{
  "schema_version": "chamgap-public-criteria-1.0",
  "title": "Black soybean seed-coat extract × Sleepiness-on-rising score",
  "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": "Preserved method HTML copies; no current method-content re-review or official tool execution"
    },
    {
      "id": "M04",
      "version": "Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04",
      "section": "§4.5, §4.6.1–4.6.3, MECIR C42",
      "official_principle": "Distinguish studies from reports and link them; do not omit a study solely because results are unreported.",
      "review_level": "Preserved method HTML copies; no current method-content re-review or official tool execution"
    },
    {
      "id": "M08",
      "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08",
      "section": "§8.1–8.2.3, Table 8.2.a",
      "official_principle": "Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.",
      "review_level": "Preserved method HTML copies; no current method-content re-review or official tool execution"
    },
    {
      "id": "M15",
      "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15",
      "section": "§15.2.4, §15.3.1–15.3.3",
      "official_principle": "Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.",
      "review_level": "Preserved method HTML copies; no current method-content re-review or official tool execution"
    },
    {
      "id": "M19",
      "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19",
      "section": "§19.1.2, §19.2.1–19.2.4",
      "official_principle": "Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.",
      "review_level": "Preserved method HTML copies; no current method-content re-review or official tool execution"
    }
  ],
  "status_dictionary": {
    "Met": "Status for necessary evidence confirmed after existing content review. No completion is declared in the current presentation.",
    "Partly verified": "Some information in the stored summary is linked into the table. External comparison/content review is not complete.",
    "Unverified": "The article leaves this unverified, or required material is absent from the current stored summary. This is distinct from zero, absence or safety.",
    "Review incomplete": "Existing content review remains incomplete.",
    "Not reported": "Not reported within the stored material actually read; not extended to the entire primary paper.",
    "Inaccessible": "Means an actual access failure. Access not attempted here is not assigned this state.",
    "Not applicable": "Not used as a substitute for an evidence gap.",
    "Conflicting data": "Requires an observed disagreement under the same comparison criteria; not automatically judged in this production.",
    "Insufficient evidence for the conditions": "Marks a gap in additional material required by the selected conditions; not a new efficacy grade."
  },
  "requirements": [
    {
      "item_id": "N01",
      "question_type": "Evidence condition",
      "question": "Selected rising-sleepiness question and original grade",
      "needed": "Selected original wording/grade versus parent score/axes",
      "role": "Required",
      "role_reason": "Distinguish Selected original wording/grade versus parent score/axes to link needed and currently available information for the selected question.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Original information and analysis scope for Selected original wording/grade versus parent score/axes must be available, with unverified information distinguished. Preserved wording is linked here; prior content review remains incomplete.",
      "basis": "M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are custom design; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is custom design; M04 §4.5, §4.6.3; limits on current material conversion reflect the review scope and custom design",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Follow-up comparative research specifying the selected scale/time point. This is a proposal; no new search, calculation or trial was performed in the recorded production."
    },
    {
      "item_id": "N02",
      "question_type": "Evidence condition",
      "question": "Healthy Japanese adults dissatisfied with sleep",
      "needed": "Actual eligibility/recruitment, sleep-dissatisfaction definition and population characteristics",
      "role": "Required",
      "role_reason": "Distinguish Actual eligibility/recruitment, sleep-dissatisfaction definition and population characteristics to link needed and currently available information for the selected question.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Original information and analysis scope for Actual eligibility/recruitment, sleep-dissatisfaction definition and population characteristics must be available, with unverified information distinguished. Preserved wording is linked here; prior content review remains incomplete.",
      "basis": "M03 §3.2.1; Detailed population conditions are Chamgap design; M03 §3.2.1–3.2.4; Dose, duration and effect-modifier details are Chamgap design",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Follow-up research with the same formulation and a specified population. This is a proposal; no new search, calculation or trial was performed in the recorded production."
    },
    {
      "item_id": "N03",
      "question_type": "Evidence condition",
      "question": "Identity of the study seed-coat extract",
      "needed": "Ingredients, formulation and standardization of the black soybean seed-coat extract",
      "role": "Required",
      "role_reason": "Distinguish Ingredients, formulation and standardization of the black soybean seed-coat extract to link needed and currently available information for the selected question.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Original information and analysis scope for Ingredients, formulation and standardization of the black soybean seed-coat extract must be available, with unverified information distinguished. Preserved wording is linked here; prior content review remains incomplete.",
      "basis": "M03 §3.2.2–3.2.3; Reverse-direction labels and assessment adaptation are Chamgap design; M03 §3.2.3 and M08 §8.2.2–8.2.3; Chamgap application",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Research distinguishing extract effects from attribution to constituents/other formulations. This is a proposal; no new search, calculation or trial was performed in the recorded production."
    },
    {
      "item_id": "N04",
      "question_type": "Evidence condition",
      "question": "Actual placebo comparison conditions",
      "needed": "Placebo composition, sensory/contact matching and expectations",
      "role": "Required",
      "role_reason": "Distinguish Placebo composition, sensory/contact matching and expectations to link needed and currently available information for the selected question.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Original information and analysis scope for Placebo composition, sensory/contact matching and expectations must be available, with unverified information distinguished. Preserved wording is linked here; prior content review remains incomplete.",
      "basis": "M03 §3.2.2–3.2.3; reverse-direction labels and testing adaptations are internally designed; M08 Table 8.2.a, M03 §3.2.4; internal application",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Follow-up trials disclosing comparison conditions. This is a proposal; no new search, calculation or trial was performed in the recorded production."
    },
    {
      "item_id": "N05",
      "question_type": "Evidence condition",
      "question": "Study exposure and 12-week duration",
      "needed": "Original 100 mg after-evening-meal exposure for 12 weeks and actual adherence",
      "role": "Required",
      "role_reason": "Distinguish Original 100 mg after-evening-meal exposure for 12 weeks and actual adherence to link needed and currently available information for the selected question.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Original information and analysis scope for Original 100 mg after-evening-meal exposure for 12 weeks and actual adherence must be available, with unverified information distinguished. Preserved wording is linked here; prior content review remains incomplete.",
      "basis": "M03 §3.2.3, M08 §8.2.2–8.2.3; internal application; M08 §8.2.2, M15 §15.3.1; internal application; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Research linking reported actual exposure to analysis populations. This is a proposal; no new search, calculation or trial was performed in the recorded production."
    },
    {
      "item_id": "N06",
      "question_type": "Evidence condition",
      "question": "Randomization and 32/32 assignment",
      "needed": "Randomization, concealment and arm-specific baseline balance",
      "role": "Required",
      "role_reason": "Distinguish Randomization, concealment and arm-specific baseline balance to link needed and currently available information for the selected question.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Original information and analysis scope for Randomization, concealment and arm-specific baseline balance must be available, with unverified information distinguished. Preserved wording is linked here; prior content review remains incomplete.",
      "basis": "M08 §8.1–8.2.3; Internal application; M03 §3.2.1; Detailed population conditions are internally designed",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Proposed follow-up trial disclosing allocation procedures; no new investigation, calculation or trial was performed in this production."
    },
    {
      "item_id": "N07",
      "question_type": "Evidence condition",
      "question": "Blinding and self-report expectations",
      "needed": "Participant/assessor/analyst blinding and self-report measurement conditions",
      "role": "Required",
      "role_reason": "Distinguish Participant/assessor/analyst blinding and self-report measurement conditions to link needed and currently available information for the selected question.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Original information and analysis scope for Participant/assessor/analyst blinding and self-report measurement conditions must be available, with unverified information distinguished. Preserved wording is linked here; prior content review remains incomplete.",
      "basis": "M08 Table 8.2.a, M03 §3.2.4; own application; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific result adaptation is our own design",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Research specifying blinding and scale-measurement conditions. This is a proposal; no new search, calculation or trial was performed in the recorded production."
    },
    {
      "item_id": "N08",
      "question_type": "Evidence condition",
      "question": "OSA-MA factor and score definitions",
      "needed": "Rising-sleepiness factor, score direction, recall/response windows and scoring",
      "role": "Required",
      "role_reason": "Distinguish Rising-sleepiness factor, score direction, recall/response windows and scoring to link needed and currently available information for the selected question.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Original information and analysis scope for Rising-sleepiness factor, score direction, recall/response windows and scoring must be available, with unverified information distinguished. Preserved wording is linked here; prior content review remains incomplete.",
      "basis": "M03 §3.2.4 and M15 §15.3.1–15.3.3; Question-specific outcome adaptation is Chamgap design; M08 Table 8.2.a and M03 §3.2.4; Chamgap application; M03 §3.2.4; Chamgap interpretation boundary",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Follow-up research specifying the selected factor's meaning and importance. This is a proposal; no new search, calculation or trial was performed in the recorded production."
    },
    {
      "item_id": "N09",
      "question_type": "Evidence condition",
      "question": "12-week change and waking assessment time",
      "needed": "Selected 12-week change, waking assessment window and other time points",
      "role": "Required",
      "role_reason": "Distinguish Selected 12-week change, waking assessment window and other time points to link needed and currently available information for the selected question.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Original information and analysis scope for Selected 12-week change, waking assessment window and other time points must be available, with unverified information distinguished. Preserved wording is linked here; prior content review remains incomplete.",
      "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are our own design; M08 §8.2.2, M15 §15.3.1; our own application",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Research reporting results separately by time point. This is a proposal; no new search, calculation or trial was performed in the recorded production."
    },
    {
      "item_id": "N10",
      "question_type": "Evidence condition",
      "question": "Positive full-FAS1 result",
      "needed": "Selected primary-endpoint result versus placebo in the full analysis population",
      "role": "Required",
      "role_reason": "Distinguish Selected primary-endpoint result versus placebo in the full analysis population to link needed and currently available information for the selected question.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Original information and analysis scope for Selected primary-endpoint result versus placebo in the full analysis population must be available, with unverified information distinguished. Preserved wording is linked here; prior content review remains incomplete.",
      "basis": "M15 §15.3.1–15.3.3; internal application; M08 §8.2.2, M15 §15.3.1; internal application; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are internally designed.",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Follow-up trials adequately reporting effects and uncertainty. This is a proposal; no new search, calculation or trial was performed in the recorded production."
    },
    {
      "item_id": "N11",
      "question_type": "Evidence condition",
      "question": "Figure-based estimated marginal means and SE",
      "needed": "Figure displays versus raw scores/change and variance estimands",
      "role": "Required",
      "role_reason": "Distinguish Figure displays versus raw scores/change and variance estimands to link needed and currently available information for the selected question.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Original information and analysis scope for Figure displays versus raw scores/change and variance estimands must be available, with unverified information distinguished. Preserved wording is linked here; prior content review remains incomplete.",
      "basis": "Collection/selection principles in M04 §4.5–4.6; Separating access from reading and the hyperlink contract are internally designed; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; Design-specific adaptations are internally designed; M08 §8.2.2, M15 §15.3.1; Internal application; M15 §15.3.1–15.3.3; Internal application",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Follow-up research publishing exact values and estimands in tables. This is a proposal; no new search, calculation or trial was performed in the recorded production."
    },
    {
      "item_id": "N12",
      "question_type": "Evidence condition",
      "question": "Effect size, CI and meaningful change",
      "needed": "Exact magnitude, 95% CI and prespecified importance thresholds",
      "role": "Required",
      "role_reason": "Distinguish Exact magnitude, 95% CI and prespecified importance thresholds to link needed and currently available information for the selected question.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Original information and analysis scope for Exact magnitude, 95% CI and prespecified importance thresholds must be available, with unverified information distinguished. Preserved wording is linked here; prior content review remains incomplete.",
      "basis": "M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; Design-specific adaptations are internally designed; M15 §15.3.1–15.3.3; Internal application; M03 §3.2.4; Internally defined extrapolation boundaries",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Follow-up trials reporting effect magnitude and precision. This is a proposal; no new search, calculation or trial was performed in the recorded production."
    },
    {
      "item_id": "N13",
      "question_type": "Evidence condition",
      "question": "Within/between-group contrasts and adjusted models",
      "needed": "Arm-specific change/effects versus placebo and modeling/adjustment conditions",
      "role": "Required",
      "role_reason": "Distinguish Arm-specific change/effects versus placebo and modeling/adjustment conditions to link needed and currently available information for the selected question.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Original information and analysis scope for Arm-specific change/effects versus placebo and modeling/adjustment conditions must be available, with unverified information distinguished. Preserved wording is linked here; prior content review remains incomplete.",
      "basis": "M08 §8.2.2, M15 §15.3.1; Chamgap's own application; M15 §15.3.1–15.3.3; Chamgap's own application; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are Chamgap's own design",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Research separately reporting within/between-group and adjusted estimands. This is a proposal; no new search, calculation or trial was performed in the recorded production."
    },
    {
      "item_id": "N14",
      "question_type": "Evidence condition",
      "question": "Primary-endpoint and analysis-population hierarchy",
      "needed": "Full-FAS1 primary endpoint versus secondary/subgroup analyses",
      "role": "Required",
      "role_reason": "Distinguish Full-FAS1 primary endpoint versus secondary/subgroup analyses to link needed and currently available information for the selected question.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Original information and analysis scope for Full-FAS1 primary endpoint versus secondary/subgroup analyses must be available, with unverified information distinguished. Preserved wording is linked here; prior content review remains incomplete.",
      "basis": "M08 Table 8.2.a, M04 §4.6.3; Chamgap application; M04 §4.6.3, M15 §15.3.1–15.3.3; separation of statuses is Chamgap's own design",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Follow-up trials specifying primary endpoints and secondary analyses. This is a proposal; no new search, calculation or trial was performed in the recorded production."
    },
    {
      "item_id": "N15",
      "question_type": "Evidence condition",
      "question": "Male and other subgroups",
      "needed": "Full-population results versus subgroups and interactions",
      "role": "Required",
      "role_reason": "Distinguish Full-population results versus subgroups and interactions to link needed and currently available information for the selected question.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Original information and analysis scope for Full-population results versus subgroups and interactions must be available, with unverified information distinguished. Preserved wording is linked here; prior content review remains incomplete.",
      "basis": "M08 Table 8.2.a, M04 §4.6.3; Internal application; M03 §3.2.1–3.2.4; Dose, persistence and effect-modification details are internally designed; Distinguishing studies from reports in M04 §4.6.1–4.6.2; Cohort/outcome linkage is an internal application",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Research prespecifying subgroups and distinguishing them from the full-population effect. This is a proposal; no new search, calculation or trial was performed in the recorded production."
    },
    {
      "item_id": "N16",
      "question_type": "Evidence condition",
      "question": "Other sleep factors and temperature outcomes",
      "needed": "Selected factor versus other sleep/temperature outcomes and their hierarchy",
      "role": "Required",
      "role_reason": "Distinguish Selected factor versus other sleep/temperature outcomes and their hierarchy to link needed and currently available information for the selected question.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Original information and analysis scope for Selected factor versus other sleep/temperature outcomes and their hierarchy must be available, with unverified information distinguished. Preserved wording is linked here; prior content review remains incomplete.",
      "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are Chamgap designs; M04 §4.6.3, M15 §15.3.1–15.3.3; status separation is a Chamgap design; M03 §3.2.4; Chamgap's own extrapolation boundary",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Follow-up research distinguishing self-reported factors from other outcomes. This is a proposal; no new search, calculation or trial was performed in the recorded production."
    },
    {
      "item_id": "N17",
      "question_type": "Evidence condition",
      "question": "Multiple factors, time points and analyses",
      "needed": "Number of tests, adjustments, prespecified order and outcome selection",
      "role": "Required",
      "role_reason": "Distinguish Number of tests, adjustments, prespecified order and outcome selection to link needed and currently available information for the selected question.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Original information and analysis scope for Number of tests, adjustments, prespecified order and outcome selection must be available, with unverified information distinguished. Preserved wording is linked here; prior content review remains incomplete.",
      "basis": "M08 Table 8.2.a, M04 §4.6.3; internal application; M04 §4.6.1–4.6.2 distinguish studies from reports; cohort/outcome linkage is internally applied",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Research separately reporting multiple outcomes and the primary analysis. This is a proposal; no new search, calculation or trial was performed in the recorded production."
    },
    {
      "item_id": "N18",
      "question_type": "Evidence condition",
      "question": "64 participants and FAS1 32/32",
      "needed": "Randomized/analysis populations and actual visit/scale-specific denominators",
      "role": "Required",
      "role_reason": "Distinguish Randomized/analysis populations and actual visit/scale-specific denominators to link needed and currently available information for the selected question.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Original information and analysis scope for Randomized/analysis populations and actual visit/scale-specific denominators must be available, with unverified information distinguished. Preserved wording is linked here; prior content review remains incomplete.",
      "basis": "M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; Design-specific adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap application",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Follow-up research specifying analysis populations and endpoint denominators. This is a proposal; no new search, calculation or trial was performed in the recorded production."
    },
    {
      "item_id": "N19",
      "question_type": "Evidence condition",
      "question": "Attrition, missingness, imputation and sensitivity",
      "needed": "Period-specific attrition, missing responses and analysis handling",
      "role": "Required",
      "role_reason": "Distinguish Period-specific attrition, missing responses and analysis handling to link needed and currently available information for the selected question.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Original information and analysis scope for Period-specific attrition, missing responses and analysis handling must be available, with unverified information distinguished. Preserved wording is linked here; prior content review remains incomplete.",
      "basis": "M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; Design-specific adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap application",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Follow-up trials disclosing the impact of missingness. This is a proposal; no new search, calculation or trial was performed in the recorded production."
    },
    {
      "item_id": "N20",
      "question_type": "Evidence condition",
      "question": "Original UMIN identifier and registry/plan access",
      "needed": "Registry identifier and actual reading scope for preregistration/protocol/SAP",
      "role": "Required",
      "role_reason": "Distinguish Registry identifier and actual reading scope for preregistration/protocol/SAP to link needed and currently available information for the selected question.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Original information and analysis scope for Registry identifier and actual reading scope for preregistration/protocol/SAP must be available, with unverified information distinguished. Preserved wording is linked here; prior content review remains incomplete.",
      "basis": "Data collection and selection principles in M04 §4.5–4.6; separation of access from reading and the hyperlink contract are internally designed; M08 Table 8.2.a, M04 §4.6.3; internal application; M04 §4.5, §4.6.3; limits of this material conversion reflect the review scope and internal design",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Follow-up research publicly linking planned and actual primary analyses. This is a proposal; no new search, calculation or trial was performed in the recorded production."
    },
    {
      "item_id": "N21",
      "question_type": "Evidence condition",
      "question": "Concurrent sleep/lifestyle and medication exposure",
      "needed": "Arm-specific lifestyle, concurrent medication, sleep management and exposure differences",
      "role": "Required",
      "role_reason": "Distinguish Arm-specific lifestyle, concurrent medication, sleep management and exposure differences to link needed and currently available information for the selected question.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Original information and analysis scope for Arm-specific lifestyle, concurrent medication, sleep management and exposure differences must be available, with unverified information distinguished. Preserved wording is linked here; prior content review remains incomplete.",
      "basis": "M03 §3.2.3, M08 §8.2.2–8.2.3; own application; M03 §3.2.2–3.2.3; reverse-direction labels and test adaptations are our own design",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Follow-up comparative research disclosing concurrent conditions. This is a proposal; no new search, calculation or trial was performed in the recorded production."
    },
    {
      "item_id": "N22",
      "question_type": "Evidence condition",
      "question": "Declaration of no specific funding",
      "needed": "Cash research grants versus other funding/support and COI",
      "role": "Required",
      "role_reason": "Distinguish Cash research grants versus other funding/support and COI to link needed and currently available information for the selected question.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Original information and analysis scope for Cash research grants versus other funding/support and COI must be available, with unverified information distinguished. Preserved wording is linked here; prior content review remains incomplete.",
      "basis": "Chamgap independence/attribution conditions. The referenced official method sections do not certify every detail of these items; Data collection/selection principles in M04 §4.5–4.6; Access/reading separation and hyperlink rules are Chamgap design",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Research separately disclosing funding, noncash support and involvement. This is a proposal; no new search, calculation or trial was performed in the recorded production."
    },
    {
      "item_id": "N23",
      "question_type": "Evidence condition",
      "question": "Fujicco provision of study food",
      "needed": "Company product support and provision to the contract site",
      "role": "Required",
      "role_reason": "Distinguish Company product support and provision to the contract site to link needed and currently available information for the selected question.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Original information and analysis scope for Company product support and provision to the contract site must be available, with unverified information distinguished. Preserved wording is linked here; prior content review remains incomplete.",
      "basis": "Chamgap’s own independence/attribution conditions. Official methodological sections used in this pilot do not guarantee every detailed item; M03 §3.2.2–3.2.3; reverse-direction labels and testing adaptations are internally designed",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Research disclosing product-support roles and scope. This is a proposal; no new search, calculation or trial was performed in the recorded production."
    },
    {
      "item_id": "N24",
      "question_type": "Evidence condition",
      "question": "Employee authors and study roles",
      "needed": "Author affiliations versus design/analysis/management/writing participation",
      "role": "Required",
      "role_reason": "Distinguish Author affiliations versus design/analysis/management/writing participation to link needed and currently available information for the selected question.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Original information and analysis scope for Author affiliations versus design/analysis/management/writing participation must be available, with unverified information distinguished. Preserved wording is linked here; prior content review remains incomplete.",
      "basis": "Chamgap's own conditions for independence and attribution. The official methodological sections used in this example do not validate every detail of these items.",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Follow-up research separately disclosing company and external-investigator roles. This is a proposal; no new search, calculation or trial was performed in the recorded production."
    },
    {
      "item_id": "N25",
      "question_type": "Evidence condition",
      "question": "One report, the same trial and independent replication",
      "needed": "Report-to-trial-to-arm/time/scale relationships and independent research",
      "role": "Required",
      "role_reason": "Distinguish Report-to-trial-to-arm/time/scale relationships and independent research to link needed and currently available information for the selected question.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Original information and analysis scope for Report-to-trial-to-arm/time/scale relationships and independent research must be available, with unverified information distinguished. Preserved wording is linked here; prior content review remains incomplete.",
      "basis": "Study/report distinction in M04 §4.6.1–4.6.2; Cohort/outcome linkage is Chamgap application; M04 §4.6.1–4.6.2 and M15 §15.3.1; Chamgap application",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Independent follow-up comparative research specifying the same selected endpoint. This is a proposal; no new search, calculation or trial was performed in the recorded production."
    },
    {
      "item_id": "N26",
      "question_type": "Evidence condition",
      "question": "Persistence and scope of other products/constituents",
      "needed": "Selected 12-week factor versus long-term/general-food and constituent effects",
      "role": "Required",
      "role_reason": "Distinguish Selected 12-week factor versus long-term/general-food and constituent effects to link needed and currently available information for the selected question.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Original information and analysis scope for Selected 12-week factor versus long-term/general-food and constituent effects must be available, with unverified information distinguished. Preserved wording is linked here; prior content review remains incomplete.",
      "basis": "M03 §3.2.1–3.2.4; dose, persistence and effect-modification details are custom design; M03 §3.2.4; custom extension boundary; M03 §3.2.2–3.2.3; reverse-direction labeling and test adaptation are custom design",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Follow-up research distinguishing persistence from direct constituent/formulation applicability. This is a proposal; no new search, calculation or trial was performed in the recorded production."
    },
    {
      "item_id": "N27",
      "question_type": "Harm-information gaps supplementing the efficacy table",
      "question": "Original safety records and rare/long-term harms",
      "needed": "Adverse-event collection, arm-specific denominators/frequency and follow-up scope",
      "role": "Supplementary",
      "role_reason": "Distinguish Adverse-event collection, arm-specific denominators/frequency and follow-up scope to link needed and currently available information for the selected question.",
      "application_exception": "Complements safety-data gaps for the selected subclaim. Intermediate/final skin hydration, self-reported sleepiness or parent cautionary wording are not used to judge safety or create harm-incidence estimates/new use instructions.",
      "criterion": "Original information and analysis scope for Adverse-event collection, arm-specific denominators/frequency and follow-up scope must be available, with unverified information distinguished. Preserved wording is linked here; prior content review remains incomplete.",
      "basis": "M19 §19.1.2–19.2.4; detailed distinctions are Chamgap’s own design; M19 §19.1.2–19.2.4; Chamgap application; M19 §19.1.2–19.2.4; Chamgap application; M19 §19.1.2–19.2.4; Chamgap application",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Research specifying harm collection and long-term/other-population scope. This is a proposal; no new search, calculation or trial was performed in the recorded production."
    },
    {
      "item_id": "N28",
      "question_type": "Evidence condition",
      "question": "Parent/subclaim, Korean/English, dates and history",
      "needed": "Original scores/axes, evidence date, corrections and cross-check narrative",
      "role": "Required",
      "role_reason": "Distinguish Original scores/axes, evidence date, corrections and cross-check narrative to link needed and currently available information for the selected question.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Original information and analysis scope for Original scores/axes, evidence date, corrections and cross-check narrative must be available, with unverified information distinguished. Preserved wording is linked here; prior content review remains incomplete.",
      "basis": "M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design; M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are internally designed",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Research distinguishing original values/history from applicability of new materials. This is a proposal; no new search, calculation or trial was performed in the recorded production."
    },
    {
      "item_id": "N29",
      "question_type": "Evidence condition",
      "question": "Actual summary reading, links and updates",
      "needed": "Preserved-summary reading versus access to external originals/figures/registry/plans",
      "role": "Required",
      "role_reason": "Distinguish Preserved-summary reading versus access to external originals/figures/registry/plans to link needed and currently available information for the selected question.",
      "application_exception": "Limited to the stored summary for the selected formulation, population, endpoint and period. It does not substitute for numbers from other formulations/trials/endpoints or unread external material.",
      "criterion": "Original information and analysis scope for Preserved-summary reading versus access to external originals/figures/registry/plans must be available, with unverified information distinguished. Preserved wording is linked here; prior content review remains incomplete.",
      "basis": "M04 §4.5–4.6 material collection/selection principles; acquisition/reading separation and hyperlink specifications are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design",
      "condition_origin": "Production conditions for turning the preserved account into a table; existing content review remains incomplete, and this is not a record of running an official tool or completing content review",
      "proposed_research": "Research updating records while distinguishing actual acquisition, dates and scope. This is a proposal; no new search, calculation or trial was performed in the recorded production."
    }
  ]
}