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

Required evidence, verification status and materials actually read
Item	AVerification status	BReading scope	CReview item	DCurrent findings	EWhy unverified	FRequired materials and conditions	GFurther research
1	Partly verified	Full text not readStored summary read	N01 · Evidence conditionWhat are the existing question, record and parent/sibling contexts?Required	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. R01	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.	Linkage of the existing question, record and parent/sibling boundaries	Follow-up materials linking new information for the same question while retaining the original question and judgment record
2	Partly verified	Full text not readStored summary read	N02 · Evidence conditionAre subclaim B/note and parent B70 different from absent subclaim scores/axes?Required	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. R01	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.	Separate preservation of subclaim/parent judgments and absent scores/axes	If a correction is actually provided, a record separating the full original text, event/version and change decision
3	Partly verified	Full text not readStored summary read	N03 · Evidence conditionHow are the same trial, report and recurrence/safety populations linked?Required	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. R01	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.	Relationships among bibliography/registration, report/trial families, populations/outcomes and related materials	A list distinguishing the same, separate or unidentified reports and outcome populations when additional materials are provided
4	Partly verified	Full text not readStored summary read	N04 · Evidence conditionHow do reading the stored summary and not reading original papers/links differ?Required	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. R01	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.	Status/reading level and original locations of the preserved summary and each external original material	Records separating actual access attempts, reading and dates when acquiring materials is allowed
5	Partly verified	Full text not readStored summary read	N05 · Evidence conditionWhat is the actual selection boundary for afebrile men with UTI?Required	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. R01	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.	Original inclusion/exclusion, baseline/culture and diagnostic/afebrile definition tables	Materials from the same trial or appropriate separate materials that directly specify the selected population/drug conditions
6	Partly verified	Full text not readStored summary read	N06 · Evidence conditionWhat are the representativeness and participant distributions at the two US VA centers?Required	The original record describes a 272-participant trial at two US VA centers. The two centers are not two independent trials. R01	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.	Center/recruitment, baseline tables and actual population/setting materials	Additional materials distinguishing conditions at each center of the same trial or populations for extension
7	Partly verified	Full text not readStored summary read	N07 · Evidence conditionWhat finished-product/drug scope applies to the study antibiotics?Required	The original drugs are ciprofloxacin or trimethoprim-sulfamethoxazole. Retains the original scope of exposure to one of these two drugs in the trial. R01	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.	Drug selection, group composition, nominal/actual exposure and drug-specific original materials	Original reports separating the applicable drug/population conditions and effects
8	Partly verified	Full text not readStored summary read	N08 · Evidence conditionDo 7 versus 14 days of exposure differ from actual dose/adherence?Required	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. R01	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.	Original treatment durations, active-drug/placebo schedules and actual adherence/change materials	Materials from the same trial separating exposure strategy and actual adherence
9	Partly verified	Full text not readStored summary read	N09 · Evidence conditionWhat actually occurred during placebo control and blinding periods?Required	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. R01	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.	Methods/appendices for original placebo/blinding, drug schedules and assessment procedures	Materials linking actual blinding and medication operation in the report/protocol
10	Partly verified	Full text not readStored summary read	N10 · Evidence conditionWhat are the 272 allocated participants, primary-analysis population of 254 and group denominators?Required	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. R01	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.	Original flow from allocation to primary/consistency analysis and assessment/safety	Materials from the same trial linking inclusion/exclusion and outcomes in each population
11	Partly verified	Full text not readStored summary read	N11 · Evidence conditionWhat is the original medication-adherence criterion?Required	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. R01	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.	Adherence definitions/measurement and original medication, exclusion and SAP materials	Materials distinguishing original criteria, inclusion/exclusion and missing data/changes
12	Partly verified	Full text not readStored summary read	N12 · Evidence conditionWhat original record describes the prespecified primary as-treated and per-protocol-type population?Required	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. R01	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.	SAP/protocol and original rules for analysis populations/per-protocol characteristics	Materials from the same trial disclosing planned and actual analysis-population inclusion/exclusion
13	Partly verified	Full text not readStored summary read	N13 · Evidence conditionDoes complete follow-up of everyone differ from primary-analysis exclusion/missing data?Required	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. R01	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.	Follow-up, assessment, medication and analysis flow, with exclusion/missing-data tables	Materials linking original completion records with each analysis/measurement scope
14	Partly verified	Full text not readStored summary read	N14 · Evidence conditionWhat people, denominators and proportions describe primary-analysis symptom resolution?Required	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. R01	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.	Original primary symptom-resolution tables, counts/definitions and population/time materials	Reports/appendices linking resolution events, original denominators and measurement rules
15	Partly verified	Full text not readStored summary read	N15 · Evidence conditionWhat defines difference +2.9%p and the favorable direction?Required	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. R01	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.	Direction/unit of the original difference, estimation model and original tables	Statistical materials specifying difference, adjustment and interval definitions
16	Partly verified	Full text not readStored summary read	N16 · Evidence conditionWhat are the lower bound and infinite upper end of the one-sided 97.5% CI?Required	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. R01	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.	One-sided interval/SAP, statistical methods and original result tables	Materials disclosing intervals/models according to the original methods
17	Partly verified	Full text not readStored summary read	N17 · Evidence conditionWhat is the comparison scope for the prespecified margin −10%p and lower bound?Required	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. R01	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.	Noninferiority-margin justification, SAP/registration and original estimation/testing plans	Materials disclosing the relationship between original margin justification/plans and results
18	Partly verified	Full text not readStored summary read	N18 · Evidence conditionHow are noninferiority, equivalence and superiority distinguished?Required	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. R01	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.	Testing objective/limits, intervals and original judgment scope	Additional materials separately distinguishing original testing objectives, patient outcomes and safety
19	Partly verified	Full text not readStored summary read	N19 · Evidence conditionWhat are the original values in the all-randomized consistency analysis of 272?Required	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. R01	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.	Original all-randomized analysis tables, definitions/missing data/SAP and intervals	Materials separately disclosing original denominators and results of the primary/all-randomized consistency populations
20	Partly verified	Full text not readStored summary read	N20 · Evidence conditionWhat differs between the primary and all-randomized populations, and what establishes robustness?Required	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. R01	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.	Analysis-population inclusion/exclusion, sensitivity analyses and original plans/result tables	Materials specifying the scope and outcomes of differing populations/handling using the original methods
21	Partly verified	Full text not readStored summary read	N21 · Evidence conditionHow were patient-reported symptom resolution and scales defined?Required	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. R01	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.	Original symptom lists/resolution judgments, patient reports and collection/measurement methods	Materials from the same trial disclosing actual definitions and measurement limits of patient-reported outcomes
22	Partly verified	Full text not readStored summary read	N22 · Evidence conditionAre 7 days of treatment and assessment within 14 days after therapy the same window?Required	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. R01	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.	Original schedules, exposure/end/assessment times by group and counting rules	Reports/protocols linking actual assessment windows with each group's treatment schedule
23	Partly verified	Full text not readStored summary read	N23 · Evidence conditionHow do blinding and medication schedules affect patient-reported measurement?Required	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. R01	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.	Blinding/unblinding, patient-report collection and assessment times/tools	Original materials linking actual symptom measurement and blinding to each endpoint
24	Partly verified	Full text not readStored summary read	N24 · Evidence conditionWhat models, between-/within-group comparisons, adjustments and missing-data handling define the difference?Required	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. R01	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.	Statistical methods/SAP, original models, analysis/missing data and result tables	Materials specifying between-group differences, models and populations using the original methods
25	Partly verified	Full text not readStored summary read	N25 · Evidence conditionWhat records describe the primary endpoint/analysis, margin and registration?Required	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. R01	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.	Registration/plan/analysis versions, margins/endpoints/populations and change materials	Records separating verified comparison scope from unexamined matters and changes when actual plans are provided
26	Unverified	Full text not readStored summary read	N26 · Evidence conditionWhat supports the importance and preserved effect of the −10%p margin?Required	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. R01	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.	Noninferiority-margin rationale, original design/historical materials and testing assumptions	A manuscript specifying the margin and current interval/population when actual justification materials are provided
27	Partly verified	Full text not readStored summary read	N27 · Evidence conditionWhat are the effects of per-protocol-type selection, adherence/rescue treatment and the effect of interest?Required	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. R01	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.	Concomitant/rescue treatment, medication/changes and analysis-inclusion/SAP materials	Materials linking strategy, actual implementation and conditional selection to original populations/outcomes
28	Partly verified	Full text not readStored summary read	N28 · Evidence conditionWhat time origin and definition apply to the sibling 28-day recurrence outcome?Required	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. R01	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.	Recurrence definitions/times, conditional populations and counting/assessment materials	Materials disclosing symptom resolution and recurrence in the same trial according to their respective original definitions/time points
29	Partly verified	Full text not readStored summary read	N29 · Evidence conditionWhat are the recorded recurrence numerators, denominators, proportions and difference?Required	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. R01	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.	Original recurrence tables, numerators/denominators/counting, conditions/assessment and versions	Linkage separating the full before/after original text and events when original result tables/corrections are provided
30	Partly verified	Full text not readStored summary read	N30 · Evidence conditionWhat does the recurrence 95% CI −10.8~6.2 cover?Required	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. R01	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.	Original recurrence intervals, statistics/plans, hierarchy and testing objectives	Materials separately disclosing recurrence estimates/intervals and plans
31	Partly verified	Full text not readStored summary read	N31 · Evidence conditionHow is sharing of the same people among recurrence, primary and all-randomized populations distinguished?Required	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. R01	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.	Endpoint/analysis-specific flow and original relationships among people, repeated events and time points	Original materials linking the same populations/different conditions to each denominator
32	Partly verified	Full text not readStored summary read	N32 · Evidence conditionWhat are the original people, denominators, proportions and difference for adverse events?Required	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. R01	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.	Original AE tables, people/event counts, populations/times and classification/collection	Original materials linking safety of the same exposure with denominators/durations
33	Partly verified	Full text not readStored summary read	N33 · Evidence conditionWhat statistical testing and causal level apply to the adverse-event difference?Required	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. R01	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.	Original safety tables/SAP, comparative statistics and attribution/collection	Materials from the same trial specifying original statistical levels and harm definitions
34	Unverified	Full text not readStored summary read	N34 · Evidence conditionWhat are the onset, recovery, discontinuation and exposure windows for safety?Required	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. R01	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.	Temporal order of harms, collection windows, exposure/discontinuation/rechallenge and original tables	Materials separating actual harm/exposure times from symptom/recurrence windows
35	Unverified	Full text not readStored summary read	N35 · Evidence conditionDoes complete follow-up mean complete collection of all AEs and long-term/rare events?Required	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. R01	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.	Safety-analysis populations, collection/omission/follow-up and type-specific original materials	Materials from the same trial or appropriate additional materials specifying actual collection, missing data and long-term scope
36	Unverified	Full text not readStored summary read	N36 · Evidence conditionWhat alternative causes of harms involve baseline conditions, concurrent drugs or culture?Required	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. R01	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.	Baseline/concurrent exposures, original event attribution and culture/drug/population-specific materials	Safety materials separating original baseline/exposure, attribution and collection scope
37	Partly verified	Full text not readStored summary read	N37 · Evidence conditionAre reduced exposure and individual/population antibiotic resistance different questions?Required	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. R01	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.	Direct resistance/culture measurements, definitions/denominators/time points and original analyses	If appropriate direct resistance materials are provided, linkage as a question separate from symptoms/exposure
38	Partly verified	Full text not readStored summary read	N38 · Evidence conditionWhat is the scope of VA public funding, product provision/sponsorship and author COI?Required	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. R01	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.	Original funding/COI, sponsor/author roles and product/data declarations	Separation of verified funding/roles from unverified matters when actual original declarations are provided
39	Partly verified	Full text not readStored summary read	N39 · Evidence conditionWhat distinguishes one report/a single trial from current independent replication?Required	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. R01	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.	Relationships among reports/trials/populations, analyses/outcomes and independent materials	Distinctions by verification level among repeated citations, the same populations and separate populations when new materials are provided
40	Partly verified	Full text not readStored summary read	N40 · Evidence conditionWhat do the cross-citations to women in 1793/862 preserve?Required	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.	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.	Materials distinguishing different populations/drugs/endpoints and the original cross-citation scope	When related materials are provided, linkage of uncomplicated cystitis in women and UTI in men as different questions
41	Partly verified	Full text not readStored summary read	N41 · Evidence conditionWhat are the parent axes, Korean/English manuscripts and false/null/empty values in judgment history?Required	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. R01	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.	Separate preservation of subclaim/parent original values, axes/languages/empty values and historical judgments	If an actual correction is provided, records of full original text, event/version and changes within each scope
42	Partly verified	Full text not readStored summary read	N42 · Evidence conditionHow do original dates, corrections/empty values and the current preparation date differ?Required	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. R01	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.	Original preservation/search/registration, corrected versions and current preparation scope/time	Preservation records distinguishing full original text, additional events and current scope when materials/corrections are actually provided
43	Unverified	Full text not readStored summary read	N43 · Evidence conditionWhat gaps remain in extending beyond afebrile patients/original drugs or to long-term outcomes?Supplementary; required for extension	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. R01	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.	Direct effect/harm materials by extended population, exposure and duration	When appropriate materials are provided, distinction of the selected 7-day noninferiority question from questions under other conditions/time points
44	Partly verified	Full text not readStored summary read	N44 · Evidence conditionAre noninferiority, recurrence and AEs kept from becoming antibiotic-selection/duration recommendations?Required	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. R01	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.	Direct materials on original research scope and extended populations/effects/harms	If materials are provided and scope allows, updates to research gaps distinguishing original tables from other application conditions

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44 itemsWhat the statuses mean

Assessment scope

Stored-material review date: Not recorded
Original evidence cut-off: 2026-08-26
Scope actually checked: Existing review summaries and stored records of methodological application. Full papers, supplements, registrations, plans and original data were not read.
What the dates mean: This is the date the stored materials were checked, not the date of a new search of the clinical literature.
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

Evidence and sources

The links below lead to the sources. A link alone does not mean the original source was read or its latest publication status verified.

R01 · Drekonja DM, et al. JAMA. 2021;326:324-331. PMID: 34313686.

PubMed

Material type: Original-report summary of a double-blind, placebo-controlled noninferiority RCT
Materials actually read: Summary read; external abstracts, full texts, registration and related judgments unread
Findings recorded in the stored 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
Study overlap and 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.

Public availability, access and reading status by material
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.

Report counts versus independent study counts

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.

Review criteria

Version 1.0 · Criteria record date 2026-10-06. These are Chamgap's own application conditions, informed by the referenced methods. They do not constitute official assessment-tool certification or a new efficacy score.

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

Required materials and conditions: Linkage of the existing question, record and parent/sibling boundaries
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.
Requirement and applicability: Required
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.
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.
Referenced methods: Internally designed question conditions referring to the corresponding stored-summary records and family application conditions C01

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

Required materials and conditions: Separate preservation of subclaim/parent judgments and absent scores/axes
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.
Requirement and applicability: Required
Application exceptions: No uniform D, parent 70 points, B1/I2 or precision null is copied to the subclaim, and no reassessment is performed.
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.
Referenced methods: Internally designed question conditions referring to the corresponding stored-summary records and family application conditions C01, C09

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

Required materials and conditions: Relationships among bibliography/registration, report/trial families, populations/outcomes and related materials
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.
Requirement and applicability: Required
Application exceptions: The two subclaim rows, 131/123, 272, 136/136 and related-judgment links are not added as independent replications or new participants.
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.
Referenced methods: Internally designed question conditions referring to the corresponding stored-summary records and family application conditions C02, E07, H07

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

Required materials and conditions: Status/reading level and original locations of the preserved summary and each external original material
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.
Requirement and applicability: Required
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.
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.
Referenced methods: Internally designed question conditions referring to the corresponding stored-summary records and family application conditions C03

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

Required materials and conditions: Original inclusion/exclusion, baseline/culture and diagnostic/afebrile definition tables
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.
Requirement and applicability: Required
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.
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.
Referenced methods: Internally designed question conditions referring to the corresponding stored-summary records and family application conditions C04, E08

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

Required materials and conditions: Center/recruitment, baseline tables and actual population/setting materials
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.
Requirement and applicability: Required
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.
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.
Referenced methods: Internally designed question conditions referring to the corresponding stored-summary records and family application conditions C04, E07

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

Required materials and conditions: Drug selection, group composition, nominal/actual exposure and drug-specific original materials
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.
Requirement and applicability: Required
Application exceptions: The two drugs are not changed to simultaneous combination treatment or extended to other antibiotics or individual drug-selection/dose recommendations.
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.
Referenced methods: Internally designed question conditions referring to the corresponding stored-summary records and family application conditions C05, E08

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

Required materials and conditions: Original treatment durations, active-drug/placebo schedules and actual adherence/change materials
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.
Requirement and applicability: Required
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.
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.
Referenced methods: Internally designed question conditions referring to the corresponding stored-summary records and family application conditions C05, E02

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

Required materials and conditions: Methods/appendices for original placebo/blinding, drug schedules and assessment procedures
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.
Requirement and applicability: Required
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.
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.
Referenced methods: Internally designed question conditions referring to the corresponding stored-summary records and family application conditions E01, E03, E02

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

Required materials and conditions: Original flow from allocation to primary/consistency analysis and assessment/safety
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.
Requirement and applicability: Required
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.
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.
Referenced methods: Internally designed question conditions referring to the corresponding stored-summary records and family application conditions C07, E04

N11 · What is the original medication-adherence criterion?

Required materials and conditions: Adherence definitions/measurement and original medication, exclusion and SAP materials
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.
Requirement and applicability: Required
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.
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.
Referenced methods: Internally designed question conditions referring to the corresponding stored-summary records and family application conditions E04, E02

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

Required materials and conditions: SAP/protocol and original rules for analysis populations/per-protocol characteristics
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.
Requirement and applicability: Required
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.
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.
Referenced methods: Internally designed question conditions referring to the corresponding stored-summary records and family application conditions E04, E06

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

Required materials and conditions: Follow-up, assessment, medication and analysis flow, with exclusion/missing-data tables
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.
Requirement and applicability: Required
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.
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.
Referenced methods: Internally designed question conditions referring to the corresponding stored-summary records and family application conditions C07, E04

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

Required materials and conditions: Original primary symptom-resolution tables, counts/definitions and population/time materials
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.
Requirement and applicability: Required
Application exceptions: Rounded proportions are not used to calculate new values/CIs, unresolved cases or participant totals, or transferred to recurrence denominators/events.
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.
Referenced methods: Internally designed question conditions referring to the corresponding stored-summary records and family application conditions C06, C07

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

Required materials and conditions: Direction/unit of the original difference, estimation model and original tables
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.
Requirement and applicability: Required
Application exceptions: No new risk ratio/difference or improvement duration is calculated, and +2.9 is not changed to statistical superiority or individual benefit.
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.
Referenced methods: Internally designed question conditions referring to the corresponding stored-summary records and family application conditions C06, E04, E05

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

Required materials and conditions: One-sided interval/SAP, statistical methods and original result tables
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.
Requirement and applicability: Required
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%.
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.
Referenced methods: Internally designed question conditions referring to the corresponding stored-summary records and family application conditions C07, E05

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

Required materials and conditions: Noninferiority-margin justification, SAP/registration and original estimation/testing plans
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.
Requirement and applicability: Required
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.
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.
Referenced methods: Internally designed question conditions referring to the corresponding stored-summary records and family application conditions E05, E06

N18 · How are noninferiority, equivalence and superiority distinguished?

Required materials and conditions: Testing objective/limits, intervals and original judgment scope
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.
Requirement and applicability: Required
Application exceptions: The existing advertising interpretation's wording 'same'/equal is not newly confirmed as exact equivalence, superiority or absence of harm.
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.
Referenced methods: Internally designed question conditions referring to the corresponding stored-summary records and family application conditions C08, E05, E09

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

Required materials and conditions: Original all-randomized analysis tables, definitions/missing data/SAP and intervals
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.
Requirement and applicability: Required
Application exceptions: Original event counts are not reconstructed, and all-randomized results/lower bounds are not copied as primary-analysis results for 254.
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.
Referenced methods: Internally designed question conditions referring to the corresponding stored-summary records and family application conditions E04, E05, C07

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

Required materials and conditions: Analysis-population inclusion/exclusion, sensitivity analyses and original plans/result tables
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.
Requirement and applicability: Required
Application exceptions: Consistency wording alone does not certify robustness across every analysis/population, and the two populations are not added as independent confirmations.
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.
Referenced methods: Internally designed question conditions referring to the corresponding stored-summary records and family application conditions E04, E05, C02

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

Required materials and conditions: Original symptom lists/resolution judgments, patient reports and collection/measurement methods
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.
Requirement and applicability: Required
Application exceptions: Symptom resolution is not changed to microbiological clearance, complication prevention or all long-term cure without original materials.
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.
Referenced methods: Internally designed question conditions referring to the corresponding stored-summary records and family application conditions C06, E03, E09

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

Required materials and conditions: Original schedules, exposure/end/assessment times by group and counting rules
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.
Requirement and applicability: Required
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.
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.
Referenced methods: Internally designed question conditions referring to the corresponding stored-summary records and family application conditions C06, E03

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

Required materials and conditions: Blinding/unblinding, patient-report collection and assessment times/tools
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.
Requirement and applicability: Required
Application exceptions: Double-blind wording is not automatically promoted to absence of measurement limitations or fulfillment of all conditions.
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.
Referenced methods: Internally designed question conditions referring to the corresponding stored-summary records and family application conditions E03, E01

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

Required materials and conditions: Statistical methods/SAP, original models, analysis/missing data and result tables
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.
Requirement and applicability: Required
Application exceptions: Models/adjustments or ITT/PP levels are not filled by inference, and superiority between drugs is not created.
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.
Referenced methods: Internally designed question conditions referring to the corresponding stored-summary records and family application conditions E04, E05

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

Required materials and conditions: Registration/plan/analysis versions, margins/endpoints/populations and change materials
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.
Requirement and applicability: Required
Application exceptions: The registration ID or original 'prespecified' wording does not certify completed current registration/plan review or absence of all selective reporting.
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.
Referenced methods: Internally designed question conditions referring to the corresponding stored-summary records and family application conditions E06, C09

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

Required materials and conditions: Noninferiority-margin rationale, original design/historical materials and testing assumptions
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.
Requirement and applicability: Required
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.
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.
Referenced methods: Internally designed question conditions referring to the corresponding stored-summary records and family application conditions E05, E06

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

Required materials and conditions: Concomitant/rescue treatment, medication/changes and analysis-inclusion/SAP materials
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.
Requirement and applicability: Required
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.
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.
Referenced methods: Internally designed question conditions referring to the corresponding stored-summary records and family application conditions E02, E04

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

Required materials and conditions: Recurrence definitions/times, conditional populations and counting/assessment materials
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.
Requirement and applicability: Required
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.
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.
Referenced methods: Internally designed question conditions referring to the corresponding stored-summary records and family application conditions C06, E03, E09

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

Required materials and conditions: Original recurrence tables, numerators/denominators/counting, conditions/assessment and versions
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.
Requirement and applicability: Required
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.
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.
Referenced methods: Internally designed question conditions referring to the corresponding stored-summary records and family application conditions C07, C08, E04

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

Required materials and conditions: Original recurrence intervals, statistics/plans, hierarchy and testing objectives
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.
Requirement and applicability: Required
Application exceptions: The primary −10%p margin is not applied to the recurrence CI to make a new noninferiority, equivalence or significant-reduction judgment.
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.
Referenced methods: Internally designed question conditions referring to the corresponding stored-summary records and family application conditions E05, C08, E06

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

Required materials and conditions: Endpoint/analysis-specific flow and original relationships among people, repeated events and time points
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.
Requirement and applicability: Required
Application exceptions: Resolution/recurrence and primary/all-randomized denominators are not added to create new participants or independent replications.
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.
Referenced methods: Internally designed question conditions referring to the corresponding stored-summary records and family application conditions C02, C07, E04

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

Required materials and conditions: Original AE tables, people/event counts, populations/times and classification/collection
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.
Requirement and applicability: Required
Application exceptions: Apart from original −3.7%p, no new CIs/risk ratios, overlapping totals or type-specific incidence rates are calculated.
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.
Referenced methods: Internally designed question conditions referring to the corresponding stored-summary records and family application conditions E10, H01, H03, H04

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

Required materials and conditions: Original safety tables/SAP, comparative statistics and attribution/collection
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.
Requirement and applicability: Required
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.
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.
Referenced methods: Internally designed question conditions referring to the corresponding stored-summary records and family application conditions H09, E05, E10

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

Required materials and conditions: Temporal order of harms, collection windows, exposure/discontinuation/rechallenge and original tables
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.
Requirement and applicability: Required
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.
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.
Referenced methods: Internally designed question conditions referring to the corresponding stored-summary records and family application conditions H02, H04, E10

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

Required materials and conditions: Safety-analysis populations, collection/omission/follow-up and type-specific original materials
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.
Requirement and applicability: Required
Application exceptions: Completion/shorter exposure does not certify absence of all harms, exclusion of rare risks or current safety.
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.
Referenced methods: Internally designed question conditions referring to the corresponding stored-summary records and family application conditions H06, H08, H04

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

Required materials and conditions: Baseline/concurrent exposures, original event attribution and culture/drug/population-specific materials
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.
Requirement and applicability: Required
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.
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.
Referenced methods: Internally designed question conditions referring to the corresponding stored-summary records and family application conditions H05, E02, E10

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

Required materials and conditions: Direct resistance/culture measurements, definitions/denominators/time points and original analyses
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.
Requirement and applicability: Required
Application exceptions: Shorter exposure is not promoted to direct efficacy for reducing individual resistance or all long-term harms.
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.
Referenced methods: Internally designed question conditions referring to the corresponding stored-summary records and family application conditions E09, E08

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

Required materials and conditions: Original funding/COI, sponsor/author roles and product/data declarations
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.
Requirement and applicability: Required
Application exceptions: Public funding/I2 is not inherited as current certification of no COI, no bias or completed independence verification.
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.
Referenced methods: Internally designed question conditions referring to the corresponding stored-summary records and family application conditions C10

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

Required materials and conditions: Relationships among reports/trials/populations, analyses/outcomes and independent materials
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.
Requirement and applicability: Required
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.
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.
Referenced methods: Internally designed question conditions referring to the corresponding stored-summary records and family application conditions C02, E07, H07

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

Required materials and conditions: Materials distinguishing different populations/drugs/endpoints and the original cross-citation scope
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.
Requirement and applicability: Required
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.
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.
Referenced methods: Internally designed question conditions referring to the corresponding stored-summary records and family application conditions C02, C04, C09, E08

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

Required materials and conditions: Separate preservation of subclaim/parent original values, axes/languages/empty values and historical judgments
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.
Requirement and applicability: Required
Application exceptions: Original listed noninferiority limitations/scores are not repeated as new limitation assessment or reassessment, and precision null is not filled with 0.
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.
Referenced methods: Internally designed question conditions referring to the corresponding stored-summary records and family application conditions C01, C09, E06

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

Required materials and conditions: Original preservation/search/registration, corrected versions and current preparation scope/time
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.
Requirement and applicability: Required
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.
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.
Referenced methods: Internally designed question conditions referring to the corresponding stored-summary records and family application conditions C09, C03

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

Required materials and conditions: Direct effect/harm materials by extended population, exposure and duration
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.
Requirement and applicability: Supplementary; required for extension
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.
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.
Referenced methods: Internally designed question conditions referring to the corresponding stored-summary records and family application conditions E08, E09, H08

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

Required materials and conditions: Direct materials on original research scope and extended populations/effects/harms
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.
Requirement and applicability: Required
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.
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.
Referenced methods: Internally designed question conditions referring to the corresponding stored-summary records and family application conditions H09, E10, E09, E08, C09

Referenced methods and the sections actually reviewed

M03 · Cochrane Handbook 6.5 (2024), chapter updated 2023-08

Official methodology · §3.1, §3.2.1–3.2.3, MECIR C5/C7/C13

Referenced principle: Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.
Extent of review: 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

Official methodology · §4.5, §4.6.1–4.6.3, MECIR C42

Referenced principle: Distinguish studies from reports and link them; do not omit a study solely because results are unreported.
Extent of review: 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

Official methodology · §8.1–8.2.3, Table 8.2.a

Referenced principle: Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.
Extent of review: 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

Official methodology · §15.2.4, §15.3.1–15.3.3

Referenced principle: Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.
Extent of review: 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

Official methodology · §19.1.2, §19.2.1–19.2.4

Referenced principle: Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.
Extent of review: 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/material version 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.

The stored-material review date (Not recorded) and original evidence cut-off (2026-08-26) were retained unchanged.

Researcher downloads

These materials provide the same evidence, scope and verification status as this page.

View all item details

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

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.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
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
Remaining uncertainty: The existing candidate's pending boundary review is historical; review of existing content and the question boundary remains incomplete.
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.
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?

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.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
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
Remaining uncertainty: No direct original subclaim score, status or axis values exist.
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.
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?

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.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
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
Remaining uncertainty: Subsequent/other paper versions, overlapping people/reports and current unique trial/participant totals remain undetermined.
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.
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?

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.
Verification status: Partly verified
Materials actually read: Summary read; external materials not 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
Remaining uncertainty: Current public availability/acquisition, access/content and URL operation have not been verified.
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.
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?

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.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
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
Remaining uncertainty: Original details of age, diagnosis/symptoms, underlying conditions, culture positivity/susceptibility, inclusion/exclusion and infection site remain unverified.
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.
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?

Current findings: The original record describes a 272-participant trial at two US VA centers. The two centers are not two independent trials.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
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
Remaining uncertainty: Recruitment/composition by center, baseline balance and direct outcomes in populations outside the VA or other settings remain unverified.
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.
Referenced methods: Internally designed question conditions referring to the corresponding stored-summary records and family application conditions C04, E07

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

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.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
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
Remaining uncertainty: Numbers by drug, selection/allocation, dose/formulation/route, actual exposure and drug-specific outcomes/interactions remain unverified.
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.
Referenced methods: Internally designed question conditions referring to the corresponding stored-summary records and family application conditions C05, E08

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

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.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
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
Remaining uncertainty: Nominal/actual amounts by drug, discontinuation/changes, adverse effects/rescue, medication schedules and total exposure details remain unverified.
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.
Referenced methods: Internally designed question conditions referring to the corresponding stored-summary records and family application conditions C05, E02

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

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.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
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
Remaining uncertainty: Active-drug/placebo periods, packaging/matching, blinding targets/maintenance, unblinding/success and assessor roles remain unverified.
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.
Referenced methods: Internally designed question conditions referring to the corresponding stored-summary records and family application conditions E01, E03, E02

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

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.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
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
Remaining uncertainty: Original flow by randomized group, counts for each exclusion/nonadherence reason, drug composition and detailed endpoint-specific assessment/safety denominators remain unverified.
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.
Referenced methods: Internally designed question conditions referring to the corresponding stored-summary records and family application conditions C07, E04

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N11 · What is the original medication-adherence criterion?

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.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
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
Remaining uncertainty: Total active-drug/placebo doses, drug-specific dosing intervals, recording/verification, criterion changes/exclusion reasons and selection effects remain unverified.
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.
Referenced methods: Internally designed question conditions referring to the corresponding stored-summary records and family application conditions E04, E02

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

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.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
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
Remaining uncertainty: The full original analysis-population definition, prespecification/changes, selection/deviations and sensitivity analyses including nonadherence have not been read externally.
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.
Referenced methods: Internally designed question conditions referring to the corresponding stored-summary records and family application conditions E04, E06

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

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.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
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
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.
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.
Referenced methods: Internally designed question conditions referring to the corresponding stored-summary records and family application conditions C07, E04

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

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.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
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
Remaining uncertainty: Original symptom definitions, criteria/assessment schedules, individual omissions and distributions by drug remain unverified.
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.
Referenced methods: Internally designed question conditions referring to the corresponding stored-summary records and family application conditions C06, C07

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

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.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
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
Remaining uncertainty: Direct original details of difference estimation/adjustment, stratification, interval methods, within-group change and absolute durations remain unverified.
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.
Referenced methods: Internally designed question conditions referring to the corresponding stored-summary records and family application conditions C06, E04, E05

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

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.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
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
Remaining uncertainty: Original interval calculation, adjustment, model/stratification, alternative intervals and two-sided intervals remain unverified.
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%.
Referenced methods: Internally designed question conditions referring to the corresponding stored-summary records and family application conditions C07, E05

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

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.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
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
Remaining uncertainty: Margin rationale, historical control effect/preservation, patient values, original alpha/power and comparison of versions remain unverified.
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.
Referenced methods: Internally designed question conditions referring to the corresponding stored-summary records and family application conditions E05, E06

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N18 · How are noninferiority, equivalence and superiority distinguished?

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.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
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
Remaining uncertainty: Superiority/equivalence plans, two-sided equivalence intervals, individual importance and superiority for safety/resistance have not been verified.
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.
Referenced methods: Internally designed question conditions referring to the corresponding stored-summary records and family application conditions C08, E05, E09

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

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.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
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
Remaining uncertainty: Original events/denominators by group, the consistency-analysis definition, missing-data/adherence handling and original models remain unverified.
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.
Referenced methods: Internally designed question conditions referring to the corresponding stored-summary records and family application conditions E04, E05, C07

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

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.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
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
Remaining uncertainty: Nonadherence/drug changes by group, relationships between people in the two populations, sensitivity analyses and magnitudes/assumptions of selection bias remain unverified.
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.
Referenced methods: Internally designed question conditions referring to the corresponding stored-summary records and family application conditions E04, E05, C02

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

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.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
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
Remaining uncertainty: Symptom lists, definitions/scales, assessors/records, resolution judgments and agreement with culture results remain unverified.
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.
Referenced methods: Internally designed question conditions referring to the corresponding stored-summary records and family application conditions C06, E03, E09

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

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.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
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
Remaining uncertainty: Original assessment days, time origins/synchronization by group, allowed windows, repeated measurements and closure/omissions remain unverified.
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.
Referenced methods: Internally designed question conditions referring to the corresponding stored-summary records and family application conditions C06, E03

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

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.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
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
Remaining uncertainty: Assessor/participant information, blinding success/unblinding, measurement tools/differences, omissions and group-specific assessment methods remain unverified.
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.
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?

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.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
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
Remaining uncertainty: Difference/interval models, adjustment/stratification, contributions by drug, missing data/deviations and original SAP details remain unverified.
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.
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?

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.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
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
Remaining uncertainty: Original comparison of registration/protocol/SAP versions, change dates and prespecified endpoints/analyses/time points has not been read.
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.
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?

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.
Verification status: Unverified
Materials actually read: Summary read; external materials not read
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
Remaining uncertainty: Margin selection, historical effects/constancy, acceptable differences and power/SAP criteria remain unverified.
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.
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?

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.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
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
Remaining uncertainty: SAP details for nonadherence/concomitant treatment, drug switching, rescue/retreatment, subsequent exposure and allocation/adherence effects remain unverified.
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.
Referenced methods: Internally designed question conditions referring to the corresponding stored-summary records and family application conditions E02, E04

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

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.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
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
Remaining uncertainty: The 28-day time origin, recurrence/reinfection, selection after resolution, records/culture/retreatment and original assessment window remain unverified.
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.
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?

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.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
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
Remaining uncertainty: Original recurrence counting rules, assessability, conditional populations, recurrence/missing data and numerical/version details remain unverified.
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.
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?

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.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
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
Remaining uncertainty: Recurrence CI calculation/models, P value, prespecified margins/hierarchy, importance and power remain unverified.
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.
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?

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.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
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
Remaining uncertainty: Original inclusion/omission in each population, resolution conditions/recurrence selection, repeated events and relationships among people at each time point remain unverified.
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.
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?

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.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
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
Remaining uncertainty: Adverse-event types/grades, collection windows, exposed populations, repeated events, attribution/discontinuation and omissions remain unverified.
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.
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?

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.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
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
Remaining uncertainty: The full scope of comparative CIs/P values, plans/tests, event attribution and causal evidence has not been read externally.
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.
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?

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.
Verification status: Unverified
Materials actually read: Summary read; external materials not read
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
Remaining uncertainty: Event onset/recovery, discontinuation/re-exposure, collection end, actual drug/placebo exposure and harms at each stage remain unverified.
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.
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?

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.
Verification status: Unverified
Materials actually read: Summary read; external materials not read
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
Remaining uncertainty: Safety omissions/detection, recall/assessment, treatment changes/follow-up, rare/long-term events and recruitment for each type remain unverified.
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.
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?

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.
Verification status: Unverified
Materials actually read: Summary read; external materials not read
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
Remaining uncertainty: Baseline risks, concurrent drugs/other treatment, events by drug, alternative causes/adjustment and suitability materials remain unverified.
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.
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?

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.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
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
Remaining uncertainty: Acquired resistance/culture, organisms/susceptibility, population selection pressure/long-term spread and direct denominators/durations/estimates remain unverified.
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.
Referenced methods: Internally designed question conditions referring to the corresponding stored-summary records and family application conditions E09, E08

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

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.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
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
Remaining uncertainty: Contracts/product supply, design/collection/statistics/writing/submission, data access, author employment and full COI have not been read externally.
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.
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?

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.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
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
Remaining uncertainty: Current additional trials/follow-up reports, independent populations/funding and contrary materials under other conditions remain undetermined without a new search.
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.
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?

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.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
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
Remaining uncertainty: Those judgment contents/original papers, populations/drugs/effects and current cross-citation review/link status have not been read or verified.
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.
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?

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.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
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
Remaining uncertainty: Original B1/I2/precision and judgment values have not been inherited as current subclaim conditions, review or scores.
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.
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?

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.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
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
Remaining uncertainty: Evidence-cutoff/classification fields are absent, and current registration, corrections, retractions, new literature or links have not been queried.
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.
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?

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.
Verification status: Unverified
Materials actually read: Summary read; external materials not read
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
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.
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.
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?

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.
Verification status: Partly verified
Materials actually read: Summary read; external materials not read
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
Remaining uncertainty: Current care/regulations, patient baseline/culture, individual drugs/durations/doses/interactions and current benefits/harms have not been verified.
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.
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