{
  "schema_version": "chamgap-public-criteria-1.0",
  "title": "Cranberry fruit powder × placebo-controlled improvement in objective urinary flow",
  "language": "en",
  "translation_date": "2026-10-16",
  "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": "Status for necessary evidence confirmed after existing content review. No completion is declared in the current presentation.",
    "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": "Existing content review remains incomplete.",
    "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": "Evidence condition",
      "question": "What are the selected objective-flow claim and original verdict?",
      "needed": "Distinguishing the subclaim, grade and note from the parent IPSS verdict",
      "role": "Required",
      "role_reason": "This condition connects Distinguishing the subclaim, grade and note from the parent IPSS verdict with the selected question, actual population, test product, comparator, symptom scale, objective outcomes, time points, denominators and harms.",
      "application_exception": "Preserve original numbers while distinguishing total IPSS/subscores/QoL, objective flow/residual urine/prostate size, group changes/placebo contrasts/between-dose comparisons, MID sources and individual/group interpretation, timing, denominators, products, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, product intake, urinary/prostate treatment, prevention or treatment-replacement advice is created.",
      "criterion": "Material for Distinguishing the subclaim, grade and note from the parent IPSS verdict must be linked to the selected subclaim, parent context, original report, time points, comparator and denominators, distinguishing unread external material.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: The stored summary has no separate subclaim score, status, axes or confirmed placebo-controlled urinary-flow effect. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N02",
      "question_type": "Evidence condition",
      "question": "Are within-group changes distinguished from placebo contrasts?",
      "needed": "Baseline change, between-group estimates, analysis model and uncertainty",
      "role": "Required",
      "role_reason": "This condition connects Baseline change, between-group estimates, analysis model and uncertainty with the selected question, actual population, test product, comparator, symptom scale, objective outcomes, time points, denominators and harms.",
      "application_exception": "Preserve original numbers while distinguishing total IPSS/subscores/QoL, objective flow/residual urine/prostate size, group changes/placebo contrasts/between-dose comparisons, MID sources and individual/group interpretation, timing, denominators, products, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, product intake, urinary/prostate treatment, prevention or treatment-replacement advice is created.",
      "criterion": "Material for Baseline change, between-group estimates, analysis model and uncertainty must be linked to the selected subclaim, parent context, original report, time points, comparator and denominators, distinguishing unread external material.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: Exact between-group flow estimates, units, CIs, denominators and models are unverified. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N03",
      "question_type": "Evidence condition",
      "question": "Which population and denominators do the results concern?",
      "needed": "Eligibility, age, symptoms, baseline objective values and group denominators",
      "role": "Required",
      "role_reason": "This condition connects Eligibility, age, symptoms, baseline objective values and group denominators with the selected question, actual population, test product, comparator, symptom scale, objective outcomes, time points, denominators and harms.",
      "application_exception": "Preserve original numbers while distinguishing total IPSS/subscores/QoL, objective flow/residual urine/prostate size, group changes/placebo contrasts/between-dose comparisons, MID sources and individual/group interpretation, timing, denominators, products, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, product intake, urinary/prostate treatment, prevention or treatment-replacement advice is created.",
      "criterion": "Material for Eligibility, age, symptoms, baseline objective values and group denominators must be linked to the selected subclaim, parent context, original report, time points, comparator and denominators, distinguishing unread external material.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: Group counts, detailed eligibility, baseline flow/residual volume, diagnoses, completion and analysis counts are unverified. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N04",
      "question_type": "Evidence condition",
      "question": "What were the test product and two doses?",
      "needed": "Branded test product, composition, planned dose and actual exposure",
      "role": "Required",
      "role_reason": "This condition connects Branded test product, composition, planned dose and actual exposure with the selected question, actual population, test product, comparator, symptom scale, objective outcomes, time points, denominators and harms.",
      "application_exception": "Preserve original numbers while distinguishing total IPSS/subscores/QoL, objective flow/residual urine/prostate size, group changes/placebo contrasts/between-dose comparisons, MID sources and individual/group interpretation, timing, denominators, products, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, product intake, urinary/prostate treatment, prevention or treatment-replacement advice is created.",
      "criterion": "Material for Branded test product, composition, planned dose and actual exposure must be linked to the selected subclaim, parent context, original report, time points, comparator and denominators, distinguishing unread external material.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: Product composition, PAC content, actual adherence, exposure distribution and measurement linkage for the500mg group are unverified. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N05",
      "question_type": "Evidence condition",
      "question": "What were the actual placebo conditions?",
      "needed": "Placebo specification, concurrent care and matched objective measurements/denominators",
      "role": "Required",
      "role_reason": "This condition connects Placebo specification, concurrent care and matched objective measurements/denominators with the selected question, actual population, test product, comparator, symptom scale, objective outcomes, time points, denominators and harms.",
      "application_exception": "Preserve original numbers while distinguishing total IPSS/subscores/QoL, objective flow/residual urine/prostate size, group changes/placebo contrasts/between-dose comparisons, MID sources and individual/group interpretation, timing, denominators, products, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, product intake, urinary/prostate treatment, prevention or treatment-replacement advice is created.",
      "criterion": "Material for Placebo specification, concurrent care and matched objective measurements/denominators must be linked to the selected subclaim, parent context, original report, time points, comparator and denominators, distinguishing unread external material.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: Placebo composition/exposure, concurrent care and between-group matching of flow measurements/denominators are unverified. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N06",
      "question_type": "Evidence condition",
      "question": "How was Qmax defined and measured?",
      "needed": "Maximum-flow definition, units, measurement method and timing",
      "role": "Required",
      "role_reason": "This condition connects Maximum-flow definition, units, measurement method and timing with the selected question, actual population, test product, comparator, symptom scale, objective outcomes, time points, denominators and harms.",
      "application_exception": "Preserve original numbers while distinguishing total IPSS/subscores/QoL, objective flow/residual urine/prostate size, group changes/placebo contrasts/between-dose comparisons, MID sources and individual/group interpretation, timing, denominators, products, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, product intake, urinary/prostate treatment, prevention or treatment-replacement advice is created.",
      "criterion": "Material for Maximum-flow definition, units, measurement method and timing must be linked to the selected subclaim, parent context, original report, time points, comparator and denominators, distinguishing unread external material.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: Qmax definition, units, measurement method, validity criteria, exact values/CIs and denominators are unverified. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N07",
      "question_type": "Evidence condition",
      "question": "Was Qavg distinguished from Qmax?",
      "needed": "Separate mean-flow definition, measurement and original results",
      "role": "Required",
      "role_reason": "This condition connects Separate mean-flow definition, measurement and original results with the selected question, actual population, test product, comparator, symptom scale, objective outcomes, time points, denominators and harms.",
      "application_exception": "Preserve original numbers while distinguishing total IPSS/subscores/QoL, objective flow/residual urine/prostate size, group changes/placebo contrasts/between-dose comparisons, MID sources and individual/group interpretation, timing, denominators, products, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, product intake, urinary/prostate treatment, prevention or treatment-replacement advice is created.",
      "criterion": "Material for Separate mean-flow definition, measurement and original results must be linked to the selected subclaim, parent context, original report, time points, comparator and denominators, distinguishing unread external material.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: Qavg definition, units, measurement, exact values/CIs, timing and denominators are unverified. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N08",
      "question_type": "Evidence condition",
      "question": "Was residual volume treated as a separate endpoint?",
      "needed": "Residual-volume definition, units, method and between-group results",
      "role": "Required",
      "role_reason": "This condition connects Residual-volume definition, units, method and between-group results with the selected question, actual population, test product, comparator, symptom scale, objective outcomes, time points, denominators and harms.",
      "application_exception": "Preserve original numbers while distinguishing total IPSS/subscores/QoL, objective flow/residual urine/prostate size, group changes/placebo contrasts/between-dose comparisons, MID sources and individual/group interpretation, timing, denominators, products, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, product intake, urinary/prostate treatment, prevention or treatment-replacement advice is created.",
      "criterion": "Material for Residual-volume definition, units, method and between-group results must be linked to the selected subclaim, parent context, original report, time points, comparator and denominators, distinguishing unread external material.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: Residual-volume methods, units, exact values/CIs, between-group contrasts and denominators are unverified. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N09",
      "question_type": "Evidence condition",
      "question": "When were the objective endpoints actually measured?",
      "needed": "Distinguishing three-/six-month IPSS from objective-test timing",
      "role": "Required",
      "role_reason": "This condition connects Distinguishing three-/six-month IPSS from objective-test timing with the selected question, actual population, test product, comparator, symptom scale, objective outcomes, time points, denominators and harms.",
      "application_exception": "Preserve original numbers while distinguishing total IPSS/subscores/QoL, objective flow/residual urine/prostate size, group changes/placebo contrasts/between-dose comparisons, MID sources and individual/group interpretation, timing, denominators, products, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, product intake, urinary/prostate treatment, prevention or treatment-replacement advice is created.",
      "criterion": "Material for Distinguishing three-/six-month IPSS from objective-test timing must be linked to the selected subclaim, parent context, original report, time points, comparator and denominators, distinguishing unread external material.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: Individual Qmax, Qavg and residual-volume times, missing measurements and follow-up windows are unverified. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N10",
      "question_type": "Evidence condition",
      "question": "What was the500mg group’s change from baseline?",
      "needed": "Original within-group values, change, P values, denominators and definitions",
      "role": "Required",
      "role_reason": "This condition connects Original within-group values, change, P values, denominators and definitions with the selected question, actual population, test product, comparator, symptom scale, objective outcomes, time points, denominators and harms.",
      "application_exception": "Preserve original numbers while distinguishing total IPSS/subscores/QoL, objective flow/residual urine/prostate size, group changes/placebo contrasts/between-dose comparisons, MID sources and individual/group interpretation, timing, denominators, products, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, product intake, urinary/prostate treatment, prevention or treatment-replacement advice is created.",
      "criterion": "Material for Original within-group values, change, P values, denominators and definitions must be linked to the selected subclaim, parent context, original report, time points, comparator and denominators, distinguishing unread external material.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: Baseline/follow-up values, within-group changes/CIs/P values, denominators and adjustment are unverified. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N11",
      "question_type": "Evidence condition",
      "question": "Are IPSS results being transferred to objective flow?",
      "needed": "Directness of subjective symptom scales versus objective tests",
      "role": "Required",
      "role_reason": "This condition connects Directness of subjective symptom scales versus objective tests with the selected question, actual population, test product, comparator, symptom scale, objective outcomes, time points, denominators and harms.",
      "application_exception": "Preserve original numbers while distinguishing total IPSS/subscores/QoL, objective flow/residual urine/prostate size, group changes/placebo contrasts/between-dose comparisons, MID sources and individual/group interpretation, timing, denominators, products, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, product intake, urinary/prostate treatment, prevention or treatment-replacement advice is created.",
      "criterion": "Material for Directness of subjective symptom scales versus objective tests must be linked to the selected subclaim, parent context, original report, time points, comparator and denominators, distinguishing unread external material.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: Individual IPSS–objective-flow correspondence and between-group objective effects are not linked. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N12",
      "question_type": "Evidence condition",
      "question": "What are the dose-pattern and other-group gaps?",
      "needed": "Objective outcomes and direct contrasts for250mg,500mg and placebo",
      "role": "Required",
      "role_reason": "This condition connects Objective outcomes and direct contrasts for250mg,500mg and placebo with the selected question, actual population, test product, comparator, symptom scale, objective outcomes, time points, denominators and harms.",
      "application_exception": "Preserve original numbers while distinguishing total IPSS/subscores/QoL, objective flow/residual urine/prostate size, group changes/placebo contrasts/between-dose comparisons, MID sources and individual/group interpretation, timing, denominators, products, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, product intake, urinary/prostate treatment, prevention or treatment-replacement advice is created.",
      "criterion": "Material for Objective outcomes and direct contrasts for250mg,500mg and placebo must be linked to the selected subclaim, parent context, original report, time points, comparator and denominators, distinguishing unread external material.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: Objective values, direct contrasts, CIs and prespecified models for250mg,500mg and placebo are unverified. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N13",
      "question_type": "Evidence condition",
      "question": "What were the objective-test denominators and missing data?",
      "needed": "Participant, test, time-point and repeated-measure denominators",
      "role": "Required",
      "role_reason": "This condition connects Participant, test, time-point and repeated-measure denominators with the selected question, actual population, test product, comparator, symptom scale, objective outcomes, time points, denominators and harms.",
      "application_exception": "Preserve original numbers while distinguishing total IPSS/subscores/QoL, objective flow/residual urine/prostate size, group changes/placebo contrasts/between-dose comparisons, MID sources and individual/group interpretation, timing, denominators, products, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, product intake, urinary/prostate treatment, prevention or treatment-replacement advice is created.",
      "criterion": "Material for Participant, test, time-point and repeated-measure denominators must be linked to the selected subclaim, parent context, original report, time points, comparator and denominators, distinguishing unread external material.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: Valid tests, missing/excluded observations, repeated-measure counts and correlations by group/time are unverified. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N14",
      "question_type": "Evidence condition",
      "question": "Was measurement standardized?",
      "needed": "Test conditions, equipment, validity criteria and repeatability",
      "role": "Required",
      "role_reason": "This condition connects Test conditions, equipment, validity criteria and repeatability with the selected question, actual population, test product, comparator, symptom scale, objective outcomes, time points, denominators and harms.",
      "application_exception": "Preserve original numbers while distinguishing total IPSS/subscores/QoL, objective flow/residual urine/prostate size, group changes/placebo contrasts/between-dose comparisons, MID sources and individual/group interpretation, timing, denominators, products, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, product intake, urinary/prostate treatment, prevention or treatment-replacement advice is created.",
      "criterion": "Material for Test conditions, equipment, validity criteria and repeatability must be linked to the selected subclaim, parent context, original report, time points, comparator and denominators, distinguishing unread external material.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: Measurement conditions, equipment, valid-test criteria and repeatability by group/time are unverified. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N15",
      "question_type": "Evidence condition",
      "question": "How were assessors and analysts masked?",
      "needed": "Objective measurement, actual masking and awareness of conditions",
      "role": "Required",
      "role_reason": "This condition connects Objective measurement, actual masking and awareness of conditions with the selected question, actual population, test product, comparator, symptom scale, objective outcomes, time points, denominators and harms.",
      "application_exception": "Preserve original numbers while distinguishing total IPSS/subscores/QoL, objective flow/residual urine/prostate size, group changes/placebo contrasts/between-dose comparisons, MID sources and individual/group interpretation, timing, denominators, products, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, product intake, urinary/prostate treatment, prevention or treatment-replacement advice is created.",
      "criterion": "Material for Objective measurement, actual masking and awareness of conditions must be linked to the selected subclaim, parent context, original report, time points, comparator and denominators, distinguishing unread external material.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: Who was masked, masking maintenance, analyst involvement and expectation/contact differences are unverified. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N16",
      "question_type": "Evidence condition",
      "question": "How were allocation and the three-group comparison conducted?",
      "needed": "Randomization, allocation concealment, baseline objective values and analysis",
      "role": "Required",
      "role_reason": "This condition connects Randomization, allocation concealment, baseline objective values and analysis with the selected question, actual population, test product, comparator, symptom scale, objective outcomes, time points, denominators and harms.",
      "application_exception": "Preserve original numbers while distinguishing total IPSS/subscores/QoL, objective flow/residual urine/prostate size, group changes/placebo contrasts/between-dose comparisons, MID sources and individual/group interpretation, timing, denominators, products, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, product intake, urinary/prostate treatment, prevention or treatment-replacement advice is created.",
      "criterion": "Material for Randomization, allocation concealment, baseline objective values and analysis must be linked to the selected subclaim, parent context, original report, time points, comparator and denominators, distinguishing unread external material.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: Sequence generation/concealment, balance in baseline objective values, between-group adjustment and models are unverified. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N17",
      "question_type": "Evidence condition",
      "question": "How were completion, attrition and ITT/PP handled?",
      "needed": "Objective-endpoint analysis populations, discontinuation and missing-data handling",
      "role": "Required",
      "role_reason": "This condition connects Objective-endpoint analysis populations, discontinuation and missing-data handling with the selected question, actual population, test product, comparator, symptom scale, objective outcomes, time points, denominators and harms.",
      "application_exception": "Preserve original numbers while distinguishing total IPSS/subscores/QoL, objective flow/residual urine/prostate size, group changes/placebo contrasts/between-dose comparisons, MID sources and individual/group interpretation, timing, denominators, products, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, product intake, urinary/prostate treatment, prevention or treatment-replacement advice is created.",
      "criterion": "Material for Objective-endpoint analysis populations, discontinuation and missing-data handling must be linked to the selected subclaim, parent context, original report, time points, comparator and denominators, distinguishing unread external material.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: Group attrition, missing tests, ITT/PP, exclusions, imputation and sensitivity analyses are unverified. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N18",
      "question_type": "Evidence condition",
      "question": "What concurrent treatment, medicines and adherence were recorded?",
      "needed": "Linking objective tests to concurrent exposures",
      "role": "Required",
      "role_reason": "This condition connects Linking objective tests to concurrent exposures with the selected question, actual population, test product, comparator, symptom scale, objective outcomes, time points, denominators and harms.",
      "application_exception": "Preserve original numbers while distinguishing total IPSS/subscores/QoL, objective flow/residual urine/prostate size, group changes/placebo contrasts/between-dose comparisons, MID sources and individual/group interpretation, timing, denominators, products, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, product intake, urinary/prostate treatment, prevention or treatment-replacement advice is created.",
      "criterion": "Material for Linking objective tests to concurrent exposures must be linked to the selected subclaim, parent context, original report, time points, comparator and denominators, distinguishing unread external material.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: Group records of concurrent treatment, medicines, lifestyle/baseline changes, adherence and discontinuation are unverified. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N19",
      "question_type": "Evidence condition",
      "question": "What was the hierarchy of prespecified IPSS and objective endpoints?",
      "needed": "Registration, protocol, SAP and endpoint-/time-specific plans",
      "role": "Required",
      "role_reason": "This condition connects Registration, protocol, SAP and endpoint-/time-specific plans with the selected question, actual population, test product, comparator, symptom scale, objective outcomes, time points, denominators and harms.",
      "application_exception": "Preserve original numbers while distinguishing total IPSS/subscores/QoL, objective flow/residual urine/prostate size, group changes/placebo contrasts/between-dose comparisons, MID sources and individual/group interpretation, timing, denominators, products, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, product intake, urinary/prostate treatment, prevention or treatment-replacement advice is created.",
      "criterion": "Material for Registration, protocol, SAP and endpoint-/time-specific plans must be linked to the selected subclaim, parent context, original report, time points, comparator and denominators, distinguishing unread external material.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: Objective-endpoint hierarchy, group contrasts, multiplicity, pre-recruitment plans, original registration and amendment history are unread. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N20",
      "question_type": "Evidence condition",
      "question": "Which measure’s threshold does the MID material concern?",
      "needed": "Distinguishing IPSS symptom thresholds from urinary-flow relevance",
      "role": "Required",
      "role_reason": "This condition connects Distinguishing IPSS symptom thresholds from urinary-flow relevance with the selected question, actual population, test product, comparator, symptom scale, objective outcomes, time points, denominators and harms.",
      "application_exception": "Preserve original numbers while distinguishing total IPSS/subscores/QoL, objective flow/residual urine/prostate size, group changes/placebo contrasts/between-dose comparisons, MID sources and individual/group interpretation, timing, denominators, products, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, product intake, urinary/prostate treatment, prevention or treatment-replacement advice is created.",
      "criterion": "Material for Distinguishing IPSS symptom thresholds from urinary-flow relevance must be linked to the selected subclaim, parent context, original report, time points, comparator and denominators, distinguishing unread external material.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: Objective-flow relevance criteria and direct correspondence with symptom thresholds are unverified. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N21",
      "question_type": "Evidence condition",
      "question": "How are the same trial, cohorts and time points related?",
      "needed": "Overlap among the efficacy trial, threshold cohort and two sheets",
      "role": "Required",
      "role_reason": "This condition connects Overlap among the efficacy trial, threshold cohort and two sheets with the selected question, actual population, test product, comparator, symptom scale, objective outcomes, time points, denominators and harms.",
      "application_exception": "Preserve original numbers while distinguishing total IPSS/subscores/QoL, objective flow/residual urine/prostate size, group changes/placebo contrasts/between-dose comparisons, MID sources and individual/group interpretation, timing, denominators, products, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, product intake, urinary/prostate treatment, prevention or treatment-replacement advice is created.",
      "criterion": "Material for Overlap among the efficacy trial, threshold cohort and two sheets must be linked to the selected subclaim, parent context, original report, time points, comparator and denominators, distinguishing unread external material.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: Separate replication under the same flow-comparison conditions and independence of study families are not linked. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N22",
      "question_type": "Evidence condition",
      "question": "Can the six-month results extend to longer periods or other populations?",
      "needed": "Exact objective-test timing, persistence and population-specific direct material",
      "role": "Required",
      "role_reason": "This condition connects Exact objective-test timing, persistence and population-specific direct material with the selected question, actual population, test product, comparator, symptom scale, objective outcomes, time points, denominators and harms.",
      "application_exception": "Preserve original numbers while distinguishing total IPSS/subscores/QoL, objective flow/residual urine/prostate size, group changes/placebo contrasts/between-dose comparisons, MID sources and individual/group interpretation, timing, denominators, products, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, product intake, urinary/prostate treatment, prevention or treatment-replacement advice is created.",
      "criterion": "Material for Exact objective-test timing, persistence and population-specific direct material must be linked to the selected subclaim, parent context, original report, time points, comparator and denominators, distinguishing unread external material.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: Long-term persistence, population-specific objective effects/denominators and safety are not linked. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N23",
      "question_type": "Evidence condition",
      "question": "Are prostate size, clinical treatment and ordinary products distinguished?",
      "needed": "Directness for objective measures versus other questions/products",
      "role": "Required",
      "role_reason": "This condition connects Directness for objective measures versus other questions/products with the selected question, actual population, test product, comparator, symptom scale, objective outcomes, time points, denominators and harms.",
      "application_exception": "Preserve original numbers while distinguishing total IPSS/subscores/QoL, objective flow/residual urine/prostate size, group changes/placebo contrasts/between-dose comparisons, MID sources and individual/group interpretation, timing, denominators, products, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, product intake, urinary/prostate treatment, prevention or treatment-replacement advice is created.",
      "criterion": "Material for Directness for objective measures versus other questions/products must be linked to the selected subclaim, parent context, original report, time points, comparator and denominators, distinguishing unread external material.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: Direct material for other clinical questions, products and treatment-replacement comparisons is not linked. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N24",
      "question_type": "Evidence condition",
      "question": "What manufacturer employment, support and interests were recorded?",
      "needed": "Original employment, product, funding and research-role material",
      "role": "Required",
      "role_reason": "This condition connects Original employment, product, funding and research-role material with the selected question, actual population, test product, comparator, symptom scale, objective outcomes, time points, denominators and harms.",
      "application_exception": "Preserve original numbers while distinguishing total IPSS/subscores/QoL, objective flow/residual urine/prostate size, group changes/placebo contrasts/between-dose comparisons, MID sources and individual/group interpretation, timing, denominators, products, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, product intake, urinary/prostate treatment, prevention or treatment-replacement advice is created.",
      "criterion": "Material for Original employment, product, funding and research-role material must be linked to the selected subclaim, parent context, original report, time points, comparator and denominators, distinguishing unread external material.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: Funding roles, product support, employee-author contributions, COI and supporting-cohort support are unverified. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N25",
      "question_type": "Harm-information gaps supplementing the efficacy table",
      "question": "What gaps concern safety, laboratory tests and interactions?",
      "needed": "Adverse events, laboratory tests, exposure, denominators and discontinuation",
      "role": "Supplementary",
      "role_reason": "This condition connects Adverse events, laboratory tests, exposure, denominators and discontinuation with the selected question, actual population, test product, comparator, symptom scale, objective outcomes, time points, denominators and harms.",
      "application_exception": "Preserve original numbers while distinguishing total IPSS/subscores/QoL, objective flow/residual urine/prostate size, group changes/placebo contrasts/between-dose comparisons, MID sources and individual/group interpretation, timing, denominators, products, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, product intake, urinary/prostate treatment, prevention or treatment-replacement advice is created.",
      "criterion": "Material for Adverse events, laboratory tests, exposure, denominators and discontinuation must be linked to the selected subclaim, parent context, original report, time points, comparator and denominators, distinguishing unread external material.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: Direct material on event collection/definitions, group denominators, discontinuation, rare harms and interactions is unverified. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N26",
      "question_type": "Evidence condition",
      "question": "Were original values, axes, bilingual text, dates and history preserved?",
      "needed": "Distinguishing parent C46, subclaim “?”, corrections and historical checks",
      "role": "Required",
      "role_reason": "This condition connects Distinguishing parent C46, subclaim “?”, corrections and historical checks with the selected question, actual population, test product, comparator, symptom scale, objective outcomes, time points, denominators and harms.",
      "application_exception": "Preserve original numbers while distinguishing total IPSS/subscores/QoL, objective flow/residual urine/prostate size, group changes/placebo contrasts/between-dose comparisons, MID sources and individual/group interpretation, timing, denominators, products, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, product intake, urinary/prostate treatment, prevention or treatment-replacement advice is created.",
      "criterion": "Material for Distinguishing parent C46, subclaim “?”, corrections and historical checks must be linked to the selected subclaim, parent context, original report, time points, comparator and denominators, distinguishing unread external material.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: Subclaim score/status/axes, new corrections and external details of historical checks are unverified. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N27",
      "question_type": "Evidence condition",
      "question": "What was actually read, and what follow-up material is needed?",
      "needed": "Stored-summary use, unread external material and update scope",
      "role": "Required",
      "role_reason": "This condition connects Stored-summary use, unread external material and update scope with the selected question, actual population, test product, comparator, symptom scale, objective outcomes, time points, denominators and harms.",
      "application_exception": "Preserve original numbers while distinguishing total IPSS/subscores/QoL, objective flow/residual urine/prostate size, group changes/placebo contrasts/between-dose comparisons, MID sources and individual/group interpretation, timing, denominators, products, harms and unread external material. No new calculations, hypothetical examples, effects, CIs, regrading, independence certification, product intake, urinary/prostate treatment, prevention or treatment-replacement advice is created.",
      "criterion": "Material for Stored-summary use, unread external material and update scope must be linked to the selected subclaim, parent context, original report, time points, comparator and denominators, distinguishing unread external material.",
      "basis": "Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.",
      "condition_origin": "Internally applied conditions preserved for the existing subclaim. They do not establish preregistration, official-tool certification or completed content review.",
      "proposed_research": "Material needed: Report-specific originals, registration, plans, support material, actual external reading and follow-up content review remain incomplete. This records needed materials; no new research was executed."
    }
  ]
}