{
  "schema_version": "chamgap-public-criteria-1.0",
  "title": "IDCC 1201 · Four-week PSG sleep efficiency — Evidence Check",
  "language": "en",
  "translation_date": "2026-10-13",
  "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": "Efficacy comparison · Preserved-material preparation",
      "question": "What are the selected question and its subclaim verdict?",
      "needed": "Original wording, subclaim grade and note for the four-week PSG sleep-efficiency question",
      "role": "Required",
      "role_reason": "Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score",
      "application_exception": "Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations",
      "criterion": "Original wording, subclaim grade and note for the four-week PSG sleep-efficiency question; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials",
      "basis": "Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions",
      "condition_origin": "Preparation conditions written under the existing content-review responsibility policy; not automatic QA, verdict or gateway completion",
      "proposed_research": "Present the original subclaim verdict separately from parent context"
    },
    {
      "item_id": "N02",
      "question_type": "Efficacy comparison · Preserved-material preparation",
      "question": "Are sleep disturbance and diagnosed sleep disorders distinguished in the trial population?",
      "needed": "Actual eligibility, exclusions, baseline characteristics and diagnostic criteria",
      "role": "Required",
      "role_reason": "Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score",
      "application_exception": "Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations",
      "criterion": "Actual eligibility, exclusions, baseline characteristics and diagnostic criteria; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials",
      "basis": "Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions",
      "condition_origin": "Preparation conditions written under the existing content-review responsibility policy; not automatic QA, verdict or gateway completion",
      "proposed_research": "Distinguish included participants from excluded sleep disorders"
    },
    {
      "item_id": "N03",
      "question_type": "Efficacy comparison · Preserved-material preparation",
      "question": "What exactly are the intervention strain, research exposure and duration?",
      "needed": "Original IDCC 1201 strain, units, research exposure and duration",
      "role": "Required",
      "role_reason": "Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score",
      "application_exception": "Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations",
      "criterion": "Original IDCC 1201 strain, units, research exposure and duration; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials",
      "basis": "Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions",
      "condition_origin": "Preparation conditions written under the existing content-review responsibility policy; not automatic QA, verdict or gateway completion",
      "proposed_research": "Preserve the research combination and its applicability limits"
    },
    {
      "item_id": "N04",
      "question_type": "Efficacy comparison · Preserved-material preparation",
      "question": "Are materials available on placebo composition and the feasibility of blinding?",
      "needed": "Placebo ingredients, appearance, sensory properties, packaging and blinding procedures",
      "role": "Required",
      "role_reason": "Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score",
      "application_exception": "Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations",
      "criterion": "Placebo ingredients, appearance, sensory properties, packaging and blinding procedures; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials",
      "basis": "Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions",
      "condition_origin": "Preparation conditions written under the existing content-review responsibility policy; not automatic QA, verdict or gateway completion",
      "proposed_research": "Present product provision separately from actual blinding characteristics"
    },
    {
      "item_id": "N05",
      "question_type": "Efficacy comparison · Preserved-material preparation",
      "question": "Are balance and changes in sleep behavior, medication and other exposures known?",
      "needed": "Concurrent exposures, medication, lifestyle changes, adherence and deviations",
      "role": "Required",
      "role_reason": "Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score",
      "application_exception": "Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations",
      "criterion": "Concurrent exposures, medication, lifestyle changes, adherence and deviations; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials",
      "basis": "Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions",
      "condition_origin": "Preparation conditions written under the existing content-review responsibility policy; not automatic QA, verdict or gateway completion",
      "proposed_research": "Present concurrent exposures and actual intervention deviations over the same period"
    },
    {
      "item_id": "N06",
      "question_type": "Efficacy comparison · Preserved-material preparation",
      "question": "Are details of randomization, concealment and blinding verified?",
      "needed": "Random sequence, allocation concealment and blinding by role",
      "role": "Required",
      "role_reason": "Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score",
      "application_exception": "Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations",
      "criterion": "Random sequence, allocation concealment and blinding by role; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials",
      "basis": "Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions",
      "condition_origin": "Preparation conditions written under the existing content-review responsibility policy; not automatic QA, verdict or gateway completion",
      "proposed_research": "Distinguish design labels from implementation materials"
    },
    {
      "item_id": "N07",
      "question_type": "Efficacy comparison · Preserved-material preparation",
      "question": "Are randomized and per-protocol analysis denominators distinguished?",
      "needed": "Allocation, completion, analysis, exclusions and flow by group",
      "role": "Required",
      "role_reason": "Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score",
      "application_exception": "Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations",
      "criterion": "Allocation, completion, analysis, exclusions and flow by group; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials",
      "basis": "Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions",
      "condition_origin": "Preparation conditions written under the existing content-review responsibility policy; not automatic QA, verdict or gateway completion",
      "proposed_research": "Present allocation and analysis denominators separately"
    },
    {
      "item_id": "N08",
      "question_type": "Efficacy comparison · Preserved-material preparation",
      "question": "Is information on PP exclusions, missing data and the effect of interest sufficient?",
      "needed": "PP definition, exclusion reasons, missing-data handling and other analysis results",
      "role": "Required",
      "role_reason": "Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score",
      "application_exception": "Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations",
      "criterion": "PP definition, exclusion reasons, missing-data handling and other analysis results; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials",
      "basis": "Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions",
      "condition_origin": "Preparation conditions written under the existing content-review responsibility policy; not automatic QA, verdict or gateway completion",
      "proposed_research": "Present the scope of analysis choices and their implications by material"
    },
    {
      "item_id": "N09",
      "question_type": "Efficacy comparison · Preserved-material preparation",
      "question": "Is the baseline sleep-efficiency imbalance retained?",
      "needed": "Group-specific baseline values and their connection to adjusted analysis",
      "role": "Required",
      "role_reason": "Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score",
      "application_exception": "Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations",
      "criterion": "Group-specific baseline values and their connection to adjusted analysis; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials",
      "basis": "Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions",
      "condition_origin": "Preparation conditions written under the existing content-review responsibility policy; not automatic QA, verdict or gateway completion",
      "proposed_research": "Present baseline imbalance, changes and adjusted results separately"
    },
    {
      "item_id": "N10",
      "question_type": "Efficacy comparison · Preserved-material preparation",
      "question": "What measurement does PSG sleep efficiency represent?",
      "needed": "Definition, measurement and scoring of objective sleep efficiency",
      "role": "Required",
      "role_reason": "Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score",
      "application_exception": "Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations",
      "criterion": "Definition, measurement and scoring of objective sleep efficiency; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials",
      "basis": "Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions",
      "condition_origin": "Preparation conditions written under the existing content-review responsibility policy; not automatic QA, verdict or gateway completion",
      "proposed_research": "Present the objective measure separately from subjective scales"
    },
    {
      "item_id": "N11",
      "question_type": "Efficacy comparison · Preserved-material preparation",
      "question": "Are the four-week time point and measurement-night or repeated-measurement denominators distinguished?",
      "needed": "Baseline/week-4 schedule, number of nights, averaging and missing-data methods",
      "role": "Required",
      "role_reason": "Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score",
      "application_exception": "Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations",
      "criterion": "Baseline/week-4 schedule, number of nights, averaging and missing-data methods; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials",
      "basis": "Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions",
      "condition_origin": "Preparation conditions written under the existing content-review responsibility policy; not automatic QA, verdict or gateway completion",
      "proposed_research": "Distinguish people from measurement nights and time points"
    },
    {
      "item_id": "N12",
      "question_type": "Efficacy comparison · Preserved-material preparation",
      "question": "Are group changes and the meaning of the ± notation preserved?",
      "needed": "Original definitions of group changes and uncertainty notation",
      "role": "Required",
      "role_reason": "Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score",
      "application_exception": "Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations",
      "criterion": "Original definitions of group changes and uncertainty notation; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials",
      "basis": "Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions",
      "condition_origin": "Preparation conditions written under the existing content-review responsibility policy; not automatic QA, verdict or gateway completion",
      "proposed_research": "Present changes, final values, dispersion and precision separately"
    },
    {
      "item_id": "N13",
      "question_type": "Efficacy comparison · Preserved-material preparation",
      "question": "What between-group difference and interval are given in the original?",
      "needed": "Between-group effect, interval, test and analysis population",
      "role": "Required",
      "role_reason": "Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score",
      "application_exception": "Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations",
      "criterion": "Between-group effect, interval, test and analysis population; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials",
      "basis": "Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions",
      "condition_origin": "Preparation conditions written under the existing content-review responsibility policy; not automatic QA, verdict or gateway completion",
      "proposed_research": "Present the directly reported difference together with the absent CI"
    },
    {
      "item_id": "N14",
      "question_type": "Efficacy comparison · Preserved-material preparation",
      "question": "Are baseline-adjusted ranked ANCOVA results distinguished from the original difference?",
      "needed": "Adjustment model, adjusted estimate, interval and P value",
      "role": "Required",
      "role_reason": "Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score",
      "application_exception": "Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations",
      "criterion": "Adjustment model, adjusted estimate, interval and P value; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials",
      "basis": "Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions",
      "condition_origin": "Preparation conditions written under the existing content-review responsibility policy; not automatic QA, verdict or gateway completion",
      "proposed_research": "Present the original difference separately from the baseline-adjusted test"
    },
    {
      "item_id": "N15",
      "question_type": "Efficacy comparison · Preserved-material preparation",
      "question": "Are prespecified criteria available for minimum important difference and clinical importance?",
      "needed": "Prespecified importance criteria and supporting grounds for PSG sleep efficiency",
      "role": "Required",
      "role_reason": "Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score",
      "application_exception": "Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations",
      "criterion": "Prespecified importance criteria and supporting grounds for PSG sleep efficiency; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials",
      "basis": "Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions",
      "condition_origin": "Preparation conditions written under the existing content-review responsibility policy; not automatic QA, verdict or gateway completion",
      "proposed_research": "Present statistical results separately from clinical importance"
    },
    {
      "item_id": "N16",
      "question_type": "Efficacy comparison · Preserved-material preparation",
      "question": "Are participant enrollment, trial completion and official registration dates separated?",
      "needed": "Actual dates of each event and registration history",
      "role": "Required",
      "role_reason": "Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score",
      "application_exception": "Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations",
      "criterion": "Actual dates of each event and registration history; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials",
      "basis": "Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions",
      "condition_origin": "Preparation conditions written under the existing content-review responsibility policy; not automatic QA, verdict or gateway completion",
      "proposed_research": "Present recruitment, completion and registration as separately dated events"
    },
    {
      "item_id": "N17",
      "question_type": "Efficacy comparison · Preserved-material preparation",
      "question": "Does a registration number establish actual reading?",
      "needed": "Distinction between KCT0011568 identity and access to or contents of the original registration",
      "role": "Required",
      "role_reason": "Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score",
      "application_exception": "Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations",
      "criterion": "Distinction between KCT0011568 identity and access to or contents of the original registration; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials",
      "basis": "Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions",
      "condition_origin": "Preparation conditions written under the existing content-review responsibility policy; not automatic QA, verdict or gateway completion",
      "proposed_research": "Distinguish the preserved registration identifier from actual reading status"
    },
    {
      "item_id": "N18",
      "question_type": "Efficacy comparison · Preserved-material preparation",
      "question": "Was the paper-labeled primary endpoint independently verified prospectively?",
      "needed": "Materials comparing the pre-recruitment plan with the paper’s primary-endpoint label",
      "role": "Required",
      "role_reason": "Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score",
      "application_exception": "Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations",
      "criterion": "Materials comparing the pre-recruitment plan with the paper’s primary-endpoint label; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials",
      "basis": "Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions",
      "condition_origin": "Preparation conditions written under the existing content-review responsibility policy; not automatic QA, verdict or gateway completion",
      "proposed_research": "Present the paper’s endpoint label separately from planning time"
    },
    {
      "item_id": "N19",
      "question_type": "Efficacy comparison · Preserved-material preparation",
      "question": "Can plans for multiplicity, additional outcomes and analysis selection be verified?",
      "needed": "Prespecified hierarchy and changes for all analyses, endpoints and adjustments",
      "role": "Required",
      "role_reason": "Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score",
      "application_exception": "Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations",
      "criterion": "Prespecified hierarchy and changes for all analyses, endpoints and adjustments; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials",
      "basis": "Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions",
      "condition_origin": "Preparation conditions written under the existing content-review responsibility policy; not automatic QA, verdict or gateway completion",
      "proposed_research": "Present the prespecified hierarchy of efficacy, additional and safety analyses"
    },
    {
      "item_id": "N20",
      "question_type": "Efficacy comparison · Preserved-material preparation",
      "question": "Are subjective insomnia improvement and PSG sleep efficiency distinguished?",
      "needed": "Original results and measurement definitions for each objective/subjective endpoint",
      "role": "Required",
      "role_reason": "Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score",
      "application_exception": "Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations",
      "criterion": "Original results and measurement definitions for each objective/subjective endpoint; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials",
      "basis": "Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions",
      "condition_origin": "Preparation conditions written under the existing content-review responsibility policy; not automatic QA, verdict or gateway completion",
      "proposed_research": "Present different sleep outcomes as separate questions"
    },
    {
      "item_id": "N21",
      "question_type": "Efficacy comparison · Preserved-material preparation",
      "question": "Was REM-related sleep efficiency combined with overall PSG sleep efficiency?",
      "needed": "Endpoint definitions and measurement scope in the current trial and review",
      "role": "Required",
      "role_reason": "Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score",
      "application_exception": "Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations",
      "criterion": "Endpoint definitions and measurement scope in the current trial and review; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials",
      "basis": "Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions",
      "condition_origin": "Preparation conditions written under the existing content-review responsibility policy; not automatic QA, verdict or gateway completion",
      "proposed_research": "Distinguish overall-sleep and REM-related measures and strains"
    },
    {
      "item_id": "N22",
      "question_type": "Efficacy comparison · Preserved-material preparation",
      "question": "What is the actual material scope of the unidentified meta-analysis context?",
      "needed": "Bibliography, included trials, strains and original endpoints for the 39-RCT review",
      "role": "Required",
      "role_reason": "Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score",
      "application_exception": "Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations",
      "criterion": "Bibliography, included trials, strains and original endpoints for the 39-RCT review; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials",
      "basis": "Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions",
      "condition_origin": "Preparation conditions written under the existing content-review responsibility policy; not automatic QA, verdict or gateway completion",
      "proposed_research": "Present unidentified preserved context separately from the identified trial report"
    },
    {
      "item_id": "N23",
      "question_type": "Efficacy comparison · Preserved-material preparation",
      "question": "Were IDCC 1201 results extended to probiotics generally?",
      "needed": "Direct comparisons and applicability evidence by strain, product, population and duration",
      "role": "Required",
      "role_reason": "Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score",
      "application_exception": "Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations",
      "criterion": "Direct comparisons and applicability evidence by strain, product, population and duration; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials",
      "basis": "Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions",
      "condition_origin": "Preparation conditions written under the existing content-review responsibility policy; not automatic QA, verdict or gateway completion",
      "proposed_research": "Preserve strain-specific applicability boundaries as separate questions"
    },
    {
      "item_id": "N24",
      "question_type": "Efficacy comparison · Preserved-material preparation",
      "question": "Were the paper, registration and related context counted as independent repeat trials?",
      "needed": "Connections and overlap among current report, registration and review context",
      "role": "Required",
      "role_reason": "Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score",
      "application_exception": "Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations",
      "criterion": "Connections and overlap among current report, registration and review context; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials",
      "basis": "Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions",
      "condition_origin": "Preparation conditions written under the existing content-review responsibility policy; not automatic QA, verdict or gateway completion",
      "proposed_research": "Distinguish report entries from trial and participant units"
    },
    {
      "item_id": "N25",
      "question_type": "Efficacy comparison · Preserved-material preparation",
      "question": "Are research funding and active/placebo product provision distinguished?",
      "needed": "Original disclosures of funding, products, contracts and company roles",
      "role": "Required",
      "role_reason": "Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score",
      "application_exception": "Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations",
      "criterion": "Original disclosures of funding, products, contracts and company roles; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials",
      "basis": "Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions",
      "condition_origin": "Preparation conditions written under the existing content-review responsibility policy; not automatic QA, verdict or gateway completion",
      "proposed_research": "Present funding, product supply and involvement in results as separate items"
    },
    {
      "item_id": "N26",
      "question_type": "Efficacy comparison · Preserved-material preparation",
      "question": "Are the names and relationships of company employee authors preserved?",
      "needed": "Employee authors, affiliations, contributions and other conflict disclosures",
      "role": "Required",
      "role_reason": "Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score",
      "application_exception": "Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations",
      "criterion": "Employee authors, affiliations, contributions and other conflict disclosures; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials",
      "basis": "Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions",
      "condition_origin": "Preparation conditions written under the existing content-review responsibility policy; not automatic QA, verdict or gateway completion",
      "proposed_research": "Present employee relationships separately from each author’s actual roles"
    },
    {
      "item_id": "N27",
      "question_type": "Efficacy comparison · Preserved-material preparation",
      "question": "Are the company’s limited role denials distinguished from overall independence?",
      "needed": "Materials on recruitment, collection, endpoint assessment, statistical analysis, design, writing and publication roles",
      "role": "Required",
      "role_reason": "Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score",
      "application_exception": "Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations",
      "criterion": "Materials on recruitment, collection, endpoint assessment, statistical analysis, design, writing and publication roles; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials",
      "basis": "Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions",
      "condition_origin": "Preparation conditions written under the existing content-review responsibility policy; not automatic QA, verdict or gateway completion",
      "proposed_research": "Distinguish disclosed role denials from involvement that remains unverified"
    },
    {
      "item_id": "N28",
      "question_type": "Supplementary harm evidence",
      "question": "Is the observation scope of four-week adverse-event nonreporting clear?",
      "needed": "Event definitions, collection methods, denominators by group and discontinuations",
      "role": "Supplementary",
      "role_reason": "Supplementary condition showing limits of harms/safety information separately from efficacy",
      "application_exception": "Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations",
      "criterion": "Event definitions, collection methods, denominators by group and discontinuations; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials",
      "basis": "Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions",
      "condition_origin": "Preparation conditions written under the existing content-review responsibility policy; not automatic QA, verdict or gateway completion",
      "proposed_research": "Present reporting scope and actual collection/exposure denominators"
    },
    {
      "item_id": "N29",
      "question_type": "Supplementary harm evidence",
      "question": "Is systolic-pressure change the same outcome as sleep efficiency or confirmed harm?",
      "needed": "Values, intervals, baseline, time points and event information for blood-pressure changes",
      "role": "Supplementary",
      "role_reason": "Supplementary condition showing limits of harms/safety information separately from efficacy",
      "application_exception": "Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations",
      "criterion": "Values, intervals, baseline, time points and event information for blood-pressure changes; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials",
      "basis": "Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions",
      "condition_origin": "Preparation conditions written under the existing content-review responsibility policy; not automatic QA, verdict or gateway completion",
      "proposed_research": "Present blood-pressure measures separately from adverse events and sleep efficiency"
    },
    {
      "item_id": "N30",
      "question_type": "Supplementary harm evidence",
      "question": "Can long-term or rare harms and safety in other populations be assessed?",
      "needed": "Long-term exposure/follow-up, vulnerable populations and rare-event materials",
      "role": "Supplementary",
      "role_reason": "Supplementary condition showing limits of harms/safety information separately from efficacy",
      "application_exception": "Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations",
      "criterion": "Long-term exposure/follow-up, vulnerable populations and rare-event materials; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials",
      "basis": "Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions",
      "condition_origin": "Preparation conditions written under the existing content-review responsibility policy; not automatic QA, verdict or gateway completion",
      "proposed_research": "Present long-term safety gaps separately from efficacy"
    },
    {
      "item_id": "N31",
      "question_type": "Efficacy comparison · Preserved-material preparation",
      "question": "Do four-week results show sustained effects after completion or sleep-disorder prevention?",
      "needed": "Direct follow-up, sustained-effect and clinical-outcome materials after completion",
      "role": "Required",
      "role_reason": "Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score",
      "application_exception": "Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations",
      "criterion": "Direct follow-up, sustained-effect and clinical-outcome materials after completion; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials",
      "basis": "Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions",
      "condition_origin": "Preparation conditions written under the existing content-review responsibility policy; not automatic QA, verdict or gateway completion",
      "proposed_research": "Present treatment-period and post-completion sustained results as separate questions"
    },
    {
      "item_id": "N32",
      "question_type": "Efficacy comparison · Preserved-material preparation",
      "question": "Are summary reading and unread external abstract, full text, registration and plans distinguished?",
      "needed": "Original form, actual reading and access status by material type",
      "role": "Required",
      "role_reason": "Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score",
      "application_exception": "Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations",
      "criterion": "Original form, actual reading and access status by material type; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials",
      "basis": "Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions",
      "condition_origin": "Preparation conditions written under the existing content-review responsibility policy; not automatic QA, verdict or gateway completion",
      "proposed_research": "Mark summary reading separately from unread external materials"
    },
    {
      "item_id": "N33",
      "question_type": "Efficacy comparison · Preserved-material preparation",
      "question": "Are parent Korean/English prose, axes, reference date and correction history preserved in original form?",
      "needed": "Whole copies of selected row, parent record and historical dates",
      "role": "Required",
      "role_reason": "Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score",
      "application_exception": "Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations",
      "criterion": "Whole copies of selected row, parent record and historical dates; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials",
      "basis": "Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions",
      "condition_origin": "Preparation conditions written under the existing content-review responsibility policy; not automatic QA, verdict or gateway completion",
      "proposed_research": "Separate existing verdict/correction history from preparation date and existing content review"
    },
    {
      "item_id": "N34",
      "question_type": "Efficacy comparison · Preserved-material preparation",
      "question": "Are the preserved candidate’s review-pending/eligibility markers separated from the current preparation event?",
      "needed": "Existing candidate metadata, preparation, review and independence status",
      "role": "Required",
      "role_reason": "Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score",
      "application_exception": "Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations",
      "criterion": "Existing candidate metadata, preparation, review and independence status; record applicability and unverified matters without creating values, clinical verdicts or independence certification absent from original materials",
      "basis": "Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions",
      "condition_origin": "Preparation conditions written under the existing content-review responsibility policy; not automatic QA, verdict or gateway completion",
      "proposed_research": "Link preparation completion separately from existing content-review status"
    }
  ]
}