IDCC 1201 · Four-week PSG sleep efficiency — Evidence Check

Required evidence, verification status and materials actually read
Item	AVerification status	BReading scope	CReview item	DCurrent findings	EWhy unverified	FRequired materials and conditions	GFurther research
1	Partly verified	Full text not readStored summary read	N01 · Efficacy comparison · Preserved-material preparationWhat are the selected question and its subclaim verdict?Required	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. R01	Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict	Original wording, subclaim grade and note for the four-week PSG sleep-efficiency question	Present the original subclaim verdict separately from parent context
2	Partly verified	Full text not readStored summary read	N02 · Efficacy comparison · Preserved-material preparationAre sleep disturbance and diagnosed sleep disorders distinguished in the trial population?Required	The record describes adults with sleep disturbance and exclusion of severe insomnia and diagnosed sleep disorders. R01	Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict	Actual eligibility, exclusions, baseline characteristics and diagnostic criteria	Distinguish included participants from excluded sleep disorders
3	Partly verified	Full text not readStored summary read	N03 · Efficacy comparison · Preserved-material preparationWhat exactly are the intervention strain, research exposure and duration?Required	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. R01	Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict	Original IDCC 1201 strain, units, research exposure and duration	Preserve the research combination and its applicability limits
4	Partly verified	Full text not readStored summary read	N04 · Efficacy comparison · Preserved-material preparationAre materials available on placebo composition and the feasibility of blinding?Required	The original summary describes a double-blind placebo-controlled trial and company provision of active and placebo capsules. R01	Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict	Placebo ingredients, appearance, sensory properties, packaging and blinding procedures	Present product provision separately from actual blinding characteristics
5	Unverified	Full text not readStored summary read	N05 · Efficacy comparison · Preserved-material preparationAre balance and changes in sleep behavior, medication and other exposures known?Required	The preserved summary provides an intervention-versus-placebo comparison but no details of concurrent sleep exposures, lifestyle changes or concomitant medication. R01	Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict	Concurrent exposures, medication, lifestyle changes, adherence and deviations	Present concurrent exposures and actual intervention deviations over the same period
6	Partly verified	Full text not readStored summary read	N06 · Efficacy comparison · Preserved-material preparationAre details of randomization, concealment and blinding verified?Required	The material describes a double-blind randomized placebo-controlled trial assigning 80 adults, 40 per group. R01	Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict	Random sequence, allocation concealment and blinding by role	Distinguish design labels from implementation materials
7	Partly verified	Full text not readStored summary read	N07 · Efficacy comparison · Preserved-material preparationAre randomized and per-protocol analysis denominators distinguished?Required	The record gives 80 randomized, 40/40, and a per-protocol analysis of 78, 39/39. R01	Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict	Allocation, completion, analysis, exclusions and flow by group	Present allocation and analysis denominators separately
8	Partly verified	Full text not readStored summary read	N08 · Efficacy comparison · Preserved-material preparationIs information on PP exclusions, missing data and the effect of interest sufficient?Required	The current efficacy summary uses results for PP78. The existing research description and evidence list explicitly identify PP. R01	Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict	PP definition, exclusion reasons, missing-data handling and other analysis results	Present the scope of analysis choices and their implications by material
9	Partly verified	Full text not readStored summary read	N09 · Efficacy comparison · Preserved-material preparationIs the baseline sleep-efficiency imbalance retained?Required	Baseline sleep efficiency is recorded as differing: 75.75% versus 85.08%, P=0.049. R01	Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict	Group-specific baseline values and their connection to adjusted analysis	Present baseline imbalance, changes and adjusted results separately
10	Partly verified	Full text not readStored summary read	N10 · Efficacy comparison · Preserved-material preparationWhat measurement does PSG sleep efficiency represent?Required	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. R01	Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict	Definition, measurement and scoring of objective sleep efficiency	Present the objective measure separately from subjective scales
11	Partly verified	Full text not readStored summary read	N11 · Efficacy comparison · Preserved-material preparationAre the four-week time point and measurement-night or repeated-measurement denominators distinguished?Required	The summary specifies baseline to four weeks. It gives no details of the number of measurement nights or handling of repeated measurements. R01	Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict	Baseline/week-4 schedule, number of nights, averaging and missing-data methods	Distinguish people from measurement nights and time points
12	Partly verified	Full text not readStored summary read	N12 · Efficacy comparison · Preserved-material preparationAre group changes and the meaning of the ± notation preserved?Required	Original values are +13.71±21.14 versus -0.15±13.35 percentage points. Do not convert these into final absolute sleep efficiency. R01	Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict	Original definitions of group changes and uncertainty notation	Present changes, final values, dispersion and precision separately
13	Partly verified	Full text not readStored summary read	N13 · Efficacy comparison · Preserved-material preparationWhat between-group difference and interval are given in the original?Required	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. R01	Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict	Between-group effect, interval, test and analysis population	Present the directly reported difference together with the absent CI
14	Partly verified	Full text not readStored summary read	N14 · Efficacy comparison · Preserved-material preparationAre baseline-adjusted ranked ANCOVA results distinguished from the original difference?Required	The preserved summary states that baseline-adjusted ranked ANCOVA was also positive, P=0.015. R01	Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict	Adjustment model, adjusted estimate, interval and P value	Present the original difference separately from the baseline-adjusted test
15	Partly verified	Full text not readStored summary read	N15 · Efficacy comparison · Preserved-material preparationAre prespecified criteria available for minimum important difference and clinical importance?Required	The existing verdict rationale states that there was no prespecified minimum important difference and that the effect CI was not reported. R01	Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict	Prespecified importance criteria and supporting grounds for PSG sleep efficiency	Present statistical results separately from clinical importance
16	Partly verified	Full text not readStored summary read	N16 · Efficacy comparison · Preserved-material preparationAre participant enrollment, trial completion and official registration dates separated?Required	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. R01	Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict	Actual dates of each event and registration history	Present recruitment, completion and registration as separately dated events
17	Partly verified	Full text not readStored summary read	N17 · Efficacy comparison · Preserved-material preparationDoes a registration number establish actual reading?Required	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. R01	Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict	Distinction between KCT0011568 identity and access to or contents of the original registration	Distinguish the preserved registration identifier from actual reading status
18	Partly verified	Full text not readStored summary read	N18 · Efficacy comparison · Preserved-material preparationWas the paper-labeled primary endpoint independently verified prospectively?Required	The preserved research narrative states that registration after trial completion weakens independent prospective verification of the paper-labeled primary endpoint. R01	Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict	Materials comparing the pre-recruitment plan with the paper’s primary-endpoint label	Present the paper’s endpoint label separately from planning time
19	Unverified	Full text not readStored summary read	N19 · Efficacy comparison · Preserved-material preparationCan plans for multiplicity, additional outcomes and analysis selection be verified?Required	The preserved summary includes PSG efficiency, baseline adjustment and some safety information, but no detailed complete plan, multiple-comparison adjustment or analysis selection. R01	Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict	Prespecified hierarchy and changes for all analyses, endpoints and adjustments	Present the prespecified hierarchy of efficacy, additional and safety analyses
20	Partly verified	Full text not readStored summary read	N20 · Efficacy comparison · Preserved-material preparationAre subjective insomnia improvement and PSG sleep efficiency distinguished?Required	The existing counterpoint states that subjective insomnia improvement and PSG sleep efficiency are different endpoints. R01	Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict	Original results and measurement definitions for each objective/subjective endpoint	Present different sleep outcomes as separate questions
21	Partly verified	Full text not readStored summary read	N21 · Efficacy comparison · Preserved-material preparationWas REM-related sleep efficiency combined with overall PSG sleep efficiency?Required	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. R01 R02	Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict	Endpoint definitions and measurement scope in the current trial and review	Distinguish overall-sleep and REM-related measures and strains
22	Partly verified	Full text not readStored summary read	N22 · Efficacy comparison · Preserved-material preparationWhat is the actual material scope of the unidentified meta-analysis context?Required	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. R02	Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict	Bibliography, included trials, strains and original endpoints for the 39-RCT review	Present unidentified preserved context separately from the identified trial report
23	Partly verified	Full text not readStored summary read	N23 · Efficacy comparison · Preserved-material preparationWere IDCC 1201 results extended to probiotics generally?Required	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. R01 R02	Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict	Direct comparisons and applicability evidence by strain, product, population and duration	Preserve strain-specific applicability boundaries as separate questions
24	Partly verified	Full text not readStored summary read	N24 · Efficacy comparison · Preserved-material preparationWere the paper, registration and related context counted as independent repeat trials?Required	The directly identified trial bibliography is one Kim et al. 2026 paper linked to KCT0011568. The preserved summary contains only one selected subclaim row. R01 R02	Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict	Connections and overlap among current report, registration and review context	Distinguish report entries from trial and participant units
25	Partly verified	Full text not readStored summary read	N25 · Efficacy comparison · Preserved-material preparationAre research funding and active/placebo product provision distinguished?Required	Ildong Bioscience provided research funding and active/placebo capsules; the original summary describes full manufacturer funding. R01	Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict	Original disclosures of funding, products, contracts and company roles	Present funding, product supply and involvement in results as separate items
26	Partly verified	Full text not readStored summary read	N26 · Efficacy comparison · Preserved-material preparationAre the names and relationships of company employee authors preserved?Required	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. R01	Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict	Employee authors, affiliations, contributions and other conflict disclosures	Present employee relationships separately from each author’s actual roles
27	Partly verified	Full text not readStored summary read	N27 · Efficacy comparison · Preserved-material preparationAre the company’s limited role denials distinguished from overall independence?Required	The summary states that the paper declared no company involvement in recruitment, collection, endpoint assessment or statistical analysis. R01	Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict	Materials on recruitment, collection, endpoint assessment, statistical analysis, design, writing and publication roles	Distinguish disclosed role denials from involvement that remains unverified
28	Partly verified	Full text not readStored summary read	N28 · Supplementary harm evidenceIs the observation scope of four-week adverse-event nonreporting clear?Supplementary	The safety summary states that no significant adverse events or intervention-related side effects were reported during four weeks. R01	Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict	Event definitions, collection methods, denominators by group and discontinuations	Present reporting scope and actual collection/exposure denominators
29	Partly verified	Full text not readStored summary read	N29 · Supplementary harm evidenceIs systolic-pressure change the same outcome as sleep efficiency or confirmed harm?Supplementary	The original safety narrative records a between-group P=0.019 for systolic-pressure change, while values were within the normal range. R01	Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict	Values, intervals, baseline, time points and event information for blood-pressure changes	Present blood-pressure measures separately from adverse events and sleep efficiency
30	Unverified	Full text not readStored summary read	N30 · Supplementary harm evidenceCan long-term or rare harms and safety in other populations be assessed?Supplementary	The preserved summary explicitly states that four weeks is short for assessing long-term safety. The parent safety-caution label is the original record. R01	Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict	Long-term exposure/follow-up, vulnerable populations and rare-event materials	Present long-term safety gaps separately from efficacy
31	Unverified	Full text not readStored summary read	N31 · Efficacy comparison · Preserved-material preparationDo four-week results show sustained effects after completion or sleep-disorder prevention?Required	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. R01	Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict	Direct follow-up, sustained-effect and clinical-outcome materials after completion	Present treatment-period and post-completion sustained results as separate questions
32	Partly verified	Full text not readStored summary read	N32 · Efficacy comparison · Preserved-material preparationAre summary reading and unread external abstract, full text, registration and plans distinguished?Required	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. R01 R02	Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict	Original form, actual reading and access status by material type	Mark summary reading separately from unread external materials
33	Partly verified	Full text not readStored summary read	N33 · Efficacy comparison · Preserved-material preparationAre parent Korean/English prose, axes, reference date and correction history preserved in original form?Required	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. R01	Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict	Whole copies of selected row, parent record and historical dates	Separate existing verdict/correction history from preparation date and existing content review
34	Partly verified	Full text not readStored summary read	N34 · Efficacy comparison · Preserved-material preparationAre the preserved candidate’s review-pending/eligibility markers separated from the current preparation event?Required	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. R01 R02	Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict	Existing candidate metadata, preparation, review and independence status	Link preparation completion separately from existing content-review status

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34 itemsWhat the statuses mean

Assessment scope

Stored-material review date: Not recorded
Original evidence cut-off: 2026-08-26
Scope actually checked: Existing review summaries and stored records of methodological application. Full papers, supplements, registrations, plans and original data were not read.
What the dates mean: This is the date the stored materials were checked, not the date of a new search of the clinical literature.
Population: 80 adults with sleep disturbance randomized; severe insomnia and diagnosed sleep disorders excluded; PP78 analyzed
Ingredient, formulation and route: 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
Measured outcome: 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
Questions outside this scope: No new formulations, populations, clinical effects, CI, verdicts, independence certification, participant totals, implementation or treatment instructions are created

Evidence and sources

The links below lead to the sources. A link alone does not mean the original source was read or its latest publication status verified.

R01 · 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.

PubMed

Material type: Preserved summary of trial-paper bibliography
Materials actually read: Stored summary read; external abstracts, full texts, registrations and plans unread
Findings recorded in the stored summary: +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
Record level: PP changes, original between-group difference and baseline-adjusted P; adjusted effect and CI are separate gaps
Study overlap and independent replication: 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

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Stored summary	Summary read	Stored summary read	Summary read	Material slot, not an independent-trial count, reading certification or link-check result; URLs absent from original materials are not invented
External abstract	Not read	External material unread	Not read	Material slot, not an independent-trial count, reading certification or link-check result; URLs absent from original materials are not invented
External full text	Not read	External material unread	Not read	Material slot, not an independent-trial count, reading certification or link-check result; URLs absent from original materials are not invented
Original registration	Not read	External material unread	Not read	Material slot, not an independent-trial count, reading certification or link-check result; URLs absent from original materials are not invented
Protocol/SAP	Not read	External material unread	Not read	Material slot, not an independent-trial count, reading certification or link-check result; URLs absent from original materials are not invented

R02 · Unidentified 39-RCT meta-analysis context mentioned in the preserved summary

Material type: Preserved-summary slot mentioning an unidentified review
Materials actually read: The preserved summary describing this context was read; the external review remains unread
Findings recorded in the stored summary: 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.
Record level: Original narrative of the REM-related three-trial MD and 39-RCT context preserved; no new trial-count certification or effect combination
Study overlap and independent replication: 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

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Stored summary	Summary read	Stored summary read	Summary read	Material slot, not an independent-trial count, reading certification or link-check result; URLs absent from original materials are not invented
External abstract	Not read	External material unread	Not read	Material slot, not an independent-trial count, reading certification or link-check result; URLs absent from original materials are not invented
External full text	Not read	External material unread	Not read	Material slot, not an independent-trial count, reading certification or link-check result; URLs absent from original materials are not invented
Original registration	Not read	External material unread	Not read	Material slot, not an independent-trial count, reading certification or link-check result; URLs absent from original materials are not invented
Protocol/SAP	Not read	External material unread	Not read	Material slot, not an independent-trial count, reading certification or link-check result; URLs absent from original materials are not invented

Report counts versus independent study counts

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

Review criteria

Version 1.0 · Criteria record date 2026-10-06. These are Chamgap's own application conditions, informed by the referenced methods. They do not constitute official assessment-tool certification or a new efficacy score.

N01 · What are the selected question and its subclaim verdict?

Required materials and conditions: Original wording, subclaim grade and note for the four-week PSG sleep-efficiency question
Conditions for verification: 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
Requirement and applicability: Required
Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations
Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score
Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions

N02 · Are sleep disturbance and diagnosed sleep disorders distinguished in the trial population?

Required materials and conditions: Actual eligibility, exclusions, baseline characteristics and diagnostic criteria
Conditions for verification: 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
Requirement and applicability: Required
Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations
Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score
Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions

N03 · What exactly are the intervention strain, research exposure and duration?

Required materials and conditions: Original IDCC 1201 strain, units, research exposure and duration
Conditions for verification: 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
Requirement and applicability: Required
Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations
Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score
Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions

N04 · Are materials available on placebo composition and the feasibility of blinding?

Required materials and conditions: Placebo ingredients, appearance, sensory properties, packaging and blinding procedures
Conditions for verification: 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
Requirement and applicability: Required
Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations
Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score
Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions

N05 · Are balance and changes in sleep behavior, medication and other exposures known?

Required materials and conditions: Concurrent exposures, medication, lifestyle changes, adherence and deviations
Conditions for verification: 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
Requirement and applicability: Required
Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations
Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score
Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions

N06 · Are details of randomization, concealment and blinding verified?

Required materials and conditions: Random sequence, allocation concealment and blinding by role
Conditions for verification: 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
Requirement and applicability: Required
Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations
Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score
Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions

N07 · Are randomized and per-protocol analysis denominators distinguished?

Required materials and conditions: Allocation, completion, analysis, exclusions and flow by group
Conditions for verification: 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
Requirement and applicability: Required
Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations
Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score
Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions

N08 · Is information on PP exclusions, missing data and the effect of interest sufficient?

Required materials and conditions: PP definition, exclusion reasons, missing-data handling and other analysis results
Conditions for verification: 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
Requirement and applicability: Required
Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations
Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score
Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions

N09 · Is the baseline sleep-efficiency imbalance retained?

Required materials and conditions: Group-specific baseline values and their connection to adjusted analysis
Conditions for verification: 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
Requirement and applicability: Required
Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations
Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score
Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions

N10 · What measurement does PSG sleep efficiency represent?

Required materials and conditions: Definition, measurement and scoring of objective sleep efficiency
Conditions for verification: 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
Requirement and applicability: Required
Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations
Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score
Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions

N11 · Are the four-week time point and measurement-night or repeated-measurement denominators distinguished?

Required materials and conditions: Baseline/week-4 schedule, number of nights, averaging and missing-data methods
Conditions for verification: 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
Requirement and applicability: Required
Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations
Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score
Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions

N12 · Are group changes and the meaning of the ± notation preserved?

Required materials and conditions: Original definitions of group changes and uncertainty notation
Conditions for verification: 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
Requirement and applicability: Required
Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations
Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score
Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions

N13 · What between-group difference and interval are given in the original?

Required materials and conditions: Between-group effect, interval, test and analysis population
Conditions for verification: 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
Requirement and applicability: Required
Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations
Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score
Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions

N14 · Are baseline-adjusted ranked ANCOVA results distinguished from the original difference?

Required materials and conditions: Adjustment model, adjusted estimate, interval and P value
Conditions for verification: 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
Requirement and applicability: Required
Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations
Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score
Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions

N15 · Are prespecified criteria available for minimum important difference and clinical importance?

Required materials and conditions: Prespecified importance criteria and supporting grounds for PSG sleep efficiency
Conditions for verification: 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
Requirement and applicability: Required
Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations
Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score
Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions

N16 · Are participant enrollment, trial completion and official registration dates separated?

Required materials and conditions: Actual dates of each event and registration history
Conditions for verification: 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
Requirement and applicability: Required
Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations
Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score
Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions

N17 · Does a registration number establish actual reading?

Required materials and conditions: Distinction between KCT0011568 identity and access to or contents of the original registration
Conditions for verification: 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
Requirement and applicability: Required
Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations
Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score
Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions

N18 · Was the paper-labeled primary endpoint independently verified prospectively?

Required materials and conditions: Materials comparing the pre-recruitment plan with the paper’s primary-endpoint label
Conditions for verification: 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
Requirement and applicability: Required
Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations
Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score
Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions

N19 · Can plans for multiplicity, additional outcomes and analysis selection be verified?

Required materials and conditions: Prespecified hierarchy and changes for all analyses, endpoints and adjustments
Conditions for verification: 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
Requirement and applicability: Required
Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations
Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score
Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions

N20 · Are subjective insomnia improvement and PSG sleep efficiency distinguished?

Required materials and conditions: Original results and measurement definitions for each objective/subjective endpoint
Conditions for verification: 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
Requirement and applicability: Required
Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations
Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score
Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions

N21 · Was REM-related sleep efficiency combined with overall PSG sleep efficiency?

Required materials and conditions: Endpoint definitions and measurement scope in the current trial and review
Conditions for verification: 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
Requirement and applicability: Required
Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations
Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score
Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions

N22 · What is the actual material scope of the unidentified meta-analysis context?

Required materials and conditions: Bibliography, included trials, strains and original endpoints for the 39-RCT review
Conditions for verification: 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
Requirement and applicability: Required
Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations
Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score
Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions

N23 · Were IDCC 1201 results extended to probiotics generally?

Required materials and conditions: Direct comparisons and applicability evidence by strain, product, population and duration
Conditions for verification: 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
Requirement and applicability: Required
Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations
Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score
Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions

N24 · Were the paper, registration and related context counted as independent repeat trials?

Required materials and conditions: Connections and overlap among current report, registration and review context
Conditions for verification: 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
Requirement and applicability: Required
Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations
Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score
Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions

N25 · Are research funding and active/placebo product provision distinguished?

Required materials and conditions: Original disclosures of funding, products, contracts and company roles
Conditions for verification: 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
Requirement and applicability: Required
Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations
Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score
Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions

N26 · Are the names and relationships of company employee authors preserved?

Required materials and conditions: Employee authors, affiliations, contributions and other conflict disclosures
Conditions for verification: 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
Requirement and applicability: Required
Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations
Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score
Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions

N27 · Are the company’s limited role denials distinguished from overall independence?

Required materials and conditions: Materials on recruitment, collection, endpoint assessment, statistical analysis, design, writing and publication roles
Conditions for verification: 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
Requirement and applicability: Required
Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations
Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score
Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions

N28 · Is the observation scope of four-week adverse-event nonreporting clear?

Required materials and conditions: Event definitions, collection methods, denominators by group and discontinuations
Conditions for verification: 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
Requirement and applicability: Supplementary
Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations
Why this condition is needed: Supplementary condition showing limits of harms/safety information separately from efficacy
Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions

N29 · Is systolic-pressure change the same outcome as sleep efficiency or confirmed harm?

Required materials and conditions: Values, intervals, baseline, time points and event information for blood-pressure changes
Conditions for verification: 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
Requirement and applicability: Supplementary
Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations
Why this condition is needed: Supplementary condition showing limits of harms/safety information separately from efficacy
Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions

N30 · Can long-term or rare harms and safety in other populations be assessed?

Required materials and conditions: Long-term exposure/follow-up, vulnerable populations and rare-event materials
Conditions for verification: 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
Requirement and applicability: Supplementary
Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations
Why this condition is needed: Supplementary condition showing limits of harms/safety information separately from efficacy
Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions

N31 · Do four-week results show sustained effects after completion or sleep-disorder prevention?

Required materials and conditions: Direct follow-up, sustained-effect and clinical-outcome materials after completion
Conditions for verification: 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
Requirement and applicability: Required
Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations
Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score
Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions

N32 · Are summary reading and unread external abstract, full text, registration and plans distinguished?

Required materials and conditions: Original form, actual reading and access status by material type
Conditions for verification: 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
Requirement and applicability: Required
Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations
Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score
Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions

N33 · Are parent Korean/English prose, axes, reference date and correction history preserved in original form?

Required materials and conditions: Whole copies of selected row, parent record and historical dates
Conditions for verification: 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
Requirement and applicability: Required
Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations
Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score
Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions

N34 · Are the preserved candidate’s review-pending/eligibility markers separated from the current preparation event?

Required materials and conditions: Existing candidate metadata, preparation, review and independence status
Conditions for verification: 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
Requirement and applicability: Required
Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations
Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score
Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions

Referenced methods and the sections actually reviewed

M03 · Cochrane Handbook 6.5 (2024), chapter updated 2023-08

Official methodology · §3.1, §3.2.1–3.2.3, MECIR C5/C7/C13

Referenced principle: Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.
Extent of review: Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed.

M04 · Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03

Official methodology · §4.5, §4.6.1–4.6.3, MECIR C42

Referenced principle: Distinguish studies from reports and link them; do not omit a study solely because results are unreported.
Extent of review: Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed.

M08 · Cochrane Handbook 6.5 (2024), chapter updated 2019-10

Official methodology · §8.1–8.2.3, Table 8.2.a

Referenced principle: Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.
Extent of review: Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed.

M15 · Cochrane Handbook 6.5 (2024), chapter updated 2023-08

Official methodology · §15.2.4, §15.3.1–15.3.3

Referenced principle: Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.
Extent of review: Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed.

M19 · Cochrane Handbook 6.5 (2024), chapter updated 2019-10

Official methodology · §19.1.2, §19.2.1–19.2.4

Referenced principle: Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.
Extent of review: Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed.

What the statuses mean

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

Change history

2026-10-13 · Public page/material version 1.0

Public views and materials were prepared from the existing 34 items. No new clinical search, verification-status changes or scoring were performed.

The stored-material review date (Not recorded) and original evidence cut-off (2026-08-26) were retained unchanged.

Researcher downloads

These materials provide the same evidence, scope and verification status as this page.

View all item details

N01 · What are the selected question and its subclaim verdict?

Current findings: 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.
Verification status: Partly verified
Materials actually read: Summary read; related external material unread
Why unverified: Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict
Reason for missing information: The selected row has no score, status or axes. Do not fill these with parent values or create a new verdict.
Required materials and conditions: Original wording, subclaim grade and note for the four-week PSG sleep-efficiency question
Materials to obtain first: Original selected row and parent verdict
Further research: Present the original subclaim verdict separately from parent context
Remaining 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
Conditions for verification: 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
Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score
Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations
Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions

Related sources R01

N02 · Are sleep disturbance and diagnosed sleep disorders distinguished in the trial population?

Current findings: The record describes adults with sleep disturbance and exclusion of severe insomnia and diagnosed sleep disorders.
Verification status: Partly verified
Materials actually read: Summary read; related external material unread
Why unverified: Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict
Reason for missing information: Detailed age, diagnoses, baseline conditions and recruitment criteria remain unread. Do not extend the result to treatment of diagnosed insomnia or all adults.
Required materials and conditions: Actual eligibility, exclusions, baseline characteristics and diagnostic criteria
Materials to obtain first: Eligibility, exclusion and baseline-characteristics tables
Further research: Distinguish included participants from excluded sleep disorders
Remaining 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
Conditions for verification: 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
Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score
Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations
Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions

Related sources R01

N03 · What exactly are the intervention strain, research exposure and duration?

Current findings: 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.
Verification status: Partly verified
Materials actually read: Summary read; related external material unread
Why unverified: Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict
Reason for missing information: This preserves research identity and is not intake guidance or a product recommendation. Equivalence of other strains, exposures, formulations or durations is not established.
Required materials and conditions: Original IDCC 1201 strain, units, research exposure and duration
Materials to obtain first: Trial product, strain and exposure specifications
Further research: Preserve the research combination and its applicability limits
Remaining 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
Conditions for verification: 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
Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score
Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations
Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions

Related sources R01

N04 · Are materials available on placebo composition and the feasibility of blinding?

Current findings: The original summary describes a double-blind placebo-controlled trial and company provision of active and placebo capsules.
Verification status: Partly verified
Materials actually read: Summary read; related external material unread
Why unverified: Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict
Reason for missing information: Capsule composition, appearance and sensory matching, blinding success, batches and storage details remain unread.
Required materials and conditions: Placebo ingredients, appearance, sensory properties, packaging and blinding procedures
Materials to obtain first: Active/placebo specifications and blinding procedures
Further research: Present product provision separately from actual blinding characteristics
Remaining 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
Conditions for verification: 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
Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score
Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations
Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions

Related sources R01

N05 · Are balance and changes in sleep behavior, medication and other exposures known?

Current findings: The preserved summary provides an intervention-versus-placebo comparison but no details of concurrent sleep exposures, lifestyle changes or concomitant medication.
Verification status: Unverified
Materials actually read: Summary read; related external material unread
Why unverified: Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict
Reason for missing information: Equality of concurrent exposures is not certified. No sleep or treatment-change instructions are written.
Required materials and conditions: Concurrent exposures, medication, lifestyle changes, adherence and deviations
Materials to obtain first: Concurrent-exposure, intervention-adherence and deviation tables
Further research: Present concurrent exposures and actual intervention deviations over the same period
Remaining 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
Conditions for verification: 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
Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score
Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations
Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions

Related sources R01

N06 · Are details of randomization, concealment and blinding verified?

Current findings: The material describes a double-blind randomized placebo-controlled trial assigning 80 adults, 40 per group.
Verification status: Partly verified
Materials actually read: Summary read; related external material unread
Why unverified: Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict
Reason for missing information: 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.
Required materials and conditions: Random sequence, allocation concealment and blinding by role
Materials to obtain first: Original randomization, concealment and blinding methods
Further research: Distinguish design labels from implementation materials
Remaining 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
Conditions for verification: 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
Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score
Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations
Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions

Related sources R01

N07 · Are randomized and per-protocol analysis denominators distinguished?

Current findings: The record gives 80 randomized, 40/40, and a per-protocol analysis of 78, 39/39.
Verification status: Partly verified
Materials actually read: Summary read; related external material unread
Why unverified: Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict
Reason for missing information: 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.
Required materials and conditions: Allocation, completion, analysis, exclusions and flow by group
Materials to obtain first: Allocation, follow-up, PP and other analysis-population flow
Further research: Present allocation and analysis denominators separately
Remaining 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
Conditions for verification: 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
Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score
Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations
Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions

Related sources R01

N08 · Is information on PP exclusions, missing data and the effect of interest sufficient?

Current findings: The current efficacy summary uses results for PP78. The existing research description and evidence list explicitly identify PP.
Verification status: Partly verified
Materials actually read: Summary read; related external material unread
Why unverified: Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict
Reason for missing information: Do not elevate PP results to effects in everyone assigned. Exclusion reasons, ITT results and sensitivity analyses remain unread.
Required materials and conditions: PP definition, exclusion reasons, missing-data handling and other analysis results
Materials to obtain first: Analysis-population definitions, missing-data handling and sensitivity analyses
Further research: Present the scope of analysis choices and their implications by material
Remaining 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
Conditions for verification: 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
Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score
Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations
Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions

Related sources R01

N09 · Is the baseline sleep-efficiency imbalance retained?

Current findings: Baseline sleep efficiency is recorded as differing: 75.75% versus 85.08%, P=0.049.
Verification status: Partly verified
Materials actually read: Summary read; related external material unread
Why unverified: Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict
Reason for missing information: Do not describe baseline imbalance as removed or newly calculate regression effects or causal magnitudes.
Required materials and conditions: Group-specific baseline values and their connection to adjusted analysis
Materials to obtain first: Baseline characteristics and prespecified adjustment model
Further research: Present baseline imbalance, changes and adjusted results separately
Remaining 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
Conditions for verification: 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
Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score
Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations
Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions

Related sources R01

N10 · What measurement does PSG sleep efficiency represent?

Current findings: 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.
Verification status: Partly verified
Materials actually read: Summary read; related external material unread
Why unverified: Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict
Reason for missing information: 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.
Required materials and conditions: Definition, measurement and scoring of objective sleep efficiency
Materials to obtain first: PSG measurement/scoring manuals and original measurement tables
Further research: Present the objective measure separately from subjective scales
Remaining 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
Conditions for verification: 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
Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score
Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations
Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions

Related sources R01

N11 · Are the four-week time point and measurement-night or repeated-measurement denominators distinguished?

Current findings: The summary specifies baseline to four weeks. It gives no details of the number of measurement nights or handling of repeated measurements.
Verification status: Partly verified
Materials actually read: Summary read; related external material unread
Why unverified: Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict
Reason for missing information: Do not count nights, repeated measurements, groups or time points as new participants or independent trials.
Required materials and conditions: Baseline/week-4 schedule, number of nights, averaging and missing-data methods
Materials to obtain first: PSG schedule, measurement-night and repeated-measurement materials
Further research: Distinguish people from measurement nights and time points
Remaining 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
Conditions for verification: 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
Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score
Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations
Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions

Related sources R01

N12 · Are group changes and the meaning of the ± notation preserved?

Current findings: Original values are +13.71±21.14 versus -0.15±13.35 percentage points. Do not convert these into final absolute sleep efficiency.
Verification status: Partly verified
Materials actually read: Summary read; related external material unread
Why unverified: Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict
Reason for missing information: 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.
Required materials and conditions: Original definitions of group changes and uncertainty notation
Materials to obtain first: Original table defining group changes and ± notation
Further research: Present changes, final values, dispersion and precision separately
Remaining 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
Conditions for verification: 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
Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score
Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations
Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions

Related sources R01

N13 · What between-group difference and interval are given in the original?

Current findings: 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.
Verification status: Partly verified
Materials actually read: Summary read; related external material unread
Why unverified: Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict
Reason for missing information: Do not calculate new CI, effects or between-group differences. Absence of an effect interval does not establish precision.
Required materials and conditions: Between-group effect, interval, test and analysis population
Materials to obtain first: Original result table, effect estimate and confidence interval
Further research: Present the directly reported difference together with the absent CI
Remaining 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
Conditions for verification: 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
Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score
Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations
Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions

Related sources R01

N14 · Are baseline-adjusted ranked ANCOVA results distinguished from the original difference?

Current findings: The preserved summary states that baseline-adjusted ranked ANCOVA was also positive, P=0.015.
Verification status: Partly verified
Materials actually read: Summary read; related external material unread
Why unverified: Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict
Reason for missing information: 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.
Required materials and conditions: Adjustment model, adjusted estimate, interval and P value
Materials to obtain first: Ranked ANCOVA model and adjusted-effect table
Further research: Present the original difference separately from the baseline-adjusted test
Remaining 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
Conditions for verification: 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
Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score
Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations
Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions

Related sources R01

N15 · Are prespecified criteria available for minimum important difference and clinical importance?

Current findings: The existing verdict rationale states that there was no prespecified minimum important difference and that the effect CI was not reported.
Verification status: Partly verified
Materials actually read: Summary read; related external material unread
Why unverified: Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict
Reason for missing information: Do not invent a clinical important difference, sleep normalization or perceived treatment effect.
Required materials and conditions: Prespecified importance criteria and supporting grounds for PSG sleep efficiency
Materials to obtain first: Prespecified importance criteria and links to clinical outcomes
Further research: Present statistical results separately from clinical importance
Remaining 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
Conditions for verification: 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
Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score
Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations
Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions

Related sources R01

N16 · Are participant enrollment, trial completion and official registration dates separated?

Current findings: 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.
Verification status: Partly verified
Materials actually read: Summary read; related external material unread
Why unverified: Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict
Reason for missing information: Do not change registration into preregistration before recruitment. Do not calculate new durations or date differences.
Required materials and conditions: Actual dates of each event and registration history
Materials to obtain first: Original CRIS registration, change history and recruitment records
Further research: Present recruitment, completion and registration as separately dated events
Remaining 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
Conditions for verification: 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
Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score
Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations
Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions

Related sources R01

N17 · Does a registration number establish actual reading?

Current findings: 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.
Verification status: Partly verified
Materials actually read: Summary read; related external material unread
Why unverified: Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict
Reason for missing information: Official registration URL, document and revision history remain unread here; an identifier alone does not certify prespecification.
Required materials and conditions: Distinction between KCT0011568 identity and access to or contents of the original registration
Materials to obtain first: Official KCT0011568 registration document
Further research: Distinguish the preserved registration identifier from actual reading status
Remaining 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
Conditions for verification: 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
Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score
Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations
Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions

Related sources R01

N18 · Was the paper-labeled primary endpoint independently verified prospectively?

Current findings: The preserved research narrative states that registration after trial completion weakens independent prospective verification of the paper-labeled primary endpoint.
Verification status: Partly verified
Materials actually read: Summary read; related external material unread
Why unverified: Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict
Reason for missing information: Do not elevate PSG efficiency to a prospectively confirmed endpoint through retrospective registration alone.
Required materials and conditions: Materials comparing the pre-recruitment plan with the paper’s primary-endpoint label
Materials to obtain first: Pre-recruitment protocol/SAP and registration/paper endpoints
Further research: Present the paper’s endpoint label separately from planning time
Remaining 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
Conditions for verification: 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
Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score
Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations
Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions

Related sources R01

N19 · Can plans for multiplicity, additional outcomes and analysis selection be verified?

Current findings: The preserved summary includes PSG efficiency, baseline adjustment and some safety information, but no detailed complete plan, multiple-comparison adjustment or analysis selection.
Verification status: Unverified
Materials actually read: Summary read; related external material unread
Why unverified: Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict
Reason for missing information: Do not newly certify plans or statistical significance for other outcomes.
Required materials and conditions: Prespecified hierarchy and changes for all analyses, endpoints and adjustments
Materials to obtain first: Protocol, SAP, endpoint list and revision history
Further research: Present the prespecified hierarchy of efficacy, additional and safety analyses
Remaining 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
Conditions for verification: 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
Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score
Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations
Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions

Related sources R01

N20 · Are subjective insomnia improvement and PSG sleep efficiency distinguished?

Current findings: The existing counterpoint states that subjective insomnia improvement and PSG sleep efficiency are different endpoints.
Verification status: Partly verified
Materials actually read: Summary read; related external material unread
Why unverified: Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict
Reason for missing information: Do not fill subjective sleep quality, overall insomnia or everyday-function efficacy with a positive objective measure.
Required materials and conditions: Original results and measurement definitions for each objective/subjective endpoint
Materials to obtain first: Endpoint-specific original results for subjective scales and daily functioning
Further research: Present different sleep outcomes as separate questions
Remaining 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
Conditions for verification: 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
Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score
Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations
Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions

Related sources R01

N21 · Was REM-related sleep efficiency combined with overall PSG sleep efficiency?

Current findings: 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.
Verification status: Partly verified
Materials actually read: Summary read; related external material unread
Why unverified: Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict
Reason for missing information: Do not establish REM-related measures as equivalent to overall PSG measures or combine different effects.
Required materials and conditions: Endpoint definitions and measurement scope in the current trial and review
Materials to obtain first: Review endpoint definitions and included-trial tables
Further research: Distinguish overall-sleep and REM-related measures and strains
Remaining 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
Conditions for verification: 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
Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score
Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations
Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions

Related sources R01 R02

N22 · What is the actual material scope of the unidentified meta-analysis context?

Current findings: 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.
Verification status: Partly verified
Materials actually read: Summary read; related external material unread
Why unverified: Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict
Reason for missing information: Do not certify 39 or three as directly read or independent-replication counts here. Leave the external review document and inclusion relationships unverified.
Required materials and conditions: Bibliography, included trials, strains and original endpoints for the 39-RCT review
Materials to obtain first: Exact bibliography, included trials and result tables of the mentioned review
Further research: Present unidentified preserved context separately from the identified trial report
Remaining 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
Conditions for verification: 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
Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score
Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations
Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions

Related sources R02

N23 · Were IDCC 1201 results extended to probiotics generally?

Current findings: 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.
Verification status: Partly verified
Materials actually read: Summary read; related external material unread
Why unverified: Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict
Reason for missing information: Do not elevate other-strain or other-endpoint results to equivalence or independent replication of IDCC 1201.
Required materials and conditions: Direct comparisons and applicability evidence by strain, product, population and duration
Materials to obtain first: Direct replication or comparison for the same strain, product and population
Further research: Preserve strain-specific applicability boundaries as separate questions
Remaining 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
Conditions for verification: 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
Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score
Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations
Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions

Related sources R01 R02

N24 · Were the paper, registration and related context counted as independent repeat trials?

Current findings: The directly identified trial bibliography is one Kim et al. 2026 paper linked to KCT0011568. The preserved summary contains only one selected subclaim row.
Verification status: Partly verified
Materials actually read: Summary read; related external material unread
Why unverified: Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict
Reason for missing information: 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.
Required materials and conditions: Connections and overlap among current report, registration and review context
Materials to obtain first: Connections among papers, registration and analyses of the same trial
Further research: Distinguish report entries from trial and participant units
Remaining 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
Conditions for verification: 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
Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score
Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations
Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions

Related sources R01 R02

N25 · Are research funding and active/placebo product provision distinguished?

Current findings: Ildong Bioscience provided research funding and active/placebo capsules; the original summary describes full manufacturer funding.
Verification status: Partly verified
Materials actually read: Summary read; related external material unread
Why unverified: Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict
Reason for missing information: Do not change funding or product support into public or independent support. Support contracts, product details and data rights remain unread.
Required materials and conditions: Original disclosures of funding, products, contracts and company roles
Materials to obtain first: Funding/product disclosures and contract/role specifications
Further research: Present funding, product supply and involvement in results as separate items
Remaining 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
Conditions for verification: 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
Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score
Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations
Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions

Related sources R01

N26 · Are the names and relationships of company employee authors preserved?

Current findings: 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.
Verification status: Partly verified
Materials actually read: Summary read; related external material unread
Why unverified: Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict
Reason for missing information: Do not remove names or employee relationships or certify all authors as independent. Full author-specific contributions remain unread in the original paper.
Required materials and conditions: Employee authors, affiliations, contributions and other conflict disclosures
Materials to obtain first: Author affiliation, contribution and COI disclosures
Further research: Present employee relationships separately from each author’s actual roles
Remaining 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
Conditions for verification: 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
Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score
Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations
Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions

Related sources R01

N27 · Are the company’s limited role denials distinguished from overall independence?

Current findings: The summary states that the paper declared no company involvement in recruitment, collection, endpoint assessment or statistical analysis.
Verification status: Partly verified
Materials actually read: Summary read; related external material unread
Why unverified: Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict
Reason for missing information: 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.
Required materials and conditions: Materials on recruitment, collection, endpoint assessment, statistical analysis, design, writing and publication roles
Materials to obtain first: Company/author roles and data/publication-rights disclosures
Further research: Distinguish disclosed role denials from involvement that remains unverified
Remaining 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
Conditions for verification: 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
Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score
Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations
Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions

Related sources R01

N28 · Is the observation scope of four-week adverse-event nonreporting clear?

Current findings: The safety summary states that no significant adverse events or intervention-related side effects were reported during four weeks.
Verification status: Partly verified
Materials actually read: Summary read; related external material unread
Why unverified: Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict
Reason for missing information: Do not convert this into zero events, complete collection for everyone or established product safety. Detailed harms tables and denominators remain unread.
Required materials and conditions: Event definitions, collection methods, denominators by group and discontinuations
Materials to obtain first: Group-specific harms/discontinuation tables and collection methods
Further research: Present reporting scope and actual collection/exposure denominators
Remaining 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
Conditions for verification: 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
Why this condition is needed: Supplementary condition showing limits of harms/safety information separately from efficacy
Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations
Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions

Related sources R01

N29 · Is systolic-pressure change the same outcome as sleep efficiency or confirmed harm?

Current findings: The original safety narrative records a between-group P=0.019 for systolic-pressure change, while values were within the normal range.
Verification status: Partly verified
Materials actually read: Summary read; related external material unread
Why unverified: Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict
Reason for missing information: 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.
Required materials and conditions: Values, intervals, baseline, time points and event information for blood-pressure changes
Materials to obtain first: Original blood-pressure results and baseline/group denominator tables
Further research: Present blood-pressure measures separately from adverse events and sleep efficiency
Remaining 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
Conditions for verification: 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
Why this condition is needed: Supplementary condition showing limits of harms/safety information separately from efficacy
Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations
Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions

Related sources R01

N30 · Can long-term or rare harms and safety in other populations be assessed?

Current findings: The preserved summary explicitly states that four weeks is short for assessing long-term safety. The parent safety-caution label is the original record.
Verification status: Unverified
Materials actually read: Summary read; related external material unread
Why unverified: Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict
Reason for missing information: Do not extend a short trial to long-term/rare harms or safety in excluded patients with diagnoses.
Required materials and conditions: Long-term exposure/follow-up, vulnerable populations and rare-event materials
Materials to obtain first: Long-term follow-up, rare events and population-specific harms materials
Further research: Present long-term safety gaps separately from efficacy
Remaining 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
Conditions for verification: 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
Why this condition is needed: Supplementary condition showing limits of harms/safety information separately from efficacy
Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations
Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions

Related sources R01

N31 · Do four-week results show sustained effects after completion or sleep-disorder prevention?

Current findings: 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.
Verification status: Unverified
Materials actually read: Summary read; related external material unread
Why unverified: Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict
Reason for missing information: Do not fill long-term persistence, treatment of diagnosed insomnia or treatment replacement with a four-week efficiency change.
Required materials and conditions: Direct follow-up, sustained-effect and clinical-outcome materials after completion
Materials to obtain first: Post-completion PSG and clinical-outcome follow-up materials
Further research: Present treatment-period and post-completion sustained results as separate questions
Remaining 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
Conditions for verification: 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
Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score
Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations
Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions

Related sources R01

N32 · Are summary reading and unread external abstract, full text, registration and plans distinguished?

Current findings: 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.
Verification status: Partly verified
Materials actually read: Summary read; related external material unread
Why unverified: Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict
Reason for missing information: 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.
Required materials and conditions: Original form, actual reading and access status by material type
Materials to obtain first: Actual paper, registration/plans and mentioned-review materials
Further research: Mark summary reading separately from unread external materials
Remaining 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
Conditions for verification: 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
Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score
Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations
Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions

Related sources R01 R02

N33 · Are parent Korean/English prose, axes, reference date and correction history preserved in original form?

Current findings: 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.
Verification status: Partly verified
Materials actually read: Summary read; related external material unread
Why unverified: Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict
Reason for missing information: 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.
Required materials and conditions: Whole copies of selected row, parent record and historical dates
Materials to obtain first: Original review summary and condition/application preparation events
Further research: Separate existing verdict/correction history from preparation date and existing content review
Remaining 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
Conditions for verification: 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
Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score
Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations
Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions

Related sources R01

N34 · Are the preserved candidate’s review-pending/eligibility markers separated from the current preparation event?

Current findings: 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.
Verification status: Partly verified
Materials actually read: Summary read; related external material unread
Why unverified: Show the presence, scope and gaps of information in the read preserved summary; this is not completed review or a new efficacy/harms verdict
Reason for missing information: 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.
Required materials and conditions: Existing candidate metadata, preparation, review and independence status
Materials to obtain first: Existing selection and freeze/application preparation events
Further research: Link preparation completion separately from existing content-review status
Remaining 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
Conditions for verification: 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
Why this condition is needed: Preparation condition showing the selected question’s interpretation scope and needed materials; not an efficacy or completed-review score
Application exceptions: Keep unread and absent original materials as separate gaps; do not replace them with values for other populations, endpoints or formulations
Referenced methods: Existing applicability conditions and preserved methodology links are retained as a preparation copy; this does not establish a complete review of the definitions

Related sources R01 R02