Black soybean seed-coat extract × Overall sleep quality — Rising-sleepiness factor and gaps in the broader claim

Required evidence, verification status and materials actually read
Item	AVerification status	BReading scope	CReview item	DCurrent findings	EWhy unverified	FRequired materials and conditions	GFurther research
1	Partly verified	Full text not readStored summary read	N01 · Evidence conditionWhich existing overall-sleep claim is being carried over?Required	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. R01	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.	Selected subclaim wording/grade and the narrower parent result	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.
2	Partly verified	Full text not readStored summary read	N02 · Evidence conditionWhat sleep condition characterized the participants?Required	Participants were 64 healthy Japanese adults dissatisfied with sleep quality. Applicability is not newly extended to diagnosed insomnia/sleep disorders or all ages/regions. R01	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.	Healthy adults dissatisfied with sleep quality	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.
3	Partly verified	Full text not readStored summary read	N03 · Evidence conditionWhat extract exposure was studied?Required	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. R01	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.	100 mg black soybean seed-coat extract versus ordinary foods	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.
4	Partly verified	Full text not readStored summary read	N04 · Evidence conditionWhat were the actual placebo and conditions in both arms?Required	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. R01	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.	32/32 allocation and placebo comparison	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.
5	Partly verified	Full text not readStored summary read	N05 · Evidence conditionAre 12-week results distinguished from sustained overall sleep?Required	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. R01	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.	Original duration, actual exposure and post-study follow-up	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.
6	Partly verified	Full text not readStored summary read	N06 · Evidence conditionDoes a 64-person FAS1 mean everyone completed follow-up?Required	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. R01	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.	Randomized, FAS1, completer and endpoint-specific denominators	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.
7	Partly verified	Full text not readStored summary read	N07 · Evidence conditionWhat does the primary rising-sleepiness factor measure?Required	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. R01	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.	12-week change in OSA-MA sleepiness on rising	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.
8	Unverified	Full text not readStored summary read	N08 · Evidence conditionDoes a specific rising-sleepiness result establish overall sleep?Required	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. R01	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.	Scope of the broader claim and direct outcomes	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.
9	Partly verified	Full text not readStored summary read	N09 · Evidence conditionWhich analysis produced P<.05?Required	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. R01	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.	Full-FAS1 primary result versus overall sleep	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.
10	Unverified	Full text not readStored summary read	N10 · Evidence conditionAre figure estimates distinguished from values absent in the text?Required	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. R01	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.	Estimated marginal means ± SE versus exact values/CIs	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.
11	Partly verified	Full text not readStored summary read	N11 · Evidence conditionAre change, absolute values and within/between-group contrasts separated?Required	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. R01	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.	Estimand for 12-week change	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.
12	Unverified	Full text not readStored summary read	N12 · Evidence conditionWhat is the hierarchy of other sleep and temperature outcomes?Required	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. R01	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.	Primary factor versus secondary sleep/temperature endpoints	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.
13	Partly verified	Full text not readStored summary read	N13 · Evidence conditionAre male/other subgroup findings distinguished from full-population results?Required	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. R01	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.	Full FAS1 versus subgroup analyses	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.
14	Unverified	Full text not readStored summary read	N14 · Evidence conditionWere multiplicity and registry plans verified in detail?Required	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. R01	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.	Testing conditions for primary/secondary/subgroup analyses	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.
15	Unverified	Full text not readStored summary read	N15 · Evidence conditionAre self-report results being transferred to objective sleep?Required	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. R01	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.	Subjective scales versus objective sleep	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.
16	Partly verified	Full text not readStored summary read	N16 · Evidence conditionAre constituent/temperature explanations direct sleep evidence?Supplementary	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. R01	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.	Constituent identity and mechanisms versus overall-sleep effects	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.
17	Partly verified	Full text not readStored summary read	N17 · Harm-information gaps supplementing the efficacy tableWhat is the scope of the 12-week adverse-event narrative?Supplementary	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. R01	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.	Small-trial reporting versus rare/long-term harms	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.
18	Partly verified	Full text not readStored summary read	N18 · Evidence conditionWhat materials were actually read in this work?Required	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. R01	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.	Preserved JSON summary and external-reading status	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.
19	Partly verified	Full text not readStored summary read	N19 · Evidence conditionAre registration, public dates, plans and current reading distinct?Required	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. R01	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.	Original registration information and detailed plans/access	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.
20	Unverified	Full text not readStored summary read	N20 · Evidence conditionWere protocol/SAP and endpoint/multiplicity plans acquired?Required	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. R01	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.	Advance plan, change and analysis materials	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.
21	Partly verified	Full text not readStored summary read	N21 · Evidence conditionAre company funding, product support, employee authors and research roles separate?Required	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. R01	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.	Four categories of company involvement and other support	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.
22	Partly verified	Full text not readStored summary read	N22 · Evidence conditionAre narrow positive results, broad-claim gaps and unverified materials distinct?Required	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. R01	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.	Direct endpoints and access/reporting limitations	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.
23	Partly verified	Full text not readStored summary read	N23 · Evidence conditionAre reports, trials, people, repeated measures and sibling sheets distinct?Required	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. R01	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.	Document linkage versus unique trials/participants	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.
24	Unverified	Full text not readStored summary read	N24 · Evidence conditionIs there evidence of separate independent confirmation?Supplementary	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. R01	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.	Original R1/I0 versus independent replication	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.
25	Partly verified	Full text not readStored summary read	N25 · Evidence conditionAre selected-subclaim and parent scores/axes preserved?Required	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. R01	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.	Subclaim grade/note, absent fields and parent context	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.
26	Partly verified	Full text not readStored summary read	N26 · Evidence conditionAre Korean/English wording and absent structured fields preserved?Required	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. R01	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.	Wording in both languages and absent classification fields	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.
27	Partly verified	Full text not readStored summary read	N27 · Evidence conditionAre reference dates, corrections, historical cross-checking and production dates distinct?Required	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. R01	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.	Original 2026-08-26 versus production/application events	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.
28	Unverified	Full text not readStored summary read	N28 · Evidence conditionWhat direct materials could fill the selected gaps?Supplementary	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. R01	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.	Definitions, direct endpoints, denominators/effects/CIs and plans	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.
29	Partly verified	Full text not readStored summary read	N29 · Evidence conditionAre production, user review and implementation instructions distinct?Supplementary	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. R01	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.	Production request, candidate history and content-review responsibility	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.

No items match your search or filter.

29 itemsWhat the statuses mean

Assessment scope

Stored-material review date: Not recorded
Original evidence cut-off: 2026-08-26
Scope actually checked: Existing review summaries and stored records of methodological application. Full papers, supplements, registrations, plans and original data were not read.
What the dates mean: This is the date the stored materials were checked, not the date of a new search of the clinical literature.
Population: 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

Evidence and sources

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

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

Material type: Double-blind randomized placebo-controlled parallel trial
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/plans remain unread
Findings recorded in the stored 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
Study overlap and 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.

Public availability, access and reading status by material
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.

Report counts versus independent study counts

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.

Review criteria

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

N01 · Which existing overall-sleep claim is being carried over?

Required materials and conditions: Selected subclaim wording/grade and the narrower parent result
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.
Requirement and applicability: Required
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.
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.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

N02 · What sleep condition characterized the participants?

Required materials and conditions: Healthy adults dissatisfied with sleep quality
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.
Requirement and applicability: Required
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.
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.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

N03 · What extract exposure was studied?

Required materials and conditions: 100 mg black soybean seed-coat extract versus ordinary foods
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.
Requirement and applicability: Required
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.
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.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

N04 · What were the actual placebo and conditions in both arms?

Required materials and conditions: 32/32 allocation and placebo comparison
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.
Requirement and applicability: Required
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.
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.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

N05 · Are 12-week results distinguished from sustained overall sleep?

Required materials and conditions: Original duration, actual exposure and post-study follow-up
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.
Requirement and applicability: Required
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.
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.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

N06 · Does a 64-person FAS1 mean everyone completed follow-up?

Required materials and conditions: Randomized, FAS1, completer and endpoint-specific denominators
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.
Requirement and applicability: Required
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.
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.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

N07 · What does the primary rising-sleepiness factor measure?

Required materials and conditions: 12-week change in OSA-MA sleepiness on rising
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.
Requirement and applicability: Required
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.
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.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

N08 · Does a specific rising-sleepiness result establish overall sleep?

Required materials and conditions: Scope of the broader claim and direct outcomes
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.
Requirement and applicability: Required
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.
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.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

N09 · Which analysis produced P<.05?

Required materials and conditions: Full-FAS1 primary result versus overall sleep
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.
Requirement and applicability: Required
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.
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.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

N10 · Are figure estimates distinguished from values absent in the text?

Required materials and conditions: Estimated marginal means ± SE versus exact values/CIs
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.
Requirement and applicability: Required
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.
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.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

N11 · Are change, absolute values and within/between-group contrasts separated?

Required materials and conditions: Estimand for 12-week change
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.
Requirement and applicability: Required
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.
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.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

N12 · What is the hierarchy of other sleep and temperature outcomes?

Required materials and conditions: Primary factor versus secondary sleep/temperature endpoints
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.
Requirement and applicability: Required
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.
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.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

N13 · Are male/other subgroup findings distinguished from full-population results?

Required materials and conditions: Full FAS1 versus subgroup analyses
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.
Requirement and applicability: Required
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.
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.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

N14 · Were multiplicity and registry plans verified in detail?

Required materials and conditions: Testing conditions for primary/secondary/subgroup analyses
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.
Requirement and applicability: Required
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.
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.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

N15 · Are self-report results being transferred to objective sleep?

Required materials and conditions: Subjective scales versus objective sleep
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.
Requirement and applicability: Required
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.
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.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

N16 · Are constituent/temperature explanations direct sleep evidence?

Required materials and conditions: Constituent identity and mechanisms versus overall-sleep effects
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.
Requirement and applicability: Supplementary
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.
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.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

N17 · What is the scope of the 12-week adverse-event narrative?

Required materials and conditions: Small-trial reporting versus rare/long-term harms
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.
Requirement and applicability: Supplementary
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.
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.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

N18 · What materials were actually read in this work?

Required materials and conditions: Preserved JSON summary and external-reading status
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.
Requirement and applicability: Required
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.
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.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

N19 · Are registration, public dates, plans and current reading distinct?

Required materials and conditions: Original registration information and detailed plans/access
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.
Requirement and applicability: Required
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.
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.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

N20 · Were protocol/SAP and endpoint/multiplicity plans acquired?

Required materials and conditions: Advance plan, change and analysis materials
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.
Requirement and applicability: Required
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.
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.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

N21 · Are company funding, product support, employee authors and research roles separate?

Required materials and conditions: Four categories of company involvement and other support
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.
Requirement and applicability: Required
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.
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.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

N22 · Are narrow positive results, broad-claim gaps and unverified materials distinct?

Required materials and conditions: Direct endpoints and access/reporting limitations
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.
Requirement and applicability: Required
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.
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.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

N23 · Are reports, trials, people, repeated measures and sibling sheets distinct?

Required materials and conditions: Document linkage versus unique trials/participants
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.
Requirement and applicability: Required
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.
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.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

N24 · Is there evidence of separate independent confirmation?

Required materials and conditions: Original R1/I0 versus independent replication
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.
Requirement and applicability: Supplementary
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.
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.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

N25 · Are selected-subclaim and parent scores/axes preserved?

Required materials and conditions: Subclaim grade/note, absent fields and parent context
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.
Requirement and applicability: Required
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.
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.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

N26 · Are Korean/English wording and absent structured fields preserved?

Required materials and conditions: Wording in both languages and absent classification fields
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.
Requirement and applicability: Required
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.
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.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

N27 · Are reference dates, corrections, historical cross-checking and production dates distinct?

Required materials and conditions: Original 2026-08-26 versus production/application events
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.
Requirement and applicability: Required
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.
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.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

N28 · What direct materials could fill the selected gaps?

Required materials and conditions: Definitions, direct endpoints, denominators/effects/CIs and plans
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.
Requirement and applicability: Supplementary
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.
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.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

N29 · Are production, user review and implementation instructions distinct?

Required materials and conditions: Production request, candidate history and content-review responsibility
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.
Requirement and applicability: Supplementary
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.
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.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

Referenced methods and the sections actually reviewed

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

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

Referenced principle: Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.
Extent of review: 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

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

Referenced principle: Distinguish studies from reports and link them; do not omit a study solely because results are unreported.
Extent of review: 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

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

Referenced principle: Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.
Extent of review: 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

Official methodology · §15.2.4, §15.3.1–15.3.3

Referenced principle: Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.
Extent of review: 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

Official methodology · §19.1.2, §19.2.1–19.2.4

Referenced principle: Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.
Extent of review: 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/material version 1.0

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

The stored-material review date (Not recorded) and original evidence cut-off (2026-08-26) were retained unchanged.

Researcher downloads

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

View all item details

N01 · Which existing overall-sleep claim is being carried over?

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.
Verification status: Partly verified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
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.
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.
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.
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?

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.
Verification status: Partly verified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
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.
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.
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.
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?

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.
Verification status: Partly verified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
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.
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.
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.
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?

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.
Verification status: Partly verified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
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.
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.
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.
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?

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.
Verification status: Partly verified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
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.
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.
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.
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?

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.
Verification status: Partly verified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
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.
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.
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.
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?

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.
Verification status: Partly verified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
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.
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.
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.
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?

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.
Verification status: Unverified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
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.
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.
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.
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?

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.
Verification status: Partly verified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
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.
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.
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.
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?

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.
Verification status: Unverified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
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.
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.
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.
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?

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.
Verification status: Partly verified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
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.
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.
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.
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?

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.
Verification status: Unverified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
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.
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.
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.
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?

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.
Verification status: Partly verified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
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.
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.
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.
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?

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.
Verification status: Unverified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
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.
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.
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.
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?

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.
Verification status: Unverified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
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.
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.
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.
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?

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.
Verification status: Partly verified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
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.
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.
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.
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?

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.
Verification status: Partly verified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
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.
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.
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.
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?

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.
Verification status: Partly verified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
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.
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.
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.
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?

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.
Verification status: Partly verified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
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.
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.
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.
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?

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.
Verification status: Unverified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
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.
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.
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.
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?

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.
Verification status: Partly verified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
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.
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.
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.
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?

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.
Verification status: Partly verified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
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.
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.
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.
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?

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.
Verification status: Partly verified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
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.
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.
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.
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?

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.
Verification status: Unverified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
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.
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.
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.
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?

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.
Verification status: Partly verified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
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.
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.
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.
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?

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.
Verification status: Partly verified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
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.
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.
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.
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?

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.
Verification status: Partly verified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
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.
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.
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.
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?

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.
Verification status: Unverified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
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.
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.
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.
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?

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.
Verification status: Partly verified
Materials actually read: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
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.
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.
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.
Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

Related sources R01