CHAMGAP
MethodologyVerdictsExplanations (KO)Evidence CheckCitation KitMonitoring

Cranberry fruit powder × six-month IPSS reduction

Select a review item to see its details.
Required evidence, verification status and materials actually read
ItemAVerification statusBReading scopeCReview itemDCurrent findingsEWhy unverifiedFRequired materials and conditionsGFurther research
1 Partly verified Full text not readStored summary read N01 · Evidence conditionSelected IPSS question and original gradeRequired
The existing question is ‘Reduction in six-month IPSS’, graded C; the note says it was statistically favorable but small versus placebo. Subclaim score, status and axes are absent and are not filled with parent C46.
S01 S02
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.
Selected wording, note, grade and parent verdict
Material needed: Separate subclaim score, status and axes are absent from the original record. This records needed materials; no new research was executed.
2 Partly verified Full text not readStored summary read N02 · Evidence conditionParticipants, symptoms and age criteriaRequired
The Korean text records 124 men aged45 or older with IPSS at least8; the English text says aged over45. The age expressions are not arbitrarily harmonized or extended to all men or diagnosed prostate disease.
S01
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.
Eligibility, baseline IPSS, age and group denominators
Material needed: Exact age range, baseline IPSS distribution, diagnoses, history and group allocation counts are unverified. This records needed materials; no new research was executed.
3 Partly verified Full text not readStored summary read N03 · Evidence conditionIdentity of the branded cranberry powderRequired
The test product was branded cranberry fruit powder, identified as Flowens™ in the citation. Ordinary cranberry, juice and products with different PAC content are not treated as the same intervention.
S01
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.
Product, manufacturing, composition, form and test-product records
Material needed: Test-product composition, PAC content, manufacturing, standardization, batches and correspondence to ordinary products are unverified. This records needed materials; no new research was executed.
4 Partly verified Full text not readStored summary read N04 · Evidence conditionResearch exposure at250 and500mgRequired
This was a six-month study of250mg/day,500mg/day and placebo. These are study conditions; personal intake, recommended amounts and juice or PAC conversions are not created.
S01
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.
Three-group plans, actual exposure, duration and adherence
Material needed: Actual adherence, discontinuation, content, intake schedule and exposure distribution are unverified. This records needed materials; no new research was executed.
5 Partly verified Full text not readStored summary read N05 · Evidence conditionActual placebo comparison conditionsRequired
The study was double-blind and placebo-controlled. The design label alone does not verify actual placebo ingredients, frequency, sensory matching or concurrent care.
S01
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.
Placebo composition, exposure, sensory matching and concurrent care
Material needed: Placebo specifications, exposure, appearance, taste, contact and matching of care are unverified. This records needed materials; no new research was executed.
6 Partly verified Full text not readStored summary read N06 · Evidence conditionRandomization and double-blinding proceduresRequired
The original design label is a three-arm double-blind randomized placebo-controlled trial. The label does not verify allocation concealment or masking of all assessors and analysts.
S01
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.
Sequence, concealment, masking targets and maintenance, and analysis
Material needed: Sequence generation, concealment, masking targets and maintenance, and analyst involvement are unverified. This records needed materials; no new research was executed.
7 Unverified Full text not readStored summary read N07 · Evidence conditionThe124 participants and group/outcome denominatorsRequired
The record of124 participants and three groups is preserved. Group counts, complete follow-up, completeness of IPSS analysis and equal allocation are not inferred.
S01
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.
Allocation, completion, analysis and attrition
Material needed: Group allocation, completion, attrition, discontinuation, outcome-analysis counts and reasons are unverified. This records needed materials; no new research was executed.
8 Partly verified Full text not readStored summary read N08 · Evidence conditionDefinition of total IPSS assessmentRequired
The original endpoint is International Prostate Symptom Score (IPSS) at three and six months. A subjective symptom scale is not converted into objective flow, residual urine or prostate-size outcomes.
S01
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.
Scale, total and subscores, responses and time points
Material needed: Total-score composition, assessment procedures, baseline distribution, scale language and missing responses are unverified. This records needed materials; no new research was executed.
9 Partly verified Full text not readStored summary read N09 · Evidence conditionSix-month changes within each groupRequired
Six-month changes of−3.1 points (250mg),−4.1 points (500mg) and−1.5 points (placebo) are group-specific records. Each group's change is not itself converted into an effect versus placebo.
S01
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.
Changes, baseline, units and denominators for each dose and placebo
Material needed: Group baseline and end values, change variance, exact analysis denominators and models are unverified. This records needed materials; no new research was executed.
10 Partly verified Full text not readStored summary read N10 · Evidence conditionOriginal approximate differences versus placeboRequired
The parent text's approximate differences of−1.6 and−2.6 points versus placebo are preserved. These are historical approximate statements, not newly calculated values, exact adjusted effects or CIs.
S01
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.
Between-group estimands, adjustment, CIs and historical calculation
Material needed: Exact between-group models, adjustment, CIs, denominators and estimand definitions are unverified. This records needed materials; no new research was executed.
11 Partly verified Full text not readStored summary read N11 · Evidence conditionDose-specific P values and comparison scopeRequired
The original comparison P values are approximately .05 for250mg and <.001 for500mg. Approximately .05 is not turned into an exact P value, within-group P value, between-dose test or prespecified success criterion.
S01
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.
Reported P values, exact contrasts, models and multiplicity
Material needed: Exact P values, tested contrasts, direction, multiplicity and adjusted models are unverified. This records needed materials; no new research was executed.
12 Partly verified Full text not readStored summary read N12 · Evidence conditionAn apparent dose-response patternRequired
The parent text describes an apparent dose-response IPSS pattern as a strength. Group changes of−3.1 and−4.1 points, or each placebo comparison, are not turned into a direct between-dose difference or proof of an optimal dose.
S01
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.
Direct comparison of doses, adherence and models
Material needed: Direct between-dose contrasts, exposure adherence, CIs and prespecified models are unverified. This records needed materials; no new research was executed.
13 Partly verified Full text not readStored summary read N13 · Evidence conditionMinimal important-difference numbers by sourceRequired
The text's patient-anchored threshold of approximately3.1–5.2 points and the supporting citation's approximately5.2 overall and3.2 for moderate symptoms are preserved separately.3.1 and3.2 are not arbitrarily harmonized or recalculated.
S01 S02
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.
Textual thresholds, supporting citation estimates, populations and units
Material needed: The exact source and conditions for3.1 in the text, and correspondence to the supporting cohort's3.2, are unverified. This records needed materials; no new research was executed.
14 Partly verified Full text not readStored summary read N14 · Evidence conditionRole of the Blanker observational cohortRequired
Blanker2019 is a Dutch primary-care observational cohort for IPSS/OABQ minimal important differences and appears only in the citations. It is not treated as cranberry efficacy, an independent RCT or a repeat of the same124 participants.
S02
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.
MID estimation design, population, denominators and criteria
Material needed: Supporting-cohort n, baseline severity, anchors, estimation methods, CIs and correspondence to the trial population are unverified. This records needed materials; no new research was executed.
15 Partly verified Full text not readStored summary read N15 · Evidence conditionMean differences and individual importance thresholdsRequired
The parent text states that approximately−1.6 and−2.6 points fell below estimated thresholds. This is not turned into no effect for every individual, treatment failure, a new grade or response rates.
S01 S02
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.
Estimands, individual versus group interpretation and relevance criteria
Material needed: Exact correspondence between group means and individually important changes, distributions and prespecified criteria is unverified. This records needed materials; no new research was executed.
16 Unverified Full text not readStored summary read N16 · Evidence conditionIPSS subscores and quality of lifeRequired
The stored summary's quantitative result is six-month IPSS change. Separately linked item, subscore or quality-of-life results are not assumed.
S01
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.
Separate total, item, subscore and QoL outcomes
Material needed: Item, subscore and QoL definitions, time points, denominators, exact effects, CIs and hierarchy are unverified. This records needed materials; no new research was executed.
17 Partly verified Full text not readStored summary read N17 · Evidence conditionThree and six months, and persistence after completionRequired
The endpoint label includes three and six months, but current quantitative values concern six months. Three months is not treated as a separate replication trial or confirmation of identical numbers.
S01
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.
Time-specific results, denominators and post-discontinuation persistence
Material needed: Three-month quantitative values, denominators, time-specific missingness and persistence beyond six months are not linked. This records needed materials; no new research was executed.
18 Partly verified Full text not readStored summary read N18 · Evidence conditionPrespecified IPSS statements and registrationRequired
The parent text describes a prespecified IPSS endpoint, while the citation flags registration as unverified. Absence of a registration-identifier key in the evidence record is not turned into no registration or completed preregistration.
S01
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.
Original prespecification statements, registration, protocol and SAP
Material needed: Original registration, recruitment and registration timing, protocol, SAP and amendment history are unread. This records needed materials; no new research was executed.
19 Unverified Full text not readStored summary read N19 · Evidence conditionPlans for multiple doses, times and outcomesRequired
The two doses,3/6 months, IPSS and objective outcomes have distinct analysis scopes. A prespecified-IPSS statement is not extended into verified prespecified primary effects for all subscores or flow outcomes.
S01
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.
Prespecified hierarchy, contrasts, multiplicity and analysis models
Material needed: Exact hierarchy, dose/time contrasts, multiplicity and the complete SAP are unverified. This records needed materials; no new research was executed.
20 Unverified Full text not readStored summary read N20 · Evidence conditionBlinding and measurement of symptomsRequired
Double-blinding and placebo control are design strengths recorded in the original text. Actual masking maintenance and standardization of symptom responses and analyses are not thereby verified.
S01
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.
Participants, assessors, scale administration and expectancy
Material needed: Masking maintenance, assessment procedures, missing responses, analysts and expectancy effects are unverified. This records needed materials; no new research was executed.
21 Unverified Full text not readStored summary read N21 · Evidence conditionConcurrent care and actual exposureRequired
This is a comparison of three branded-powder groups. Identical or absent concurrent urinary-symptom care, medication, lifestyle changes and product adherence are not inferred.
S01
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.
Medication, lifestyle, concurrent interventions and adherence
Material needed: Concurrent treatment, lifestyle changes, adherence, discontinuation and baseline adjustment are unverified. This records needed materials; no new research was executed.
22 Unverified Full text not readStored summary read N22 · Evidence conditionAnalysis populations and missing-data handlingRequired
The original124 describes total participants; completion counts, missingness rates, ITT and PP are not provided. Parent scores and design labels do not fill the analysis scope.
S01
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.
ITT, PP, group attrition/discontinuation and missing outcomes
Material needed: Group attrition, missing IPSS, exclusions, ITT, PP, imputation and sensitivity analyses are unverified. This records needed materials; no new research was executed.
23 Partly verified Full text not readStored summary read N23 · Evidence conditionWithin-group objective-flow and residual-urine comparisonsRequired
The original text says Qmax, Qavg and residual urine changed from baseline in the500mg group, without presenting a confirmed effect versus placebo. The placebo-controlled IPSS signal is not transferred into flow or residual-urine success.
S01
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.
IPSS versus Qmax, Qavg and residual urine; within/between-group distinctions
Material needed: Exact objective values, units, time points, denominators, between-group effects and CIs are unverified. This records needed materials; no new research was executed.
24 Partly verified Full text not readStored summary read N24 · Evidence conditionScope of other clinical and product questionsRequired
The parent text records that definitive prostate-size and urinary-flow claims exceed scope. The IPSS signal is not turned into prostate treatment, infection prevention, treatment replacement or efficacy of ordinary juice or other PAC products.
S01
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.
Direct measurement, comparisons and generalization
Material needed: Direct evidence for other clinical outcomes, products, populations and treatment replacement is not linked. This records needed materials; no new research was executed.
25 Partly verified Full text not readStored summary read N25 · Evidence conditionOne shared trial, supporting thresholds and independent replicationRequired
The Vidlar2016 trial of124 participants, three groups and3/6 months is shared by two sheets. The Blanker MID cohort is not efficacy replication. Groups, times, supporting citations and the two sheets are not counted as unique trials or participant totals.
S01 S02
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.
Efficacy reports, cohort roles and duplicate times/sheets
Material needed: Separate efficacy replication with the same product, population and comparison, and actual independent-study relationships, are not linked. This records needed materials; no new research was executed.
26 Partly verified Full text not readStored summary read N26 · Evidence conditionNaturex employee authors, support and conflictsRequired
The original funding field records two Naturex-employed authors and a branded test product. Employment information is not turned into complete verification of funding, free product support or conflicts. Support for the Blanker cohort is separate.
S01 S02
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.
Employment, product, funding, support and conflict disclosures
Material needed: Funding roles, product supply and free support, employee-author roles, conflicts and supporting-cohort support are unverified. This records needed materials; no new research was executed.
27 Unverified Full text not readStored summary read N27 · Harm-information gaps supplementing the efficacy tableLaboratory changes and clinical safetySupplementary
Parent safety is unknown; no clinical-chemistry or hematology change over six months is an original statement. It is not turned into zero adverse events, exclusion of rare harms or long-term safety. Interactions such as warfarin remain a possibility statement in the original text.
S01
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.
Adverse events, hematology/clinical chemistry, exposure and denominators
Material needed: Event definitions, collection, group denominators, discontinuation, rare and long-term harms, and direct interaction evidence are unverified. This records needed materials; no new research was executed.
28 Partly verified Full text not readStored summary read N28 · Evidence conditionParent/subclaim values, languages and datesRequired
Parent C46, B/P/R1/I0/E~/B1, unrecorded precision, four false flags, empty override reasons, and subclaim C/note are preserved. Original languages,2026-09-07, empty corrections array/deliberation string, and historical PubMed/effect/scoring checks are not inherited as current review or subclaim scores.
S01 S02
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.
Parent C46, subclaim C, axes, corrections and history
Material needed: Subclaim score, status and axes, new corrections and external details behind historical checks are unverified. This records needed materials; no new research was executed.
29 Partly verified Full text not readStored summary read N29 · Evidence conditionSummary reading, source links and updatesRequired
The efficacy summary and supporting citation's MID wording were used, retaining original paper links. External abstracts, full texts, registration, protocols, SAPs and conflict disclosures are unread and access was not attempted. External source links were not tested.
S01 S02
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.
Efficacy/MID summaries versus unread external material
Material needed: External original acquisition, reading, source-link verification and review of existing content remain incomplete. This records needed materials; no new research was executed.
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29 itemsWhat the statuses mean

Assessment scope

Stored-material review date
Not recorded
Original evidence cut-off
2026-09-07
Scope actually checked
Existing review summaries and stored records of methodological application. Full papers, supplements, registrations, plans and original data were not read.
What the dates mean
This is the date the stored materials were checked, not the date of a new search of the clinical literature.
Population
The Korean text records124 men aged45 or older with IPSS at least8; the English text says aged over45. Group allocation, completion, analysis, attrition and baseline IPSS are unverified.
Ingredient, formulation and route
Three groups received Flowens™ branded cranberry fruit powder250mg/day,500mg/day or placebo. Composition, PAC content, actual adherence and supply details are unverified.
Dose
250/500mg/day and six months are research-exposure records. Recommended intake, juice or PAC conversions, and preventive or treatment doses are not created.
Comparator
Double-blind placebo control. Placebo composition, sensory matching, exposure, concurrent care and masking-maintenance details are unverified.
Measured outcome
Distinguish six-month group IPSS changes of−3.1/−4.1/−1.5 points, the text’s approximate placebo differences of−1.6/−2.6 points, and comparison P values of approximately .05 for250mg and <.001 for500mg. Exact adjusted effects, CIs and denominators are unverified. Objective-flow/residual-urine changes from baseline in the500mg group are separate.
Duration
Endpoint labels include three and six months; current quantitative values concern six months. Three-month values/denominators, exact objective-outcome times, post-trial persistence and long-term clinical outcomes are not linked.
Questions outside this scope
Mixing group-specific changes with historical approximate placebo differences, or creating new effects, CIs or arithmetic; Arbitrarily harmonizing the text’s MID3.1–5.2 with supporting-citation values5.2 overall/3.2 moderate, or inferring no effect for every individual; Transferring values, units or timing across total IPSS, subscores, QoL, objective flow, residual urine, prostate size, or three/six months; Treating the Flowens test product and250/500mg research exposure as equivalent to juice, other PAC products or recommended intake; Adding the same124 participants, groups, times, two sheets and observational MID cohort as independent efficacy trials or participant totals; Inheriting parent C46, axes or historical checks as subclaim scores/current review, or creating intake, urinary/prostate-treatment, preventive or replacement advice

Evidence and sources

The links below lead to the sources. A link alone does not mean the original source was read or its latest publication status verified.

S01 · Vidlar A et al. 2016

PubMed

Material type
Three-arm double-blind randomized placebo-controlled trial
Materials actually read
Summary read; external material unread
Findings recorded in the stored summary
Six-month changes−3.1 points (250mg),−4.1 points (500mg),−1.5 points (placebo)
Record level
Original efficacy summary; group changes distinguished from placebo differences
Study overlap and independent replication
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.
Public availability, access and reading status by material
MaterialPublic availabilityAccess statusActually readNotes
Stored summaryStored fileStored summarySummary readOnly stored-summary and bibliographic content was used for production. External material verification/review is not complete.
External paperPublic availability unverified; only bibliography links preservedUnread; access not attemptedNot readNo external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.
Registration materialPublic availability unverified; only bibliography links preservedUnread; access not attemptedNot readNo external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.
ProtocolPublic availability unverified; only bibliography links preservedUnread; access not attemptedNot readNo external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.
Statistical analysis planPublic availability unverified; only bibliography links preservedUnread; access not attemptedNot readNo external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.
Funding, product-support and COI materialPublic availability unverified; only bibliography links preservedUnread; access not attemptedNot readNo external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.

S02 · 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. DOI: 10.1136/bmjopen-2019-032795.

PubMed

Material type
Observational-cohort minimal important-difference estimate; supporting citation
Materials actually read
Summary read; external material unread
Findings recorded in the stored summary
Patient-anchored IPSS minimal important differences were estimated at approximately5.2 points overall and3.2 for moderate symptoms.
Record level
Observational-cohort MID citation summary; not an efficacy result
Study overlap and independent replication
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.
Public availability, access and reading status by material
MaterialPublic availabilityAccess statusActually readNotes
Stored summaryStored fileStored summarySummary readOnly stored-summary and bibliographic content was used for production. External material verification/review is not complete.
External paperPublic availability unverified; only bibliography links preservedUnread; access not attemptedNot readNo external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.
Registration materialPublic availability unverified; only bibliography links preservedUnread; access not attemptedNot readNo external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.
ProtocolPublic availability unverified; only bibliography links preservedUnread; access not attemptedNot readNo external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.
Statistical analysis planPublic availability unverified; only bibliography links preservedUnread; access not attemptedNot readNo external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.
Funding, product-support and COI materialPublic availability unverified; only bibliography links preservedUnread; access not attemptedNot readNo external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.

Report counts versus independent study counts

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.

Review criteria

Version 1.0 · Criteria record date 2026-10-06. These are Chamgap's own application conditions, informed by the referenced methods. They do not constitute official assessment-tool certification or a new efficacy score.

N01 · Selected IPSS question and original grade
Required materials and conditions
Selected wording, note, grade and parent verdict
Conditions for verification
Material for Selected wording, note, grade and parent verdict must be linked to the selected subclaim, parent context, original report, time points, comparator and denominators, distinguishing unread external material.
Requirement and applicability
Required
Application exceptions
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.
Why this condition is needed
This condition connects Selected wording, note, grade and parent verdict with the selected question, actual population, test product, comparator, symptom scale, objective outcomes, time points, denominators and harms.
Referenced methods
Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.
N02 · Participants, symptoms and age criteria
Required materials and conditions
Eligibility, baseline IPSS, age and group denominators
Conditions for verification
Material for Eligibility, baseline IPSS, age and group denominators must be linked to the selected subclaim, parent context, original report, time points, comparator and denominators, distinguishing unread external material.
Requirement and applicability
Required
Application exceptions
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.
Why this condition is needed
This condition connects Eligibility, baseline IPSS, age and group denominators with the selected question, actual population, test product, comparator, symptom scale, objective outcomes, time points, denominators and harms.
Referenced methods
Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.
N03 · Identity of the branded cranberry powder
Required materials and conditions
Product, manufacturing, composition, form and test-product records
Conditions for verification
Material for Product, manufacturing, composition, form and test-product records must be linked to the selected subclaim, parent context, original report, time points, comparator and denominators, distinguishing unread external material.
Requirement and applicability
Required
Application exceptions
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.
Why this condition is needed
This condition connects Product, manufacturing, composition, form and test-product records with the selected question, actual population, test product, comparator, symptom scale, objective outcomes, time points, denominators and harms.
Referenced methods
Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.
N04 · Research exposure at250 and500mg
Required materials and conditions
Three-group plans, actual exposure, duration and adherence
Conditions for verification
Material for Three-group plans, actual exposure, duration and adherence must be linked to the selected subclaim, parent context, original report, time points, comparator and denominators, distinguishing unread external material.
Requirement and applicability
Required
Application exceptions
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.
Why this condition is needed
This condition connects Three-group plans, actual exposure, duration and adherence with the selected question, actual population, test product, comparator, symptom scale, objective outcomes, time points, denominators and harms.
Referenced methods
Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.
N05 · Actual placebo comparison conditions
Required materials and conditions
Placebo composition, exposure, sensory matching and concurrent care
Conditions for verification
Material for Placebo composition, exposure, sensory matching and concurrent care must be linked to the selected subclaim, parent context, original report, time points, comparator and denominators, distinguishing unread external material.
Requirement and applicability
Required
Application exceptions
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.
Why this condition is needed
This condition connects Placebo composition, exposure, sensory matching and concurrent care with the selected question, actual population, test product, comparator, symptom scale, objective outcomes, time points, denominators and harms.
Referenced methods
Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.
N06 · Randomization and double-blinding procedures
Required materials and conditions
Sequence, concealment, masking targets and maintenance, and analysis
Conditions for verification
Material for Sequence, concealment, masking targets and maintenance, and analysis must be linked to the selected subclaim, parent context, original report, time points, comparator and denominators, distinguishing unread external material.
Requirement and applicability
Required
Application exceptions
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.
Why this condition is needed
This condition connects Sequence, concealment, masking targets and maintenance, and analysis with the selected question, actual population, test product, comparator, symptom scale, objective outcomes, time points, denominators and harms.
Referenced methods
Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.
N07 · The124 participants and group/outcome denominators
Required materials and conditions
Allocation, completion, analysis and attrition
Conditions for verification
Material for Allocation, completion, analysis and attrition must be linked to the selected subclaim, parent context, original report, time points, comparator and denominators, distinguishing unread external material.
Requirement and applicability
Required
Application exceptions
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.
Why this condition is needed
This condition connects Allocation, completion, analysis and attrition with the selected question, actual population, test product, comparator, symptom scale, objective outcomes, time points, denominators and harms.
Referenced methods
Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.
N08 · Definition of total IPSS assessment
Required materials and conditions
Scale, total and subscores, responses and time points
Conditions for verification
Material for Scale, total and subscores, responses and time points must be linked to the selected subclaim, parent context, original report, time points, comparator and denominators, distinguishing unread external material.
Requirement and applicability
Required
Application exceptions
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.
Why this condition is needed
This condition connects Scale, total and subscores, responses and time points with the selected question, actual population, test product, comparator, symptom scale, objective outcomes, time points, denominators and harms.
Referenced methods
Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.
N09 · Six-month changes within each group
Required materials and conditions
Changes, baseline, units and denominators for each dose and placebo
Conditions for verification
Material for Changes, baseline, units and denominators for each dose and placebo must be linked to the selected subclaim, parent context, original report, time points, comparator and denominators, distinguishing unread external material.
Requirement and applicability
Required
Application exceptions
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.
Why this condition is needed
This condition connects Changes, baseline, units and denominators for each dose and placebo with the selected question, actual population, test product, comparator, symptom scale, objective outcomes, time points, denominators and harms.
Referenced methods
Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.
N10 · Original approximate differences versus placebo
Required materials and conditions
Between-group estimands, adjustment, CIs and historical calculation
Conditions for verification
Material for Between-group estimands, adjustment, CIs and historical calculation must be linked to the selected subclaim, parent context, original report, time points, comparator and denominators, distinguishing unread external material.
Requirement and applicability
Required
Application exceptions
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.
Why this condition is needed
This condition connects Between-group estimands, adjustment, CIs and historical calculation with the selected question, actual population, test product, comparator, symptom scale, objective outcomes, time points, denominators and harms.
Referenced methods
Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.
N11 · Dose-specific P values and comparison scope
Required materials and conditions
Reported P values, exact contrasts, models and multiplicity
Conditions for verification
Material for Reported P values, exact contrasts, models and multiplicity must be linked to the selected subclaim, parent context, original report, time points, comparator and denominators, distinguishing unread external material.
Requirement and applicability
Required
Application exceptions
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.
Why this condition is needed
This condition connects Reported P values, exact contrasts, models and multiplicity with the selected question, actual population, test product, comparator, symptom scale, objective outcomes, time points, denominators and harms.
Referenced methods
Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.
N12 · An apparent dose-response pattern
Required materials and conditions
Direct comparison of doses, adherence and models
Conditions for verification
Material for Direct comparison of doses, adherence and models must be linked to the selected subclaim, parent context, original report, time points, comparator and denominators, distinguishing unread external material.
Requirement and applicability
Required
Application exceptions
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.
Why this condition is needed
This condition connects Direct comparison of doses, adherence and models with the selected question, actual population, test product, comparator, symptom scale, objective outcomes, time points, denominators and harms.
Referenced methods
Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.
N13 · Minimal important-difference numbers by source
Required materials and conditions
Textual thresholds, supporting citation estimates, populations and units
Conditions for verification
Material for Textual thresholds, supporting citation estimates, populations and units must be linked to the selected subclaim, parent context, original report, time points, comparator and denominators, distinguishing unread external material.
Requirement and applicability
Required
Application exceptions
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.
Why this condition is needed
This condition connects Textual thresholds, supporting citation estimates, populations and units with the selected question, actual population, test product, comparator, symptom scale, objective outcomes, time points, denominators and harms.
Referenced methods
Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.
N14 · Role of the Blanker observational cohort
Required materials and conditions
MID estimation design, population, denominators and criteria
Conditions for verification
Material for MID estimation design, population, denominators and criteria must be linked to the selected subclaim, parent context, original report, time points, comparator and denominators, distinguishing unread external material.
Requirement and applicability
Required
Application exceptions
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.
Why this condition is needed
This condition connects MID estimation design, population, denominators and criteria with the selected question, actual population, test product, comparator, symptom scale, objective outcomes, time points, denominators and harms.
Referenced methods
Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.
N15 · Mean differences and individual importance thresholds
Required materials and conditions
Estimands, individual versus group interpretation and relevance criteria
Conditions for verification
Material for Estimands, individual versus group interpretation and relevance criteria must be linked to the selected subclaim, parent context, original report, time points, comparator and denominators, distinguishing unread external material.
Requirement and applicability
Required
Application exceptions
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.
Why this condition is needed
This condition connects Estimands, individual versus group interpretation and relevance criteria with the selected question, actual population, test product, comparator, symptom scale, objective outcomes, time points, denominators and harms.
Referenced methods
Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.
N16 · IPSS subscores and quality of life
Required materials and conditions
Separate total, item, subscore and QoL outcomes
Conditions for verification
Material for Separate total, item, subscore and QoL outcomes must be linked to the selected subclaim, parent context, original report, time points, comparator and denominators, distinguishing unread external material.
Requirement and applicability
Required
Application exceptions
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.
Why this condition is needed
This condition connects Separate total, item, subscore and QoL outcomes with the selected question, actual population, test product, comparator, symptom scale, objective outcomes, time points, denominators and harms.
Referenced methods
Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.
N17 · Three and six months, and persistence after completion
Required materials and conditions
Time-specific results, denominators and post-discontinuation persistence
Conditions for verification
Material for Time-specific results, denominators and post-discontinuation persistence must be linked to the selected subclaim, parent context, original report, time points, comparator and denominators, distinguishing unread external material.
Requirement and applicability
Required
Application exceptions
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.
Why this condition is needed
This condition connects Time-specific results, denominators and post-discontinuation persistence with the selected question, actual population, test product, comparator, symptom scale, objective outcomes, time points, denominators and harms.
Referenced methods
Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.
N18 · Prespecified IPSS statements and registration
Required materials and conditions
Original prespecification statements, registration, protocol and SAP
Conditions for verification
Material for Original prespecification statements, registration, protocol and SAP must be linked to the selected subclaim, parent context, original report, time points, comparator and denominators, distinguishing unread external material.
Requirement and applicability
Required
Application exceptions
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.
Why this condition is needed
This condition connects Original prespecification statements, registration, protocol and SAP with the selected question, actual population, test product, comparator, symptom scale, objective outcomes, time points, denominators and harms.
Referenced methods
Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.
N19 · Plans for multiple doses, times and outcomes
Required materials and conditions
Prespecified hierarchy, contrasts, multiplicity and analysis models
Conditions for verification
Material for Prespecified hierarchy, contrasts, multiplicity and analysis models must be linked to the selected subclaim, parent context, original report, time points, comparator and denominators, distinguishing unread external material.
Requirement and applicability
Required
Application exceptions
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.
Why this condition is needed
This condition connects Prespecified hierarchy, contrasts, multiplicity and analysis models with the selected question, actual population, test product, comparator, symptom scale, objective outcomes, time points, denominators and harms.
Referenced methods
Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.
N20 · Blinding and measurement of symptoms
Required materials and conditions
Participants, assessors, scale administration and expectancy
Conditions for verification
Material for Participants, assessors, scale administration and expectancy must be linked to the selected subclaim, parent context, original report, time points, comparator and denominators, distinguishing unread external material.
Requirement and applicability
Required
Application exceptions
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.
Why this condition is needed
This condition connects Participants, assessors, scale administration and expectancy with the selected question, actual population, test product, comparator, symptom scale, objective outcomes, time points, denominators and harms.
Referenced methods
Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.
N21 · Concurrent care and actual exposure
Required materials and conditions
Medication, lifestyle, concurrent interventions and adherence
Conditions for verification
Material for Medication, lifestyle, concurrent interventions and adherence must be linked to the selected subclaim, parent context, original report, time points, comparator and denominators, distinguishing unread external material.
Requirement and applicability
Required
Application exceptions
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.
Why this condition is needed
This condition connects Medication, lifestyle, concurrent interventions and adherence with the selected question, actual population, test product, comparator, symptom scale, objective outcomes, time points, denominators and harms.
Referenced methods
Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.
N22 · Analysis populations and missing-data handling
Required materials and conditions
ITT, PP, group attrition/discontinuation and missing outcomes
Conditions for verification
Material for ITT, PP, group attrition/discontinuation and missing outcomes must be linked to the selected subclaim, parent context, original report, time points, comparator and denominators, distinguishing unread external material.
Requirement and applicability
Required
Application exceptions
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.
Why this condition is needed
This condition connects ITT, PP, group attrition/discontinuation and missing outcomes with the selected question, actual population, test product, comparator, symptom scale, objective outcomes, time points, denominators and harms.
Referenced methods
Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.
N23 · Within-group objective-flow and residual-urine comparisons
Required materials and conditions
IPSS versus Qmax, Qavg and residual urine; within/between-group distinctions
Conditions for verification
Material for IPSS versus Qmax, Qavg and residual urine; within/between-group distinctions must be linked to the selected subclaim, parent context, original report, time points, comparator and denominators, distinguishing unread external material.
Requirement and applicability
Required
Application exceptions
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.
Why this condition is needed
This condition connects IPSS versus Qmax, Qavg and residual urine; within/between-group distinctions with the selected question, actual population, test product, comparator, symptom scale, objective outcomes, time points, denominators and harms.
Referenced methods
Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.
N24 · Scope of other clinical and product questions
Required materials and conditions
Direct measurement, comparisons and generalization
Conditions for verification
Material for Direct measurement, comparisons and generalization must be linked to the selected subclaim, parent context, original report, time points, comparator and denominators, distinguishing unread external material.
Requirement and applicability
Required
Application exceptions
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.
Why this condition is needed
This condition connects Direct measurement, comparisons and generalization with the selected question, actual population, test product, comparator, symptom scale, objective outcomes, time points, denominators and harms.
Referenced methods
Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.
N25 · One shared trial, supporting thresholds and independent replication
Required materials and conditions
Efficacy reports, cohort roles and duplicate times/sheets
Conditions for verification
Material for Efficacy reports, cohort roles and duplicate times/sheets must be linked to the selected subclaim, parent context, original report, time points, comparator and denominators, distinguishing unread external material.
Requirement and applicability
Required
Application exceptions
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.
Why this condition is needed
This condition connects Efficacy reports, cohort roles and duplicate times/sheets with the selected question, actual population, test product, comparator, symptom scale, objective outcomes, time points, denominators and harms.
Referenced methods
Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.
N26 · Naturex employee authors, support and conflicts
Required materials and conditions
Employment, product, funding, support and conflict disclosures
Conditions for verification
Material for Employment, product, funding, support and conflict disclosures must be linked to the selected subclaim, parent context, original report, time points, comparator and denominators, distinguishing unread external material.
Requirement and applicability
Required
Application exceptions
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.
Why this condition is needed
This condition connects Employment, product, funding, support and conflict disclosures with the selected question, actual population, test product, comparator, symptom scale, objective outcomes, time points, denominators and harms.
Referenced methods
Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.
N27 · Laboratory changes and clinical safety
Required materials and conditions
Adverse events, hematology/clinical chemistry, exposure and denominators
Conditions for verification
Material for Adverse events, hematology/clinical chemistry, exposure and denominators must be linked to the selected subclaim, parent context, original report, time points, comparator and denominators, distinguishing unread external material.
Requirement and applicability
Supplementary
Application exceptions
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.
Why this condition is needed
This condition connects Adverse events, hematology/clinical chemistry, exposure and denominators with the selected question, actual population, test product, comparator, symptom scale, objective outcomes, time points, denominators and harms.
Referenced methods
Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.
N28 · Parent/subclaim values, languages and dates
Required materials and conditions
Parent C46, subclaim C, axes, corrections and history
Conditions for verification
Material for Parent C46, subclaim C, axes, corrections and history must be linked to the selected subclaim, parent context, original report, time points, comparator and denominators, distinguishing unread external material.
Requirement and applicability
Required
Application exceptions
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.
Why this condition is needed
This condition connects Parent C46, subclaim C, axes, corrections and history with the selected question, actual population, test product, comparator, symptom scale, objective outcomes, time points, denominators and harms.
Referenced methods
Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.
N29 · Summary reading, source links and updates
Required materials and conditions
Efficacy/MID summaries versus unread external material
Conditions for verification
Material for Efficacy/MID summaries versus unread external material must be linked to the selected subclaim, parent context, original report, time points, comparator and denominators, distinguishing unread external material.
Requirement and applicability
Required
Application exceptions
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.
Why this condition is needed
This condition connects Efficacy/MID summaries versus unread external material with the selected question, actual population, test product, comparator, symptom scale, objective outcomes, time points, denominators and harms.
Referenced methods
Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.
Referenced methods and the sections actually reviewed

M03 · Cochrane Handbook 6.5 (2024), chapter updated 2023-08

Official methodology · §3.1, §3.2.1–3.2.3, MECIR C5/C7/C13

Referenced principle
Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.
Extent of review
Preserved method HTML copies; no current method-content re-review or official tool execution

M04 · Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03

Official methodology · §4.5, §4.6.1–4.6.3, MECIR C42

Referenced principle
Distinguish studies from reports and link them; do not omit a study solely because results are unreported.
Extent of review
Preserved method HTML copies; no current method-content re-review or official tool execution

M08 · Cochrane Handbook 6.5 (2024), chapter updated 2019-10

Official methodology · §8.1–8.2.3, Table 8.2.a

Referenced principle
Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.
Extent of review
Preserved method HTML copies; no current method-content re-review or official tool execution

M15 · Cochrane Handbook 6.5 (2024), chapter updated 2023-08

Official methodology · §15.2.4, §15.3.1–15.3.3

Referenced principle
Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.
Extent of review
Preserved method HTML copies; no current method-content re-review or official tool execution

M19 · Cochrane Handbook 6.5 (2024), chapter updated 2019-10

Official methodology · §19.1.2, §19.2.1–19.2.4

Referenced principle
Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.
Extent of review
Preserved method HTML copies; no current method-content re-review or official tool execution
What the statuses mean
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.

Change history

2026-10-16 · Public page/material version 1.0

Public pages and materials were created from the existing 29 items. No new clinical search, verification-status change or scoring was performed.

The stored-material review date (Not recorded) and original evidence cut-off (2026-09-07) were retained unchanged.

Researcher downloads

These materials provide the same evidence, scope and verification status as this page.

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N01 · Selected IPSS question and original grade

Current findings
The existing question is ‘Reduction in six-month IPSS’, graded C; the note says it was statistically favorable but small versus placebo. Subclaim score, status and axes are absent and are not filled with parent C46.
Verification status
Partly verified
Materials actually read
Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread
Why unverified
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.
Reason for missing information
Separate subclaim score, status and axes are absent from the original record.
Required materials and conditions
Selected wording, note, grade and parent verdict
Materials to obtain first
Separate subclaim score, status and axes are absent from the original record.
Further research
Material needed: Separate subclaim score, status and axes are absent from the original record. This records needed materials; no new research was executed.
Remaining 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.
Conditions for verification
Material for Selected wording, note, grade and parent verdict must be linked to the selected subclaim, parent context, original report, time points, comparator and denominators, distinguishing unread external material.
Why this condition is needed
This condition connects Selected wording, note, grade and parent verdict with the selected question, actual population, test product, comparator, symptom scale, objective outcomes, time points, denominators and harms.
Application exceptions
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.
Referenced methods
Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources S01 S02

N02 · Participants, symptoms and age criteria

Current findings
The Korean text records 124 men aged45 or older with IPSS at least8; the English text says aged over45. The age expressions are not arbitrarily harmonized or extended to all men or diagnosed prostate disease.
Verification status
Partly verified
Materials actually read
Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread
Why unverified
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.
Reason for missing information
Exact age range, baseline IPSS distribution, diagnoses, history and group allocation counts are unverified.
Required materials and conditions
Eligibility, baseline IPSS, age and group denominators
Materials to obtain first
Exact age range, baseline IPSS distribution, diagnoses, history and group allocation counts are unverified.
Further research
Material needed: Exact age range, baseline IPSS distribution, diagnoses, history and group allocation counts are unverified. This records needed materials; no new research was executed.
Remaining 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.
Conditions for verification
Material for Eligibility, baseline IPSS, age and group denominators must be linked to the selected subclaim, parent context, original report, time points, comparator and denominators, distinguishing unread external material.
Why this condition is needed
This condition connects Eligibility, baseline IPSS, age and group denominators with the selected question, actual population, test product, comparator, symptom scale, objective outcomes, time points, denominators and harms.
Application exceptions
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.
Referenced methods
Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources S01

N03 · Identity of the branded cranberry powder

Current findings
The test product was branded cranberry fruit powder, identified as Flowens™ in the citation. Ordinary cranberry, juice and products with different PAC content are not treated as the same intervention.
Verification status
Partly verified
Materials actually read
Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread
Why unverified
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.
Reason for missing information
Test-product composition, PAC content, manufacturing, standardization, batches and correspondence to ordinary products are unverified.
Required materials and conditions
Product, manufacturing, composition, form and test-product records
Materials to obtain first
Test-product composition, PAC content, manufacturing, standardization, batches and correspondence to ordinary products are unverified.
Further research
Material needed: Test-product composition, PAC content, manufacturing, standardization, batches and correspondence to ordinary products are unverified. This records needed materials; no new research was executed.
Remaining 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.
Conditions for verification
Material for Product, manufacturing, composition, form and test-product records must be linked to the selected subclaim, parent context, original report, time points, comparator and denominators, distinguishing unread external material.
Why this condition is needed
This condition connects Product, manufacturing, composition, form and test-product records with the selected question, actual population, test product, comparator, symptom scale, objective outcomes, time points, denominators and harms.
Application exceptions
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.
Referenced methods
Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources S01

N04 · Research exposure at250 and500mg

Current findings
This was a six-month study of250mg/day,500mg/day and placebo. These are study conditions; personal intake, recommended amounts and juice or PAC conversions are not created.
Verification status
Partly verified
Materials actually read
Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread
Why unverified
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.
Reason for missing information
Actual adherence, discontinuation, content, intake schedule and exposure distribution are unverified.
Required materials and conditions
Three-group plans, actual exposure, duration and adherence
Materials to obtain first
Actual adherence, discontinuation, content, intake schedule and exposure distribution are unverified.
Further research
Material needed: Actual adherence, discontinuation, content, intake schedule and exposure distribution are unverified. This records needed materials; no new research was executed.
Remaining 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.
Conditions for verification
Material for Three-group plans, actual exposure, duration and adherence must be linked to the selected subclaim, parent context, original report, time points, comparator and denominators, distinguishing unread external material.
Why this condition is needed
This condition connects Three-group plans, actual exposure, duration and adherence with the selected question, actual population, test product, comparator, symptom scale, objective outcomes, time points, denominators and harms.
Application exceptions
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.
Referenced methods
Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources S01

N05 · Actual placebo comparison conditions

Current findings
The study was double-blind and placebo-controlled. The design label alone does not verify actual placebo ingredients, frequency, sensory matching or concurrent care.
Verification status
Partly verified
Materials actually read
Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread
Why unverified
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.
Reason for missing information
Placebo specifications, exposure, appearance, taste, contact and matching of care are unverified.
Required materials and conditions
Placebo composition, exposure, sensory matching and concurrent care
Materials to obtain first
Placebo specifications, exposure, appearance, taste, contact and matching of care are unverified.
Further research
Material needed: Placebo specifications, exposure, appearance, taste, contact and matching of care are unverified. This records needed materials; no new research was executed.
Remaining 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.
Conditions for verification
Material for Placebo composition, exposure, sensory matching and concurrent care must be linked to the selected subclaim, parent context, original report, time points, comparator and denominators, distinguishing unread external material.
Why this condition is needed
This condition connects Placebo composition, exposure, sensory matching and concurrent care with the selected question, actual population, test product, comparator, symptom scale, objective outcomes, time points, denominators and harms.
Application exceptions
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.
Referenced methods
Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources S01

N06 · Randomization and double-blinding procedures

Current findings
The original design label is a three-arm double-blind randomized placebo-controlled trial. The label does not verify allocation concealment or masking of all assessors and analysts.
Verification status
Partly verified
Materials actually read
Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread
Why unverified
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.
Reason for missing information
Sequence generation, concealment, masking targets and maintenance, and analyst involvement are unverified.
Required materials and conditions
Sequence, concealment, masking targets and maintenance, and analysis
Materials to obtain first
Sequence generation, concealment, masking targets and maintenance, and analyst involvement are unverified.
Further research
Material needed: Sequence generation, concealment, masking targets and maintenance, and analyst involvement are unverified. This records needed materials; no new research was executed.
Remaining 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.
Conditions for verification
Material for Sequence, concealment, masking targets and maintenance, and analysis must be linked to the selected subclaim, parent context, original report, time points, comparator and denominators, distinguishing unread external material.
Why this condition is needed
This condition connects Sequence, concealment, masking targets and maintenance, and analysis with the selected question, actual population, test product, comparator, symptom scale, objective outcomes, time points, denominators and harms.
Application exceptions
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.
Referenced methods
Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources S01

N07 · The124 participants and group/outcome denominators

Current findings
The record of124 participants and three groups is preserved. Group counts, complete follow-up, completeness of IPSS analysis and equal allocation are not inferred.
Verification status
Unverified
Materials actually read
Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread
Why unverified
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.
Reason for missing information
Group allocation, completion, attrition, discontinuation, outcome-analysis counts and reasons are unverified.
Required materials and conditions
Allocation, completion, analysis and attrition
Materials to obtain first
Group allocation, completion, attrition, discontinuation, outcome-analysis counts and reasons are unverified.
Further research
Material needed: Group allocation, completion, attrition, discontinuation, outcome-analysis counts and reasons are unverified. This records needed materials; no new research was executed.
Remaining 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.
Conditions for verification
Material for Allocation, completion, analysis and attrition must be linked to the selected subclaim, parent context, original report, time points, comparator and denominators, distinguishing unread external material.
Why this condition is needed
This condition connects Allocation, completion, analysis and attrition with the selected question, actual population, test product, comparator, symptom scale, objective outcomes, time points, denominators and harms.
Application exceptions
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.
Referenced methods
Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources S01

N08 · Definition of total IPSS assessment

Current findings
The original endpoint is International Prostate Symptom Score (IPSS) at three and six months. A subjective symptom scale is not converted into objective flow, residual urine or prostate-size outcomes.
Verification status
Partly verified
Materials actually read
Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread
Why unverified
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.
Reason for missing information
Total-score composition, assessment procedures, baseline distribution, scale language and missing responses are unverified.
Required materials and conditions
Scale, total and subscores, responses and time points
Materials to obtain first
Total-score composition, assessment procedures, baseline distribution, scale language and missing responses are unverified.
Further research
Material needed: Total-score composition, assessment procedures, baseline distribution, scale language and missing responses are unverified. This records needed materials; no new research was executed.
Remaining 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.
Conditions for verification
Material for Scale, total and subscores, responses and time points must be linked to the selected subclaim, parent context, original report, time points, comparator and denominators, distinguishing unread external material.
Why this condition is needed
This condition connects Scale, total and subscores, responses and time points with the selected question, actual population, test product, comparator, symptom scale, objective outcomes, time points, denominators and harms.
Application exceptions
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.
Referenced methods
Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources S01

N09 · Six-month changes within each group

Current findings
Six-month changes of−3.1 points (250mg),−4.1 points (500mg) and−1.5 points (placebo) are group-specific records. Each group's change is not itself converted into an effect versus placebo.
Verification status
Partly verified
Materials actually read
Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread
Why unverified
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.
Reason for missing information
Group baseline and end values, change variance, exact analysis denominators and models are unverified.
Required materials and conditions
Changes, baseline, units and denominators for each dose and placebo
Materials to obtain first
Group baseline and end values, change variance, exact analysis denominators and models are unverified.
Further research
Material needed: Group baseline and end values, change variance, exact analysis denominators and models are unverified. This records needed materials; no new research was executed.
Remaining 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.
Conditions for verification
Material for Changes, baseline, units and denominators for each dose and placebo must be linked to the selected subclaim, parent context, original report, time points, comparator and denominators, distinguishing unread external material.
Why this condition is needed
This condition connects Changes, baseline, units and denominators for each dose and placebo with the selected question, actual population, test product, comparator, symptom scale, objective outcomes, time points, denominators and harms.
Application exceptions
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.
Referenced methods
Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources S01

N10 · Original approximate differences versus placebo

Current findings
The parent text's approximate differences of−1.6 and−2.6 points versus placebo are preserved. These are historical approximate statements, not newly calculated values, exact adjusted effects or CIs.
Verification status
Partly verified
Materials actually read
Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread
Why unverified
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.
Reason for missing information
Exact between-group models, adjustment, CIs, denominators and estimand definitions are unverified.
Required materials and conditions
Between-group estimands, adjustment, CIs and historical calculation
Materials to obtain first
Exact between-group models, adjustment, CIs, denominators and estimand definitions are unverified.
Further research
Material needed: Exact between-group models, adjustment, CIs, denominators and estimand definitions are unverified. This records needed materials; no new research was executed.
Remaining 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.
Conditions for verification
Material for Between-group estimands, adjustment, CIs and historical calculation must be linked to the selected subclaim, parent context, original report, time points, comparator and denominators, distinguishing unread external material.
Why this condition is needed
This condition connects Between-group estimands, adjustment, CIs and historical calculation with the selected question, actual population, test product, comparator, symptom scale, objective outcomes, time points, denominators and harms.
Application exceptions
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.
Referenced methods
Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources S01

N11 · Dose-specific P values and comparison scope

Current findings
The original comparison P values are approximately .05 for250mg and <.001 for500mg. Approximately .05 is not turned into an exact P value, within-group P value, between-dose test or prespecified success criterion.
Verification status
Partly verified
Materials actually read
Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread
Why unverified
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.
Reason for missing information
Exact P values, tested contrasts, direction, multiplicity and adjusted models are unverified.
Required materials and conditions
Reported P values, exact contrasts, models and multiplicity
Materials to obtain first
Exact P values, tested contrasts, direction, multiplicity and adjusted models are unverified.
Further research
Material needed: Exact P values, tested contrasts, direction, multiplicity and adjusted models are unverified. This records needed materials; no new research was executed.
Remaining 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.
Conditions for verification
Material for Reported P values, exact contrasts, models and multiplicity must be linked to the selected subclaim, parent context, original report, time points, comparator and denominators, distinguishing unread external material.
Why this condition is needed
This condition connects Reported P values, exact contrasts, models and multiplicity with the selected question, actual population, test product, comparator, symptom scale, objective outcomes, time points, denominators and harms.
Application exceptions
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.
Referenced methods
Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources S01

N12 · An apparent dose-response pattern

Current findings
The parent text describes an apparent dose-response IPSS pattern as a strength. Group changes of−3.1 and−4.1 points, or each placebo comparison, are not turned into a direct between-dose difference or proof of an optimal dose.
Verification status
Partly verified
Materials actually read
Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread
Why unverified
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.
Reason for missing information
Direct between-dose contrasts, exposure adherence, CIs and prespecified models are unverified.
Required materials and conditions
Direct comparison of doses, adherence and models
Materials to obtain first
Direct between-dose contrasts, exposure adherence, CIs and prespecified models are unverified.
Further research
Material needed: Direct between-dose contrasts, exposure adherence, CIs and prespecified models are unverified. This records needed materials; no new research was executed.
Remaining 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.
Conditions for verification
Material for Direct comparison of doses, adherence and models must be linked to the selected subclaim, parent context, original report, time points, comparator and denominators, distinguishing unread external material.
Why this condition is needed
This condition connects Direct comparison of doses, adherence and models with the selected question, actual population, test product, comparator, symptom scale, objective outcomes, time points, denominators and harms.
Application exceptions
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.
Referenced methods
Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources S01

N13 · Minimal important-difference numbers by source

Current findings
The text's patient-anchored threshold of approximately3.1–5.2 points and the supporting citation's approximately5.2 overall and3.2 for moderate symptoms are preserved separately.3.1 and3.2 are not arbitrarily harmonized or recalculated.
Verification status
Partly verified
Materials actually read
Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread
Why unverified
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.
Reason for missing information
The exact source and conditions for3.1 in the text, and correspondence to the supporting cohort's3.2, are unverified.
Required materials and conditions
Textual thresholds, supporting citation estimates, populations and units
Materials to obtain first
The exact source and conditions for3.1 in the text, and correspondence to the supporting cohort's3.2, are unverified.
Further research
Material needed: The exact source and conditions for3.1 in the text, and correspondence to the supporting cohort's3.2, are unverified. This records needed materials; no new research was executed.
Remaining 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.
Conditions for verification
Material for Textual thresholds, supporting citation estimates, populations and units must be linked to the selected subclaim, parent context, original report, time points, comparator and denominators, distinguishing unread external material.
Why this condition is needed
This condition connects Textual thresholds, supporting citation estimates, populations and units with the selected question, actual population, test product, comparator, symptom scale, objective outcomes, time points, denominators and harms.
Application exceptions
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.
Referenced methods
Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources S01 S02

N14 · Role of the Blanker observational cohort

Current findings
Blanker2019 is a Dutch primary-care observational cohort for IPSS/OABQ minimal important differences and appears only in the citations. It is not treated as cranberry efficacy, an independent RCT or a repeat of the same124 participants.
Verification status
Partly verified
Materials actually read
Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread
Why unverified
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.
Reason for missing information
Supporting-cohort n, baseline severity, anchors, estimation methods, CIs and correspondence to the trial population are unverified.
Required materials and conditions
MID estimation design, population, denominators and criteria
Materials to obtain first
Supporting-cohort n, baseline severity, anchors, estimation methods, CIs and correspondence to the trial population are unverified.
Further research
Material needed: Supporting-cohort n, baseline severity, anchors, estimation methods, CIs and correspondence to the trial population are unverified. This records needed materials; no new research was executed.
Remaining 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.
Conditions for verification
Material for MID estimation design, population, denominators and criteria must be linked to the selected subclaim, parent context, original report, time points, comparator and denominators, distinguishing unread external material.
Why this condition is needed
This condition connects MID estimation design, population, denominators and criteria with the selected question, actual population, test product, comparator, symptom scale, objective outcomes, time points, denominators and harms.
Application exceptions
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.
Referenced methods
Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources S02

N15 · Mean differences and individual importance thresholds

Current findings
The parent text states that approximately−1.6 and−2.6 points fell below estimated thresholds. This is not turned into no effect for every individual, treatment failure, a new grade or response rates.
Verification status
Partly verified
Materials actually read
Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread
Why unverified
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.
Reason for missing information
Exact correspondence between group means and individually important changes, distributions and prespecified criteria is unverified.
Required materials and conditions
Estimands, individual versus group interpretation and relevance criteria
Materials to obtain first
Exact correspondence between group means and individually important changes, distributions and prespecified criteria is unverified.
Further research
Material needed: Exact correspondence between group means and individually important changes, distributions and prespecified criteria is unverified. This records needed materials; no new research was executed.
Remaining 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.
Conditions for verification
Material for Estimands, individual versus group interpretation and relevance criteria must be linked to the selected subclaim, parent context, original report, time points, comparator and denominators, distinguishing unread external material.
Why this condition is needed
This condition connects Estimands, individual versus group interpretation and relevance criteria with the selected question, actual population, test product, comparator, symptom scale, objective outcomes, time points, denominators and harms.
Application exceptions
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.
Referenced methods
Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources S01 S02

N16 · IPSS subscores and quality of life

Current findings
The stored summary's quantitative result is six-month IPSS change. Separately linked item, subscore or quality-of-life results are not assumed.
Verification status
Unverified
Materials actually read
Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread
Why unverified
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.
Reason for missing information
Item, subscore and QoL definitions, time points, denominators, exact effects, CIs and hierarchy are unverified.
Required materials and conditions
Separate total, item, subscore and QoL outcomes
Materials to obtain first
Item, subscore and QoL definitions, time points, denominators, exact effects, CIs and hierarchy are unverified.
Further research
Material needed: Item, subscore and QoL definitions, time points, denominators, exact effects, CIs and hierarchy are unverified. This records needed materials; no new research was executed.
Remaining 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.
Conditions for verification
Material for Separate total, item, subscore and QoL outcomes must be linked to the selected subclaim, parent context, original report, time points, comparator and denominators, distinguishing unread external material.
Why this condition is needed
This condition connects Separate total, item, subscore and QoL outcomes with the selected question, actual population, test product, comparator, symptom scale, objective outcomes, time points, denominators and harms.
Application exceptions
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.
Referenced methods
Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources S01

N17 · Three and six months, and persistence after completion

Current findings
The endpoint label includes three and six months, but current quantitative values concern six months. Three months is not treated as a separate replication trial or confirmation of identical numbers.
Verification status
Partly verified
Materials actually read
Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread
Why unverified
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.
Reason for missing information
Three-month quantitative values, denominators, time-specific missingness and persistence beyond six months are not linked.
Required materials and conditions
Time-specific results, denominators and post-discontinuation persistence
Materials to obtain first
Three-month quantitative values, denominators, time-specific missingness and persistence beyond six months are not linked.
Further research
Material needed: Three-month quantitative values, denominators, time-specific missingness and persistence beyond six months are not linked. This records needed materials; no new research was executed.
Remaining 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.
Conditions for verification
Material for Time-specific results, denominators and post-discontinuation persistence must be linked to the selected subclaim, parent context, original report, time points, comparator and denominators, distinguishing unread external material.
Why this condition is needed
This condition connects Time-specific results, denominators and post-discontinuation persistence with the selected question, actual population, test product, comparator, symptom scale, objective outcomes, time points, denominators and harms.
Application exceptions
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.
Referenced methods
Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources S01

N18 · Prespecified IPSS statements and registration

Current findings
The parent text describes a prespecified IPSS endpoint, while the citation flags registration as unverified. Absence of a registration-identifier key in the evidence record is not turned into no registration or completed preregistration.
Verification status
Partly verified
Materials actually read
Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread
Why unverified
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.
Reason for missing information
Original registration, recruitment and registration timing, protocol, SAP and amendment history are unread.
Required materials and conditions
Original prespecification statements, registration, protocol and SAP
Materials to obtain first
Original registration, recruitment and registration timing, protocol, SAP and amendment history are unread.
Further research
Material needed: Original registration, recruitment and registration timing, protocol, SAP and amendment history are unread. This records needed materials; no new research was executed.
Remaining 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.
Conditions for verification
Material for Original prespecification statements, registration, protocol and SAP must be linked to the selected subclaim, parent context, original report, time points, comparator and denominators, distinguishing unread external material.
Why this condition is needed
This condition connects Original prespecification statements, registration, protocol and SAP with the selected question, actual population, test product, comparator, symptom scale, objective outcomes, time points, denominators and harms.
Application exceptions
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.
Referenced methods
Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources S01

N19 · Plans for multiple doses, times and outcomes

Current findings
The two doses,3/6 months, IPSS and objective outcomes have distinct analysis scopes. A prespecified-IPSS statement is not extended into verified prespecified primary effects for all subscores or flow outcomes.
Verification status
Unverified
Materials actually read
Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread
Why unverified
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.
Reason for missing information
Exact hierarchy, dose/time contrasts, multiplicity and the complete SAP are unverified.
Required materials and conditions
Prespecified hierarchy, contrasts, multiplicity and analysis models
Materials to obtain first
Exact hierarchy, dose/time contrasts, multiplicity and the complete SAP are unverified.
Further research
Material needed: Exact hierarchy, dose/time contrasts, multiplicity and the complete SAP are unverified. This records needed materials; no new research was executed.
Remaining 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.
Conditions for verification
Material for Prespecified hierarchy, contrasts, multiplicity and analysis models must be linked to the selected subclaim, parent context, original report, time points, comparator and denominators, distinguishing unread external material.
Why this condition is needed
This condition connects Prespecified hierarchy, contrasts, multiplicity and analysis models with the selected question, actual population, test product, comparator, symptom scale, objective outcomes, time points, denominators and harms.
Application exceptions
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.
Referenced methods
Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources S01

N20 · Blinding and measurement of symptoms

Current findings
Double-blinding and placebo control are design strengths recorded in the original text. Actual masking maintenance and standardization of symptom responses and analyses are not thereby verified.
Verification status
Unverified
Materials actually read
Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread
Why unverified
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.
Reason for missing information
Masking maintenance, assessment procedures, missing responses, analysts and expectancy effects are unverified.
Required materials and conditions
Participants, assessors, scale administration and expectancy
Materials to obtain first
Masking maintenance, assessment procedures, missing responses, analysts and expectancy effects are unverified.
Further research
Material needed: Masking maintenance, assessment procedures, missing responses, analysts and expectancy effects are unverified. This records needed materials; no new research was executed.
Remaining 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.
Conditions for verification
Material for Participants, assessors, scale administration and expectancy must be linked to the selected subclaim, parent context, original report, time points, comparator and denominators, distinguishing unread external material.
Why this condition is needed
This condition connects Participants, assessors, scale administration and expectancy with the selected question, actual population, test product, comparator, symptom scale, objective outcomes, time points, denominators and harms.
Application exceptions
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.
Referenced methods
Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources S01

N21 · Concurrent care and actual exposure

Current findings
This is a comparison of three branded-powder groups. Identical or absent concurrent urinary-symptom care, medication, lifestyle changes and product adherence are not inferred.
Verification status
Unverified
Materials actually read
Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread
Why unverified
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.
Reason for missing information
Concurrent treatment, lifestyle changes, adherence, discontinuation and baseline adjustment are unverified.
Required materials and conditions
Medication, lifestyle, concurrent interventions and adherence
Materials to obtain first
Concurrent treatment, lifestyle changes, adherence, discontinuation and baseline adjustment are unverified.
Further research
Material needed: Concurrent treatment, lifestyle changes, adherence, discontinuation and baseline adjustment are unverified. This records needed materials; no new research was executed.
Remaining 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.
Conditions for verification
Material for Medication, lifestyle, concurrent interventions and adherence must be linked to the selected subclaim, parent context, original report, time points, comparator and denominators, distinguishing unread external material.
Why this condition is needed
This condition connects Medication, lifestyle, concurrent interventions and adherence with the selected question, actual population, test product, comparator, symptom scale, objective outcomes, time points, denominators and harms.
Application exceptions
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.
Referenced methods
Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources S01

N22 · Analysis populations and missing-data handling

Current findings
The original124 describes total participants; completion counts, missingness rates, ITT and PP are not provided. Parent scores and design labels do not fill the analysis scope.
Verification status
Unverified
Materials actually read
Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread
Why unverified
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.
Reason for missing information
Group attrition, missing IPSS, exclusions, ITT, PP, imputation and sensitivity analyses are unverified.
Required materials and conditions
ITT, PP, group attrition/discontinuation and missing outcomes
Materials to obtain first
Group attrition, missing IPSS, exclusions, ITT, PP, imputation and sensitivity analyses are unverified.
Further research
Material needed: Group attrition, missing IPSS, exclusions, ITT, PP, imputation and sensitivity analyses are unverified. This records needed materials; no new research was executed.
Remaining 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.
Conditions for verification
Material for ITT, PP, group attrition/discontinuation and missing outcomes must be linked to the selected subclaim, parent context, original report, time points, comparator and denominators, distinguishing unread external material.
Why this condition is needed
This condition connects ITT, PP, group attrition/discontinuation and missing outcomes with the selected question, actual population, test product, comparator, symptom scale, objective outcomes, time points, denominators and harms.
Application exceptions
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.
Referenced methods
Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources S01

N23 · Within-group objective-flow and residual-urine comparisons

Current findings
The original text says Qmax, Qavg and residual urine changed from baseline in the500mg group, without presenting a confirmed effect versus placebo. The placebo-controlled IPSS signal is not transferred into flow or residual-urine success.
Verification status
Partly verified
Materials actually read
Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread
Why unverified
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.
Reason for missing information
Exact objective values, units, time points, denominators, between-group effects and CIs are unverified.
Required materials and conditions
IPSS versus Qmax, Qavg and residual urine; within/between-group distinctions
Materials to obtain first
Exact objective values, units, time points, denominators, between-group effects and CIs are unverified.
Further research
Material needed: Exact objective values, units, time points, denominators, between-group effects and CIs are unverified. This records needed materials; no new research was executed.
Remaining 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.
Conditions for verification
Material for IPSS versus Qmax, Qavg and residual urine; within/between-group distinctions must be linked to the selected subclaim, parent context, original report, time points, comparator and denominators, distinguishing unread external material.
Why this condition is needed
This condition connects IPSS versus Qmax, Qavg and residual urine; within/between-group distinctions with the selected question, actual population, test product, comparator, symptom scale, objective outcomes, time points, denominators and harms.
Application exceptions
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.
Referenced methods
Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources S01

N24 · Scope of other clinical and product questions

Current findings
The parent text records that definitive prostate-size and urinary-flow claims exceed scope. The IPSS signal is not turned into prostate treatment, infection prevention, treatment replacement or efficacy of ordinary juice or other PAC products.
Verification status
Partly verified
Materials actually read
Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread
Why unverified
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.
Reason for missing information
Direct evidence for other clinical outcomes, products, populations and treatment replacement is not linked.
Required materials and conditions
Direct measurement, comparisons and generalization
Materials to obtain first
Direct evidence for other clinical outcomes, products, populations and treatment replacement is not linked.
Further research
Material needed: Direct evidence for other clinical outcomes, products, populations and treatment replacement is not linked. This records needed materials; no new research was executed.
Remaining 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.
Conditions for verification
Material for Direct measurement, comparisons and generalization must be linked to the selected subclaim, parent context, original report, time points, comparator and denominators, distinguishing unread external material.
Why this condition is needed
This condition connects Direct measurement, comparisons and generalization with the selected question, actual population, test product, comparator, symptom scale, objective outcomes, time points, denominators and harms.
Application exceptions
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.
Referenced methods
Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources S01

N25 · One shared trial, supporting thresholds and independent replication

Current findings
The Vidlar2016 trial of124 participants, three groups and3/6 months is shared by two sheets. The Blanker MID cohort is not efficacy replication. Groups, times, supporting citations and the two sheets are not counted as unique trials or participant totals.
Verification status
Partly verified
Materials actually read
Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread
Why unverified
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.
Reason for missing information
Separate efficacy replication with the same product, population and comparison, and actual independent-study relationships, are not linked.
Required materials and conditions
Efficacy reports, cohort roles and duplicate times/sheets
Materials to obtain first
Separate efficacy replication with the same product, population and comparison, and actual independent-study relationships, are not linked.
Further research
Material needed: Separate efficacy replication with the same product, population and comparison, and actual independent-study relationships, are not linked. This records needed materials; no new research was executed.
Remaining 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.
Conditions for verification
Material for Efficacy reports, cohort roles and duplicate times/sheets must be linked to the selected subclaim, parent context, original report, time points, comparator and denominators, distinguishing unread external material.
Why this condition is needed
This condition connects Efficacy reports, cohort roles and duplicate times/sheets with the selected question, actual population, test product, comparator, symptom scale, objective outcomes, time points, denominators and harms.
Application exceptions
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.
Referenced methods
Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources S01 S02

N26 · Naturex employee authors, support and conflicts

Current findings
The original funding field records two Naturex-employed authors and a branded test product. Employment information is not turned into complete verification of funding, free product support or conflicts. Support for the Blanker cohort is separate.
Verification status
Partly verified
Materials actually read
Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread
Why unverified
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.
Reason for missing information
Funding roles, product supply and free support, employee-author roles, conflicts and supporting-cohort support are unverified.
Required materials and conditions
Employment, product, funding, support and conflict disclosures
Materials to obtain first
Funding roles, product supply and free support, employee-author roles, conflicts and supporting-cohort support are unverified.
Further research
Material needed: Funding roles, product supply and free support, employee-author roles, conflicts and supporting-cohort support are unverified. This records needed materials; no new research was executed.
Remaining 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.
Conditions for verification
Material for Employment, product, funding, support and conflict disclosures must be linked to the selected subclaim, parent context, original report, time points, comparator and denominators, distinguishing unread external material.
Why this condition is needed
This condition connects Employment, product, funding, support and conflict disclosures with the selected question, actual population, test product, comparator, symptom scale, objective outcomes, time points, denominators and harms.
Application exceptions
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.
Referenced methods
Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources S01 S02

N27 · Laboratory changes and clinical safety

Current findings
Parent safety is unknown; no clinical-chemistry or hematology change over six months is an original statement. It is not turned into zero adverse events, exclusion of rare harms or long-term safety. Interactions such as warfarin remain a possibility statement in the original text.
Verification status
Unverified
Materials actually read
Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread
Why unverified
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.
Reason for missing information
Event definitions, collection, group denominators, discontinuation, rare and long-term harms, and direct interaction evidence are unverified.
Required materials and conditions
Adverse events, hematology/clinical chemistry, exposure and denominators
Materials to obtain first
Event definitions, collection, group denominators, discontinuation, rare and long-term harms, and direct interaction evidence are unverified.
Further research
Material needed: Event definitions, collection, group denominators, discontinuation, rare and long-term harms, and direct interaction evidence are unverified. This records needed materials; no new research was executed.
Remaining 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.
Conditions for verification
Material for Adverse events, hematology/clinical chemistry, exposure and denominators must be linked to the selected subclaim, parent context, original report, time points, comparator and denominators, distinguishing unread external material.
Why this condition is needed
This condition connects Adverse events, hematology/clinical chemistry, exposure and denominators with the selected question, actual population, test product, comparator, symptom scale, objective outcomes, time points, denominators and harms.
Application exceptions
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.
Referenced methods
Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources S01

N28 · Parent/subclaim values, languages and dates

Current findings
Parent C46, B/P/R1/I0/E~/B1, unrecorded precision, four false flags, empty override reasons, and subclaim C/note are preserved. Original languages,2026-09-07, empty corrections array/deliberation string, and historical PubMed/effect/scoring checks are not inherited as current review or subclaim scores.
Verification status
Partly verified
Materials actually read
Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread
Why unverified
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.
Reason for missing information
Subclaim score, status and axes, new corrections and external details behind historical checks are unverified.
Required materials and conditions
Parent C46, subclaim C, axes, corrections and history
Materials to obtain first
Subclaim score, status and axes, new corrections and external details behind historical checks are unverified.
Further research
Material needed: Subclaim score, status and axes, new corrections and external details behind historical checks are unverified. This records needed materials; no new research was executed.
Remaining 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.
Conditions for verification
Material for Parent C46, subclaim C, axes, corrections and history must be linked to the selected subclaim, parent context, original report, time points, comparator and denominators, distinguishing unread external material.
Why this condition is needed
This condition connects Parent C46, subclaim C, axes, corrections and history with the selected question, actual population, test product, comparator, symptom scale, objective outcomes, time points, denominators and harms.
Application exceptions
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.
Referenced methods
Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources S01 S02

N29 · Summary reading, source links and updates

Current findings
The efficacy summary and supporting citation's MID wording were used, retaining original paper links. External abstracts, full texts, registration, protocols, SAPs and conflict disclosures are unread and access was not attempted. External source links were not tested.
Verification status
Partly verified
Materials actually read
Stored summary read; external abstracts, full texts, registration, protocols and SAPs unread
Why unverified
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.
Reason for missing information
External original acquisition, reading, source-link verification and review of existing content remain incomplete.
Required materials and conditions
Efficacy/MID summaries versus unread external material
Materials to obtain first
External original acquisition, reading, source-link verification and review of existing content remain incomplete.
Further research
Material needed: External original acquisition, reading, source-link verification and review of existing content remain incomplete. This records needed materials; no new research was executed.
Remaining 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.
Conditions for verification
Material for Efficacy/MID summaries versus unread external material must be linked to the selected subclaim, parent context, original report, time points, comparator and denominators, distinguishing unread external material.
Why this condition is needed
This condition connects Efficacy/MID summaries versus unread external material with the selected question, actual population, test product, comparator, symptom scale, objective outcomes, time points, denominators and harms.
Application exceptions
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.
Referenced methods
Preserved C/E/H application conditions concerning questions, populations, interventions, comparators, reports versus studies, endpoints, denominators and harms were referenced.

Related sources S01 S02