# Black soybean seed-coat extract × Overall sleep quality — Rising-sleepiness factor and gaps in the broader claim Verdict 2978 · Evidence Check Stored-material review date: Not recorded Original evidence cut-off: 2026-08-26 Review-criteria version: 1.0 Public page/material preparation date: 2026-10-14 Clinical papers were not read directly; existing review summaries were checked. No new clinical-literature search was performed. Unverified does not mean that research is absent or that there is no effect. ## Assessment scope - Population: 64 healthy Japanese adults dissatisfied with sleep quality; FAS1 32/32. Baseline status and completion/attrition details are unverified. - Ingredient, formulation and route: 100 mg black soybean seed-coat polyphenol extract, distinguished from ordinary black soybeans/soy foods - Dose: Original study exposure: 100 mg after the evening meal for 12 weeks. No cumulative-dose calculation or extract/product-intake/sleep instructions. - Comparator: Placebo, 32 participants; actual composition, blinding and concurrent exposures in both arms are unverified. - Measured outcome: Selected overall sleep quality: the broader claim is unverified, distinguished from the parent full-FAS1 primary 12-week change in OSA-MA rising sleepiness. - Duration: 12 weeks; actual exposure/adherence, endpoint-specific observations/analyses and persistence/long-term follow-up after completion remain unverified in detail - Questions outside this scope: Repurposing narrow morning-drowsiness/questionnaire symptom-day outcomes as general sleep, objective sleep, confirmed-infection prevention or clinical effects; Deriving new quantitative effects/CIs/adjusted values or invented examples from figure/text reporting limits, P values or denominators; Substituting FAS1/PPS, allocation/completion, people/days/symptoms/time points as the same denominator; Adding the same report, people, groups, time points, scales, bibliography or sibling sheets as new independent trials/participants; New grades/reassessment/independence certification or extract/product/drink-consumption, sleep/cold-management, infection-prevention or treatment-replacement instructions ## Checklist items ### N01 · Which existing overall-sleep claim is being carried over? Verification status: Partly verified Reading scope: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread - Current findings: The selected claim is improved overall sleep quality, originally graded ?. Its note limits this verdict to one sleepiness-on-rising score rather than the broader claim. Absent subclaim score/status/axes are distinguished from parent C50. - Why unverified: Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification. - Reason for missing information: Exact overall-sleep definition, population, time point, direct comparisons and user review of the question boundary are needed. Parent scores are not used to fill subclaim values. - Required materials and conditions: Selected subclaim wording/grade and the narrower parent result - Materials to obtain first: Exact overall-sleep definition, population, time point, direct comparisons and user review of the question boundary are needed. Parent scores are not used to fill subclaim values. - Further research: Materials needed: Exact overall-sleep definition, population, time point, direct comparisons and user review of the question boundary are needed. Parent scores are not used to fill subclaim values. Only information requests/research needs are recorded; no new lookup or research is performed in this production. - Conditions for verification: Show original information about Selected subclaim wording/grade and the narrower parent result, the selected subclaim/parent boundary, direct endpoints/estimands, denominators and scope of external reading together. - Why this condition is needed: Needed to connect Selected subclaim wording/grade and the narrower parent result with the selected question, actual population/intervention/comparator, endpoints/hierarchy/estimands, denominators/duration, reports and harms. - Application exceptions: Distinguish the specific rising-sleepiness factor, overall/objective sleep, other scales/temperature, primary/secondary/subgroup outcomes, multiplicity, exact effects/CIs, populations/intervention/placebo, 12-week/FAS1 denominators, company involvement and harms. Only original numbers are preserved; no new calculations, hypothetical quantities, effects/CIs, grades/regrading, independence certification or extract/product/drink-intake, sleep/cold-management, infection-prevention or treatment-substitution instructions. - Remaining uncertainty: External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification. - Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production - Related sources: R01 ### N02 · What sleep condition characterized the participants? Verification status: Partly verified Reading scope: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread - Current findings: Participants were 64 healthy Japanese adults dissatisfied with sleep quality. Applicability is not newly extended to diagnosed insomnia/sleep disorders or all ages/regions. - Why unverified: Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification. - Reason for missing information: Actual eligibility/exclusions, baseline sleep/health, age/sex, comorbidities/medication and direct comparisons in other populations are needed. - Required materials and conditions: Healthy adults dissatisfied with sleep quality - Materials to obtain first: Actual eligibility/exclusions, baseline sleep/health, age/sex, comorbidities/medication and direct comparisons in other populations are needed. - Further research: Materials needed: Actual eligibility/exclusions, baseline sleep/health, age/sex, comorbidities/medication and direct comparisons in other populations are needed. Only information requests/research needs are recorded; no new lookup or research is performed in this production. - Conditions for verification: Show original information about Healthy adults dissatisfied with sleep quality, the selected subclaim/parent boundary, direct endpoints/estimands, denominators and scope of external reading together. - Why this condition is needed: Needed to connect Healthy adults dissatisfied with sleep quality with the selected question, actual population/intervention/comparator, endpoints/hierarchy/estimands, denominators/duration, reports and harms. - Application exceptions: Distinguish the specific rising-sleepiness factor, overall/objective sleep, other scales/temperature, primary/secondary/subgroup outcomes, multiplicity, exact effects/CIs, populations/intervention/placebo, 12-week/FAS1 denominators, company involvement and harms. Only original numbers are preserved; no new calculations, hypothetical quantities, effects/CIs, grades/regrading, independence certification or extract/product/drink-intake, sleep/cold-management, infection-prevention or treatment-substitution instructions. - Remaining uncertainty: External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification. - Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production - Related sources: R01 ### N03 · What extract exposure was studied? Verification status: Partly verified Reading scope: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread - Current findings: The original intervention studied 100 mg black soybean seed-coat polyphenol extract after the evening meal for 12 weeks. Original constituent descriptions including proanthocyanidins and epicatechins are preserved; the result is not treated as equivalent to ordinary black soybeans/soy foods or other extracts. - Why unverified: Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification. - Reason for missing information: Original formulation, quantified constituents, product/manufacture, accompanying ingredients and adherence data are needed. Beyond identifying study exposure, no product/extract-intake or sleep instructions are supplied. - Required materials and conditions: 100 mg black soybean seed-coat extract versus ordinary foods - Materials to obtain first: Original formulation, quantified constituents, product/manufacture, accompanying ingredients and adherence data are needed. Beyond identifying study exposure, no product/extract-intake or sleep instructions are supplied. - Further research: Materials needed: Original formulation, quantified constituents, product/manufacture, accompanying ingredients and adherence data are needed. Beyond identifying study exposure, no product/extract-intake or sleep instructions are supplied. Only information requests/research needs are recorded; no new lookup or research is performed in this production. - Conditions for verification: Show original information about 100 mg black soybean seed-coat extract versus ordinary foods, the selected subclaim/parent boundary, direct endpoints/estimands, denominators and scope of external reading together. - Why this condition is needed: Needed to connect 100 mg black soybean seed-coat extract versus ordinary foods with the selected question, actual population/intervention/comparator, endpoints/hierarchy/estimands, denominators/duration, reports and harms. - Application exceptions: Distinguish the specific rising-sleepiness factor, overall/objective sleep, other scales/temperature, primary/secondary/subgroup outcomes, multiplicity, exact effects/CIs, populations/intervention/placebo, 12-week/FAS1 denominators, company involvement and harms. Only original numbers are preserved; no new calculations, hypothetical quantities, effects/CIs, grades/regrading, independence certification or extract/product/drink-intake, sleep/cold-management, infection-prevention or treatment-substitution instructions. - Remaining uncertainty: External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification. - Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production - Related sources: R01 ### N04 · What were the actual placebo and conditions in both arms? Verification status: Partly verified Reading scope: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread - Current findings: The original records 64 participants assigned 32 each to extract and placebo. Actual placebo composition, blinding/sensory conditions and arm-specific sleep habits/other exposures are unverified. - Why unverified: Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification. - Reason for missing information: Placebo/active implementation, allocation concealment, contact/expectations, concurrent diet/medication and sleep exposures are needed. Findings are not substituted for overall-sleep effects against other comparators. - Required materials and conditions: 32/32 allocation and placebo comparison - Materials to obtain first: Placebo/active implementation, allocation concealment, contact/expectations, concurrent diet/medication and sleep exposures are needed. Findings are not substituted for overall-sleep effects against other comparators. - Further research: Materials needed: Placebo/active implementation, allocation concealment, contact/expectations, concurrent diet/medication and sleep exposures are needed. Findings are not substituted for overall-sleep effects against other comparators. Only information requests/research needs are recorded; no new lookup or research is performed in this production. - Conditions for verification: Show original information about 32/32 allocation and placebo comparison, the selected subclaim/parent boundary, direct endpoints/estimands, denominators and scope of external reading together. - Why this condition is needed: Needed to connect 32/32 allocation and placebo comparison with the selected question, actual population/intervention/comparator, endpoints/hierarchy/estimands, denominators/duration, reports and harms. - Application exceptions: Distinguish the specific rising-sleepiness factor, overall/objective sleep, other scales/temperature, primary/secondary/subgroup outcomes, multiplicity, exact effects/CIs, populations/intervention/placebo, 12-week/FAS1 denominators, company involvement and harms. Only original numbers are preserved; no new calculations, hypothetical quantities, effects/CIs, grades/regrading, independence certification or extract/product/drink-intake, sleep/cold-management, infection-prevention or treatment-substitution instructions. - Remaining uncertainty: External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification. - Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production - Related sources: R01 ### N05 · Are 12-week results distinguished from sustained overall sleep? Verification status: Partly verified Reading scope: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread - Current findings: The original duration was 12 weeks. Details of actual exposure/adherence, discontinuation, measurement schedules, persistence after completion and direct long-term overall-sleep data are unverified. No new cumulative amounts, day counts or long-term efficacy are created. - Why unverified: Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification. - Reason for missing information: Time-specific overall/factor results, actual exposure, follow-up and discontinuation/recurrence data are needed. Short-term specific scores are not converted into long-term sleep effects. - Required materials and conditions: Original duration, actual exposure and post-study follow-up - Materials to obtain first: Time-specific overall/factor results, actual exposure, follow-up and discontinuation/recurrence data are needed. Short-term specific scores are not converted into long-term sleep effects. - Further research: Materials needed: Time-specific overall/factor results, actual exposure, follow-up and discontinuation/recurrence data are needed. Short-term specific scores are not converted into long-term sleep effects. Only information requests/research needs are recorded; no new lookup or research is performed in this production. - Conditions for verification: Show original information about Original duration, actual exposure and post-study follow-up, the selected subclaim/parent boundary, direct endpoints/estimands, denominators and scope of external reading together. - Why this condition is needed: Needed to connect Original duration, actual exposure and post-study follow-up with the selected question, actual population/intervention/comparator, endpoints/hierarchy/estimands, denominators/duration, reports and harms. - Application exceptions: Distinguish the specific rising-sleepiness factor, overall/objective sleep, other scales/temperature, primary/secondary/subgroup outcomes, multiplicity, exact effects/CIs, populations/intervention/placebo, 12-week/FAS1 denominators, company involvement and harms. Only original numbers are preserved; no new calculations, hypothetical quantities, effects/CIs, grades/regrading, independence certification or extract/product/drink-intake, sleep/cold-management, infection-prevention or treatment-substitution instructions. - Remaining uncertainty: External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification. - Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production - Related sources: R01 ### N06 · Does a 64-person FAS1 mean everyone completed follow-up? Verification status: Partly verified Reading scope: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread - Current findings: The original evidence records 64 randomized participants in FAS1 (32/32). The summary does not establish FAS1 definitions, completion/attrition or time-specific observation/missingness details. Complete 12-week follow-up or identical denominators for every measure are not assumed. - Why unverified: Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification. - Reason for missing information: FAS1 definitions, arm-specific flow, observation/analysis denominators and attrition/missingness reasons/handling are needed. No new attrition counts/rates or repeated-measurement totals are calculated. - Required materials and conditions: Randomized, FAS1, completer and endpoint-specific denominators - Materials to obtain first: FAS1 definitions, arm-specific flow, observation/analysis denominators and attrition/missingness reasons/handling are needed. No new attrition counts/rates or repeated-measurement totals are calculated. - Further research: Materials needed: FAS1 definitions, arm-specific flow, observation/analysis denominators and attrition/missingness reasons/handling are needed. No new attrition counts/rates or repeated-measurement totals are calculated. Only information requests/research needs are recorded; no new lookup or research is performed in this production. - Conditions for verification: Show original information about Randomized, FAS1, completer and endpoint-specific denominators, the selected subclaim/parent boundary, direct endpoints/estimands, denominators and scope of external reading together. - Why this condition is needed: Needed to connect Randomized, FAS1, completer and endpoint-specific denominators with the selected question, actual population/intervention/comparator, endpoints/hierarchy/estimands, denominators/duration, reports and harms. - Application exceptions: Distinguish the specific rising-sleepiness factor, overall/objective sleep, other scales/temperature, primary/secondary/subgroup outcomes, multiplicity, exact effects/CIs, populations/intervention/placebo, 12-week/FAS1 denominators, company involvement and harms. Only original numbers are preserved; no new calculations, hypothetical quantities, effects/CIs, grades/regrading, independence certification or extract/product/drink-intake, sleep/cold-management, infection-prevention or treatment-substitution instructions. - Remaining uncertainty: External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification. - Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production - Related sources: R01 ### N07 · What does the primary rising-sleepiness factor measure? Verification status: Partly verified Reading scope: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread - Current findings: The original primary endpoint is 12-week change in OSA-MA sleepiness-on-rising score. It is a specific self-reported sleep-scale factor; total scores, other factors and overall sleep are not newly declared the same measure. - Why unverified: Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification. - Reason for missing information: OSA-MA version, factors/items, score direction, measurement dates/times and relationships to overall/other scales are needed. - Required materials and conditions: 12-week change in OSA-MA sleepiness on rising - Materials to obtain first: OSA-MA version, factors/items, score direction, measurement dates/times and relationships to overall/other scales are needed. - Further research: Materials needed: OSA-MA version, factors/items, score direction, measurement dates/times and relationships to overall/other scales are needed. Only information requests/research needs are recorded; no new lookup or research is performed in this production. - Conditions for verification: Show original information about 12-week change in OSA-MA sleepiness on rising, the selected subclaim/parent boundary, direct endpoints/estimands, denominators and scope of external reading together. - Why this condition is needed: Needed to connect 12-week change in OSA-MA sleepiness on rising with the selected question, actual population/intervention/comparator, endpoints/hierarchy/estimands, denominators/duration, reports and harms. - Application exceptions: Distinguish the specific rising-sleepiness factor, overall/objective sleep, other scales/temperature, primary/secondary/subgroup outcomes, multiplicity, exact effects/CIs, populations/intervention/placebo, 12-week/FAS1 denominators, company involvement and harms. Only original numbers are preserved; no new calculations, hypothetical quantities, effects/CIs, grades/regrading, independence certification or extract/product/drink-intake, sleep/cold-management, infection-prevention or treatment-substitution instructions. - Remaining uncertainty: External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification. - Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production - Related sources: R01 ### N08 · Does a specific rising-sleepiness result establish overall sleep? Verification status: Unverified Reading scope: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread - Current findings: Original Korean/English text and the subclaim note limit the claim to one rising-sleepiness score rather than overall sleep improvement. Appropriate direct overall-sleep measures, full results and effects are not established within the preserved scope. - Why unverified: Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification. - Reason for missing information: Prespecified direct overall-sleep endpoints, full results, denominators, effects/CIs and confirmation are needed. A narrow signal is not promoted into certification of the broader claim. - Required materials and conditions: Scope of the broader claim and direct outcomes - Materials to obtain first: Prespecified direct overall-sleep endpoints, full results, denominators, effects/CIs and confirmation are needed. A narrow signal is not promoted into certification of the broader claim. - Further research: Materials needed: Prespecified direct overall-sleep endpoints, full results, denominators, effects/CIs and confirmation are needed. A narrow signal is not promoted into certification of the broader claim. Only information requests/research needs are recorded; no new lookup or research is performed in this production. - Conditions for verification: Show original information about Scope of the broader claim and direct outcomes, the selected subclaim/parent boundary, direct endpoints/estimands, denominators and scope of external reading together. - Why this condition is needed: Needed to connect Scope of the broader claim and direct outcomes with the selected question, actual population/intervention/comparator, endpoints/hierarchy/estimands, denominators/duration, reports and harms. - Application exceptions: Distinguish the specific rising-sleepiness factor, overall/objective sleep, other scales/temperature, primary/secondary/subgroup outcomes, multiplicity, exact effects/CIs, populations/intervention/placebo, 12-week/FAS1 denominators, company involvement and harms. Only original numbers are preserved; no new calculations, hypothetical quantities, effects/CIs, grades/regrading, independence certification or extract/product/drink-intake, sleep/cold-management, infection-prevention or treatment-substitution instructions. - Remaining uncertainty: External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification. - Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production - Related sources: R01 ### N09 · Which analysis produced P<.05? Verification status: Partly verified Reading scope: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread - Current findings: The full-FAS1 primary rising-sleepiness score improved versus placebo, P<0.05. This P value is not copied into overall/objective sleep, subgroups or other scales. No exact P value is newly estimated. - Why unverified: Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification. - Reason for missing information: Original primary analysis/models, denominators, exact effects/CIs, clinical importance and separate overall-sleep data are needed. P alone is not used to derive new magnitudes/CIs. - Required materials and conditions: Full-FAS1 primary result versus overall sleep - Materials to obtain first: Original primary analysis/models, denominators, exact effects/CIs, clinical importance and separate overall-sleep data are needed. P alone is not used to derive new magnitudes/CIs. - Further research: Materials needed: Original primary analysis/models, denominators, exact effects/CIs, clinical importance and separate overall-sleep data are needed. P alone is not used to derive new magnitudes/CIs. Only information requests/research needs are recorded; no new lookup or research is performed in this production. - Conditions for verification: Show original information about Full-FAS1 primary result versus overall sleep, the selected subclaim/parent boundary, direct endpoints/estimands, denominators and scope of external reading together. - Why this condition is needed: Needed to connect Full-FAS1 primary result versus overall sleep with the selected question, actual population/intervention/comparator, endpoints/hierarchy/estimands, denominators/duration, reports and harms. - Application exceptions: Distinguish the specific rising-sleepiness factor, overall/objective sleep, other scales/temperature, primary/secondary/subgroup outcomes, multiplicity, exact effects/CIs, populations/intervention/placebo, 12-week/FAS1 denominators, company involvement and harms. Only original numbers are preserved; no new calculations, hypothetical quantities, effects/CIs, grades/regrading, independence certification or extract/product/drink-intake, sleep/cold-management, infection-prevention or treatment-substitution instructions. - Remaining uncertainty: External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification. - Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production - Related sources: R01 ### N10 · Are figure estimates distinguished from values absent in the text? Verification status: Unverified Reading scope: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread - Current findings: The original describes estimated marginal means ± standard errors displayed in a figure, with exact group values and 95% CIs absent from the main text. This does not establish that all figures/raw data are unavailable; figures were not newly read or digitized. - Why unverified: Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification. - Reason for missing information: Original figures, supplementary tables, exact group values, estimation models and effects/CIs are needed. No numerical reading/back-calculation, hypothetical examples or CI calculations are performed. - Required materials and conditions: Estimated marginal means ± SE versus exact values/CIs - Materials to obtain first: Original figures, supplementary tables, exact group values, estimation models and effects/CIs are needed. No numerical reading/back-calculation, hypothetical examples or CI calculations are performed. - Further research: Materials needed: Original figures, supplementary tables, exact group values, estimation models and effects/CIs are needed. No numerical reading/back-calculation, hypothetical examples or CI calculations are performed. Only information requests/research needs are recorded; no new lookup or research is performed in this production. - Conditions for verification: Show original information about Estimated marginal means ± SE versus exact values/CIs, the selected subclaim/parent boundary, direct endpoints/estimands, denominators and scope of external reading together. - Why this condition is needed: Needed to connect Estimated marginal means ± SE versus exact values/CIs with the selected question, actual population/intervention/comparator, endpoints/hierarchy/estimands, denominators/duration, reports and harms. - Application exceptions: Distinguish the specific rising-sleepiness factor, overall/objective sleep, other scales/temperature, primary/secondary/subgroup outcomes, multiplicity, exact effects/CIs, populations/intervention/placebo, 12-week/FAS1 denominators, company involvement and harms. Only original numbers are preserved; no new calculations, hypothetical quantities, effects/CIs, grades/regrading, independence certification or extract/product/drink-intake, sleep/cold-management, infection-prevention or treatment-substitution instructions. - Remaining uncertainty: External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification. - Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production - Related sources: R01 ### N11 · Are change, absolute values and within/between-group contrasts separated? Verification status: Partly verified Reading scope: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread - Current findings: The endpoint is 12-week change, and the original describes improvement versus placebo in full FAS1. Exact baseline/end values, arm-specific changes, estimands and models are unverified. Within-group improvement is not newly calculated as an additional effect versus placebo. - Why unverified: Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification. - Reason for missing information: Arm-specific baseline/end/change values and estimands, baseline adjustment, repeated measurements, missing-data handling and models are needed. No new changes, ratios or effects are calculated. - Required materials and conditions: Estimand for 12-week change - Materials to obtain first: Arm-specific baseline/end/change values and estimands, baseline adjustment, repeated measurements, missing-data handling and models are needed. No new changes, ratios or effects are calculated. - Further research: Materials needed: Arm-specific baseline/end/change values and estimands, baseline adjustment, repeated measurements, missing-data handling and models are needed. No new changes, ratios or effects are calculated. Only information requests/research needs are recorded; no new lookup or research is performed in this production. - Conditions for verification: Show original information about Estimand for 12-week change, the selected subclaim/parent boundary, direct endpoints/estimands, denominators and scope of external reading together. - Why this condition is needed: Needed to connect Estimand for 12-week change with the selected question, actual population/intervention/comparator, endpoints/hierarchy/estimands, denominators/duration, reports and harms. - Application exceptions: Distinguish the specific rising-sleepiness factor, overall/objective sleep, other scales/temperature, primary/secondary/subgroup outcomes, multiplicity, exact effects/CIs, populations/intervention/placebo, 12-week/FAS1 denominators, company involvement and harms. Only original numbers are preserved; no new calculations, hypothetical quantities, effects/CIs, grades/regrading, independence certification or extract/product/drink-intake, sleep/cold-management, infection-prevention or treatment-substitution instructions. - Remaining uncertainty: External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification. - Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production - Related sources: R01 ### N12 · What is the hierarchy of other sleep and temperature outcomes? Verification status: Unverified Reading scope: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread - Current findings: The original counterview distinguishes other sleep/temperature endpoints as secondary outcomes. The summary does not establish complete labels, effects/CIs, significant/null result lists or prespecified hierarchy. Temperature/other factors are not combined as proof of overall sleep. - Why unverified: Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification. - Reason for missing information: Complete endpoint tables, registry/protocol/SAP, secondary hierarchy, direct endpoint results/denominators and multiplicity plans are needed. Unread materials are not treated as absence/nullity of every outcome. - Required materials and conditions: Primary factor versus secondary sleep/temperature endpoints - Materials to obtain first: Complete endpoint tables, registry/protocol/SAP, secondary hierarchy, direct endpoint results/denominators and multiplicity plans are needed. Unread materials are not treated as absence/nullity of every outcome. - Further research: Materials needed: Complete endpoint tables, registry/protocol/SAP, secondary hierarchy, direct endpoint results/denominators and multiplicity plans are needed. Unread materials are not treated as absence/nullity of every outcome. Only information requests/research needs are recorded; no new lookup or research is performed in this production. - Conditions for verification: Show original information about Primary factor versus secondary sleep/temperature endpoints, the selected subclaim/parent boundary, direct endpoints/estimands, denominators and scope of external reading together. - Why this condition is needed: Needed to connect Primary factor versus secondary sleep/temperature endpoints with the selected question, actual population/intervention/comparator, endpoints/hierarchy/estimands, denominators/duration, reports and harms. - Application exceptions: Distinguish the specific rising-sleepiness factor, overall/objective sleep, other scales/temperature, primary/secondary/subgroup outcomes, multiplicity, exact effects/CIs, populations/intervention/placebo, 12-week/FAS1 denominators, company involvement and harms. Only original numbers are preserved; no new calculations, hypothetical quantities, effects/CIs, grades/regrading, independence certification or extract/product/drink-intake, sleep/cold-management, infection-prevention or treatment-substitution instructions. - Remaining uncertainty: External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification. - Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production - Related sources: R01 ### N13 · Are male/other subgroup findings distinguished from full-population results? Verification status: Partly verified Reading scope: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread - Current findings: The original explains that male-only positive and other subgroup analyses did not replace the full-FAS1 primary positive result or broaden it into overall sleep improvement. Subgroup counts, exact effects and interactions are unverified. - Why unverified: Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification. - Reason for missing information: Original subgroup prespecification, denominators/effects/CIs, interactions, multiplicity and relationships to full analyses are needed. Subgroups are not counted as added independent trials/participants. - Required materials and conditions: Full FAS1 versus subgroup analyses - Materials to obtain first: Original subgroup prespecification, denominators/effects/CIs, interactions, multiplicity and relationships to full analyses are needed. Subgroups are not counted as added independent trials/participants. - Further research: Materials needed: Original subgroup prespecification, denominators/effects/CIs, interactions, multiplicity and relationships to full analyses are needed. Subgroups are not counted as added independent trials/participants. Only information requests/research needs are recorded; no new lookup or research is performed in this production. - Conditions for verification: Show original information about Full FAS1 versus subgroup analyses, the selected subclaim/parent boundary, direct endpoints/estimands, denominators and scope of external reading together. - Why this condition is needed: Needed to connect Full FAS1 versus subgroup analyses with the selected question, actual population/intervention/comparator, endpoints/hierarchy/estimands, denominators/duration, reports and harms. - Application exceptions: Distinguish the specific rising-sleepiness factor, overall/objective sleep, other scales/temperature, primary/secondary/subgroup outcomes, multiplicity, exact effects/CIs, populations/intervention/placebo, 12-week/FAS1 denominators, company involvement and harms. Only original numbers are preserved; no new calculations, hypothetical quantities, effects/CIs, grades/regrading, independence certification or extract/product/drink-intake, sleep/cold-management, infection-prevention or treatment-substitution instructions. - Remaining uncertainty: External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification. - Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production - Related sources: R01 ### N14 · Were multiplicity and registry plans verified in detail? Verification status: Unverified Reading scope: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread - Current findings: The original used only the full-FAS1 primary analysis as verdict evidence. Total tests, adjustments, hierarchy/changes across sleep/temperature and subgroup analyses are unverified; UMIN/protocol records were not read in this production. Adjusted results are not newly judged. - Why unverified: Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification. - Reason for missing information: Actual UMIN000051261 registry records, protocol/SAP, all endpoints/multiplicity, public/amendment dates and the original report are needed. No new adjusted P values or grades. - Required materials and conditions: Testing conditions for primary/secondary/subgroup analyses - Materials to obtain first: Actual UMIN000051261 registry records, protocol/SAP, all endpoints/multiplicity, public/amendment dates and the original report are needed. No new adjusted P values or grades. - Further research: Materials needed: Actual UMIN000051261 registry records, protocol/SAP, all endpoints/multiplicity, public/amendment dates and the original report are needed. No new adjusted P values or grades. Only information requests/research needs are recorded; no new lookup or research is performed in this production. - Conditions for verification: Show original information about Testing conditions for primary/secondary/subgroup analyses, the selected subclaim/parent boundary, direct endpoints/estimands, denominators and scope of external reading together. - Why this condition is needed: Needed to connect Testing conditions for primary/secondary/subgroup analyses with the selected question, actual population/intervention/comparator, endpoints/hierarchy/estimands, denominators/duration, reports and harms. - Application exceptions: Distinguish the specific rising-sleepiness factor, overall/objective sleep, other scales/temperature, primary/secondary/subgroup outcomes, multiplicity, exact effects/CIs, populations/intervention/placebo, 12-week/FAS1 denominators, company involvement and harms. Only original numbers are preserved; no new calculations, hypothetical quantities, effects/CIs, grades/regrading, independence certification or extract/product/drink-intake, sleep/cold-management, infection-prevention or treatment-substitution instructions. - Remaining uncertainty: External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification. - Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production - Related sources: R01 ### N15 · Are self-report results being transferred to objective sleep? Verification status: Unverified Reading scope: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread - Current findings: The original evidence concerns the rising-sleepiness factor of a self-reported sleep scale. Direct objective PSG/activity-recording, sleep duration/efficiency, onset and awakening results are not provided within the preserved materials. Unread records do not establish that these tests were unmeasured. - Why unverified: Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification. - Reason for missing information: Objective instruments/measurements, direct results separate from subjective scales, times/denominators and effects/CIs are needed. Other physiological measures do not establish overall sleep. - Required materials and conditions: Subjective scales versus objective sleep - Materials to obtain first: Objective instruments/measurements, direct results separate from subjective scales, times/denominators and effects/CIs are needed. Other physiological measures do not establish overall sleep. - Further research: Materials needed: Objective instruments/measurements, direct results separate from subjective scales, times/denominators and effects/CIs are needed. Other physiological measures do not establish overall sleep. Only information requests/research needs are recorded; no new lookup or research is performed in this production. - Conditions for verification: Show original information about Subjective scales versus objective sleep, the selected subclaim/parent boundary, direct endpoints/estimands, denominators and scope of external reading together. - Why this condition is needed: Needed to connect Subjective scales versus objective sleep with the selected question, actual population/intervention/comparator, endpoints/hierarchy/estimands, denominators/duration, reports and harms. - Application exceptions: Distinguish the specific rising-sleepiness factor, overall/objective sleep, other scales/temperature, primary/secondary/subgroup outcomes, multiplicity, exact effects/CIs, populations/intervention/placebo, 12-week/FAS1 denominators, company involvement and harms. Only original numbers are preserved; no new calculations, hypothetical quantities, effects/CIs, grades/regrading, independence certification or extract/product/drink-intake, sleep/cold-management, infection-prevention or treatment-substitution instructions. - Remaining uncertainty: External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification. - Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production - Related sources: R01 ### N16 · Are constituent/temperature explanations direct sleep evidence? Verification status: Partly verified Reading scope: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread - Current findings: Proanthocyanidins and epicatechins describe original extract constituents; temperature results are described as secondary. Constituents, mechanisms and temperature do not newly establish overall/clinical sleep effects. - Why unverified: Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification. - Reason for missing information: Formulation/quantification and mechanism data should be linked separately from direct sleep endpoints/effects. No efficacy expansion beyond the original primary/secondary conditions. - Required materials and conditions: Constituent identity and mechanisms versus overall-sleep effects - Materials to obtain first: Formulation/quantification and mechanism data should be linked separately from direct sleep endpoints/effects. No efficacy expansion beyond the original primary/secondary conditions. - Further research: Materials needed: Formulation/quantification and mechanism data should be linked separately from direct sleep endpoints/effects. No efficacy expansion beyond the original primary/secondary conditions. Only information requests/research needs are recorded; no new lookup or research is performed in this production. - Conditions for verification: Show original information about Constituent identity and mechanisms versus overall-sleep effects, the selected subclaim/parent boundary, direct endpoints/estimands, denominators and scope of external reading together. - Why this condition is needed: Needed to connect Constituent identity and mechanisms versus overall-sleep effects with the selected question, actual population/intervention/comparator, endpoints/hierarchy/estimands, denominators/duration, reports and harms. - Application exceptions: Distinguish the specific rising-sleepiness factor, overall/objective sleep, other scales/temperature, primary/secondary/subgroup outcomes, multiplicity, exact effects/CIs, populations/intervention/placebo, 12-week/FAS1 denominators, company involvement and harms. Only original numbers are preserved; no new calculations, hypothetical quantities, effects/CIs, grades/regrading, independence certification or extract/product/drink-intake, sleep/cold-management, infection-prevention or treatment-substitution instructions. - Remaining uncertainty: External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification. - Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production - Related sources: R01 ### N17 · What is the scope of the 12-week adverse-event narrative? Verification status: Partly verified Reading scope: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread - Current findings: The original states that no adverse events were reported in the 12-week trial and explicitly says the small 64-person trial cannot exclude rare or long-term harms. This is not expanded into zero harms of every kind or long-term safety. - Why unverified: Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification. - Reason for missing information: AE collection, arm-specific exposure/observation, harm denominators, discontinuation/relatedness and rare/long-term data are needed. No new harm rates or extract/product/sleep-management instructions. - Required materials and conditions: Small-trial reporting versus rare/long-term harms - Materials to obtain first: AE collection, arm-specific exposure/observation, harm denominators, discontinuation/relatedness and rare/long-term data are needed. No new harm rates or extract/product/sleep-management instructions. - Further research: Materials needed: AE collection, arm-specific exposure/observation, harm denominators, discontinuation/relatedness and rare/long-term data are needed. No new harm rates or extract/product/sleep-management instructions. Only information requests/research needs are recorded; no new lookup or research is performed in this production. - Conditions for verification: Show original information about Small-trial reporting versus rare/long-term harms, the selected subclaim/parent boundary, direct endpoints/estimands, denominators and scope of external reading together. - Why this condition is needed: Needed to connect Small-trial reporting versus rare/long-term harms with the selected question, actual population/intervention/comparator, endpoints/hierarchy/estimands, denominators/duration, reports and harms. - Application exceptions: Distinguish the specific rising-sleepiness factor, overall/objective sleep, other scales/temperature, primary/secondary/subgroup outcomes, multiplicity, exact effects/CIs, populations/intervention/placebo, 12-week/FAS1 denominators, company involvement and harms. Only original numbers are preserved; no new calculations, hypothetical quantities, effects/CIs, grades/regrading, independence certification or extract/product/drink-intake, sleep/cold-management, infection-prevention or treatment-substitution instructions. - Remaining uncertainty: External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification. - Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production - Related sources: R01 ### N18 · What materials were actually read in this work? Verification status: Partly verified Reading scope: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread - Current findings: The complete parent JSON was read for production and preserved in its original form. Summary reading concerns the preserved summary; external abstracts, full texts, registration and protocol/SAP remain unread in this work. URL/bibliography presence is not upgraded into external reading. - Why unverified: Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification. - Reason for missing information: Materials for users to record actual external acquisition/reading scope, versions and timing. No current link/click/access tests. - Required materials and conditions: Preserved JSON summary and external-reading status - Materials to obtain first: Materials for users to record actual external acquisition/reading scope, versions and timing. No current link/click/access tests. - Further research: Materials needed: Materials for users to record actual external acquisition/reading scope, versions and timing. No current link/click/access tests. Only material requests/research needs are recorded; no current lookup or research execution. - Conditions for verification: Show originals for preserved JSON summary and external-reading status with selected-subclaim/parent boundaries, direct endpoints/estimand, denominators and external-reading scope. - Why this condition is needed: Needed to connect preserved JSON summary and external-reading status with the selected question, actual population/intervention/comparator, endpoints/hierarchy/estimand, denominators/duration and reports/harms. - Application exceptions: Distinguish the specific rising-sleepiness factor, overall/objective sleep, other scales/temperature, primary/secondary/subgroup outcomes, multiplicity, exact effects/CIs, populations/intervention/placebo, 12-week/FAS1 denominators, company involvement and harms. Only original numbers are preserved; no new calculations, hypothetical quantities, effects/CIs, grades/regrading, independence certification or extract/product/drink-intake, sleep/cold-management, infection-prevention or treatment-substitution instructions. - Remaining uncertainty: External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification. - Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production - Related sources: R01 ### N19 · Are registration, public dates, plans and current reading distinct? Verification status: Partly verified Reading scope: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread - Current findings: The original evidence/Korean text supplies UMIN000051261; the citation has no registry identifier/official registry URL. Actual registration/start dates, versions, prospective status and plan comparisons are unverified in this production. Official URLs are not guessed. - Why unverified: Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification. - Reason for missing information: Original registration texts/versions, public/start/change dates, endpoint/analysis and report-linkage materials. Only historical narratives are preserved; no current prespecification/access certification. - Required materials and conditions: Original registration information and detailed plans/access - Materials to obtain first: Original registration texts/versions, public/start/change dates, endpoint/analysis and report-linkage materials. Only historical narratives are preserved; no current prespecification/access certification. - Further research: Materials needed: Original registration texts/versions, public/start/change dates, endpoint/analysis and report-linkage materials. Only historical narratives are preserved; no current prespecification/access certification. Only material requests/research needs are recorded; no current lookup or research execution. - Conditions for verification: Show originals for original registration information and detailed plans/access with selected-subclaim/parent boundaries, direct endpoints/estimand, denominators and external-reading scope. - Why this condition is needed: Needed to connect original registration information and detailed plans/access with the selected question, actual population/intervention/comparator, endpoints/hierarchy/estimand, denominators/duration and reports/harms. - Application exceptions: Distinguish the specific rising-sleepiness factor, overall/objective sleep, other scales/temperature, primary/secondary/subgroup outcomes, multiplicity, exact effects/CIs, populations/intervention/placebo, 12-week/FAS1 denominators, company involvement and harms. Only original numbers are preserved; no new calculations, hypothetical quantities, effects/CIs, grades/regrading, independence certification or extract/product/drink-intake, sleep/cold-management, infection-prevention or treatment-substitution instructions. - Remaining uncertainty: External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification. - Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production - Related sources: R01 ### N20 · Were protocol/SAP and endpoint/multiplicity plans acquired? Verification status: Unverified Reading scope: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread - Current findings: The original registration identifier, historical cross-checking and primary/secondary narratives are preserved. Individual protocol/SAP originals, versions/dates, complete endpoints/analyses/multiplicity and plan changes were not read in this work. - Why unverified: Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification. - Reason for missing information: Protocol, SAP, revision history, complete endpoints/estimands/missingness, multiple comparisons, public dates and paper-comparison materials. Unread external materials are not assumed to mean absent documents. - Required materials and conditions: Advance plan, change and analysis materials - Materials to obtain first: Protocol, SAP, revision history, complete endpoints/estimands/missingness, multiple comparisons, public dates and paper-comparison materials. Unread external materials are not assumed to mean absent documents. - Further research: Materials needed: Protocol, SAP, revision history, complete endpoints/estimands/missingness, multiple comparisons, public dates and paper-comparison materials. Unread external materials are not assumed to mean absent documents. Only material requests/research needs are recorded; no current lookup or research execution. - Conditions for verification: Show originals for advance plan, change and analysis materials with selected-subclaim/parent boundaries, direct endpoints/estimand, denominators and external-reading scope. - Why this condition is needed: Needed to connect advance plan, change and analysis materials with the selected question, actual population/intervention/comparator, endpoints/hierarchy/estimand, denominators/duration and reports/harms. - Application exceptions: Distinguish the specific rising-sleepiness factor, overall/objective sleep, other scales/temperature, primary/secondary/subgroup outcomes, multiplicity, exact effects/CIs, populations/intervention/placebo, 12-week/FAS1 denominators, company involvement and harms. Only original numbers are preserved; no new calculations, hypothetical quantities, effects/CIs, grades/regrading, independence certification or extract/product/drink-intake, sleep/cold-management, infection-prevention or treatment-substitution instructions. - Remaining uncertainty: External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification. - Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production - Related sources: R01 ### N21 · Are company funding, product support, employee authors and research roles separate? Verification status: Partly verified Reading scope: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread - Current findings: The original distinguishes the no-specific-funding declaration, three Fujicco employee authors R.A./T.M./K.M., study-food provision to the contract site and employee involvement in conceptualization, methods, analysis, data management and drafting. No specific cash funding does not mean no COI or company involvement. - Why unverified: Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification. - Reason for missing information: Separate originals for company cash funding, product/food manufacturing support, author employment/contractor relationships, design/analysis/data control and other support/COI. The original independence axis is not used as new certification. - Required materials and conditions: Four categories of company involvement and other support - Materials to obtain first: Separate originals for company cash funding, product/food manufacturing support, author employment/contractor relationships, design/analysis/data control and other support/COI. The original independence axis is not used as new certification. - Further research: Materials needed: Separate originals for company cash funding, product/food manufacturing support, author employment/contractor relationships, design/analysis/data control and other support/COI. The original independence axis is not used as new certification. Only material requests/research needs are recorded; no current lookup or research execution. - Conditions for verification: Show originals for four categories of company involvement and other support with selected-subclaim/parent boundaries, direct endpoints/estimand, denominators and external-reading scope. - Why this condition is needed: Needed to connect four categories of company involvement and other support with the selected question, actual population/intervention/comparator, endpoints/hierarchy/estimand, denominators/duration and reports/harms. - Application exceptions: Distinguish the specific rising-sleepiness factor, overall/objective sleep, other scales/temperature, primary/secondary/subgroup outcomes, multiplicity, exact effects/CIs, populations/intervention/placebo, 12-week/FAS1 denominators, company involvement and harms. Only original numbers are preserved; no new calculations, hypothetical quantities, effects/CIs, grades/regrading, independence certification or extract/product/drink-intake, sleep/cold-management, infection-prevention or treatment-substitution instructions. - Remaining uncertainty: External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification. - Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production - Related sources: R01 ### N22 · Are narrow positive results, broad-claim gaps and unverified materials distinct? Verification status: Partly verified Reading scope: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread - Current findings: The positive full-FAS1 primary rising-sleepiness P<.05 is distinguished from the unverified overall-sleep claim and absent exact effects/CIs in the main text. - Why unverified: Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification. - Reason for missing information: Materials verifying question-specific actual measurements/definitions, original tables/denominators, plans and actual access scope. Unread is not substituted for unreported, zero studies or zero effect. - Required materials and conditions: Direct endpoints and access/reporting limitations - Materials to obtain first: Materials verifying question-specific actual measurements/definitions, original tables/denominators, plans and actual access scope. Unread is not substituted for unreported, zero studies or zero effect. - Further research: Materials needed: Materials verifying question-specific actual measurements/definitions, original tables/denominators, plans and actual access scope. Unread is not substituted for unreported, zero studies or zero effect. Only material requests/research needs are recorded; no current lookup or research execution. - Conditions for verification: Show originals for direct endpoints and access/reporting limitations with selected-subclaim/parent boundaries, direct endpoints/estimand, denominators and external-reading scope. - Why this condition is needed: Needed to connect direct endpoints and access/reporting limitations with the selected question, actual population/intervention/comparator, endpoints/hierarchy/estimand, denominators/duration and reports/harms. - Application exceptions: Distinguish the specific rising-sleepiness factor, overall/objective sleep, other scales/temperature, primary/secondary/subgroup outcomes, multiplicity, exact effects/CIs, populations/intervention/placebo, 12-week/FAS1 denominators, company involvement and harms. Only original numbers are preserved; no new calculations, hypothetical quantities, effects/CIs, grades/regrading, independence certification or extract/product/drink-intake, sleep/cold-management, infection-prevention or treatment-substitution instructions. - Remaining uncertainty: External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification. - Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production - Related sources: R01 ### N23 · Are reports, trials, people, repeated measures and sibling sheets distinct? Verification status: Partly verified Reading scope: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread - Current findings: Parent 2978 and the existing sibling sheets share the same Akagi 2025 report and 64-person/12-week trial context. The same people, arms, times, factors, subgroups, citation and sibling sheets are not added as new independent trials/participants. One current report link does not certify unique trial/participant counts. - Why unverified: Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification. - Reason for missing information: Original registration/report, actual cohort/analysis, endpoint/time-point and repeated-measure relationships. Unique trial counts and unique participant totals remain unrecorded. - Required materials and conditions: Document linkage versus unique trials/participants - Materials to obtain first: Original registration/report, actual cohort/analysis, endpoint/time-point and repeated-measure relationships. Unique trial counts and unique participant totals remain unrecorded. - Further research: Materials needed: Original registration/report, actual cohort/analysis, endpoint/time-point and repeated-measure relationships. Unique trial counts and unique participant totals remain unrecorded. Only material requests/research needs are recorded; no current lookup or research execution. - Conditions for verification: Show originals for document linkage versus unique trials/participants with selected-subclaim/parent boundaries, direct endpoints/estimand, denominators and external-reading scope. - Why this condition is needed: Needed to connect document linkage versus unique trials/participants with the selected question, actual population/intervention/comparator, endpoints/hierarchy/estimand, denominators/duration and reports/harms. - Application exceptions: Distinguish the specific rising-sleepiness factor, overall/objective sleep, other scales/temperature, primary/secondary/subgroup outcomes, multiplicity, exact effects/CIs, populations/intervention/placebo, 12-week/FAS1 denominators, company involvement and harms. Only original numbers are preserved; no new calculations, hypothetical quantities, effects/CIs, grades/regrading, independence certification or extract/product/drink-intake, sleep/cold-management, infection-prevention or treatment-substitution instructions. - Remaining uncertainty: External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification. - Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production - Related sources: R01 ### N24 · Is there evidence of separate independent confirmation? Verification status: Unverified Reading scope: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread - Current findings: Parent replication R1 and independence I0 are preserved. The same report, subgroup, scale, repeated days or sibling sheets are not certified as new independent efficacy/harm replications. - Why unverified: Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification. - Reason for missing information: Confirmatory materials showing selected-question advance plans, separate populations/comparators, direct endpoints/denominators, effects/CIs, duration/funding and author relationships. No current search or independence judgment. - Required materials and conditions: Original R1/I0 versus independent replication - Materials to obtain first: Confirmatory materials showing selected-question advance plans, separate populations/comparators, direct endpoints/denominators, effects/CIs, duration/funding and author relationships. No current search or independence judgment. - Further research: Materials needed: Confirmatory materials showing selected-question advance plans, separate populations/comparators, direct endpoints/denominators, effects/CIs, duration/funding and author relationships. No current search or independence judgment. Only material requests/research needs are recorded; no current lookup or research execution. - Conditions for verification: Show originals for original R1/I0 versus independent replication with selected-subclaim/parent boundaries, direct endpoints/estimand, denominators and external-reading scope. - Why this condition is needed: Needed to connect original R1/I0 versus independent replication with the selected question, actual population/intervention/comparator, endpoints/hierarchy/estimand, denominators/duration and reports/harms. - Application exceptions: Distinguish the specific rising-sleepiness factor, overall/objective sleep, other scales/temperature, primary/secondary/subgroup outcomes, multiplicity, exact effects/CIs, populations/intervention/placebo, 12-week/FAS1 denominators, company involvement and harms. Only original numbers are preserved; no new calculations, hypothetical quantities, effects/CIs, grades/regrading, independence certification or extract/product/drink-intake, sleep/cold-management, infection-prevention or treatment-substitution instructions. - Remaining uncertainty: External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification. - Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production - Related sources: R01 ### N25 · Are selected-subclaim and parent scores/axes preserved? Verification status: Partly verified Reading scope: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread - Current findings: Selected grade/note and Korean/English claim wording are preserved, with absent subclaim score/status/axes left unrecorded. Parent C50, good safety and B/P/R1/I0/E+, bias axis and unrecorded precision are parent context, not a score for the selected row. - Why unverified: Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification. - Reason for missing information: User subclaim/parent-boundary review and actual correction materials. No new score/grade or official RoB 2/GRADE certification. - Required materials and conditions: Subclaim grade/note, absent fields and parent context - Materials to obtain first: User subclaim/parent-boundary review and actual correction materials. No new score/grade or official RoB 2/GRADE certification. - Further research: Materials needed: User subclaim/parent-boundary review and actual correction materials. No new score/grade or official RoB 2/GRADE certification. Only material-request/research needs are recorded; no search/research was performed in this production. - Conditions for verification: Show originals for subclaim grade/note, absent fields and parent context with selected-subclaim/parent boundaries, direct endpoints/estimand, denominators and external-reading scope. - Why this condition is needed: Needed to connect subclaim grade/note, absent fields and parent context with the selected question, actual population/intervention/comparator, endpoints/hierarchy/estimand, denominators/duration and reports/harms. - Application exceptions: Distinguish the specific rising-sleepiness factor, overall/objective sleep, other scales/temperature, primary/secondary/subgroup outcomes, multiplicity, exact effects/CIs, populations/intervention/placebo, 12-week/FAS1 denominators, company involvement and harms. Only original numbers are preserved; no new calculations, hypothetical quantities, effects/CIs, grades/regrading, independence certification or extract/product/drink-intake, sleep/cold-management, infection-prevention or treatment-substitution instructions. - Remaining uncertainty: External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification. - Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production - Related sources: R01 ### N26 · Are Korean/English wording and absent structured fields preserved? Verification status: Partly verified Reading scope: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread - Current findings: Parent Korean/English text, evidence/citation lists, axes and original selected-subclaim wording are preserved in the complete summary. Korean/English classification fields are absent; no new fields are filled in the original materials. External English papers were not compared. - Why unverified: Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification. - Reason for missing information: Materials for content review of bilingual terms, endpoints/durations, absent fields and selected scope. Production explanations remain distinct from original wording. - Required materials and conditions: Wording in both languages and absent classification fields - Materials to obtain first: Materials for content review of bilingual terms, endpoints/durations, absent fields and selected scope. Production explanations remain distinct from original wording. - Further research: Materials needed: Materials for content review of bilingual terms, endpoints/durations, absent fields and selected scope. Production explanations remain distinct from original wording. Only material requests/research needs are recorded; no current lookup or research execution. - Conditions for verification: Show originals for wording in both languages and absent classification fields with selected-subclaim/parent boundaries, direct endpoints/estimand, denominators and external-reading scope. - Why this condition is needed: Needed to connect wording in both languages and absent classification fields with the selected question, actual population/intervention/comparator, endpoints/hierarchy/estimand, denominators/duration and reports/harms. - Application exceptions: Distinguish the specific rising-sleepiness factor, overall/objective sleep, other scales/temperature, primary/secondary/subgroup outcomes, multiplicity, exact effects/CIs, populations/intervention/placebo, 12-week/FAS1 denominators, company involvement and harms. Only original numbers are preserved; no new calculations, hypothetical quantities, effects/CIs, grades/regrading, independence certification or extract/product/drink-intake, sleep/cold-management, infection-prevention or treatment-substitution instructions. - Remaining uncertainty: External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification. - Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production - Related sources: R01 ### N27 · Are reference dates, corrections, historical cross-checking and production dates distinct? Verification status: Partly verified Reading scope: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread - Current findings: Original reference date 2026-08-26, empty corrections/deliberation and grade-decision cross-check narratives are preserved. This history is not current condition freezing/application, production date or completed content review. - Why unverified: Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification. - Reason for missing information: When new materials/corrections arise, materials for separate updates to originals, events, conditions/observations and verdict decisions. Historical narratives are not used as new clinical review. - Required materials and conditions: Original 2026-08-26 versus production/application events - Materials to obtain first: When new materials/corrections arise, materials for separate updates to originals, events, conditions/observations and verdict decisions. Historical narratives are not used as new clinical review. - Further research: Materials needed: When new materials/corrections arise, materials for separate updates to originals, events, conditions/observations and verdict decisions. Historical narratives are not used as new clinical review. Only material requests/research needs are recorded; no current lookup or research execution. - Conditions for verification: Show originals for original 2026-08-26 versus production/application events with selected-subclaim/parent boundaries, direct endpoints/estimand, denominators and external-reading scope. - Why this condition is needed: Needed to connect original 2026-08-26 versus production/application events with the selected question, actual population/intervention/comparator, endpoints/hierarchy/estimand, denominators/duration and reports/harms. - Application exceptions: Distinguish the specific rising-sleepiness factor, overall/objective sleep, other scales/temperature, primary/secondary/subgroup outcomes, multiplicity, exact effects/CIs, populations/intervention/placebo, 12-week/FAS1 denominators, company involvement and harms. Only original numbers are preserved; no new calculations, hypothetical quantities, effects/CIs, grades/regrading, independence certification or extract/product/drink-intake, sleep/cold-management, infection-prevention or treatment-substitution instructions. - Remaining uncertainty: External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification. - Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production - Related sources: R01 ### N28 · What direct materials could fill the selected gaps? Verification status: Unverified Reading scope: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread - Current findings: Confirming the overall-sleep claim requires information directly defining its overall/objective endpoints; the rising-sleepiness factor, temperature or subgroups do not substitute for this. - Why unverified: Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification. - Reason for missing information: Question-matched advance direct comparisons, overall/symptom-specific denominators, estimands/CIs, measurement/missingness, multiplicity and separate confirmation/long-term harms. Only need is recorded; no current lookup or clinical study. - Required materials and conditions: Definitions, direct endpoints, denominators/effects/CIs and plans - Materials to obtain first: Question-matched advance direct comparisons, overall/symptom-specific denominators, estimands/CIs, measurement/missingness, multiplicity and separate confirmation/long-term harms. Only need is recorded; no current lookup or clinical study. - Further research: Materials needed: Question-matched advance direct comparisons, overall/symptom-specific denominators, estimands/CIs, measurement/missingness, multiplicity and separate confirmation/long-term harms. Only need is recorded; no current lookup or clinical study. Only material requests/research needs are recorded; no current lookup or research execution. - Conditions for verification: Show originals for definitions, direct endpoints, denominators/effects/CIs and plans with selected-subclaim/parent boundaries, direct endpoints/estimand, denominators and external-reading scope. - Why this condition is needed: Needed to connect definitions, direct endpoints, denominators/effects/CIs and plans with the selected question, actual population/intervention/comparator, endpoints/hierarchy/estimand, denominators/duration and reports/harms. - Application exceptions: Distinguish the specific rising-sleepiness factor, overall/objective sleep, other scales/temperature, primary/secondary/subgroup outcomes, multiplicity, exact effects/CIs, populations/intervention/placebo, 12-week/FAS1 denominators, company involvement and harms. Only original numbers are preserved; no new calculations, hypothetical quantities, effects/CIs, grades/regrading, independence certification or extract/product/drink-intake, sleep/cold-management, infection-prevention or treatment-substitution instructions. - Remaining uncertainty: External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification. - Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production - Related sources: R01 ### N29 · Are production, user review and implementation instructions distinct? Verification status: Partly verified Reading scope: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread - Current findings: This is table-content production from the preserved summary. Existing content and question-boundary review remain incomplete, and candidate pending/eligibility flags are preserved as history. Existing review status is recorded as it stands. - Why unverified: Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification. - Reason for missing information: Existing content review and later actual-material/correction work. The historical production record did not perform clinical-original comparison, external access, new calculations, grade changes or product/drink-consumption, sleep/cold-management, infection-prevention or treatment-replacement instructions. - Required materials and conditions: Production request, candidate history and content-review responsibility - Materials to obtain first: Existing content review and later actual-material/correction work. The historical production record did not perform clinical-original comparison, external access, new calculations, grade changes or product/drink-consumption, sleep/cold-management, infection-prevention or treatment-replacement instructions. - Further research: Materials needed: Existing content review and later actual-material/correction work. The historical production record did not perform clinical-original comparison, external access, new calculations, grade changes or product/drink-consumption, sleep/cold-management, infection-prevention or treatment-replacement instructions. Only material requests/research needs are recorded; no current lookup or research execution. - Conditions for verification: Show originals for production request, candidate history and content-review responsibility with selected-subclaim/parent boundaries, direct endpoints/estimand, denominators and external-reading scope. - Why this condition is needed: Needed to connect production request, candidate history and content-review responsibility with the selected question, actual population/intervention/comparator, endpoints/hierarchy/estimand, denominators/duration and reports/harms. - Application exceptions: Distinguish the specific rising-sleepiness factor, overall/objective sleep, other scales/temperature, primary/secondary/subgroup outcomes, multiplicity, exact effects/CIs, populations/intervention/placebo, 12-week/FAS1 denominators, company involvement and harms. Only original numbers are preserved; no new calculations, hypothetical quantities, effects/CIs, grades/regrading, independence certification or extract/product/drink-intake, sleep/cold-management, infection-prevention or treatment-substitution instructions. - Remaining uncertainty: External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification. - Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production - Related sources: R01 ## Evidence and sources ### R01 Akagi R, et al. Effects of Consumption of Black Soybean Seed Coat Extract on Sleep Quality in Healthy Japanese. Food Sci Nutr. 2025;13:e70156. PMID: 40501501. [PubMed](https://pubmed.ncbi.nlm.nih.gov/40501501/) Materials actually read: Preserved summary read; external abstracts/full texts/registrations/plans remain unread Findings recorded in the summary: Improved versus placebo in full FAS1, P<0.05; exact group values and 95% CI not provided in the text Record level: Original evidence-list summary of the parent endpoint; boundaries between the selected direct question and other scales/symptoms/infection outcomes are distinguished in condition rows and roles Independent replication: Parent 2978 and the existing sibling sheets share the same Akagi 2025 report and 64-person/12-week trial context. The same people, arms, times, factors, subgroups, citation and sibling sheets are not added as new independent trials/participants. Citation/registry links are provisional, without certification of unique trials/participants or independence. | Material | Public availability | Access status | Actually read | Notes | |---|---|---|---|---| | Stored summary | Local preserved copy of the complete parent summary | Stored summary read | Summary read | Only original PubMed URLs/registration identifiers are preserved; no new certification of external reading, access, prespecification or condition fulfillment. No full-text/registration/plan URLs are guessed. | | External abstract | Original identifier/bibliography or required-material entry; public availability/access details remain unverified | Unread; access testing not performed | Not read | Only original PubMed URLs/registration identifiers are preserved; no new certification of external reading, access, prespecification or condition fulfillment. No full-text/registration/plan URLs are guessed. | | External full text | Original identifier/bibliography or required-material entry; public availability/access details remain unverified | Unread; access testing not performed | Not read | Only original PubMed URLs/registration identifiers are preserved; no new certification of external reading, access, prespecification or condition fulfillment. No full-text/registration/plan URLs are guessed. | | Original registration | Original identifier/bibliography or required-material entry; public availability/access details remain unverified | Unread; access testing not performed | Not read | Only original PubMed URLs/registration identifiers are preserved; no new certification of external reading, access, prespecification or condition fulfillment. No full-text/registration/plan URLs are guessed. | | Protocol/SAP | Original identifier/bibliography or required-material entry; public availability/access details remain unverified | Unread; access testing not performed | Not read | Only original PubMed URLs/registration identifiers are preserved; no new certification of external reading, access, prespecification or condition fulfillment. No full-text/registration/plan URLs are guessed. | ## Review criteria and methods These are Chamgap's own application conditions, informed by the relevant sections of official methodological guidance. They do not constitute official assessment-tool certification or a new efficacy score. - M03 [Cochrane Handbook 6.5 (2024), chapter updated 2023-08](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03) · §3.1, §3.2.1–3.2.3, MECIR C5/C7/C13 · Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions. · Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed. - M04 [Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04) · §4.5, §4.6.1–4.6.3, MECIR C42 · Distinguish studies from reports and link them; do not omit a study solely because results are unreported. · Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed. - M08 [Cochrane Handbook 6.5 (2024), chapter updated 2019-10](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08) · §8.1–8.2.3, Table 8.2.a · Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting. · Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed. - M15 [Cochrane Handbook 6.5 (2024), chapter updated 2023-08](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15) · §15.2.4, §15.3.1–15.3.3 · Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision. · Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed. - M19 [Cochrane Handbook 6.5 (2024), chapter updated 2019-10](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19) · §19.1.2, §19.2.1–19.2.4 · Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates. · Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed. ## What the statuses mean - Partly verified: Some information exists in the preserved review summary; detailed original materials remain unverified. This does not certify a passed review or clinical efficacy. - Unverified: Detailed materials for the selected condition could not be established within the stored scope; this does not mean zero effect, zero studies or safety - Review incomplete: Review of existing content incomplete - Met: Use only within the relevant conditions after existing content review; no automatic designation in this preparation - Not reported: Distinguish only within materials actually read; do not turn unread external materials into unreported findings - Inaccessible: Not applied during this preparation because actual access was not tested - Not applicable: Use with a reason for non-applicability based on an explicit question boundary - Conflicting data: Judge after actual material comparison; review was not performed during this preparation - Insufficient evidence for the conditions: Do not use as a clinical grade encompassing currently unread materials ## Change history 2026-10-14 · Public page/materials 1.0. Public pages and materials were created from the existing 29 items. No new clinical search, verification-status change or scoring was performed.