{
  "schema_version": "chamgap-public-criteria-1.0",
  "title": "7 versus 14 days of antibiotics · Afebrile men with UTI · Symptom-resolution noninferiority evidence checklist",
  "language": "en",
  "translation_date": "2026-10-10",
  "criteria_version": "1.0",
  "criteria_date": "2026-10-06",
  "condition_origin": "Chamgap's own application conditions",
  "method_sources": [
    {
      "id": "M03",
      "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03",
      "section": "§3.1, §3.2.1–3.2.3, MECIR C5/C7/C13",
      "official_principle": "Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.",
      "review_level": "Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work."
    },
    {
      "id": "M04",
      "version": "Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04",
      "section": "§4.5, §4.6.1–4.6.3, MECIR C42",
      "official_principle": "Distinguish studies from reports and link them; do not omit a study solely because results are unreported.",
      "review_level": "Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work."
    },
    {
      "id": "M08",
      "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08",
      "section": "§8.1–8.2.3, Table 8.2.a",
      "official_principle": "Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.",
      "review_level": "Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work."
    },
    {
      "id": "M15",
      "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15",
      "section": "§15.2.4, §15.3.1–15.3.3",
      "official_principle": "Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.",
      "review_level": "Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work."
    },
    {
      "id": "M19",
      "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19",
      "section": "§19.1.2, §19.2.1–19.2.4",
      "official_principle": "Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.",
      "review_level": "Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work."
    }
  ],
  "status_dictionary": {
    "Met": "The original content has been reviewed as meeting the conditions. This status is not used in this preparation.",
    "Partly verified": "Some information in the stored summary was linked during preparation; clinical verification or review is not complete.",
    "Unverified": "Required direct values, definitions or materials have not been established within the current storage and reading scope. This does not mean zero effect, no papers or failed access.",
    "Review incomplete": "Review of existing content or actual review incomplete.",
    "Not reported": "Used only when original materials were actually read and the outcome was judged unreported. Not used for external materials unread in this work.",
    "Inaccessible": "Used only when an actual access attempt has a recorded failure. Not used for access that was not attempted in this work.",
    "Insufficient evidence for the conditions": "Indicates insufficient direct materials for the relevant scope or conditions; it is not a new grade.",
    "Not applicable": "Used when the reason it does not apply to the original question is stated.",
    "Conflicting data": "Retains the scope of conflicting statements in original materials; it is not an arbitrary reassessment."
  },
  "requirements": [
    {
      "item_id": "N01",
      "question_type": "Evidence condition",
      "question": "What are the existing question, record and parent/sibling contexts?",
      "needed": "Linkage of the existing question, record and parent/sibling boundaries",
      "role": "Required",
      "role_reason": "Required to address 'What are the existing question, record and parent/sibling contexts?' separately for the selected question of 7-day symptom-resolution noninferiority.",
      "application_exception": "The existing candidate's pending boundary review is historical; review of existing content and the question boundary remains incomplete. Empty values are not filled with new calculations, numerical examples or judgments; the original scope is retained.",
      "criterion": "Link original values, definitions, denominators, times, margins/direction and unverified matters for 'What are the existing question, record and parent/sibling contexts?' to the corresponding original records. The existing candidate's pending boundary review is historical; review of existing content and the question boundary remains incomplete.",
      "basis": "Internally designed question conditions referring to the corresponding stored-summary records and family application conditions C01",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Follow-up materials linking new information for the same question while retaining the original question and judgment record"
    },
    {
      "item_id": "N02",
      "question_type": "Evidence condition",
      "question": "Are subclaim B/note and parent B70 different from absent subclaim scores/axes?",
      "needed": "Separate preservation of subclaim/parent judgments and absent scores/axes",
      "role": "Required",
      "role_reason": "Required to address 'Are subclaim B/note and parent B70 different from absent subclaim scores/axes?' separately for the selected question of 7-day symptom-resolution noninferiority.",
      "application_exception": "No uniform D, parent 70 points, B1/I2 or precision null is copied to the subclaim, and no reassessment is performed.",
      "criterion": "Link original values, definitions, denominators, times, margins/direction and unverified matters for 'Are subclaim B/note and parent B70 different from absent subclaim scores/axes?' to the corresponding original records. No direct original subclaim score, status or axis values exist.",
      "basis": "Internally designed question conditions referring to the corresponding stored-summary records and family application conditions C01, C09",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "If a correction is actually provided, a record separating the full original text, event/version and change decision"
    },
    {
      "item_id": "N03",
      "question_type": "Evidence condition",
      "question": "How are the same trial, report and recurrence/safety populations linked?",
      "needed": "Relationships among bibliography/registration, report/trial families, populations/outcomes and related materials",
      "role": "Required",
      "role_reason": "Required to address 'How are the same trial, report and recurrence/safety populations linked?' separately for the selected question of 7-day symptom-resolution noninferiority.",
      "application_exception": "The two subclaim rows, 131/123, 272, 136/136 and related-judgment links are not added as independent replications or new participants.",
      "criterion": "Link original values, definitions, denominators, times, margins/direction and unverified matters for 'How are the same trial, report and recurrence/safety populations linked?' to the corresponding original records. Subsequent/other paper versions, overlapping people/reports and current unique trial/participant totals remain undetermined.",
      "basis": "Internally designed question conditions referring to the corresponding stored-summary records and family application conditions C02, E07, H07",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "A list distinguishing the same, separate or unidentified reports and outcome populations when additional materials are provided"
    },
    {
      "item_id": "N04",
      "question_type": "Evidence condition",
      "question": "How do reading the stored summary and not reading original papers/links differ?",
      "needed": "Status/reading level and original locations of the preserved summary and each external original material",
      "role": "Required",
      "role_reason": "Required to address 'How do reading the stored summary and not reading original papers/links differ?' separately for the selected question of 7-day symptom-resolution noninferiority.",
      "application_exception": "Summary reading is not promoted to verification of full texts, registration or related judgments; unattempted access is not changed to failure or zero existence.",
      "criterion": "Link original values, definitions, denominators, times, margins/direction and unverified matters for 'How do reading the stored summary and not reading original papers/links differ?' to the corresponding original records. Current public availability/acquisition, access/content and URL operation have not been verified.",
      "basis": "Internally designed question conditions referring to the corresponding stored-summary records and family application conditions C03",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Records separating actual access attempts, reading and dates when acquiring materials is allowed"
    },
    {
      "item_id": "N05",
      "question_type": "Evidence condition",
      "question": "What is the actual selection boundary for afebrile men with UTI?",
      "needed": "Original inclusion/exclusion, baseline/culture and diagnostic/afebrile definition tables",
      "role": "Required",
      "role_reason": "Required to address 'What is the actual selection boundary for afebrile men with UTI?' separately for the selected question of 7-day symptom-resolution noninferiority.",
      "application_exception": "Original details of age, diagnosis/symptoms, underlying conditions, culture positivity/susceptibility, inclusion/exclusion and infection site remain unverified. Empty values are not filled with new calculations, numerical examples or judgments; the original scope is retained.",
      "criterion": "Link original values, definitions, denominators, times, margins/direction and unverified matters for 'What is the actual selection boundary for afebrile men with UTI?' to the corresponding original records. Original details of age, diagnosis/symptoms, underlying conditions, culture positivity/susceptibility, inclusion/exclusion and infection site remain unverified.",
      "basis": "Internally designed question conditions referring to the corresponding stored-summary records and family application conditions C04, E08",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Materials from the same trial or appropriate separate materials that directly specify the selected population/drug conditions"
    },
    {
      "item_id": "N06",
      "question_type": "Evidence condition",
      "question": "What are the representativeness and participant distributions at the two US VA centers?",
      "needed": "Center/recruitment, baseline tables and actual population/setting materials",
      "role": "Required",
      "role_reason": "Required to address 'What are the representativeness and participant distributions at the two US VA centers?' separately for the selected question of 7-day symptom-resolution noninferiority.",
      "application_exception": "The selected VA sample is not presented as having the same effect in all men/women with UTI or as independent replication at two institutions.",
      "criterion": "Link original values, definitions, denominators, times, margins/direction and unverified matters for 'What are the representativeness and participant distributions at the two US VA centers?' to the corresponding original records. Recruitment/composition by center, baseline balance and direct outcomes in populations outside the VA or other settings remain unverified.",
      "basis": "Internally designed question conditions referring to the corresponding stored-summary records and family application conditions C04, E07",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Additional materials distinguishing conditions at each center of the same trial or populations for extension"
    },
    {
      "item_id": "N07",
      "question_type": "Evidence condition",
      "question": "What finished-product/drug scope applies to the study antibiotics?",
      "needed": "Drug selection, group composition, nominal/actual exposure and drug-specific original materials",
      "role": "Required",
      "role_reason": "Required to address 'What finished-product/drug scope applies to the study antibiotics?' separately for the selected question of 7-day symptom-resolution noninferiority.",
      "application_exception": "The two drugs are not changed to simultaneous combination treatment or extended to other antibiotics or individual drug-selection/dose recommendations.",
      "criterion": "Link original values, definitions, denominators, times, margins/direction and unverified matters for 'What finished-product/drug scope applies to the study antibiotics?' to the corresponding original records. Numbers by drug, selection/allocation, dose/formulation/route, actual exposure and drug-specific outcomes/interactions remain unverified.",
      "basis": "Internally designed question conditions referring to the corresponding stored-summary records and family application conditions C05, E08",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Original reports separating the applicable drug/population conditions and effects"
    },
    {
      "item_id": "N08",
      "question_type": "Evidence condition",
      "question": "Do 7 versus 14 days of exposure differ from actual dose/adherence?",
      "needed": "Original treatment durations, active-drug/placebo schedules and actual adherence/change materials",
      "role": "Required",
      "role_reason": "Required to address 'Do 7 versus 14 days of exposure differ from actual dose/adherence?' separately for the selected question of 7-day symptom-resolution noninferiority.",
      "application_exception": "The halving statement is not changed to a new dose conversion, instructions on individual duration or stopping medication, or actual cumulative drug amount.",
      "criterion": "Link original values, definitions, denominators, times, margins/direction and unverified matters for 'Do 7 versus 14 days of exposure differ from actual dose/adherence?' to the corresponding original records. Nominal/actual amounts by drug, discontinuation/changes, adverse effects/rescue, medication schedules and total exposure details remain unverified.",
      "basis": "Internally designed question conditions referring to the corresponding stored-summary records and family application conditions C05, E02",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Materials from the same trial separating exposure strategy and actual adherence"
    },
    {
      "item_id": "N09",
      "question_type": "Evidence condition",
      "question": "What actually occurred during placebo control and blinding periods?",
      "needed": "Methods/appendices for original placebo/blinding, drug schedules and assessment procedures",
      "role": "Required",
      "role_reason": "Required to address 'What actually occurred during placebo control and blinding periods?' separately for the selected question of 7-day symptom-resolution noninferiority.",
      "application_exception": "Periods or replacement-drug/placebo allocation dates absent from the review summary are not created, and the double-blind label does not certify completion of current measurement/bias review.",
      "criterion": "Link original values, definitions, denominators, times, margins/direction and unverified matters for 'What actually occurred during placebo control and blinding periods?' to the corresponding original records. Active-drug/placebo periods, packaging/matching, blinding targets/maintenance, unblinding/success and assessor roles remain unverified.",
      "basis": "Internally designed question conditions referring to the corresponding stored-summary records and family application conditions E01, E03, E02",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Materials linking actual blinding and medication operation in the report/protocol"
    },
    {
      "item_id": "N10",
      "question_type": "Evidence condition",
      "question": "What are the 272 allocated participants, primary-analysis population of 254 and group denominators?",
      "needed": "Original flow from allocation to primary/consistency analysis and assessment/safety",
      "role": "Required",
      "role_reason": "Required to address 'What are the 272 allocated participants, primary-analysis population of 254 and group denominators?' separately for the selected question of 7-day symptom-resolution noninferiority.",
      "application_exception": "272−254 is not calculated as a new dropout count, and safety denominators 136/136 are not transferred as verified primary-analysis denominators.",
      "criterion": "Link original values, definitions, denominators, times, margins/direction and unverified matters for 'What are the 272 allocated participants, primary-analysis population of 254 and group denominators?' to the corresponding original records. Original flow by randomized group, counts for each exclusion/nonadherence reason, drug composition and detailed endpoint-specific assessment/safety denominators remain unverified.",
      "basis": "Internally designed question conditions referring to the corresponding stored-summary records and family application conditions C07, E04",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Materials from the same trial linking inclusion/exclusion and outcomes in each population"
    },
    {
      "item_id": "N11",
      "question_type": "Evidence condition",
      "question": "What is the original medication-adherence criterion?",
      "needed": "Adherence definitions/measurement and original medication, exclusion and SAP materials",
      "role": "Required",
      "role_reason": "Required to address 'What is the original medication-adherence criterion?' separately for the selected question of 7-day symptom-resolution noninferiority.",
      "application_exception": "28/26 doses are not converted to individual instructions, daily frequency or active-drug dose, and the adherence criterion is not presented as a treatment recommendation.",
      "criterion": "Link original values, definitions, denominators, times, margins/direction and unverified matters for 'What is the original medication-adherence criterion?' to the corresponding original records. Total active-drug/placebo doses, drug-specific dosing intervals, recording/verification, criterion changes/exclusion reasons and selection effects remain unverified.",
      "basis": "Internally designed question conditions referring to the corresponding stored-summary records and family application conditions E04, E02",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Materials distinguishing original criteria, inclusion/exclusion and missing data/changes"
    },
    {
      "item_id": "N12",
      "question_type": "Evidence condition",
      "question": "What original record describes the prespecified primary as-treated and per-protocol-type population?",
      "needed": "SAP/protocol and original rules for analysis populations/per-protocol characteristics",
      "role": "Required",
      "role_reason": "Required to address 'What original record describes the prespecified primary as-treated and per-protocol-type population?' separately for the selected question of 7-day symptom-resolution noninferiority.",
      "application_exception": "The primary analysis is not renamed as an all-randomized ITT analysis, and per-protocol characteristics are not substituted for complete observation or successful current review.",
      "criterion": "Link original values, definitions, denominators, times, margins/direction and unverified matters for 'What original record describes the prespecified primary as-treated and per-protocol-type population?' to the corresponding original records. The full original analysis-population definition, prespecification/changes, selection/deviations and sensitivity analyses including nonadherence have not been read externally.",
      "basis": "Internally designed question conditions referring to the corresponding stored-summary records and family application conditions E04, E06",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Materials from the same trial disclosing planned and actual analysis-population inclusion/exclusion"
    },
    {
      "item_id": "N13",
      "question_type": "Evidence condition",
      "question": "Does complete follow-up of everyone differ from primary-analysis exclusion/missing data?",
      "needed": "Follow-up, assessment, medication and analysis flow, with exclusion/missing-data tables",
      "role": "Required",
      "role_reason": "Required to address 'Does complete follow-up of everyone differ from primary-analysis exclusion/missing data?' separately for the selected question of 7-day symptom-resolution noninferiority.",
      "application_exception": "Participants outside the 254 are not calculated as dropouts, and completion records are not expanded to complete collection of all primary, secondary or safety data.",
      "criterion": "Link original values, definitions, denominators, times, margins/direction and unverified matters for 'Does complete follow-up of everyone differ from primary-analysis exclusion/missing data?' to the corresponding original records. Completion definitions/methods, omissions by assessment, reasons/counts by group outside the primary analysis and missing data at later time points remain unverified.",
      "basis": "Internally designed question conditions referring to the corresponding stored-summary records and family application conditions C07, E04",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Materials linking original completion records with each analysis/measurement scope"
    },
    {
      "item_id": "N14",
      "question_type": "Evidence condition",
      "question": "What people, denominators and proportions describe primary-analysis symptom resolution?",
      "needed": "Original primary symptom-resolution tables, counts/definitions and population/time materials",
      "role": "Required",
      "role_reason": "Required to address 'What people, denominators and proportions describe primary-analysis symptom resolution?' separately for the selected question of 7-day symptom-resolution noninferiority.",
      "application_exception": "Rounded proportions are not used to calculate new values/CIs, unresolved cases or participant totals, or transferred to recurrence denominators/events.",
      "criterion": "Link original values, definitions, denominators, times, margins/direction and unverified matters for 'What people, denominators and proportions describe primary-analysis symptom resolution?' to the corresponding original records. Original symptom definitions, criteria/assessment schedules, individual omissions and distributions by drug remain unverified.",
      "basis": "Internally designed question conditions referring to the corresponding stored-summary records and family application conditions C06, C07",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Reports/appendices linking resolution events, original denominators and measurement rules"
    },
    {
      "item_id": "N15",
      "question_type": "Evidence condition",
      "question": "What defines difference +2.9%p and the favorable direction?",
      "needed": "Direction/unit of the original difference, estimation model and original tables",
      "role": "Required",
      "role_reason": "Required to address 'What defines difference +2.9%p and the favorable direction?' separately for the selected question of 7-day symptom-resolution noninferiority.",
      "application_exception": "No new risk ratio/difference or improvement duration is calculated, and +2.9 is not changed to statistical superiority or individual benefit.",
      "criterion": "Link original values, definitions, denominators, times, margins/direction and unverified matters for 'What defines difference +2.9%p and the favorable direction?' to the corresponding original records. Direct original details of difference estimation/adjustment, stratification, interval methods, within-group change and absolute durations remain unverified.",
      "basis": "Internally designed question conditions referring to the corresponding stored-summary records and family application conditions C06, E04, E05",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Statistical materials specifying difference, adjustment and interval definitions"
    },
    {
      "item_id": "N16",
      "question_type": "Evidence condition",
      "question": "What are the lower bound and infinite upper end of the one-sided 97.5% CI?",
      "needed": "One-sided interval/SAP, statistical methods and original result tables",
      "role": "Required",
      "role_reason": "Required to address 'What are the lower bound and infinite upper end of the one-sided 97.5% CI?' separately for the selected question of 7-day symptom-resolution noninferiority.",
      "application_exception": "The infinite upper end is not filled with the JSON number Infinity or a confirmed upper bound, and one-sided 97.5% is not changed to two-sided 95%.",
      "criterion": "Link original values, definitions, denominators, times, margins/direction and unverified matters for 'What are the lower bound and infinite upper end of the one-sided 97.5% CI?' to the corresponding original records. Original interval calculation, adjustment, model/stratification, alternative intervals and two-sided intervals remain unverified.",
      "basis": "Internally designed question conditions referring to the corresponding stored-summary records and family application conditions C07, E05",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Materials disclosing intervals/models according to the original methods"
    },
    {
      "item_id": "N17",
      "question_type": "Evidence condition",
      "question": "What is the comparison scope for the prespecified margin −10%p and lower bound?",
      "needed": "Noninferiority-margin justification, SAP/registration and original estimation/testing plans",
      "role": "Required",
      "role_reason": "Required to address 'What is the comparison scope for the prespecified margin −10%p and lower bound?' separately for the selected question of 7-day symptom-resolution noninferiority.",
      "application_exception": "The margin is not inherited as a universal MCID or exact-equivalence limit, and no new value between the lower bound and margin is calculated.",
      "criterion": "Link original values, definitions, denominators, times, margins/direction and unverified matters for 'What is the comparison scope for the prespecified margin −10%p and lower bound?' to the corresponding original records. Margin rationale, historical control effect/preservation, patient values, original alpha/power and comparison of versions remain unverified.",
      "basis": "Internally designed question conditions referring to the corresponding stored-summary records and family application conditions E05, E06",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Materials disclosing the relationship between original margin justification/plans and results"
    },
    {
      "item_id": "N18",
      "question_type": "Evidence condition",
      "question": "How are noninferiority, equivalence and superiority distinguished?",
      "needed": "Testing objective/limits, intervals and original judgment scope",
      "role": "Required",
      "role_reason": "Required to address 'How are noninferiority, equivalence and superiority distinguished?' separately for the selected question of 7-day symptom-resolution noninferiority.",
      "application_exception": "The existing advertising interpretation's wording 'same'/equal is not newly confirmed as exact equivalence, superiority or absence of harm.",
      "criterion": "Link original values, definitions, denominators, times, margins/direction and unverified matters for 'How are noninferiority, equivalence and superiority distinguished?' to the corresponding original records. Superiority/equivalence plans, two-sided equivalence intervals, individual importance and superiority for safety/resistance have not been verified.",
      "basis": "Internally designed question conditions referring to the corresponding stored-summary records and family application conditions C08, E05, E09",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Additional materials separately distinguishing original testing objectives, patient outcomes and safety"
    },
    {
      "item_id": "N19",
      "question_type": "Evidence condition",
      "question": "What are the original values in the all-randomized consistency analysis of 272?",
      "needed": "Original all-randomized analysis tables, definitions/missing data/SAP and intervals",
      "role": "Required",
      "role_reason": "Required to address 'What are the original values in the all-randomized consistency analysis of 272?' separately for the selected question of 7-day symptom-resolution noninferiority.",
      "application_exception": "Original event counts are not reconstructed, and all-randomized results/lower bounds are not copied as primary-analysis results for 254.",
      "criterion": "Link original values, definitions, denominators, times, margins/direction and unverified matters for 'What are the original values in the all-randomized consistency analysis of 272?' to the corresponding original records. Original events/denominators by group, the consistency-analysis definition, missing-data/adherence handling and original models remain unverified.",
      "basis": "Internally designed question conditions referring to the corresponding stored-summary records and family application conditions E04, E05, C07",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Materials separately disclosing original denominators and results of the primary/all-randomized consistency populations"
    },
    {
      "item_id": "N20",
      "question_type": "Evidence condition",
      "question": "What differs between the primary and all-randomized populations, and what establishes robustness?",
      "needed": "Analysis-population inclusion/exclusion, sensitivity analyses and original plans/result tables",
      "role": "Required",
      "role_reason": "Required to address 'What differs between the primary and all-randomized populations, and what establishes robustness?' separately for the selected question of 7-day symptom-resolution noninferiority.",
      "application_exception": "Consistency wording alone does not certify robustness across every analysis/population, and the two populations are not added as independent confirmations.",
      "criterion": "Link original values, definitions, denominators, times, margins/direction and unverified matters for 'What differs between the primary and all-randomized populations, and what establishes robustness?' to the corresponding original records. Nonadherence/drug changes by group, relationships between people in the two populations, sensitivity analyses and magnitudes/assumptions of selection bias remain unverified.",
      "basis": "Internally designed question conditions referring to the corresponding stored-summary records and family application conditions E04, E05, C02",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Materials specifying the scope and outcomes of differing populations/handling using the original methods"
    },
    {
      "item_id": "N21",
      "question_type": "Evidence condition",
      "question": "How were patient-reported symptom resolution and scales defined?",
      "needed": "Original symptom lists/resolution judgments, patient reports and collection/measurement methods",
      "role": "Required",
      "role_reason": "Required to address 'How were patient-reported symptom resolution and scales defined?' separately for the selected question of 7-day symptom-resolution noninferiority.",
      "application_exception": "Symptom resolution is not changed to microbiological clearance, complication prevention or all long-term cure without original materials.",
      "criterion": "Link original values, definitions, denominators, times, margins/direction and unverified matters for 'How were patient-reported symptom resolution and scales defined?' to the corresponding original records. Symptom lists, definitions/scales, assessors/records, resolution judgments and agreement with culture results remain unverified.",
      "basis": "Internally designed question conditions referring to the corresponding stored-summary records and family application conditions C06, E03, E09",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Materials from the same trial disclosing actual definitions and measurement limits of patient-reported outcomes"
    },
    {
      "item_id": "N22",
      "question_type": "Evidence condition",
      "question": "Are 7 days of treatment and assessment within 14 days after therapy the same window?",
      "needed": "Original schedules, exposure/end/assessment times by group and counting rules",
      "role": "Required",
      "role_reason": "Required to address 'Are 7 days of treatment and assessment within 14 days after therapy the same window?' separately for the selected question of 7-day symptom-resolution noninferiority.",
      "application_exception": "7 days in the existing question is not changed to assessment of resolution on day 7, and no total calendar duration absent from original materials is calculated.",
      "criterion": "Link original values, definitions, denominators, times, margins/direction and unverified matters for 'Are 7 days of treatment and assessment within 14 days after therapy the same window?' to the corresponding original records. Original assessment days, time origins/synchronization by group, allowed windows, repeated measurements and closure/omissions remain unverified.",
      "basis": "Internally designed question conditions referring to the corresponding stored-summary records and family application conditions C06, E03",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Reports/protocols linking actual assessment windows with each group's treatment schedule"
    },
    {
      "item_id": "N23",
      "question_type": "Evidence condition",
      "question": "How do blinding and medication schedules affect patient-reported measurement?",
      "needed": "Blinding/unblinding, patient-report collection and assessment times/tools",
      "role": "Required",
      "role_reason": "Required to address 'How do blinding and medication schedules affect patient-reported measurement?' separately for the selected question of 7-day symptom-resolution noninferiority.",
      "application_exception": "Double-blind wording is not automatically promoted to absence of measurement limitations or fulfillment of all conditions.",
      "criterion": "Link original values, definitions, denominators, times, margins/direction and unverified matters for 'How do blinding and medication schedules affect patient-reported measurement?' to the corresponding original records. Assessor/participant information, blinding success/unblinding, measurement tools/differences, omissions and group-specific assessment methods remain unverified.",
      "basis": "Internally designed question conditions referring to the corresponding stored-summary records and family application conditions E03, E01",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Original materials linking actual symptom measurement and blinding to each endpoint"
    },
    {
      "item_id": "N24",
      "question_type": "Evidence condition",
      "question": "What models, between-/within-group comparisons, adjustments and missing-data handling define the difference?",
      "needed": "Statistical methods/SAP, original models, analysis/missing data and result tables",
      "role": "Required",
      "role_reason": "Required to address 'What models, between-/within-group comparisons, adjustments and missing-data handling define the difference?' separately for the selected question of 7-day symptom-resolution noninferiority.",
      "application_exception": "Models/adjustments or ITT/PP levels are not filled by inference, and superiority between drugs is not created.",
      "criterion": "Link original values, definitions, denominators, times, margins/direction and unverified matters for 'What models, between-/within-group comparisons, adjustments and missing-data handling define the difference?' to the corresponding original records. Difference/interval models, adjustment/stratification, contributions by drug, missing data/deviations and original SAP details remain unverified.",
      "basis": "Internally designed question conditions referring to the corresponding stored-summary records and family application conditions E04, E05",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Materials specifying between-group differences, models and populations using the original methods"
    },
    {
      "item_id": "N25",
      "question_type": "Evidence condition",
      "question": "What records describe the primary endpoint/analysis, margin and registration?",
      "needed": "Registration/plan/analysis versions, margins/endpoints/populations and change materials",
      "role": "Required",
      "role_reason": "Required to address 'What records describe the primary endpoint/analysis, margin and registration?' separately for the selected question of 7-day symptom-resolution noninferiority.",
      "application_exception": "The registration ID or original 'prespecified' wording does not certify completed current registration/plan review or absence of all selective reporting.",
      "criterion": "Link original values, definitions, denominators, times, margins/direction and unverified matters for 'What records describe the primary endpoint/analysis, margin and registration?' to the corresponding original records. Original comparison of registration/protocol/SAP versions, change dates and prespecified endpoints/analyses/time points has not been read.",
      "basis": "Internally designed question conditions referring to the corresponding stored-summary records and family application conditions E06, C09",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Records separating verified comparison scope from unexamined matters and changes when actual plans are provided"
    },
    {
      "item_id": "N26",
      "question_type": "Evidence condition",
      "question": "What supports the importance and preserved effect of the −10%p margin?",
      "needed": "Noninferiority-margin rationale, original design/historical materials and testing assumptions",
      "role": "Required",
      "role_reason": "Required to address 'What supports the importance and preserved effect of the −10%p margin?' separately for the selected question of 7-day symptom-resolution noninferiority.",
      "application_exception": "−10%p is not used as a common importance threshold for every symptom, infection or safety result, and no new margin/grade is selected.",
      "criterion": "Link original values, definitions, denominators, times, margins/direction and unverified matters for 'What supports the importance and preserved effect of the −10%p margin?' to the corresponding original records. Margin selection, historical effects/constancy, acceptable differences and power/SAP criteria remain unverified.",
      "basis": "Internally designed question conditions referring to the corresponding stored-summary records and family application conditions E05, E06",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "A manuscript specifying the margin and current interval/population when actual justification materials are provided"
    },
    {
      "item_id": "N27",
      "question_type": "Evidence condition",
      "question": "What are the effects of per-protocol-type selection, adherence/rescue treatment and the effect of interest?",
      "needed": "Concomitant/rescue treatment, medication/changes and analysis-inclusion/SAP materials",
      "role": "Required",
      "role_reason": "Required to address 'What are the effects of per-protocol-type selection, adherence/rescue treatment and the effect of interest?' separately for the selected question of 7-day symptom-resolution noninferiority.",
      "application_exception": "SAP details for nonadherence/concomitant treatment, drug switching, rescue/retreatment, subsequent exposure and allocation/adherence effects remain unverified. Empty values are not filled with new calculations, numerical examples or judgments; the original scope is retained.",
      "criterion": "Link original values, definitions, denominators, times, margins/direction and unverified matters for 'What are the effects of per-protocol-type selection, adherence/rescue treatment and the effect of interest?' to the corresponding original records. SAP details for nonadherence/concomitant treatment, drug switching, rescue/retreatment, subsequent exposure and allocation/adherence effects remain unverified.",
      "basis": "Internally designed question conditions referring to the corresponding stored-summary records and family application conditions E02, E04",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Materials linking strategy, actual implementation and conditional selection to original populations/outcomes"
    },
    {
      "item_id": "N28",
      "question_type": "Evidence condition",
      "question": "What time origin and definition apply to the sibling 28-day recurrence outcome?",
      "needed": "Recurrence definitions/times, conditional populations and counting/assessment materials",
      "role": "Required",
      "role_reason": "Required to address 'What time origin and definition apply to the sibling 28-day recurrence outcome?' separately for the selected question of 7-day symptom-resolution noninferiority.",
      "application_exception": "28 days is not asserted to be after treatment ends or begins without original materials, and recurrence is not transferred to the original primary-resolution result.",
      "criterion": "Link original values, definitions, denominators, times, margins/direction and unverified matters for 'What time origin and definition apply to the sibling 28-day recurrence outcome?' to the corresponding original records. The 28-day time origin, recurrence/reinfection, selection after resolution, records/culture/retreatment and original assessment window remain unverified.",
      "basis": "Internally designed question conditions referring to the corresponding stored-summary records and family application conditions C06, E03, E09",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Materials disclosing symptom resolution and recurrence in the same trial according to their respective original definitions/time points"
    },
    {
      "item_id": "N29",
      "question_type": "Evidence condition",
      "question": "What are the recorded recurrence numerators, denominators, proportions and difference?",
      "needed": "Original recurrence tables, numerators/denominators/counting, conditions/assessment and versions",
      "role": "Required",
      "role_reason": "Required to address 'What are the recorded recurrence numerators, denominators, proportions and difference?' separately for the selected question of 7-day symptom-resolution noninferiority.",
      "application_exception": "Original fractions/proportions are not recalculated, rounded differently or corrected without checking original tables, and no new recurrence differences or summed participants are created.",
      "criterion": "Link original values, definitions, denominators, times, margins/direction and unverified matters for 'What are the recorded recurrence numerators, denominators, proportions and difference?' to the corresponding original records. Original recurrence counting rules, assessability, conditional populations, recurrence/missing data and numerical/version details remain unverified.",
      "basis": "Internally designed question conditions referring to the corresponding stored-summary records and family application conditions C07, C08, E04",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Linkage separating the full before/after original text and events when original result tables/corrections are provided"
    },
    {
      "item_id": "N30",
      "question_type": "Evidence condition",
      "question": "What does the recurrence 95% CI −10.8~6.2 cover?",
      "needed": "Original recurrence intervals, statistics/plans, hierarchy and testing objectives",
      "role": "Required",
      "role_reason": "Required to address 'What does the recurrence 95% CI −10.8~6.2 cover?' separately for the selected question of 7-day symptom-resolution noninferiority.",
      "application_exception": "The primary −10%p margin is not applied to the recurrence CI to make a new noninferiority, equivalence or significant-reduction judgment.",
      "criterion": "Link original values, definitions, denominators, times, margins/direction and unverified matters for 'What does the recurrence 95% CI −10.8~6.2 cover?' to the corresponding original records. Recurrence CI calculation/models, P value, prespecified margins/hierarchy, importance and power remain unverified.",
      "basis": "Internally designed question conditions referring to the corresponding stored-summary records and family application conditions E05, C08, E06",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Materials separately disclosing recurrence estimates/intervals and plans"
    },
    {
      "item_id": "N31",
      "question_type": "Evidence condition",
      "question": "How is sharing of the same people among recurrence, primary and all-randomized populations distinguished?",
      "needed": "Endpoint/analysis-specific flow and original relationships among people, repeated events and time points",
      "role": "Required",
      "role_reason": "Required to address 'How is sharing of the same people among recurrence, primary and all-randomized populations distinguished?' separately for the selected question of 7-day symptom-resolution noninferiority.",
      "application_exception": "Resolution/recurrence and primary/all-randomized denominators are not added to create new participants or independent replications.",
      "criterion": "Link original values, definitions, denominators, times, margins/direction and unverified matters for 'How is sharing of the same people among recurrence, primary and all-randomized populations distinguished?' to the corresponding original records. Original inclusion/omission in each population, resolution conditions/recurrence selection, repeated events and relationships among people at each time point remain unverified.",
      "basis": "Internally designed question conditions referring to the corresponding stored-summary records and family application conditions C02, C07, E04",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Original materials linking the same populations/different conditions to each denominator"
    },
    {
      "item_id": "N32",
      "question_type": "Evidence condition",
      "question": "What are the original people, denominators, proportions and difference for adverse events?",
      "needed": "Original AE tables, people/event counts, populations/times and classification/collection",
      "role": "Required",
      "role_reason": "Required to address 'What are the original people, denominators, proportions and difference for adverse events?' separately for the selected question of 7-day symptom-resolution noninferiority.",
      "application_exception": "Apart from original −3.7%p, no new CIs/risk ratios, overlapping totals or type-specific incidence rates are calculated.",
      "criterion": "Link original values, definitions, denominators, times, margins/direction and unverified matters for 'What are the original people, denominators, proportions and difference for adverse events?' to the corresponding original records. Adverse-event types/grades, collection windows, exposed populations, repeated events, attribution/discontinuation and omissions remain unverified.",
      "basis": "Internally designed question conditions referring to the corresponding stored-summary records and family application conditions E10, H01, H03, H04",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Original materials linking safety of the same exposure with denominators/durations"
    },
    {
      "item_id": "N33",
      "question_type": "Evidence condition",
      "question": "What statistical testing and causal level apply to the adverse-event difference?",
      "needed": "Original safety tables/SAP, comparative statistics and attribution/collection",
      "role": "Required",
      "role_reason": "Required to address 'What statistical testing and causal level apply to the adverse-event difference?' separately for the selected question of 7-day symptom-resolution noninferiority.",
      "application_exception": "The original record of no test is not labeled as unreported testing verified by current full-text reading, or expanded to significant reduction or absence of harm.",
      "criterion": "Link original values, definitions, denominators, times, margins/direction and unverified matters for 'What statistical testing and causal level apply to the adverse-event difference?' to the corresponding original records. The full scope of comparative CIs/P values, plans/tests, event attribution and causal evidence has not been read externally.",
      "basis": "Internally designed question conditions referring to the corresponding stored-summary records and family application conditions H09, E05, E10",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Materials from the same trial specifying original statistical levels and harm definitions"
    },
    {
      "item_id": "N34",
      "question_type": "Evidence condition",
      "question": "What are the onset, recovery, discontinuation and exposure windows for safety?",
      "needed": "Temporal order of harms, collection windows, exposure/discontinuation/rechallenge and original tables",
      "role": "Required",
      "role_reason": "Required to address 'What are the onset, recovery, discontinuation and exposure windows for safety?' separately for the selected question of 7-day symptom-resolution noninferiority.",
      "application_exception": "Event onset/recovery, discontinuation/re-exposure, collection end, actual drug/placebo exposure and harms at each stage remain unverified. Empty values are not filled with new calculations, numerical examples or judgments; the original scope is retained.",
      "criterion": "Link original values, definitions, denominators, times, margins/direction and unverified matters for 'What are the onset, recovery, discontinuation and exposure windows for safety?' to the corresponding original records. Event onset/recovery, discontinuation/re-exposure, collection end, actual drug/placebo exposure and harms at each stage remain unverified.",
      "basis": "Internally designed question conditions referring to the corresponding stored-summary records and family application conditions H02, H04, E10",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Materials separating actual harm/exposure times from symptom/recurrence windows"
    },
    {
      "item_id": "N35",
      "question_type": "Evidence condition",
      "question": "Does complete follow-up mean complete collection of all AEs and long-term/rare events?",
      "needed": "Safety-analysis populations, collection/omission/follow-up and type-specific original materials",
      "role": "Required",
      "role_reason": "Required to address 'Does complete follow-up mean complete collection of all AEs and long-term/rare events?' separately for the selected question of 7-day symptom-resolution noninferiority.",
      "application_exception": "Completion/shorter exposure does not certify absence of all harms, exclusion of rare risks or current safety.",
      "criterion": "Link original values, definitions, denominators, times, margins/direction and unverified matters for 'Does complete follow-up mean complete collection of all AEs and long-term/rare events?' to the corresponding original records. Safety omissions/detection, recall/assessment, treatment changes/follow-up, rare/long-term events and recruitment for each type remain unverified.",
      "basis": "Internally designed question conditions referring to the corresponding stored-summary records and family application conditions H06, H08, H04",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Materials from the same trial or appropriate additional materials specifying actual collection, missing data and long-term scope"
    },
    {
      "item_id": "N36",
      "question_type": "Evidence condition",
      "question": "What alternative causes of harms involve baseline conditions, concurrent drugs or culture?",
      "needed": "Baseline/concurrent exposures, original event attribution and culture/drug/population-specific materials",
      "role": "Required",
      "role_reason": "Required to address 'What alternative causes of harms involve baseline conditions, concurrent drugs or culture?' separately for the selected question of 7-day symptom-resolution noninferiority.",
      "application_exception": "Absence of other causes is not asserted, and original safety wording is not rewritten as individual advice on antibiotic selection, dose, duration or suitability.",
      "criterion": "Link original values, definitions, denominators, times, margins/direction and unverified matters for 'What alternative causes of harms involve baseline conditions, concurrent drugs or culture?' to the corresponding original records. Baseline risks, concurrent drugs/other treatment, events by drug, alternative causes/adjustment and suitability materials remain unverified.",
      "basis": "Internally designed question conditions referring to the corresponding stored-summary records and family application conditions H05, E02, E10",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Safety materials separating original baseline/exposure, attribution and collection scope"
    },
    {
      "item_id": "N37",
      "question_type": "Evidence condition",
      "question": "Are reduced exposure and individual/population antibiotic resistance different questions?",
      "needed": "Direct resistance/culture measurements, definitions/denominators/time points and original analyses",
      "role": "Required",
      "role_reason": "Required to address 'Are reduced exposure and individual/population antibiotic resistance different questions?' separately for the selected question of 7-day symptom-resolution noninferiority.",
      "application_exception": "Shorter exposure is not promoted to direct efficacy for reducing individual resistance or all long-term harms.",
      "criterion": "Link original values, definitions, denominators, times, margins/direction and unverified matters for 'Are reduced exposure and individual/population antibiotic resistance different questions?' to the corresponding original records. Acquired resistance/culture, organisms/susceptibility, population selection pressure/long-term spread and direct denominators/durations/estimates remain unverified.",
      "basis": "Internally designed question conditions referring to the corresponding stored-summary records and family application conditions E09, E08",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "If appropriate direct resistance materials are provided, linkage as a question separate from symptoms/exposure"
    },
    {
      "item_id": "N38",
      "question_type": "Evidence condition",
      "question": "What is the scope of VA public funding, product provision/sponsorship and author COI?",
      "needed": "Original funding/COI, sponsor/author roles and product/data declarations",
      "role": "Required",
      "role_reason": "Required to address 'What is the scope of VA public funding, product provision/sponsorship and author COI?' separately for the selected question of 7-day symptom-resolution noninferiority.",
      "application_exception": "Public funding/I2 is not inherited as current certification of no COI, no bias or completed independence verification.",
      "criterion": "Link original values, definitions, denominators, times, margins/direction and unverified matters for 'What is the scope of VA public funding, product provision/sponsorship and author COI?' to the corresponding original records. Contracts/product supply, design/collection/statistics/writing/submission, data access, author employment and full COI have not been read externally.",
      "basis": "Internally designed question conditions referring to the corresponding stored-summary records and family application conditions C10",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Separation of verified funding/roles from unverified matters when actual original declarations are provided"
    },
    {
      "item_id": "N39",
      "question_type": "Evidence condition",
      "question": "What distinguishes one report/a single trial from current independent replication?",
      "needed": "Relationships among reports/trials/populations, analyses/outcomes and independent materials",
      "role": "Required",
      "role_reason": "Required to address 'What distinguishes one report/a single trial from current independent replication?' separately for the selected question of 7-day symptom-resolution noninferiority.",
      "application_exception": "The one report entry is not confirmed as the total number of trials worldwide, and the two analyses/outcomes are not counted as independent confirmations.",
      "criterion": "Link original values, definitions, denominators, times, margins/direction and unverified matters for 'What distinguishes one report/a single trial from current independent replication?' to the corresponding original records. Current additional trials/follow-up reports, independent populations/funding and contrary materials under other conditions remain undetermined without a new search.",
      "basis": "Internally designed question conditions referring to the corresponding stored-summary records and family application conditions C02, E07, H07",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Distinctions by verification level among repeated citations, the same populations and separate populations when new materials are provided"
    },
    {
      "item_id": "N40",
      "question_type": "Evidence condition",
      "question": "What do the cross-citations to women in 1793/862 preserve?",
      "needed": "Materials distinguishing different populations/drugs/endpoints and the original cross-citation scope",
      "role": "Required",
      "role_reason": "Required to address 'What do the cross-citations to women in 1793/862 preserve?' separately for the selected question of 7-day symptom-resolution noninferiority.",
      "application_exception": "Related judgments/original grades/product exposures are not transferred to efficacy of 7 days in men, new clinical reports/trials or completed current verification.",
      "criterion": "Link original values, definitions, denominators, times, margins/direction and unverified matters for 'What do the cross-citations to women in 1793/862 preserve?' to the corresponding original records. Those judgment contents/original papers, populations/drugs/effects and current cross-citation review/link status have not been read or verified.",
      "basis": "Internally designed question conditions referring to the corresponding stored-summary records and family application conditions C02, C04, C09, E08",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "When related materials are provided, linkage of uncomplicated cystitis in women and UTI in men as different questions"
    },
    {
      "item_id": "N41",
      "question_type": "Evidence condition",
      "question": "What are the parent axes, Korean/English manuscripts and false/null/empty values in judgment history?",
      "needed": "Separate preservation of subclaim/parent original values, axes/languages/empty values and historical judgments",
      "role": "Required",
      "role_reason": "Required to address 'What are the parent axes, Korean/English manuscripts and false/null/empty values in judgment history?' separately for the selected question of 7-day symptom-resolution noninferiority.",
      "application_exception": "Original listed noninferiority limitations/scores are not repeated as new limitation assessment or reassessment, and precision null is not filled with 0.",
      "criterion": "Link original values, definitions, denominators, times, margins/direction and unverified matters for 'What are the parent axes, Korean/English manuscripts and false/null/empty values in judgment history?' to the corresponding original records. Original B1/I2/precision and judgment values have not been inherited as current subclaim conditions, review or scores.",
      "basis": "Internally designed question conditions referring to the corresponding stored-summary records and family application conditions C01, C09, E06",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "If an actual correction is provided, records of full original text, event/version and changes within each scope"
    },
    {
      "item_id": "N42",
      "question_type": "Evidence condition",
      "question": "How do original dates, corrections/empty values and the current preparation date differ?",
      "needed": "Original preservation/search/registration, corrected versions and current preparation scope/time",
      "role": "Required",
      "role_reason": "Required to address 'How do original dates, corrections/empty values and the current preparation date differ?' separately for the selected question of 7-day symptom-resolution noninferiority.",
      "application_exception": "Original dates/verification wording are not borrowed as current review dates, and empty corrections or no new search are not used to certify zero current studies/corrections.",
      "criterion": "Link original values, definitions, denominators, times, margins/direction and unverified matters for 'How do original dates, corrections/empty values and the current preparation date differ?' to the corresponding original records. Evidence-cutoff/classification fields are absent, and current registration, corrections, retractions, new literature or links have not been queried.",
      "basis": "Internally designed question conditions referring to the corresponding stored-summary records and family application conditions C09, C03",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "Preservation records distinguishing full original text, additional events and current scope when materials/corrections are actually provided"
    },
    {
      "item_id": "N43",
      "question_type": "Evidence condition",
      "question": "What gaps remain in extending beyond afebrile patients/original drugs or to long-term outcomes?",
      "needed": "Direct effect/harm materials by extended population, exposure and duration",
      "role": "Supplementary; required for extension",
      "role_reason": "Required to address 'What gaps remain in extending beyond afebrile patients/original drugs or to long-term outcomes?' separately for the selected question of 7-day symptom-resolution noninferiority.",
      "application_exception": "Direct materials on other ages/baseline conditions, fever/infection sites, other drugs/doses, long-term recurrence/complications, quality of life and resistance remain unverified. Empty values are not filled with new calculations, numerical examples or judgments; the original scope is retained.",
      "criterion": "Link original values, definitions, denominators, times, margins/direction and unverified matters for 'What gaps remain in extending beyond afebrile patients/original drugs or to long-term outcomes?' to the corresponding original records. Direct materials on other ages/baseline conditions, fever/infection sites, other drugs/doses, long-term recurrence/complications, quality of life and resistance remain unverified.",
      "basis": "Internally designed question conditions referring to the corresponding stored-summary records and family application conditions E08, E09, H08",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "When appropriate materials are provided, distinction of the selected 7-day noninferiority question from questions under other conditions/time points"
    },
    {
      "item_id": "N44",
      "question_type": "Evidence condition",
      "question": "Are noninferiority, recurrence and AEs kept from becoming antibiotic-selection/duration recommendations?",
      "needed": "Direct materials on original research scope and extended populations/effects/harms",
      "role": "Required",
      "role_reason": "Required to address 'Are noninferiority, recurrence and AEs kept from becoming antibiotic-selection/duration recommendations?' separately for the selected question of 7-day symptom-resolution noninferiority.",
      "application_exception": "Noninferiority/reduced exposure is not written as recommendations on antibiotic selection, duration, dose, stopping/substitution or infection suitability, or as guarantees of individual safety.",
      "criterion": "Link original values, definitions, denominators, times, margins/direction and unverified matters for 'Are noninferiority, recurrence and AEs kept from becoming antibiotic-selection/duration recommendations?' to the corresponding original records. Current care/regulations, patient baseline/culture, individual drugs/durations/doses/interactions and current benefits/harms have not been verified.",
      "basis": "Internally designed question conditions referring to the corresponding stored-summary records and family application conditions H09, E10, E09, E08, C09",
      "condition_origin": "Case-specific question conditions; review of the existing content incomplete",
      "proposed_research": "If materials are provided and scope allows, updates to research gaps distinguishing original tables from other application conditions"
    }
  ]
}