{
  "schema_version": "chamgap-public-criteria-1.0",
  "title": "Evidence check: 7 versus 14 days of antibiotics × 28-day symptom recurrence in afebrile men with UTI",
  "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": "Preserved method HTML copies; no current method-content re-review or official tool execution"
    },
    {
      "id": "M04",
      "version": "Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04",
      "section": "§4.5, §4.6.1–4.6.3, MECIR C42",
      "official_principle": "Distinguish studies from reports and link them; do not omit a study solely because results are unreported.",
      "review_level": "Preserved method HTML copies; no current method-content re-review or official tool execution"
    },
    {
      "id": "M08",
      "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08",
      "section": "§8.1–8.2.3, Table 8.2.a",
      "official_principle": "Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.",
      "review_level": "Preserved method HTML copies; no current method-content re-review or official tool execution"
    },
    {
      "id": "M15",
      "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15",
      "section": "§15.2.4, §15.3.1–15.3.3",
      "official_principle": "Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.",
      "review_level": "Preserved method HTML copies; no current method-content re-review or official tool execution"
    },
    {
      "id": "M19",
      "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19",
      "section": "§19.1.2, §19.2.1–19.2.4",
      "official_principle": "Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.",
      "review_level": "Preserved method HTML copies; no current method-content re-review or official tool execution"
    }
  ],
  "status_dictionary": {
    "Met": "A state used when required evidence is confirmed after user review. This production does not declare that review complete.",
    "Partly verified": "Some information in the stored summary is linked into the table. External comparison/content review is not complete.",
    "Unverified": "The article leaves this unverified, or required material is absent from the current stored summary. This is distinct from zero, absence or safety.",
    "Review incomplete": "User review pending.",
    "Not reported": "Not reported within the stored material actually read; not extended to the entire primary paper.",
    "Inaccessible": "Means an actual access failure. Access not attempted here is not assigned this state.",
    "Not applicable": "Not used as a substitute for an evidence gap.",
    "Conflicting data": "Requires an observed disagreement under the same comparison criteria; not automatically judged in this production.",
    "Insufficient evidence for the conditions": "Marks a gap in additional material required by the selected conditions; not a new efficacy grade."
  },
  "requirements": [
    {
      "item_id": "N01",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "How does 28-day recurrence differ from the parent symptom-resolution judgment?",
      "needed": "Distinguishing the subclaim's D grade and note, absent score, status and axes, from the parent's B70 and axes",
      "role": "Required",
      "role_reason": "An item prepared to distinguish Distinguishing the subclaim's D grade and note, absent score, status and axes, from the parent's B70 and axes and connect the selected question's required materials with the available materials.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Relevant original materials and the scope of analysis for Distinguishing the subclaim's D grade and note, absent score, status and axes, from the parent's B70 and axes must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of existing content remains incomplete.",
      "basis": "M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design",
      "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run",
      "proposed_research": "A proposal for follow-up materials linking Distinguishing the subclaim's D grade and note, absent score, status and axes, from the parent's B70 and axes as a separate item; no new research, calculation or testing is performed in this preparation."
    },
    {
      "item_id": "N02",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "What are the originally recorded recurrence fractions and rates?",
      "needed": "The original records of 13/131(9.9%) and 15/123(12.9%)",
      "role": "Required",
      "role_reason": "An item prepared to distinguish The original records of 13/131(9.9%) and 15/123(12.9%) and connect the selected question's required materials with the available materials.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Relevant original materials and the scope of analysis for The original records of 13/131(9.9%) and 15/123(12.9%) must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of existing content remains incomplete.",
      "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are our own design; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are our own design",
      "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run",
      "proposed_research": "A proposal for follow-up materials linking The original records of 13/131(9.9%) and 15/123(12.9%) as a separate item; no new research, calculation or testing is performed in this preparation."
    },
    {
      "item_id": "N03",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "What estimand does the recurrence difference and its 95% interval represent?",
      "needed": "The original −3.0%p and 95% CI −10.8~6.2, and the direction of comparison",
      "role": "Required",
      "role_reason": "An item prepared to distinguish The original −3.0%p and 95% CI −10.8~6.2, and the direction of comparison and connect the selected question's required materials with the available materials.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Relevant original materials and the scope of analysis for The original −3.0%p and 95% CI −10.8~6.2, and the direction of comparison must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of existing content remains incomplete.",
      "basis": "M08 §8.2.2, M15 §15.3.1; Chamgap's own application; M15 §15.3.1–15.3.3; Chamgap's own application; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are Chamgap's own design",
      "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run",
      "proposed_research": "A proposal for follow-up materials linking The original −3.0%p and 95% CI −10.8~6.2, and the direction of comparison as a separate item; no new research, calculation or testing is performed in this preparation."
    },
    {
      "item_id": "N04",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "Where does the 28-day observation window begin?",
      "needed": "The existing 28-day timing definition, treatment start or end, and first or repeated recurrence",
      "role": "Required",
      "role_reason": "An item prepared to distinguish The existing 28-day timing definition, treatment start or end, and first or repeated recurrence and connect the selected question's required materials with the available materials.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Relevant original materials and the scope of analysis for The existing 28-day timing definition, treatment start or end, and first or repeated recurrence must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of existing content remains incomplete.",
      "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are our own design; M08 Table 8.2.a, M04 §4.6.3; our own application; M03 §3.2.1–3.2.4; dose, duration and effect-modification details are our own design",
      "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run",
      "proposed_research": "A proposal for follow-up materials linking The existing 28-day timing definition, treatment start or end, and first or repeated recurrence as a separate item; no new research, calculation or testing is performed in this preparation."
    },
    {
      "item_id": "N05",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "How is symptom recurrence defined?",
      "needed": "Distinguishing symptom criteria, patient reporting or culture, and a new event after resolution",
      "role": "Required",
      "role_reason": "An item prepared to distinguish Distinguishing symptom criteria, patient reporting or culture, and a new event after resolution and connect the selected question's required materials with the available materials.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Relevant original materials and the scope of analysis for Distinguishing symptom criteria, patient reporting or culture, and a new event after resolution must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of existing content remains incomplete.",
      "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are our own design; M08 Table 8.2.a, M03 §3.2.4; our own application",
      "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run",
      "proposed_research": "A proposal for follow-up materials linking Distinguishing symptom criteria, patient reporting or culture, and a new event after resolution as a separate item; no new research, calculation or testing is performed in this preparation."
    },
    {
      "item_id": "N06",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "How do the recurrence denominators 131/123 relate to the 272/254 participants?",
      "needed": "Distinguishing randomized participants, the adherent primary analysis, and the recurrence observation population or missing data",
      "role": "Required",
      "role_reason": "An item prepared to distinguish Distinguishing randomized participants, the adherent primary analysis, and the recurrence observation population or missing data and connect the selected question's required materials with the available materials.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Relevant original materials and the scope of analysis for Distinguishing randomized participants, the adherent primary analysis, and the recurrence observation population or missing data must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of existing content remains incomplete.",
      "basis": "M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; Design-specific adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap application",
      "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run",
      "proposed_research": "A proposal for follow-up materials linking Distinguishing randomized participants, the adherent primary analysis, and the recurrence observation population or missing data as a separate item; no new research, calculation or testing is performed in this preparation."
    },
    {
      "item_id": "N07",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "What scope do the prespecified adherence criteria have for recurrence?",
      "needed": "The original selection criteria of at least 26 of 28 doses and no more than 2 consecutive missed doses",
      "role": "Required",
      "role_reason": "An item prepared to distinguish The original selection criteria of at least 26 of 28 doses and no more than 2 consecutive missed doses and connect the selected question's required materials with the available materials.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Relevant original materials and the scope of analysis for The original selection criteria of at least 26 of 28 doses and no more than 2 consecutive missed doses must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of existing content remains incomplete.",
      "basis": "M08 §8.2.2, M15 §15.3.1; our own application; M03 §3.2.3, M08 §8.2.2–8.2.3; our own application",
      "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run",
      "proposed_research": "A proposal for follow-up materials linking The original selection criteria of at least 26 of 28 doses and no more than 2 consecutive missed doses as a separate item; no new research, calculation or testing is performed in this preparation."
    },
    {
      "item_id": "N08",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "Are the consistency-analysis results for all randomized participants recurrence results?",
      "needed": "The separate role of symptom resolution at 91.9/90.4%, +1.5 and the one-sided lower bound −5.8",
      "role": "Required",
      "role_reason": "An item prepared to distinguish The separate role of symptom resolution at 91.9/90.4%, +1.5 and the one-sided lower bound −5.8 and connect the selected question's required materials with the available materials.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Relevant original materials and the scope of analysis for The separate role of symptom resolution at 91.9/90.4%, +1.5 and the one-sided lower bound −5.8 must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of existing content remains incomplete.",
      "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are our own design; M08 §8.2.2, M15 §15.3.1; our own application",
      "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run",
      "proposed_research": "A proposal for follow-up materials linking The separate role of symptom resolution at 91.9/90.4%, +1.5 and the one-sided lower bound −5.8 as a separate item; no new research, calculation or testing is performed in this preparation."
    },
    {
      "item_id": "N09",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "Does the −10%p noninferiority margin for symptom resolution apply to recurrence?",
      "needed": "Distinguishing the parent's primary-resolution margin and one-sided CI from the two-sided recurrence interval",
      "role": "Required",
      "role_reason": "An item prepared to distinguish Distinguishing the parent's primary-resolution margin and one-sided CI from the two-sided recurrence interval and connect the selected question's required materials with the available materials.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Relevant original materials and the scope of analysis for Distinguishing the parent's primary-resolution margin and one-sided CI from the two-sided recurrence interval must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of existing content remains incomplete.",
      "basis": "M15 §15.3.1–15.3.3; our own application; M08 Table 8.2.a, M04 §4.6.3; our own application; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are our own design",
      "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run",
      "proposed_research": "A proposal for follow-up materials linking Distinguishing the parent's primary-resolution margin and one-sided CI from the two-sided recurrence interval as a separate item; no new research, calculation or testing is performed in this preparation."
    },
    {
      "item_id": "N10",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "What position does recurrence have in the prespecified endpoint hierarchy?",
      "needed": "The primary symptom-resolution endpoint and prespecification or multiplicity for recurrence",
      "role": "Required",
      "role_reason": "An item prepared to distinguish The primary symptom-resolution endpoint and prespecification or multiplicity for recurrence and connect the selected question's required materials with the available materials.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Relevant original materials and the scope of analysis for The primary symptom-resolution endpoint and prespecification or multiplicity for recurrence must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of existing content remains incomplete.",
      "basis": "M08 Table 8.2.a, M04 §4.6.3; Chamgap's own application",
      "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run",
      "proposed_research": "A proposal for follow-up materials linking The primary symptom-resolution endpoint and prespecification or multiplicity for recurrence as a separate item; no new research, calculation or testing is performed in this preparation."
    },
    {
      "item_id": "N11",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "What are the actual population and US VA study conditions?",
      "needed": "Afebrile men with UTI, two centers, and eligibility or baseline conditions",
      "role": "Required",
      "role_reason": "An item prepared to distinguish Afebrile men with UTI, two centers, and eligibility or baseline conditions and connect the selected question's required materials with the available materials.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Relevant original materials and the scope of analysis for Afebrile men with UTI, two centers, and eligibility or baseline conditions must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of existing content remains incomplete.",
      "basis": "M03 §3.2.1; detailed population conditions are Chamgap's own design",
      "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run",
      "proposed_research": "A proposal for follow-up materials linking Afebrile men with UTI, two centers, and eligibility or baseline conditions as a separate item; no new research, calculation or testing is performed in this preparation."
    },
    {
      "item_id": "N12",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "What historical comparison do 7 versus 14 days and the two antibiotics represent?",
      "needed": "The study duration and drugs, placebo, and actual exposure or concomitant treatment",
      "role": "Required",
      "role_reason": "An item prepared to distinguish The study duration and drugs, placebo, and actual exposure or concomitant treatment and connect the selected question's required materials with the available materials.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Relevant original materials and the scope of analysis for The study duration and drugs, placebo, and actual exposure or concomitant treatment must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of existing content remains incomplete.",
      "basis": "M03 §3.2.2–3.2.3; reverse-direction labels and checking adaptations are internally designed; M03 §3.2.3, M08 §8.2.2–8.2.3; internal application; M03 §3.2.1–3.2.4; dose, duration and effect-modification details are internally designed",
      "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run",
      "proposed_research": "A proposal for follow-up materials linking The study duration and drugs, placebo, and actual exposure or concomitant treatment as a separate item; no new research, calculation or testing is performed in this preparation."
    },
    {
      "item_id": "N13",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "Has the double-blind, placebo-controlled design been verified through recurrence measurement?",
      "needed": "Allocation or concealment, recurrence collection or assessors, and awareness of assignment",
      "role": "Required",
      "role_reason": "An item prepared to distinguish Allocation or concealment, recurrence collection or assessors, and awareness of assignment and connect the selected question's required materials with the available materials.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Relevant original materials and the scope of analysis for Allocation or concealment, recurrence collection or assessors, and awareness of assignment must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of existing content remains incomplete.",
      "basis": "M08 §8.1–8.2.3; internal application; M08 Table 8.2.a, M03 §3.2.4; internal application",
      "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run",
      "proposed_research": "A proposal for follow-up materials linking Allocation or concealment, recurrence collection or assessors, and awareness of assignment as a separate item; no new research, calculation or testing is performed in this preparation."
    },
    {
      "item_id": "N14",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "Are reports, populations and the sibling resolution question kept from being counted as new replications?",
      "needed": "The same Drekonja trial, 272/254 participants, and shared resolution, recurrence and safety results",
      "role": "Required",
      "role_reason": "An item prepared to distinguish The same Drekonja trial, 272/254 participants, and shared resolution, recurrence and safety results and connect the selected question's required materials with the available materials.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Relevant original materials and the scope of analysis for The same Drekonja trial, 272/254 participants, and shared resolution, recurrence and safety results must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of existing content remains incomplete.",
      "basis": "Study/report distinction in M04 §4.6.1–4.6.2; Cohort/outcome linkage is Chamgap application; M04 §4.6.1–4.6.2 and M15 §15.3.1; Chamgap application",
      "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run",
      "proposed_research": "A proposal for follow-up materials linking The same Drekonja trial, 272/254 participants, and shared resolution, recurrence and safety results as a separate item; no new research, calculation or testing is performed in this preparation."
    },
    {
      "item_id": "N15",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "Is the 1793 nitrofurantoin article reference a direct recurrence report?",
      "needed": "The B70 reference for uncomplicated cystitis in women and differences from men or the two drugs",
      "role": "Required",
      "role_reason": "An item prepared to distinguish The B70 reference for uncomplicated cystitis in women and differences from men or the two drugs and connect the selected question's required materials with the available materials.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Relevant original materials and the scope of analysis for The B70 reference for uncomplicated cystitis in women and differences from men or the two drugs must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of existing content remains incomplete.",
      "basis": "Question clarification principles in M03 §3.1, §3.2.1–3.2.4; detailed separation rules are internally designed; distinction between studies and reports in M04 §4.6.1–4.6.2; cohort/outcome linkage is an internal application; M03 §3.2.1; detailed population conditions are internally designed",
      "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run",
      "proposed_research": "A proposal for follow-up materials linking The B70 reference for uncomplicated cystitis in women and differences from men or the two drugs as a separate item; no new research, calculation or testing is performed in this preparation."
    },
    {
      "item_id": "N16",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "What different question does the 862 fosfomycin article reference concern?",
      "needed": "The boundary between B62 single-dose treatment in nonpregnant women and 28-day recurrence in men",
      "role": "Required",
      "role_reason": "An item prepared to distinguish The boundary between B62 single-dose treatment in nonpregnant women and 28-day recurrence in men and connect the selected question's required materials with the available materials.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Relevant original materials and the scope of analysis for The boundary between B62 single-dose treatment in nonpregnant women and 28-day recurrence in men must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of existing content remains incomplete.",
      "basis": "Question clarification principles in M03 §3.1, §3.2.1–3.2.4; detailed separation rules are internally designed; distinction between studies and reports in M04 §4.6.1–4.6.2; cohort/outcome linkage is an internal application; M03 §3.2.2–3.2.3; reverse-direction labels and test adaptation are internally designed",
      "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run",
      "proposed_research": "A proposal for follow-up materials linking The boundary between B62 single-dose treatment in nonpregnant women and 28-day recurrence in men as a separate item; no new research, calculation or testing is performed in this preparation."
    },
    {
      "item_id": "N17",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "What is the scope of VA support, products, employees and COI?",
      "needed": "The US VA Cooperative Studies Program and actual roles or support",
      "role": "Required",
      "role_reason": "An item prepared to distinguish The US VA Cooperative Studies Program and actual roles or support and connect the selected question's required materials with the available materials.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Relevant original materials and the scope of analysis for The US VA Cooperative Studies Program and actual roles or support must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of existing content remains incomplete.",
      "basis": "Chamgap's own conditions for independence and attribution. The official methodological sections used in this example do not validate every detail of these items.",
      "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run",
      "proposed_research": "A proposal for follow-up materials linking The US VA Cooperative Studies Program and actual roles or support as a separate item; no new research, calculation or testing is performed in this preparation."
    },
    {
      "item_id": "N18",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "Have the registration and prespecified recurrence plan actually been read?",
      "needed": "The NCT01994538 record, recurrence timing, hierarchy and denominator, and SAP",
      "role": "Required",
      "role_reason": "An item prepared to distinguish The NCT01994538 record, recurrence timing, hierarchy and denominator, and SAP and connect the selected question's required materials with the available materials.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Relevant original materials and the scope of analysis for The NCT01994538 record, recurrence timing, hierarchy and denominator, and SAP must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of existing content remains incomplete.",
      "basis": "M04 §4.5–4.6 material collection/selection principles; acquisition/reading separation and hyperlink specifications are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design; M08 Table 8.2.a, M04 §4.6.3; internal application",
      "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run",
      "proposed_research": "A proposal for follow-up materials linking The NCT01994538 record, recurrence timing, hierarchy and denominator, and SAP as a separate item; no new research, calculation or testing is performed in this preparation."
    },
    {
      "item_id": "N19",
      "question_type": "Harm-information gaps supplementing the efficacy table",
      "question": "Are adverse-event denominators and differences a separate outcome from recurrence?",
      "needed": "28/136(20.6%), 33/136(24.3%), −3.7%p and the absence of a reported significance test",
      "role": "Supplementary",
      "role_reason": "An item prepared to distinguish 28/136(20.6%), 33/136(24.3%), −3.7%p and the absence of a reported significance test and connect the selected question's required materials with the available materials.",
      "application_exception": "Addresses gaps in harm information for the selected recurrence/additional tuberculosis prevention question. Original efficacy, recurrence or safety wording is not used to judge overall safety or generate harm rates or guidance on antibiotic or vaccine selection, use or suitability.",
      "criterion": "Relevant original materials and the scope of analysis for 28/136(20.6%), 33/136(24.3%), −3.7%p and the absence of a reported significance test must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of existing content remains incomplete.",
      "basis": "M19 §19.1.2–19.2.4; Chamgap application; M19 §19.1.2–19.2.4; Detailed distinctions are Chamgap design; M19 §19.1.2–19.2.4; Chamgap application; Chamgap interpretation boundary. M19 principles are referenced; no official causality tool was run",
      "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run",
      "proposed_research": "A proposal for follow-up materials linking 28/136(20.6%), 33/136(24.3%), −3.7%p and the absence of a reported significance test as a separate item; no new research, calculation or testing is performed in this preparation."
    },
    {
      "item_id": "N20",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "Does reduced exposure establish reduced individual resistance or long-term recurrence?",
      "needed": "Distinguishing exposure, resistance or culture, and outcomes beyond 28 days",
      "role": "Required",
      "role_reason": "An item prepared to distinguish Distinguishing exposure, resistance or culture, and outcomes beyond 28 days and connect the selected question's required materials with the available materials.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Relevant original materials and the scope of analysis for Distinguishing exposure, resistance or culture, and outcomes beyond 28 days must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of existing content remains incomplete.",
      "basis": "M03 §3.2.4; our own extension boundary; M03 §3.2.1–3.2.4; dose, duration and effect-modification details are our own design; M19 §19.1.2–19.2.4; our own application",
      "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run",
      "proposed_research": "A proposal for follow-up materials linking Distinguishing exposure, resistance or culture, and outcomes beyond 28 days as a separate item; no new research, calculation or testing is performed in this preparation."
    },
    {
      "item_id": "N21",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "How are fractions, rates, differences and Korean or English article expressions preserved?",
      "needed": "Existing records, unread external original tables, and no calculation or correction",
      "role": "Required",
      "role_reason": "An item prepared to distinguish Existing records, unread external original tables, and no calculation or correction and connect the selected question's required materials with the available materials.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Relevant original materials and the scope of analysis for Existing records, unread external original tables, and no calculation or correction must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of existing content remains incomplete.",
      "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are our own design; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and our own design",
      "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run",
      "proposed_research": "A proposal for follow-up materials linking Existing records, unread external original tables, and no calculation or correction as a separate item; no new research, calculation or testing is performed in this preparation."
    },
    {
      "item_id": "N22",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "At what level have the stored summary and external paper or article URLs been read?",
      "needed": "The entire stored summary, 1 clinical report and 2 other articles, with external materials unread",
      "role": "Required",
      "role_reason": "An item prepared to distinguish The entire stored summary, 1 clinical report and 2 other articles, with external materials unread and connect the selected question's required materials with the available materials.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Relevant original materials and the scope of analysis for The entire stored summary, 1 clinical report and 2 other articles, with external materials unread must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of existing content remains incomplete.",
      "basis": "M04 §4.5–4.6 material collection/selection principles; acquisition/reading separation and hyperlink specifications are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design",
      "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run",
      "proposed_research": "A proposal for follow-up materials linking The entire stored summary, 1 clinical report and 2 other articles, with external materials unread as a separate item; no new research, calculation or testing is performed in this preparation."
    },
    {
      "item_id": "N23",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "Are dates, axes, null or false values, empty correction records and absent scores preserved?",
      "needed": "The parent's B70, subclaim D, 2026-08-26, existing Korean and English articles, and empty values",
      "role": "Required",
      "role_reason": "An item prepared to distinguish The parent's B70, subclaim D, 2026-08-26, existing Korean and English articles, and empty values and connect the selected question's required materials with the available materials.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Relevant original materials and the scope of analysis for The parent's B70, subclaim D, 2026-08-26, existing Korean and English articles, and empty values must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of existing content remains incomplete.",
      "basis": "M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design",
      "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run",
      "proposed_research": "A proposal for follow-up materials linking The parent's B70, subclaim D, 2026-08-26, existing Korean and English articles, and empty values as a separate item; no new research, calculation or testing is performed in this preparation."
    },
    {
      "item_id": "N24",
      "question_type": "Efficacy comparison and presentation of stored material",
      "question": "How are condition preservation, case production and content review distinguished?",
      "needed": "Records of condition preservation, freezing/application, case preparation and incomplete content review",
      "role": "Required",
      "role_reason": "An item prepared to distinguish Records of condition preservation, freezing/application, case preparation and incomplete content review and connect the selected question's required materials with the available materials.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Relevant original materials and the scope of analysis for Records of condition preservation, freezing/application, case preparation and incomplete content review must be provided, with unverified matters distinguished. This preparation links wording in the stored summary; review of existing content remains incomplete.",
      "basis": "M04 §4.5–4.6 material collection/selection principles; acquisition/reading separation and hyperlink specifications are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design",
      "condition_origin": "Conditions for presenting the stored article as a table; user review is pending. No official assessment tool or QA was run",
      "proposed_research": "A proposal for follow-up materials linking Records of condition preservation, freezing/application, case preparation and incomplete content review as a separate item; no new research, calculation or testing is performed in this preparation."
    }
  ]
}