# Black soybean seed-coat extract × Sleepiness-on-rising score Verdict 2978 · Evidence Check Stored-material review date: Not recorded Original evidence cut-off: 2026-08-26 Review-criteria version: 1.0 Public page/material preparation date: 2026-10-14 Clinical papers were not read directly; existing review summaries were checked. No new clinical-literature search was performed. Unverified does not mean that research is absent or that there is no effect. ## Assessment scope - Population: 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 ## Checklist items ### N01 · Selected rising-sleepiness question and original grade Verification status: Partly verified Reading scope: Summary read; external material unread - 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. - 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. - 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. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - 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 Verification status: Partly verified Reading scope: Summary read; external material unread - 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. - 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. - 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. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - 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 Verification status: Partly verified Reading scope: Summary read; external material unread - 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. - 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. - 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. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - 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 Verification status: Partly verified Reading scope: Summary read; external material unread - 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. - 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. - 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. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - 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 Verification status: Partly verified Reading scope: Summary read; external material unread - 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. - 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. - 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. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - 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 - Related sources: S01 ### N06 · Randomization and 32/32 assignment Verification status: Partly verified Reading scope: Summary read; external material unread - 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. - 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. - 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. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - Referenced methods: M08 §8.1–8.2.3; Internal application; M03 §3.2.1; Detailed population conditions are internally designed - Related sources: S01 ### N07 · Blinding and self-report expectations Verification status: Partly verified Reading scope: Summary read; external material unread - 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. - 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. - 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. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - 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 - Related sources: S01 ### N08 · OSA-MA factor and score definitions Verification status: Partly verified Reading scope: Summary read; external material unread - 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. - 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. - 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. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - 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 - Related sources: S01 ### N09 · 12-week change and waking assessment time Verification status: Partly verified Reading scope: Summary read; external material unread - 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. - 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. - 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. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - 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 - Related sources: S01 ### N10 · Positive full-FAS1 result Verification status: Partly verified Reading scope: Summary read; external material unread - 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. - 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. - 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. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - 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. - Related sources: S01 ### N11 · Figure-based estimated marginal means and SE Verification status: Partly verified Reading scope: Summary read; external material unread - 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. - 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. - 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. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - 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 - Related sources: S01 ### N12 · Effect size, CI and meaningful change Verification status: Partly verified Reading scope: Summary read; external material unread - 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. - 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. - 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. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - 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 - Related sources: S01 ### N13 · Within/between-group contrasts and adjusted models Verification status: Partly verified Reading scope: Summary read; external material unread - 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. - 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. - 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. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - 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 - Related sources: S01 ### N14 · Primary-endpoint and analysis-population hierarchy Verification status: Partly verified Reading scope: Summary read; external material unread - 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. - 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. - 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. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - 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 - Related sources: S01 ### N15 · Male and other subgroups Verification status: Partly verified Reading scope: Summary read; external material unread - 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. - 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. - 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. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - 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 Verification status: Partly verified Reading scope: Summary read; external material unread - 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. - 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. - 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. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - 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 - Related sources: S01 ### N17 · Multiple factors, time points and analyses Verification status: Unverified Reading scope: Summary read; external material unread - 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. - 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. - 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. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - 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 - Related sources: S01 ### N18 · 64 participants and FAS1 32/32 Verification status: Partly verified Reading scope: Summary read; external material unread - 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. - 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. - 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. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - 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 - Related sources: S01 ### N19 · Attrition, missingness, imputation and sensitivity Verification status: Unverified Reading scope: Summary read; external material unread - 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. - 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. - 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. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - 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 - Related sources: S01 ### N20 · Original UMIN identifier and registry/plan access Verification status: Partly verified Reading scope: Summary read; external material unread - 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. - 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. - 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. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - 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 - Related sources: S01 ### N21 · Concurrent sleep/lifestyle and medication exposure Verification status: Unverified Reading scope: Summary read; external material unread - 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. - 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. - 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. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - 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 - Related sources: S01 ### N22 · Declaration of no specific funding Verification status: Partly verified Reading scope: Summary read; external material unread - 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. - 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. - 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. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - 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 - Related sources: S01 ### N23 · Fujicco provision of study food Verification status: Partly verified Reading scope: Summary read; external material unread - 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. - 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. - 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. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - 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 - Related sources: S01 ### N24 · Employee authors and study roles Verification status: Partly verified Reading scope: Summary read; external material unread - 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. - 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. - 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. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - 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. - Related sources: S01 ### N25 · One report, the same trial and independent replication Verification status: Partly verified Reading scope: Summary read; external material unread - 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. - 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. - 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. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - 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 - Related sources: S01 ### N26 · Persistence and scope of other products/constituents Verification status: Partly verified Reading scope: Summary read; external material unread - 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. - 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. - 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. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - 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 - Related sources: S01 ### N27 · Original safety records and rare/long-term harms Verification status: Partly verified Reading scope: Summary read; external material unread - 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. - 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. - 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. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - 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 - Related sources: S01 ### N28 · Parent/subclaim, Korean/English, dates and history Verification status: Partly verified Reading scope: Summary read; external material unread - 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. - 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. - 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. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - 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 - Related sources: S01 ### N29 · Actual summary reading, links and updates Verification status: Partly verified Reading scope: Summary read; external material unread - 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. - 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. - 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. - Remaining uncertainty: This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review. - 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 ## Evidence and sources ### S01 Akagi R et al. 2025 [PubMed](https://pubmed.ncbi.nlm.nih.gov/40501501/) Materials actually read: Summary read; external material unread Findings recorded in the summary: Improved versus placebo in full FAS1, P<0.05; exact group values and 95% CI not provided in the text Record level: Outcome wording in the stored summary 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. | 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. | ## Review criteria and methods These are Chamgap's own application conditions, informed by the relevant sections of official methodological guidance. They do not constitute official assessment-tool certification or a new efficacy score. - M03 [Cochrane Handbook 6.5 (2024), chapter updated 2023-08](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03) · §3.1, §3.2.1–3.2.3, MECIR C5/C7/C13 · Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions. · 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](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04) · §4.5, §4.6.1–4.6.3, MECIR C42 · Distinguish studies from reports and link them; do not omit a study solely because results are unreported. · Preserved method HTML copies; no current method-content re-review or official tool execution - M08 [Cochrane Handbook 6.5 (2024), chapter updated 2019-10](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08) · §8.1–8.2.3, Table 8.2.a · Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting. · Preserved method HTML copies; no current method-content re-review or official tool execution - M15 [Cochrane Handbook 6.5 (2024), chapter updated 2023-08](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15) · §15.2.4, §15.3.1–15.3.3 · Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision. · Preserved method HTML copies; no current method-content re-review or official tool execution - M19 [Cochrane Handbook 6.5 (2024), chapter updated 2019-10](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19) · §19.1.2, §19.2.1–19.2.4 · Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates. · 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/materials 1.0. Public pages and materials were created from the existing 29 items. No new clinical search, verification-status change or scoring was performed.