{
  "schema_version": "chamgap-public-criteria-1.0",
  "title": "Black soybean seed-coat extract × Overall sleep quality — Rising-sleepiness factor and gaps in the broader claim",
  "language": "en",
  "translation_date": "2026-10-14",
  "criteria_version": "1.0",
  "criteria_date": "2026-10-06",
  "condition_origin": "Chamgap's own application conditions",
  "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. Sample size alone does not determine precision.",
      "review_level": "Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed."
    },
    {
      "id": "M19",
      "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19",
      "section": "§19.1.2, §19.2.1–19.2.4",
      "official_principle": "Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.",
      "review_level": "Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed."
    }
  ],
  "status_dictionary": {
    "Partly verified": "Some information exists in the preserved review summary; detailed original materials remain unverified. This does not certify a passed review or clinical efficacy.",
    "Unverified": "Detailed materials for the selected condition could not be established within the stored scope; this does not mean zero effect, zero studies or safety",
    "Review incomplete": "Review of existing content incomplete",
    "Met": "Use only within the relevant conditions after existing content review; no automatic designation in this preparation",
    "Not reported": "Distinguish only within materials actually read; do not turn unread external materials into unreported findings",
    "Inaccessible": "Not applied during this preparation because actual access was not tested",
    "Not applicable": "Use with a reason for non-applicability based on an explicit question boundary",
    "Conflicting data": "Judge after actual material comparison; review was not performed during this preparation",
    "Insufficient evidence for the conditions": "Do not use as a clinical grade encompassing currently unread materials"
  },
  "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    },
    {
      "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."
    }
  ]
}