{ "schema_version": "chamgap-public-evidence-check-1.0", "public_id": "v2986-s1", "verdict_number": "2986", "title": "Cranberry fruit powder × placebo-controlled improvement in objective urinary flow", "view_version": "1.0", "view_created_date": "2026-10-16", "criteria_version": "1.0", "criteria_date": "2026-10-06", "review_date": null, "legacy_evidence_date": "2026-09-07", "review_scope": { "materials_read": "Existing review summaries and stored records of methodological application", "clinical_papers_directly_read": false, "new_clinical_search": false, "limitation": "The whole stored parent-verdict summary and selected subclaim were read for production. External papers, abstracts, full texts, registry, protocol, SAP and funding disclosures were not separately read or accessed. Historical review records are not inherited as current clinical verification or a new verdict.", "date_meaning": "This is the date the stored materials were checked, not the date of a new search of the clinical literature." }, "claim_context": { "population": "The Korean text records124 men aged45 or older with IPSS at least8; the English text says aged over45. Group-/objective-test-specific denominators, baseline flow/residual volume, diagnoses and attrition are unverified.", "intervention": "Three groups received Flowens™ branded fruit powder250mg/day,500mg/day or placebo. Objective outcomes are described as changes from baseline in the500mg group; composition, PAC content and actual adherence are unverified.", "dose": "250/500mg/day and six months are research-exposure records. No urinary-flow dose response, optimal dose, ordinary-product equivalence, recommended intake or conversion is created.", "comparator": "The trial was placebo-controlled, but reported objective changes mainly concern baseline comparisons in the500mg group. Exact between-group effects, CIs and control-measurement conditions for Qmax, Qavg and residual volume are unverified.", "endpoint": "Placebo-controlled objective-flow improvement retains original grade? and the note that comparisons were mainly within-group. Individual Qmax/Qavg/residual-volume definitions, units, values, times, denominators and between-group effects are unverified. IPSS changes, approximate group differences, P values and MIDs are not transferred to objective effects or units.", "duration": "Distinguish the parent six-month trial and evidence-list three-/six-month IPSS from exact objective-test timing. Long-term persistence and direct flow effects in other populations/products are not linked.", "excluded_extensions": [ "Transferring500mg baseline objective changes to confirmed placebo effects/CIs or250mg results", "Mixing Qmax, Qavg or residual-volume units, times and denominators, or transferring IPSS/MID values to flow effects", "Converting an unconfirmed placebo comparison with original grade? into zero effect, a new failure grade or definite harm", "Using the overall124 participants, groups, times or tests as objective-test denominators, complete follow-up or independent participant totals", "Using the supporting observational MID cohort as independent cranberry/urinary-flow efficacy replication", "Transferring the test product/exposure to ordinary products, optimal doses or treatment replacement, or creating new arithmetic, effects, CIs, grades, hypothetical numbers, intake, urinary/prostate treatment, prevention or replacement advice" ] }, "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.", "current_reports": [ "S01", "S02" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread", "observation": "The selected claim is “Placebo-controlled improvement in objective urinary flow,” with original grade “?” and note “Reported changes were mainly within-group comparisons.” Subclaim score, status and axes are unrecorded; parent C46 or IPSS grade C is not inserted.", "condition_status": "Partly verified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "The stored summary has no separate subclaim score, status, axes or confirmed placebo-controlled urinary-flow effect.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "The stored summary has no separate subclaim score, status, axes or confirmed placebo-controlled urinary-flow effect." }, { "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.", "current_reports": [ "S01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread", "observation": "The text’s Qmax, Qavg and residual-volume changes concern change from baseline in the500mg group, not confirmed placebo contrasts. They are not converted into placebo-controlled efficacy, zero effect or a new failure grade.", "condition_status": "Partly verified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Exact between-group flow estimates, units, CIs, denominators and models are unverified.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Exact between-group flow estimates, units, CIs, denominators and models are unverified." }, { "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.", "current_reports": [ "S01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread", "observation": "The Korean text records124 men aged45 or older with IPSS at least8; the English text says aged over45. Both original wordings are preserved. Group or urinary-flow analysis denominators and an objective obstruction diagnosis are not inferred.", "condition_status": "Partly verified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Group counts, detailed eligibility, baseline flow/residual volume, diagnoses, completion and analysis counts are unverified.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Group counts, detailed eligibility, baseline flow/residual volume, diagnoses, completion and analysis counts are unverified." }, { "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.", "current_reports": [ "S01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread", "observation": "S01 is a six-month trial comparing Flowens™ branded fruit powder250mg/day,500mg/day and placebo in three groups. It is not converted into ordinary cranberry, juice, other PAC products or a urinary-flow treatment dose.", "condition_status": "Partly verified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Product composition, PAC content, actual adherence, exposure distribution and measurement linkage for the500mg group are unverified.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Product composition, PAC content, actual adherence, exposure distribution and measurement linkage for the500mg group are unverified." }, { "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.", "current_reports": [ "S01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread", "observation": "S01 is a double-blind placebo-controlled trial, but the text records that a confirmed placebo-controlled objective-flow effect was not presented. The design label alone does not verify control conditions, denominators or complete measurement.", "condition_status": "Partly verified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Placebo composition/exposure, concurrent care and between-group matching of flow measurements/denominators are unverified.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Placebo composition/exposure, concurrent care and between-group matching of flow measurements/denominators are unverified." }, { "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.", "current_reports": [ "S01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread", "observation": "Qmax is mentioned as an objective outcome in the context of change from baseline in the500mg group. It is not treated as the same measure as IPSS points, Qavg or residual volume.", "condition_status": "Partly verified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Qmax definition, units, measurement method, validity criteria, exact values/CIs and denominators are unverified.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Qmax definition, units, measurement method, validity criteria, exact values/CIs and denominators are unverified." }, { "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.", "current_reports": [ "S01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread", "observation": "Qavg is an objective outcome mentioned separately from Qmax, in the context of change from baseline in the500mg group. Significance or effects for one measure are not transferred to another flow measure.", "condition_status": "Partly verified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Qavg definition, units, measurement, exact values/CIs, timing and denominators are unverified.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Qavg definition, units, measurement, exact values/CIs, timing and denominators are unverified." }, { "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.", "current_reports": [ "S01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread", "observation": "Residual volume is a separate objective outcome described as change from baseline in the500mg group. A residual-volume reduction is not transferred to placebo-controlled Qmax/Qavg improvement or prostate-size change.", "condition_status": "Partly verified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Residual-volume methods, units, exact values/CIs, between-group contrasts and denominators are unverified.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Residual-volume methods, units, exact values/CIs, between-group contrasts and denominators are unverified." }, { "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.", "current_reports": [ "S01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread", "observation": "The parent trial lasted six months, and evidence-list endpoints are IPSS at three and six months. Exact flow/residual-volume test times and results are not automatically assigned those same times.", "condition_status": "Unverified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Individual Qmax, Qavg and residual-volume times, missing measurements and follow-up windows are unverified.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Individual Qmax, Qavg and residual-volume times, missing measurements and follow-up windows are unverified." }, { "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.", "current_reports": [ "S01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread", "observation": "The text says changes from baseline were reported in the500mg group. This is not converted into the same result for250mg/placebo or into a placebo difference.", "condition_status": "Partly verified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Baseline/follow-up values, within-group changes/CIs/P values, denominators and adjustment are unverified.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Baseline/follow-up values, within-group changes/CIs/P values, denominators and adjustment are unverified." }, { "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.", "current_reports": [ "S01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread", "observation": "Six-month IPSS changes−3.1/−4.1/−1.5 points, historical approximate placebo differences−1.6/−2.6 points and dose-specific P values are symptom results. Their values/significance are not transferred to flow/residual-volume effects, CIs or units.", "condition_status": "Partly verified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Individual IPSS–objective-flow correspondence and between-group objective effects are not linked.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Individual IPSS–objective-flow correspondence and between-group objective effects are not linked." }, { "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.", "current_reports": [ "S01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread", "observation": "An apparent IPSS dose pattern does not prove an objective-flow dose response. Within-group500mg change is not used as an optimal dose or as evidence of failure/success in other groups.", "condition_status": "Unverified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Objective values, direct contrasts, CIs and prespecified models for250mg,500mg and placebo are unverified.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Objective values, direct contrasts, CIs and prespecified models for250mg,500mg and placebo are unverified." }, { "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.", "current_reports": [ "S01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread", "observation": "The overall124 participants and three groups are not used as denominators for every flow/residual-volume test or as proof of complete follow-up. Groups, times and tests are not summed as independent participants or trials.", "condition_status": "Unverified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Valid tests, missing/excluded observations, repeated-measure counts and correlations by group/time are unverified.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Valid tests, missing/excluded observations, repeated-measure counts and correlations by group/time are unverified." }, { "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.", "current_reports": [ "S01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread", "observation": "The label “objective urinary flow” alone does not confirm identical measurement conditions, equipment, test volumes, repetition or validity criteria.", "condition_status": "Unverified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Measurement conditions, equipment, valid-test criteria and repeatability by group/time are unverified.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Measurement conditions, equipment, valid-test criteria and repeatability by group/time are unverified." }, { "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.", "current_reports": [ "S01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread", "observation": "The original trial was double-blind and placebo-controlled. Objective testing alone does not verify assessor/analyst masking, product recognition or test standardization.", "condition_status": "Partly verified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Who was masked, masking maintenance, analyst involvement and expectation/contact differences are unverified.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Who was masked, masking maintenance, analyst involvement and expectation/contact differences are unverified." }, { "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.", "current_reports": [ "S01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread", "observation": "The three-group randomized design is preserved, but a report of within-group change alone is not converted into an estimate from a randomized between-group comparison.", "condition_status": "Partly verified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Sequence generation/concealment, balance in baseline objective values, between-group adjustment and models are unverified.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Sequence generation/concealment, balance in baseline objective values, between-group adjustment and models are unverified." }, { "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.", "current_reports": [ "S01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread", "observation": "The summary records124 participants without linked completion/attrition counts. IPSS or urinary-flow ITT/PP, missing-data handling and complete-participant analysis are not filled in.", "condition_status": "Unverified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Group attrition, missing tests, ITT/PP, exclusions, imputation and sensitivity analyses are unverified.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Group attrition, missing tests, ITT/PP, exclusions, imputation and sensitivity analyses are unverified." }, { "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.", "current_reports": [ "S01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread", "observation": "The three-group powder/placebo comparison does not establish that actual product adherence, concurrent urinary management, medicines and lifestyle changes were all verified.", "condition_status": "Unverified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Group records of concurrent treatment, medicines, lifestyle/baseline changes, adherence and discontinuation are unverified.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Group records of concurrent treatment, medicines, lifestyle/baseline changes, adherence and discontinuation are unverified." }, { "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.", "current_reports": [ "S01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread", "observation": "The parent’s prespecified-IPSS wording is not expanded into confirmation that Qmax/Qavg/residual volume were prespecified primary endpoints or planned between-group analyses. Unverified registration and the absent registration-identifier field are preserved.", "condition_status": "Unverified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Objective-endpoint hierarchy, group contrasts, multiplicity, pre-recruitment plans, original registration and amendment history are unread.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Objective-endpoint hierarchy, group contrasts, multiplicity, pre-recruitment plans, original registration and amendment history are unread." }, { "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.", "current_reports": [ "S01", "S02" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread", "observation": "S02 Blanker2019 concerns observational-cohort IPSS/OABQ thresholds. The text’s approximate3.1–5.2 points and citation values5.2 overall/3.2 moderate are preserved separately, not used as flow/residual-volume thresholds or effects.", "condition_status": "Partly verified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Objective-flow relevance criteria and direct correspondence with symptom thresholds are unverified.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Objective-flow relevance criteria and direct correspondence with symptom thresholds are unverified." }, { "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.", "current_reports": [ "S01", "S02" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread", "observation": "S01 Vidlar2016’s124 participants, three groups, multiple times and two selected sheets share one trial. The S02 observational MID cohort is not urinary-flow/cranberry efficacy replication and is not added as new unique trials or participants.", "condition_status": "Partly verified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Separate replication under the same flow-comparison conditions and independence of study families are not linked.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Separate replication under the same flow-comparison conditions and independence of study families are not linked." }, { "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.", "current_reports": [ "S01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread", "observation": "The parent trial lasted six months, while exact objective-test times remain unlinked. Placebo-controlled flow effects are not generalized to other ages/diagnoses or repeated/long-term exposure.", "condition_status": "Unverified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Long-term persistence, population-specific objective effects/denominators and safety are not linked.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Long-term persistence, population-specific objective effects/denominators and safety are not linked." }, { "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.", "current_reports": [ "S01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread", "observation": "The parent text records that definite prostate-shrinkage or stronger-flow claims exceed scope. Within-group flow/symptom signals are not converted into prostate treatment, prevention, replacement of standard treatment, or effects of ordinary juice/other PAC products.", "condition_status": "Partly verified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Direct material for other clinical questions, products and treatment-replacement comparisons is not linked.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct material for other clinical questions, products and treatment-replacement comparisons is not linked." }, { "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.", "current_reports": [ "S01", "S02" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread", "observation": "The record of two Naturex-employed authors and a branded test product is preserved. This does not substitute for complete funding, free support or COI verification, or a urinary-flow verdict. S02 cohort support is separately unverified.", "condition_status": "Partly verified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Funding roles, product support, employee-author contributions, COI and supporting-cohort support are unverified.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Funding roles, product support, employee-author contributions, COI and supporting-cohort support are unverified." }, { "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.", "current_reports": [ "S01" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread", "observation": "Parent safety “Unknown” and no six-month clinical-chemistry/hematology change are original statements. No laboratory change is not converted into zero harm or long-term safety; possible warfarin/other interactions are preserved only in their original context.", "condition_status": "Unverified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Direct material on event collection/definitions, group denominators, discontinuation, rare harms and interactions is unverified.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct material on event collection/definitions, group denominators, discontinuation, rare harms and interactions is unverified." }, { "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.", "current_reports": [ "S01", "S02" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread", "observation": "Parent C46, B/P/R1/I0/E~/B1, unrecorded precision, four false flags, empty override reasons, and subclaim “?”/note are preserved. Bilingual text,2026-09-07, empty corrections/deliberation and historical effect/scoring checks are not inherited as current review or subclaim scores.", "condition_status": "Partly verified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. 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Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Subclaim score/status/axes, new corrections and external details of historical checks are unverified." }, { "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.", "current_reports": [ "S01", "S02" ], "existence": "Display information in the original parent stored summary is preserved. Public availability, acquisition and actual reading of detailed external material are separately unverified.", "acquired_read": "Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread", "observation": "S01 efficacy/objective-outcome statements and the S02 MID citation were used for production, retaining original links. External abstracts, full texts, registration, protocols, SAPs and COI material are unread and were not accessed.", "condition_status": "Partly verified", "status_reason": "The selected claim, parent material and reports are distinguished and transferred from the stored summary. Detailed original material is unverified and review of existing content remains incomplete. This does not establish completed clinical review or certification.", "missingness": "Report-specific originals, registration, plans, support material, actual external reading and follow-up content review remain incomplete.", "uncertainty": "External original material is unread and review of existing content remains incomplete. Original grades, scores, axes, historical verification and independence statements are not treated as new verdicts or certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Report-specific originals, registration, plans, support material, actual external reading and follow-up content review remain incomplete." } ], "reports": [ { "report_id": "S01", "title": "Vidlar A et al. 2016", "url": "https://pubmed.ncbi.nlm.nih.gov/26049866/", "report_type": "Three-arm double-blind randomized placebo-controlled trial", "existence": "Stored bibliography exists; external identity unverified", "acquired_read": "Summary read; external material unread", "study_family": "RG2986-VIDLAR-2016", "independent_replication": "Review of existing content remains incomplete. 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URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Protocol", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-07", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Statistical analysis plan", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-07", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Funding, product-support and COI material", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-07", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/26049866/" } ] }, { "report_id": "S02", "title": "Blanker MH, et al. Determining the minimal important differences in the International Prostate Symptom Score and Overactive Bladder Questionnaire: results from an observational cohort study in Dutch primary care. BMJ Open. 2019;9:e032795. PMID: 31874883. PMCID: PMC7008409. 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External material verification/review is not complete." }, { "material_type": "External paper", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-07", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Registration material", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-07", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Protocol", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-07", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Statistical analysis plan", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-07", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Funding, product-support and COI material", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-09-07", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/31874883/" } ] } ], "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." }, "study_overlap": { "state": "Unverified", "unique_trial_count": null, "unique_participant_count": null, "reason": "The Vidlar2016 Flowens trial of124 participants, three groups and3/6 months is shared by two sheets. Group IPSS changes, historical approximate placebo contrasts and objective-flow/residual-urine changes from baseline in the500mg group are distinguished. Blanker2019 is a supporting observational MID cohort, not cranberry efficacy replication. Textual3.1–5.2 and citation values5.2 overall/3.2 moderate are preserved separately. The same participants, groups, times, sheets and supporting citations are not newly added as unique trials or participant totals. Confirmed unique-trial, participant and independent-replication totals remain unrecorded." }, "history": [ { "date": "2026-10-16", "kind": "Separation of public-facing pages and materials", "view_version": "1.0", "change": "Public pages and materials were prepared from the existing 27 items. No new clinical search, verification-status change or scoring was performed." } ], "language": "en", "translation_date": "2026-10-16" }