{ "schema_version": "chamgap-public-criteria-1.0", "title": "Cranberry fruit powder × six-month IPSS reduction", "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": "Selected IPSS question and original grade", "needed": "Selected wording, note, grade and parent verdict", "role": "Required", "role_reason": "This condition connects Selected wording, note, grade and parent 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 Selected wording, note, grade and parent 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: Separate subclaim score, status and axes are absent from the original record. This records needed materials; no new research was executed." }, { "item_id": "N02", "question_type": "Evidence condition", "question": "Participants, symptoms and age criteria", "needed": "Eligibility, baseline IPSS, age and group denominators", "role": "Required", "role_reason": "This condition connects Eligibility, baseline IPSS, age 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, baseline IPSS, age 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: Exact age range, baseline IPSS distribution, diagnoses, history and group allocation counts are unverified. This records needed materials; no new research was executed." }, { "item_id": "N03", "question_type": "Evidence condition", "question": "Identity of the branded cranberry powder", "needed": "Product, manufacturing, composition, form and test-product records", "role": "Required", "role_reason": "This condition connects Product, manufacturing, composition, form and test-product records 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 Product, manufacturing, composition, form and test-product records 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: Test-product composition, PAC content, manufacturing, standardization, batches and correspondence to ordinary products are unverified. This records needed materials; no new research was executed." }, { "item_id": "N04", "question_type": "Evidence condition", "question": "Research exposure at250 and500mg", "needed": "Three-group plans, actual exposure, duration and adherence", "role": "Required", "role_reason": "This condition connects Three-group plans, actual exposure, duration and adherence 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 Three-group plans, actual exposure, duration and adherence 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: Actual adherence, discontinuation, content, intake schedule and exposure distribution are unverified. This records needed materials; no new research was executed." }, { "item_id": "N05", "question_type": "Evidence condition", "question": "Actual placebo comparison conditions", "needed": "Placebo composition, exposure, sensory matching and concurrent care", "role": "Required", "role_reason": "This condition connects Placebo composition, exposure, sensory matching and concurrent care 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 composition, exposure, sensory matching and concurrent care 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 specifications, exposure, appearance, taste, contact and matching of care are unverified. This records needed materials; no new research was executed." }, { "item_id": "N06", "question_type": "Evidence condition", "question": "Randomization and double-blinding procedures", "needed": "Sequence, concealment, masking targets and maintenance, and analysis", "role": "Required", "role_reason": "This condition connects Sequence, concealment, masking targets and maintenance, 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 Sequence, concealment, masking targets and maintenance, 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, masking targets and maintenance, and analyst involvement are unverified. This records needed materials; no new research was executed." }, { "item_id": "N07", "question_type": "Evidence condition", "question": "The124 participants and group/outcome denominators", "needed": "Allocation, completion, analysis and attrition", "role": "Required", "role_reason": "This condition connects Allocation, completion, analysis and attrition 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 Allocation, completion, analysis and attrition 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 allocation, completion, attrition, discontinuation, outcome-analysis counts and reasons are unverified. This records needed materials; no new research was executed." }, { "item_id": "N08", "question_type": "Evidence condition", "question": "Definition of total IPSS assessment", "needed": "Scale, total and subscores, responses and time points", "role": "Required", "role_reason": "This condition connects Scale, total and subscores, responses and time points 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 Scale, total and subscores, responses and time points 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: Total-score composition, assessment procedures, baseline distribution, scale language and missing responses are unverified. This records needed materials; no new research was executed." }, { "item_id": "N09", "question_type": "Evidence condition", "question": "Six-month changes within each group", "needed": "Changes, baseline, units and denominators for each dose and placebo", "role": "Required", "role_reason": "This condition connects Changes, baseline, units and denominators for each dose 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 Changes, baseline, units and denominators for each dose 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: Group baseline and end values, change variance, exact analysis denominators and models are unverified. This records needed materials; no new research was executed." }, { "item_id": "N10", "question_type": "Evidence condition", "question": "Original approximate differences versus placebo", "needed": "Between-group estimands, adjustment, CIs and historical calculation", "role": "Required", "role_reason": "This condition connects Between-group estimands, adjustment, CIs and historical calculation 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 Between-group estimands, adjustment, CIs and historical calculation 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 models, adjustment, CIs, denominators and estimand definitions are unverified. This records needed materials; no new research was executed." }, { "item_id": "N11", "question_type": "Evidence condition", "question": "Dose-specific P values and comparison scope", "needed": "Reported P values, exact contrasts, models and multiplicity", "role": "Required", "role_reason": "This condition connects Reported P values, exact contrasts, models and multiplicity 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 Reported P values, exact contrasts, models and multiplicity 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 P values, tested contrasts, direction, multiplicity and adjusted models are unverified. This records needed materials; no new research was executed." }, { "item_id": "N12", "question_type": "Evidence condition", "question": "An apparent dose-response pattern", "needed": "Direct comparison of doses, adherence and models", "role": "Required", "role_reason": "This condition connects Direct comparison of doses, adherence and models 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 Direct comparison of doses, adherence and models 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 between-dose contrasts, exposure adherence, CIs and prespecified models are unverified. This records needed materials; no new research was executed." }, { "item_id": "N13", "question_type": "Evidence condition", "question": "Minimal important-difference numbers by source", "needed": "Textual thresholds, supporting citation estimates, populations and units", "role": "Required", "role_reason": "This condition connects Textual thresholds, supporting citation estimates, populations and units 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 Textual thresholds, supporting citation estimates, populations and units 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 exact source and conditions for3.1 in the text, and correspondence to the supporting cohort's3.2, are unverified. This records needed materials; no new research was executed." }, { "item_id": "N14", "question_type": "Evidence condition", "question": "Role of the Blanker observational cohort", "needed": "MID estimation design, population, denominators and criteria", "role": "Required", "role_reason": "This condition connects MID estimation design, population, denominators and criteria 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 MID estimation design, population, denominators and criteria 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: Supporting-cohort n, baseline severity, anchors, estimation methods, CIs and correspondence to the trial population are unverified. This records needed materials; no new research was executed." }, { "item_id": "N15", "question_type": "Evidence condition", "question": "Mean differences and individual importance thresholds", "needed": "Estimands, individual versus group interpretation and relevance criteria", "role": "Required", "role_reason": "This condition connects Estimands, individual versus group interpretation and relevance criteria 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 Estimands, individual versus group interpretation and relevance criteria 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 correspondence between group means and individually important changes, distributions and prespecified criteria is unverified. This records needed materials; no new research was executed." }, { "item_id": "N16", "question_type": "Evidence condition", "question": "IPSS subscores and quality of life", "needed": "Separate total, item, subscore and QoL outcomes", "role": "Required", "role_reason": "This condition connects Separate total, item, subscore and QoL outcomes 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 total, item, subscore and QoL outcomes 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: Item, subscore and QoL definitions, time points, denominators, exact effects, CIs and hierarchy are unverified. This records needed materials; no new research was executed." }, { "item_id": "N17", "question_type": "Evidence condition", "question": "Three and six months, and persistence after completion", "needed": "Time-specific results, denominators and post-discontinuation persistence", "role": "Required", "role_reason": "This condition connects Time-specific results, denominators and post-discontinuation persistence 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 Time-specific results, denominators and post-discontinuation persistence 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: Three-month quantitative values, denominators, time-specific missingness and persistence beyond six months are not linked. This records needed materials; no new research was executed." }, { "item_id": "N18", "question_type": "Evidence condition", "question": "Prespecified IPSS statements and registration", "needed": "Original prespecification statements, registration, protocol and SAP", "role": "Required", "role_reason": "This condition connects Original prespecification statements, registration, protocol and SAP 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 prespecification statements, registration, protocol and SAP 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: Original registration, recruitment and registration timing, protocol, SAP and amendment history are unread. This records needed materials; no new research was executed." }, { "item_id": "N19", "question_type": "Evidence condition", "question": "Plans for multiple doses, times and outcomes", "needed": "Prespecified hierarchy, contrasts, multiplicity and analysis models", "role": "Required", "role_reason": "This condition connects Prespecified hierarchy, contrasts, multiplicity and analysis models 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 Prespecified hierarchy, contrasts, multiplicity and analysis models 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 hierarchy, dose/time contrasts, multiplicity and the complete SAP are unverified. This records needed materials; no new research was executed." }, { "item_id": "N20", "question_type": "Evidence condition", "question": "Blinding and measurement of symptoms", "needed": "Participants, assessors, scale administration and expectancy", "role": "Required", "role_reason": "This condition connects Participants, assessors, scale administration and expectancy 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 Participants, assessors, scale administration and expectancy 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: Masking maintenance, assessment procedures, missing responses, analysts and expectancy effects are unverified. This records needed materials; no new research was executed." }, { "item_id": "N21", "question_type": "Evidence condition", "question": "Concurrent care and actual exposure", "needed": "Medication, lifestyle, concurrent interventions and adherence", "role": "Required", "role_reason": "This condition connects Medication, lifestyle, concurrent interventions and adherence 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 Medication, lifestyle, concurrent interventions and adherence 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: Concurrent treatment, lifestyle changes, adherence, discontinuation and baseline adjustment are unverified. This records needed materials; no new research was executed." }, { "item_id": "N22", "question_type": "Evidence condition", "question": "Analysis populations and missing-data handling", "needed": "ITT, PP, group attrition/discontinuation and missing outcomes", "role": "Required", "role_reason": "This condition connects ITT, PP, group attrition/discontinuation and missing outcomes 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 ITT, PP, group attrition/discontinuation and missing outcomes 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 IPSS, exclusions, ITT, PP, imputation and sensitivity analyses are unverified. This records needed materials; no new research was executed." }, { "item_id": "N23", "question_type": "Evidence condition", "question": "Within-group objective-flow and residual-urine comparisons", "needed": "IPSS versus Qmax, Qavg and residual urine; within/between-group distinctions", "role": "Required", "role_reason": "This condition connects IPSS versus Qmax, Qavg and residual urine; within/between-group distinctions 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 IPSS versus Qmax, Qavg and residual urine; within/between-group distinctions 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 objective values, units, time points, denominators, between-group effects and CIs are unverified. This records needed materials; no new research was executed." }, { "item_id": "N24", "question_type": "Evidence condition", "question": "Scope of other clinical and product questions", "needed": "Direct measurement, comparisons and generalization", "role": "Required", "role_reason": "This condition connects Direct measurement, comparisons and generalization 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 Direct measurement, comparisons and generalization 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 evidence for other clinical outcomes, products, populations and treatment replacement is not linked. This records needed materials; no new research was executed." }, { "item_id": "N25", "question_type": "Evidence condition", "question": "One shared trial, supporting thresholds and independent replication", "needed": "Efficacy reports, cohort roles and duplicate times/sheets", "role": "Required", "role_reason": "This condition connects Efficacy reports, cohort roles and duplicate times/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 Efficacy reports, cohort roles and duplicate times/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 efficacy replication with the same product, population and comparison, and actual independent-study relationships, are not linked. This records needed materials; no new research was executed." }, { "item_id": "N26", "question_type": "Evidence condition", "question": "Naturex employee authors, support and conflicts", "needed": "Employment, product, funding, support and conflict disclosures", "role": "Required", "role_reason": "This condition connects Employment, product, funding, support and conflict disclosures 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 Employment, product, funding, support and conflict disclosures 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 supply and free support, employee-author roles, conflicts and supporting-cohort support are unverified. This records needed materials; no new research was executed." }, { "item_id": "N27", "question_type": "Harm-information gaps supplementing the efficacy table", "question": "Laboratory changes and clinical safety", "needed": "Adverse events, hematology/clinical chemistry, exposure and denominators", "role": "Supplementary", "role_reason": "This condition connects Adverse events, hematology/clinical chemistry, exposure and 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 Adverse events, hematology/clinical chemistry, exposure and 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: Event definitions, collection, group denominators, discontinuation, rare and long-term harms, and direct interaction evidence are unverified. This records needed materials; no new research was executed." }, { "item_id": "N28", "question_type": "Evidence condition", "question": "Parent/subclaim values, languages and dates", "needed": "Parent C46, subclaim C, axes, corrections and history", "role": "Required", "role_reason": "This condition connects Parent C46, subclaim C, axes, corrections and history 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 Parent C46, subclaim C, axes, corrections and history 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 and axes, new corrections and external details behind historical checks are unverified. This records needed materials; no new research was executed." }, { "item_id": "N29", "question_type": "Evidence condition", "question": "Summary reading, source links and updates", "needed": "Efficacy/MID summaries versus unread external material", "role": "Required", "role_reason": "This condition connects Efficacy/MID summaries versus unread external 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 Efficacy/MID summaries versus unread external 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: External original acquisition, reading, source-link verification and review of existing content remain incomplete. This records needed materials; no new research was executed." } ] }