What are the original people, denominators, proportions and difference for adverse events?' separately for the selected question of 7-day symptom-resolution noninferiority.", "application_exception": "Apart from original −3.7%p, no new CIs/risk ratios, overlapping totals or type-specific incidence rates are calculated.", "criterion": "Link original values, definitions, denominators, times, margins/direction and unverified matters for 'What are the original people, denominators, proportions and difference for adverse events?' to the corresponding original records. Adverse-event types/grades, collection windows, exposed populations, repeated events, attribution/discontinuation and omissions remain unverified.", "basis": "Internally designed question conditions referring to the corresponding stored-summary records and family application conditions E10, H01, H03, H04", "condition_origin": "Case-specific question conditions; review of the existing content incomplete", "proposed_research": "Original materials linking safety of the same exposure with denominators/durations", "current_reports": [ "R01" ], "existence": "Relevant accounts in the stored summary; existence/acquisition of direct original materials remains unverified", "acquired_read": "Summary read; external materials not read", "observation": "The existing advertising interpretation records 28/136 (20.6%) versus 33/136 (24.3%), absolute difference −3.7%p. This is an original safety count separate from symptoms/recurrence.", "condition_status": "Partly verified", "status_reason": "Some information in the stored summary was linked for preparation. Adverse-event types/grades, collection windows, exposed populations, repeated events, attribution/discontinuation and omissions remain unverified. Review of existing content remains incomplete; this is not verification of clinical condition fulfillment, an effect of 0 or absence of materials.", "missingness": "Adverse-event types/grades, collection windows, exposed populations, repeated events, attribution/discontinuation and omissions remain unverified.", "uncertainty": "Adverse-event types/grades, collection windows, exposed populations, repeated events, attribution/discontinuation and omissions remain unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original AE tables, people/event counts, populations/times and classification/collection" }, { "item_id": "N33", "question_type": "Evidence condition", "question": "What statistical testing and causal level apply to the adverse-event difference?", "needed": "Original safety tables/SAP, comparative statistics and attribution/collection", "role": "Required", "role_reason": "Required to address 'What statistical testing and causal level apply to the adverse-event difference?' separately for the selected question of 7-day symptom-resolution noninferiority.", "application_exception": "The original record of no test is not labeled as unreported testing verified by current full-text reading, or expanded to significant reduction or absence of harm.", "criterion": "Link original values, definitions, denominators, times, margins/direction and unverified matters for 'What statistical testing and causal level apply to the adverse-event difference?' to the corresponding original records. The full scope of comparative CIs/P values, plans/tests, event attribution and causal evidence has not been read externally.", "basis": "Internally designed question conditions referring to the corresponding stored-summary records and family application conditions H09, E05, E10", "condition_origin": "Case-specific question conditions; review of the existing content incomplete", "proposed_research": "Materials from the same trial specifying original statistical levels and harm definitions", "current_reports": [ "R01" ], "existence": "Relevant accounts in the stored summary; existence/acquisition of direct original materials remains unverified", "acquired_read": "Summary read; external materials not read", "observation": "The existing Korean/English advertising interpretation records no reported significance/inferential test for the adverse-event comparison. Lower observed proportions and significant safety superiority are distinguished.", "condition_status": "Partly verified", "status_reason": "Some information in the stored summary was linked for preparation. The full scope of comparative CIs/P values, plans/tests, event attribution and causal evidence has not been read externally. Review of existing content remains incomplete; this is not verification of clinical condition fulfillment, an effect of 0 or absence of materials.", "missingness": "The full scope of comparative CIs/P values, plans/tests, event attribution and causal evidence has not been read externally.", "uncertainty": "The full scope of comparative CIs/P values, plans/tests, event attribution and causal evidence has not been read externally.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original safety tables/SAP, comparative statistics and attribution/collection" }, { "item_id": "N34", "question_type": "Evidence condition", "question": "What are the onset, recovery, discontinuation and exposure windows for safety?", "needed": "Temporal order of harms, collection windows, exposure/discontinuation/rechallenge and original tables", "role": "Required", "role_reason": "Required to address 'What are the onset, recovery, discontinuation and exposure windows for safety?' separately for the selected question of 7-day symptom-resolution noninferiority.", "application_exception": "Event onset/recovery, discontinuation/re-exposure, collection end, actual drug/placebo exposure and harms at each stage remain unverified. Empty values are not filled with new calculations, numerical examples or judgments; the original scope is retained.", "criterion": "Link original values, definitions, denominators, times, margins/direction and unverified matters for 'What are the onset, recovery, discontinuation and exposure windows for safety?' to the corresponding original records. Event onset/recovery, discontinuation/re-exposure, collection end, actual drug/placebo exposure and harms at each stage remain unverified.", "basis": "Internally designed question conditions referring to the corresponding stored-summary records and family application conditions H02, H04, E10", "condition_origin": "Case-specific question conditions; review of the existing content incomplete", "proposed_research": "Materials separating actual harm/exposure times from symptom/recurrence windows", "current_reports": [ "R01" ], "existence": "Relevant accounts in the stored summary; existence/acquisition of direct original materials remains unverified", "acquired_read": "Summary read; external materials not read", "observation": "The original study uses 7-day/14-day strategies and provides original AE proportions. Symptom-assessment windows or 28-day recurrence periods are not automatically identical to harm-collection/exposure periods.", "condition_status": "Unverified", "status_reason": "Required direct details could not be verified within the preserved-summary/unread-external-material scope. Event onset/recovery, discontinuation/re-exposure, collection end, actual drug/placebo exposure and harms at each stage remain unverified. Review of existing content remains incomplete; this is not verification of clinical condition fulfillment, an effect of 0 or absence of materials.", "missingness": "Event onset/recovery, discontinuation/re-exposure, collection end, actual drug/placebo exposure and harms at each stage remain unverified.", "uncertainty": "Event onset/recovery, discontinuation/re-exposure, collection end, actual drug/placebo exposure and harms at each stage remain unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Temporal order of harms, collection windows, exposure/discontinuation/rechallenge and original tables" }, { "item_id": "N35", "question_type": "Evidence condition", "question": "Does complete follow-up mean complete collection of all AEs and long-term/rare events?", "needed": "Safety-analysis populations, collection/omission/follow-up and type-specific original materials", "role": "Required", "role_reason": "Required to address 'Does complete follow-up mean complete collection of all AEs and long-term/rare events?' separately for the selected question of 7-day symptom-resolution noninferiority.", "application_exception": "Completion/shorter exposure does not certify absence of all harms, exclusion of rare risks or current safety.", "criterion": "Link original values, definitions, denominators, times, margins/direction and unverified matters for 'Does complete follow-up mean complete collection of all AEs and long-term/rare events?' to the corresponding original records. Safety omissions/detection, recall/assessment, treatment changes/follow-up, rare/long-term events and recruitment for each type remain unverified.", "basis": "Internally designed question conditions referring to the corresponding stored-summary records and family application conditions H06, H08, H04", "condition_origin": "Case-specific question conditions; review of the existing content incomplete", "proposed_research": "Materials from the same trial or appropriate additional materials specifying actual collection, missing data and long-term scope", "current_reports": [ "R01" ], "existence": "Relevant accounts in the stored summary; existence/acquisition of direct original materials remains unverified", "acquired_read": "Summary read; external materials not read", "observation": "The original states complete follow-up for all 272 and AE denominators 136/136, but does not separately provide collection definitions or complete observation of every period/type.", "condition_status": "Unverified", "status_reason": "Required direct details could not be verified within the preserved-summary/unread-external-material scope. Safety omissions/detection, recall/assessment, treatment changes/follow-up, rare/long-term events and recruitment for each type remain unverified. Review of existing content remains incomplete; this is not verification of clinical condition fulfillment, an effect of 0 or absence of materials.", "missingness": "Safety omissions/detection, recall/assessment, treatment changes/follow-up, rare/long-term events and recruitment for each type remain unverified.", "uncertainty": "Safety omissions/detection, recall/assessment, treatment changes/follow-up, rare/long-term events and recruitment for each type remain unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Safety-analysis populations, collection/omission/follow-up and type-specific original materials" }, { "item_id": "N36", "question_type": "Evidence condition", "question": "What alternative causes of harms involve baseline conditions, concurrent drugs or culture?", "needed": "Baseline/concurrent exposures, original event attribution and culture/drug/population-specific materials", "role": "Required", "role_reason": "Required to address 'What alternative causes of harms involve baseline conditions, concurrent drugs or culture?' separately for the selected question of 7-day symptom-resolution noninferiority.", "application_exception": "Absence of other causes is not asserted, and original safety wording is not rewritten as individual advice on antibiotic selection, dose, duration or suitability.", "criterion": "Link original values, definitions, denominators, times, margins/direction and unverified matters for 'What alternative causes of harms involve baseline conditions, concurrent drugs or culture?' to the corresponding original records. Baseline risks, concurrent drugs/other treatment, events by drug, alternative causes/adjustment and suitability materials remain unverified.", "basis": "Internally designed question conditions referring to the corresponding stored-summary records and family application conditions H05, E02, E10", "condition_origin": "Case-specific question conditions; review of the existing content incomplete", "proposed_research": "Safety materials separating original baseline/exposure, attribution and collection scope", "current_reports": [ "R01" ], "existence": "Relevant accounts in the stored summary; existence/acquisition of direct original materials remains unverified", "acquired_read": "Summary read; external materials not read", "observation": "The existing safety description provides context on renal function, interactions, allergies and culture susceptibility. These are preserved in the full stored summary; original numerical study data/safety attribution for each factor are not provided.", "condition_status": "Unverified", "status_reason": "Required direct details could not be verified within the preserved-summary/unread-external-material scope. Baseline risks, concurrent drugs/other treatment, events by drug, alternative causes/adjustment and suitability materials remain unverified. Review of existing content remains incomplete; this is not verification of clinical condition fulfillment, an effect of 0 or absence of materials.", "missingness": "Baseline risks, concurrent drugs/other treatment, events by drug, alternative causes/adjustment and suitability materials remain unverified.", "uncertainty": "Baseline risks, concurrent drugs/other treatment, events by drug, alternative causes/adjustment and suitability materials remain unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Baseline/concurrent exposures, original event attribution and culture/drug/population-specific materials" }, { "item_id": "N37", "question_type": "Evidence condition", "question": "Are reduced exposure and individual/population antibiotic resistance different questions?", "needed": "Direct resistance/culture measurements, definitions/denominators/time points and original analyses", "role": "Required", "role_reason": "Required to address 'Are reduced exposure and individual/population antibiotic resistance different questions?' separately for the selected question of 7-day symptom-resolution noninferiority.", "application_exception": "Shorter exposure is not promoted to direct efficacy for reducing individual resistance or all long-term harms.", "criterion": "Link original values, definitions, denominators, times, margins/direction and unverified matters for 'Are reduced exposure and individual/population antibiotic resistance different questions?' to the corresponding original records. Acquired resistance/culture, organisms/susceptibility, population selection pressure/long-term spread and direct denominators/durations/estimates remain unverified.", "basis": "Internally designed question conditions referring to the corresponding stored-summary records and family application conditions E09, E08", "condition_origin": "Case-specific question conditions; review of the existing content incomplete", "proposed_research": "If appropriate direct resistance materials are provided, linkage as a question separate from symptoms/exposure", "current_reports": [ "R01" ], "existence": "Relevant accounts in the stored summary; existence/acquisition of direct original materials remains unverified", "acquired_read": "Summary read; external materials not read", "observation": "Preserves the existing central summary's halved-exposure account and the advertising interpretation's selection-pressure advantage. The original explicitly states that this trial did not demonstrate reduced individual resistance.", "condition_status": "Partly verified", "status_reason": "Some information in the stored summary was linked for preparation. Acquired resistance/culture, organisms/susceptibility, population selection pressure/long-term spread and direct denominators/durations/estimates remain unverified. Review of existing content remains incomplete; this is not verification of clinical condition fulfillment, an effect of 0 or absence of materials.", "missingness": "Acquired resistance/culture, organisms/susceptibility, population selection pressure/long-term spread and direct denominators/durations/estimates remain unverified.", "uncertainty": "Acquired resistance/culture, organisms/susceptibility, population selection pressure/long-term spread and direct denominators/durations/estimates remain unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct resistance/culture measurements, definitions/denominators/time points and original analyses" }, { "item_id": "N38", "question_type": "Evidence condition", "question": "What is the scope of VA public funding, product provision/sponsorship and author COI?", "needed": "Original funding/COI, sponsor/author roles and product/data declarations", "role": "Required", "role_reason": "Required to address 'What is the scope of VA public funding, product provision/sponsorship and author COI?' separately for the selected question of 7-day symptom-resolution noninferiority.", "application_exception": "Public funding/I2 is not inherited as current certification of no COI, no bias or completed independence verification.", "criterion": "Link original values, definitions, denominators, times, margins/direction and unverified matters for 'What is the scope of VA public funding, product provision/sponsorship and author COI?' to the corresponding original records. Contracts/product supply, design/collection/statistics/writing/submission, data access, author employment and full COI have not been read externally.", "basis": "Internally designed question conditions referring to the corresponding stored-summary records and family application conditions C10", "condition_origin": "Case-specific question conditions; review of the existing content incomplete", "proposed_research": "Separation of verified funding/roles from unverified matters when actual original declarations are provided", "current_reports": [ "R01" ], "existence": "Relevant accounts in the stored summary; existence/acquisition of direct original materials remains unverified", "acquired_read": "Summary read; external materials not read", "observation": "Original funding is the US Department of Veterans Affairs Cooperative Studies Program; the parent records public funding/I2. Original report funding and current role verification are distinguished.", "condition_status": "Partly verified", "status_reason": "Some information in the stored summary was linked for preparation. Contracts/product supply, design/collection/statistics/writing/submission, data access, author employment and full COI have not been read externally. Review of existing content remains incomplete; this is not verification of clinical condition fulfillment, an effect of 0 or absence of materials.", "missingness": "Contracts/product supply, design/collection/statistics/writing/submission, data access, author employment and full COI have not been read externally.", "uncertainty": "Contracts/product supply, design/collection/statistics/writing/submission, data access, author employment and full COI have not been read externally.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original funding/COI, sponsor/author roles and product/data declarations" }, { "item_id": "N39", "question_type": "Evidence condition", "question": "What distinguishes one report/a single trial from current independent replication?", "needed": "Relationships among reports/trials/populations, analyses/outcomes and independent materials", "role": "Required", "role_reason": "Required to address 'What distinguishes one report/a single trial from current independent replication?' separately for the selected question of 7-day symptom-resolution noninferiority.", "application_exception": "The one report entry is not confirmed as the total number of trials worldwide, and the two analyses/outcomes are not counted as independent confirmations.", "criterion": "Link original values, definitions, denominators, times, margins/direction and unverified matters for 'What distinguishes one report/a single trial from current independent replication?' to the corresponding original records. Current additional trials/follow-up reports, independent populations/funding and contrary materials under other conditions remain undetermined without a new search.", "basis": "Internally designed question conditions referring to the corresponding stored-summary records and family application conditions C02, E07, H07", "condition_origin": "Case-specific question conditions; review of the existing content incomplete", "proposed_research": "Distinctions by verification level among repeated citations, the same populations and separate populations when new materials are provided", "current_reports": [ "R01" ], "existence": "Relevant accounts in the stored summary; existence/acquisition of direct original materials remains unverified", "acquired_read": "Summary read; external materials not read", "observation": "The original one-report evidence entry, PMID/NCT and R1 are historical scope. Primary/consistency analyses, symptoms/recurrence/AEs, two VA centers and sibling sheets are different materials from the same trial.", "condition_status": "Partly verified", "status_reason": "Some information in the stored summary was linked for preparation. Current additional trials/follow-up reports, independent populations/funding and contrary materials under other conditions remain undetermined without a new search. Review of existing content remains incomplete; this is not verification of clinical condition fulfillment, an effect of 0 or absence of materials.", "missingness": "Current additional trials/follow-up reports, independent populations/funding and contrary materials under other conditions remain undetermined without a new search.", "uncertainty": "Current additional trials/follow-up reports, independent populations/funding and contrary materials under other conditions remain undetermined without a new search.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Relationships among reports/trials/populations, analyses/outcomes and independent materials" }, { "item_id": "N40", "question_type": "Evidence condition", "question": "What do the cross-citations to women in 1793/862 preserve?", "needed": "Materials distinguishing different populations/drugs/endpoints and the original cross-citation scope", "role": "Required", "role_reason": "Required to address 'What do the cross-citations to women in 1793/862 preserve?' separately for the selected question of 7-day symptom-resolution noninferiority.", "application_exception": "Related judgments/original grades/product exposures are not transferred to efficacy of 7 days in men, new clinical reports/trials or completed current verification.", "criterion": "Link original values, definitions, denominators, times, margins/direction and unverified matters for 'What do the cross-citations to women in 1793/862 preserve?' to the corresponding original records. Those judgment contents/original papers, populations/drugs/effects and current cross-citation review/link status have not been read or verified.", "basis": "Internally designed question conditions referring to the corresponding stored-summary records and family application conditions C02, C04, C09, E08", "condition_origin": "Case-specific question conditions; review of the existing content incomplete", "proposed_research": "When related materials are provided, linkage of uncomplicated cystitis in women and UTI in men as different questions", "current_reports": [], "existence": "Relevant accounts in the stored summary; existence/acquisition of direct original materials remains unverified", "acquired_read": "Summary read; external materials not read", "observation": "Existing citation 1 is 1793 nitrofurantoin for clinical cure of acute uncomplicated cystitis in women, B70; citation 2 is the women's fosfomycin question 862, B62. Original 'verified cross-citation' wording and URLs are preserved only as history.", "condition_status": "Partly verified", "status_reason": "Some information in the stored summary was linked for preparation. Those judgment contents/original papers, populations/drugs/effects and current cross-citation review/link status have not been read or verified. Review of existing content remains incomplete; this is not verification of clinical condition fulfillment, an effect of 0 or absence of materials.", "missingness": "Those judgment contents/original papers, populations/drugs/effects and current cross-citation review/link status have not been read or verified.", "uncertainty": "Those judgment contents/original papers, populations/drugs/effects and current cross-citation review/link status have not been read or verified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Materials distinguishing different populations/drugs/endpoints and the original cross-citation scope" }, { "item_id": "N41", "question_type": "Evidence condition", "question": "What are the parent axes, Korean/English manuscripts and false/null/empty values in judgment history?", "needed": "Separate preservation of subclaim/parent original values, axes/languages/empty values and historical judgments", "role": "Required", "role_reason": "Required to address 'What are the parent axes, Korean/English manuscripts and false/null/empty values in judgment history?' separately for the selected question of 7-day symptom-resolution noninferiority.", "application_exception": "Original listed noninferiority limitations/scores are not repeated as new limitation assessment or reassessment, and precision null is not filled with 0.", "criterion": "Link original values, definitions, denominators, times, margins/direction and unverified matters for 'What are the parent axes, Korean/English manuscripts and false/null/empty values in judgment history?' to the corresponding original records. Original B1/I2/precision and judgment values have not been inherited as current subclaim conditions, review or scores.", "basis": "Internally designed question conditions referring to the corresponding stored-summary records and family application conditions C01, C09, E06", "condition_origin": "Case-specific question conditions; review of the existing content incomplete", "proposed_research": "If an actual correction is provided, records of full original text, event/version and changes within each scope", "current_reports": [ "R01" ], "existence": "Relevant accounts in the stored summary; existence/acquisition of direct original materials remains unverified", "acquired_read": "Summary read; external materials not read", "observation": "Preserves parent B70/Caution, axes B/P/R1/I2/E+/B1, precision null, false flags for co-primary outcome splitting, large hard-endpoint RCT and no human study, and empty override reasons. Synthesis/judgment decisions, the listed noninferiority-design limitation and cross-checks are original parent history.", "condition_status": "Partly verified", "status_reason": "Some information in the stored summary was linked for preparation. Original B1/I2/precision and judgment values have not been inherited as current subclaim conditions, review or scores. Review of existing content remains incomplete; this is not verification of clinical condition fulfillment, an effect of 0 or absence of materials.", "missingness": "Original B1/I2/precision and judgment values have not been inherited as current subclaim conditions, review or scores.", "uncertainty": "Original B1/I2/precision and judgment values have not been inherited as current subclaim conditions, review or scores.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Separate preservation of subclaim/parent original values, axes/languages/empty values and historical judgments" }, { "item_id": "N42", "question_type": "Evidence condition", "question": "How do original dates, corrections/empty values and the current preparation date differ?", "needed": "Original preservation/search/registration, corrected versions and current preparation scope/time", "role": "Required", "role_reason": "Required to address 'How do original dates, corrections/empty values and the current preparation date differ?' separately for the selected question of 7-day symptom-resolution noninferiority.", "application_exception": "Original dates/verification wording are not borrowed as current review dates, and empty corrections or no new search are not used to certify zero current studies/corrections.", "criterion": "Link original values, definitions, denominators, times, margins/direction and unverified matters for 'How do original dates, corrections/empty values and the current preparation date differ?' to the corresponding original records. Evidence-cutoff/classification fields are absent, and current registration, corrections, retractions, new literature or links have not been queried.", "basis": "Internally designed question conditions referring to the corresponding stored-summary records and family application conditions C09, C03", "condition_origin": "Case-specific question conditions; review of the existing content incomplete", "proposed_research": "Preservation records distinguishing full original text, additional events and current scope when materials/corrections are actually provided", "current_reports": [ "R01" ], "existence": "Relevant accounts in the stored summary; existence/acquisition of direct original materials remains unverified", "acquired_read": "Summary read; external materials not read", "observation": "Preserves original date 2026-08-26, empty correction/deliberation records and 2021 bibliography/registration. The current timestamp records condition creation/freezing, separate application and case preservation events.", "condition_status": "Partly verified", "status_reason": "Some information in the stored summary was linked for preparation. Evidence-cutoff/classification fields are absent, and current registration, corrections, retractions, new literature or links have not been queried. Review of existing content remains incomplete; this is not verification of clinical condition fulfillment, an effect of 0 or absence of materials.", "missingness": "Evidence-cutoff/classification fields are absent, and current registration, corrections, retractions, new literature or links have not been queried.", "uncertainty": "Evidence-cutoff/classification fields are absent, and current registration, corrections, retractions, new literature or links have not been queried.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original preservation/search/registration, corrected versions and current preparation scope/time" }, { "item_id": "N43", "question_type": "Evidence condition", "question": "What gaps remain in extending beyond afebrile patients/original drugs or to long-term outcomes?", "needed": "Direct effect/harm materials by extended population, exposure and duration", "role": "Supplementary; required for extension", "role_reason": "Required to address 'What gaps remain in extending beyond afebrile patients/original drugs or to long-term outcomes?' separately for the selected question of 7-day symptom-resolution noninferiority.", "application_exception": "Direct materials on other ages/baseline conditions, fever/infection sites, other drugs/doses, long-term recurrence/complications, quality of life and resistance remain unverified. Empty values are not filled with new calculations, numerical examples or judgments; the original scope is retained.", "criterion": "Link original values, definitions, denominators, times, margins/direction and unverified matters for 'What gaps remain in extending beyond afebrile patients/original drugs or to long-term outcomes?' to the corresponding original records. Direct materials on other ages/baseline conditions, fever/infection sites, other drugs/doses, long-term recurrence/complications, quality of life and resistance remain unverified.", "basis": "Internally designed question conditions referring to the corresponding stored-summary records and family application conditions E08, E09, H08", "condition_origin": "Case-specific question conditions; review of the existing content incomplete", "proposed_research": "When appropriate materials are provided, distinction of the selected 7-day noninferiority question from questions under other conditions/time points", "current_reports": [ "R01" ], "existence": "Relevant accounts in the stored summary; existence/acquisition of direct original materials remains unverified", "acquired_read": "Summary read; external materials not read", "observation": "The existing counterpoint states that the result cannot be directly applied to febrile UTI, prostatitis or other antibiotics, and distinguishes uncomplicated cystitis in women. Primary symptoms, 28-day recurrence and AEs are different outcomes.", "condition_status": "Unverified", "status_reason": "Required direct details could not be verified within the preserved-summary/unread-external-material scope. Direct materials on other ages/baseline conditions, fever/infection sites, other drugs/doses, long-term recurrence/complications, quality of life and resistance remain unverified. Review of existing content remains incomplete; this is not verification of clinical condition fulfillment, an effect of 0 or absence of materials.", "missingness": "Direct materials on other ages/baseline conditions, fever/infection sites, other drugs/doses, long-term recurrence/complications, quality of life and resistance remain unverified.", "uncertainty": "Direct materials on other ages/baseline conditions, fever/infection sites, other drugs/doses, long-term recurrence/complications, quality of life and resistance remain unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct effect/harm materials by extended population, exposure and duration" }, { "item_id": "N44", "question_type": "Evidence condition", "question": "Are noninferiority, recurrence and AEs kept from becoming antibiotic-selection/duration recommendations?", "needed": "Direct materials on original research scope and extended populations/effects/harms", "role": "Required", "role_reason": "Required to address 'Are noninferiority, recurrence and AEs kept from becoming antibiotic-selection/duration recommendations?' separately for the selected question of 7-day symptom-resolution noninferiority.", "application_exception": "Noninferiority/reduced exposure is not written as recommendations on antibiotic selection, duration, dose, stopping/substitution or infection suitability, or as guarantees of individual safety.", "criterion": "Link original values, definitions, denominators, times, margins/direction and unverified matters for 'Are noninferiority, recurrence and AEs kept from becoming antibiotic-selection/duration recommendations?' to the corresponding original records. Current care/regulations, patient baseline/culture, individual drugs/durations/doses/interactions and current benefits/harms have not been verified.", "basis": "Internally designed question conditions referring to the corresponding stored-summary records and family application conditions H09, E10, E09, E08, C09", "condition_origin": "Case-specific question conditions; review of the existing content incomplete", "proposed_research": "If materials are provided and scope allows, updates to research gaps distinguishing original tables from other application conditions", "current_reports": [ "R01" ], "existence": "Relevant accounts in the stored summary; existence/acquisition of direct original materials remains unverified", "acquired_read": "Summary read; external materials not read", "observation": "This sheet describes the existing 7-day/14-day symptom-resolution noninferiority question and primary/consistency, recurrence/safety and exposure/resistance boundaries of the same report. Individual treatment/suitability judgments are outside the preparation scope.", "condition_status": "Partly verified", "status_reason": "Some information in the stored summary was linked for preparation. Current care/regulations, patient baseline/culture, individual drugs/durations/doses/interactions and current benefits/harms have not been verified. Review of existing content remains incomplete; this is not verification of clinical condition fulfillment, an effect of 0 or absence of materials.", "missingness": "Current care/regulations, patient baseline/culture, individual drugs/durations/doses/interactions and current benefits/harms have not been verified.", "uncertainty": "Current care/regulations, patient baseline/culture, individual drugs/durations/doses/interactions and current benefits/harms have not been verified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct materials on original research scope and extended populations/effects/harms" } ], "reports": [ { "report_id": "R01", "title": "Drekonja DM, et al. JAMA. 2021;326:324-331. PMID: 34313686.", "url": "https://pubmed.ncbi.nlm.nih.gov/34313686/", "report_type": "Original-report summary of a double-blind, placebo-controlled noninferiority RCT", "existence": "Clinical-report entry 0 in the stored summary's evidence/citation lists; citation entries 1/2 concern related judgments on other questions", "acquired_read": "Summary read; external abstracts, full texts, registration and related judgments unread", "study_family": "F01", "independent_replication": false, "observed_result": "93.1% versus 90.2%, difference +2.9%p, one-sided 97.5% CI -5.2%p~infinity; margin -10%p", "result_level": null, "source_evidence_date": "2026-08-26", "materials": [ { "material_type": "Stored summary", "public_status": "Full stored-summary copy", "access_status": "Stored-summary copy acquired; summary read", "acquired": true, "actually_read": "Summary read", "as_of": "2026-10-06T18:43:10.519193+09:00", "qualification": "Full parent/subclaim accounts, primary/consistency analyses, recurrence/AEs/margins and original bibliography/registration/funding were read for preparation; the original paper was not read." }, { "material_type": "External abstract", "public_status": "External materials unread; access not attempted", "access_status": "Access not attempted; not acquired", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Original PubMed URL links identity only; no abstract acquisition/reading or link testing." }, { "material_type": "External full text", "public_status": "External materials unread; access not attempted", "access_status": "Access not attempted; not acquired", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "The original URL identifies the bibliography; it does not certify full-text access/acquisition." }, { "material_type": "External registration", "public_status": "External materials unread; access not attempted", "access_status": "Access not attempted; not acquired", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Original ID preserved; no registration URL/dates absent from the review summary were created, and no access/comparison was performed." }, { "material_type": "Required protocol", "public_status": "Not acquired; detailed existence unverified", "access_status": "Access not attempted; not acquired", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Materials needed on afebrile selection, original exposure/assessment windows, adherence and prespecified plans/changes for the noninferiority margin/primary population." }, { "material_type": "Required analysis plan", "public_status": "Not acquired; detailed existence unverified", "access_status": "Access not attempted; not acquired", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Original materials needed on difference/interval models, margin justification, primary/all-randomized populations, recurrence/AE testing levels and missing data." }, { "material_type": "Required result tables and safety material", "public_status": "Not acquired; detailed existence unverified", "access_status": "Access not attempted; not acquired", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Original tables needed for each event/denominator/proportion, recurrence counting/time points, assessment omissions and AE collection/duration/attribution; no new calculation/correction." }, { "material_type": "Required funding and interests", "public_status": "Not acquired; detailed existence unverified", "access_status": "Access not attempted; not acquired", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Original funding preserved; sponsorship/product supply, data/analysis/publication and full COI unread." }, { "material_type": "Related judgment manuscript", "public_status": "External materials unread; access not attempted", "access_status": "Access not attempted; not acquired", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Different question; original verification wording/grade is historical and is not promoted to a new clinical report, independent trial or current review." }, { "material_type": "Related judgment manuscript", "public_status": "External materials unread; access not attempted", "access_status": "Access not attempted; not acquired", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Only links to other questions with original bibliography/product-exposure wording/grades are preserved; original judgments/papers were not read and click testing was not performed." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/34313686/" } ] } ], "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": "Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work." }, { "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": "Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work." }, { "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": "Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work." }, { "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": "Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work." }, { "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": "Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work." } ], "status_dictionary": { "Met": "The original content has been reviewed as meeting the conditions. This status is not used in this preparation.", "Partly verified": "Some information in the stored summary was linked during preparation; clinical verification or review is not complete.", "Unverified": "Required direct values, definitions or materials have not been established within the current storage and reading scope. This does not mean zero effect, no papers or failed access.", "Review incomplete": "Review of existing content or actual review incomplete.", "Not reported": "Used only when original materials were actually read and the outcome was judged unreported. Not used for external materials unread in this work.", "Inaccessible": "Used only when an actual access attempt has a recorded failure. Not used for access that was not attempted in this work.", "Insufficient evidence for the conditions": "Indicates insufficient direct materials for the relevant scope or conditions; it is not a new grade.", "Not applicable": "Used when the reason it does not apply to the original question is stated.", "Conflicting data": "Retains the scope of conflicting statements in original materials; it is not an arbitrary reassessment." }, "study_overlap": { "state": "Unverified", "unique_trial_count": null, "unique_participant_count": null, "reason": "Drekonja2021/PMID34313686/NCT01994538, 272 participants, primary 254/131/123, all-randomized consistency, recurrence/AEs and sibling questions share the same trial/population context. 1793/862 are URLs for different questions in women, and are not new clinical reports/independent replications." }, "history": [ { "date": "2026-10-10", "kind": "Separation of public-facing pages and materials", "view_version": "1.0", "change": "A public view and materials were prepared from the existing 44 items. No new clinical search, verification-status change or scoring was performed." } ], "language": "en", "translation_date": "2026-10-10" }