Black soybean seed-coat extract × Sleepiness-on-rising score

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 conditionSelected rising-sleepiness question and original gradeRequired	The selected subclaim is improved sleepiness-on-rising score, grade C, with the note that the full FAS1 primary analysis had P<0.05. The subclaim lacks score/status/axes; parent C50 is not used to fill its score. S01	Only the relevant preserved-summary information is recorded; detailed originals remain unread and prior content review is incomplete. The subclaim score, status and axes are absent. No sleep effect broader than the original scope is created. Prior content review remains incomplete.	Selected original wording/grade versus parent score/axes	Follow-up comparative research specifying the selected scale/time point. This is a proposal; no new search, calculation or trial was performed in the recorded production.
2	Partly verified	Full text not readStored summary read	N02 · Evidence conditionHealthy Japanese adults dissatisfied with sleepRequired	Participants were 64 healthy Japanese adults dissatisfied with sleep quality. The original summary is not generalized to treatment effects in all ages or diagnosed sleep-disorder populations. S01	Only the relevant preserved-summary information is recorded; detailed originals remain unread and prior content review is incomplete. Detailed eligibility, age/sex, baseline scales, sleep-disorder diagnoses/exclusions and recruitment are unverified. Prior content review remains incomplete.	Actual eligibility/recruitment, sleep-dissatisfaction definition and population characteristics	Follow-up research with the same formulation and a specified population. This is a proposal; no new search, calculation or trial was performed in the recorded production.
3	Partly verified	Full text not readStored summary read	N03 · Evidence conditionIdentity of the study seed-coat extractRequired	The study intervention was 100 mg black soybean seed-coat polyphenol extract. Recorded major constituents include proanthocyanidins and epicatechins. These are not effects of whole black soybeans, ordinary soy foods or individual constituents. S01	Only the relevant preserved-summary information is recorded; detailed originals remain unread and prior content review is incomplete. Extraction/standardization, actual constituent content, product specifications/batches and correspondence to other formulations are unverified. Prior content review remains incomplete.	Ingredients, formulation and standardization of the black soybean seed-coat extract	Research distinguishing extract effects from attribution to constituents/other formulations. This is a proposal; no new search, calculation or trial was performed in the recorded production.
4	Partly verified	Full text not readStored summary read	N04 · Evidence conditionActual placebo comparison conditionsRequired	The original report is a double-blind randomized placebo-controlled parallel trial. The placebo label alone does not verify matching of all ingredients, sensory/contact conditions or participant expectations. S01	Only the relevant preserved-summary information is recorded; detailed originals remain unread and prior content review is incomplete. Placebo ingredients, appearance/taste, contact/instructions and blinding maintenance are unverified. Prior content review remains incomplete.	Placebo composition, sensory/contact matching and expectations	Follow-up trials disclosing comparison conditions. This is a proposal; no new search, calculation or trial was performed in the recorded production.
5	Partly verified	Full text not readStored summary read	N05 · Evidence conditionStudy exposure and 12-week durationRequired	The original records 12-week follow-up of 100 mg after-evening-meal and placebo groups. Only study exposure is preserved; it is not converted into product-intake or sleep-management instructions. S01	Only the relevant preserved-summary information is recorded; detailed originals remain unread and prior content review is incomplete. Exact daily frequency, cumulative exposure, arm-specific adherence/discontinuation, batches and actual receipt records are unverified. Prior content review remains incomplete.	Original 100 mg after-evening-meal exposure for 12 weeks and actual adherence	Research linking reported actual exposure to analysis populations. This is a proposal; no new search, calculation or trial was performed in the recorded production.
6	Partly verified	Full text not readStored summary read	N06 · Evidence conditionRandomization and 32/32 assignmentRequired	The original 64 participants assigned 32/32 and randomized-design label are preserved without upgrading them to verification of the full allocation process. S01	Only the relevant preserved-summary information is recorded; detailed originals remain unread and prior content review is incomplete. Sequence generation, concealment, implementers, baseline balance and protocol violations are unverified. Prior content review remains incomplete.	Randomization, concealment and arm-specific baseline balance	Proposed follow-up trial disclosing allocation procedures; no new investigation, calculation or trial was performed in this production.
7	Partly verified	Full text not readStored summary read	N07 · Evidence conditionBlinding and self-report expectationsRequired	The original double-blind label and self-reported sleep scale are preserved. Successful blinding, analyst roles and exclusion of expectation effects are not treated as verified. S01	Only the relevant preserved-summary information is recorded; detailed originals remain unread and prior content review is incomplete. Role-specific blinding, maintenance/unblinding, participant expectations and assessment conditions are unverified. Prior content review remains incomplete.	Participant/assessor/analyst blinding and self-report measurement conditions	Research specifying blinding and scale-measurement conditions. This is a proposal; no new search, calculation or trial was performed in the recorded production.
8	Partly verified	Full text not readStored summary read	N08 · Evidence conditionOSA-MA factor and score definitionsRequired	The selected endpoint is 12-week change in OSA-MA sleepiness-on-rising score. It is distinguished from other sleep factors, general sleep-quality improvement and clinical diagnostic treatment. S01	Only the relevant preserved-summary information is recorded; detailed originals remain unread and prior content review is incomplete. Items, score range/direction, administration timing/repetition, scoring and importance thresholds are unverified. Prior content review remains incomplete.	Rising-sleepiness factor, score direction, recall/response windows and scoring	Follow-up research specifying the selected factor's meaning and importance. This is a proposal; no new search, calculation or trial was performed in the recorded production.
9	Partly verified	Full text not readStored summary read	N09 · Evidence condition12-week change and waking assessment timeRequired	The parent claim is improved rising-sleepiness score after 12 weeks, and the original endpoint is 12-week change. It is not extended to single acute sleepiness or sleepiness throughout the day. S01	Only the relevant preserved-summary information is recorded; detailed originals remain unread and prior content review is incomplete. Exact assessment day/time after waking, within-period repetition, earlier outcomes and change-from-baseline definitions are unverified. Prior content review remains incomplete.	Selected 12-week change, waking assessment window and other time points	Research reporting results separately by time point. This is a proposal; no new search, calculation or trial was performed in the recorded production.
10	Partly verified	Full text not readStored summary read	N10 · Evidence conditionPositive full-FAS1 resultRequired	The original result is improved rising-sleepiness score versus placebo in full FAS1, P<0.05. No exact group values, new differences/CIs or response rates are created. S01	Only the relevant preserved-summary information is recorded; detailed originals remain unread and prior content review is incomplete. Exact between-group estimates, P values, CIs, individual changes and clinical importance are unverified. Prior content review remains incomplete.	Selected primary-endpoint result versus placebo in the full analysis population	Follow-up trials adequately reporting effects and uncertainty. This is a proposal; no new search, calculation or trial was performed in the recorded production.
11	Partly verified	Full text not readStored summary read	N11 · Evidence conditionFigure-based estimated marginal means and SERequired	The original records that the main paper displayed results only as estimated marginal means ± standard errors in a figure. The figure is not newly opened or digitized to create exact values/CIs. S01	Only the relevant preserved-summary information is recorded; detailed originals remain unread and prior content review is incomplete. Exact group values in the text, actual figure values/axes, model adjustment and the estimand associated with SE are unverified. Prior content review remains incomplete.	Figure displays versus raw scores/change and variance estimands	Follow-up research publishing exact values and estimands in tables. This is a proposal; no new search, calculation or trial was performed in the recorded production.
12	Partly verified	Full text not readStored summary read	N12 · Evidence conditionEffect size, CI and meaningful changeRequired	The original statement that the text lacks exact group values and 95% CIs is preserved. No magnitude interpretation beyond P<0.05, standardized effects, relative changes or new CIs are created. S01	Only the relevant preserved-summary information is recorded; detailed originals remain unread and prior content review is incomplete. Exact effect sizes, CIs and prespecified meaningful-change thresholds are unverified. Prior content review remains incomplete.	Exact magnitude, 95% CI and prespecified importance thresholds	Follow-up trials reporting effect magnitude and precision. This is a proposal; no new search, calculation or trial was performed in the recorded production.
13	Partly verified	Full text not readStored summary read	N13 · Evidence conditionWithin/between-group contrasts and adjusted modelsRequired	The original records a positive result versus placebo in full FAS1. Within-group improvements are not substituted for between-group benefit, and differences absent from the original are not calculated. S01	Only the relevant preserved-summary information is recorded; detailed originals remain unread and prior content review is incomplete. Within-group results, baseline adjustment, model terms/covariates, repeated measurements and change formulas are unverified. Prior content review remains incomplete.	Arm-specific change/effects versus placebo and modeling/adjustment conditions	Research separately reporting within/between-group and adjusted estimands. This is a proposal; no new search, calculation or trial was performed in the recorded production.
14	Partly verified	Full text not readStored summary read	N14 · Evidence conditionPrimary-endpoint and analysis-population hierarchyRequired	The original verdict is supported by the full-FAS1 primary rising-sleepiness result. Male/other subgroup and other sleep/temperature endpoints are not promoted to new primary results. S01	Only the relevant preserved-summary information is recorded; detailed originals remain unread and prior content review is incomplete. Preregistered plans, the exact primary analysis, analysis-population/endpoint hierarchy and change history are unverified. Prior content review remains incomplete.	Full-FAS1 primary endpoint versus secondary/subgroup analyses	Follow-up trials specifying primary endpoints and secondary analyses. This is a proposal; no new search, calculation or trial was performed in the recorded production.
15	Partly verified	Full text not readStored summary read	N15 · Evidence conditionMale and other subgroupsRequired	Male-only positive analyses and other subgroup results were not promoted into the original main verdict. They are not added as replications of the overall effect or confirmations of superiority by sex. S01	Only the relevant preserved-summary information is recorded; detailed originals remain unread and prior content review is incomplete. Subgroup denominators/values, prespecified plans, interactions, multiplicity and other subgroup results are unverified. Prior content review remains incomplete.	Full-population results versus subgroups and interactions	Research prespecifying subgroups and distinguishing them from the full-population effect. This is a proposal; no new search, calculation or trial was performed in the recorded production.
16	Partly verified	Full text not readStored summary read	N16 · Evidence conditionOther sleep factors and temperature outcomesRequired	The original records other sleep/temperature endpoints as secondary outcomes. They are not transferred into replacements for the selected rising-sleepiness outcome, overall sleep improvement or clinical treatment. S01	Only the relevant preserved-summary information is recorded; detailed originals remain unread and prior content review is incomplete. Exact values/directions, times, tests and sleep-physiology results for other factors are unverified. Prior content review remains incomplete.	Selected factor versus other sleep/temperature outcomes and their hierarchy	Follow-up research distinguishing self-reported factors from other outcomes. This is a proposal; no new search, calculation or trial was performed in the recorded production.
17	Unverified	Full text not readStored summary read	N17 · Evidence conditionMultiple factors, time points and analysesRequired	The full-FAS1 primary result is distinguished from subgroup/secondary findings. Multiple factors, times or P values are not added as new trials/independent replications. S01	Information currently needed from the preserved summary is unverified. Total test counts, adjustment, order and outcome selection/changes are unverified. Prior content review remains incomplete.	Number of tests, adjustments, prespecified order and outcome selection	Research separately reporting multiple outcomes and the primary analysis. This is a proposal; no new search, calculation or trial was performed in the recorded production.
18	Partly verified	Full text not readStored summary read	N18 · Evidence condition64 participants and FAS1 32/32Required	The original evidence records 64 randomized participants in FAS1 (32/32). This is not converted into complete attendance/measurement at every visit/item or certification of a unique clinical participant total. S01	Only the relevant preserved-summary information is recorded; detailed originals remain unread and prior content review is incomplete. Valid denominators by assessment visit, FAS1 definition, other populations/exclusion criteria and PPS/ITT correspondence are unverified. Prior content review remains incomplete.	Randomized/analysis populations and actual visit/scale-specific denominators	Follow-up research specifying analysis populations and endpoint denominators. This is a proposal; no new search, calculation or trial was performed in the recorded production.
19	Unverified	Full text not readStored summary read	N19 · Evidence conditionAttrition, missingness, imputation and sensitivityRequired	The original 64-person/FAS1 narrative is preserved. Participant counts alone do not verify no missing responses/attrition or absence of their influence. S01	Information currently needed from the preserved summary is unverified. Arm-specific missingness/attrition reasons and times, imputation/model handling and sensitivity analyses are unverified. Prior content review remains incomplete.	Period-specific attrition, missing responses and analysis handling	Follow-up trials disclosing the impact of missingness. This is a proposal; no new search, calculation or trial was performed in the recorded production.
20	Partly verified	Full text not readStored summary read	N20 · Evidence conditionOriginal UMIN identifier and registry/plan accessRequired	The original registry-identifier field is UMIN000051261. It is preserved unchanged without upgrading it to external registry verification or reading of prespecified plans. S01	Only the relevant preserved-summary information is recorded; detailed originals remain unread and prior content review is incomplete. Registry dates/amendments, pre-recruitment plans, complete protocol/SAP and correspondence to reports remain unread. Prior content review remains incomplete.	Registry identifier and actual reading scope for preregistration/protocol/SAP	Follow-up research publicly linking planned and actual primary analyses. This is a proposal; no new search, calculation or trial was performed in the recorded production.
21	Unverified	Full text not readStored summary read	N21 · Evidence conditionConcurrent sleep/lifestyle and medication exposureRequired	The original scope is a 12-week comparison in healthy adults dissatisfied with sleep. It does not establish identical or fully controlled lifestyle, medication and sleep conditions. S01	Information currently needed from the preserved summary is unverified. Concurrent medication, diet, sleep/lifestyle, waking conditions, other interventions, arm differences and handling are unverified. Prior content review remains incomplete.	Arm-specific lifestyle, concurrent medication, sleep management and exposure differences	Follow-up comparative research disclosing concurrent conditions. This is a proposal; no new search, calculation or trial was performed in the recorded production.
22	Partly verified	Full text not readStored summary read	N22 · Evidence conditionDeclaration of no specific fundingRequired	The original records the paper's statement that no specific funding was received. This is not converted into absence of product support, employee participation or all conflicts of interest. S01	Only the relevant preserved-summary information is recorded; detailed originals remain unread and prior content review is incomplete. Original funding disclosures, other support/writing/publication costs and complete roles/COI remain unread. Prior content review remains incomplete.	Cash research grants versus other funding/support and COI	Research separately disclosing funding, noncash support and involvement. This is a proposal; no new search, calculation or trial was performed in the recorded production.
23	Partly verified	Full text not readStored summary read	N23 · Evidence conditionFujicco provision of study foodRequired	The original statement that Fujicco provided study food to the contract site is preserved. Provision alone does not verify all quality/support details or placebo supply. S01	Only the relevant preserved-summary information is recorded; detailed originals remain unread and prior content review is incomplete. Provision contracts, batches/quality, support scope and contractor roles/decision authority are unverified. Prior content review remains incomplete.	Company product support and provision to the contract site	Research disclosing product-support roles and scope. This is a proposal; no new search, calculation or trial was performed in the recorded production.
24	Partly verified	Full text not readStored summary read	N24 · Evidence conditionEmployee authors and study rolesRequired	The original records R.A., T.M. and K.M. as Fujicco employees who participated in conceptualization, methods, analysis, data management and drafting. Independence is not newly certified. S01	Only the relevant preserved-summary information is recorded; detailed originals remain unread and prior content review is incomplete. Original contributions/COI, data access, publication decisions and all external-analysis roles remain unread. Prior content review remains incomplete.	Author affiliations versus design/analysis/management/writing participation	Follow-up research separately disclosing company and external-investigator roles. This is a proposal; no new search, calculation or trial was performed in the recorded production.
25	Partly verified	Full text not readStored summary read	N25 · Evidence conditionOne report, the same trial and independent replicationRequired	S01 Akagi 2025 is one manufacturer-linked 64-person trial. Its two arms, multiple factors/times, citation/registry and sibling sheets are not added as separate independent trials/participants. S01	Only the relevant preserved-summary information is recorded; detailed originals remain unread and prior content review is incomplete. Independent confirming reports for the same application/endpoint and unique clinical trial/participant totals are not established. Prior content review remains incomplete.	Report-to-trial-to-arm/time/scale relationships and independent research	Independent follow-up comparative research specifying the same selected endpoint. This is a proposal; no new search, calculation or trial was performed in the recorded production.
26	Partly verified	Full text not readStored summary read	N26 · Evidence conditionPersistence and scope of other products/constituentsRequired	The claim is limited to one rising-sleepiness score for a particular seed-coat extract. It is not broadened to whole black soybeans, ordinary soy foods, individual polyphenols, other sleep effects or long-term cognitive effects. S01	Only the relevant preserved-summary information is recorded; detailed originals remain unread and prior content review is incomplete. Persistence/discontinuation follow-up beyond 12 weeks and direct comparisons of other formulations/populations/individual constituents are unverified. Prior content review remains incomplete.	Selected 12-week factor versus long-term/general-food and constituent effects	Follow-up research distinguishing persistence from direct constituent/formulation applicability. This is a proposal; no new search, calculation or trial was performed in the recorded production.
27	Partly verified	Full text not readStored summary read	N27 · Harm-information gaps supplementing the efficacy tableOriginal safety records and rare/long-term harmsSupplementary	The parent good safety status and original record of no adverse events reported over 12 weeks are preserved. The original states that a 64-person trial cannot exclude rare or long-term harms. S01	Only the relevant preserved-summary information is recorded; detailed originals remain unread and prior content review is incomplete. Collection/adjudication, arm-specific frequencies/denominators, discontinuations, rare/long-term harms and safety in other populations are unverified. Prior content review remains incomplete.	Adverse-event collection, arm-specific denominators/frequency and follow-up scope	Research specifying harm collection and long-term/other-population scope. This is a proposal; no new search, calculation or trial was performed in the recorded production.
28	Partly verified	Full text not readStored summary read	N28 · Evidence conditionParent/subclaim, Korean/English, dates and historyRequired	Parent C50, B/P/R1/I0/E+/B1, unrecorded precision, three false flags, empty grade-override reasons and the subclaim C grade/note are preserved. Bilingual text, 2026-08-26, empty corrections/deliberation and historical cross-checks are not inherited as current review. S01	Only the relevant preserved-summary information is recorded; detailed originals remain unread and prior content review is incomplete. The subclaim lacks score/status/axes. They are not filled from parent values, and no new scores/verdicts are created. Prior content review remains incomplete.	Original scores/axes, evidence date, corrections and cross-check narrative	Research distinguishing original values/history from applicability of new materials. This is a proposal; no new search, calculation or trial was performed in the recorded production.
29	Partly verified	Full text not readStored summary read	N29 · Evidence conditionActual summary reading, links and updatesRequired	The complete preserved summary and bibliography were used in production, and links were preserved. Original paper/figures, registry, protocol, SAP and support/COI disclosures remain unread; access and link testing were not attempted in that production. S01	Only the relevant preserved-summary information is recorded; detailed originals remain unread and prior content review is incomplete. External content, exact values and actual access availability are unverified. Prior content review remains incomplete.	Preserved-summary reading versus access to external originals/figures/registry/plans	Research updating records while distinguishing actual acquisition, dates and scope. This is a proposal; no new search, calculation or trial was performed in the recorded production.

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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: Original data concern 64 healthy Japanese adults dissatisfied with sleep quality, randomized/FAS1 32/32. Detailed eligibility, baseline conditions, visit/scale denominators and completion/attrition/missingness are unverified.
Ingredient, formulation and route: Black soybean seed-coat polyphenol extract, 100 mg. The original records major constituents including proanthocyanidins and epicatechins; findings are not transferred to whole black soybeans, ordinary soy foods or individual constituents. Specifications/batches and exact constituent content are unverified.
Dose: Only original study exposure is recorded: 100 mg after-evening-meal and placebo groups followed for 12 weeks. Exact daily frequency, actual cumulative exposure/adherence and discontinuation are unverified; no new intake/sleep-management instructions are created.
Comparator: Double-blind randomized placebo-controlled parallel trial. Actual placebo ingredients, sensory/contact conditions, allocation/blinding and concurrent sleep/lifestyle conditions are unverified.
Measured outcome: The full-FAS1 primary OSA-MA rising-sleepiness score change at 12 weeks improved versus placebo, P<0.05. The original records figure-based estimated marginal means ± SE separately from absent exact group values/95% CIs in the text. No new numerical extraction, effects/CIs or between-group differences are created. Male/other subgroups, other sleep/temperature outcomes, overall sleep and clinical treatment are separate scopes.
Duration: Selected rising-sleepiness factor after 12 weeks. Single-dose/all-day or other-factor effects, long-term persistence/discontinuation follow-up and direct effects in other populations/formulations are unverified.
Questions outside this scope: Opening the figure to calculate new exact values, effects/CIs or response rates from estimated marginal means ± SE; Changing full-FAS1 rising-sleepiness P<0.05 into other sleep factors/temperature, male-subgroup results, overall sleep or clinical treatment; Mixing estimands for change, within/between-group comparisons, model adjustment and time points/scales; Using 64 participants, 32/32 arms, times, scales, citation/registry and sibling sheets as independent trial/participant totals; Transferring a specific seed-coat extract result to whole black soybeans, ordinary soy foods, individual polyphenols or other formulations; Replacing a no-specific-funding declaration with absence of product support, employee involvement or COI, or certification of independence; Inheriting parent values/axes and historical cross-checks as subclaim scores, current review or original-source reading; New calculations, hypothetical values, effects/CIs, grades, independence certification, drink/extract/product intake, skin/sleep management or treatment-substitution 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.

S01 · Akagi R et al. 2025

PubMed

Material type: Double-blind randomized placebo-controlled parallel trial
Materials actually read: Summary read; external material 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: Outcome wording in the stored summary
Study overlap and independent replication: S01 Akagi 2025 is a single parallel report of 64 healthy Japanese adults dissatisfied with sleep quality, randomized/FAS1 32/32. In the 12-week comparison of 100 mg specific black soybean seed-coat extract after the evening meal versus placebo, full-FAS1 OSA-MA rising-sleepiness change was positive, P<0.05. Figure-based estimated marginal means ± SE and absent exact group values/95% CI in the text are preserved. These are not transferred to male/other subgroups, other sleep/temperature outcomes, ordinary soy/individual constituents or overall sleep. The same 64 people, arms, scales, times, citation/registry and sibling sheets are not new independent trials/participants. Report counts are not unique clinical trial/participant or independent-replication totals; no new summation or independence certification is performed.

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Stored summary	Stored file	Stored summary	Summary read	Only stored-summary and bibliographic content was used for production. External material verification/review is not complete.
External paper	Public availability unverified; only bibliography links preserved	Unread; access not attempted	Not read	No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.
Registration material	Public availability unverified; only bibliography links preserved	Unread; access not attempted	Not read	No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.
Protocol	Public availability unverified; only bibliography links preserved	Unread; access not attempted	Not read	No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.
Statistical analysis plan	Public availability unverified; only bibliography links preserved	Unread; access not attempted	Not read	No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.
Funding, product-support and COI material	Public availability unverified; only bibliography links preserved	Unread; access not attempted	Not read	No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status.

Report counts versus independent study counts

S01 Akagi 2025 is a single parallel report of 64 healthy Japanese adults dissatisfied with sleep quality, randomized/FAS1 32/32. In the 12-week comparison of 100 mg specific black soybean seed-coat extract after the evening meal versus placebo, full-FAS1 OSA-MA rising-sleepiness change was positive, P<0.05. Figure-based estimated marginal means ± SE and absent exact group values/95% CI in the text are preserved. These are not transferred to male/other subgroups, other sleep/temperature outcomes, ordinary soy/individual constituents or overall sleep. The same 64 people, arms, scales, times, citation/registry and sibling sheets are not new independent trials/participants. Report counts are not unique clinical trial/participant or independent-replication totals; no new summation or independence certification is performed.

Review criteria

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

N01 · Selected rising-sleepiness question and original grade

Required materials and conditions: Selected original wording/grade versus parent score/axes
Conditions for verification: Original information and analysis scope for Selected original wording/grade versus parent score/axes must be available, with unverified information distinguished. Preserved wording is linked here; prior content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: Distinguish Selected original wording/grade versus parent score/axes to link needed and currently available information for the selected question.
Referenced methods: M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are custom design; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is custom design; M04 §4.5, §4.6.3; limits on current material conversion reflect the review scope and custom design

N02 · Healthy Japanese adults dissatisfied with sleep

Required materials and conditions: Actual eligibility/recruitment, sleep-dissatisfaction definition and population characteristics
Conditions for verification: Original information and analysis scope for Actual eligibility/recruitment, sleep-dissatisfaction definition and population characteristics must be available, with unverified information distinguished. Preserved wording is linked here; prior content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: Distinguish Actual eligibility/recruitment, sleep-dissatisfaction definition and population characteristics to link needed and currently available information for the selected question.
Referenced methods: M03 §3.2.1; Detailed population conditions are Chamgap design; M03 §3.2.1–3.2.4; Dose, duration and effect-modifier details are Chamgap design

N03 · Identity of the study seed-coat extract

Required materials and conditions: Ingredients, formulation and standardization of the black soybean seed-coat extract
Conditions for verification: Original information and analysis scope for Ingredients, formulation and standardization of the black soybean seed-coat extract must be available, with unverified information distinguished. Preserved wording is linked here; prior content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: Distinguish Ingredients, formulation and standardization of the black soybean seed-coat extract to link needed and currently available information for the selected question.
Referenced methods: M03 §3.2.2–3.2.3; Reverse-direction labels and assessment adaptation are Chamgap design; M03 §3.2.3 and M08 §8.2.2–8.2.3; Chamgap application

N04 · Actual placebo comparison conditions

Required materials and conditions: Placebo composition, sensory/contact matching and expectations
Conditions for verification: Original information and analysis scope for Placebo composition, sensory/contact matching and expectations must be available, with unverified information distinguished. Preserved wording is linked here; prior content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: Distinguish Placebo composition, sensory/contact matching and expectations to link needed and currently available information for the selected question.
Referenced methods: M03 §3.2.2–3.2.3; reverse-direction labels and testing adaptations are internally designed; M08 Table 8.2.a, M03 §3.2.4; internal application

N05 · Study exposure and 12-week duration

Required materials and conditions: Original 100 mg after-evening-meal exposure for 12 weeks and actual adherence
Conditions for verification: Original information and analysis scope for Original 100 mg after-evening-meal exposure for 12 weeks and actual adherence must be available, with unverified information distinguished. Preserved wording is linked here; prior content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: Distinguish Original 100 mg after-evening-meal exposure for 12 weeks and actual adherence to link needed and currently available information for the selected question.
Referenced methods: M03 §3.2.3, M08 §8.2.2–8.2.3; internal application; M08 §8.2.2, M15 §15.3.1; internal application; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed

N06 · Randomization and 32/32 assignment

Required materials and conditions: Randomization, concealment and arm-specific baseline balance
Conditions for verification: Original information and analysis scope for Randomization, concealment and arm-specific baseline balance must be available, with unverified information distinguished. Preserved wording is linked here; prior content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: Distinguish Randomization, concealment and arm-specific baseline balance to link needed and currently available information for the selected question.
Referenced methods: M08 §8.1–8.2.3; Internal application; M03 §3.2.1; Detailed population conditions are internally designed

N07 · Blinding and self-report expectations

Required materials and conditions: Participant/assessor/analyst blinding and self-report measurement conditions
Conditions for verification: Original information and analysis scope for Participant/assessor/analyst blinding and self-report measurement conditions must be available, with unverified information distinguished. Preserved wording is linked here; prior content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: Distinguish Participant/assessor/analyst blinding and self-report measurement conditions to link needed and currently available information for the selected question.
Referenced methods: M08 Table 8.2.a, M03 §3.2.4; own application; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific result adaptation is our own design

N08 · OSA-MA factor and score definitions

Required materials and conditions: Rising-sleepiness factor, score direction, recall/response windows and scoring
Conditions for verification: Original information and analysis scope for Rising-sleepiness factor, score direction, recall/response windows and scoring must be available, with unverified information distinguished. Preserved wording is linked here; prior content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: Distinguish Rising-sleepiness factor, score direction, recall/response windows and scoring to link needed and currently available information for the selected question.
Referenced methods: M03 §3.2.4 and M15 §15.3.1–15.3.3; Question-specific outcome adaptation is Chamgap design; M08 Table 8.2.a and M03 §3.2.4; Chamgap application; M03 §3.2.4; Chamgap interpretation boundary

N09 · 12-week change and waking assessment time

Required materials and conditions: Selected 12-week change, waking assessment window and other time points
Conditions for verification: Original information and analysis scope for Selected 12-week change, waking assessment window and other time points must be available, with unverified information distinguished. Preserved wording is linked here; prior content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: Distinguish Selected 12-week change, waking assessment window and other time points to link needed and currently available information for the selected question.
Referenced methods: M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are our own design; M08 §8.2.2, M15 §15.3.1; our own application

N10 · Positive full-FAS1 result

Required materials and conditions: Selected primary-endpoint result versus placebo in the full analysis population
Conditions for verification: Original information and analysis scope for Selected primary-endpoint result versus placebo in the full analysis population must be available, with unverified information distinguished. Preserved wording is linked here; prior content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: Distinguish Selected primary-endpoint result versus placebo in the full analysis population to link needed and currently available information for the selected question.
Referenced methods: M15 §15.3.1–15.3.3; internal application; M08 §8.2.2, M15 §15.3.1; internal application; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are internally designed.

N11 · Figure-based estimated marginal means and SE

Required materials and conditions: Figure displays versus raw scores/change and variance estimands
Conditions for verification: Original information and analysis scope for Figure displays versus raw scores/change and variance estimands must be available, with unverified information distinguished. Preserved wording is linked here; prior content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: Distinguish Figure displays versus raw scores/change and variance estimands to link needed and currently available information for the selected question.
Referenced methods: Collection/selection principles in M04 §4.5–4.6; Separating access from reading and the hyperlink contract are internally designed; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; Design-specific adaptations are internally designed; M08 §8.2.2, M15 §15.3.1; Internal application; M15 §15.3.1–15.3.3; Internal application

N12 · Effect size, CI and meaningful change

Required materials and conditions: Exact magnitude, 95% CI and prespecified importance thresholds
Conditions for verification: Original information and analysis scope for Exact magnitude, 95% CI and prespecified importance thresholds must be available, with unverified information distinguished. Preserved wording is linked here; prior content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: Distinguish Exact magnitude, 95% CI and prespecified importance thresholds to link needed and currently available information for the selected question.
Referenced methods: M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; Design-specific adaptations are internally designed; M15 §15.3.1–15.3.3; Internal application; M03 §3.2.4; Internally defined extrapolation boundaries

N13 · Within/between-group contrasts and adjusted models

Required materials and conditions: Arm-specific change/effects versus placebo and modeling/adjustment conditions
Conditions for verification: Original information and analysis scope for Arm-specific change/effects versus placebo and modeling/adjustment conditions must be available, with unverified information distinguished. Preserved wording is linked here; prior content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: Distinguish Arm-specific change/effects versus placebo and modeling/adjustment conditions to link needed and currently available information for the selected question.
Referenced methods: M08 §8.2.2, M15 §15.3.1; Chamgap's own application; M15 §15.3.1–15.3.3; Chamgap's own application; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are Chamgap's own design

N14 · Primary-endpoint and analysis-population hierarchy

Required materials and conditions: Full-FAS1 primary endpoint versus secondary/subgroup analyses
Conditions for verification: Original information and analysis scope for Full-FAS1 primary endpoint versus secondary/subgroup analyses must be available, with unverified information distinguished. Preserved wording is linked here; prior content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: Distinguish Full-FAS1 primary endpoint versus secondary/subgroup analyses to link needed and currently available information for the selected question.
Referenced methods: M08 Table 8.2.a, M04 §4.6.3; Chamgap application; M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses is Chamgap's own design

N15 · Male and other subgroups

Required materials and conditions: Full-population results versus subgroups and interactions
Conditions for verification: Original information and analysis scope for Full-population results versus subgroups and interactions must be available, with unverified information distinguished. Preserved wording is linked here; prior content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: Distinguish Full-population results versus subgroups and interactions to link needed and currently available information for the selected question.
Referenced methods: M08 Table 8.2.a, M04 §4.6.3; Internal application; M03 §3.2.1–3.2.4; Dose, persistence and effect-modification details are internally designed; Distinguishing studies from reports in M04 §4.6.1–4.6.2; Cohort/outcome linkage is an internal application

N16 · Other sleep factors and temperature outcomes

Required materials and conditions: Selected factor versus other sleep/temperature outcomes and their hierarchy
Conditions for verification: Original information and analysis scope for Selected factor versus other sleep/temperature outcomes and their hierarchy must be available, with unverified information distinguished. Preserved wording is linked here; prior content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: Distinguish Selected factor versus other sleep/temperature outcomes and their hierarchy to link needed and currently available information for the selected question.
Referenced methods: M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are Chamgap designs; M04 §4.6.3, M15 §15.3.1–15.3.3; status separation is a Chamgap design; M03 §3.2.4; Chamgap's own extrapolation boundary

N17 · Multiple factors, time points and analyses

Required materials and conditions: Number of tests, adjustments, prespecified order and outcome selection
Conditions for verification: Original information and analysis scope for Number of tests, adjustments, prespecified order and outcome selection must be available, with unverified information distinguished. Preserved wording is linked here; prior content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: Distinguish Number of tests, adjustments, prespecified order and outcome selection to link needed and currently available information for the selected question.
Referenced methods: M08 Table 8.2.a, M04 §4.6.3; internal application; M04 §4.6.1–4.6.2 distinguish studies from reports; cohort/outcome linkage is internally applied

N18 · 64 participants and FAS1 32/32

Required materials and conditions: Randomized/analysis populations and actual visit/scale-specific denominators
Conditions for verification: Original information and analysis scope for Randomized/analysis populations and actual visit/scale-specific denominators must be available, with unverified information distinguished. Preserved wording is linked here; prior content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: Distinguish Randomized/analysis populations and actual visit/scale-specific denominators to link needed and currently available information for the selected question.
Referenced methods: M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; Design-specific adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap application

N19 · Attrition, missingness, imputation and sensitivity

Required materials and conditions: Period-specific attrition, missing responses and analysis handling
Conditions for verification: Original information and analysis scope for Period-specific attrition, missing responses and analysis handling must be available, with unverified information distinguished. Preserved wording is linked here; prior content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: Distinguish Period-specific attrition, missing responses and analysis handling to link needed and currently available information for the selected question.
Referenced methods: M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; Design-specific adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap application

N20 · Original UMIN identifier and registry/plan access

Required materials and conditions: Registry identifier and actual reading scope for preregistration/protocol/SAP
Conditions for verification: Original information and analysis scope for Registry identifier and actual reading scope for preregistration/protocol/SAP must be available, with unverified information distinguished. Preserved wording is linked here; prior content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: Distinguish Registry identifier and actual reading scope for preregistration/protocol/SAP to link needed and currently available information for the selected question.
Referenced methods: Data collection and selection principles in M04 §4.5–4.6; separation of access from reading and the hyperlink contract are internally designed; M08 Table 8.2.a, M04 §4.6.3; internal application; M04 §4.5, §4.6.3; limits of this material conversion reflect the review scope and internal design

N21 · Concurrent sleep/lifestyle and medication exposure

Required materials and conditions: Arm-specific lifestyle, concurrent medication, sleep management and exposure differences
Conditions for verification: Original information and analysis scope for Arm-specific lifestyle, concurrent medication, sleep management and exposure differences must be available, with unverified information distinguished. Preserved wording is linked here; prior content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: Distinguish Arm-specific lifestyle, concurrent medication, sleep management and exposure differences to link needed and currently available information for the selected question.
Referenced methods: M03 §3.2.3, M08 §8.2.2–8.2.3; own application; M03 §3.2.2–3.2.3; reverse-direction labels and test adaptations are our own design

N22 · Declaration of no specific funding

Required materials and conditions: Cash research grants versus other funding/support and COI
Conditions for verification: Original information and analysis scope for Cash research grants versus other funding/support and COI must be available, with unverified information distinguished. Preserved wording is linked here; prior content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: Distinguish Cash research grants versus other funding/support and COI to link needed and currently available information for the selected question.
Referenced methods: Chamgap independence/attribution conditions. The referenced official method sections do not certify every detail of these items; Data collection/selection principles in M04 §4.5–4.6; Access/reading separation and hyperlink rules are Chamgap design

N23 · Fujicco provision of study food

Required materials and conditions: Company product support and provision to the contract site
Conditions for verification: Original information and analysis scope for Company product support and provision to the contract site must be available, with unverified information distinguished. Preserved wording is linked here; prior content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: Distinguish Company product support and provision to the contract site to link needed and currently available information for the selected question.
Referenced methods: Chamgap’s own independence/attribution conditions. Official methodological sections used in this pilot do not guarantee every detailed item; M03 §3.2.2–3.2.3; reverse-direction labels and testing adaptations are internally designed

N24 · Employee authors and study roles

Required materials and conditions: Author affiliations versus design/analysis/management/writing participation
Conditions for verification: Original information and analysis scope for Author affiliations versus design/analysis/management/writing participation must be available, with unverified information distinguished. Preserved wording is linked here; prior content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: Distinguish Author affiliations versus design/analysis/management/writing participation to link needed and currently available information for the selected question.
Referenced methods: Chamgap's own conditions for independence and attribution. The official methodological sections used in this example do not validate every detail of these items.

N25 · One report, the same trial and independent replication

Required materials and conditions: Report-to-trial-to-arm/time/scale relationships and independent research
Conditions for verification: Original information and analysis scope for Report-to-trial-to-arm/time/scale relationships and independent research must be available, with unverified information distinguished. Preserved wording is linked here; prior content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: Distinguish Report-to-trial-to-arm/time/scale relationships and independent research to link needed and currently available information for the selected question.
Referenced methods: Study/report distinction in M04 §4.6.1–4.6.2; Cohort/outcome linkage is Chamgap application; M04 §4.6.1–4.6.2 and M15 §15.3.1; Chamgap application

N26 · Persistence and scope of other products/constituents

Required materials and conditions: Selected 12-week factor versus long-term/general-food and constituent effects
Conditions for verification: Original information and analysis scope for Selected 12-week factor versus long-term/general-food and constituent effects must be available, with unverified information distinguished. Preserved wording is linked here; prior content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: Distinguish Selected 12-week factor versus long-term/general-food and constituent effects to link needed and currently available information for the selected question.
Referenced methods: M03 §3.2.1–3.2.4; dose, persistence and effect-modification details are custom design; M03 §3.2.4; custom extension boundary; M03 §3.2.2–3.2.3; reverse-direction labeling and test adaptation are custom design

N27 · Original safety records and rare/long-term harms

Required materials and conditions: Adverse-event collection, arm-specific denominators/frequency and follow-up scope
Conditions for verification: Original information and analysis scope for Adverse-event collection, arm-specific denominators/frequency and follow-up scope must be available, with unverified information distinguished. Preserved wording is linked here; prior content review remains incomplete.
Requirement and applicability: Supplementary
Application exceptions: Complements safety-data gaps for the selected subclaim. Intermediate/final skin hydration, self-reported sleepiness or parent cautionary wording are not used to judge safety or create harm-incidence estimates/new use instructions.
Why this condition is needed: Distinguish Adverse-event collection, arm-specific denominators/frequency and follow-up scope to link needed and currently available information for the selected question.
Referenced methods: M19 §19.1.2–19.2.4; detailed distinctions are Chamgap’s own design; M19 §19.1.2–19.2.4; Chamgap application; M19 §19.1.2–19.2.4; Chamgap application; M19 §19.1.2–19.2.4; Chamgap application

N28 · Parent/subclaim, Korean/English, dates and history

Required materials and conditions: Original scores/axes, evidence date, corrections and cross-check narrative
Conditions for verification: Original information and analysis scope for Original scores/axes, evidence date, corrections and cross-check narrative must be available, with unverified information distinguished. Preserved wording is linked here; prior content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: Distinguish Original scores/axes, evidence date, corrections and cross-check narrative to link needed and currently available information for the selected question.
Referenced methods: M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design; M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are internally designed

N29 · Actual summary reading, links and updates

Required materials and conditions: Preserved-summary reading versus access to external originals/figures/registry/plans
Conditions for verification: Original information and analysis scope for Preserved-summary reading versus access to external originals/figures/registry/plans must be available, with unverified information distinguished. Preserved wording is linked here; prior content review remains incomplete.
Requirement and applicability: Required
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Why this condition is needed: Distinguish Preserved-summary reading versus access to external originals/figures/registry/plans to link needed and currently available information for the selected question.
Referenced methods: M04 §4.5–4.6 material collection/selection principles; acquisition/reading separation and hyperlink specifications are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design

Referenced methods and the sections actually reviewed

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

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

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

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

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

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

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

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

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

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

Official methodology · §15.2.4, §15.3.1–15.3.3

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

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

Official methodology · §19.1.2, §19.2.1–19.2.4

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

What the statuses mean

Met: Status for necessary evidence confirmed after existing content review. No completion is declared in the current presentation.
Partly verified: Some information in the stored summary is linked into the table. External comparison/content review is not complete.
Unverified: The article leaves this unverified, or required material is absent from the current stored summary. This is distinct from zero, absence or safety.
Review incomplete: Existing content review remains incomplete.
Not reported: Not reported within the stored material actually read; not extended to the entire primary paper.
Inaccessible: Means an actual access failure. Access not attempted here is not assigned this state.
Not applicable: Not used as a substitute for an evidence gap.
Conflicting data: Requires an observed disagreement under the same comparison criteria; not automatically judged in this production.
Insufficient evidence for the conditions: Marks a gap in additional material required by the selected conditions; not a new efficacy grade.

Change history

2026-10-14 · 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 · Selected rising-sleepiness question and original grade

Current findings: The selected subclaim is improved sleepiness-on-rising score, grade C, with the note that the full FAS1 primary analysis had P<0.05. The subclaim lacks score/status/axes; parent C50 is not used to fill its score.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only the relevant preserved-summary information is recorded; detailed originals remain unread and prior content review is incomplete. The subclaim score, status and axes are absent. No sleep effect broader than the original scope is created. Prior content review remains incomplete.
Reason for missing information: The subclaim score, status and axes are absent. No sleep effect broader than the original scope is created.
Required materials and conditions: Selected original wording/grade versus parent score/axes
Materials to obtain first: Original selected subclaim and parent verdict, and user correction comments
Further research: Follow-up comparative research specifying the selected scale/time point. This is a proposal; no new search, calculation or trial was performed in the recorded production.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Original information and analysis scope for Selected original wording/grade versus parent score/axes must be available, with unverified information distinguished. Preserved wording is linked here; prior content review remains incomplete.
Why this condition is needed: Distinguish Selected original wording/grade versus parent score/axes to link needed and currently available information for the selected question.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are custom design; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is custom design; M04 §4.5, §4.6.3; limits on current material conversion reflect the review scope and custom design

Related sources S01

N02 · Healthy Japanese adults dissatisfied with sleep

Current findings: Participants were 64 healthy Japanese adults dissatisfied with sleep quality. The original summary is not generalized to treatment effects in all ages or diagnosed sleep-disorder populations.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only the relevant preserved-summary information is recorded; detailed originals remain unread and prior content review is incomplete. Detailed eligibility, age/sex, baseline scales, sleep-disorder diagnoses/exclusions and recruitment are unverified. Prior content review remains incomplete.
Reason for missing information: Detailed eligibility, age/sex, baseline scales, sleep-disorder diagnoses/exclusions and recruitment are unverified.
Required materials and conditions: Actual eligibility/recruitment, sleep-dissatisfaction definition and population characteristics
Materials to obtain first: Eligibility/recruitment, baseline characteristics and population definitions
Further research: Follow-up research with the same formulation and a specified population. This is a proposal; no new search, calculation or trial was performed in the recorded production.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Original information and analysis scope for Actual eligibility/recruitment, sleep-dissatisfaction definition and population characteristics must be available, with unverified information distinguished. Preserved wording is linked here; prior content review remains incomplete.
Why this condition is needed: Distinguish Actual eligibility/recruitment, sleep-dissatisfaction definition and population characteristics to link needed and currently available information for the selected question.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M03 §3.2.1; Detailed population conditions are Chamgap design; M03 §3.2.1–3.2.4; Dose, duration and effect-modifier details are Chamgap design

Related sources S01

N03 · Identity of the study seed-coat extract

Current findings: The study intervention was 100 mg black soybean seed-coat polyphenol extract. Recorded major constituents include proanthocyanidins and epicatechins. These are not effects of whole black soybeans, ordinary soy foods or individual constituents.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only the relevant preserved-summary information is recorded; detailed originals remain unread and prior content review is incomplete. Extraction/standardization, actual constituent content, product specifications/batches and correspondence to other formulations are unverified. Prior content review remains incomplete.
Reason for missing information: Extraction/standardization, actual constituent content, product specifications/batches and correspondence to other formulations are unverified.
Required materials and conditions: Ingredients, formulation and standardization of the black soybean seed-coat extract
Materials to obtain first: Study-food ingredients and manufacturing/standardization information
Further research: Research distinguishing extract effects from attribution to constituents/other formulations. This is a proposal; no new search, calculation or trial was performed in the recorded production.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Original information and analysis scope for Ingredients, formulation and standardization of the black soybean seed-coat extract must be available, with unverified information distinguished. Preserved wording is linked here; prior content review remains incomplete.
Why this condition is needed: Distinguish Ingredients, formulation and standardization of the black soybean seed-coat extract to link needed and currently available information for the selected question.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M03 §3.2.2–3.2.3; Reverse-direction labels and assessment adaptation are Chamgap design; M03 §3.2.3 and M08 §8.2.2–8.2.3; Chamgap application

Related sources S01

N04 · Actual placebo comparison conditions

Current findings: The original report is a double-blind randomized placebo-controlled parallel trial. The placebo label alone does not verify matching of all ingredients, sensory/contact conditions or participant expectations.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only the relevant preserved-summary information is recorded; detailed originals remain unread and prior content review is incomplete. Placebo ingredients, appearance/taste, contact/instructions and blinding maintenance are unverified. Prior content review remains incomplete.
Reason for missing information: Placebo ingredients, appearance/taste, contact/instructions and blinding maintenance are unverified.
Required materials and conditions: Placebo composition, sensory/contact matching and expectations
Materials to obtain first: Placebo composition, sensory/contact matching and blinding information
Further research: Follow-up trials disclosing comparison conditions. This is a proposal; no new search, calculation or trial was performed in the recorded production.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Original information and analysis scope for Placebo composition, sensory/contact matching and expectations must be available, with unverified information distinguished. Preserved wording is linked here; prior content review remains incomplete.
Why this condition is needed: Distinguish Placebo composition, sensory/contact matching and expectations to link needed and currently available information for the selected question.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M03 §3.2.2–3.2.3; reverse-direction labels and testing adaptations are internally designed; M08 Table 8.2.a, M03 §3.2.4; internal application

Related sources S01

N05 · Study exposure and 12-week duration

Current findings: The original records 12-week follow-up of 100 mg after-evening-meal and placebo groups. Only study exposure is preserved; it is not converted into product-intake or sleep-management instructions.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only the relevant preserved-summary information is recorded; detailed originals remain unread and prior content review is incomplete. Exact daily frequency, cumulative exposure, arm-specific adherence/discontinuation, batches and actual receipt records are unverified. Prior content review remains incomplete.
Reason for missing information: Exact daily frequency, cumulative exposure, arm-specific adherence/discontinuation, batches and actual receipt records are unverified.
Required materials and conditions: Original 100 mg after-evening-meal exposure for 12 weeks and actual adherence
Materials to obtain first: Exposure/adherence, discontinuation and study-food records
Further research: Research linking reported actual exposure to analysis populations. This is a proposal; no new search, calculation or trial was performed in the recorded production.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Original information and analysis scope for Original 100 mg after-evening-meal exposure for 12 weeks and actual adherence must be available, with unverified information distinguished. Preserved wording is linked here; prior content review remains incomplete.
Why this condition is needed: Distinguish Original 100 mg after-evening-meal exposure for 12 weeks and actual adherence to link needed and currently available information for the selected question.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M03 §3.2.3, M08 §8.2.2–8.2.3; internal application; M08 §8.2.2, M15 §15.3.1; internal application; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed

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N06 · Randomization and 32/32 assignment

Current findings: The original 64 participants assigned 32/32 and randomized-design label are preserved without upgrading them to verification of the full allocation process.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only the relevant preserved-summary information is recorded; detailed originals remain unread and prior content review is incomplete. Sequence generation, concealment, implementers, baseline balance and protocol violations are unverified. Prior content review remains incomplete.
Reason for missing information: Sequence generation, concealment, implementers, baseline balance and protocol violations are unverified.
Required materials and conditions: Randomization, concealment and arm-specific baseline balance
Materials to obtain first: Randomization/concealment, baseline tables and allocation information
Further research: Proposed follow-up trial disclosing allocation procedures; no new investigation, calculation or trial was performed in this production.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Original information and analysis scope for Randomization, concealment and arm-specific baseline balance must be available, with unverified information distinguished. Preserved wording is linked here; prior content review remains incomplete.
Why this condition is needed: Distinguish Randomization, concealment and arm-specific baseline balance to link needed and currently available information for the selected question.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M08 §8.1–8.2.3; Internal application; M03 §3.2.1; Detailed population conditions are internally designed

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N07 · Blinding and self-report expectations

Current findings: The original double-blind label and self-reported sleep scale are preserved. Successful blinding, analyst roles and exclusion of expectation effects are not treated as verified.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only the relevant preserved-summary information is recorded; detailed originals remain unread and prior content review is incomplete. Role-specific blinding, maintenance/unblinding, participant expectations and assessment conditions are unverified. Prior content review remains incomplete.
Reason for missing information: Role-specific blinding, maintenance/unblinding, participant expectations and assessment conditions are unverified.
Required materials and conditions: Participant/assessor/analyst blinding and self-report measurement conditions
Materials to obtain first: Blinding, questionnaire administration and assessor/analyst roles
Further research: Research specifying blinding and scale-measurement conditions. This is a proposal; no new search, calculation or trial was performed in the recorded production.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Original information and analysis scope for Participant/assessor/analyst blinding and self-report measurement conditions must be available, with unverified information distinguished. Preserved wording is linked here; prior content review remains incomplete.
Why this condition is needed: Distinguish Participant/assessor/analyst blinding and self-report measurement conditions to link needed and currently available information for the selected question.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M08 Table 8.2.a, M03 §3.2.4; own application; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific result adaptation is our own design

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N08 · OSA-MA factor and score definitions

Current findings: The selected endpoint is 12-week change in OSA-MA sleepiness-on-rising score. It is distinguished from other sleep factors, general sleep-quality improvement and clinical diagnostic treatment.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only the relevant preserved-summary information is recorded; detailed originals remain unread and prior content review is incomplete. Items, score range/direction, administration timing/repetition, scoring and importance thresholds are unverified. Prior content review remains incomplete.
Reason for missing information: Items, score range/direction, administration timing/repetition, scoring and importance thresholds are unverified.
Required materials and conditions: Rising-sleepiness factor, score direction, recall/response windows and scoring
Materials to obtain first: OSA-MA instrument, administration/scoring and endpoint definitions
Further research: Follow-up research specifying the selected factor's meaning and importance. This is a proposal; no new search, calculation or trial was performed in the recorded production.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Original information and analysis scope for Rising-sleepiness factor, score direction, recall/response windows and scoring must be available, with unverified information distinguished. Preserved wording is linked here; prior content review remains incomplete.
Why this condition is needed: Distinguish Rising-sleepiness factor, score direction, recall/response windows and scoring to link needed and currently available information for the selected question.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M03 §3.2.4 and M15 §15.3.1–15.3.3; Question-specific outcome adaptation is Chamgap design; M08 Table 8.2.a and M03 §3.2.4; Chamgap application; M03 §3.2.4; Chamgap interpretation boundary

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N09 · 12-week change and waking assessment time

Current findings: The parent claim is improved rising-sleepiness score after 12 weeks, and the original endpoint is 12-week change. It is not extended to single acute sleepiness or sleepiness throughout the day.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only the relevant preserved-summary information is recorded; detailed originals remain unread and prior content review is incomplete. Exact assessment day/time after waking, within-period repetition, earlier outcomes and change-from-baseline definitions are unverified. Prior content review remains incomplete.
Reason for missing information: Exact assessment day/time after waking, within-period repetition, earlier outcomes and change-from-baseline definitions are unverified.
Required materials and conditions: Selected 12-week change, waking assessment window and other time points
Materials to obtain first: Visit/questionnaire times, baseline/change definitions and all time-point results
Further research: Research reporting results separately by time point. This is a proposal; no new search, calculation or trial was performed in the recorded production.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Original information and analysis scope for Selected 12-week change, waking assessment window and other time points must be available, with unverified information distinguished. Preserved wording is linked here; prior content review remains incomplete.
Why this condition is needed: Distinguish Selected 12-week change, waking assessment window and other time points to link needed and currently available information for the selected question.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are our own design; M08 §8.2.2, M15 §15.3.1; our own application

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N10 · Positive full-FAS1 result

Current findings: The original result is improved rising-sleepiness score versus placebo in full FAS1, P<0.05. No exact group values, new differences/CIs or response rates are created.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only the relevant preserved-summary information is recorded; detailed originals remain unread and prior content review is incomplete. Exact between-group estimates, P values, CIs, individual changes and clinical importance are unverified. Prior content review remains incomplete.
Reason for missing information: Exact between-group estimates, P values, CIs, individual changes and clinical importance are unverified.
Required materials and conditions: Selected primary-endpoint result versus placebo in the full analysis population
Materials to obtain first: Full-FAS1 primary-analysis outcome tables, estimates and CIs
Further research: Follow-up trials adequately reporting effects and uncertainty. This is a proposal; no new search, calculation or trial was performed in the recorded production.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Original information and analysis scope for Selected primary-endpoint result versus placebo in the full analysis population must be available, with unverified information distinguished. Preserved wording is linked here; prior content review remains incomplete.
Why this condition is needed: Distinguish Selected primary-endpoint result versus placebo in the full analysis population to link needed and currently available information for the selected question.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M15 §15.3.1–15.3.3; internal application; M08 §8.2.2, M15 §15.3.1; internal application; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are internally designed.

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N11 · Figure-based estimated marginal means and SE

Current findings: The original records that the main paper displayed results only as estimated marginal means ± standard errors in a figure. The figure is not newly opened or digitized to create exact values/CIs.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only the relevant preserved-summary information is recorded; detailed originals remain unread and prior content review is incomplete. Exact group values in the text, actual figure values/axes, model adjustment and the estimand associated with SE are unverified. Prior content review remains incomplete.
Reason for missing information: Exact group values in the text, actual figure values/axes, model adjustment and the estimand associated with SE are unverified.
Required materials and conditions: Figure displays versus raw scores/change and variance estimands
Materials to obtain first: Original figures/tables, estimated marginal means and model definitions
Further research: Follow-up research publishing exact values and estimands in tables. This is a proposal; no new search, calculation or trial was performed in the recorded production.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Original information and analysis scope for Figure displays versus raw scores/change and variance estimands must be available, with unverified information distinguished. Preserved wording is linked here; prior content review remains incomplete.
Why this condition is needed: Distinguish Figure displays versus raw scores/change and variance estimands to link needed and currently available information for the selected question.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: Collection/selection principles in M04 §4.5–4.6; Separating access from reading and the hyperlink contract are internally designed; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; Design-specific adaptations are internally designed; M08 §8.2.2, M15 §15.3.1; Internal application; M15 §15.3.1–15.3.3; Internal application

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N12 · Effect size, CI and meaningful change

Current findings: The original statement that the text lacks exact group values and 95% CIs is preserved. No magnitude interpretation beyond P<0.05, standardized effects, relative changes or new CIs are created.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only the relevant preserved-summary information is recorded; detailed originals remain unread and prior content review is incomplete. Exact effect sizes, CIs and prespecified meaningful-change thresholds are unverified. Prior content review remains incomplete.
Reason for missing information: Exact effect sizes, CIs and prespecified meaningful-change thresholds are unverified.
Required materials and conditions: Exact magnitude, 95% CI and prespecified importance thresholds
Materials to obtain first: Within/between-group effect tables, CIs and importance thresholds
Further research: Follow-up trials reporting effect magnitude and precision. This is a proposal; no new search, calculation or trial was performed in the recorded production.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Original information and analysis scope for Exact magnitude, 95% CI and prespecified importance thresholds must be available, with unverified information distinguished. Preserved wording is linked here; prior content review remains incomplete.
Why this condition is needed: Distinguish Exact magnitude, 95% CI and prespecified importance thresholds to link needed and currently available information for the selected question.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; Design-specific adaptations are internally designed; M15 §15.3.1–15.3.3; Internal application; M03 §3.2.4; Internally defined extrapolation boundaries

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N13 · Within/between-group contrasts and adjusted models

Current findings: The original records a positive result versus placebo in full FAS1. Within-group improvements are not substituted for between-group benefit, and differences absent from the original are not calculated.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only the relevant preserved-summary information is recorded; detailed originals remain unread and prior content review is incomplete. Within-group results, baseline adjustment, model terms/covariates, repeated measurements and change formulas are unverified. Prior content review remains incomplete.
Reason for missing information: Within-group results, baseline adjustment, model terms/covariates, repeated measurements and change formulas are unverified.
Required materials and conditions: Arm-specific change/effects versus placebo and modeling/adjustment conditions
Materials to obtain first: Primary-analysis models, contrast definitions and original result tables
Further research: Research separately reporting within/between-group and adjusted estimands. This is a proposal; no new search, calculation or trial was performed in the recorded production.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Original information and analysis scope for Arm-specific change/effects versus placebo and modeling/adjustment conditions must be available, with unverified information distinguished. Preserved wording is linked here; prior content review remains incomplete.
Why this condition is needed: Distinguish Arm-specific change/effects versus placebo and modeling/adjustment conditions to link needed and currently available information for the selected question.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M08 §8.2.2, M15 §15.3.1; Chamgap's own application; M15 §15.3.1–15.3.3; Chamgap's own application; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are Chamgap's own design

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N14 · Primary-endpoint and analysis-population hierarchy

Current findings: The original verdict is supported by the full-FAS1 primary rising-sleepiness result. Male/other subgroup and other sleep/temperature endpoints are not promoted to new primary results.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only the relevant preserved-summary information is recorded; detailed originals remain unread and prior content review is incomplete. Preregistered plans, the exact primary analysis, analysis-population/endpoint hierarchy and change history are unverified. Prior content review remains incomplete.
Reason for missing information: Preregistered plans, the exact primary analysis, analysis-population/endpoint hierarchy and change history are unverified.
Required materials and conditions: Full-FAS1 primary endpoint versus secondary/subgroup analyses
Materials to obtain first: Registry, protocol and SAP hierarchy/analysis-population information
Further research: Follow-up trials specifying primary endpoints and secondary analyses. This is a proposal; no new search, calculation or trial was performed in the recorded production.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Original information and analysis scope for Full-FAS1 primary endpoint versus secondary/subgroup analyses must be available, with unverified information distinguished. Preserved wording is linked here; prior content review remains incomplete.
Why this condition is needed: Distinguish Full-FAS1 primary endpoint versus secondary/subgroup analyses to link needed and currently available information for the selected question.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M08 Table 8.2.a, M04 §4.6.3; Chamgap application; M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses is Chamgap's own design

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N15 · Male and other subgroups

Current findings: Male-only positive analyses and other subgroup results were not promoted into the original main verdict. They are not added as replications of the overall effect or confirmations of superiority by sex.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only the relevant preserved-summary information is recorded; detailed originals remain unread and prior content review is incomplete. Subgroup denominators/values, prespecified plans, interactions, multiplicity and other subgroup results are unverified. Prior content review remains incomplete.
Reason for missing information: Subgroup denominators/values, prespecified plans, interactions, multiplicity and other subgroup results are unverified.
Required materials and conditions: Full-population results versus subgroups and interactions
Materials to obtain first: Full-population/subgroup tables, prespecified plans and interaction information
Further research: Research prespecifying subgroups and distinguishing them from the full-population effect. This is a proposal; no new search, calculation or trial was performed in the recorded production.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Original information and analysis scope for Full-population results versus subgroups and interactions must be available, with unverified information distinguished. Preserved wording is linked here; prior content review remains incomplete.
Why this condition is needed: Distinguish Full-population results versus subgroups and interactions to link needed and currently available information for the selected question.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M08 Table 8.2.a, M04 §4.6.3; Internal application; M03 §3.2.1–3.2.4; Dose, persistence and effect-modification details are internally designed; Distinguishing studies from reports in M04 §4.6.1–4.6.2; Cohort/outcome linkage is an internal application

Related sources S01

N16 · Other sleep factors and temperature outcomes

Current findings: The original records other sleep/temperature endpoints as secondary outcomes. They are not transferred into replacements for the selected rising-sleepiness outcome, overall sleep improvement or clinical treatment.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only the relevant preserved-summary information is recorded; detailed originals remain unread and prior content review is incomplete. Exact values/directions, times, tests and sleep-physiology results for other factors are unverified. Prior content review remains incomplete.
Reason for missing information: Exact values/directions, times, tests and sleep-physiology results for other factors are unverified.
Required materials and conditions: Selected factor versus other sleep/temperature outcomes and their hierarchy
Materials to obtain first: Complete sleep/temperature result tables and endpoint/time-point definitions
Further research: Follow-up research distinguishing self-reported factors from other outcomes. This is a proposal; no new search, calculation or trial was performed in the recorded production.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Original information and analysis scope for Selected factor versus other sleep/temperature outcomes and their hierarchy must be available, with unverified information distinguished. Preserved wording is linked here; prior content review remains incomplete.
Why this condition is needed: Distinguish Selected factor versus other sleep/temperature outcomes and their hierarchy to link needed and currently available information for the selected question.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are Chamgap designs; M04 §4.6.3, M15 §15.3.1–15.3.3; status separation is a Chamgap design; M03 §3.2.4; Chamgap's own extrapolation boundary

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N17 · Multiple factors, time points and analyses

Current findings: The full-FAS1 primary result is distinguished from subgroup/secondary findings. Multiple factors, times or P values are not added as new trials/independent replications.
Verification status: Unverified
Materials actually read: Summary read; external material unread
Why unverified: Information currently needed from the preserved summary is unverified. Total test counts, adjustment, order and outcome selection/changes are unverified. Prior content review remains incomplete.
Reason for missing information: Total test counts, adjustment, order and outcome selection/changes are unverified.
Required materials and conditions: Number of tests, adjustments, prespecified order and outcome selection
Materials to obtain first: SAP, complete results and multiplicity/change information
Further research: Research separately reporting multiple outcomes and the primary analysis. This is a proposal; no new search, calculation or trial was performed in the recorded production.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Original information and analysis scope for Number of tests, adjustments, prespecified order and outcome selection must be available, with unverified information distinguished. Preserved wording is linked here; prior content review remains incomplete.
Why this condition is needed: Distinguish Number of tests, adjustments, prespecified order and outcome selection to link needed and currently available information for the selected question.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M08 Table 8.2.a, M04 §4.6.3; internal application; M04 §4.6.1–4.6.2 distinguish studies from reports; cohort/outcome linkage is internally applied

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N18 · 64 participants and FAS1 32/32

Current findings: The original evidence records 64 randomized participants in FAS1 (32/32). This is not converted into complete attendance/measurement at every visit/item or certification of a unique clinical participant total.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only the relevant preserved-summary information is recorded; detailed originals remain unread and prior content review is incomplete. Valid denominators by assessment visit, FAS1 definition, other populations/exclusion criteria and PPS/ITT correspondence are unverified. Prior content review remains incomplete.
Reason for missing information: Valid denominators by assessment visit, FAS1 definition, other populations/exclusion criteria and PPS/ITT correspondence are unverified.
Required materials and conditions: Randomized/analysis populations and actual visit/scale-specific denominators
Materials to obtain first: Analysis-population definitions, flow and visit/factor-specific denominators
Further research: Follow-up research specifying analysis populations and endpoint denominators. This is a proposal; no new search, calculation or trial was performed in the recorded production.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Original information and analysis scope for Randomized/analysis populations and actual visit/scale-specific denominators must be available, with unverified information distinguished. Preserved wording is linked here; prior content review remains incomplete.
Why this condition is needed: Distinguish Randomized/analysis populations and actual visit/scale-specific denominators to link needed and currently available information for the selected question.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; Design-specific adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap application

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N19 · Attrition, missingness, imputation and sensitivity

Current findings: The original 64-person/FAS1 narrative is preserved. Participant counts alone do not verify no missing responses/attrition or absence of their influence.
Verification status: Unverified
Materials actually read: Summary read; external material unread
Why unverified: Information currently needed from the preserved summary is unverified. Arm-specific missingness/attrition reasons and times, imputation/model handling and sensitivity analyses are unverified. Prior content review remains incomplete.
Reason for missing information: Arm-specific missingness/attrition reasons and times, imputation/model handling and sensitivity analyses are unverified.
Required materials and conditions: Period-specific attrition, missing responses and analysis handling
Materials to obtain first: Participant flow, missing-data handling and sensitivity results
Further research: Follow-up trials disclosing the impact of missingness. This is a proposal; no new search, calculation or trial was performed in the recorded production.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Original information and analysis scope for Period-specific attrition, missing responses and analysis handling must be available, with unverified information distinguished. Preserved wording is linked here; prior content review remains incomplete.
Why this condition is needed: Distinguish Period-specific attrition, missing responses and analysis handling to link needed and currently available information for the selected question.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; Design-specific adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap application

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N20 · Original UMIN identifier and registry/plan access

Current findings: The original registry-identifier field is UMIN000051261. It is preserved unchanged without upgrading it to external registry verification or reading of prespecified plans.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only the relevant preserved-summary information is recorded; detailed originals remain unread and prior content review is incomplete. Registry dates/amendments, pre-recruitment plans, complete protocol/SAP and correspondence to reports remain unread. Prior content review remains incomplete.
Reason for missing information: Registry dates/amendments, pre-recruitment plans, complete protocol/SAP and correspondence to reports remain unread.
Required materials and conditions: Registry identifier and actual reading scope for preregistration/protocol/SAP
Materials to obtain first: UMIN registry history, protocol and SAP
Further research: Follow-up research publicly linking planned and actual primary analyses. This is a proposal; no new search, calculation or trial was performed in the recorded production.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Original information and analysis scope for Registry identifier and actual reading scope for preregistration/protocol/SAP must be available, with unverified information distinguished. Preserved wording is linked here; prior content review remains incomplete.
Why this condition is needed: Distinguish Registry identifier and actual reading scope for preregistration/protocol/SAP to link needed and currently available information for the selected question.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: Data collection and selection principles in M04 §4.5–4.6; separation of access from reading and the hyperlink contract are internally designed; M08 Table 8.2.a, M04 §4.6.3; internal application; M04 §4.5, §4.6.3; limits of this material conversion reflect the review scope and internal design

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N21 · Concurrent sleep/lifestyle and medication exposure

Current findings: The original scope is a 12-week comparison in healthy adults dissatisfied with sleep. It does not establish identical or fully controlled lifestyle, medication and sleep conditions.
Verification status: Unverified
Materials actually read: Summary read; external material unread
Why unverified: Information currently needed from the preserved summary is unverified. Concurrent medication, diet, sleep/lifestyle, waking conditions, other interventions, arm differences and handling are unverified. Prior content review remains incomplete.
Reason for missing information: Concurrent medication, diet, sleep/lifestyle, waking conditions, other interventions, arm differences and handling are unverified.
Required materials and conditions: Arm-specific lifestyle, concurrent medication, sleep management and exposure differences
Materials to obtain first: Concurrent exposures, lifestyle/sleep records and analyses
Further research: Follow-up comparative research disclosing concurrent conditions. This is a proposal; no new search, calculation or trial was performed in the recorded production.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Original information and analysis scope for Arm-specific lifestyle, concurrent medication, sleep management and exposure differences must be available, with unverified information distinguished. Preserved wording is linked here; prior content review remains incomplete.
Why this condition is needed: Distinguish Arm-specific lifestyle, concurrent medication, sleep management and exposure differences to link needed and currently available information for the selected question.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M03 §3.2.3, M08 §8.2.2–8.2.3; own application; M03 §3.2.2–3.2.3; reverse-direction labels and test adaptations are our own design

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N22 · Declaration of no specific funding

Current findings: The original records the paper's statement that no specific funding was received. This is not converted into absence of product support, employee participation or all conflicts of interest.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only the relevant preserved-summary information is recorded; detailed originals remain unread and prior content review is incomplete. Original funding disclosures, other support/writing/publication costs and complete roles/COI remain unread. Prior content review remains incomplete.
Reason for missing information: Original funding disclosures, other support/writing/publication costs and complete roles/COI remain unread.
Required materials and conditions: Cash research grants versus other funding/support and COI
Materials to obtain first: Original funding, support, medical-writing/publication-cost and COI disclosures
Further research: Research separately disclosing funding, noncash support and involvement. This is a proposal; no new search, calculation or trial was performed in the recorded production.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Original information and analysis scope for Cash research grants versus other funding/support and COI must be available, with unverified information distinguished. Preserved wording is linked here; prior content review remains incomplete.
Why this condition is needed: Distinguish Cash research grants versus other funding/support and COI to link needed and currently available information for the selected question.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: Chamgap independence/attribution conditions. The referenced official method sections do not certify every detail of these items; Data collection/selection principles in M04 §4.5–4.6; Access/reading separation and hyperlink rules are Chamgap design

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N23 · Fujicco provision of study food

Current findings: The original statement that Fujicco provided study food to the contract site is preserved. Provision alone does not verify all quality/support details or placebo supply.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only the relevant preserved-summary information is recorded; detailed originals remain unread and prior content review is incomplete. Provision contracts, batches/quality, support scope and contractor roles/decision authority are unverified. Prior content review remains incomplete.
Reason for missing information: Provision contracts, batches/quality, support scope and contractor roles/decision authority are unverified.
Required materials and conditions: Company product support and provision to the contract site
Materials to obtain first: Study-food provision, contract-site agreements and product information
Further research: Research disclosing product-support roles and scope. This is a proposal; no new search, calculation or trial was performed in the recorded production.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Original information and analysis scope for Company product support and provision to the contract site must be available, with unverified information distinguished. Preserved wording is linked here; prior content review remains incomplete.
Why this condition is needed: Distinguish Company product support and provision to the contract site to link needed and currently available information for the selected question.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: Chamgap’s own independence/attribution conditions. Official methodological sections used in this pilot do not guarantee every detailed item; M03 §3.2.2–3.2.3; reverse-direction labels and testing adaptations are internally designed

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N24 · Employee authors and study roles

Current findings: The original records R.A., T.M. and K.M. as Fujicco employees who participated in conceptualization, methods, analysis, data management and drafting. Independence is not newly certified.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only the relevant preserved-summary information is recorded; detailed originals remain unread and prior content review is incomplete. Original contributions/COI, data access, publication decisions and all external-analysis roles remain unread. Prior content review remains incomplete.
Reason for missing information: Original contributions/COI, data access, publication decisions and all external-analysis roles remain unread.
Required materials and conditions: Author affiliations versus design/analysis/management/writing participation
Materials to obtain first: Original author-contribution, COI and analysis/publication-role disclosures
Further research: Follow-up research separately disclosing company and external-investigator roles. This is a proposal; no new search, calculation or trial was performed in the recorded production.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Original information and analysis scope for Author affiliations versus design/analysis/management/writing participation must be available, with unverified information distinguished. Preserved wording is linked here; prior content review remains incomplete.
Why this condition is needed: Distinguish Author affiliations versus design/analysis/management/writing participation to link needed and currently available information for the selected question.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: Chamgap's own conditions for independence and attribution. The official methodological sections used in this example do not validate every detail of these items.

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N25 · One report, the same trial and independent replication

Current findings: S01 Akagi 2025 is one manufacturer-linked 64-person trial. Its two arms, multiple factors/times, citation/registry and sibling sheets are not added as separate independent trials/participants.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only the relevant preserved-summary information is recorded; detailed originals remain unread and prior content review is incomplete. Independent confirming reports for the same application/endpoint and unique clinical trial/participant totals are not established. Prior content review remains incomplete.
Reason for missing information: Independent confirming reports for the same application/endpoint and unique clinical trial/participant totals are not established.
Required materials and conditions: Report-to-trial-to-arm/time/scale relationships and independent research
Materials to obtain first: Report/registry cohort relationships and original independent-trial reports
Further research: Independent follow-up comparative research specifying the same selected endpoint. This is a proposal; no new search, calculation or trial was performed in the recorded production.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Original information and analysis scope for Report-to-trial-to-arm/time/scale relationships and independent research must be available, with unverified information distinguished. Preserved wording is linked here; prior content review remains incomplete.
Why this condition is needed: Distinguish Report-to-trial-to-arm/time/scale relationships and independent research to link needed and currently available information for the selected question.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: Study/report distinction in M04 §4.6.1–4.6.2; Cohort/outcome linkage is Chamgap application; M04 §4.6.1–4.6.2 and M15 §15.3.1; Chamgap application

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N26 · Persistence and scope of other products/constituents

Current findings: The claim is limited to one rising-sleepiness score for a particular seed-coat extract. It is not broadened to whole black soybeans, ordinary soy foods, individual polyphenols, other sleep effects or long-term cognitive effects.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only the relevant preserved-summary information is recorded; detailed originals remain unread and prior content review is incomplete. Persistence/discontinuation follow-up beyond 12 weeks and direct comparisons of other formulations/populations/individual constituents are unverified. Prior content review remains incomplete.
Reason for missing information: Persistence/discontinuation follow-up beyond 12 weeks and direct comparisons of other formulations/populations/individual constituents are unverified.
Required materials and conditions: Selected 12-week factor versus long-term/general-food and constituent effects
Materials to obtain first: Follow-up, formulation/population and constituent-attribution trial information
Further research: Follow-up research distinguishing persistence from direct constituent/formulation applicability. This is a proposal; no new search, calculation or trial was performed in the recorded production.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Original information and analysis scope for Selected 12-week factor versus long-term/general-food and constituent effects must be available, with unverified information distinguished. Preserved wording is linked here; prior content review remains incomplete.
Why this condition is needed: Distinguish Selected 12-week factor versus long-term/general-food and constituent effects to link needed and currently available information for the selected question.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M03 §3.2.1–3.2.4; dose, persistence and effect-modification details are custom design; M03 §3.2.4; custom extension boundary; M03 §3.2.2–3.2.3; reverse-direction labeling and test adaptation are custom design

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N27 · Original safety records and rare/long-term harms

Current findings: The parent good safety status and original record of no adverse events reported over 12 weeks are preserved. The original states that a 64-person trial cannot exclude rare or long-term harms.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only the relevant preserved-summary information is recorded; detailed originals remain unread and prior content review is incomplete. Collection/adjudication, arm-specific frequencies/denominators, discontinuations, rare/long-term harms and safety in other populations are unverified. Prior content review remains incomplete.
Reason for missing information: Collection/adjudication, arm-specific frequencies/denominators, discontinuations, rare/long-term harms and safety in other populations are unverified.
Required materials and conditions: Adverse-event collection, arm-specific denominators/frequency and follow-up scope
Materials to obtain first: Adverse-event tables, collection, discontinuation and long-term follow-up information
Further research: Research specifying harm collection and long-term/other-population scope. This is a proposal; no new search, calculation or trial was performed in the recorded production.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Original information and analysis scope for Adverse-event collection, arm-specific denominators/frequency and follow-up scope must be available, with unverified information distinguished. Preserved wording is linked here; prior content review remains incomplete.
Why this condition is needed: Distinguish Adverse-event collection, arm-specific denominators/frequency and follow-up scope to link needed and currently available information for the selected question.
Application exceptions: Complements safety-data gaps for the selected subclaim. Intermediate/final skin hydration, self-reported sleepiness or parent cautionary wording are not used to judge safety or create harm-incidence estimates/new use instructions.
Referenced methods: M19 §19.1.2–19.2.4; detailed distinctions are Chamgap’s own design; M19 §19.1.2–19.2.4; Chamgap application; M19 §19.1.2–19.2.4; Chamgap application; M19 §19.1.2–19.2.4; Chamgap application

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N28 · Parent/subclaim, Korean/English, dates and history

Current findings: Parent C50, B/P/R1/I0/E+/B1, unrecorded precision, three false flags, empty grade-override reasons and the subclaim C grade/note are preserved. Bilingual text, 2026-08-26, empty corrections/deliberation and historical cross-checks are not inherited as current review.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only the relevant preserved-summary information is recorded; detailed originals remain unread and prior content review is incomplete. The subclaim lacks score/status/axes. They are not filled from parent values, and no new scores/verdicts are created. Prior content review remains incomplete.
Reason for missing information: The subclaim lacks score/status/axes. They are not filled from parent values, and no new scores/verdicts are created.
Required materials and conditions: Original scores/axes, evidence date, corrections and cross-check narrative
Materials to obtain first: Corrections, versions and user correction comments
Further research: Research distinguishing original values/history from applicability of new materials. This is a proposal; no new search, calculation or trial was performed in the recorded production.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Original information and analysis scope for Original scores/axes, evidence date, corrections and cross-check narrative must be available, with unverified information distinguished. Preserved wording is linked here; prior content review remains incomplete.
Why this condition is needed: Distinguish Original scores/axes, evidence date, corrections and cross-check narrative to link needed and currently available information for the selected question.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design; M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are internally designed

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N29 · Actual summary reading, links and updates

Current findings: The complete preserved summary and bibliography were used in production, and links were preserved. Original paper/figures, registry, protocol, SAP and support/COI disclosures remain unread; access and link testing were not attempted in that production.
Verification status: Partly verified
Materials actually read: Summary read; external material unread
Why unverified: Only the relevant preserved-summary information is recorded; detailed originals remain unread and prior content review is incomplete. External content, exact values and actual access availability are unverified. Prior content review remains incomplete.
Reason for missing information: External content, exact values and actual access availability are unverified.
Required materials and conditions: Preserved-summary reading versus access to external originals/figures/registry/plans
Materials to obtain first: Original paper/figures, registry, protocol, SAP and support/COI materials or user comments
Further research: Research updating records while distinguishing actual acquisition, dates and scope. This is a proposal; no new search, calculation or trial was performed in the recorded production.
Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.
Conditions for verification: Original information and analysis scope for Preserved-summary reading versus access to external originals/figures/registry/plans must be available, with unverified information distinguished. Preserved wording is linked here; prior content review remains incomplete.
Why this condition is needed: Distinguish Preserved-summary reading versus access to external originals/figures/registry/plans to link needed and currently available information for the selected question.
Application exceptions: Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.
Referenced methods: M04 §4.5–4.6 material collection/selection principles; acquisition/reading separation and hyperlink specifications are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design

Related sources S01