{
  "schema_version": "chamgap-public-evidence-check-1.0",
  "public_id": "v2967-s0",
  "verdict_number": "2967",
  "title": "IDCC 1201 · Four-week PSG sleep efficiency — Evidence Check",
  "view_version": "1.0",
  "view_created_date": "2026-10-13",
  "criteria_version": "1.0",
  "criteria_date": "2026-10-06",
  "review_date": null,
  "legacy_evidence_date": "2026-08-26",
  "review_scope": {
    "materials_read": "Existing review summaries and stored records of methodological application",
    "clinical_papers_directly_read": false,
    "new_clinical_search": false,
    "limitation": "The whole stored parent-verdict summary and selected subclaim were read for production. External papers, abstracts, full texts, registry, protocol, SAP and funding disclosures were not separately read or accessed. Historical review records are not inherited as current clinical verification or a new verdict.",
    "date_meaning": "This is the date the stored materials were checked, not the date of a new search of the clinical literature."
  },
  "claim_context": {
    "population": "80 adults with sleep disturbance randomized; severe insomnia and diagnosed sleep disorders excluded; PP78 analyzed",
    "intervention": "Bacillus coagulans IDCC 1201 trial capsules",
    "dose": "Research exposure: 5 billion CFU/day, one hour before bedtime, four weeks; not intake guidance",
    "comparator": "Trial placebo capsules; original composition/matching details unread",
    "endpoint": "Change from baseline to week 4 in PSG sleep efficiency; changes, between-group difference and baseline-adjusted P distinguished",
    "duration": "Four-week research exposure and results; sustained effects after completion and long-term safety unverified",
    "excluded_extensions": [
      "No new formulations, populations, clinical effects, CI, verdicts, independence certification, participant totals, implementation or treatment instructions are created"
    ]
  },
  "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",
      "current_reports": [
        "R01"
      ],
      "existence": "The existing review summary contains the corresponding wording, bibliography or applicability scope; necessary detailed external materials remain unverified",
      "acquired_read": "Summary read; related external material unread",
      "observation": "The selected subclaim is improved four-week PSG sleep efficiency, originally graded C, with a note that the baseline-adjusted analysis was also positive but this is one short manufacturer trial. The parent verdict is C with 50 points.",
      "condition_status": "Partly verified",
      "status_reason": "Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict",
      "missingness": "The selected row has no score, status or axes. Do not fill these with parent values or create a new verdict.",
      "uncertainty": "Within the preserved-summary scope; external abstract, full text, registration, protocol and SAP were not read, and no new clinical content review or external link verification was performed",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Original selected row and parent verdict"
    },
    {
      "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",
      "current_reports": [
        "R01"
      ],
      "existence": "The existing review summary contains the corresponding wording, bibliography or applicability scope; necessary detailed external materials remain unverified",
      "acquired_read": "Summary read; related external material unread",
      "observation": "The record describes adults with sleep disturbance and exclusion of severe insomnia and diagnosed sleep disorders.",
      "condition_status": "Partly verified",
      "status_reason": "Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict",
      "missingness": "Detailed age, diagnoses, baseline conditions and recruitment criteria remain unread. Do not extend the result to treatment of diagnosed insomnia or all adults.",
      "uncertainty": "Within the preserved-summary scope; external abstract, full text, registration, protocol and SAP were not read, and no new clinical content review or external link verification was performed",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Eligibility, exclusion and baseline-characteristics tables"
    },
    {
      "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",
      "current_reports": [
        "R01"
      ],
      "existence": "The existing review summary contains the corresponding wording, bibliography or applicability scope; necessary detailed external materials remain unverified",
      "acquired_read": "Summary read; related external material unread",
      "observation": "The research combination is described as Bacillus coagulans IDCC 1201, 5 billion CFU/day, one hour before bedtime, for four weeks. Active and placebo capsules were used.",
      "condition_status": "Partly verified",
      "status_reason": "Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict",
      "missingness": "This preserves research identity and is not intake guidance or a product recommendation. Equivalence of other strains, exposures, formulations or durations is not established.",
      "uncertainty": "Within the preserved-summary scope; external abstract, full text, registration, protocol and SAP were not read, and no new clinical content review or external link verification was performed",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Trial product, strain and exposure specifications"
    },
    {
      "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",
      "current_reports": [
        "R01"
      ],
      "existence": "The existing review summary contains the corresponding wording, bibliography or applicability scope; necessary detailed external materials remain unverified",
      "acquired_read": "Summary read; related external material unread",
      "observation": "The original summary describes a double-blind placebo-controlled trial and company provision of active and placebo capsules.",
      "condition_status": "Partly verified",
      "status_reason": "Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict",
      "missingness": "Capsule composition, appearance and sensory matching, blinding success, batches and storage details remain unread.",
      "uncertainty": "Within the preserved-summary scope; external abstract, full text, registration, protocol and SAP were not read, and no new clinical content review or external link verification was performed",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Active/placebo specifications and blinding procedures"
    },
    {
      "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",
      "current_reports": [
        "R01"
      ],
      "existence": "The existing review summary contains the corresponding wording, bibliography or applicability scope; necessary detailed external materials remain unverified",
      "acquired_read": "Summary read; related external material unread",
      "observation": "The preserved summary provides an intervention-versus-placebo comparison but no details of concurrent sleep exposures, lifestyle changes or concomitant medication.",
      "condition_status": "Unverified",
      "status_reason": "Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict",
      "missingness": "Equality of concurrent exposures is not certified. No sleep or treatment-change instructions are written.",
      "uncertainty": "Within the preserved-summary scope; external abstract, full text, registration, protocol and SAP were not read, and no new clinical content review or external link verification was performed",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Concurrent-exposure, intervention-adherence and deviation tables"
    },
    {
      "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",
      "current_reports": [
        "R01"
      ],
      "existence": "The existing review summary contains the corresponding wording, bibliography or applicability scope; necessary detailed external materials remain unverified",
      "acquired_read": "Summary read; related external material unread",
      "observation": "The material describes a double-blind randomized placebo-controlled trial assigning 80 adults, 40 per group.",
      "condition_status": "Partly verified",
      "status_reason": "Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict",
      "missingness": "Original methods for sequence generation, concealment, code release and blinding by role remain externally unread. The parent B2 axis is not converted into a new assessment.",
      "uncertainty": "Within the preserved-summary scope; external abstract, full text, registration, protocol and SAP were not read, and no new clinical content review or external link verification was performed",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Original randomization, concealment and blinding methods"
    },
    {
      "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",
      "current_reports": [
        "R01"
      ],
      "existence": "The existing review summary contains the corresponding wording, bibliography or applicability scope; necessary detailed external materials remain unverified",
      "acquired_read": "Summary read; related external material unread",
      "observation": "The record gives 80 randomized, 40/40, and a per-protocol analysis of 78, 39/39.",
      "condition_status": "Partly verified",
      "status_reason": "Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict",
      "missingness": "Do not convert PP78 into all 80 assigned or everyone completing the trial. Reasons for analysis exclusions and group-specific flow are absent from the summary.",
      "uncertainty": "Within the preserved-summary scope; external abstract, full text, registration, protocol and SAP were not read, and no new clinical content review or external link verification was performed",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Allocation, follow-up, PP and other analysis-population flow"
    },
    {
      "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",
      "current_reports": [
        "R01"
      ],
      "existence": "The existing review summary contains the corresponding wording, bibliography or applicability scope; necessary detailed external materials remain unverified",
      "acquired_read": "Summary read; related external material unread",
      "observation": "The current efficacy summary uses results for PP78. The existing research description and evidence list explicitly identify PP.",
      "condition_status": "Partly verified",
      "status_reason": "Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict",
      "missingness": "Do not elevate PP results to effects in everyone assigned. Exclusion reasons, ITT results and sensitivity analyses remain unread.",
      "uncertainty": "Within the preserved-summary scope; external abstract, full text, registration, protocol and SAP were not read, and no new clinical content review or external link verification was performed",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Analysis-population definitions, missing-data handling and sensitivity analyses"
    },
    {
      "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",
      "current_reports": [
        "R01"
      ],
      "existence": "The existing review summary contains the corresponding wording, bibliography or applicability scope; necessary detailed external materials remain unverified",
      "acquired_read": "Summary read; related external material unread",
      "observation": "Baseline sleep efficiency is recorded as differing: 75.75% versus 85.08%, P=0.049.",
      "condition_status": "Partly verified",
      "status_reason": "Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict",
      "missingness": "Do not describe baseline imbalance as removed or newly calculate regression effects or causal magnitudes.",
      "uncertainty": "Within the preserved-summary scope; external abstract, full text, registration, protocol and SAP were not read, and no new clinical content review or external link verification was performed",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Baseline characteristics and prespecified adjustment model"
    },
    {
      "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",
      "current_reports": [
        "R01"
      ],
      "existence": "The existing review summary contains the corresponding wording, bibliography or applicability scope; necessary detailed external materials remain unverified",
      "acquired_read": "Summary read; related external material unread",
      "observation": "The existing product explanation describes the proportion of time in bed actually spent asleep. The evidence endpoint is change from baseline to week 4 in PSG sleep efficiency.",
      "condition_status": "Partly verified",
      "status_reason": "Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict",
      "missingness": "PSG scoring rules, equipment, scorers and original total-sleep-time and time-in-bed values remain unread. Do not combine this with subjective insomnia scales.",
      "uncertainty": "Within the preserved-summary scope; external abstract, full text, registration, protocol and SAP were not read, and no new clinical content review or external link verification was performed",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "PSG measurement/scoring manuals and original measurement tables"
    },
    {
      "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",
      "current_reports": [
        "R01"
      ],
      "existence": "The existing review summary contains the corresponding wording, bibliography or applicability scope; necessary detailed external materials remain unverified",
      "acquired_read": "Summary read; related external material unread",
      "observation": "The summary specifies baseline to four weeks. It gives no details of the number of measurement nights or handling of repeated measurements.",
      "condition_status": "Partly verified",
      "status_reason": "Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict",
      "missingness": "Do not count nights, repeated measurements, groups or time points as new participants or independent trials.",
      "uncertainty": "Within the preserved-summary scope; external abstract, full text, registration, protocol and SAP were not read, and no new clinical content review or external link verification was performed",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "PSG schedule, measurement-night and repeated-measurement materials"
    },
    {
      "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",
      "current_reports": [
        "R01"
      ],
      "existence": "The existing review summary contains the corresponding wording, bibliography or applicability scope; necessary detailed external materials remain unverified",
      "acquired_read": "Summary read; related external material unread",
      "observation": "Original values are +13.71±21.14 versus -0.15±13.35 percentage points. Do not convert these into final absolute sleep efficiency.",
      "condition_status": "Partly verified",
      "status_reason": "Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict",
      "missingness": "The summary does not specify whether ± denotes SD or SE, so no label is assigned. Do not construct final group values by adding changes to baseline.",
      "uncertainty": "Within the preserved-summary scope; external abstract, full text, registration, protocol and SAP were not read, and no new clinical content review or external link verification was performed",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Original table defining group changes and ± notation"
    },
    {
      "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",
      "current_reports": [
        "R01"
      ],
      "existence": "The existing review summary contains the corresponding wording, bibliography or applicability scope; necessary detailed external materials remain unverified",
      "acquired_read": "Summary read; related external material unread",
      "observation": "For PP78, the original between-group difference is +13.86 percentage points, P=0.002; the summary states that a confidence interval was not reported.",
      "condition_status": "Partly verified",
      "status_reason": "Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict",
      "missingness": "Do not calculate new CI, effects or between-group differences. Absence of an effect interval does not establish precision.",
      "uncertainty": "Within the preserved-summary scope; external abstract, full text, registration, protocol and SAP were not read, and no new clinical content review or external link verification was performed",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Original result table, effect estimate and confidence interval"
    },
    {
      "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",
      "current_reports": [
        "R01"
      ],
      "existence": "The existing review summary contains the corresponding wording, bibliography or applicability scope; necessary detailed external materials remain unverified",
      "acquired_read": "Summary read; related external material unread",
      "observation": "The preserved summary states that baseline-adjusted ranked ANCOVA was also positive, P=0.015.",
      "condition_status": "Partly verified",
      "status_reason": "Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict",
      "missingness": "The adjusted effect and CI are absent from the summary. Do not automatically use the original +13.86-percentage-point difference as the adjusted estimate.",
      "uncertainty": "Within the preserved-summary scope; external abstract, full text, registration, protocol and SAP were not read, and no new clinical content review or external link verification was performed",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Ranked ANCOVA model and adjusted-effect table"
    },
    {
      "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",
      "current_reports": [
        "R01"
      ],
      "existence": "The existing review summary contains the corresponding wording, bibliography or applicability scope; necessary detailed external materials remain unverified",
      "acquired_read": "Summary read; related external material unread",
      "observation": "The existing verdict rationale states that there was no prespecified minimum important difference and that the effect CI was not reported.",
      "condition_status": "Partly verified",
      "status_reason": "Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict",
      "missingness": "Do not invent a clinical important difference, sleep normalization or perceived treatment effect.",
      "uncertainty": "Within the preserved-summary scope; external abstract, full text, registration, protocol and SAP were not read, and no new clinical content review or external link verification was performed",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Prespecified importance criteria and links to clinical outcomes"
    },
    {
      "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",
      "current_reports": [
        "R01"
      ],
      "existence": "The existing review summary contains the corresponding wording, bibliography or applicability scope; necessary detailed external materials remain unverified",
      "acquired_read": "Summary read; related external material unread",
      "observation": "Participant enrollment began 2025-02-03; the trial ended 2025-07-02; CRIS KCT0011568 registration was 2026-02-02. The preserved summary describes registration seven months after trial completion.",
      "condition_status": "Partly verified",
      "status_reason": "Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict",
      "missingness": "Do not change registration into preregistration before recruitment. Do not calculate new durations or date differences.",
      "uncertainty": "Within the preserved-summary scope; external abstract, full text, registration, protocol and SAP were not read, and no new clinical content review or external link verification was performed",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Original CRIS registration, change history and recruitment records"
    },
    {
      "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",
      "current_reports": [
        "R01"
      ],
      "existence": "The existing review summary contains the corresponding wording, bibliography or applicability scope; necessary detailed external materials remain unverified",
      "acquired_read": "Summary read; related external material unread",
      "observation": "The existing registration-identifier record contains KCT0011568, and the research narrative identifies CRIS registration. Do not relabel this as NCT registration because of the original storage field name.",
      "condition_status": "Partly verified",
      "status_reason": "Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict",
      "missingness": "Official registration URL, document and revision history remain unread here; an identifier alone does not certify prespecification.",
      "uncertainty": "Within the preserved-summary scope; external abstract, full text, registration, protocol and SAP were not read, and no new clinical content review or external link verification was performed",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Official KCT0011568 registration document"
    },
    {
      "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",
      "current_reports": [
        "R01"
      ],
      "existence": "The existing review summary contains the corresponding wording, bibliography or applicability scope; necessary detailed external materials remain unverified",
      "acquired_read": "Summary read; related external material unread",
      "observation": "The preserved research narrative states that registration after trial completion weakens independent prospective verification of the paper-labeled primary endpoint.",
      "condition_status": "Partly verified",
      "status_reason": "Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict",
      "missingness": "Do not elevate PSG efficiency to a prospectively confirmed endpoint through retrospective registration alone.",
      "uncertainty": "Within the preserved-summary scope; external abstract, full text, registration, protocol and SAP were not read, and no new clinical content review or external link verification was performed",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Pre-recruitment protocol/SAP and registration/paper endpoints"
    },
    {
      "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",
      "current_reports": [
        "R01"
      ],
      "existence": "The existing review summary contains the corresponding wording, bibliography or applicability scope; necessary detailed external materials remain unverified",
      "acquired_read": "Summary read; related external material unread",
      "observation": "The preserved summary includes PSG efficiency, baseline adjustment and some safety information, but no detailed complete plan, multiple-comparison adjustment or analysis selection.",
      "condition_status": "Unverified",
      "status_reason": "Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict",
      "missingness": "Do not newly certify plans or statistical significance for other outcomes.",
      "uncertainty": "Within the preserved-summary scope; external abstract, full text, registration, protocol and SAP were not read, and no new clinical content review or external link verification was performed",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Protocol, SAP, endpoint list and revision history"
    },
    {
      "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",
      "current_reports": [
        "R01"
      ],
      "existence": "The existing review summary contains the corresponding wording, bibliography or applicability scope; necessary detailed external materials remain unverified",
      "acquired_read": "Summary read; related external material unread",
      "observation": "The existing counterpoint states that subjective insomnia improvement and PSG sleep efficiency are different endpoints.",
      "condition_status": "Partly verified",
      "status_reason": "Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict",
      "missingness": "Do not fill subjective sleep quality, overall insomnia or everyday-function efficacy with a positive objective measure.",
      "uncertainty": "Within the preserved-summary scope; external abstract, full text, registration, protocol and SAP were not read, and no new clinical content review or external link verification was performed",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Endpoint-specific original results for subjective scales and daily functioning"
    },
    {
      "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",
      "current_reports": [
        "R01",
        "R02"
      ],
      "existence": "The existing review summary contains the corresponding wording, bibliography or applicability scope; necessary detailed external materials remain unverified",
      "acquired_read": "Summary read; related external material unread",
      "observation": "The existing counterview mentions a meta-analysis of REM-related sleep efficiency. The current IDCC 1201 trial endpoint is change from baseline to four weeks in PSG sleep efficiency.",
      "condition_status": "Partly verified",
      "status_reason": "Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict",
      "missingness": "Do not establish REM-related measures as equivalent to overall PSG measures or combine different effects.",
      "uncertainty": "Within the preserved-summary scope; external abstract, full text, registration, protocol and SAP were not read, and no new clinical content review or external link verification was performed",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Review endpoint definitions and included-trial tables"
    },
    {
      "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",
      "current_reports": [
        "R02"
      ],
      "existence": "The existing review summary contains the corresponding wording, bibliography or applicability scope; necessary detailed external materials remain unverified",
      "acquired_read": "Summary read; related external material unread",
      "observation": "The preserved summary describes a null REM-related sleep-efficiency result from three trials in a 39-RCT meta-analysis: MD 1.64 percentage points, 95% CI -0.35 to 3.64. The review bibliography is not provided.",
      "condition_status": "Partly verified",
      "status_reason": "Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict",
      "missingness": "Do not certify 39 or three as directly read or independent-replication counts here. Leave the external review document and inclusion relationships unverified.",
      "uncertainty": "Within the preserved-summary scope; external abstract, full text, registration, protocol and SAP were not read, and no new clinical content review or external link verification was performed",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Exact bibliography, included trials and result tables of the mentioned review"
    },
    {
      "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",
      "current_reports": [
        "R01",
        "R02"
      ],
      "existence": "The existing review summary contains the corresponding wording, bibliography or applicability scope; necessary detailed external materials remain unverified",
      "acquired_read": "Summary read; related external material unread",
      "observation": "The summary states that null whole-group trials of other strains address a different question and that these results cannot be extended to probiotics generally or treatment of diagnosed insomnia.",
      "condition_status": "Partly verified",
      "status_reason": "Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict",
      "missingness": "Do not elevate other-strain or other-endpoint results to equivalence or independent replication of IDCC 1201.",
      "uncertainty": "Within the preserved-summary scope; external abstract, full text, registration, protocol and SAP were not read, and no new clinical content review or external link verification was performed",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Direct replication or comparison for the same strain, product and population"
    },
    {
      "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",
      "current_reports": [
        "R01",
        "R02"
      ],
      "existence": "The existing review summary contains the corresponding wording, bibliography or applicability scope; necessary detailed external materials remain unverified",
      "acquired_read": "Summary read; related external material unread",
      "observation": "The directly identified trial bibliography is one Kim et al. 2026 paper linked to KCT0011568. The preserved summary contains only one selected subclaim row.",
      "condition_status": "Partly verified",
      "status_reason": "Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict",
      "missingness": "Do not count the paper, registration, PSG time points, review or parent summary as new independent trials or sum participants. Confirmed independent-trial and participant totals remain unrecorded.",
      "uncertainty": "Within the preserved-summary scope; external abstract, full text, registration, protocol and SAP were not read, and no new clinical content review or external link verification was performed",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Connections among papers, registration and analyses of the same trial"
    },
    {
      "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",
      "current_reports": [
        "R01"
      ],
      "existence": "The existing review summary contains the corresponding wording, bibliography or applicability scope; necessary detailed external materials remain unverified",
      "acquired_read": "Summary read; related external material unread",
      "observation": "Ildong Bioscience provided research funding and active/placebo capsules; the original summary describes full manufacturer funding.",
      "condition_status": "Partly verified",
      "status_reason": "Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict",
      "missingness": "Do not change funding or product support into public or independent support. Support contracts, product details and data rights remain unread.",
      "uncertainty": "Within the preserved-summary scope; external abstract, full text, registration, protocol and SAP were not read, and no new clinical content review or external link verification was performed",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Funding/product disclosures and contract/role specifications"
    },
    {
      "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",
      "current_reports": [
        "R01"
      ],
      "existence": "The existing review summary contains the corresponding wording, bibliography or applicability scope; necessary detailed external materials remain unverified",
      "acquired_read": "Summary read; related external material unread",
      "observation": "Hayoung Kim, Jinho Lee, Won Yeong Bang, Han Bin Lee and Jin Seok Moon are recorded as company employees in the preserved summary. The evidence list records five employee authors.",
      "condition_status": "Partly verified",
      "status_reason": "Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict",
      "missingness": "Do not remove names or employee relationships or certify all authors as independent. Full author-specific contributions remain unread in the original paper.",
      "uncertainty": "Within the preserved-summary scope; external abstract, full text, registration, protocol and SAP were not read, and no new clinical content review or external link verification was performed",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Author affiliation, contribution and COI disclosures"
    },
    {
      "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",
      "current_reports": [
        "R01"
      ],
      "existence": "The existing review summary contains the corresponding wording, bibliography or applicability scope; necessary detailed external materials remain unverified",
      "acquired_read": "Summary read; related external material unread",
      "observation": "The summary states that the paper declared no company involvement in recruitment, collection, endpoint assessment or statistical analysis.",
      "condition_status": "Partly verified",
      "status_reason": "Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict",
      "missingness": "Do not extend denial of these four roles to no involvement in design, outsourced analysis, medical writing, publication costs, publication control or everything else, or to independent-replication certification.",
      "uncertainty": "Within the preserved-summary scope; external abstract, full text, registration, protocol and SAP were not read, and no new clinical content review or external link verification was performed",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Company/author roles and data/publication-rights disclosures"
    },
    {
      "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",
      "current_reports": [
        "R01"
      ],
      "existence": "The existing review summary contains the corresponding wording, bibliography or applicability scope; necessary detailed external materials remain unverified",
      "acquired_read": "Summary read; related external material unread",
      "observation": "The safety summary states that no significant adverse events or intervention-related side effects were reported during four weeks.",
      "condition_status": "Partly verified",
      "status_reason": "Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict",
      "missingness": "Do not convert this into zero events, complete collection for everyone or established product safety. Detailed harms tables and denominators remain unread.",
      "uncertainty": "Within the preserved-summary scope; external abstract, full text, registration, protocol and SAP were not read, and no new clinical content review or external link verification was performed",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Group-specific harms/discontinuation tables and collection methods"
    },
    {
      "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",
      "current_reports": [
        "R01"
      ],
      "existence": "The existing review summary contains the corresponding wording, bibliography or applicability scope; necessary detailed external materials remain unverified",
      "acquired_read": "Summary read; related external material unread",
      "observation": "The original safety narrative records a between-group P=0.019 for systolic-pressure change, while values were within the normal range.",
      "condition_status": "Partly verified",
      "status_reason": "Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict",
      "missingness": "Original values, direction, CI and event counts are absent from the summary. Do not establish new hypertension harm or clinical harmlessness or combine this with PSG efficacy.",
      "uncertainty": "Within the preserved-summary scope; external abstract, full text, registration, protocol and SAP were not read, and no new clinical content review or external link verification was performed",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Original blood-pressure results and baseline/group denominator tables"
    },
    {
      "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",
      "current_reports": [
        "R01"
      ],
      "existence": "The existing review summary contains the corresponding wording, bibliography or applicability scope; necessary detailed external materials remain unverified",
      "acquired_read": "Summary read; related external material unread",
      "observation": "The preserved summary explicitly states that four weeks is short for assessing long-term safety. The parent safety-caution label is the original record.",
      "condition_status": "Unverified",
      "status_reason": "Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict",
      "missingness": "Do not extend a short trial to long-term/rare harms or safety in excluded patients with diagnoses.",
      "uncertainty": "Within the preserved-summary scope; external abstract, full text, registration, protocol and SAP were not read, and no new clinical content review or external link verification was performed",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Long-term follow-up, rare events and population-specific harms materials"
    },
    {
      "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",
      "current_reports": [
        "R01"
      ],
      "existence": "The existing review summary contains the corresponding wording, bibliography or applicability scope; necessary detailed external materials remain unverified",
      "acquired_read": "Summary read; related external material unread",
      "observation": "The directly preserved trial exposure and PSG results cover four weeks. The summary has no results for sustained sleep efficiency or disease prevention after completion.",
      "condition_status": "Unverified",
      "status_reason": "Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict",
      "missingness": "Do not fill long-term persistence, treatment of diagnosed insomnia or treatment replacement with a four-week efficiency change.",
      "uncertainty": "Within the preserved-summary scope; external abstract, full text, registration, protocol and SAP were not read, and no new clinical content review or external link verification was performed",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Post-completion PSG and clinical-outcome follow-up materials"
    },
    {
      "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",
      "current_reports": [
        "R01",
        "R02"
      ],
      "existence": "The existing review summary contains the corresponding wording, bibliography or applicability scope; necessary detailed external materials remain unverified",
      "acquired_read": "Summary read; related external material unread",
      "observation": "The entire preserved summary was read. The original PubMed URL in the citation list is linked; external abstract, full text, registration, protocol and SAP are marked unread.",
      "condition_status": "Partly verified",
      "status_reason": "Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict",
      "missingness": "Link existence or passages quoted in the original do not establish external reading or completed content review here. Do not invent a URL for the unidentified review.",
      "uncertainty": "Within the preserved-summary scope; external abstract, full text, registration, protocol and SAP were not read, and no new clinical content review or external link verification was performed",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Actual paper, registration/plans and mentioned-review 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",
      "current_reports": [
        "R01"
      ],
      "existence": "The existing review summary contains the corresponding wording, bibliography or applicability scope; necessary detailed external materials remain unverified",
      "acquired_read": "Summary read; related external material unread",
      "observation": "Parent Korean/English prose, axes, the 2026-08-26 reference date, the empty corrections array and deliberation string, and the selected row are preserved in the complete existing summary. The reference date is not used as the current review date.",
      "condition_status": "Partly verified",
      "status_reason": "Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict",
      "missingness": "The selected row’s absent score, status and axes remain absent; parent C with 50 points and B2/I0 axes are not recalculated as a new verdict.",
      "uncertainty": "Within the preserved-summary scope; external abstract, full text, registration, protocol and SAP were not read, and no new clinical content review or external link verification was performed",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Original review summary and condition/application preparation events"
    },
    {
      "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",
      "current_reports": [
        "R01",
        "R02"
      ],
      "existence": "The existing review summary contains the corresponding wording, bibliography or applicability scope; necessary detailed external materials remain unverified",
      "acquired_read": "Summary read; related external material unread",
      "observation": "The existing subclaim unit is prepared, distinguishing question and verdict record. Candidate review-pending, production-eligibility and independence markers are preserved as historical selection metadata.",
      "condition_status": "Partly verified",
      "status_reason": "Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict",
      "missingness": "Content review belongs to the user. Do not invent completed model, content or boundary review; retain zero new structural units and unrecorded confirmed independent-trial/participant totals.",
      "uncertainty": "Within the preserved-summary scope; external abstract, full text, registration, protocol and SAP were not read, and no new clinical content review or external link verification was performed",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Existing selection and freeze/application preparation events"
    }
  ],
  "reports": [
    {
      "report_id": "R01",
      "title": "Kim H, et al. Efficacy and Safety of Bacillus coagulans IDCC 1201 for Sleep Improvement in Adults with Sleep Disturbance. Nutrients. 2026;18:1525. PMID: 42196985.",
      "url": "https://pubmed.ncbi.nlm.nih.gov/42196985/",
      "report_type": "Preserved summary of trial-paper bibliography",
      "existence": "Present in the preserved summary’s paper bibliography and research narrative",
      "acquired_read": "Stored summary read; external abstracts, full texts, registrations and plans unread",
      "independent_replication": "Connection among preserved reports; not certification of independent replication",
      "observed_result": "+13.71±21.14 versus -0.15±13.35 percentage points; difference +13.86 percentage points, P=0.002; baseline-adjusted P=0.015; CI not reported",
      "result_level": "PP changes, original between-group difference and baseline-adjusted P; adjusted effect and CI are separate gaps",
      "source_evidence_date": "2026-08-26",
      "materials": [
        {
          "material_type": "Stored summary",
          "public_status": "Summary read",
          "access_status": "Stored summary read",
          "acquired": true,
          "actually_read": "Summary read",
          "as_of": "2026-08-26",
          "qualification": "Material slot, not an independent-trial count, reading certification or link-check result; URLs absent from original materials are not invented"
        },
        {
          "material_type": "External abstract",
          "public_status": "Not read",
          "access_status": "External material unread",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-08-26",
          "qualification": "Material slot, not an independent-trial count, reading certification or link-check result; URLs absent from original materials are not invented"
        },
        {
          "material_type": "External full text",
          "public_status": "Not read",
          "access_status": "External material unread",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-08-26",
          "qualification": "Material slot, not an independent-trial count, reading certification or link-check result; URLs absent from original materials are not invented"
        },
        {
          "material_type": "Original registration",
          "public_status": "Not read",
          "access_status": "External material unread",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-08-26",
          "qualification": "Material slot, not an independent-trial count, reading certification or link-check result; URLs absent from original materials are not invented"
        },
        {
          "material_type": "Protocol/SAP",
          "public_status": "Not read",
          "access_status": "External material unread",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-08-26",
          "qualification": "Material slot, not an independent-trial count, reading certification or link-check result; URLs absent from original materials are not invented"
        }
      ],
      "links": [
        {
          "label": "PubMed",
          "url": "https://pubmed.ncbi.nlm.nih.gov/42196985/"
        }
      ]
    },
    {
      "report_id": "R02",
      "title": "Unidentified 39-RCT meta-analysis context mentioned in the preserved summary",
      "url": null,
      "report_type": "Preserved-summary slot mentioning an unidentified review",
      "existence": "Mentioned only in the existing counterview; exact external bibliography unverified",
      "acquired_read": "The preserved summary describing this context was read; the external review remains unread",
      "independent_replication": "Not elevated to independent replication of IDCC 1201",
      "observed_result": "Null whole-group trials of other strains do not address exactly the same question. The preserved 39-RCT meta-analysis context describes a null REM-related sleep-efficiency result in three trials: MD 1.64 percentage points, 95% CI -0.35 to 3.64. It therefore cannot be generalized to probiotics improving sleep.",
      "result_level": "Original narrative of the REM-related three-trial MD and 39-RCT context preserved; no new trial-count certification or effect combination",
      "source_evidence_date": "2026-08-26",
      "materials": [
        {
          "material_type": "Stored summary",
          "public_status": "Summary read",
          "access_status": "Stored summary read",
          "acquired": true,
          "actually_read": "Summary read",
          "as_of": "2026-08-26",
          "qualification": "Material slot, not an independent-trial count, reading certification or link-check result; URLs absent from original materials are not invented"
        },
        {
          "material_type": "External abstract",
          "public_status": "Not read",
          "access_status": "External material unread",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-08-26",
          "qualification": "Material slot, not an independent-trial count, reading certification or link-check result; URLs absent from original materials are not invented"
        },
        {
          "material_type": "External full text",
          "public_status": "Not read",
          "access_status": "External material unread",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-08-26",
          "qualification": "Material slot, not an independent-trial count, reading certification or link-check result; URLs absent from original materials are not invented"
        },
        {
          "material_type": "Original registration",
          "public_status": "Not read",
          "access_status": "External material unread",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-08-26",
          "qualification": "Material slot, not an independent-trial count, reading certification or link-check result; URLs absent from original materials are not invented"
        },
        {
          "material_type": "Protocol/SAP",
          "public_status": "Not read",
          "access_status": "External material unread",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-08-26",
          "qualification": "Material slot, not an independent-trial count, reading certification or link-check result; URLs absent from original materials are not invented"
        }
      ],
      "links": []
    }
  ],
  "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"
  },
  "study_overlap": {
    "state": "Unverified",
    "unique_trial_count": null,
    "unique_participant_count": null,
    "reason": "Connections among the paper, registration, analyses and parent/selected summaries of the same IDCC 1201 trial; unidentified-review bibliography context slot; independence of included trials, inclusion of the current trial and overlap unverified"
  },
  "history": [
    {
      "date": "2026-10-13",
      "kind": "Separation of public-facing pages and materials",
      "view_version": "1.0",
      "change": "Public views and materials were prepared from the existing 34 items. No new clinical search, verification-status changes or scoring were performed."
    }
  ],
  "language": "en",
  "translation_date": "2026-10-13"
}