{ "schema_version": "chamgap-public-evidence-check-1.0", "public_id": "v2978-s1", "verdict_number": "2978", "title": "Black soybean seed-coat extract × Overall sleep quality — Rising-sleepiness factor and gaps in the broader claim", "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": "64 healthy Japanese adults dissatisfied with sleep quality; FAS1 32/32. Baseline status and completion/attrition details are unverified.", "intervention": "100 mg black soybean seed-coat polyphenol extract, distinguished from ordinary black soybeans/soy foods", "dose": "Original study exposure: 100 mg after the evening meal for 12 weeks. No cumulative-dose calculation or extract/product-intake/sleep instructions.", "comparator": "Placebo, 32 participants; actual composition, blinding and concurrent exposures in both arms are unverified.", "endpoint": "Selected overall sleep quality: the broader claim is unverified, distinguished from the parent full-FAS1 primary 12-week change in OSA-MA rising sleepiness.", "duration": "12 weeks; actual exposure/adherence, endpoint-specific observations/analyses and persistence/long-term follow-up after completion remain unverified in detail", "excluded_extensions": [ "Repurposing narrow morning-drowsiness/questionnaire symptom-day outcomes as general sleep, objective sleep, confirmed-infection prevention or clinical effects", "Deriving new quantitative effects/CIs/adjusted values or invented examples from figure/text reporting limits, P values or denominators", "Substituting FAS1/PPS, allocation/completion, people/days/symptoms/time points as the same denominator", "Adding the same report, people, groups, time points, scales, bibliography or sibling sheets as new independent trials/participants", "New grades/reassessment/independence certification or extract/product/drink-consumption, sleep/cold-management, infection-prevention or treatment-replacement instructions" ] }, "requirements": [ { "item_id": "N01", "question_type": "Evidence condition", "question": "Which existing overall-sleep claim is being carried over?", "needed": "Selected subclaim wording/grade and the narrower parent result", "role": "Required", "role_reason": "Needed to connect Selected subclaim wording/grade and the narrower parent result with the selected question, actual population/intervention/comparator, endpoints/hierarchy/estimands, denominators/duration, reports and harms.", "application_exception": "Distinguish the specific rising-sleepiness factor, overall/objective sleep, other scales/temperature, primary/secondary/subgroup outcomes, multiplicity, exact effects/CIs, populations/intervention/placebo, 12-week/FAS1 denominators, company involvement and harms. Only original numbers are preserved; no new calculations, hypothetical quantities, effects/CIs, grades/regrading, independence certification or extract/product/drink-intake, sleep/cold-management, infection-prevention or treatment-substitution instructions.", "criterion": "Show original information about Selected subclaim wording/grade and the narrower parent result, the selected subclaim/parent boundary, direct endpoints/estimands, denominators and scope of external reading together.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_research": "Materials needed: Exact overall-sleep definition, population, time point, direct comparisons and user review of the question boundary are needed. Parent scores are not used to fill subclaim values. Only information requests/research needs are recorded; no new lookup or research is performed in this production.", "current_reports": [ "R01" ], "existence": "The original parent-summary display record is preserved; public availability, acquisition and actual reading of detailed external materials remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "The selected claim is improved overall sleep quality, originally graded ?. Its note limits this verdict to one sleepiness-on-rising score rather than the broader claim. Absent subclaim score/status/axes are distinguished from parent C50.", "condition_status": "Partly verified", "status_reason": "Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.", "missingness": "Exact overall-sleep definition, population, time point, direct comparisons and user review of the question boundary are needed. Parent scores are not used to fill subclaim values.", "uncertainty": "External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Exact overall-sleep definition, population, time point, direct comparisons and user review of the question boundary are needed. Parent scores are not used to fill subclaim values." }, { "item_id": "N02", "question_type": "Evidence condition", "question": "What sleep condition characterized the participants?", "needed": "Healthy adults dissatisfied with sleep quality", "role": "Required", "role_reason": "Needed to connect Healthy adults dissatisfied with sleep quality with the selected question, actual population/intervention/comparator, endpoints/hierarchy/estimands, denominators/duration, reports and harms.", "application_exception": "Distinguish the specific rising-sleepiness factor, overall/objective sleep, other scales/temperature, primary/secondary/subgroup outcomes, multiplicity, exact effects/CIs, populations/intervention/placebo, 12-week/FAS1 denominators, company involvement and harms. Only original numbers are preserved; no new calculations, hypothetical quantities, effects/CIs, grades/regrading, independence certification or extract/product/drink-intake, sleep/cold-management, infection-prevention or treatment-substitution instructions.", "criterion": "Show original information about Healthy adults dissatisfied with sleep quality, the selected subclaim/parent boundary, direct endpoints/estimands, denominators and scope of external reading together.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_research": "Materials needed: Actual eligibility/exclusions, baseline sleep/health, age/sex, comorbidities/medication and direct comparisons in other populations are needed. Only information requests/research needs are recorded; no new lookup or research is performed in this production.", "current_reports": [ "R01" ], "existence": "The original parent-summary display record is preserved; public availability, acquisition and actual reading of detailed external materials remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "Participants were 64 healthy Japanese adults dissatisfied with sleep quality. Applicability is not newly extended to diagnosed insomnia/sleep disorders or all ages/regions.", "condition_status": "Partly verified", "status_reason": "Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.", "missingness": "Actual eligibility/exclusions, baseline sleep/health, age/sex, comorbidities/medication and direct comparisons in other populations are needed.", "uncertainty": "External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Actual eligibility/exclusions, baseline sleep/health, age/sex, comorbidities/medication and direct comparisons in other populations are needed." }, { "item_id": "N03", "question_type": "Evidence condition", "question": "What extract exposure was studied?", "needed": "100 mg black soybean seed-coat extract versus ordinary foods", "role": "Required", "role_reason": "Needed to connect 100 mg black soybean seed-coat extract versus ordinary foods with the selected question, actual population/intervention/comparator, endpoints/hierarchy/estimands, denominators/duration, reports and harms.", "application_exception": "Distinguish the specific rising-sleepiness factor, overall/objective sleep, other scales/temperature, primary/secondary/subgroup outcomes, multiplicity, exact effects/CIs, populations/intervention/placebo, 12-week/FAS1 denominators, company involvement and harms. Only original numbers are preserved; no new calculations, hypothetical quantities, effects/CIs, grades/regrading, independence certification or extract/product/drink-intake, sleep/cold-management, infection-prevention or treatment-substitution instructions.", "criterion": "Show original information about 100 mg black soybean seed-coat extract versus ordinary foods, the selected subclaim/parent boundary, direct endpoints/estimands, denominators and scope of external reading together.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_research": "Materials needed: Original formulation, quantified constituents, product/manufacture, accompanying ingredients and adherence data are needed. Beyond identifying study exposure, no product/extract-intake or sleep instructions are supplied. Only information requests/research needs are recorded; no new lookup or research is performed in this production.", "current_reports": [ "R01" ], "existence": "The original parent-summary display record is preserved; public availability, acquisition and actual reading of detailed external materials remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "The original intervention studied 100 mg black soybean seed-coat polyphenol extract after the evening meal for 12 weeks. Original constituent descriptions including proanthocyanidins and epicatechins are preserved; the result is not treated as equivalent to ordinary black soybeans/soy foods or other extracts.", "condition_status": "Partly verified", "status_reason": "Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.", "missingness": "Original formulation, quantified constituents, product/manufacture, accompanying ingredients and adherence data are needed. Beyond identifying study exposure, no product/extract-intake or sleep instructions are supplied.", "uncertainty": "External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original formulation, quantified constituents, product/manufacture, accompanying ingredients and adherence data are needed. Beyond identifying study exposure, no product/extract-intake or sleep instructions are supplied." }, { "item_id": "N04", "question_type": "Evidence condition", "question": "What were the actual placebo and conditions in both arms?", "needed": "32/32 allocation and placebo comparison", "role": "Required", "role_reason": "Needed to connect 32/32 allocation and placebo comparison with the selected question, actual population/intervention/comparator, endpoints/hierarchy/estimands, denominators/duration, reports and harms.", "application_exception": "Distinguish the specific rising-sleepiness factor, overall/objective sleep, other scales/temperature, primary/secondary/subgroup outcomes, multiplicity, exact effects/CIs, populations/intervention/placebo, 12-week/FAS1 denominators, company involvement and harms. Only original numbers are preserved; no new calculations, hypothetical quantities, effects/CIs, grades/regrading, independence certification or extract/product/drink-intake, sleep/cold-management, infection-prevention or treatment-substitution instructions.", "criterion": "Show original information about 32/32 allocation and placebo comparison, the selected subclaim/parent boundary, direct endpoints/estimands, denominators and scope of external reading together.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_research": "Materials needed: Placebo/active implementation, allocation concealment, contact/expectations, concurrent diet/medication and sleep exposures are needed. Findings are not substituted for overall-sleep effects against other comparators. Only information requests/research needs are recorded; no new lookup or research is performed in this production.", "current_reports": [ "R01" ], "existence": "The original parent-summary display record is preserved; public availability, acquisition and actual reading of detailed external materials remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "The original records 64 participants assigned 32 each to extract and placebo. Actual placebo composition, blinding/sensory conditions and arm-specific sleep habits/other exposures are unverified.", "condition_status": "Partly verified", "status_reason": "Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.", "missingness": "Placebo/active implementation, allocation concealment, contact/expectations, concurrent diet/medication and sleep exposures are needed. Findings are not substituted for overall-sleep effects against other comparators.", "uncertainty": "External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Placebo/active implementation, allocation concealment, contact/expectations, concurrent diet/medication and sleep exposures are needed. Findings are not substituted for overall-sleep effects against other comparators." }, { "item_id": "N05", "question_type": "Evidence condition", "question": "Are 12-week results distinguished from sustained overall sleep?", "needed": "Original duration, actual exposure and post-study follow-up", "role": "Required", "role_reason": "Needed to connect Original duration, actual exposure and post-study follow-up with the selected question, actual population/intervention/comparator, endpoints/hierarchy/estimands, denominators/duration, reports and harms.", "application_exception": "Distinguish the specific rising-sleepiness factor, overall/objective sleep, other scales/temperature, primary/secondary/subgroup outcomes, multiplicity, exact effects/CIs, populations/intervention/placebo, 12-week/FAS1 denominators, company involvement and harms. Only original numbers are preserved; no new calculations, hypothetical quantities, effects/CIs, grades/regrading, independence certification or extract/product/drink-intake, sleep/cold-management, infection-prevention or treatment-substitution instructions.", "criterion": "Show original information about Original duration, actual exposure and post-study follow-up, the selected subclaim/parent boundary, direct endpoints/estimands, denominators and scope of external reading together.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_research": "Materials needed: Time-specific overall/factor results, actual exposure, follow-up and discontinuation/recurrence data are needed. Short-term specific scores are not converted into long-term sleep effects. Only information requests/research needs are recorded; no new lookup or research is performed in this production.", "current_reports": [ "R01" ], "existence": "The original parent-summary display record is preserved; public availability, acquisition and actual reading of detailed external materials remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "The original duration was 12 weeks. Details of actual exposure/adherence, discontinuation, measurement schedules, persistence after completion and direct long-term overall-sleep data are unverified. No new cumulative amounts, day counts or long-term efficacy are created.", "condition_status": "Partly verified", "status_reason": "Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.", "missingness": "Time-specific overall/factor results, actual exposure, follow-up and discontinuation/recurrence data are needed. Short-term specific scores are not converted into long-term sleep effects.", "uncertainty": "External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Time-specific overall/factor results, actual exposure, follow-up and discontinuation/recurrence data are needed. Short-term specific scores are not converted into long-term sleep effects." }, { "item_id": "N06", "question_type": "Evidence condition", "question": "Does a 64-person FAS1 mean everyone completed follow-up?", "needed": "Randomized, FAS1, completer and endpoint-specific denominators", "role": "Required", "role_reason": "Needed to connect Randomized, FAS1, completer and endpoint-specific denominators with the selected question, actual population/intervention/comparator, endpoints/hierarchy/estimands, denominators/duration, reports and harms.", "application_exception": "Distinguish the specific rising-sleepiness factor, overall/objective sleep, other scales/temperature, primary/secondary/subgroup outcomes, multiplicity, exact effects/CIs, populations/intervention/placebo, 12-week/FAS1 denominators, company involvement and harms. Only original numbers are preserved; no new calculations, hypothetical quantities, effects/CIs, grades/regrading, independence certification or extract/product/drink-intake, sleep/cold-management, infection-prevention or treatment-substitution instructions.", "criterion": "Show original information about Randomized, FAS1, completer and endpoint-specific denominators, the selected subclaim/parent boundary, direct endpoints/estimands, denominators and scope of external reading together.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_research": "Materials needed: FAS1 definitions, arm-specific flow, observation/analysis denominators and attrition/missingness reasons/handling are needed. No new attrition counts/rates or repeated-measurement totals are calculated. Only information requests/research needs are recorded; no new lookup or research is performed in this production.", "current_reports": [ "R01" ], "existence": "The original parent-summary display record is preserved; public availability, acquisition and actual reading of detailed external materials remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "The original evidence records 64 randomized participants in FAS1 (32/32). The summary does not establish FAS1 definitions, completion/attrition or time-specific observation/missingness details. Complete 12-week follow-up or identical denominators for every measure are not assumed.", "condition_status": "Partly verified", "status_reason": "Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.", "missingness": "FAS1 definitions, arm-specific flow, observation/analysis denominators and attrition/missingness reasons/handling are needed. No new attrition counts/rates or repeated-measurement totals are calculated.", "uncertainty": "External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "FAS1 definitions, arm-specific flow, observation/analysis denominators and attrition/missingness reasons/handling are needed. No new attrition counts/rates or repeated-measurement totals are calculated." }, { "item_id": "N07", "question_type": "Evidence condition", "question": "What does the primary rising-sleepiness factor measure?", "needed": "12-week change in OSA-MA sleepiness on rising", "role": "Required", "role_reason": "Needed to connect 12-week change in OSA-MA sleepiness on rising with the selected question, actual population/intervention/comparator, endpoints/hierarchy/estimands, denominators/duration, reports and harms.", "application_exception": "Distinguish the specific rising-sleepiness factor, overall/objective sleep, other scales/temperature, primary/secondary/subgroup outcomes, multiplicity, exact effects/CIs, populations/intervention/placebo, 12-week/FAS1 denominators, company involvement and harms. Only original numbers are preserved; no new calculations, hypothetical quantities, effects/CIs, grades/regrading, independence certification or extract/product/drink-intake, sleep/cold-management, infection-prevention or treatment-substitution instructions.", "criterion": "Show original information about 12-week change in OSA-MA sleepiness on rising, the selected subclaim/parent boundary, direct endpoints/estimands, denominators and scope of external reading together.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_research": "Materials needed: OSA-MA version, factors/items, score direction, measurement dates/times and relationships to overall/other scales are needed. Only information requests/research needs are recorded; no new lookup or research is performed in this production.", "current_reports": [ "R01" ], "existence": "The original parent-summary display record is preserved; public availability, acquisition and actual reading of detailed external materials remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "The original primary endpoint is 12-week change in OSA-MA sleepiness-on-rising score. It is a specific self-reported sleep-scale factor; total scores, other factors and overall sleep are not newly declared the same measure.", "condition_status": "Partly verified", "status_reason": "Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.", "missingness": "OSA-MA version, factors/items, score direction, measurement dates/times and relationships to overall/other scales are needed.", "uncertainty": "External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "OSA-MA version, factors/items, score direction, measurement dates/times and relationships to overall/other scales are needed." }, { "item_id": "N08", "question_type": "Evidence condition", "question": "Does a specific rising-sleepiness result establish overall sleep?", "needed": "Scope of the broader claim and direct outcomes", "role": "Required", "role_reason": "Needed to connect Scope of the broader claim and direct outcomes with the selected question, actual population/intervention/comparator, endpoints/hierarchy/estimands, denominators/duration, reports and harms.", "application_exception": "Distinguish the specific rising-sleepiness factor, overall/objective sleep, other scales/temperature, primary/secondary/subgroup outcomes, multiplicity, exact effects/CIs, populations/intervention/placebo, 12-week/FAS1 denominators, company involvement and harms. Only original numbers are preserved; no new calculations, hypothetical quantities, effects/CIs, grades/regrading, independence certification or extract/product/drink-intake, sleep/cold-management, infection-prevention or treatment-substitution instructions.", "criterion": "Show original information about Scope of the broader claim and direct outcomes, the selected subclaim/parent boundary, direct endpoints/estimands, denominators and scope of external reading together.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_research": "Materials needed: Prespecified direct overall-sleep endpoints, full results, denominators, effects/CIs and confirmation are needed. A narrow signal is not promoted into certification of the broader claim. Only information requests/research needs are recorded; no new lookup or research is performed in this production.", "current_reports": [ "R01" ], "existence": "The original parent-summary display record is preserved; public availability, acquisition and actual reading of detailed external materials remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "Original Korean/English text and the subclaim note limit the claim to one rising-sleepiness score rather than overall sleep improvement. Appropriate direct overall-sleep measures, full results and effects are not established within the preserved scope.", "condition_status": "Unverified", "status_reason": "Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.", "missingness": "Prespecified direct overall-sleep endpoints, full results, denominators, effects/CIs and confirmation are needed. A narrow signal is not promoted into certification of the broader claim.", "uncertainty": "External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Prespecified direct overall-sleep endpoints, full results, denominators, effects/CIs and confirmation are needed. A narrow signal is not promoted into certification of the broader claim." }, { "item_id": "N09", "question_type": "Evidence condition", "question": "Which analysis produced P<.05?", "needed": "Full-FAS1 primary result versus overall sleep", "role": "Required", "role_reason": "Needed to connect Full-FAS1 primary result versus overall sleep with the selected question, actual population/intervention/comparator, endpoints/hierarchy/estimands, denominators/duration, reports and harms.", "application_exception": "Distinguish the specific rising-sleepiness factor, overall/objective sleep, other scales/temperature, primary/secondary/subgroup outcomes, multiplicity, exact effects/CIs, populations/intervention/placebo, 12-week/FAS1 denominators, company involvement and harms. Only original numbers are preserved; no new calculations, hypothetical quantities, effects/CIs, grades/regrading, independence certification or extract/product/drink-intake, sleep/cold-management, infection-prevention or treatment-substitution instructions.", "criterion": "Show original information about Full-FAS1 primary result versus overall sleep, the selected subclaim/parent boundary, direct endpoints/estimands, denominators and scope of external reading together.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_research": "Materials needed: Original primary analysis/models, denominators, exact effects/CIs, clinical importance and separate overall-sleep data are needed. P alone is not used to derive new magnitudes/CIs. Only information requests/research needs are recorded; no new lookup or research is performed in this production.", "current_reports": [ "R01" ], "existence": "The original parent-summary display record is preserved; public availability, acquisition and actual reading of detailed external materials remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "The full-FAS1 primary rising-sleepiness score improved versus placebo, P<0.05. This P value is not copied into overall/objective sleep, subgroups or other scales. No exact P value is newly estimated.", "condition_status": "Partly verified", "status_reason": "Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.", "missingness": "Original primary analysis/models, denominators, exact effects/CIs, clinical importance and separate overall-sleep data are needed. P alone is not used to derive new magnitudes/CIs.", "uncertainty": "External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original primary analysis/models, denominators, exact effects/CIs, clinical importance and separate overall-sleep data are needed. P alone is not used to derive new magnitudes/CIs." }, { "item_id": "N10", "question_type": "Evidence condition", "question": "Are figure estimates distinguished from values absent in the text?", "needed": "Estimated marginal means ± SE versus exact values/CIs", "role": "Required", "role_reason": "Needed to connect Estimated marginal means ± SE versus exact values/CIs with the selected question, actual population/intervention/comparator, endpoints/hierarchy/estimands, denominators/duration, reports and harms.", "application_exception": "Distinguish the specific rising-sleepiness factor, overall/objective sleep, other scales/temperature, primary/secondary/subgroup outcomes, multiplicity, exact effects/CIs, populations/intervention/placebo, 12-week/FAS1 denominators, company involvement and harms. Only original numbers are preserved; no new calculations, hypothetical quantities, effects/CIs, grades/regrading, independence certification or extract/product/drink-intake, sleep/cold-management, infection-prevention or treatment-substitution instructions.", "criterion": "Show original information about Estimated marginal means ± SE versus exact values/CIs, the selected subclaim/parent boundary, direct endpoints/estimands, denominators and scope of external reading together.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_research": "Materials needed: Original figures, supplementary tables, exact group values, estimation models and effects/CIs are needed. No numerical reading/back-calculation, hypothetical examples or CI calculations are performed. Only information requests/research needs are recorded; no new lookup or research is performed in this production.", "current_reports": [ "R01" ], "existence": "The original parent-summary display record is preserved; public availability, acquisition and actual reading of detailed external materials remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "The original describes estimated marginal means ± standard errors displayed in a figure, with exact group values and 95% CIs absent from the main text. This does not establish that all figures/raw data are unavailable; figures were not newly read or digitized.", "condition_status": "Unverified", "status_reason": "Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.", "missingness": "Original figures, supplementary tables, exact group values, estimation models and effects/CIs are needed. No numerical reading/back-calculation, hypothetical examples or CI calculations are performed.", "uncertainty": "External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original figures, supplementary tables, exact group values, estimation models and effects/CIs are needed. No numerical reading/back-calculation, hypothetical examples or CI calculations are performed." }, { "item_id": "N11", "question_type": "Evidence condition", "question": "Are change, absolute values and within/between-group contrasts separated?", "needed": "Estimand for 12-week change", "role": "Required", "role_reason": "Needed to connect Estimand for 12-week change with the selected question, actual population/intervention/comparator, endpoints/hierarchy/estimands, denominators/duration, reports and harms.", "application_exception": "Distinguish the specific rising-sleepiness factor, overall/objective sleep, other scales/temperature, primary/secondary/subgroup outcomes, multiplicity, exact effects/CIs, populations/intervention/placebo, 12-week/FAS1 denominators, company involvement and harms. Only original numbers are preserved; no new calculations, hypothetical quantities, effects/CIs, grades/regrading, independence certification or extract/product/drink-intake, sleep/cold-management, infection-prevention or treatment-substitution instructions.", "criterion": "Show original information about Estimand for 12-week change, the selected subclaim/parent boundary, direct endpoints/estimands, denominators and scope of external reading together.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_research": "Materials needed: Arm-specific baseline/end/change values and estimands, baseline adjustment, repeated measurements, missing-data handling and models are needed. No new changes, ratios or effects are calculated. Only information requests/research needs are recorded; no new lookup or research is performed in this production.", "current_reports": [ "R01" ], "existence": "The original parent-summary display record is preserved; public availability, acquisition and actual reading of detailed external materials remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "The endpoint is 12-week change, and the original describes improvement versus placebo in full FAS1. Exact baseline/end values, arm-specific changes, estimands and models are unverified. Within-group improvement is not newly calculated as an additional effect versus placebo.", "condition_status": "Partly verified", "status_reason": "Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.", "missingness": "Arm-specific baseline/end/change values and estimands, baseline adjustment, repeated measurements, missing-data handling and models are needed. No new changes, ratios or effects are calculated.", "uncertainty": "External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Arm-specific baseline/end/change values and estimands, baseline adjustment, repeated measurements, missing-data handling and models are needed. No new changes, ratios or effects are calculated." }, { "item_id": "N12", "question_type": "Evidence condition", "question": "What is the hierarchy of other sleep and temperature outcomes?", "needed": "Primary factor versus secondary sleep/temperature endpoints", "role": "Required", "role_reason": "Needed to connect Primary factor versus secondary sleep/temperature endpoints with the selected question, actual population/intervention/comparator, endpoints/hierarchy/estimands, denominators/duration, reports and harms.", "application_exception": "Distinguish the specific rising-sleepiness factor, overall/objective sleep, other scales/temperature, primary/secondary/subgroup outcomes, multiplicity, exact effects/CIs, populations/intervention/placebo, 12-week/FAS1 denominators, company involvement and harms. Only original numbers are preserved; no new calculations, hypothetical quantities, effects/CIs, grades/regrading, independence certification or extract/product/drink-intake, sleep/cold-management, infection-prevention or treatment-substitution instructions.", "criterion": "Show original information about Primary factor versus secondary sleep/temperature endpoints, the selected subclaim/parent boundary, direct endpoints/estimands, denominators and scope of external reading together.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_research": "Materials needed: Complete endpoint tables, registry/protocol/SAP, secondary hierarchy, direct endpoint results/denominators and multiplicity plans are needed. Unread materials are not treated as absence/nullity of every outcome. Only information requests/research needs are recorded; no new lookup or research is performed in this production.", "current_reports": [ "R01" ], "existence": "The original parent-summary display record is preserved; public availability, acquisition and actual reading of detailed external materials remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "The original counterview distinguishes other sleep/temperature endpoints as secondary outcomes. The summary does not establish complete labels, effects/CIs, significant/null result lists or prespecified hierarchy. Temperature/other factors are not combined as proof of overall sleep.", "condition_status": "Unverified", "status_reason": "Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.", "missingness": "Complete endpoint tables, registry/protocol/SAP, secondary hierarchy, direct endpoint results/denominators and multiplicity plans are needed. Unread materials are not treated as absence/nullity of every outcome.", "uncertainty": "External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Complete endpoint tables, registry/protocol/SAP, secondary hierarchy, direct endpoint results/denominators and multiplicity plans are needed. Unread materials are not treated as absence/nullity of every outcome." }, { "item_id": "N13", "question_type": "Evidence condition", "question": "Are male/other subgroup findings distinguished from full-population results?", "needed": "Full FAS1 versus subgroup analyses", "role": "Required", "role_reason": "Needed to connect Full FAS1 versus subgroup analyses with the selected question, actual population/intervention/comparator, endpoints/hierarchy/estimands, denominators/duration, reports and harms.", "application_exception": "Distinguish the specific rising-sleepiness factor, overall/objective sleep, other scales/temperature, primary/secondary/subgroup outcomes, multiplicity, exact effects/CIs, populations/intervention/placebo, 12-week/FAS1 denominators, company involvement and harms. Only original numbers are preserved; no new calculations, hypothetical quantities, effects/CIs, grades/regrading, independence certification or extract/product/drink-intake, sleep/cold-management, infection-prevention or treatment-substitution instructions.", "criterion": "Show original information about Full FAS1 versus subgroup analyses, the selected subclaim/parent boundary, direct endpoints/estimands, denominators and scope of external reading together.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_research": "Materials needed: Original subgroup prespecification, denominators/effects/CIs, interactions, multiplicity and relationships to full analyses are needed. Subgroups are not counted as added independent trials/participants. Only information requests/research needs are recorded; no new lookup or research is performed in this production.", "current_reports": [ "R01" ], "existence": "The original parent-summary display record is preserved; public availability, acquisition and actual reading of detailed external materials remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "The original explains that male-only positive and other subgroup analyses did not replace the full-FAS1 primary positive result or broaden it into overall sleep improvement. Subgroup counts, exact effects and interactions are unverified.", "condition_status": "Partly verified", "status_reason": "Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.", "missingness": "Original subgroup prespecification, denominators/effects/CIs, interactions, multiplicity and relationships to full analyses are needed. Subgroups are not counted as added independent trials/participants.", "uncertainty": "External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original subgroup prespecification, denominators/effects/CIs, interactions, multiplicity and relationships to full analyses are needed. Subgroups are not counted as added independent trials/participants." }, { "item_id": "N14", "question_type": "Evidence condition", "question": "Were multiplicity and registry plans verified in detail?", "needed": "Testing conditions for primary/secondary/subgroup analyses", "role": "Required", "role_reason": "Needed to connect Testing conditions for primary/secondary/subgroup analyses with the selected question, actual population/intervention/comparator, endpoints/hierarchy/estimands, denominators/duration, reports and harms.", "application_exception": "Distinguish the specific rising-sleepiness factor, overall/objective sleep, other scales/temperature, primary/secondary/subgroup outcomes, multiplicity, exact effects/CIs, populations/intervention/placebo, 12-week/FAS1 denominators, company involvement and harms. Only original numbers are preserved; no new calculations, hypothetical quantities, effects/CIs, grades/regrading, independence certification or extract/product/drink-intake, sleep/cold-management, infection-prevention or treatment-substitution instructions.", "criterion": "Show original information about Testing conditions for primary/secondary/subgroup analyses, the selected subclaim/parent boundary, direct endpoints/estimands, denominators and scope of external reading together.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_research": "Materials needed: Actual UMIN000051261 registry records, protocol/SAP, all endpoints/multiplicity, public/amendment dates and the original report are needed. No new adjusted P values or grades. Only information requests/research needs are recorded; no new lookup or research is performed in this production.", "current_reports": [ "R01" ], "existence": "The original parent-summary display record is preserved; public availability, acquisition and actual reading of detailed external materials remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "The original used only the full-FAS1 primary analysis as verdict evidence. Total tests, adjustments, hierarchy/changes across sleep/temperature and subgroup analyses are unverified; UMIN/protocol records were not read in this production. Adjusted results are not newly judged.", "condition_status": "Unverified", "status_reason": "Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.", "missingness": "Actual UMIN000051261 registry records, protocol/SAP, all endpoints/multiplicity, public/amendment dates and the original report are needed. No new adjusted P values or grades.", "uncertainty": "External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Actual UMIN000051261 registry records, protocol/SAP, all endpoints/multiplicity, public/amendment dates and the original report are needed. No new adjusted P values or grades." }, { "item_id": "N15", "question_type": "Evidence condition", "question": "Are self-report results being transferred to objective sleep?", "needed": "Subjective scales versus objective sleep", "role": "Required", "role_reason": "Needed to connect Subjective scales versus objective sleep with the selected question, actual population/intervention/comparator, endpoints/hierarchy/estimands, denominators/duration, reports and harms.", "application_exception": "Distinguish the specific rising-sleepiness factor, overall/objective sleep, other scales/temperature, primary/secondary/subgroup outcomes, multiplicity, exact effects/CIs, populations/intervention/placebo, 12-week/FAS1 denominators, company involvement and harms. Only original numbers are preserved; no new calculations, hypothetical quantities, effects/CIs, grades/regrading, independence certification or extract/product/drink-intake, sleep/cold-management, infection-prevention or treatment-substitution instructions.", "criterion": "Show original information about Subjective scales versus objective sleep, the selected subclaim/parent boundary, direct endpoints/estimands, denominators and scope of external reading together.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_research": "Materials needed: Objective instruments/measurements, direct results separate from subjective scales, times/denominators and effects/CIs are needed. Other physiological measures do not establish overall sleep. Only information requests/research needs are recorded; no new lookup or research is performed in this production.", "current_reports": [ "R01" ], "existence": "The original parent-summary display record is preserved; public availability, acquisition and actual reading of detailed external materials remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "The original evidence concerns the rising-sleepiness factor of a self-reported sleep scale. Direct objective PSG/activity-recording, sleep duration/efficiency, onset and awakening results are not provided within the preserved materials. Unread records do not establish that these tests were unmeasured.", "condition_status": "Unverified", "status_reason": "Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.", "missingness": "Objective instruments/measurements, direct results separate from subjective scales, times/denominators and effects/CIs are needed. Other physiological measures do not establish overall sleep.", "uncertainty": "External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Objective instruments/measurements, direct results separate from subjective scales, times/denominators and effects/CIs are needed. Other physiological measures do not establish overall sleep." }, { "item_id": "N16", "question_type": "Evidence condition", "question": "Are constituent/temperature explanations direct sleep evidence?", "needed": "Constituent identity and mechanisms versus overall-sleep effects", "role": "Supplementary", "role_reason": "Needed to connect Constituent identity and mechanisms versus overall-sleep effects with the selected question, actual population/intervention/comparator, endpoints/hierarchy/estimands, denominators/duration, reports and harms.", "application_exception": "Distinguish the specific rising-sleepiness factor, overall/objective sleep, other scales/temperature, primary/secondary/subgroup outcomes, multiplicity, exact effects/CIs, populations/intervention/placebo, 12-week/FAS1 denominators, company involvement and harms. Only original numbers are preserved; no new calculations, hypothetical quantities, effects/CIs, grades/regrading, independence certification or extract/product/drink-intake, sleep/cold-management, infection-prevention or treatment-substitution instructions.", "criterion": "Show original information about Constituent identity and mechanisms versus overall-sleep effects, the selected subclaim/parent boundary, direct endpoints/estimands, denominators and scope of external reading together.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_research": "Materials needed: Formulation/quantification and mechanism data should be linked separately from direct sleep endpoints/effects. No efficacy expansion beyond the original primary/secondary conditions. Only information requests/research needs are recorded; no new lookup or research is performed in this production.", "current_reports": [ "R01" ], "existence": "The original parent-summary display record is preserved; public availability, acquisition and actual reading of detailed external materials remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "Proanthocyanidins and epicatechins describe original extract constituents; temperature results are described as secondary. Constituents, mechanisms and temperature do not newly establish overall/clinical sleep effects.", "condition_status": "Partly verified", "status_reason": "Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.", "missingness": "Formulation/quantification and mechanism data should be linked separately from direct sleep endpoints/effects. No efficacy expansion beyond the original primary/secondary conditions.", "uncertainty": "External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Formulation/quantification and mechanism data should be linked separately from direct sleep endpoints/effects. No efficacy expansion beyond the original primary/secondary conditions." }, { "item_id": "N17", "question_type": "Harm-information gaps supplementing the efficacy table", "question": "What is the scope of the 12-week adverse-event narrative?", "needed": "Small-trial reporting versus rare/long-term harms", "role": "Supplementary", "role_reason": "Needed to connect Small-trial reporting versus rare/long-term harms with the selected question, actual population/intervention/comparator, endpoints/hierarchy/estimands, denominators/duration, reports and harms.", "application_exception": "Distinguish the specific rising-sleepiness factor, overall/objective sleep, other scales/temperature, primary/secondary/subgroup outcomes, multiplicity, exact effects/CIs, populations/intervention/placebo, 12-week/FAS1 denominators, company involvement and harms. Only original numbers are preserved; no new calculations, hypothetical quantities, effects/CIs, grades/regrading, independence certification or extract/product/drink-intake, sleep/cold-management, infection-prevention or treatment-substitution instructions.", "criterion": "Show original information about Small-trial reporting versus rare/long-term harms, the selected subclaim/parent boundary, direct endpoints/estimands, denominators and scope of external reading together.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_research": "Materials needed: AE collection, arm-specific exposure/observation, harm denominators, discontinuation/relatedness and rare/long-term data are needed. No new harm rates or extract/product/sleep-management instructions. Only information requests/research needs are recorded; no new lookup or research is performed in this production.", "current_reports": [ "R01" ], "existence": "The original parent-summary display record is preserved; public availability, acquisition and actual reading of detailed external materials remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "The original states that no adverse events were reported in the 12-week trial and explicitly says the small 64-person trial cannot exclude rare or long-term harms. This is not expanded into zero harms of every kind or long-term safety.", "condition_status": "Partly verified", "status_reason": "Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.", "missingness": "AE collection, arm-specific exposure/observation, harm denominators, discontinuation/relatedness and rare/long-term data are needed. No new harm rates or extract/product/sleep-management instructions.", "uncertainty": "External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "AE collection, arm-specific exposure/observation, harm denominators, discontinuation/relatedness and rare/long-term data are needed. No new harm rates or extract/product/sleep-management instructions." }, { "item_id": "N18", "question_type": "Evidence condition", "question": "What materials were actually read in this work?", "needed": "Preserved JSON summary and external-reading status", "role": "Required", "role_reason": "Needed to connect preserved JSON summary and external-reading status with the selected question, actual population/intervention/comparator, endpoints/hierarchy/estimand, denominators/duration and reports/harms.", "application_exception": "Distinguish the specific rising-sleepiness factor, overall/objective sleep, other scales/temperature, primary/secondary/subgroup outcomes, multiplicity, exact effects/CIs, populations/intervention/placebo, 12-week/FAS1 denominators, company involvement and harms. Only original numbers are preserved; no new calculations, hypothetical quantities, effects/CIs, grades/regrading, independence certification or extract/product/drink-intake, sleep/cold-management, infection-prevention or treatment-substitution instructions.", "criterion": "Show originals for preserved JSON summary and external-reading status with selected-subclaim/parent boundaries, direct endpoints/estimand, denominators and external-reading scope.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_research": "Materials needed: Materials for users to record actual external acquisition/reading scope, versions and timing. No current link/click/access tests. Only material requests/research needs are recorded; no current lookup or research execution.", "current_reports": [ "R01" ], "existence": "The original parent-summary display record is preserved; public availability, acquisition and actual reading of detailed external materials remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "The complete parent JSON was read for production and preserved in its original form. Summary reading concerns the preserved summary; external abstracts, full texts, registration and protocol/SAP remain unread in this work. URL/bibliography presence is not upgraded into external reading.", "condition_status": "Partly verified", "status_reason": "Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.", "missingness": "Materials for users to record actual external acquisition/reading scope, versions and timing. No current link/click/access tests.", "uncertainty": "External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Materials for users to record actual external acquisition/reading scope, versions and timing. No current link/click/access tests." }, { "item_id": "N19", "question_type": "Evidence condition", "question": "Are registration, public dates, plans and current reading distinct?", "needed": "Original registration information and detailed plans/access", "role": "Required", "role_reason": "Needed to connect original registration information and detailed plans/access with the selected question, actual population/intervention/comparator, endpoints/hierarchy/estimand, denominators/duration and reports/harms.", "application_exception": "Distinguish the specific rising-sleepiness factor, overall/objective sleep, other scales/temperature, primary/secondary/subgroup outcomes, multiplicity, exact effects/CIs, populations/intervention/placebo, 12-week/FAS1 denominators, company involvement and harms. Only original numbers are preserved; no new calculations, hypothetical quantities, effects/CIs, grades/regrading, independence certification or extract/product/drink-intake, sleep/cold-management, infection-prevention or treatment-substitution instructions.", "criterion": "Show originals for original registration information and detailed plans/access with selected-subclaim/parent boundaries, direct endpoints/estimand, denominators and external-reading scope.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_research": "Materials needed: Original registration texts/versions, public/start/change dates, endpoint/analysis and report-linkage materials. Only historical narratives are preserved; no current prespecification/access certification. Only material requests/research needs are recorded; no current lookup or research execution.", "current_reports": [ "R01" ], "existence": "The original parent-summary display record is preserved; public availability, acquisition and actual reading of detailed external materials remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "The original evidence/Korean text supplies UMIN000051261; the citation has no registry identifier/official registry URL. Actual registration/start dates, versions, prospective status and plan comparisons are unverified in this production. Official URLs are not guessed.", "condition_status": "Partly verified", "status_reason": "Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.", "missingness": "Original registration texts/versions, public/start/change dates, endpoint/analysis and report-linkage materials. Only historical narratives are preserved; no current prespecification/access certification.", "uncertainty": "External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original registration texts/versions, public/start/change dates, endpoint/analysis and report-linkage materials. Only historical narratives are preserved; no current prespecification/access certification." }, { "item_id": "N20", "question_type": "Evidence condition", "question": "Were protocol/SAP and endpoint/multiplicity plans acquired?", "needed": "Advance plan, change and analysis materials", "role": "Required", "role_reason": "Needed to connect advance plan, change and analysis materials with the selected question, actual population/intervention/comparator, endpoints/hierarchy/estimand, denominators/duration and reports/harms.", "application_exception": "Distinguish the specific rising-sleepiness factor, overall/objective sleep, other scales/temperature, primary/secondary/subgroup outcomes, multiplicity, exact effects/CIs, populations/intervention/placebo, 12-week/FAS1 denominators, company involvement and harms. Only original numbers are preserved; no new calculations, hypothetical quantities, effects/CIs, grades/regrading, independence certification or extract/product/drink-intake, sleep/cold-management, infection-prevention or treatment-substitution instructions.", "criterion": "Show originals for advance plan, change and analysis materials with selected-subclaim/parent boundaries, direct endpoints/estimand, denominators and external-reading scope.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_research": "Materials needed: Protocol, SAP, revision history, complete endpoints/estimands/missingness, multiple comparisons, public dates and paper-comparison materials. Unread external materials are not assumed to mean absent documents. Only material requests/research needs are recorded; no current lookup or research execution.", "current_reports": [ "R01" ], "existence": "The original parent-summary display record is preserved; public availability, acquisition and actual reading of detailed external materials remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "The original registration identifier, historical cross-checking and primary/secondary narratives are preserved. Individual protocol/SAP originals, versions/dates, complete endpoints/analyses/multiplicity and plan changes were not read in this work.", "condition_status": "Unverified", "status_reason": "Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.", "missingness": "Protocol, SAP, revision history, complete endpoints/estimands/missingness, multiple comparisons, public dates and paper-comparison materials. Unread external materials are not assumed to mean absent documents.", "uncertainty": "External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Protocol, SAP, revision history, complete endpoints/estimands/missingness, multiple comparisons, public dates and paper-comparison materials. Unread external materials are not assumed to mean absent documents." }, { "item_id": "N21", "question_type": "Evidence condition", "question": "Are company funding, product support, employee authors and research roles separate?", "needed": "Four categories of company involvement and other support", "role": "Required", "role_reason": "Needed to connect four categories of company involvement and other support with the selected question, actual population/intervention/comparator, endpoints/hierarchy/estimand, denominators/duration and reports/harms.", "application_exception": "Distinguish the specific rising-sleepiness factor, overall/objective sleep, other scales/temperature, primary/secondary/subgroup outcomes, multiplicity, exact effects/CIs, populations/intervention/placebo, 12-week/FAS1 denominators, company involvement and harms. Only original numbers are preserved; no new calculations, hypothetical quantities, effects/CIs, grades/regrading, independence certification or extract/product/drink-intake, sleep/cold-management, infection-prevention or treatment-substitution instructions.", "criterion": "Show originals for four categories of company involvement and other support with selected-subclaim/parent boundaries, direct endpoints/estimand, denominators and external-reading scope.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_research": "Materials needed: Separate originals for company cash funding, product/food manufacturing support, author employment/contractor relationships, design/analysis/data control and other support/COI. The original independence axis is not used as new certification. Only material requests/research needs are recorded; no current lookup or research execution.", "current_reports": [ "R01" ], "existence": "The original parent-summary display record is preserved; public availability, acquisition and actual reading of detailed external materials remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "The original distinguishes the no-specific-funding declaration, three Fujicco employee authors R.A./T.M./K.M., study-food provision to the contract site and employee involvement in conceptualization, methods, analysis, data management and drafting. No specific cash funding does not mean no COI or company involvement.", "condition_status": "Partly verified", "status_reason": "Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.", "missingness": "Separate originals for company cash funding, product/food manufacturing support, author employment/contractor relationships, design/analysis/data control and other support/COI. The original independence axis is not used as new certification.", "uncertainty": "External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Separate originals for company cash funding, product/food manufacturing support, author employment/contractor relationships, design/analysis/data control and other support/COI. The original independence axis is not used as new certification." }, { "item_id": "N22", "question_type": "Evidence condition", "question": "Are narrow positive results, broad-claim gaps and unverified materials distinct?", "needed": "Direct endpoints and access/reporting limitations", "role": "Required", "role_reason": "Needed to connect direct endpoints and access/reporting limitations with the selected question, actual population/intervention/comparator, endpoints/hierarchy/estimand, denominators/duration and reports/harms.", "application_exception": "Distinguish the specific rising-sleepiness factor, overall/objective sleep, other scales/temperature, primary/secondary/subgroup outcomes, multiplicity, exact effects/CIs, populations/intervention/placebo, 12-week/FAS1 denominators, company involvement and harms. Only original numbers are preserved; no new calculations, hypothetical quantities, effects/CIs, grades/regrading, independence certification or extract/product/drink-intake, sleep/cold-management, infection-prevention or treatment-substitution instructions.", "criterion": "Show originals for direct endpoints and access/reporting limitations with selected-subclaim/parent boundaries, direct endpoints/estimand, denominators and external-reading scope.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_research": "Materials needed: Materials verifying question-specific actual measurements/definitions, original tables/denominators, plans and actual access scope. Unread is not substituted for unreported, zero studies or zero effect. Only material requests/research needs are recorded; no current lookup or research execution.", "current_reports": [ "R01" ], "existence": "The original parent-summary display record is preserved; public availability, acquisition and actual reading of detailed external materials remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "The positive full-FAS1 primary rising-sleepiness P<.05 is distinguished from the unverified overall-sleep claim and absent exact effects/CIs in the main text.", "condition_status": "Partly verified", "status_reason": "Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.", "missingness": "Materials verifying question-specific actual measurements/definitions, original tables/denominators, plans and actual access scope. Unread is not substituted for unreported, zero studies or zero effect.", "uncertainty": "External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Materials verifying question-specific actual measurements/definitions, original tables/denominators, plans and actual access scope. Unread is not substituted for unreported, zero studies or zero effect." }, { "item_id": "N23", "question_type": "Evidence condition", "question": "Are reports, trials, people, repeated measures and sibling sheets distinct?", "needed": "Document linkage versus unique trials/participants", "role": "Required", "role_reason": "Needed to connect document linkage versus unique trials/participants with the selected question, actual population/intervention/comparator, endpoints/hierarchy/estimand, denominators/duration and reports/harms.", "application_exception": "Distinguish the specific rising-sleepiness factor, overall/objective sleep, other scales/temperature, primary/secondary/subgroup outcomes, multiplicity, exact effects/CIs, populations/intervention/placebo, 12-week/FAS1 denominators, company involvement and harms. Only original numbers are preserved; no new calculations, hypothetical quantities, effects/CIs, grades/regrading, independence certification or extract/product/drink-intake, sleep/cold-management, infection-prevention or treatment-substitution instructions.", "criterion": "Show originals for document linkage versus unique trials/participants with selected-subclaim/parent boundaries, direct endpoints/estimand, denominators and external-reading scope.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_research": "Materials needed: Original registration/report, actual cohort/analysis, endpoint/time-point and repeated-measure relationships. Unique trial counts and unique participant totals remain unrecorded. Only material requests/research needs are recorded; no current lookup or research execution.", "current_reports": [ "R01" ], "existence": "The original parent-summary display record is preserved; public availability, acquisition and actual reading of detailed external materials remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "Parent 2978 and the existing sibling sheets share the same Akagi 2025 report and 64-person/12-week trial context. The same people, arms, times, factors, subgroups, citation and sibling sheets are not added as new independent trials/participants. One current report link does not certify unique trial/participant counts.", "condition_status": "Partly verified", "status_reason": "Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.", "missingness": "Original registration/report, actual cohort/analysis, endpoint/time-point and repeated-measure relationships. Unique trial counts and unique participant totals remain unrecorded.", "uncertainty": "External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original registration/report, actual cohort/analysis, endpoint/time-point and repeated-measure relationships. Unique trial counts and unique participant totals remain unrecorded." }, { "item_id": "N24", "question_type": "Evidence condition", "question": "Is there evidence of separate independent confirmation?", "needed": "Original R1/I0 versus independent replication", "role": "Supplementary", "role_reason": "Needed to connect original R1/I0 versus independent replication with the selected question, actual population/intervention/comparator, endpoints/hierarchy/estimand, denominators/duration and reports/harms.", "application_exception": "Distinguish the specific rising-sleepiness factor, overall/objective sleep, other scales/temperature, primary/secondary/subgroup outcomes, multiplicity, exact effects/CIs, populations/intervention/placebo, 12-week/FAS1 denominators, company involvement and harms. Only original numbers are preserved; no new calculations, hypothetical quantities, effects/CIs, grades/regrading, independence certification or extract/product/drink-intake, sleep/cold-management, infection-prevention or treatment-substitution instructions.", "criterion": "Show originals for original R1/I0 versus independent replication with selected-subclaim/parent boundaries, direct endpoints/estimand, denominators and external-reading scope.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_research": "Materials needed: Confirmatory materials showing selected-question advance plans, separate populations/comparators, direct endpoints/denominators, effects/CIs, duration/funding and author relationships. No current search or independence judgment. Only material requests/research needs are recorded; no current lookup or research execution.", "current_reports": [ "R01" ], "existence": "The original parent-summary display record is preserved; public availability, acquisition and actual reading of detailed external materials remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "Parent replication R1 and independence I0 are preserved. The same report, subgroup, scale, repeated days or sibling sheets are not certified as new independent efficacy/harm replications.", "condition_status": "Unverified", "status_reason": "Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.", "missingness": "Confirmatory materials showing selected-question advance plans, separate populations/comparators, direct endpoints/denominators, effects/CIs, duration/funding and author relationships. No current search or independence judgment.", "uncertainty": "External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Confirmatory materials showing selected-question advance plans, separate populations/comparators, direct endpoints/denominators, effects/CIs, duration/funding and author relationships. No current search or independence judgment." }, { "item_id": "N25", "question_type": "Evidence condition", "question": "Are selected-subclaim and parent scores/axes preserved?", "needed": "Subclaim grade/note, absent fields and parent context", "role": "Required", "role_reason": "Needed to connect subclaim grade/note, absent fields and parent context with the selected question, actual population/intervention/comparator, endpoints/hierarchy/estimand, denominators/duration and reports/harms.", "application_exception": "Distinguish the specific rising-sleepiness factor, overall/objective sleep, other scales/temperature, primary/secondary/subgroup outcomes, multiplicity, exact effects/CIs, populations/intervention/placebo, 12-week/FAS1 denominators, company involvement and harms. Only original numbers are preserved; no new calculations, hypothetical quantities, effects/CIs, grades/regrading, independence certification or extract/product/drink-intake, sleep/cold-management, infection-prevention or treatment-substitution instructions.", "criterion": "Show originals for subclaim grade/note, absent fields and parent context with selected-subclaim/parent boundaries, direct endpoints/estimand, denominators and external-reading scope.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_research": "Materials needed: User subclaim/parent-boundary review and actual correction materials. No new score/grade or official RoB 2/GRADE certification. Only material-request/research needs are recorded; no search/research was performed in this production.", "current_reports": [ "R01" ], "existence": "The original parent-summary display record is preserved; public availability, acquisition and actual reading of detailed external materials remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "Selected grade/note and Korean/English claim wording are preserved, with absent subclaim score/status/axes left unrecorded. Parent C50, good safety and B/P/R1/I0/E+, bias axis and unrecorded precision are parent context, not a score for the selected row.", "condition_status": "Partly verified", "status_reason": "Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.", "missingness": "User subclaim/parent-boundary review and actual correction materials. No new score/grade or official RoB 2/GRADE certification.", "uncertainty": "External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "User subclaim/parent-boundary review and actual correction materials. No new score/grade or official RoB 2/GRADE certification." }, { "item_id": "N26", "question_type": "Evidence condition", "question": "Are Korean/English wording and absent structured fields preserved?", "needed": "Wording in both languages and absent classification fields", "role": "Required", "role_reason": "Needed to connect wording in both languages and absent classification fields with the selected question, actual population/intervention/comparator, endpoints/hierarchy/estimand, denominators/duration and reports/harms.", "application_exception": "Distinguish the specific rising-sleepiness factor, overall/objective sleep, other scales/temperature, primary/secondary/subgroup outcomes, multiplicity, exact effects/CIs, populations/intervention/placebo, 12-week/FAS1 denominators, company involvement and harms. Only original numbers are preserved; no new calculations, hypothetical quantities, effects/CIs, grades/regrading, independence certification or extract/product/drink-intake, sleep/cold-management, infection-prevention or treatment-substitution instructions.", "criterion": "Show originals for wording in both languages and absent classification fields with selected-subclaim/parent boundaries, direct endpoints/estimand, denominators and external-reading scope.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_research": "Materials needed: Materials for content review of bilingual terms, endpoints/durations, absent fields and selected scope. Production explanations remain distinct from original wording. Only material requests/research needs are recorded; no current lookup or research execution.", "current_reports": [ "R01" ], "existence": "The original parent-summary display record is preserved; public availability, acquisition and actual reading of detailed external materials remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "Parent Korean/English text, evidence/citation lists, axes and original selected-subclaim wording are preserved in the complete summary. Korean/English classification fields are absent; no new fields are filled in the original materials. External English papers were not compared.", "condition_status": "Partly verified", "status_reason": "Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.", "missingness": "Materials for content review of bilingual terms, endpoints/durations, absent fields and selected scope. Production explanations remain distinct from original wording.", "uncertainty": "External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Materials for content review of bilingual terms, endpoints/durations, absent fields and selected scope. Production explanations remain distinct from original wording." }, { "item_id": "N27", "question_type": "Evidence condition", "question": "Are reference dates, corrections, historical cross-checking and production dates distinct?", "needed": "Original 2026-08-26 versus production/application events", "role": "Required", "role_reason": "Needed to connect original 2026-08-26 versus production/application events with the selected question, actual population/intervention/comparator, endpoints/hierarchy/estimand, denominators/duration and reports/harms.", "application_exception": "Distinguish the specific rising-sleepiness factor, overall/objective sleep, other scales/temperature, primary/secondary/subgroup outcomes, multiplicity, exact effects/CIs, populations/intervention/placebo, 12-week/FAS1 denominators, company involvement and harms. Only original numbers are preserved; no new calculations, hypothetical quantities, effects/CIs, grades/regrading, independence certification or extract/product/drink-intake, sleep/cold-management, infection-prevention or treatment-substitution instructions.", "criterion": "Show originals for original 2026-08-26 versus production/application events with selected-subclaim/parent boundaries, direct endpoints/estimand, denominators and external-reading scope.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_research": "Materials needed: When new materials/corrections arise, materials for separate updates to originals, events, conditions/observations and verdict decisions. Historical narratives are not used as new clinical review. Only material requests/research needs are recorded; no current lookup or research execution.", "current_reports": [ "R01" ], "existence": "The original parent-summary display record is preserved; public availability, acquisition and actual reading of detailed external materials remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "Original reference date 2026-08-26, empty corrections/deliberation and grade-decision cross-check narratives are preserved. This history is not current condition freezing/application, production date or completed content review.", "condition_status": "Partly verified", "status_reason": "Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.", "missingness": "When new materials/corrections arise, materials for separate updates to originals, events, conditions/observations and verdict decisions. Historical narratives are not used as new clinical review.", "uncertainty": "External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "When new materials/corrections arise, materials for separate updates to originals, events, conditions/observations and verdict decisions. Historical narratives are not used as new clinical review." }, { "item_id": "N28", "question_type": "Evidence condition", "question": "What direct materials could fill the selected gaps?", "needed": "Definitions, direct endpoints, denominators/effects/CIs and plans", "role": "Supplementary", "role_reason": "Needed to connect definitions, direct endpoints, denominators/effects/CIs and plans with the selected question, actual population/intervention/comparator, endpoints/hierarchy/estimand, denominators/duration and reports/harms.", "application_exception": "Distinguish the specific rising-sleepiness factor, overall/objective sleep, other scales/temperature, primary/secondary/subgroup outcomes, multiplicity, exact effects/CIs, populations/intervention/placebo, 12-week/FAS1 denominators, company involvement and harms. Only original numbers are preserved; no new calculations, hypothetical quantities, effects/CIs, grades/regrading, independence certification or extract/product/drink-intake, sleep/cold-management, infection-prevention or treatment-substitution instructions.", "criterion": "Show originals for definitions, direct endpoints, denominators/effects/CIs and plans with selected-subclaim/parent boundaries, direct endpoints/estimand, denominators and external-reading scope.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_research": "Materials needed: Question-matched advance direct comparisons, overall/symptom-specific denominators, estimands/CIs, measurement/missingness, multiplicity and separate confirmation/long-term harms. Only need is recorded; no current lookup or clinical study. Only material requests/research needs are recorded; no current lookup or research execution.", "current_reports": [ "R01" ], "existence": "The original parent-summary display record is preserved; public availability, acquisition and actual reading of detailed external materials remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "Confirming the overall-sleep claim requires information directly defining its overall/objective endpoints; the rising-sleepiness factor, temperature or subgroups do not substitute for this.", "condition_status": "Unverified", "status_reason": "Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.", "missingness": "Question-matched advance direct comparisons, overall/symptom-specific denominators, estimands/CIs, measurement/missingness, multiplicity and separate confirmation/long-term harms. Only need is recorded; no current lookup or clinical study.", "uncertainty": "External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Question-matched advance direct comparisons, overall/symptom-specific denominators, estimands/CIs, measurement/missingness, multiplicity and separate confirmation/long-term harms. Only need is recorded; no current lookup or clinical study." }, { "item_id": "N29", "question_type": "Evidence condition", "question": "Are production, user review and implementation instructions distinct?", "needed": "Production request, candidate history and content-review responsibility", "role": "Supplementary", "role_reason": "Needed to connect production request, candidate history and content-review responsibility with the selected question, actual population/intervention/comparator, endpoints/hierarchy/estimand, denominators/duration and reports/harms.", "application_exception": "Distinguish the specific rising-sleepiness factor, overall/objective sleep, other scales/temperature, primary/secondary/subgroup outcomes, multiplicity, exact effects/CIs, populations/intervention/placebo, 12-week/FAS1 denominators, company involvement and harms. Only original numbers are preserved; no new calculations, hypothetical quantities, effects/CIs, grades/regrading, independence certification or extract/product/drink-intake, sleep/cold-management, infection-prevention or treatment-substitution instructions.", "criterion": "Show originals for production request, candidate history and content-review responsibility with selected-subclaim/parent boundaries, direct endpoints/estimand, denominators and external-reading scope.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_research": "Materials needed: Existing content review and later actual-material/correction work. The historical production record did not perform clinical-original comparison, external access, new calculations, grade changes or product/drink-consumption, sleep/cold-management, infection-prevention or treatment-replacement instructions. Only material requests/research needs are recorded; no current lookup or research execution.", "current_reports": [ "R01" ], "existence": "The original parent-summary display record is preserved; public availability, acquisition and actual reading of detailed external materials remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "This is table-content production from the preserved summary. Existing content and question-boundary review remain incomplete, and candidate pending/eligibility flags are preserved as history. Existing review status is recorded as it stands.", "condition_status": "Partly verified", "status_reason": "Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.", "missingness": "Existing content review and later actual-material/correction work. The historical production record did not perform clinical-original comparison, external access, new calculations, grade changes or product/drink-consumption, sleep/cold-management, infection-prevention or treatment-replacement instructions.", "uncertainty": "External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Existing content review and later actual-material/correction work. The historical production record did not perform clinical-original comparison, external access, new calculations, grade changes or product/drink-consumption, sleep/cold-management, infection-prevention or treatment-replacement instructions." } ], "reports": [ { "report_id": "R01", "title": "Akagi R, et al. Effects of Consumption of Black Soybean Seed Coat Extract on Sleep Quality in Healthy Japanese. Food Sci Nutr. 2025;13:e70156. PMID: 40501501.", "url": "https://pubmed.ncbi.nlm.nih.gov/40501501/", "report_type": "Double-blind randomized placebo-controlled parallel trial", "existence": "Report bibliography exists in original citations; external availability/access remain unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/plans remain unread", "study_family": "F01", "independent_replication": "Provisional linkage of the same report/sibling sheets; not certification of separate independent trials or efficacy replication", "observed_result": "Improved versus placebo in full FAS1, P<0.05; exact group values and 95% CI not provided in the text", "result_level": "Original evidence-list summary of the parent endpoint; boundaries between the selected direct question and other scales/symptoms/infection outcomes are distinguished in condition rows and roles", "source_evidence_date": "2026-08-26", "materials": [ { "material_type": "Stored summary", "public_status": "Local preserved copy of the complete parent summary", "access_status": "Stored summary read", "acquired": true, "actually_read": "Summary read", "as_of": "2026-08-26", "qualification": "Only original PubMed URLs/registration identifiers are preserved; no new certification of external reading, access, prespecification or condition fulfillment. No full-text/registration/plan URLs are guessed." }, { "material_type": "External abstract", "public_status": "Original identifier/bibliography or required-material entry; public availability/access details remain unverified", "access_status": "Unread; access testing not performed", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "Only original PubMed URLs/registration identifiers are preserved; no new certification of external reading, access, prespecification or condition fulfillment. No full-text/registration/plan URLs are guessed." }, { "material_type": "External full text", "public_status": "Original identifier/bibliography or required-material entry; public availability/access details remain unverified", "access_status": "Unread; access testing not performed", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "Only original PubMed URLs/registration identifiers are preserved; no new certification of external reading, access, prespecification or condition fulfillment. No full-text/registration/plan URLs are guessed." }, { "material_type": "Original registration", "public_status": "Original identifier/bibliography or required-material entry; public availability/access details remain unverified", "access_status": "Unread; access testing not performed", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "Only original PubMed URLs/registration identifiers are preserved; no new certification of external reading, access, prespecification or condition fulfillment. No full-text/registration/plan URLs are guessed." }, { "material_type": "Protocol/SAP", "public_status": "Original identifier/bibliography or required-material entry; public availability/access details remain unverified", "access_status": "Unread; access testing not performed", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "Only original PubMed URLs/registration identifiers are preserved; no new certification of external reading, access, prespecification or condition fulfillment. No full-text/registration/plan URLs are guessed." } ], "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": "Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed." }, { "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": "Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed." }, { "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": "Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed." }, { "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. 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This does not certify a passed review or clinical efficacy.", "Unverified": "Detailed materials for the selected condition could not be established within the stored scope; this does not mean zero effect, zero studies or safety", "Review incomplete": "Review of existing content incomplete", "Met": "Use only within the relevant conditions after existing content review; no automatic designation in this preparation", "Not reported": "Distinguish only within materials actually read; do not turn unread external materials into unreported findings", "Inaccessible": "Not applied during this preparation because actual access was not tested", "Not applicable": "Use with a reason for non-applicability based on an explicit question boundary", "Conflicting data": "Judge after actual material comparison; review was not performed during this preparation", "Insufficient evidence for the conditions": "Do not use as a clinical grade encompassing currently unread materials" }, "study_overlap": { "state": "Unverified", "unique_trial_count": null, "unique_participant_count": null, "reason": "Parent 2978 and the existing sibling sheets share the same Akagi 2025 report and 64-person/12-week trial context. The same people, arms, times, factors, subgroups, citation and sibling sheets are not added as new independent trials/participants. Citation/registry links are provisional, without certification of unique trials/participants or independence." }, "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" }