# 7 versus 14 days of antibiotics · Afebrile men with UTI · Symptom-resolution noninferiority evidence checklist

Verdict 2930 · Evidence Check

Stored-material review date: Not recorded  
Original evidence cut-off: 2026-08-26  
Review-criteria version: 1.0  
Public page/material preparation date: 2026-10-10

Clinical papers were not read directly; existing review summaries were checked. No new clinical-literature search was performed. Unverified does not mean that research is absent or that there is no effect.

## Assessment scope

- Population: Afebrile men with UTI at two US VA centers; age/diagnosis/baseline/culture and inclusion/exclusion details remain unverified
- Ingredient, formulation and route: 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
- Measured outcome: 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
- Questions outside this scope: 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

## Checklist items

### N01 · What are the existing question, record and parent/sibling contexts?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: The existing candidate's pending boundary review is historical; review of existing content and the question boundary remains incomplete.
- Required materials and conditions: Linkage of the existing question, record and parent/sibling boundaries
- Materials to obtain first: Linkage of the existing question, record and parent/sibling boundaries
- Further research: Follow-up materials linking new information for the same question while retaining the original question and judgment record
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining uncertainty: The existing candidate's pending boundary review is historical; review of existing content and the question boundary remains incomplete.
- Referenced methods: Internally designed question conditions referring to the corresponding stored-summary records and family application conditions C01
- Related sources: R01

### N02 · Are subclaim B/note and parent B70 different from absent subclaim scores/axes?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: No direct original subclaim score, status or axis values exist.
- Required materials and conditions: Separate preservation of subclaim/parent judgments and absent scores/axes
- Materials to obtain first: Separate preservation of subclaim/parent judgments and absent scores/axes
- Further research: If a correction is actually provided, a record separating the full original text, event/version and change decision
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: No uniform D, parent 70 points, B1/I2 or precision null is copied to the subclaim, and no reassessment is performed.
- Remaining uncertainty: No direct original subclaim score, status or axis values exist.
- Referenced methods: Internally designed question conditions referring to the corresponding stored-summary records and family application conditions C01, C09
- Related sources: R01

### N03 · How are the same trial, report and recurrence/safety populations linked?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: Subsequent/other paper versions, overlapping people/reports and current unique trial/participant totals remain undetermined.
- Required materials and conditions: Relationships among bibliography/registration, report/trial families, populations/outcomes and related materials
- Materials to obtain first: Relationships among bibliography/registration, report/trial families, populations/outcomes and related materials
- Further research: A list distinguishing the same, separate or unidentified reports and outcome populations when additional materials are provided
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: The two subclaim rows, 131/123, 272, 136/136 and related-judgment links are not added as independent replications or new participants.
- Remaining uncertainty: Subsequent/other paper versions, overlapping people/reports and current unique trial/participant totals remain undetermined.
- Referenced methods: Internally designed question conditions referring to the corresponding stored-summary records and family application conditions C02, E07, H07
- Related sources: R01

### N04 · How do reading the stored summary and not reading original papers/links differ?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: Current public availability/acquisition, access/content and URL operation have not been verified.
- Required materials and conditions: Status/reading level and original locations of the preserved summary and each external original material
- Materials to obtain first: Status/reading level and original locations of the preserved summary and each external original material
- Further research: Records separating actual access attempts, reading and dates when acquiring materials is allowed
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: Summary reading is not promoted to verification of full texts, registration or related judgments; unattempted access is not changed to failure or zero existence.
- Remaining uncertainty: Current public availability/acquisition, access/content and URL operation have not been verified.
- Referenced methods: Internally designed question conditions referring to the corresponding stored-summary records and family application conditions C03
- Related sources: R01

### N05 · What is the actual selection boundary for afebrile men with UTI?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: Original details of age, diagnosis/symptoms, underlying conditions, culture positivity/susceptibility, inclusion/exclusion and infection site remain unverified.
- Required materials and conditions: Original inclusion/exclusion, baseline/culture and diagnostic/afebrile definition tables
- Materials to obtain first: Original inclusion/exclusion, baseline/culture and diagnostic/afebrile definition tables
- Further research: Materials from the same trial or appropriate separate materials that directly specify the selected population/drug conditions
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining uncertainty: Original details of age, diagnosis/symptoms, underlying conditions, culture positivity/susceptibility, inclusion/exclusion and infection site remain unverified.
- Referenced methods: Internally designed question conditions referring to the corresponding stored-summary records and family application conditions C04, E08
- Related sources: R01

### N06 · What are the representativeness and participant distributions at the two US VA centers?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- Current findings: The original record describes a 272-participant trial at two US VA centers. The two centers are not two independent trials.
- Why unverified: 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.
- Reason for missing information: Recruitment/composition by center, baseline balance and direct outcomes in populations outside the VA or other settings remain unverified.
- Required materials and conditions: Center/recruitment, baseline tables and actual population/setting materials
- Materials to obtain first: Center/recruitment, baseline tables and actual population/setting materials
- Further research: Additional materials distinguishing conditions at each center of the same trial or populations for extension
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining uncertainty: Recruitment/composition by center, baseline balance and direct outcomes in populations outside the VA or other settings remain unverified.
- Referenced methods: Internally designed question conditions referring to the corresponding stored-summary records and family application conditions C04, E07
- Related sources: R01

### N07 · What finished-product/drug scope applies to the study antibiotics?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- Current findings: The original drugs are ciprofloxacin or trimethoprim-sulfamethoxazole. Retains the original scope of exposure to one of these two drugs in the trial.
- Why unverified: 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.
- Reason for missing information: Numbers by drug, selection/allocation, dose/formulation/route, actual exposure and drug-specific outcomes/interactions remain unverified.
- Required materials and conditions: Drug selection, group composition, nominal/actual exposure and drug-specific original materials
- Materials to obtain first: Drug selection, group composition, nominal/actual exposure and drug-specific original materials
- Further research: Original reports separating the applicable drug/population conditions and effects
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: The two drugs are not changed to simultaneous combination treatment or extended to other antibiotics or individual drug-selection/dose recommendations.
- Remaining uncertainty: Numbers by drug, selection/allocation, dose/formulation/route, actual exposure and drug-specific outcomes/interactions remain unverified.
- Referenced methods: Internally designed question conditions referring to the corresponding stored-summary records and family application conditions C05, E08
- Related sources: R01

### N08 · Do 7 versus 14 days of exposure differ from actual dose/adherence?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: Nominal/actual amounts by drug, discontinuation/changes, adverse effects/rescue, medication schedules and total exposure details remain unverified.
- Required materials and conditions: Original treatment durations, active-drug/placebo schedules and actual adherence/change materials
- Materials to obtain first: Original treatment durations, active-drug/placebo schedules and actual adherence/change materials
- Further research: Materials from the same trial separating exposure strategy and actual adherence
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: The halving statement is not changed to a new dose conversion, instructions on individual duration or stopping medication, or actual cumulative drug amount.
- Remaining uncertainty: Nominal/actual amounts by drug, discontinuation/changes, adverse effects/rescue, medication schedules and total exposure details remain unverified.
- Referenced methods: Internally designed question conditions referring to the corresponding stored-summary records and family application conditions C05, E02
- Related sources: R01

### N09 · What actually occurred during placebo control and blinding periods?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: Active-drug/placebo periods, packaging/matching, blinding targets/maintenance, unblinding/success and assessor roles remain unverified.
- Required materials and conditions: Methods/appendices for original placebo/blinding, drug schedules and assessment procedures
- Materials to obtain first: Methods/appendices for original placebo/blinding, drug schedules and assessment procedures
- Further research: Materials linking actual blinding and medication operation in the report/protocol
- Conditions for verification: 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.
- Why this condition is needed: Required to address 'What actually occurred during placebo control and blinding periods?' separately for the selected question of 7-day symptom-resolution noninferiority.
- Application exceptions: 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.
- Remaining uncertainty: Active-drug/placebo periods, packaging/matching, blinding targets/maintenance, unblinding/success and assessor roles remain unverified.
- Referenced methods: Internally designed question conditions referring to the corresponding stored-summary records and family application conditions E01, E03, E02
- Related sources: R01

### N10 · What are the 272 allocated participants, primary-analysis population of 254 and group denominators?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: Original flow by randomized group, counts for each exclusion/nonadherence reason, drug composition and detailed endpoint-specific assessment/safety denominators remain unverified.
- Required materials and conditions: Original flow from allocation to primary/consistency analysis and assessment/safety
- Materials to obtain first: Original flow from allocation to primary/consistency analysis and assessment/safety
- Further research: Materials from the same trial linking inclusion/exclusion and outcomes in each population
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 272−254 is not calculated as a new dropout count, and safety denominators 136/136 are not transferred as verified primary-analysis denominators.
- Remaining uncertainty: Original flow by randomized group, counts for each exclusion/nonadherence reason, drug composition and detailed endpoint-specific assessment/safety denominators remain unverified.
- Referenced methods: Internally designed question conditions referring to the corresponding stored-summary records and family application conditions C07, E04
- Related sources: R01

### N11 · What is the original medication-adherence criterion?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: Total active-drug/placebo doses, drug-specific dosing intervals, recording/verification, criterion changes/exclusion reasons and selection effects remain unverified.
- Required materials and conditions: Adherence definitions/measurement and original medication, exclusion and SAP materials
- Materials to obtain first: Adherence definitions/measurement and original medication, exclusion and SAP materials
- Further research: Materials distinguishing original criteria, inclusion/exclusion and missing data/changes
- Conditions for verification: 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.
- Why this condition is needed: Required to address 'What is the original medication-adherence criterion?' separately for the selected question of 7-day symptom-resolution noninferiority.
- Application exceptions: 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.
- Remaining uncertainty: Total active-drug/placebo doses, drug-specific dosing intervals, recording/verification, criterion changes/exclusion reasons and selection effects remain unverified.
- Referenced methods: Internally designed question conditions referring to the corresponding stored-summary records and family application conditions E04, E02
- Related sources: R01

### N12 · What original record describes the prespecified primary as-treated and per-protocol-type population?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: The full original analysis-population definition, prespecification/changes, selection/deviations and sensitivity analyses including nonadherence have not been read externally.
- Required materials and conditions: SAP/protocol and original rules for analysis populations/per-protocol characteristics
- Materials to obtain first: SAP/protocol and original rules for analysis populations/per-protocol characteristics
- Further research: Materials from the same trial disclosing planned and actual analysis-population inclusion/exclusion
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining uncertainty: The full original analysis-population definition, prespecification/changes, selection/deviations and sensitivity analyses including nonadherence have not been read externally.
- Referenced methods: Internally designed question conditions referring to the corresponding stored-summary records and family application conditions E04, E06
- Related sources: R01

### N13 · Does complete follow-up of everyone differ from primary-analysis exclusion/missing data?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: Completion definitions/methods, omissions by assessment, reasons/counts by group outside the primary analysis and missing data at later time points remain unverified.
- Required materials and conditions: Follow-up, assessment, medication and analysis flow, with exclusion/missing-data tables
- Materials to obtain first: Follow-up, assessment, medication and analysis flow, with exclusion/missing-data tables
- Further research: Materials linking original completion records with each analysis/measurement scope
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining uncertainty: Completion definitions/methods, omissions by assessment, reasons/counts by group outside the primary analysis and missing data at later time points remain unverified.
- Referenced methods: Internally designed question conditions referring to the corresponding stored-summary records and family application conditions C07, E04
- Related sources: R01

### N14 · What people, denominators and proportions describe primary-analysis symptom resolution?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: Original symptom definitions, criteria/assessment schedules, individual omissions and distributions by drug remain unverified.
- Required materials and conditions: Original primary symptom-resolution tables, counts/definitions and population/time materials
- Materials to obtain first: Original primary symptom-resolution tables, counts/definitions and population/time materials
- Further research: Reports/appendices linking resolution events, original denominators and measurement rules
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: Rounded proportions are not used to calculate new values/CIs, unresolved cases or participant totals, or transferred to recurrence denominators/events.
- Remaining uncertainty: Original symptom definitions, criteria/assessment schedules, individual omissions and distributions by drug remain unverified.
- Referenced methods: Internally designed question conditions referring to the corresponding stored-summary records and family application conditions C06, C07
- Related sources: R01

### N15 · What defines difference +2.9%p and the favorable direction?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: Direct original details of difference estimation/adjustment, stratification, interval methods, within-group change and absolute durations remain unverified.
- Required materials and conditions: Direction/unit of the original difference, estimation model and original tables
- Materials to obtain first: Direction/unit of the original difference, estimation model and original tables
- Further research: Statistical materials specifying difference, adjustment and interval definitions
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: No new risk ratio/difference or improvement duration is calculated, and +2.9 is not changed to statistical superiority or individual benefit.
- Remaining uncertainty: Direct original details of difference estimation/adjustment, stratification, interval methods, within-group change and absolute durations remain unverified.
- Referenced methods: Internally designed question conditions referring to the corresponding stored-summary records and family application conditions C06, E04, E05
- Related sources: R01

### N16 · What are the lower bound and infinite upper end of the one-sided 97.5% CI?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: Original interval calculation, adjustment, model/stratification, alternative intervals and two-sided intervals remain unverified.
- Required materials and conditions: One-sided interval/SAP, statistical methods and original result tables
- Materials to obtain first: One-sided interval/SAP, statistical methods and original result tables
- Further research: Materials disclosing intervals/models according to the original methods
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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%.
- Remaining uncertainty: Original interval calculation, adjustment, model/stratification, alternative intervals and two-sided intervals remain unverified.
- Referenced methods: Internally designed question conditions referring to the corresponding stored-summary records and family application conditions C07, E05
- Related sources: R01

### N17 · What is the comparison scope for the prespecified margin −10%p and lower bound?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: Margin rationale, historical control effect/preservation, patient values, original alpha/power and comparison of versions remain unverified.
- Required materials and conditions: Noninferiority-margin justification, SAP/registration and original estimation/testing plans
- Materials to obtain first: Noninferiority-margin justification, SAP/registration and original estimation/testing plans
- Further research: Materials disclosing the relationship between original margin justification/plans and results
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining uncertainty: Margin rationale, historical control effect/preservation, patient values, original alpha/power and comparison of versions remain unverified.
- Referenced methods: Internally designed question conditions referring to the corresponding stored-summary records and family application conditions E05, E06
- Related sources: R01

### N18 · How are noninferiority, equivalence and superiority distinguished?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: Superiority/equivalence plans, two-sided equivalence intervals, individual importance and superiority for safety/resistance have not been verified.
- Required materials and conditions: Testing objective/limits, intervals and original judgment scope
- Materials to obtain first: Testing objective/limits, intervals and original judgment scope
- Further research: Additional materials separately distinguishing original testing objectives, patient outcomes and safety
- Conditions for verification: 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.
- Why this condition is needed: Required to address 'How are noninferiority, equivalence and superiority distinguished?' separately for the selected question of 7-day symptom-resolution noninferiority.
- Application exceptions: The existing advertising interpretation's wording 'same'/equal is not newly confirmed as exact equivalence, superiority or absence of harm.
- Remaining uncertainty: Superiority/equivalence plans, two-sided equivalence intervals, individual importance and superiority for safety/resistance have not been verified.
- Referenced methods: Internally designed question conditions referring to the corresponding stored-summary records and family application conditions C08, E05, E09
- Related sources: R01

### N19 · What are the original values in the all-randomized consistency analysis of 272?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: Original events/denominators by group, the consistency-analysis definition, missing-data/adherence handling and original models remain unverified.
- Required materials and conditions: Original all-randomized analysis tables, definitions/missing data/SAP and intervals
- Materials to obtain first: Original all-randomized analysis tables, definitions/missing data/SAP and intervals
- Further research: Materials separately disclosing original denominators and results of the primary/all-randomized consistency populations
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: Original event counts are not reconstructed, and all-randomized results/lower bounds are not copied as primary-analysis results for 254.
- Remaining uncertainty: Original events/denominators by group, the consistency-analysis definition, missing-data/adherence handling and original models remain unverified.
- Referenced methods: Internally designed question conditions referring to the corresponding stored-summary records and family application conditions E04, E05, C07
- Related sources: R01

### N20 · What differs between the primary and all-randomized populations, and what establishes robustness?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: Nonadherence/drug changes by group, relationships between people in the two populations, sensitivity analyses and magnitudes/assumptions of selection bias remain unverified.
- Required materials and conditions: Analysis-population inclusion/exclusion, sensitivity analyses and original plans/result tables
- Materials to obtain first: Analysis-population inclusion/exclusion, sensitivity analyses and original plans/result tables
- Further research: Materials specifying the scope and outcomes of differing populations/handling using the original methods
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: Consistency wording alone does not certify robustness across every analysis/population, and the two populations are not added as independent confirmations.
- Remaining uncertainty: Nonadherence/drug changes by group, relationships between people in the two populations, sensitivity analyses and magnitudes/assumptions of selection bias remain unverified.
- Referenced methods: Internally designed question conditions referring to the corresponding stored-summary records and family application conditions E04, E05, C02
- Related sources: R01

### N21 · How were patient-reported symptom resolution and scales defined?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: Symptom lists, definitions/scales, assessors/records, resolution judgments and agreement with culture results remain unverified.
- Required materials and conditions: Original symptom lists/resolution judgments, patient reports and collection/measurement methods
- Materials to obtain first: Original symptom lists/resolution judgments, patient reports and collection/measurement methods
- Further research: Materials from the same trial disclosing actual definitions and measurement limits of patient-reported outcomes
- Conditions for verification: 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.
- Why this condition is needed: Required to address 'How were patient-reported symptom resolution and scales defined?' separately for the selected question of 7-day symptom-resolution noninferiority.
- Application exceptions: Symptom resolution is not changed to microbiological clearance, complication prevention or all long-term cure without original materials.
- Remaining uncertainty: Symptom lists, definitions/scales, assessors/records, resolution judgments and agreement with culture results remain unverified.
- Referenced methods: Internally designed question conditions referring to the corresponding stored-summary records and family application conditions C06, E03, E09
- Related sources: R01

### N22 · Are 7 days of treatment and assessment within 14 days after therapy the same window?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: Original assessment days, time origins/synchronization by group, allowed windows, repeated measurements and closure/omissions remain unverified.
- Required materials and conditions: Original schedules, exposure/end/assessment times by group and counting rules
- Materials to obtain first: Original schedules, exposure/end/assessment times by group and counting rules
- Further research: Reports/protocols linking actual assessment windows with each group's treatment schedule
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining uncertainty: Original assessment days, time origins/synchronization by group, allowed windows, repeated measurements and closure/omissions remain unverified.
- Referenced methods: Internally designed question conditions referring to the corresponding stored-summary records and family application conditions C06, E03
- Related sources: R01

### N23 · How do blinding and medication schedules affect patient-reported measurement?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: Assessor/participant information, blinding success/unblinding, measurement tools/differences, omissions and group-specific assessment methods remain unverified.
- Required materials and conditions: Blinding/unblinding, patient-report collection and assessment times/tools
- Materials to obtain first: Blinding/unblinding, patient-report collection and assessment times/tools
- Further research: Original materials linking actual symptom measurement and blinding to each endpoint
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: Double-blind wording is not automatically promoted to absence of measurement limitations or fulfillment of all conditions.
- Remaining uncertainty: Assessor/participant information, blinding success/unblinding, measurement tools/differences, omissions and group-specific assessment methods remain unverified.
- Referenced methods: Internally designed question conditions referring to the corresponding stored-summary records and family application conditions E03, E01
- Related sources: R01

### N24 · What models, between-/within-group comparisons, adjustments and missing-data handling define the difference?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: Difference/interval models, adjustment/stratification, contributions by drug, missing data/deviations and original SAP details remain unverified.
- Required materials and conditions: Statistical methods/SAP, original models, analysis/missing data and result tables
- Materials to obtain first: Statistical methods/SAP, original models, analysis/missing data and result tables
- Further research: Materials specifying between-group differences, models and populations using the original methods
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: Models/adjustments or ITT/PP levels are not filled by inference, and superiority between drugs is not created.
- Remaining uncertainty: Difference/interval models, adjustment/stratification, contributions by drug, missing data/deviations and original SAP details remain unverified.
- Referenced methods: Internally designed question conditions referring to the corresponding stored-summary records and family application conditions E04, E05
- Related sources: R01

### N25 · What records describe the primary endpoint/analysis, margin and registration?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: Original comparison of registration/protocol/SAP versions, change dates and prespecified endpoints/analyses/time points has not been read.
- Required materials and conditions: Registration/plan/analysis versions, margins/endpoints/populations and change materials
- Materials to obtain first: Registration/plan/analysis versions, margins/endpoints/populations and change materials
- Further research: Records separating verified comparison scope from unexamined matters and changes when actual plans are provided
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: The registration ID or original 'prespecified' wording does not certify completed current registration/plan review or absence of all selective reporting.
- Remaining uncertainty: Original comparison of registration/protocol/SAP versions, change dates and prespecified endpoints/analyses/time points has not been read.
- Referenced methods: Internally designed question conditions referring to the corresponding stored-summary records and family application conditions E06, C09
- Related sources: R01

### N26 · What supports the importance and preserved effect of the −10%p margin?

Verification status: Unverified  
Reading scope: Summary read; external materials not read

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: Margin selection, historical effects/constancy, acceptable differences and power/SAP criteria remain unverified.
- Required materials and conditions: Noninferiority-margin rationale, original design/historical materials and testing assumptions
- Materials to obtain first: Noninferiority-margin rationale, original design/historical materials and testing assumptions
- Further research: A manuscript specifying the margin and current interval/population when actual justification materials are provided
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: −10%p is not used as a common importance threshold for every symptom, infection or safety result, and no new margin/grade is selected.
- Remaining uncertainty: Margin selection, historical effects/constancy, acceptable differences and power/SAP criteria remain unverified.
- Referenced methods: Internally designed question conditions referring to the corresponding stored-summary records and family application conditions E05, E06
- Related sources: R01

### N27 · What are the effects of per-protocol-type selection, adherence/rescue treatment and the effect of interest?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: SAP details for nonadherence/concomitant treatment, drug switching, rescue/retreatment, subsequent exposure and allocation/adherence effects remain unverified.
- Required materials and conditions: Concomitant/rescue treatment, medication/changes and analysis-inclusion/SAP materials
- Materials to obtain first: Concomitant/rescue treatment, medication/changes and analysis-inclusion/SAP materials
- Further research: Materials linking strategy, actual implementation and conditional selection to original populations/outcomes
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining uncertainty: SAP details for nonadherence/concomitant treatment, drug switching, rescue/retreatment, subsequent exposure and allocation/adherence effects remain unverified.
- Referenced methods: Internally designed question conditions referring to the corresponding stored-summary records and family application conditions E02, E04
- Related sources: R01

### N28 · What time origin and definition apply to the sibling 28-day recurrence outcome?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: The 28-day time origin, recurrence/reinfection, selection after resolution, records/culture/retreatment and original assessment window remain unverified.
- Required materials and conditions: Recurrence definitions/times, conditional populations and counting/assessment materials
- Materials to obtain first: Recurrence definitions/times, conditional populations and counting/assessment materials
- Further research: Materials disclosing symptom resolution and recurrence in the same trial according to their respective original definitions/time points
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining uncertainty: The 28-day time origin, recurrence/reinfection, selection after resolution, records/culture/retreatment and original assessment window remain unverified.
- Referenced methods: Internally designed question conditions referring to the corresponding stored-summary records and family application conditions C06, E03, E09
- Related sources: R01

### N29 · What are the recorded recurrence numerators, denominators, proportions and difference?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: Original recurrence counting rules, assessability, conditional populations, recurrence/missing data and numerical/version details remain unverified.
- Required materials and conditions: Original recurrence tables, numerators/denominators/counting, conditions/assessment and versions
- Materials to obtain first: Original recurrence tables, numerators/denominators/counting, conditions/assessment and versions
- Further research: Linkage separating the full before/after original text and events when original result tables/corrections are provided
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: Original fractions/proportions are not recalculated, rounded differently or corrected without checking original tables, and no new recurrence differences or summed participants are created.
- Remaining uncertainty: Original recurrence counting rules, assessability, conditional populations, recurrence/missing data and numerical/version details remain unverified.
- Referenced methods: Internally designed question conditions referring to the corresponding stored-summary records and family application conditions C07, C08, E04
- Related sources: R01

### N30 · What does the recurrence 95% CI −10.8~6.2 cover?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: Recurrence CI calculation/models, P value, prespecified margins/hierarchy, importance and power remain unverified.
- Required materials and conditions: Original recurrence intervals, statistics/plans, hierarchy and testing objectives
- Materials to obtain first: Original recurrence intervals, statistics/plans, hierarchy and testing objectives
- Further research: Materials separately disclosing recurrence estimates/intervals and plans
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: The primary −10%p margin is not applied to the recurrence CI to make a new noninferiority, equivalence or significant-reduction judgment.
- Remaining uncertainty: Recurrence CI calculation/models, P value, prespecified margins/hierarchy, importance and power remain unverified.
- Referenced methods: Internally designed question conditions referring to the corresponding stored-summary records and family application conditions E05, C08, E06
- Related sources: R01

### N31 · How is sharing of the same people among recurrence, primary and all-randomized populations distinguished?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: Original inclusion/omission in each population, resolution conditions/recurrence selection, repeated events and relationships among people at each time point remain unverified.
- Required materials and conditions: Endpoint/analysis-specific flow and original relationships among people, repeated events and time points
- Materials to obtain first: Endpoint/analysis-specific flow and original relationships among people, repeated events and time points
- Further research: Original materials linking the same populations/different conditions to each denominator
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: Resolution/recurrence and primary/all-randomized denominators are not added to create new participants or independent replications.
- Remaining uncertainty: Original inclusion/omission in each population, resolution conditions/recurrence selection, repeated events and relationships among people at each time point remain unverified.
- Referenced methods: Internally designed question conditions referring to the corresponding stored-summary records and family application conditions C02, C07, E04
- Related sources: R01

### N32 · What are the original people, denominators, proportions and difference for adverse events?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: Adverse-event types/grades, collection windows, exposed populations, repeated events, attribution/discontinuation and omissions remain unverified.
- Required materials and conditions: Original AE tables, people/event counts, populations/times and classification/collection
- Materials to obtain first: Original AE tables, people/event counts, populations/times and classification/collection
- Further research: Original materials linking safety of the same exposure with denominators/durations
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: Apart from original −3.7%p, no new CIs/risk ratios, overlapping totals or type-specific incidence rates are calculated.
- Remaining uncertainty: Adverse-event types/grades, collection windows, exposed populations, repeated events, attribution/discontinuation and omissions remain unverified.
- Referenced methods: Internally designed question conditions referring to the corresponding stored-summary records and family application conditions E10, H01, H03, H04
- Related sources: R01

### N33 · What statistical testing and causal level apply to the adverse-event difference?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: The full scope of comparative CIs/P values, plans/tests, event attribution and causal evidence has not been read externally.
- Required materials and conditions: Original safety tables/SAP, comparative statistics and attribution/collection
- Materials to obtain first: Original safety tables/SAP, comparative statistics and attribution/collection
- Further research: Materials from the same trial specifying original statistical levels and harm definitions
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining uncertainty: The full scope of comparative CIs/P values, plans/tests, event attribution and causal evidence has not been read externally.
- Referenced methods: Internally designed question conditions referring to the corresponding stored-summary records and family application conditions H09, E05, E10
- Related sources: R01

### N34 · What are the onset, recovery, discontinuation and exposure windows for safety?

Verification status: Unverified  
Reading scope: Summary read; external materials not read

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: Event onset/recovery, discontinuation/re-exposure, collection end, actual drug/placebo exposure and harms at each stage remain unverified.
- Required materials and conditions: Temporal order of harms, collection windows, exposure/discontinuation/rechallenge and original tables
- Materials to obtain first: Temporal order of harms, collection windows, exposure/discontinuation/rechallenge and original tables
- Further research: Materials separating actual harm/exposure times from symptom/recurrence windows
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining uncertainty: Event onset/recovery, discontinuation/re-exposure, collection end, actual drug/placebo exposure and harms at each stage remain unverified.
- Referenced methods: Internally designed question conditions referring to the corresponding stored-summary records and family application conditions H02, H04, E10
- Related sources: R01

### N35 · Does complete follow-up mean complete collection of all AEs and long-term/rare events?

Verification status: Unverified  
Reading scope: Summary read; external materials not read

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: Safety omissions/detection, recall/assessment, treatment changes/follow-up, rare/long-term events and recruitment for each type remain unverified.
- Required materials and conditions: Safety-analysis populations, collection/omission/follow-up and type-specific original materials
- Materials to obtain first: Safety-analysis populations, collection/omission/follow-up and type-specific original materials
- Further research: Materials from the same trial or appropriate additional materials specifying actual collection, missing data and long-term scope
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: Completion/shorter exposure does not certify absence of all harms, exclusion of rare risks or current safety.
- Remaining uncertainty: Safety omissions/detection, recall/assessment, treatment changes/follow-up, rare/long-term events and recruitment for each type remain unverified.
- Referenced methods: Internally designed question conditions referring to the corresponding stored-summary records and family application conditions H06, H08, H04
- Related sources: R01

### N36 · What alternative causes of harms involve baseline conditions, concurrent drugs or culture?

Verification status: Unverified  
Reading scope: Summary read; external materials not read

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: Baseline risks, concurrent drugs/other treatment, events by drug, alternative causes/adjustment and suitability materials remain unverified.
- Required materials and conditions: Baseline/concurrent exposures, original event attribution and culture/drug/population-specific materials
- Materials to obtain first: Baseline/concurrent exposures, original event attribution and culture/drug/population-specific materials
- Further research: Safety materials separating original baseline/exposure, attribution and collection scope
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: Absence of other causes is not asserted, and original safety wording is not rewritten as individual advice on antibiotic selection, dose, duration or suitability.
- Remaining uncertainty: Baseline risks, concurrent drugs/other treatment, events by drug, alternative causes/adjustment and suitability materials remain unverified.
- Referenced methods: Internally designed question conditions referring to the corresponding stored-summary records and family application conditions H05, E02, E10
- Related sources: R01

### N37 · Are reduced exposure and individual/population antibiotic resistance different questions?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: Acquired resistance/culture, organisms/susceptibility, population selection pressure/long-term spread and direct denominators/durations/estimates remain unverified.
- Required materials and conditions: Direct resistance/culture measurements, definitions/denominators/time points and original analyses
- Materials to obtain first: Direct resistance/culture measurements, definitions/denominators/time points and original analyses
- Further research: If appropriate direct resistance materials are provided, linkage as a question separate from symptoms/exposure
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: Shorter exposure is not promoted to direct efficacy for reducing individual resistance or all long-term harms.
- Remaining uncertainty: Acquired resistance/culture, organisms/susceptibility, population selection pressure/long-term spread and direct denominators/durations/estimates remain unverified.
- Referenced methods: Internally designed question conditions referring to the corresponding stored-summary records and family application conditions E09, E08
- Related sources: R01

### N38 · What is the scope of VA public funding, product provision/sponsorship and author COI?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: Contracts/product supply, design/collection/statistics/writing/submission, data access, author employment and full COI have not been read externally.
- Required materials and conditions: Original funding/COI, sponsor/author roles and product/data declarations
- Materials to obtain first: Original funding/COI, sponsor/author roles and product/data declarations
- Further research: Separation of verified funding/roles from unverified matters when actual original declarations are provided
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: Public funding/I2 is not inherited as current certification of no COI, no bias or completed independence verification.
- Remaining uncertainty: Contracts/product supply, design/collection/statistics/writing/submission, data access, author employment and full COI have not been read externally.
- Referenced methods: Internally designed question conditions referring to the corresponding stored-summary records and family application conditions C10
- Related sources: R01

### N39 · What distinguishes one report/a single trial from current independent replication?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: Current additional trials/follow-up reports, independent populations/funding and contrary materials under other conditions remain undetermined without a new search.
- Required materials and conditions: Relationships among reports/trials/populations, analyses/outcomes and independent materials
- Materials to obtain first: Relationships among reports/trials/populations, analyses/outcomes and independent materials
- Further research: Distinctions by verification level among repeated citations, the same populations and separate populations when new materials are provided
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining uncertainty: Current additional trials/follow-up reports, independent populations/funding and contrary materials under other conditions remain undetermined without a new search.
- Referenced methods: Internally designed question conditions referring to the corresponding stored-summary records and family application conditions C02, E07, H07
- Related sources: R01

### N40 · What do the cross-citations to women in 1793/862 preserve?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: Those judgment contents/original papers, populations/drugs/effects and current cross-citation review/link status have not been read or verified.
- Required materials and conditions: Materials distinguishing different populations/drugs/endpoints and the original cross-citation scope
- Materials to obtain first: Materials distinguishing different populations/drugs/endpoints and the original cross-citation scope
- Further research: When related materials are provided, linkage of uncomplicated cystitis in women and UTI in men as different questions
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: Related judgments/original grades/product exposures are not transferred to efficacy of 7 days in men, new clinical reports/trials or completed current verification.
- Remaining uncertainty: Those judgment contents/original papers, populations/drugs/effects and current cross-citation review/link status have not been read or verified.
- Referenced methods: Internally designed question conditions referring to the corresponding stored-summary records and family application conditions C02, C04, C09, E08
- Related sources: 

### N41 · What are the parent axes, Korean/English manuscripts and false/null/empty values in judgment history?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: Original B1/I2/precision and judgment values have not been inherited as current subclaim conditions, review or scores.
- Required materials and conditions: Separate preservation of subclaim/parent original values, axes/languages/empty values and historical judgments
- Materials to obtain first: Separate preservation of subclaim/parent original values, axes/languages/empty values and historical judgments
- Further research: If an actual correction is provided, records of full original text, event/version and changes within each scope
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: Original listed noninferiority limitations/scores are not repeated as new limitation assessment or reassessment, and precision null is not filled with 0.
- Remaining uncertainty: Original B1/I2/precision and judgment values have not been inherited as current subclaim conditions, review or scores.
- Referenced methods: Internally designed question conditions referring to the corresponding stored-summary records and family application conditions C01, C09, E06
- Related sources: R01

### N42 · How do original dates, corrections/empty values and the current preparation date differ?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: Evidence-cutoff/classification fields are absent, and current registration, corrections, retractions, new literature or links have not been queried.
- Required materials and conditions: Original preservation/search/registration, corrected versions and current preparation scope/time
- Materials to obtain first: Original preservation/search/registration, corrected versions and current preparation scope/time
- Further research: Preservation records distinguishing full original text, additional events and current scope when materials/corrections are actually provided
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining uncertainty: Evidence-cutoff/classification fields are absent, and current registration, corrections, retractions, new literature or links have not been queried.
- Referenced methods: Internally designed question conditions referring to the corresponding stored-summary records and family application conditions C09, C03
- Related sources: R01

### N43 · What gaps remain in extending beyond afebrile patients/original drugs or to long-term outcomes?

Verification status: Unverified  
Reading scope: Summary read; external materials not read

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: Direct materials on other ages/baseline conditions, fever/infection sites, other drugs/doses, long-term recurrence/complications, quality of life and resistance remain unverified.
- Required materials and conditions: Direct effect/harm materials by extended population, exposure and duration
- Materials to obtain first: Direct effect/harm materials by extended population, exposure and duration
- Further research: When appropriate materials are provided, distinction of the selected 7-day noninferiority question from questions under other conditions/time points
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: 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.
- Remaining 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.
- Referenced methods: Internally designed question conditions referring to the corresponding stored-summary records and family application conditions E08, E09, H08
- Related sources: R01

### N44 · Are noninferiority, recurrence and AEs kept from becoming antibiotic-selection/duration recommendations?

Verification status: Partly verified  
Reading scope: Summary read; external materials not read

- Current findings: 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.
- Why unverified: 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.
- Reason for missing information: Current care/regulations, patient baseline/culture, individual drugs/durations/doses/interactions and current benefits/harms have not been verified.
- Required materials and conditions: Direct materials on original research scope and extended populations/effects/harms
- Materials to obtain first: Direct materials on original research scope and extended populations/effects/harms
- Further research: If materials are provided and scope allows, updates to research gaps distinguishing original tables from other application conditions
- Conditions for verification: 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.
- Why this condition is needed: 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 exceptions: Noninferiority/reduced exposure is not written as recommendations on antibiotic selection, duration, dose, stopping/substitution or infection suitability, or as guarantees of individual safety.
- Remaining uncertainty: Current care/regulations, patient baseline/culture, individual drugs/durations/doses/interactions and current benefits/harms have not been verified.
- Referenced methods: Internally designed question conditions referring to the corresponding stored-summary records and family application conditions H09, E10, E09, E08, C09
- Related sources: R01

## Evidence and sources

### R01

Drekonja DM, et al. JAMA. 2021;326:324-331. PMID: 34313686.

[PubMed](https://pubmed.ncbi.nlm.nih.gov/34313686/)

Materials actually read: Summary read; external abstracts, full texts, registration and related judgments unread  
Findings recorded in the summary: 93.1% versus 90.2%, difference +2.9%p, one-sided 97.5% CI -5.2%p~infinity; margin -10%p  
Record level: Not recorded  
Independent replication: 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.

| Material | Public availability | Access status | Actually read | Notes |
|---|---|---|---|---|
| Stored summary | Full stored-summary copy | Stored-summary copy acquired; summary read | Summary read | 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. |
| External abstract | External materials unread; access not attempted | Access not attempted; not acquired | Not read | Original PubMed URL links identity only; no abstract acquisition/reading or link testing. |
| External full text | External materials unread; access not attempted | Access not attempted; not acquired | Not read | The original URL identifies the bibliography; it does not certify full-text access/acquisition. |
| External registration | External materials unread; access not attempted | Access not attempted; not acquired | Not read | Original ID preserved; no registration URL/dates absent from the review summary were created, and no access/comparison was performed. |
| Required protocol | Not acquired; detailed existence unverified | Access not attempted; not acquired | Not read | Materials needed on afebrile selection, original exposure/assessment windows, adherence and prespecified plans/changes for the noninferiority margin/primary population. |
| Required analysis plan | Not acquired; detailed existence unverified | Access not attempted; not acquired | Not read | Original materials needed on difference/interval models, margin justification, primary/all-randomized populations, recurrence/AE testing levels and missing data. |
| Required result tables and safety material | Not acquired; detailed existence unverified | Access not attempted; not acquired | Not read | Original tables needed for each event/denominator/proportion, recurrence counting/time points, assessment omissions and AE collection/duration/attribution; no new calculation/correction. |
| Required funding and interests | Not acquired; detailed existence unverified | Access not attempted; not acquired | Not read | Original funding preserved; sponsorship/product supply, data/analysis/publication and full COI unread. |
| Related judgment manuscript | External materials unread; access not attempted | Access not attempted; not acquired | Not read | Different question; original verification wording/grade is historical and is not promoted to a new clinical report, independent trial or current review. |
| Related judgment manuscript | External materials unread; access not attempted | Access not attempted; not acquired | Not read | 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. |

## Review criteria and methods

These are Chamgap's own application conditions, informed by the relevant sections of official methodological guidance. They do not constitute official assessment-tool certification or a new efficacy score.

- M03 [Cochrane Handbook 6.5 (2024), chapter updated 2023-08](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03) · §3.1, §3.2.1–3.2.3, MECIR C5/C7/C13 · Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions. · Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work.
- M04 [Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04) · §4.5, §4.6.1–4.6.3, MECIR C42 · Distinguish studies from reports and link them; do not omit a study solely because results are unreported. · Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work.
- M08 [Cochrane Handbook 6.5 (2024), chapter updated 2019-10](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08) · §8.1–8.2.3, Table 8.2.a · Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting. · Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work.
- M15 [Cochrane Handbook 6.5 (2024), chapter updated 2023-08](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15) · §15.2.4, §15.3.1–15.3.3 · Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision. · Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work.
- M19 [Cochrane Handbook 6.5 (2024), chapter updated 2019-10](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19) · §19.1.2, §19.2.1–19.2.4 · Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates. · Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work.

## What the statuses mean

- 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.

## Change history

2026-10-10 · Public page/materials 1.0. A public view and materials were prepared from the existing 44 items. No new clinical search, verification-status change or scoring was performed.