{ "schema_version": "chamgap-public-evidence-check-1.0", "public_id": "v2978-s0", "verdict_number": "2978", "title": "Black soybean seed-coat extract × Sleepiness-on-rising score", "view_version": "1.0", "view_created_date": "2026-10-14", "criteria_version": "1.0", "criteria_date": "2026-10-06", "review_date": null, "legacy_evidence_date": "2026-08-26", "review_scope": { "materials_read": "Existing review summaries and stored records of methodological application", "clinical_papers_directly_read": false, "new_clinical_search": false, "limitation": "The whole stored parent-verdict summary and selected subclaim were read for production. External papers, abstracts, full texts, registry, protocol, SAP and funding disclosures were not separately read or accessed. Historical review records are not inherited as current clinical verification or a new verdict.", "date_meaning": "This is the date the stored materials were checked, not the date of a new search of the clinical literature." }, "claim_context": { "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.", "intervention": "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.", "endpoint": "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.", "excluded_extensions": [ "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" ] }, "requirements": [ { "item_id": "N01", "question_type": "Evidence condition", "question": "Selected rising-sleepiness question and original grade", "needed": "Selected original wording/grade versus parent score/axes", "role": "Required", "role_reason": "Distinguish Selected original wording/grade versus parent score/axes to link needed and currently available information for the selected question.", "application_exception": "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.", "criterion": "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.", "basis": "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", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_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.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "The subclaim score, status and axes are absent. No sleep effect broader than the original scope is created.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original selected subclaim and parent verdict, and user correction comments" }, { "item_id": "N02", "question_type": "Evidence condition", "question": "Healthy Japanese adults dissatisfied with sleep", "needed": "Actual eligibility/recruitment, sleep-dissatisfaction definition and population characteristics", "role": "Required", "role_reason": "Distinguish Actual eligibility/recruitment, sleep-dissatisfaction definition and population characteristics to link needed and currently available information for the selected question.", "application_exception": "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.", "criterion": "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.", "basis": "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", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_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.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Detailed eligibility, age/sex, baseline scales, sleep-disorder diagnoses/exclusions and recruitment are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Eligibility/recruitment, baseline characteristics and population definitions" }, { "item_id": "N03", "question_type": "Evidence condition", "question": "Identity of the study seed-coat extract", "needed": "Ingredients, formulation and standardization of the black soybean seed-coat extract", "role": "Required", "role_reason": "Distinguish Ingredients, formulation and standardization of the black soybean seed-coat extract to link needed and currently available information for the selected question.", "application_exception": "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.", "criterion": "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.", "basis": "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", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_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.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Extraction/standardization, actual constituent content, product specifications/batches and correspondence to other formulations are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Study-food ingredients and manufacturing/standardization information" }, { "item_id": "N04", "question_type": "Evidence condition", "question": "Actual placebo comparison conditions", "needed": "Placebo composition, sensory/contact matching and expectations", "role": "Required", "role_reason": "Distinguish Placebo composition, sensory/contact matching and expectations to link needed and currently available information for the selected question.", "application_exception": "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.", "criterion": "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.", "basis": "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", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Follow-up trials disclosing comparison conditions. This is a proposal; no new search, calculation or trial was performed in the recorded production.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Placebo ingredients, appearance/taste, contact/instructions and blinding maintenance are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Placebo composition, sensory/contact matching and blinding information" }, { "item_id": "N05", "question_type": "Evidence condition", "question": "Study exposure and 12-week duration", "needed": "Original 100 mg after-evening-meal exposure for 12 weeks and actual adherence", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_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.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Exact daily frequency, cumulative exposure, arm-specific adherence/discontinuation, batches and actual receipt records are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Exposure/adherence, discontinuation and study-food records" }, { "item_id": "N06", "question_type": "Evidence condition", "question": "Randomization and 32/32 assignment", "needed": "Randomization, concealment and arm-specific baseline balance", "role": "Required", "role_reason": "Distinguish Randomization, concealment and arm-specific baseline balance to link needed and currently available information for the selected question.", "application_exception": "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.", "criterion": "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.", "basis": "M08 §8.1–8.2.3; Internal application; M03 §3.2.1; Detailed population conditions are internally designed", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Proposed follow-up trial disclosing allocation procedures; no new investigation, calculation or trial was performed in this production.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original 64 participants assigned 32/32 and randomized-design label are preserved without upgrading them to verification of the full allocation process.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Sequence generation, concealment, implementers, baseline balance and protocol violations are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Randomization/concealment, baseline tables and allocation information" }, { "item_id": "N07", "question_type": "Evidence condition", "question": "Blinding and self-report expectations", "needed": "Participant/assessor/analyst blinding and self-report measurement conditions", "role": "Required", "role_reason": "Distinguish Participant/assessor/analyst blinding and self-report measurement conditions to link needed and currently available information for the selected question.", "application_exception": "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.", "criterion": "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.", "basis": "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", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Research specifying blinding and scale-measurement conditions. This is a proposal; no new search, calculation or trial was performed in the recorded production.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Role-specific blinding, maintenance/unblinding, participant expectations and assessment conditions are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Blinding, questionnaire administration and assessor/analyst roles" }, { "item_id": "N08", "question_type": "Evidence condition", "question": "OSA-MA factor and score definitions", "needed": "Rising-sleepiness factor, score direction, recall/response windows and scoring", "role": "Required", "role_reason": "Distinguish Rising-sleepiness factor, score direction, recall/response windows and scoring to link needed and currently available information for the selected question.", "application_exception": "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.", "criterion": "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.", "basis": "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", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_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.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Items, score range/direction, administration timing/repetition, scoring and importance thresholds are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "OSA-MA instrument, administration/scoring and endpoint definitions" }, { "item_id": "N09", "question_type": "Evidence condition", "question": "12-week change and waking assessment time", "needed": "Selected 12-week change, waking assessment window and other time points", "role": "Required", "role_reason": "Distinguish Selected 12-week change, waking assessment window and other time points to link needed and currently available information for the selected question.", "application_exception": "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.", "criterion": "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.", "basis": "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", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Research reporting results separately by time point. This is a proposal; no new search, calculation or trial was performed in the recorded production.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Exact assessment day/time after waking, within-period repetition, earlier outcomes and change-from-baseline definitions are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Visit/questionnaire times, baseline/change definitions and all time-point results" }, { "item_id": "N10", "question_type": "Evidence condition", "question": "Positive full-FAS1 result", "needed": "Selected primary-endpoint result versus placebo in the full analysis population", "role": "Required", "role_reason": "Distinguish Selected primary-endpoint result versus placebo in the full analysis population to link needed and currently available information for the selected question.", "application_exception": "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.", "criterion": "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.", "basis": "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.", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_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.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Exact between-group estimates, P values, CIs, individual changes and clinical importance are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Full-FAS1 primary-analysis outcome tables, estimates and CIs" }, { "item_id": "N11", "question_type": "Evidence condition", "question": "Figure-based estimated marginal means and SE", "needed": "Figure displays versus raw scores/change and variance estimands", "role": "Required", "role_reason": "Distinguish Figure displays versus raw scores/change and variance estimands to link needed and currently available information for the selected question.", "application_exception": "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.", "criterion": "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.", "basis": "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", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_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.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Exact group values in the text, actual figure values/axes, model adjustment and the estimand associated with SE are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original figures/tables, estimated marginal means and model definitions" }, { "item_id": "N12", "question_type": "Evidence condition", "question": "Effect size, CI and meaningful change", "needed": "Exact magnitude, 95% CI and prespecified importance thresholds", "role": "Required", "role_reason": "Distinguish Exact magnitude, 95% CI and prespecified importance thresholds to link needed and currently available information for the selected question.", "application_exception": "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.", "criterion": "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.", "basis": "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", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_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.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Exact effect sizes, CIs and prespecified meaningful-change thresholds are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Within/between-group effect tables, CIs and importance thresholds" }, { "item_id": "N13", "question_type": "Evidence condition", "question": "Within/between-group contrasts and adjusted models", "needed": "Arm-specific change/effects versus placebo and modeling/adjustment conditions", "role": "Required", "role_reason": "Distinguish Arm-specific change/effects versus placebo and modeling/adjustment conditions to link needed and currently available information for the selected question.", "application_exception": "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.", "criterion": "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.", "basis": "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", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_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.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Within-group results, baseline adjustment, model terms/covariates, repeated measurements and change formulas are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Primary-analysis models, contrast definitions and original result tables" }, { "item_id": "N14", "question_type": "Evidence condition", "question": "Primary-endpoint and analysis-population hierarchy", "needed": "Full-FAS1 primary endpoint versus secondary/subgroup analyses", "role": "Required", "role_reason": "Distinguish Full-FAS1 primary endpoint versus secondary/subgroup analyses to link needed and currently available information for the selected question.", "application_exception": "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.", "criterion": "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.", "basis": "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", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_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.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Preregistered plans, the exact primary analysis, analysis-population/endpoint hierarchy and change history are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Registry, protocol and SAP hierarchy/analysis-population information" }, { "item_id": "N15", "question_type": "Evidence condition", "question": "Male and other subgroups", "needed": "Full-population results versus subgroups and interactions", "role": "Required", "role_reason": "Distinguish Full-population results versus subgroups and interactions to link needed and currently available information for the selected question.", "application_exception": "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.", "criterion": "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.", "basis": "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", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_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.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Subgroup denominators/values, prespecified plans, interactions, multiplicity and other subgroup results are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Full-population/subgroup tables, prespecified plans and interaction information" }, { "item_id": "N16", "question_type": "Evidence condition", "question": "Other sleep factors and temperature outcomes", "needed": "Selected factor versus other sleep/temperature outcomes and their hierarchy", "role": "Required", "role_reason": "Distinguish Selected factor versus other sleep/temperature outcomes and their hierarchy to link needed and currently available information for the selected question.", "application_exception": "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.", "criterion": "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.", "basis": "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", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_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.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Exact values/directions, times, tests and sleep-physiology results for other factors are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Complete sleep/temperature result tables and endpoint/time-point definitions" }, { "item_id": "N17", "question_type": "Evidence condition", "question": "Multiple factors, time points and analyses", "needed": "Number of tests, adjustments, prespecified order and outcome selection", "role": "Required", "role_reason": "Distinguish Number of tests, adjustments, prespecified order and outcome selection to link needed and currently available information for the selected question.", "application_exception": "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.", "criterion": "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.", "basis": "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", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_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.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "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.", "condition_status": "Unverified", "status_reason": "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.", "missingness": "Total test counts, adjustment, order and outcome selection/changes are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "SAP, complete results and multiplicity/change information" }, { "item_id": "N18", "question_type": "Evidence condition", "question": "64 participants and FAS1 32/32", "needed": "Randomized/analysis populations and actual visit/scale-specific denominators", "role": "Required", "role_reason": "Distinguish Randomized/analysis populations and actual visit/scale-specific denominators to link needed and currently available information for the selected question.", "application_exception": "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.", "criterion": "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.", "basis": "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", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_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.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Valid denominators by assessment visit, FAS1 definition, other populations/exclusion criteria and PPS/ITT correspondence are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Analysis-population definitions, flow and visit/factor-specific denominators" }, { "item_id": "N19", "question_type": "Evidence condition", "question": "Attrition, missingness, imputation and sensitivity", "needed": "Period-specific attrition, missing responses and analysis handling", "role": "Required", "role_reason": "Distinguish Period-specific attrition, missing responses and analysis handling to link needed and currently available information for the selected question.", "application_exception": "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.", "criterion": "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.", "basis": "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", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_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.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original 64-person/FAS1 narrative is preserved. Participant counts alone do not verify no missing responses/attrition or absence of their influence.", "condition_status": "Unverified", "status_reason": "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.", "missingness": "Arm-specific missingness/attrition reasons and times, imputation/model handling and sensitivity analyses are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Participant flow, missing-data handling and sensitivity results" }, { "item_id": "N20", "question_type": "Evidence condition", "question": "Original UMIN identifier and registry/plan access", "needed": "Registry identifier and actual reading scope for preregistration/protocol/SAP", "role": "Required", "role_reason": "Distinguish Registry identifier and actual reading scope for preregistration/protocol/SAP to link needed and currently available information for the selected question.", "application_exception": "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.", "criterion": "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.", "basis": "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", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_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.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "The original registry-identifier field is UMIN000051261. It is preserved unchanged without upgrading it to external registry verification or reading of prespecified plans.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Registry dates/amendments, pre-recruitment plans, complete protocol/SAP and correspondence to reports remain unread.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "UMIN registry history, protocol and SAP" }, { "item_id": "N21", "question_type": "Evidence condition", "question": "Concurrent sleep/lifestyle and medication exposure", "needed": "Arm-specific lifestyle, concurrent medication, sleep management and exposure differences", "role": "Required", "role_reason": "Distinguish Arm-specific lifestyle, concurrent medication, sleep management and exposure differences to link needed and currently available information for the selected question.", "application_exception": "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.", "criterion": "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.", "basis": "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", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Follow-up comparative research disclosing concurrent conditions. This is a proposal; no new search, calculation or trial was performed in the recorded production.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "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.", "condition_status": "Unverified", "status_reason": "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.", "missingness": "Concurrent medication, diet, sleep/lifestyle, waking conditions, other interventions, arm differences and handling are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Concurrent exposures, lifestyle/sleep records and analyses" }, { "item_id": "N22", "question_type": "Evidence condition", "question": "Declaration of no specific funding", "needed": "Cash research grants versus other funding/support and COI", "role": "Required", "role_reason": "Distinguish Cash research grants versus other funding/support and COI to link needed and currently available information for the selected question.", "application_exception": "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.", "criterion": "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.", "basis": "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", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_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.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Original funding disclosures, other support/writing/publication costs and complete roles/COI remain unread.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original funding, support, medical-writing/publication-cost and COI disclosures" }, { "item_id": "N23", "question_type": "Evidence condition", "question": "Fujicco provision of study food", "needed": "Company product support and provision to the contract site", "role": "Required", "role_reason": "Distinguish Company product support and provision to the contract site to link needed and currently available information for the selected question.", "application_exception": "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.", "criterion": "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.", "basis": "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", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Research disclosing product-support roles and scope. This is a proposal; no new search, calculation or trial was performed in the recorded production.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Provision contracts, batches/quality, support scope and contractor roles/decision authority are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Study-food provision, contract-site agreements and product information" }, { "item_id": "N24", "question_type": "Evidence condition", "question": "Employee authors and study roles", "needed": "Author affiliations versus design/analysis/management/writing participation", "role": "Required", "role_reason": "Distinguish Author affiliations versus design/analysis/management/writing participation to link needed and currently available information for the selected question.", "application_exception": "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.", "criterion": "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.", "basis": "Chamgap's own conditions for independence and attribution. The official methodological sections used in this example do not validate every detail of these items.", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_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.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Original contributions/COI, data access, publication decisions and all external-analysis roles remain unread.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original author-contribution, COI and analysis/publication-role disclosures" }, { "item_id": "N25", "question_type": "Evidence condition", "question": "One report, the same trial and independent replication", "needed": "Report-to-trial-to-arm/time/scale relationships and independent research", "role": "Required", "role_reason": "Distinguish Report-to-trial-to-arm/time/scale relationships and independent research to link needed and currently available information for the selected question.", "application_exception": "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.", "criterion": "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.", "basis": "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", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_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.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Independent confirming reports for the same application/endpoint and unique clinical trial/participant totals are not established.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Report/registry cohort relationships and original independent-trial reports" }, { "item_id": "N26", "question_type": "Evidence condition", "question": "Persistence and scope of other products/constituents", "needed": "Selected 12-week factor versus long-term/general-food and constituent effects", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "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", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_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.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Persistence/discontinuation follow-up beyond 12 weeks and direct comparisons of other formulations/populations/individual constituents are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Follow-up, formulation/population and constituent-attribution trial information" }, { "item_id": "N27", "question_type": "Harm-information gaps supplementing the efficacy table", "question": "Original safety records and rare/long-term harms", "needed": "Adverse-event collection, arm-specific denominators/frequency and follow-up scope", "role": "Supplementary", "role_reason": "Distinguish Adverse-event collection, arm-specific denominators/frequency and follow-up scope to link needed and currently available information for the selected question.", "application_exception": "Complements safety-data gaps for the selected subclaim. 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This is a proposal; no new search, calculation or trial was performed in the recorded production.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Collection/adjudication, arm-specific frequencies/denominators, discontinuations, rare/long-term harms and safety in other populations are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Adverse-event tables, collection, discontinuation and long-term follow-up information" }, { "item_id": "N28", "question_type": "Evidence condition", "question": "Parent/subclaim, Korean/English, dates and history", "needed": "Original scores/axes, evidence date, corrections and cross-check narrative", "role": "Required", "role_reason": "Distinguish Original scores/axes, evidence date, corrections and cross-check narrative to link needed and currently available information for the selected question.", "application_exception": "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.", "criterion": "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.", "basis": "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", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_research": "Research distinguishing original values/history from applicability of new materials. 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They are not filled from parent values, and no new scores/verdicts are created.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Corrections, versions and user correction comments" }, { "item_id": "N29", "question_type": "Evidence condition", "question": "Actual summary reading, links and updates", "needed": "Preserved-summary reading versus access to external originals/figures/registry/plans", "role": "Required", "role_reason": "Distinguish Preserved-summary reading versus access to external originals/figures/registry/plans to link needed and currently available information for the selected question.", "application_exception": "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.", "criterion": "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.", "basis": "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", "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review", "proposed_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.", "current_reports": [ "S01" ], "existence": "Stored summary/bibliography links; external identity unverified", "acquired_read": "Summary read; external material unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "External content, exact values and actual access availability are unverified.", "uncertainty": "This record links preserved-summary statements; it does not establish external-paper comparison, a new efficacy verdict or completed content review.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original paper/figures, registry, protocol, SAP and support/COI materials or user comments" } ], "reports": [ { "report_id": "S01", "title": "Akagi R et al. 2025", "url": "https://pubmed.ncbi.nlm.nih.gov/40501501/", "report_type": "Double-blind randomized placebo-controlled parallel trial", "existence": "Stored bibliography exists; external identity unverified", "acquired_read": "Summary read; external material unread", "study_family": "RG2978-AKAGI-2025", "independent_replication": null, "observed_result": "Improved versus placebo in full FAS1, P<0.05; exact group values and 95% CI not provided in the text", "result_level": "Outcome wording in the stored summary", "source_evidence_date": "2026-08-26", "materials": [ { "material_type": "Stored summary", "public_status": "Stored file", "access_status": "Stored summary", "acquired": true, "actually_read": "Summary read", "as_of": "2026-08-26", "qualification": "Only stored-summary and bibliographic content was used for production. External material verification/review is not complete." }, { "material_type": "External paper", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Registration material", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Protocol", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Statistical analysis plan", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." }, { "material_type": "Funding, product-support and COI material", "public_status": "Public availability unverified; only bibliography links preserved", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "No external access or click testing was performed in the original preparation. URLs or registration identifiers alone do not upgrade acquisition/reading status." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/40501501/" } ] } ], "method_sources": [ { "id": "M03", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03", "section": "§3.1, §3.2.1–3.2.3, MECIR C5/C7/C13", "official_principle": "Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.", "review_level": "Preserved method HTML copies; no current method-content re-review or official tool execution" }, { "id": "M04", "version": "Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04", "section": "§4.5, §4.6.1–4.6.3, MECIR C42", "official_principle": "Distinguish studies from reports and link them; do not omit a study solely because results are unreported.", "review_level": "Preserved method HTML copies; no current method-content re-review or official tool execution" }, { "id": "M08", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08", "section": "§8.1–8.2.3, Table 8.2.a", "official_principle": "Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.", "review_level": "Preserved method HTML copies; no current method-content re-review or official tool execution" }, { "id": "M15", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15", "section": "§15.2.4, §15.3.1–15.3.3", "official_principle": "Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.", "review_level": "Preserved method HTML copies; no current method-content re-review or official tool execution" }, { "id": "M19", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19", "section": "§19.1.2, §19.2.1–19.2.4", "official_principle": "Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.", "review_level": "Preserved method HTML copies; no current method-content re-review or official tool execution" } ], "status_dictionary": { "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." }, "study_overlap": { "state": "Unverified", "unique_trial_count": null, "unique_participant_count": null, "reason": "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." }, "history": [ { "date": "2026-10-14", "kind": "Separation of public-facing pages and materials", "view_version": "1.0", "change": "Public pages and materials were created from the existing 29 items. No new clinical search, verification-status change or scoring was performed." } ], "language": "en", "translation_date": "2026-10-14" }