Casein-derived MKP × Orientation: Positive secondary finding and gaps in total-score and multiplicity evidence

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 · Evidence conditionWhich existing Orientation claim is being presented?Required	The selected claim is improved Orientation subscale, with original subclaim grade C and a note that P=0.022 does not overturn failure of the primary total score. Subclaim score, status and axes are absent and are retained separately from parent D30 values. R01	An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.	Separate the selected subscale wording and subclaim grade from parent values	Material needed: Orientation's exact effect of interest, visit, hierarchy and review of the claim boundary. Parent scores or axes and total-score grade D are not used to overwrite subclaim values. Only the need for material or research is recorded; no new retrieval or research is performed.
2	Partly verified	Full text not readStored summary read	N02 · Evidence conditionWhich population's subscale results are these?Required	The original trial involved 268 community-dwelling Japanese adults aged 40 or older without dementia. The subscale signal is not extended to people with dementia, all cognitive problems, or other ages or regions. R01	An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.	Community-dwelling Japanese adults aged 40 or older without dementia	Material needed: Original eligibility and exclusion criteria, baseline cognition and clinical status, comorbidities and medication, and direct outcomes in other populations. Only the need for material or research is recorded; no new retrieval or research is performed.
3	Unverified	Full text not readStored summary read	N03 · Evidence conditionAre baseline total scores also baseline Orientation scores?Required	Baseline total scores were MKP 4.08±2.17 and placebo 4.10±2.10. Group-specific baseline and final Orientation values and distributions are not established in the summary. Total-score values are not used to create subscale values or floor or ceiling effects. R01	An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.	Baseline distributions of total scores and subscale scores	Material needed: Original Orientation tables, score range and direction, baseline and final distributions, and analyses by clinical status. No new conversion between total and subscale scores or diagnosis. Only the need for material or research is recorded; no new retrieval or research is performed.
4	Partly verified	Full text not readStored summary read	N04 · Evidence conditionIs study MKP distinguished from ordinary milk?Required	The original intervention was casein-derived Met-Lys-Pro (MKP), 200 μg/day, and the manufacturer supplied casein-hydrolysate tablets containing MKP. This is not converted into amounts of ordinary milk or other products, or their subscale effects. R01	An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.	Study tablets containing casein-derived MKP	Material needed: Original tablet composition, MKP quantification, other ingredients, manufacture and adherence, and product identity. Study exposure is identified without consumption or product advice. Only the need for material or research is recorded; no new retrieval or research is performed.
5	Partly verified	Full text not readStored summary read	N05 · Evidence conditionWhat were the actual control and concurrent exposures?Required	The original record states allocation to MKP or dextrin placebo tablets, 134/134. Actual placebo conditions, contact, diet and medication in both groups, expectations and adherence are not verified in detail. R01	An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.	Dextrin placebo and conditions in both groups	Material needed: Placebo and active composition, blinding, concurrent exposures, contact and adherence. Original data specifying the subscale effect of interest for additional benefit versus placebo. Only the need for material or research is recorded; no new retrieval or research is performed.
6	Partly verified	Full text not readStored summary read	N06 · Evidence conditionIs 24-week exposure distinguished from sustained improvement?Required	The study used 200 μg/day for 24 weeks, with Orientation as a secondary finding from that trial. Actual exposure, adherence and discontinuation, visit-specific analyses and persistence after the study are not verified in detail. Sustained subscale efficacy is not newly established. R01	An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.	Original duration, actual exposure and post-study follow-up	Material needed: Visit-specific subscale analyses, actual exposure, visits and discontinuation, and follow-up after the study. No cumulative dose, number of days, consumption advice or care instructions. Only the need for material or research is recorded; no new retrieval or research is performed.
7	Partly verified	Full text not readStored summary read	N07 · Evidence conditionAre ITT denominators separated from observed subscale denominators?Required	The existing evidence list records 268 randomized participants and ITT analysis (134/134). Actual observed and analyzed Orientation denominators, completion, withdrawal and missingness are not verified in detail. ITT is not recast as observation or completion by everyone for the subscale. R01	An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.	ITT for 268 participants and Orientation-specific missingness and completion	Material needed: Group-specific flow, observed and analyzed denominators by Orientation outcome and visit, reasons for withdrawal and missingness, and handling methods. No new denominator, withdrawal count or rate is calculated. Only the need for material or research is recorded; no new retrieval or research is performed.
8	Partly verified	Full text not readStored summary read	N08 · Evidence conditionWhat exactly did Orientation measure?Required	The original material provides the subscale name Orientation and P=0.022. Items, score range and direction, test version, assessors, visits and details of its relationship to the total score are not established in the summary. R01	An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.	Subscale definition, scores and interpretation	Material needed: Original Orientation test definitions, items and calculations, assessment methods, version, prespecified plans and tables. The name alone is not substituted for measurement of global cognition or daily function. Only the need for material or research is recorded; no new retrieval or research is performed.
9	Unverified	Full text not readStored summary read	N09 · Evidence conditionWere subscale effect sizes and CIs provided?Required	The original subscale P=0.022 is retained. Group-specific values, exact between-group differences, effect sizes, CIs and variance are not provided in the current stored summary. Total-score d=0.12, P=.302 or before-and-after values are not copied into the subscale. R01	An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.	Orientation P value and unverified quantitative effects	Material needed: Original group-specific baseline and final Orientation values, effect of interest, effects and CIs, denominators, models and clinical importance. No new effect or CI is calculated from P alone. Only the need for material or research is recorded; no new retrieval or research is performed.
10	Partly verified	Full text not readStored summary read	N10 · Evidence conditionWhich comparison or model produced the subscale P value?Required	Detailed comparisons, models, adjustment and visits underlying Orientation P=0.022 are not specified in the summary. It is not automatically declared to use the same model as the baseline-adjusted total score, and within-group improvement is not transferred into additional between-group benefit. R01	An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.	Orientation effect of interest, within-group and between-group comparisons, and adjustment	Material needed: Exact subscale comparison, analysis population, baseline adjustment or repeated measures, effect of interest and original tables. No new between-group or within-group difference is calculated. Only the need for material or research is recorded; no new retrieval or research is performed.
11	Partly verified	Full text not readStored summary read	N11 · Evidence conditionIs the null primary total score retained separately?Required	The original record that the baseline-adjusted total-score result was null, P=.302 and d=.12, with no 95% CI reported, is retained. The original statement that Orientation P=.022 neither means total-score success nor overturns its failure is preserved. R01	An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.	Different findings for the global cognition total score and Orientation	Material needed: Original total-score and subscale outcomes, exact visits, denominators, prespecified hierarchy and plans. Subscale and total-score values and conclusions are not transferred to each other. Only the need for material or research is recorded; no new retrieval or research is performed.
12	Partly verified	Full text not readStored summary read	N12 · Evidence conditionAre secondary and exploratory findings distinguished from prespecified plans?Required	The original Korean and English texts disclose Orientation as a secondary finding. The registration citation lists ADAS-Jcog as the prespecified primary endpoint. Orientation's prespecification, exact secondary or exploratory hierarchy, and amendment history have not been established through new reading of the registration or protocol. R01 R02	An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.	Relationship between the secondary subscale and registered primary endpoint	Material needed: Subscale lists and hierarchy, prespecification, amendments and disclosure dates in the complete registration, protocol and SAP. The subscale is not newly designated as a prespecified confirmatory endpoint. Only the need for material or research is recorded; no new retrieval or research is performed.
13	Unverified	Full text not readStored summary read	N13 · Evidence conditionAre multiplicity plans and adjustments verified?Required	The original material explains that one positive subscale is not promoted into a total-score effect. The total number of tests, multiplicity adjustment, allocation of significance levels and selective reporting are not verified in detail. Significance or nonsignificance after adjustment is not newly adjudicated. R01	An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.	Testing specifications for multiple subscales and tests	Material needed: Complete outcome and endpoint lists, prespecified testing and multiplicity, adjustment methods, selective reporting, and original comparisons of the paper with plans. No new adjusted P value or hypothetical example. Only the need for material or research is recorded; no new retrieval or research is performed.
14	Partly verified	Full text not readStored summary read	N14 · Evidence conditionAre total-score and Orientation numbers distinguished?Required	Total scores of 4.08±2.17 to 3.18±1.88 versus 4.10±2.10 to 3.43±2.10, with d=.12, and Orientation P=.022 are different findings. Within-group total-score decreases, d and the absence of reported CIs are not copied into Orientation values, variance or effects. R01	An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.	Before-and-after total scores and d versus the subscale P value	Material needed: Original tables, scores, variance, effects and CIs, visits, denominators and models for each endpoint. Different subscales are not averaged or added together. Only the need for material or research is recorded; no new retrieval or research is performed.
15	Unverified	Full text not readStored summary read	N15 · Evidence conditionHave other subscale and test findings been newly filled in?Required	The current stored material distinguishes the total score and Orientation. Other subscale or test names, the number of tests, group-specific results and comparisons are not verified in detail. Unread material is not treated as proof that all other findings were null or absent. R01	An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.	Scope of all tests and subscales	Material needed: Complete outcome tables, test lists, primary and secondary plans, denominators and visits, and effects and CIs. No new subscale or test results are invented. Only the need for material or research is recorded; no new retrieval or research is performed.
16	Partly verified	Full text not readStored summary read	N16 · Evidence conditionIs the repeat-testing interpretation automatically applied to the subscale?Required	The original material interprets total-score improvement in both groups as a repeat-testing effect. Orientation values in both groups, practice effects, expectations and comparison-model details are unverified. The total-score interpretation is not newly established as a causal mechanism for the subscale. R01	An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.	Original total-score interpretation and the Orientation comparison	Material needed: Endpoint-specific baseline and final values, practice effects and expectations, assessments, effects of interest and models, and original tables. Within-group improvement is not newly calculated as an ingredient-specific effect. Only the need for material or research is recorded; no new retrieval or research is performed.
17	Unverified	Full text not readStored summary read	N17 · Evidence conditionIs the subscale extended to global cognition, dementia prevention or clinical function?Required	The original material explains that a positive Orientation finding is not evidence of improved global cognition. Separate direct data on dementia prevention, daily function and clinical outcomes are not provided within the preserved scope. These are not established from the subscale signal. R01	An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.	Directness of the selected subscale for clinical outcomes	Material needed: Actual definitions, measurements and follow-up, group-specific denominators, effects and CIs for clinical function or dementia events, and direct confirmatory data relevant to the question. Unread material is not treated as proof that outcomes were not measured. Only the need for material or research is recorded; no new retrieval or research is performed.
18	Partly verified	Full text not readStored summary read	N18 · Evidence conditionAre the same design and people counted as separate independent replication?Required	The original design statements on computer block allocation, multiple blinding roles and ITT apply to Orientation within the same trial context. Total scores, subscales, visits, groups, references, registration and related sheets are not added as new independent trials or participants. R01 R02	An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.	Total-score and subscale findings from the same randomized trial	Material needed: Original links among reports, registration, cohorts and analyses, and endpoint-specific denominators. Strong design statements are not converted into certification of subscale prespecification, confirmation or independence. Only the need for material or research is recorded; no new retrieval or research is performed.
19	Partly verified	Full text not readStored summary read	N19 · Harm-information gaps supplementing the efficacy tableIs safety separate from subscale efficacy?Supplementary	The original material retains the scope that no serious adverse events attributed to MKP consumption were reported over 24 weeks, together with the milk-protein allergy caution. This is not evidence of Orientation efficacy and is not extended to zero harms of every kind or long-term safety. R01	An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.	Related serious adverse events over 24 weeks, allergy and long-term harms	Material needed: Group-specific AE and SAE collection, attribution and discontinuation, exposure and denominators, and allergy and long-term data. No consumption or product advice, or cognition or dementia care instructions. Only the need for material or research is recorded; no new retrieval or research is performed.
20	Partly verified	Full text not readStored summary read	N20 · Evidence conditionWhat materials were actually read in this work?Required	The complete parent summary was read for production and preserved in its original form. Summary reading refers to the stored summary; the external abstract, full paper, UMIN registration, protocol and SAP remain unread in this work. The existence of a URL is not promoted into reading. R01 R02	An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.	Preserved-summary reading and external paper or registration status	Material needed: Records of actual acquisition and reading scope, versions and dates. No separate external-link click or access test was performed. Only material requests and research needs are recorded; no retrieval or research is performed in this work.
21	Partly verified	Full text not readStored summary read	N21 · Evidence conditionAre historical registration dates and primary-endpoint names distinguished from current reading?Required	The original Korean and English texts describe prospective registration, with disclosure on 2018-06-04 and a planned start on 2018-06-07. The registration citation describes prespecified ADAS-Jcog and manufacturer funding. Only original dates and statements are retained; actual start, versions and plan agreement are not newly verified. R01 R02	An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.	UMIN000032833 history and prespecified plans	Material needed: Original registration text and versions, disclosure, start and change dates, ADAS-Jcog naming and endpoint specifications, and funding compared with the paper. The original official URL is retained without clicking it. Only material requests and research needs are recorded; no retrieval or research is performed in this work.
22	Unverified	Full text not readStored summary read	N22 · Evidence conditionWere protocol, SAP, subscale and multiplicity plans acquired?Required	Original registration and historical cross-checking statements are retained. The original protocol and SAP, versions and dates, subscale and multiplicity plans, and clinical thresholds have not been read in this work. A registration statement about the primary endpoint does not establish all secondary plans. R01 R02	An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.	Separate evidence for prespecified plans, analyses and changes	Material needed: Original protocol, SAP, amendments, all outcomes and analyses, multiplicity, clinical thresholds and public-disclosure timing. Unread external material is not assumed to mean a document is absent. Only material requests and research needs are recorded; no retrieval or research is performed in this work.
23	Partly verified	Full text not readStored summary read	N23 · Evidence conditionAre company funding, product support, employee authors and research roles separated?Required	The source records Morinaga Milk study support, manufacture and supply of MKP-containing hydrolysate and placebo tablets, four employee authors N.Y., M.T., K.Y. and F.A., and a supervision fee for N.S. The original limitation that separate public cofunding, medical-writing and publication support were not reported is retained. Design, analysis and data-control details are not newly established. R01 R02	An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.	Four categories of Morinaga involvement and other support	Material needed: Individual original records of company funding and products, author employment and supervision fees, design, analysis, data control, other support and conflicts of interest. Absence of public support and all roles are not certified in this work. Only material requests and research needs are recorded; no retrieval or research is performed in this work.
24	Partly verified	Full text not readStored summary read	N24 · Evidence conditionAre null, positive secondary and unverified findings distinguished?Required	The null original total-score result, P=.302 and d=.12, is retained alongside the positive secondary Orientation P=.022, which does not overturn failure of the total score. Unverified details of CIs, plans and denominators differ from unread external material. R01	An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.	Total-score and subscale findings and material-access states	Material needed: Original endpoint-specific tables, direct measurement and analysis, plans, clinical importance and actual access scope. Null is not replaced with zero effect or equivalence, and unread is not replaced with unreported. Only material requests and research needs are recorded; no retrieval or research is performed in this work.
25	Partly verified	Full text not readStored summary read	N25 · Evidence conditionWere the paper and registration counted as separate clinical trials?Required	Parent verdict 2980 and the total-score and Orientation sheets share the same Yuda2020 paper, UMIN000032833 registration and 268-person, 24-week trial. The same people, groups, visits, total scores, subscales, references, registration and related sheets are not added as new independent trials or participants. Two linked documents comprise one clinical paper and one registration record, not certified counts of unique trials or participants. R01 R02	An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.	Report and registration linkage versus actual trials and participants	Material needed: Original references, registration and links to the same cohort, analyses, visits and outcomes. Totals of unique trials and participants remain unrecorded. Only material requests and research needs are recorded; no retrieval or research is performed in this work.
26	Unverified	Full text not readStored summary read	N26 · Evidence conditionIs there separate independent confirmation?Supplementary	The original parent replication axis R1 and independence axis I0 are retained. The paper, registration, subscales in the same participants and related sheets are not certified as new independent replications. No separate replication of harm findings is created in this work. R01	An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.	Distinguish a single manufacturer trial from independent replication	Material needed: Confirmatory evidence with question-specific prespecified plans, separate populations and controls, direct endpoints and durations, effects and CIs, and funding or author relationships. No new search or independence verdict. Only material requests and research needs are recorded; no retrieval or research is performed in this work.
27	Partly verified	Full text not readStored summary read	N27 · Evidence conditionAre subclaim grades distinguished from original parent scores and axes?Required	The selected record's grade, note and Korean and English question wording are retained; absent subclaim score, status and axes remain unrecorded. Parent D30, Good safety and B/P/R1/I0/E0/B0/C0 are parent context and are not transferred to the subclaim. R01	An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.	Subclaim grade, note and absences versus parent D30	Material needed: Review of subclaim and parent boundaries and actual correction records. No new score or grade, or official RoB2 or GRADE certification. Only material requests and research needs are recorded; no retrieval or research is performed in this work.
28	Partly verified	Full text not readStored summary read	N28 · Evidence conditionAre both languages and absent structured fields preserved?Required	The parent Korean and English texts, evidence and citations, axes and original selected subclaim are retained in the full stored summary. Separate Korean and English classification fields are absent; no new fields are inserted into the original summary. No external comparison with the English paper was performed. R01	An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.	Korean and English originals and absent separate classification fields	Material needed: Review material for language-specific terminology, endpoints, visits, original statements and absences. Application-condition descriptions are distinguished from the preserved original record. Only material requests and research needs are recorded; no retrieval or research is performed in this work.
29	Partly verified	Full text not readStored summary read	N29 · Evidence conditionAre the reference date, corrections and historical cross-checking separated from production?Required	The 2026-08-26 reference date, empty correction array and deliberation string, and historical cross-checking in the verdict-decision record are retained. The original date and history are not condition-freezing, application, production or completed-content-review dates. R01	An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.	Original 2026-08-26 reference date and empty corrections	Material needed: When actual new corrections or material arise, retain the original text and separate events, conditions, observations and verdict decisions for updates. Historical records are not treated as new quality review. Only material requests and research needs are recorded; no retrieval or research is performed in this work.
30	Unverified	Full text not readStored summary read	N30 · Evidence conditionWhich direct material would fill the selected gaps?Supplementary	Gaps in the secondary Orientation signal, quantitative effects, CIs, hierarchy and multiplicity are retained. Confirmation of the subscale requires prespecified direct comparison data for that endpoint; it is not converted into total-score success or dementia prevention. R01	An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.	Prespecified questions, direct effects, CIs, plans and follow-up	Material needed: Question-specific prespecified direct effects and CIs, denominators, missingness, measurement, effects of interest, clinical thresholds, multiplicity, separate confirmation, longer-term clinical outcomes and harms. Only material needs are recorded; no research or retrieval is performed. Only material requests and research needs are recorded; no retrieval or research is performed in this work.
31	Partly verified	Full text not readStored summary read	N31 · Evidence conditionAre production, existing content review and practical instructions separated?Supplementary	This is an application-condition record based on the preserved summary. Existing content and question-boundary review are incomplete; historical candidate pending and eligibility labels are retained as history. Existing review status is recorded as it stands. R01	An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.	Production request, historical candidate record and responsibility for existing content review	Material needed: Existing content review and subsequent actual material and correction records. The original production performed no comparison of clinical source material, external reading, new calculations, grade changes or advice on MKP, milk or products, cognition or dementia care, or treatment replacement. Only material requests and research needs are recorded; no retrieval or research is performed in this work.

No items match your search or filter.

31 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: 268 community-dwelling Japanese adults aged 40 or older without dementia; intention-to-treat analysis, 134/134. Completion, withdrawal and observed denominators for the selected endpoint are not verified in detail.
Ingredient, formulation and route: Casein hydrolysate tablets containing the casein-derived peptide Met-Lys-Pro (MKP)
Dose: Original study exposure only: MKP 200 μg/day for 24 weeks. No cumulative dose calculation or advice on consuming MKP, milk or products.
Comparator: Dextrin placebo tablets, 134 participants; sensory matching, blinding and concurrent exposures are not verified in detail.
Measured outcome: Secondary Orientation subscale finding, P=.022; distinguished from the primary total score, other subscales, global cognition and clinical function
Duration: 24 weeks; actual adherence, discontinuation, visit-specific follow-up and follow-up after the study are not verified in detail.
Questions outside this scope: Promoting positive Orientation findings into primary total-score success, improved global cognition, dementia prevention or clinical function; Copying group-specific total-score values, d, P or CI limitations into subscale results; Rejudging within-group improvement as an additional effect versus placebo, equivalence, noninferiority or a zero effect; Adding the same paper, registration, people, groups, visits, subscales or related sheets as new independent trials or participants; New calculations, hypothetical quantities, effects, CIs, grades or independence certification, or instructions on MKP, milk or product consumption, cognition or dementia care, or replacement of treatment

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 · Yuda N, et al. Effect of the Casein-Derived Peptide Met-Lys-Pro on Cognitive Function in Community-Dwelling Adults Without Dementia. Clin Interv Aging. 2020;15:743-754. PMID: 32546992.

PubMed

Material type: Double-blind randomized placebo-controlled parallel trial
Materials actually read: Stored summary read; external abstract, full text, registration and plans unread
Findings recorded in the stored summary: 4.08±2.17 to 3.18±1.88 versus 4.10±2.10 to 3.43±2.10; baseline-adjusted P=0.302, d=0.12; 95% CI not reported
Record level: Total-score summary in the preserved evidence list; Orientation is linked separately to its subclaim and the original counterview.
Study overlap and independent replication: Parent verdict 2980 and the total-score and Orientation sheets share the same Yuda2020 paper, UMIN000032833 registration and 268-person, 24-week trial context. The same people, groups, visits, total score, subscales, references, registration and related sheets are not added as new independent trials or participants. R01, the paper, and R02, the registration, are documents linked by the same UMIN identifier, not certified counts of unique trials or participants or a certification of independence.

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Stored summary	A preserved local copy of the complete parent summary	Stored summary read	Summary read	Only original PubMed and official UMIN URLs and identifiers are retained. No new external reading, access, confirmation of prespecification or certification of fulfillment is claimed. Missing full-text or plan URLs are not guessed.
External abstract	An original identifier, citation or needed-material entry; public availability and access details are unverified.	Unread; no access test performed	Not read	Only original PubMed and official UMIN URLs and identifiers are retained. No new external reading, access, confirmation of prespecification or certification of fulfillment is claimed. Missing full-text or plan URLs are not guessed.
External full text	An original identifier, citation or needed-material entry; public availability and access details are unverified.	Unread; no access test performed	Not read	Only original PubMed and official UMIN URLs and identifiers are retained. No new external reading, access, confirmation of prespecification or certification of fulfillment is claimed. Missing full-text or plan URLs are not guessed.
Original registration	An original identifier, citation or needed-material entry; public availability and access details are unverified.	Unread; no access test performed	Not read	Only original PubMed and official UMIN URLs and identifiers are retained. No new external reading, access, confirmation of prespecification or certification of fulfillment is claimed. Missing full-text or plan URLs are not guessed.
Protocol/SAP	An original identifier, citation or needed-material entry; public availability and access details are unverified.	Unread; no access test performed	Not read	Only original PubMed and official UMIN URLs and identifiers are retained. No new external reading, access, confirmation of prespecification or certification of fulfillment is claimed. Missing full-text or plan URLs are not guessed.

R02 · UMIN Clinical Trials Registry. UMIN000032833.

Official source

Material type: Official registration record for the same trial; not a separate report of effects
Materials actually read: Stored summary read; external abstract, full text, registration and plans unread
Findings recorded in the stored summary: ADAS-Jcog was the prespecified primary endpoint, and public disclosure preceded the planned start.
Record level: Existing citation statement about registration plans; not a new clinical effect or result
Study overlap and independent replication: Parent verdict 2980 and the total-score and Orientation sheets share the same Yuda2020 paper, UMIN000032833 registration and 268-person, 24-week trial context. The same people, groups, visits, total score, subscales, references, registration and related sheets are not added as new independent trials or participants. R01, the paper, and R02, the registration, are documents linked by the same UMIN identifier, not certified counts of unique trials or participants or a certification of independence.

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Stored summary	A preserved local copy of the complete parent summary	Stored summary read	Summary read	Only original PubMed and official UMIN URLs and identifiers are retained. No new external reading, access, confirmation of prespecification or certification of fulfillment is claimed. Missing full-text or plan URLs are not guessed.
Original registration	An original identifier, citation or needed-material entry; public availability and access details are unverified.	Unread; no access test performed	Not read	Only original PubMed and official UMIN URLs and identifiers are retained. No new external reading, access, confirmation of prespecification or certification of fulfillment is claimed. Missing full-text or plan URLs are not guessed.
Registration amendment history	An original identifier, citation or needed-material entry; public availability and access details are unverified.	Unread; no access test performed	Not read	Only original PubMed and official UMIN URLs and identifiers are retained. No new external reading, access, confirmation of prespecification or certification of fulfillment is claimed. Missing full-text or plan URLs are not guessed.
Original protocol	An original identifier, citation or needed-material entry; public availability and access details are unverified.	Unread; no access test performed	Not read	Only original PubMed and official UMIN URLs and identifiers are retained. No new external reading, access, confirmation of prespecification or certification of fulfillment is claimed. Missing full-text or plan URLs are not guessed.
Original analysis plan	An original identifier, citation or needed-material entry; public availability and access details are unverified.	Unread; no access test performed	Not read	Only original PubMed and official UMIN URLs and identifiers are retained. No new external reading, access, confirmation of prespecification or certification of fulfillment is claimed. Missing full-text or plan URLs are not guessed.

Report counts versus independent study counts

Parent verdict 2980 and the total-score and Orientation sheets share the same Yuda2020 paper, UMIN000032833 registration and 268-person, 24-week trial context. The same people, groups, visits, total score, subscales, references, registration and related sheets are not added as new independent trials or participants. R01, the paper, and R02, the registration, are documents linked by the same UMIN identifier, not certified counts of unique trials or participants or a certification of independence.

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 · Which existing Orientation claim is being presented?

Required materials and conditions: Separate the selected subscale wording and subclaim grade from parent values
Conditions for verification: Present original data on separate the selected subscale wording and subclaim grade from parent values, together with the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope.
Requirement and applicability: Required
Application exceptions: Distinguish the secondary Orientation P value from unverified group-specific values, effects, CIs, comparison models, prespecified or exploratory hierarchy and multiplicity; also distinguish the null primary total score, other tests, daily function, baseline cognition, population, intervention, control, duration, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.
Why this condition is needed: This is needed to connect separate the selected subscale wording and subclaim grade from parent values with the selected question, actual population, intervention and control, total scores and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

N02 · Which population's subscale results are these?

Required materials and conditions: Community-dwelling Japanese adults aged 40 or older without dementia
Conditions for verification: Present original data on community-dwelling Japanese adults aged 40 or older without dementia, together with the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope.
Requirement and applicability: Required
Application exceptions: Distinguish the secondary Orientation P value from unverified group-specific values, effects, CIs, comparison models, prespecified or exploratory hierarchy and multiplicity; also distinguish the null primary total score, other tests, daily function, baseline cognition, population, intervention, control, duration, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.
Why this condition is needed: This is needed to connect community-dwelling Japanese adults aged 40 or older without dementia with the selected question, actual population, intervention and control, total scores and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

N03 · Are baseline total scores also baseline Orientation scores?

Required materials and conditions: Baseline distributions of total scores and subscale scores
Conditions for verification: Present original data on baseline distributions of total scores and subscale scores, together with the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope.
Requirement and applicability: Required
Application exceptions: Distinguish the secondary Orientation P value from unverified group-specific values, effects, CIs, comparison models, prespecified or exploratory hierarchy and multiplicity; also distinguish the null primary total score, other tests, daily function, baseline cognition, population, intervention, control, duration, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.
Why this condition is needed: This is needed to connect baseline distributions of total scores and subscale scores with the selected question, actual population, intervention and control, total scores and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

N04 · Is study MKP distinguished from ordinary milk?

Required materials and conditions: Study tablets containing casein-derived MKP
Conditions for verification: Present original data on study tablets containing casein-derived MKP, together with the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope.
Requirement and applicability: Required
Application exceptions: Distinguish the secondary Orientation P value from unverified group-specific values, effects, CIs, comparison models, prespecified or exploratory hierarchy and multiplicity; also distinguish the null primary total score, other tests, daily function, baseline cognition, population, intervention, control, duration, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.
Why this condition is needed: This is needed to connect study tablets containing casein-derived MKP with the selected question, actual population, intervention and control, total scores and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

N05 · What were the actual control and concurrent exposures?

Required materials and conditions: Dextrin placebo and conditions in both groups
Conditions for verification: Present original data on dextrin placebo and conditions in both groups, together with the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope.
Requirement and applicability: Required
Application exceptions: Distinguish the secondary Orientation P value from unverified group-specific values, effects, CIs, comparison models, prespecified or exploratory hierarchy and multiplicity; also distinguish the null primary total score, other tests, daily function, baseline cognition, population, intervention, control, duration, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.
Why this condition is needed: This is needed to connect dextrin placebo and conditions in both groups with the selected question, actual population, intervention and control, total scores and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

N06 · Is 24-week exposure distinguished from sustained improvement?

Required materials and conditions: Original duration, actual exposure and post-study follow-up
Conditions for verification: Present original data on original duration, actual exposure and follow-up after the study, together with the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope.
Requirement and applicability: Required
Application exceptions: Distinguish the secondary Orientation P value from unverified group-specific values, effects, CIs, comparison models, prespecified or exploratory hierarchy and multiplicity; also distinguish the null primary total score, other tests, daily function, baseline cognition, population, intervention, control, duration, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.
Why this condition is needed: This is needed to connect original duration, actual exposure and follow-up after the study with the selected question, actual population, intervention and control, total scores and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

N07 · Are ITT denominators separated from observed subscale denominators?

Required materials and conditions: ITT for 268 participants and Orientation-specific missingness and completion
Conditions for verification: Present original data on ITT for 268 participants and Orientation-specific missingness and completion, together with the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope.
Requirement and applicability: Required
Application exceptions: Distinguish the secondary Orientation P value from unverified group-specific values, effects, CIs, comparison models, prespecified or exploratory hierarchy and multiplicity; also distinguish the null primary total score, other tests, daily function, baseline cognition, population, intervention, control, duration, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.
Why this condition is needed: This is needed to connect ITT for 268 participants and Orientation-specific missingness and completion with the selected question, actual population, intervention and control, total scores and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

N08 · What exactly did Orientation measure?

Required materials and conditions: Subscale definition, scores and interpretation
Conditions for verification: Present original data on subscale definition, scores and interpretation, together with the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope.
Requirement and applicability: Required
Application exceptions: Distinguish the secondary Orientation P value from unverified group-specific values, effects, CIs, comparison models, prespecified or exploratory hierarchy and multiplicity; also distinguish the null primary total score, other tests, daily function, baseline cognition, population, intervention, control, duration, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.
Why this condition is needed: This is needed to connect subscale definition, scores and interpretation with the selected question, actual population, intervention and control, total scores and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

N09 · Were subscale effect sizes and CIs provided?

Required materials and conditions: Orientation P value and unverified quantitative effects
Conditions for verification: Present original data on Orientation P value and unverified quantitative effects, together with the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope.
Requirement and applicability: Required
Application exceptions: Distinguish the secondary Orientation P value from unverified group-specific values, effects, CIs, comparison models, prespecified or exploratory hierarchy and multiplicity; also distinguish the null primary total score, other tests, daily function, baseline cognition, population, intervention, control, duration, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.
Why this condition is needed: This is needed to connect Orientation P value and unverified quantitative effects with the selected question, actual population, intervention and control, total scores and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

N10 · Which comparison or model produced the subscale P value?

Required materials and conditions: Orientation effect of interest, within-group and between-group comparisons, and adjustment
Conditions for verification: Present original data on Orientation effect of interest, within-group and between-group comparisons, and adjustment, together with the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope.
Requirement and applicability: Required
Application exceptions: Distinguish the secondary Orientation P value from unverified group-specific values, effects, CIs, comparison models, prespecified or exploratory hierarchy and multiplicity; also distinguish the null primary total score, other tests, daily function, baseline cognition, population, intervention, control, duration, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.
Why this condition is needed: This is needed to connect Orientation effect of interest, within-group and between-group comparisons, and adjustment with the selected question, actual population, intervention and control, total scores and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

N11 · Is the null primary total score retained separately?

Required materials and conditions: Different findings for the global cognition total score and Orientation
Conditions for verification: Present original data on different findings for the global cognition total score and Orientation, together with the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope.
Requirement and applicability: Required
Application exceptions: Distinguish the secondary Orientation P value from unverified group-specific values, effects, CIs, comparison models, prespecified or exploratory hierarchy and multiplicity; also distinguish the null primary total score, other tests, daily function, baseline cognition, population, intervention, control, duration, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.
Why this condition is needed: This is needed to connect different findings for the global cognition total score and Orientation with the selected question, actual population, intervention and control, total scores and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

N12 · Are secondary and exploratory findings distinguished from prespecified plans?

Required materials and conditions: Relationship between the secondary subscale and registered primary endpoint
Conditions for verification: Present original data on relationship between the secondary subscale and registered primary endpoint, together with the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope.
Requirement and applicability: Required
Application exceptions: Distinguish the secondary Orientation P value from unverified group-specific values, effects, CIs, comparison models, prespecified or exploratory hierarchy and multiplicity; also distinguish the null primary total score, other tests, daily function, baseline cognition, population, intervention, control, duration, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.
Why this condition is needed: This is needed to connect relationship between the secondary subscale and registered primary endpoint with the selected question, actual population, intervention and control, total scores and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

N13 · Are multiplicity plans and adjustments verified?

Required materials and conditions: Testing specifications for multiple subscales and tests
Conditions for verification: Present original data on testing specifications for multiple subscales and tests, together with the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope.
Requirement and applicability: Required
Application exceptions: Distinguish the secondary Orientation P value from unverified group-specific values, effects, CIs, comparison models, prespecified or exploratory hierarchy and multiplicity; also distinguish the null primary total score, other tests, daily function, baseline cognition, population, intervention, control, duration, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.
Why this condition is needed: This is needed to connect testing specifications for multiple subscales and tests with the selected question, actual population, intervention and control, total scores and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

N14 · Are total-score and Orientation numbers distinguished?

Required materials and conditions: Before-and-after total scores and d versus the subscale P value
Conditions for verification: Present original data on before-and-after total scores and d versus the subscale P value, together with the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope.
Requirement and applicability: Required
Application exceptions: Distinguish the secondary Orientation P value from unverified group-specific values, effects, CIs, comparison models, prespecified or exploratory hierarchy and multiplicity; also distinguish the null primary total score, other tests, daily function, baseline cognition, population, intervention, control, duration, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.
Why this condition is needed: This is needed to connect before-and-after total scores and d versus the subscale P value with the selected question, actual population, intervention and control, total scores and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

N15 · Have other subscale and test findings been newly filled in?

Required materials and conditions: Scope of all tests and subscales
Conditions for verification: Present original data on scope of all tests and subscales, together with the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope.
Requirement and applicability: Required
Application exceptions: Distinguish the secondary Orientation P value from unverified group-specific values, effects, CIs, comparison models, prespecified or exploratory hierarchy and multiplicity; also distinguish the null primary total score, other tests, daily function, baseline cognition, population, intervention, control, duration, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.
Why this condition is needed: This is needed to connect scope of all tests and subscales with the selected question, actual population, intervention and control, total scores and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

N16 · Is the repeat-testing interpretation automatically applied to the subscale?

Required materials and conditions: Original total-score interpretation and the Orientation comparison
Conditions for verification: Present original data on original total-score interpretation and the Orientation comparison, together with the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope.
Requirement and applicability: Required
Application exceptions: Distinguish the secondary Orientation P value from unverified group-specific values, effects, CIs, comparison models, prespecified or exploratory hierarchy and multiplicity; also distinguish the null primary total score, other tests, daily function, baseline cognition, population, intervention, control, duration, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.
Why this condition is needed: This is needed to connect original total-score interpretation and the Orientation comparison with the selected question, actual population, intervention and control, total scores and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

N17 · Is the subscale extended to global cognition, dementia prevention or clinical function?

Required materials and conditions: Directness of the selected subscale for clinical outcomes
Conditions for verification: Present original data on directness of the selected subscale for clinical outcomes, together with the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope.
Requirement and applicability: Required
Application exceptions: Distinguish the secondary Orientation P value from unverified group-specific values, effects, CIs, comparison models, prespecified or exploratory hierarchy and multiplicity; also distinguish the null primary total score, other tests, daily function, baseline cognition, population, intervention, control, duration, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.
Why this condition is needed: This is needed to connect directness of the selected subscale for clinical outcomes with the selected question, actual population, intervention and control, total scores and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

N18 · Are the same design and people counted as separate independent replication?

Required materials and conditions: Total-score and subscale findings from the same randomized trial
Conditions for verification: Present original data on total-score and subscale findings from the same randomized trial, together with the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope.
Requirement and applicability: Required
Application exceptions: Distinguish the secondary Orientation P value from unverified group-specific values, effects, CIs, comparison models, prespecified or exploratory hierarchy and multiplicity; also distinguish the null primary total score, other tests, daily function, baseline cognition, population, intervention, control, duration, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.
Why this condition is needed: This is needed to connect total-score and subscale findings from the same randomized trial with the selected question, actual population, intervention and control, total scores and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

N19 · Is safety separate from subscale efficacy?

Required materials and conditions: Related serious adverse events over 24 weeks, allergy and long-term harms
Conditions for verification: Present original data on related serious adverse events over 24 weeks, allergy and long-term harms, together with the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope.
Requirement and applicability: Supplementary
Application exceptions: Distinguish the secondary Orientation P value from unverified group-specific values, effects, CIs, comparison models, prespecified or exploratory hierarchy and multiplicity; also distinguish the null primary total score, other tests, daily function, baseline cognition, population, intervention, control, duration, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.
Why this condition is needed: This is needed to connect related serious adverse events over 24 weeks, allergy and long-term harms with the selected question, actual population, intervention and control, total scores and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

N20 · What materials were actually read in this work?

Required materials and conditions: Preserved-summary reading and external paper or registration status
Conditions for verification: Show source material and scope for the following evidence need, including the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope: Preserved-summary reading and external paper or registration status.
Requirement and applicability: Required
Application exceptions: Distinguish the secondary Orientation P value from unverified group-specific values, effects, CIs, comparison models, prespecified or exploratory hierarchy and multiplicity; also distinguish the null primary total score, other tests, daily function, baseline cognition, population, intervention, control, duration, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.
Why this condition is needed: This condition links the evidence need with the selected question, actual population, intervention and control, total score and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms: Preserved-summary reading and external paper or registration status.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

N21 · Are historical registration dates and primary-endpoint names distinguished from current reading?

Required materials and conditions: UMIN000032833 history and prespecified plans
Conditions for verification: Show source material and scope for the following evidence need, including the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope: UMIN000032833 history and prespecified plans.
Requirement and applicability: Required
Application exceptions: Distinguish the secondary Orientation P value from unverified group-specific values, effects, CIs, comparison models, prespecified or exploratory hierarchy and multiplicity; also distinguish the null primary total score, other tests, daily function, baseline cognition, population, intervention, control, duration, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.
Why this condition is needed: This condition links the evidence need with the selected question, actual population, intervention and control, total score and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms: UMIN000032833 history and prespecified plans.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

N22 · Were protocol, SAP, subscale and multiplicity plans acquired?

Required materials and conditions: Separate evidence for prespecified plans, analyses and changes
Conditions for verification: Show source material and scope for the following evidence need, including the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope: Separate evidence for prespecified plans, analyses and changes.
Requirement and applicability: Required
Application exceptions: Distinguish the secondary Orientation P value from unverified group-specific values, effects, CIs, comparison models, prespecified or exploratory hierarchy and multiplicity; also distinguish the null primary total score, other tests, daily function, baseline cognition, population, intervention, control, duration, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.
Why this condition is needed: This condition links the evidence need with the selected question, actual population, intervention and control, total score and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms: Separate evidence for prespecified plans, analyses and changes.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

N23 · Are company funding, product support, employee authors and research roles separated?

Required materials and conditions: Four categories of Morinaga involvement and other support
Conditions for verification: Show source material and scope for the following evidence need, including the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope: Four categories of Morinaga involvement and other support.
Requirement and applicability: Required
Application exceptions: Distinguish the secondary Orientation P value from unverified group-specific values, effects, CIs, comparison models, prespecified or exploratory hierarchy and multiplicity; also distinguish the null primary total score, other tests, daily function, baseline cognition, population, intervention, control, duration, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.
Why this condition is needed: This condition links the evidence need with the selected question, actual population, intervention and control, total score and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms: Four categories of Morinaga involvement and other support.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

N24 · Are null, positive secondary and unverified findings distinguished?

Required materials and conditions: Total-score and subscale findings and material-access states
Conditions for verification: Show source material and scope for the following evidence need, including the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope: Total-score and subscale findings and material-access states.
Requirement and applicability: Required
Application exceptions: Distinguish the secondary Orientation P value from unverified group-specific values, effects, CIs, comparison models, prespecified or exploratory hierarchy and multiplicity; also distinguish the null primary total score, other tests, daily function, baseline cognition, population, intervention, control, duration, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.
Why this condition is needed: This condition links the evidence need with the selected question, actual population, intervention and control, total score and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms: Total-score and subscale findings and material-access states.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

N25 · Were the paper and registration counted as separate clinical trials?

Required materials and conditions: Report and registration linkage versus actual trials and participants
Conditions for verification: Show source material and scope for the following evidence need, including the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope: Report and registration linkage versus actual trials and participants.
Requirement and applicability: Required
Application exceptions: Distinguish the secondary Orientation P value from unverified group-specific values, effects, CIs, comparison models, prespecified or exploratory hierarchy and multiplicity; also distinguish the null primary total score, other tests, daily function, baseline cognition, population, intervention, control, duration, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.
Why this condition is needed: This condition links the evidence need with the selected question, actual population, intervention and control, total score and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms: Report and registration linkage versus actual trials and participants.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

N26 · Is there separate independent confirmation?

Required materials and conditions: Distinguish a single manufacturer trial from independent replication
Conditions for verification: Show source material and scope for the following evidence need, including the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope: Distinguish a single manufacturer trial from independent replication.
Requirement and applicability: Supplementary
Application exceptions: Distinguish the secondary Orientation P value from unverified group-specific values, effects, CIs, comparison models, prespecified or exploratory hierarchy and multiplicity; also distinguish the null primary total score, other tests, daily function, baseline cognition, population, intervention, control, duration, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.
Why this condition is needed: This condition links the evidence need with the selected question, actual population, intervention and control, total score and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms: Distinguish a single manufacturer trial from independent replication.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

N27 · Are subclaim grades distinguished from original parent scores and axes?

Required materials and conditions: Subclaim grade, note and absences versus parent D30
Conditions for verification: Show source material and scope for the following evidence need, including the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope: Subclaim grade, note and absences versus parent D30.
Requirement and applicability: Required
Application exceptions: Distinguish the secondary Orientation P value from unverified group-specific values, effects, CIs, comparison models, prespecified or exploratory hierarchy and multiplicity; also distinguish the null primary total score, other tests, daily function, baseline cognition, population, intervention, control, duration, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.
Why this condition is needed: This condition links the evidence need with the selected question, actual population, intervention and control, total score and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms: Subclaim grade, note and absences versus parent D30.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

N28 · Are both languages and absent structured fields preserved?

Required materials and conditions: Korean and English originals and absent separate classification fields
Conditions for verification: Show source material and scope for the following evidence need, including the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope: Korean and English originals and absent separate classification fields.
Requirement and applicability: Required
Application exceptions: Distinguish the secondary Orientation P value from unverified group-specific values, effects, CIs, comparison models, prespecified or exploratory hierarchy and multiplicity; also distinguish the null primary total score, other tests, daily function, baseline cognition, population, intervention, control, duration, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.
Why this condition is needed: This condition links the evidence need with the selected question, actual population, intervention and control, total score and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms: Korean and English originals and absent separate classification fields.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

N29 · Are the reference date, corrections and historical cross-checking separated from production?

Required materials and conditions: Original 2026-08-26 reference date and empty corrections
Conditions for verification: Show source material and scope for the following evidence need, including the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope: Original 2026-08-26 reference date and empty corrections.
Requirement and applicability: Required
Application exceptions: Distinguish the secondary Orientation P value from unverified group-specific values, effects, CIs, comparison models, prespecified or exploratory hierarchy and multiplicity; also distinguish the null primary total score, other tests, daily function, baseline cognition, population, intervention, control, duration, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.
Why this condition is needed: This condition links the evidence need with the selected question, actual population, intervention and control, total score and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms: Original 2026-08-26 reference date and empty corrections.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

N30 · Which direct material would fill the selected gaps?

Required materials and conditions: Prespecified questions, direct effects, CIs, plans and follow-up
Conditions for verification: Show source material and scope for the following evidence need, including the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope: Prespecified questions, direct effects, CIs, plans and follow-up.
Requirement and applicability: Supplementary
Application exceptions: Distinguish the secondary Orientation P value from unverified group-specific values, effects, CIs, comparison models, prespecified or exploratory hierarchy and multiplicity; also distinguish the null primary total score, other tests, daily function, baseline cognition, population, intervention, control, duration, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.
Why this condition is needed: This condition links the evidence need with the selected question, actual population, intervention and control, total score and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms: Prespecified questions, direct effects, CIs, plans and follow-up.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

N31 · Are production, existing content review and practical instructions separated?

Required materials and conditions: Production request, historical candidate record and responsibility for existing content review
Conditions for verification: Show source material and scope for the following evidence need, including the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope: Production request, historical candidate record and responsibility for existing content review.
Requirement and applicability: Supplementary
Application exceptions: Distinguish the secondary Orientation P value from unverified group-specific values, effects, CIs, comparison models, prespecified or exploratory hierarchy and multiplicity; also distinguish the null primary total score, other tests, daily function, baseline cognition, population, intervention, control, duration, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.
Why this condition is needed: This condition links the evidence need with the selected question, actual population, intervention and control, total score and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms: Production request, historical candidate record and responsibility for existing content review.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

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

2026-10-15 · Public page/material version 1.0

A public view and materials were prepared from the existing31 items. No new clinical search, verification-status change or scoring was 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 · Which existing Orientation claim is being presented?

Current findings: The selected claim is improved Orientation subscale, with original subclaim grade C and a note that P=0.022 does not overturn failure of the primary total score. Subclaim score, status and axes are absent and are retained separately from parent D30 values.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstract, full text, registration, protocol and SAP unread
Why unverified: An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.
Reason for missing information: Orientation's exact effect of interest, visit, hierarchy and review of the claim boundary. Parent scores or axes and total-score grade D are not used to overwrite subclaim values.
Required materials and conditions: Separate the selected subscale wording and subclaim grade from parent values
Materials to obtain first: Orientation's exact effect of interest, visit, hierarchy and review of the claim boundary. Parent scores or axes and total-score grade D are not used to overwrite subclaim values.
Further research: Material needed: Orientation's exact effect of interest, visit, hierarchy and review of the claim boundary. Parent scores or axes and total-score grade D are not used to overwrite subclaim values. Only the need for material or research is recorded; no new retrieval or research is performed.
Remaining uncertainty: External original material has not been read and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.
Conditions for verification: Present original data on separate the selected subscale wording and subclaim grade from parent values, together with the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope.
Why this condition is needed: This is needed to connect separate the selected subscale wording and subclaim grade from parent values with the selected question, actual population, intervention and control, total scores and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms.
Application exceptions: Distinguish the secondary Orientation P value from unverified group-specific values, effects, CIs, comparison models, prespecified or exploratory hierarchy and multiplicity; also distinguish the null primary total score, other tests, daily function, baseline cognition, population, intervention, control, duration, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

Related sources R01

N02 · Which population's subscale results are these?

Current findings: The original trial involved 268 community-dwelling Japanese adults aged 40 or older without dementia. The subscale signal is not extended to people with dementia, all cognitive problems, or other ages or regions.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstract, full text, registration, protocol and SAP unread
Why unverified: An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.
Reason for missing information: Original eligibility and exclusion criteria, baseline cognition and clinical status, comorbidities and medication, and direct outcomes in other populations.
Required materials and conditions: Community-dwelling Japanese adults aged 40 or older without dementia
Materials to obtain first: Original eligibility and exclusion criteria, baseline cognition and clinical status, comorbidities and medication, and direct outcomes in other populations.
Further research: Material needed: Original eligibility and exclusion criteria, baseline cognition and clinical status, comorbidities and medication, and direct outcomes in other populations. Only the need for material or research is recorded; no new retrieval or research is performed.
Remaining uncertainty: External original material has not been read and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.
Conditions for verification: Present original data on community-dwelling Japanese adults aged 40 or older without dementia, together with the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope.
Why this condition is needed: This is needed to connect community-dwelling Japanese adults aged 40 or older without dementia with the selected question, actual population, intervention and control, total scores and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms.
Application exceptions: Distinguish the secondary Orientation P value from unverified group-specific values, effects, CIs, comparison models, prespecified or exploratory hierarchy and multiplicity; also distinguish the null primary total score, other tests, daily function, baseline cognition, population, intervention, control, duration, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

Related sources R01

N03 · Are baseline total scores also baseline Orientation scores?

Current findings: Baseline total scores were MKP 4.08±2.17 and placebo 4.10±2.10. Group-specific baseline and final Orientation values and distributions are not established in the summary. Total-score values are not used to create subscale values or floor or ceiling effects.
Verification status: Unverified
Materials actually read: Stored summary read; external abstract, full text, registration, protocol and SAP unread
Why unverified: An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.
Reason for missing information: Original Orientation tables, score range and direction, baseline and final distributions, and analyses by clinical status. No new conversion between total and subscale scores or diagnosis.
Required materials and conditions: Baseline distributions of total scores and subscale scores
Materials to obtain first: Original Orientation tables, score range and direction, baseline and final distributions, and analyses by clinical status. No new conversion between total and subscale scores or diagnosis.
Further research: Material needed: Original Orientation tables, score range and direction, baseline and final distributions, and analyses by clinical status. No new conversion between total and subscale scores or diagnosis. Only the need for material or research is recorded; no new retrieval or research is performed.
Remaining uncertainty: External original material has not been read and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.
Conditions for verification: Present original data on baseline distributions of total scores and subscale scores, together with the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope.
Why this condition is needed: This is needed to connect baseline distributions of total scores and subscale scores with the selected question, actual population, intervention and control, total scores and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms.
Application exceptions: Distinguish the secondary Orientation P value from unverified group-specific values, effects, CIs, comparison models, prespecified or exploratory hierarchy and multiplicity; also distinguish the null primary total score, other tests, daily function, baseline cognition, population, intervention, control, duration, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

Related sources R01

N04 · Is study MKP distinguished from ordinary milk?

Current findings: The original intervention was casein-derived Met-Lys-Pro (MKP), 200 μg/day, and the manufacturer supplied casein-hydrolysate tablets containing MKP. This is not converted into amounts of ordinary milk or other products, or their subscale effects.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstract, full text, registration, protocol and SAP unread
Why unverified: An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.
Reason for missing information: Original tablet composition, MKP quantification, other ingredients, manufacture and adherence, and product identity. Study exposure is identified without consumption or product advice.
Required materials and conditions: Study tablets containing casein-derived MKP
Materials to obtain first: Original tablet composition, MKP quantification, other ingredients, manufacture and adherence, and product identity. Study exposure is identified without consumption or product advice.
Further research: Material needed: Original tablet composition, MKP quantification, other ingredients, manufacture and adherence, and product identity. Study exposure is identified without consumption or product advice. Only the need for material or research is recorded; no new retrieval or research is performed.
Remaining uncertainty: External original material has not been read and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.
Conditions for verification: Present original data on study tablets containing casein-derived MKP, together with the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope.
Why this condition is needed: This is needed to connect study tablets containing casein-derived MKP with the selected question, actual population, intervention and control, total scores and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms.
Application exceptions: Distinguish the secondary Orientation P value from unverified group-specific values, effects, CIs, comparison models, prespecified or exploratory hierarchy and multiplicity; also distinguish the null primary total score, other tests, daily function, baseline cognition, population, intervention, control, duration, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

Related sources R01

N05 · What were the actual control and concurrent exposures?

Current findings: The original record states allocation to MKP or dextrin placebo tablets, 134/134. Actual placebo conditions, contact, diet and medication in both groups, expectations and adherence are not verified in detail.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstract, full text, registration, protocol and SAP unread
Why unverified: An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.
Reason for missing information: Placebo and active composition, blinding, concurrent exposures, contact and adherence. Original data specifying the subscale effect of interest for additional benefit versus placebo.
Required materials and conditions: Dextrin placebo and conditions in both groups
Materials to obtain first: Placebo and active composition, blinding, concurrent exposures, contact and adherence. Original data specifying the subscale effect of interest for additional benefit versus placebo.
Further research: Material needed: Placebo and active composition, blinding, concurrent exposures, contact and adherence. Original data specifying the subscale effect of interest for additional benefit versus placebo. Only the need for material or research is recorded; no new retrieval or research is performed.
Remaining uncertainty: External original material has not been read and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.
Conditions for verification: Present original data on dextrin placebo and conditions in both groups, together with the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope.
Why this condition is needed: This is needed to connect dextrin placebo and conditions in both groups with the selected question, actual population, intervention and control, total scores and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms.
Application exceptions: Distinguish the secondary Orientation P value from unverified group-specific values, effects, CIs, comparison models, prespecified or exploratory hierarchy and multiplicity; also distinguish the null primary total score, other tests, daily function, baseline cognition, population, intervention, control, duration, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

Related sources R01

N06 · Is 24-week exposure distinguished from sustained improvement?

Current findings: The study used 200 μg/day for 24 weeks, with Orientation as a secondary finding from that trial. Actual exposure, adherence and discontinuation, visit-specific analyses and persistence after the study are not verified in detail. Sustained subscale efficacy is not newly established.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstract, full text, registration, protocol and SAP unread
Why unverified: An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.
Reason for missing information: Visit-specific subscale analyses, actual exposure, visits and discontinuation, and follow-up after the study. No cumulative dose, number of days, consumption advice or care instructions.
Required materials and conditions: Original duration, actual exposure and post-study follow-up
Materials to obtain first: Visit-specific subscale analyses, actual exposure, visits and discontinuation, and follow-up after the study. No cumulative dose, number of days, consumption advice or care instructions.
Further research: Material needed: Visit-specific subscale analyses, actual exposure, visits and discontinuation, and follow-up after the study. No cumulative dose, number of days, consumption advice or care instructions. Only the need for material or research is recorded; no new retrieval or research is performed.
Remaining uncertainty: External original material has not been read and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.
Conditions for verification: Present original data on original duration, actual exposure and follow-up after the study, together with the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope.
Why this condition is needed: This is needed to connect original duration, actual exposure and follow-up after the study with the selected question, actual population, intervention and control, total scores and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms.
Application exceptions: Distinguish the secondary Orientation P value from unverified group-specific values, effects, CIs, comparison models, prespecified or exploratory hierarchy and multiplicity; also distinguish the null primary total score, other tests, daily function, baseline cognition, population, intervention, control, duration, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

Related sources R01

N07 · Are ITT denominators separated from observed subscale denominators?

Current findings: The existing evidence list records 268 randomized participants and ITT analysis (134/134). Actual observed and analyzed Orientation denominators, completion, withdrawal and missingness are not verified in detail. ITT is not recast as observation or completion by everyone for the subscale.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstract, full text, registration, protocol and SAP unread
Why unverified: An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.
Reason for missing information: Group-specific flow, observed and analyzed denominators by Orientation outcome and visit, reasons for withdrawal and missingness, and handling methods. No new denominator, withdrawal count or rate is calculated.
Required materials and conditions: ITT for 268 participants and Orientation-specific missingness and completion
Materials to obtain first: Group-specific flow, observed and analyzed denominators by Orientation outcome and visit, reasons for withdrawal and missingness, and handling methods. No new denominator, withdrawal count or rate is calculated.
Further research: Material needed: Group-specific flow, observed and analyzed denominators by Orientation outcome and visit, reasons for withdrawal and missingness, and handling methods. No new denominator, withdrawal count or rate is calculated. Only the need for material or research is recorded; no new retrieval or research is performed.
Remaining uncertainty: External original material has not been read and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.
Conditions for verification: Present original data on ITT for 268 participants and Orientation-specific missingness and completion, together with the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope.
Why this condition is needed: This is needed to connect ITT for 268 participants and Orientation-specific missingness and completion with the selected question, actual population, intervention and control, total scores and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms.
Application exceptions: Distinguish the secondary Orientation P value from unverified group-specific values, effects, CIs, comparison models, prespecified or exploratory hierarchy and multiplicity; also distinguish the null primary total score, other tests, daily function, baseline cognition, population, intervention, control, duration, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

Related sources R01

N08 · What exactly did Orientation measure?

Current findings: The original material provides the subscale name Orientation and P=0.022. Items, score range and direction, test version, assessors, visits and details of its relationship to the total score are not established in the summary.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstract, full text, registration, protocol and SAP unread
Why unverified: An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.
Reason for missing information: Original Orientation test definitions, items and calculations, assessment methods, version, prespecified plans and tables. The name alone is not substituted for measurement of global cognition or daily function.
Required materials and conditions: Subscale definition, scores and interpretation
Materials to obtain first: Original Orientation test definitions, items and calculations, assessment methods, version, prespecified plans and tables. The name alone is not substituted for measurement of global cognition or daily function.
Further research: Material needed: Original Orientation test definitions, items and calculations, assessment methods, version, prespecified plans and tables. The name alone is not substituted for measurement of global cognition or daily function. Only the need for material or research is recorded; no new retrieval or research is performed.
Remaining uncertainty: External original material has not been read and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.
Conditions for verification: Present original data on subscale definition, scores and interpretation, together with the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope.
Why this condition is needed: This is needed to connect subscale definition, scores and interpretation with the selected question, actual population, intervention and control, total scores and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms.
Application exceptions: Distinguish the secondary Orientation P value from unverified group-specific values, effects, CIs, comparison models, prespecified or exploratory hierarchy and multiplicity; also distinguish the null primary total score, other tests, daily function, baseline cognition, population, intervention, control, duration, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

Related sources R01

N09 · Were subscale effect sizes and CIs provided?

Current findings: The original subscale P=0.022 is retained. Group-specific values, exact between-group differences, effect sizes, CIs and variance are not provided in the current stored summary. Total-score d=0.12, P=.302 or before-and-after values are not copied into the subscale.
Verification status: Unverified
Materials actually read: Stored summary read; external abstract, full text, registration, protocol and SAP unread
Why unverified: An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.
Reason for missing information: Original group-specific baseline and final Orientation values, effect of interest, effects and CIs, denominators, models and clinical importance. No new effect or CI is calculated from P alone.
Required materials and conditions: Orientation P value and unverified quantitative effects
Materials to obtain first: Original group-specific baseline and final Orientation values, effect of interest, effects and CIs, denominators, models and clinical importance. No new effect or CI is calculated from P alone.
Further research: Material needed: Original group-specific baseline and final Orientation values, effect of interest, effects and CIs, denominators, models and clinical importance. No new effect or CI is calculated from P alone. Only the need for material or research is recorded; no new retrieval or research is performed.
Remaining uncertainty: External original material has not been read and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.
Conditions for verification: Present original data on Orientation P value and unverified quantitative effects, together with the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope.
Why this condition is needed: This is needed to connect Orientation P value and unverified quantitative effects with the selected question, actual population, intervention and control, total scores and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms.
Application exceptions: Distinguish the secondary Orientation P value from unverified group-specific values, effects, CIs, comparison models, prespecified or exploratory hierarchy and multiplicity; also distinguish the null primary total score, other tests, daily function, baseline cognition, population, intervention, control, duration, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

Related sources R01

N10 · Which comparison or model produced the subscale P value?

Current findings: Detailed comparisons, models, adjustment and visits underlying Orientation P=0.022 are not specified in the summary. It is not automatically declared to use the same model as the baseline-adjusted total score, and within-group improvement is not transferred into additional between-group benefit.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstract, full text, registration, protocol and SAP unread
Why unverified: An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.
Reason for missing information: Exact subscale comparison, analysis population, baseline adjustment or repeated measures, effect of interest and original tables. No new between-group or within-group difference is calculated.
Required materials and conditions: Orientation effect of interest, within-group and between-group comparisons, and adjustment
Materials to obtain first: Exact subscale comparison, analysis population, baseline adjustment or repeated measures, effect of interest and original tables. No new between-group or within-group difference is calculated.
Further research: Material needed: Exact subscale comparison, analysis population, baseline adjustment or repeated measures, effect of interest and original tables. No new between-group or within-group difference is calculated. Only the need for material or research is recorded; no new retrieval or research is performed.
Remaining uncertainty: External original material has not been read and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.
Conditions for verification: Present original data on Orientation effect of interest, within-group and between-group comparisons, and adjustment, together with the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope.
Why this condition is needed: This is needed to connect Orientation effect of interest, within-group and between-group comparisons, and adjustment with the selected question, actual population, intervention and control, total scores and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms.
Application exceptions: Distinguish the secondary Orientation P value from unverified group-specific values, effects, CIs, comparison models, prespecified or exploratory hierarchy and multiplicity; also distinguish the null primary total score, other tests, daily function, baseline cognition, population, intervention, control, duration, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

Related sources R01

N11 · Is the null primary total score retained separately?

Current findings: The original record that the baseline-adjusted total-score result was null, P=.302 and d=.12, with no 95% CI reported, is retained. The original statement that Orientation P=.022 neither means total-score success nor overturns its failure is preserved.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstract, full text, registration, protocol and SAP unread
Why unverified: An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.
Reason for missing information: Original total-score and subscale outcomes, exact visits, denominators, prespecified hierarchy and plans. Subscale and total-score values and conclusions are not transferred to each other.
Required materials and conditions: Different findings for the global cognition total score and Orientation
Materials to obtain first: Original total-score and subscale outcomes, exact visits, denominators, prespecified hierarchy and plans. Subscale and total-score values and conclusions are not transferred to each other.
Further research: Material needed: Original total-score and subscale outcomes, exact visits, denominators, prespecified hierarchy and plans. Subscale and total-score values and conclusions are not transferred to each other. Only the need for material or research is recorded; no new retrieval or research is performed.
Remaining uncertainty: External original material has not been read and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.
Conditions for verification: Present original data on different findings for the global cognition total score and Orientation, together with the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope.
Why this condition is needed: This is needed to connect different findings for the global cognition total score and Orientation with the selected question, actual population, intervention and control, total scores and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms.
Application exceptions: Distinguish the secondary Orientation P value from unverified group-specific values, effects, CIs, comparison models, prespecified or exploratory hierarchy and multiplicity; also distinguish the null primary total score, other tests, daily function, baseline cognition, population, intervention, control, duration, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

Related sources R01

N12 · Are secondary and exploratory findings distinguished from prespecified plans?

Current findings: The original Korean and English texts disclose Orientation as a secondary finding. The registration citation lists ADAS-Jcog as the prespecified primary endpoint. Orientation's prespecification, exact secondary or exploratory hierarchy, and amendment history have not been established through new reading of the registration or protocol.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstract, full text, registration, protocol and SAP unread
Why unverified: An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.
Reason for missing information: Subscale lists and hierarchy, prespecification, amendments and disclosure dates in the complete registration, protocol and SAP. The subscale is not newly designated as a prespecified confirmatory endpoint.
Required materials and conditions: Relationship between the secondary subscale and registered primary endpoint
Materials to obtain first: Subscale lists and hierarchy, prespecification, amendments and disclosure dates in the complete registration, protocol and SAP. The subscale is not newly designated as a prespecified confirmatory endpoint.
Further research: Material needed: Subscale lists and hierarchy, prespecification, amendments and disclosure dates in the complete registration, protocol and SAP. The subscale is not newly designated as a prespecified confirmatory endpoint. Only the need for material or research is recorded; no new retrieval or research is performed.
Remaining uncertainty: External original material has not been read and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.
Conditions for verification: Present original data on relationship between the secondary subscale and registered primary endpoint, together with the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope.
Why this condition is needed: This is needed to connect relationship between the secondary subscale and registered primary endpoint with the selected question, actual population, intervention and control, total scores and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms.
Application exceptions: Distinguish the secondary Orientation P value from unverified group-specific values, effects, CIs, comparison models, prespecified or exploratory hierarchy and multiplicity; also distinguish the null primary total score, other tests, daily function, baseline cognition, population, intervention, control, duration, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

Related sources R01 R02

N13 · Are multiplicity plans and adjustments verified?

Current findings: The original material explains that one positive subscale is not promoted into a total-score effect. The total number of tests, multiplicity adjustment, allocation of significance levels and selective reporting are not verified in detail. Significance or nonsignificance after adjustment is not newly adjudicated.
Verification status: Unverified
Materials actually read: Stored summary read; external abstract, full text, registration, protocol and SAP unread
Why unverified: An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.
Reason for missing information: Complete outcome and endpoint lists, prespecified testing and multiplicity, adjustment methods, selective reporting, and original comparisons of the paper with plans. No new adjusted P value or hypothetical example.
Required materials and conditions: Testing specifications for multiple subscales and tests
Materials to obtain first: Complete outcome and endpoint lists, prespecified testing and multiplicity, adjustment methods, selective reporting, and original comparisons of the paper with plans. No new adjusted P value or hypothetical example.
Further research: Material needed: Complete outcome and endpoint lists, prespecified testing and multiplicity, adjustment methods, selective reporting, and original comparisons of the paper with plans. No new adjusted P value or hypothetical example. Only the need for material or research is recorded; no new retrieval or research is performed.
Remaining uncertainty: External original material has not been read and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.
Conditions for verification: Present original data on testing specifications for multiple subscales and tests, together with the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope.
Why this condition is needed: This is needed to connect testing specifications for multiple subscales and tests with the selected question, actual population, intervention and control, total scores and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms.
Application exceptions: Distinguish the secondary Orientation P value from unverified group-specific values, effects, CIs, comparison models, prespecified or exploratory hierarchy and multiplicity; also distinguish the null primary total score, other tests, daily function, baseline cognition, population, intervention, control, duration, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

Related sources R01

N14 · Are total-score and Orientation numbers distinguished?

Current findings: Total scores of 4.08±2.17 to 3.18±1.88 versus 4.10±2.10 to 3.43±2.10, with d=.12, and Orientation P=.022 are different findings. Within-group total-score decreases, d and the absence of reported CIs are not copied into Orientation values, variance or effects.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstract, full text, registration, protocol and SAP unread
Why unverified: An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.
Reason for missing information: Original tables, scores, variance, effects and CIs, visits, denominators and models for each endpoint. Different subscales are not averaged or added together.
Required materials and conditions: Before-and-after total scores and d versus the subscale P value
Materials to obtain first: Original tables, scores, variance, effects and CIs, visits, denominators and models for each endpoint. Different subscales are not averaged or added together.
Further research: Material needed: Original tables, scores, variance, effects and CIs, visits, denominators and models for each endpoint. Different subscales are not averaged or added together. Only the need for material or research is recorded; no new retrieval or research is performed.
Remaining uncertainty: External original material has not been read and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.
Conditions for verification: Present original data on before-and-after total scores and d versus the subscale P value, together with the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope.
Why this condition is needed: This is needed to connect before-and-after total scores and d versus the subscale P value with the selected question, actual population, intervention and control, total scores and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms.
Application exceptions: Distinguish the secondary Orientation P value from unverified group-specific values, effects, CIs, comparison models, prespecified or exploratory hierarchy and multiplicity; also distinguish the null primary total score, other tests, daily function, baseline cognition, population, intervention, control, duration, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

Related sources R01

N15 · Have other subscale and test findings been newly filled in?

Current findings: The current stored material distinguishes the total score and Orientation. Other subscale or test names, the number of tests, group-specific results and comparisons are not verified in detail. Unread material is not treated as proof that all other findings were null or absent.
Verification status: Unverified
Materials actually read: Stored summary read; external abstract, full text, registration, protocol and SAP unread
Why unverified: An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.
Reason for missing information: Complete outcome tables, test lists, primary and secondary plans, denominators and visits, and effects and CIs. No new subscale or test results are invented.
Required materials and conditions: Scope of all tests and subscales
Materials to obtain first: Complete outcome tables, test lists, primary and secondary plans, denominators and visits, and effects and CIs. No new subscale or test results are invented.
Further research: Material needed: Complete outcome tables, test lists, primary and secondary plans, denominators and visits, and effects and CIs. No new subscale or test results are invented. Only the need for material or research is recorded; no new retrieval or research is performed.
Remaining uncertainty: External original material has not been read and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.
Conditions for verification: Present original data on scope of all tests and subscales, together with the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope.
Why this condition is needed: This is needed to connect scope of all tests and subscales with the selected question, actual population, intervention and control, total scores and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms.
Application exceptions: Distinguish the secondary Orientation P value from unverified group-specific values, effects, CIs, comparison models, prespecified or exploratory hierarchy and multiplicity; also distinguish the null primary total score, other tests, daily function, baseline cognition, population, intervention, control, duration, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

Related sources R01

N16 · Is the repeat-testing interpretation automatically applied to the subscale?

Current findings: The original material interprets total-score improvement in both groups as a repeat-testing effect. Orientation values in both groups, practice effects, expectations and comparison-model details are unverified. The total-score interpretation is not newly established as a causal mechanism for the subscale.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstract, full text, registration, protocol and SAP unread
Why unverified: An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.
Reason for missing information: Endpoint-specific baseline and final values, practice effects and expectations, assessments, effects of interest and models, and original tables. Within-group improvement is not newly calculated as an ingredient-specific effect.
Required materials and conditions: Original total-score interpretation and the Orientation comparison
Materials to obtain first: Endpoint-specific baseline and final values, practice effects and expectations, assessments, effects of interest and models, and original tables. Within-group improvement is not newly calculated as an ingredient-specific effect.
Further research: Material needed: Endpoint-specific baseline and final values, practice effects and expectations, assessments, effects of interest and models, and original tables. Within-group improvement is not newly calculated as an ingredient-specific effect. Only the need for material or research is recorded; no new retrieval or research is performed.
Remaining uncertainty: External original material has not been read and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.
Conditions for verification: Present original data on original total-score interpretation and the Orientation comparison, together with the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope.
Why this condition is needed: This is needed to connect original total-score interpretation and the Orientation comparison with the selected question, actual population, intervention and control, total scores and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms.
Application exceptions: Distinguish the secondary Orientation P value from unverified group-specific values, effects, CIs, comparison models, prespecified or exploratory hierarchy and multiplicity; also distinguish the null primary total score, other tests, daily function, baseline cognition, population, intervention, control, duration, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

Related sources R01

N17 · Is the subscale extended to global cognition, dementia prevention or clinical function?

Current findings: The original material explains that a positive Orientation finding is not evidence of improved global cognition. Separate direct data on dementia prevention, daily function and clinical outcomes are not provided within the preserved scope. These are not established from the subscale signal.
Verification status: Unverified
Materials actually read: Stored summary read; external abstract, full text, registration, protocol and SAP unread
Why unverified: An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.
Reason for missing information: Actual definitions, measurements and follow-up, group-specific denominators, effects and CIs for clinical function or dementia events, and direct confirmatory data relevant to the question. Unread material is not treated as proof that outcomes were not measured.
Required materials and conditions: Directness of the selected subscale for clinical outcomes
Materials to obtain first: Actual definitions, measurements and follow-up, group-specific denominators, effects and CIs for clinical function or dementia events, and direct confirmatory data relevant to the question. Unread material is not treated as proof that outcomes were not measured.
Further research: Material needed: Actual definitions, measurements and follow-up, group-specific denominators, effects and CIs for clinical function or dementia events, and direct confirmatory data relevant to the question. Unread material is not treated as proof that outcomes were not measured. Only the need for material or research is recorded; no new retrieval or research is performed.
Remaining uncertainty: External original material has not been read and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.
Conditions for verification: Present original data on directness of the selected subscale for clinical outcomes, together with the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope.
Why this condition is needed: This is needed to connect directness of the selected subscale for clinical outcomes with the selected question, actual population, intervention and control, total scores and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms.
Application exceptions: Distinguish the secondary Orientation P value from unverified group-specific values, effects, CIs, comparison models, prespecified or exploratory hierarchy and multiplicity; also distinguish the null primary total score, other tests, daily function, baseline cognition, population, intervention, control, duration, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

Related sources R01

N18 · Are the same design and people counted as separate independent replication?

Current findings: The original design statements on computer block allocation, multiple blinding roles and ITT apply to Orientation within the same trial context. Total scores, subscales, visits, groups, references, registration and related sheets are not added as new independent trials or participants.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstract, full text, registration, protocol and SAP unread
Why unverified: An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.
Reason for missing information: Original links among reports, registration, cohorts and analyses, and endpoint-specific denominators. Strong design statements are not converted into certification of subscale prespecification, confirmation or independence.
Required materials and conditions: Total-score and subscale findings from the same randomized trial
Materials to obtain first: Original links among reports, registration, cohorts and analyses, and endpoint-specific denominators. Strong design statements are not converted into certification of subscale prespecification, confirmation or independence.
Further research: Material needed: Original links among reports, registration, cohorts and analyses, and endpoint-specific denominators. Strong design statements are not converted into certification of subscale prespecification, confirmation or independence. Only the need for material or research is recorded; no new retrieval or research is performed.
Remaining uncertainty: External original material has not been read and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.
Conditions for verification: Present original data on total-score and subscale findings from the same randomized trial, together with the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope.
Why this condition is needed: This is needed to connect total-score and subscale findings from the same randomized trial with the selected question, actual population, intervention and control, total scores and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms.
Application exceptions: Distinguish the secondary Orientation P value from unverified group-specific values, effects, CIs, comparison models, prespecified or exploratory hierarchy and multiplicity; also distinguish the null primary total score, other tests, daily function, baseline cognition, population, intervention, control, duration, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

Related sources R01 R02

N19 · Is safety separate from subscale efficacy?

Current findings: The original material retains the scope that no serious adverse events attributed to MKP consumption were reported over 24 weeks, together with the milk-protein allergy caution. This is not evidence of Orientation efficacy and is not extended to zero harms of every kind or long-term safety.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstract, full text, registration, protocol and SAP unread
Why unverified: An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.
Reason for missing information: Group-specific AE and SAE collection, attribution and discontinuation, exposure and denominators, and allergy and long-term data. No consumption or product advice, or cognition or dementia care instructions.
Required materials and conditions: Related serious adverse events over 24 weeks, allergy and long-term harms
Materials to obtain first: Group-specific AE and SAE collection, attribution and discontinuation, exposure and denominators, and allergy and long-term data. No consumption or product advice, or cognition or dementia care instructions.
Further research: Material needed: Group-specific AE and SAE collection, attribution and discontinuation, exposure and denominators, and allergy and long-term data. No consumption or product advice, or cognition or dementia care instructions. Only the need for material or research is recorded; no new retrieval or research is performed.
Remaining uncertainty: External original material has not been read and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.
Conditions for verification: Present original data on related serious adverse events over 24 weeks, allergy and long-term harms, together with the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope.
Why this condition is needed: This is needed to connect related serious adverse events over 24 weeks, allergy and long-term harms with the selected question, actual population, intervention and control, total scores and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms.
Application exceptions: Distinguish the secondary Orientation P value from unverified group-specific values, effects, CIs, comparison models, prespecified or exploratory hierarchy and multiplicity; also distinguish the null primary total score, other tests, daily function, baseline cognition, population, intervention, control, duration, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

Related sources R01

N20 · What materials were actually read in this work?

Current findings: The complete parent summary was read for production and preserved in its original form. Summary reading refers to the stored summary; the external abstract, full paper, UMIN registration, protocol and SAP remain unread in this work. The existence of a URL is not promoted into reading.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstract, full text, registration, protocol and SAP unread
Why unverified: An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.
Reason for missing information: Records of actual acquisition and reading scope, versions and dates. No separate external-link click or access test was performed.
Required materials and conditions: Preserved-summary reading and external paper or registration status
Materials to obtain first: Records of actual acquisition and reading scope, versions and dates. No separate external-link click or access test was performed.
Further research: Material needed: Records of actual acquisition and reading scope, versions and dates. No separate external-link click or access test was performed. Only material requests and research needs are recorded; no retrieval or research is performed in this work.
Remaining uncertainty: External original material has not been read and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.
Conditions for verification: Show source material and scope for the following evidence need, including the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope: Preserved-summary reading and external paper or registration status.
Why this condition is needed: This condition links the evidence need with the selected question, actual population, intervention and control, total score and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms: Preserved-summary reading and external paper or registration status.
Application exceptions: Distinguish the secondary Orientation P value from unverified group-specific values, effects, CIs, comparison models, prespecified or exploratory hierarchy and multiplicity; also distinguish the null primary total score, other tests, daily function, baseline cognition, population, intervention, control, duration, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

Related sources R01 R02

N21 · Are historical registration dates and primary-endpoint names distinguished from current reading?

Current findings: The original Korean and English texts describe prospective registration, with disclosure on 2018-06-04 and a planned start on 2018-06-07. The registration citation describes prespecified ADAS-Jcog and manufacturer funding. Only original dates and statements are retained; actual start, versions and plan agreement are not newly verified.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstract, full text, registration, protocol and SAP unread
Why unverified: An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.
Reason for missing information: Original registration text and versions, disclosure, start and change dates, ADAS-Jcog naming and endpoint specifications, and funding compared with the paper. The original official URL is retained without clicking it.
Required materials and conditions: UMIN000032833 history and prespecified plans
Materials to obtain first: Original registration text and versions, disclosure, start and change dates, ADAS-Jcog naming and endpoint specifications, and funding compared with the paper. The original official URL is retained without clicking it.
Further research: Material needed: Original registration text and versions, disclosure, start and change dates, ADAS-Jcog naming and endpoint specifications, and funding compared with the paper. The original official URL is retained without clicking it. Only material requests and research needs are recorded; no retrieval or research is performed in this work.
Remaining uncertainty: External original material has not been read and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.
Conditions for verification: Show source material and scope for the following evidence need, including the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope: UMIN000032833 history and prespecified plans.
Why this condition is needed: This condition links the evidence need with the selected question, actual population, intervention and control, total score and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms: UMIN000032833 history and prespecified plans.
Application exceptions: Distinguish the secondary Orientation P value from unverified group-specific values, effects, CIs, comparison models, prespecified or exploratory hierarchy and multiplicity; also distinguish the null primary total score, other tests, daily function, baseline cognition, population, intervention, control, duration, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

Related sources R01 R02

N22 · Were protocol, SAP, subscale and multiplicity plans acquired?

Current findings: Original registration and historical cross-checking statements are retained. The original protocol and SAP, versions and dates, subscale and multiplicity plans, and clinical thresholds have not been read in this work. A registration statement about the primary endpoint does not establish all secondary plans.
Verification status: Unverified
Materials actually read: Stored summary read; external abstract, full text, registration, protocol and SAP unread
Why unverified: An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.
Reason for missing information: Original protocol, SAP, amendments, all outcomes and analyses, multiplicity, clinical thresholds and public-disclosure timing. Unread external material is not assumed to mean a document is absent.
Required materials and conditions: Separate evidence for prespecified plans, analyses and changes
Materials to obtain first: Original protocol, SAP, amendments, all outcomes and analyses, multiplicity, clinical thresholds and public-disclosure timing. Unread external material is not assumed to mean a document is absent.
Further research: Material needed: Original protocol, SAP, amendments, all outcomes and analyses, multiplicity, clinical thresholds and public-disclosure timing. Unread external material is not assumed to mean a document is absent. Only material requests and research needs are recorded; no retrieval or research is performed in this work.
Remaining uncertainty: External original material has not been read and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.
Conditions for verification: Show source material and scope for the following evidence need, including the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope: Separate evidence for prespecified plans, analyses and changes.
Why this condition is needed: This condition links the evidence need with the selected question, actual population, intervention and control, total score and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms: Separate evidence for prespecified plans, analyses and changes.
Application exceptions: Distinguish the secondary Orientation P value from unverified group-specific values, effects, CIs, comparison models, prespecified or exploratory hierarchy and multiplicity; also distinguish the null primary total score, other tests, daily function, baseline cognition, population, intervention, control, duration, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

Related sources R01 R02

N23 · Are company funding, product support, employee authors and research roles separated?

Current findings: The source records Morinaga Milk study support, manufacture and supply of MKP-containing hydrolysate and placebo tablets, four employee authors N.Y., M.T., K.Y. and F.A., and a supervision fee for N.S. The original limitation that separate public cofunding, medical-writing and publication support were not reported is retained. Design, analysis and data-control details are not newly established.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstract, full text, registration, protocol and SAP unread
Why unverified: An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.
Reason for missing information: Individual original records of company funding and products, author employment and supervision fees, design, analysis, data control, other support and conflicts of interest. Absence of public support and all roles are not certified in this work.
Required materials and conditions: Four categories of Morinaga involvement and other support
Materials to obtain first: Individual original records of company funding and products, author employment and supervision fees, design, analysis, data control, other support and conflicts of interest. Absence of public support and all roles are not certified in this work.
Further research: Material needed: Individual original records of company funding and products, author employment and supervision fees, design, analysis, data control, other support and conflicts of interest. Absence of public support and all roles are not certified in this work. Only material requests and research needs are recorded; no retrieval or research is performed in this work.
Remaining uncertainty: External original material has not been read and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.
Conditions for verification: Show source material and scope for the following evidence need, including the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope: Four categories of Morinaga involvement and other support.
Why this condition is needed: This condition links the evidence need with the selected question, actual population, intervention and control, total score and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms: Four categories of Morinaga involvement and other support.
Application exceptions: Distinguish the secondary Orientation P value from unverified group-specific values, effects, CIs, comparison models, prespecified or exploratory hierarchy and multiplicity; also distinguish the null primary total score, other tests, daily function, baseline cognition, population, intervention, control, duration, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

Related sources R01 R02

N24 · Are null, positive secondary and unverified findings distinguished?

Current findings: The null original total-score result, P=.302 and d=.12, is retained alongside the positive secondary Orientation P=.022, which does not overturn failure of the total score. Unverified details of CIs, plans and denominators differ from unread external material.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstract, full text, registration, protocol and SAP unread
Why unverified: An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.
Reason for missing information: Original endpoint-specific tables, direct measurement and analysis, plans, clinical importance and actual access scope. Null is not replaced with zero effect or equivalence, and unread is not replaced with unreported.
Required materials and conditions: Total-score and subscale findings and material-access states
Materials to obtain first: Original endpoint-specific tables, direct measurement and analysis, plans, clinical importance and actual access scope. Null is not replaced with zero effect or equivalence, and unread is not replaced with unreported.
Further research: Material needed: Original endpoint-specific tables, direct measurement and analysis, plans, clinical importance and actual access scope. Null is not replaced with zero effect or equivalence, and unread is not replaced with unreported. Only material requests and research needs are recorded; no retrieval or research is performed in this work.
Remaining uncertainty: External original material has not been read and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.
Conditions for verification: Show source material and scope for the following evidence need, including the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope: Total-score and subscale findings and material-access states.
Why this condition is needed: This condition links the evidence need with the selected question, actual population, intervention and control, total score and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms: Total-score and subscale findings and material-access states.
Application exceptions: Distinguish the secondary Orientation P value from unverified group-specific values, effects, CIs, comparison models, prespecified or exploratory hierarchy and multiplicity; also distinguish the null primary total score, other tests, daily function, baseline cognition, population, intervention, control, duration, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

Related sources R01

N25 · Were the paper and registration counted as separate clinical trials?

Current findings: Parent verdict 2980 and the total-score and Orientation sheets share the same Yuda2020 paper, UMIN000032833 registration and 268-person, 24-week trial. The same people, groups, visits, total scores, subscales, references, registration and related sheets are not added as new independent trials or participants. Two linked documents comprise one clinical paper and one registration record, not certified counts of unique trials or participants.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstract, full text, registration, protocol and SAP unread
Why unverified: An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.
Reason for missing information: Original references, registration and links to the same cohort, analyses, visits and outcomes. Totals of unique trials and participants remain unrecorded.
Required materials and conditions: Report and registration linkage versus actual trials and participants
Materials to obtain first: Original references, registration and links to the same cohort, analyses, visits and outcomes. Totals of unique trials and participants remain unrecorded.
Further research: Material needed: Original references, registration and links to the same cohort, analyses, visits and outcomes. Totals of unique trials and participants remain unrecorded. Only material requests and research needs are recorded; no retrieval or research is performed in this work.
Remaining uncertainty: External original material has not been read and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.
Conditions for verification: Show source material and scope for the following evidence need, including the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope: Report and registration linkage versus actual trials and participants.
Why this condition is needed: This condition links the evidence need with the selected question, actual population, intervention and control, total score and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms: Report and registration linkage versus actual trials and participants.
Application exceptions: Distinguish the secondary Orientation P value from unverified group-specific values, effects, CIs, comparison models, prespecified or exploratory hierarchy and multiplicity; also distinguish the null primary total score, other tests, daily function, baseline cognition, population, intervention, control, duration, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

Related sources R01 R02

N26 · Is there separate independent confirmation?

Current findings: The original parent replication axis R1 and independence axis I0 are retained. The paper, registration, subscales in the same participants and related sheets are not certified as new independent replications. No separate replication of harm findings is created in this work.
Verification status: Unverified
Materials actually read: Stored summary read; external abstract, full text, registration, protocol and SAP unread
Why unverified: An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.
Reason for missing information: Confirmatory evidence with question-specific prespecified plans, separate populations and controls, direct endpoints and durations, effects and CIs, and funding or author relationships. No new search or independence verdict.
Required materials and conditions: Distinguish a single manufacturer trial from independent replication
Materials to obtain first: Confirmatory evidence with question-specific prespecified plans, separate populations and controls, direct endpoints and durations, effects and CIs, and funding or author relationships. No new search or independence verdict.
Further research: Material needed: Confirmatory evidence with question-specific prespecified plans, separate populations and controls, direct endpoints and durations, effects and CIs, and funding or author relationships. No new search or independence verdict. Only material requests and research needs are recorded; no retrieval or research is performed in this work.
Remaining uncertainty: External original material has not been read and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.
Conditions for verification: Show source material and scope for the following evidence need, including the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope: Distinguish a single manufacturer trial from independent replication.
Why this condition is needed: This condition links the evidence need with the selected question, actual population, intervention and control, total score and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms: Distinguish a single manufacturer trial from independent replication.
Application exceptions: Distinguish the secondary Orientation P value from unverified group-specific values, effects, CIs, comparison models, prespecified or exploratory hierarchy and multiplicity; also distinguish the null primary total score, other tests, daily function, baseline cognition, population, intervention, control, duration, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

Related sources R01

N27 · Are subclaim grades distinguished from original parent scores and axes?

Current findings: The selected record's grade, note and Korean and English question wording are retained; absent subclaim score, status and axes remain unrecorded. Parent D30, Good safety and B/P/R1/I0/E0/B0/C0 are parent context and are not transferred to the subclaim.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstract, full text, registration, protocol and SAP unread
Why unverified: An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.
Reason for missing information: Review of subclaim and parent boundaries and actual correction records. No new score or grade, or official RoB2 or GRADE certification.
Required materials and conditions: Subclaim grade, note and absences versus parent D30
Materials to obtain first: Review of subclaim and parent boundaries and actual correction records. No new score or grade, or official RoB2 or GRADE certification.
Further research: Material needed: Review of subclaim and parent boundaries and actual correction records. No new score or grade, or official RoB2 or GRADE certification. Only material requests and research needs are recorded; no retrieval or research is performed in this work.
Remaining uncertainty: External original material has not been read and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.
Conditions for verification: Show source material and scope for the following evidence need, including the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope: Subclaim grade, note and absences versus parent D30.
Why this condition is needed: This condition links the evidence need with the selected question, actual population, intervention and control, total score and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms: Subclaim grade, note and absences versus parent D30.
Application exceptions: Distinguish the secondary Orientation P value from unverified group-specific values, effects, CIs, comparison models, prespecified or exploratory hierarchy and multiplicity; also distinguish the null primary total score, other tests, daily function, baseline cognition, population, intervention, control, duration, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

Related sources R01

N28 · Are both languages and absent structured fields preserved?

Current findings: The parent Korean and English texts, evidence and citations, axes and original selected subclaim are retained in the full stored summary. Separate Korean and English classification fields are absent; no new fields are inserted into the original summary. No external comparison with the English paper was performed.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstract, full text, registration, protocol and SAP unread
Why unverified: An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.
Reason for missing information: Review material for language-specific terminology, endpoints, visits, original statements and absences. Application-condition descriptions are distinguished from the preserved original record.
Required materials and conditions: Korean and English originals and absent separate classification fields
Materials to obtain first: Review material for language-specific terminology, endpoints, visits, original statements and absences. Application-condition descriptions are distinguished from the preserved original record.
Further research: Material needed: Review material for language-specific terminology, endpoints, visits, original statements and absences. Application-condition descriptions are distinguished from the preserved original record. Only material requests and research needs are recorded; no retrieval or research is performed in this work.
Remaining uncertainty: External original material has not been read and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.
Conditions for verification: Show source material and scope for the following evidence need, including the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope: Korean and English originals and absent separate classification fields.
Why this condition is needed: This condition links the evidence need with the selected question, actual population, intervention and control, total score and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms: Korean and English originals and absent separate classification fields.
Application exceptions: Distinguish the secondary Orientation P value from unverified group-specific values, effects, CIs, comparison models, prespecified or exploratory hierarchy and multiplicity; also distinguish the null primary total score, other tests, daily function, baseline cognition, population, intervention, control, duration, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

Related sources R01

N29 · Are the reference date, corrections and historical cross-checking separated from production?

Current findings: The 2026-08-26 reference date, empty correction array and deliberation string, and historical cross-checking in the verdict-decision record are retained. The original date and history are not condition-freezing, application, production or completed-content-review dates.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstract, full text, registration, protocol and SAP unread
Why unverified: An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.
Reason for missing information: When actual new corrections or material arise, retain the original text and separate events, conditions, observations and verdict decisions for updates. Historical records are not treated as new quality review.
Required materials and conditions: Original 2026-08-26 reference date and empty corrections
Materials to obtain first: When actual new corrections or material arise, retain the original text and separate events, conditions, observations and verdict decisions for updates. Historical records are not treated as new quality review.
Further research: Material needed: When actual new corrections or material arise, retain the original text and separate events, conditions, observations and verdict decisions for updates. Historical records are not treated as new quality review. Only material requests and research needs are recorded; no retrieval or research is performed in this work.
Remaining uncertainty: External original material has not been read and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.
Conditions for verification: Show source material and scope for the following evidence need, including the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope: Original 2026-08-26 reference date and empty corrections.
Why this condition is needed: This condition links the evidence need with the selected question, actual population, intervention and control, total score and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms: Original 2026-08-26 reference date and empty corrections.
Application exceptions: Distinguish the secondary Orientation P value from unverified group-specific values, effects, CIs, comparison models, prespecified or exploratory hierarchy and multiplicity; also distinguish the null primary total score, other tests, daily function, baseline cognition, population, intervention, control, duration, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

Related sources R01

N30 · Which direct material would fill the selected gaps?

Current findings: Gaps in the secondary Orientation signal, quantitative effects, CIs, hierarchy and multiplicity are retained. Confirmation of the subscale requires prespecified direct comparison data for that endpoint; it is not converted into total-score success or dementia prevention.
Verification status: Unverified
Materials actually read: Stored summary read; external abstract, full text, registration, protocol and SAP unread
Why unverified: An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.
Reason for missing information: Question-specific prespecified direct effects and CIs, denominators, missingness, measurement, effects of interest, clinical thresholds, multiplicity, separate confirmation, longer-term clinical outcomes and harms. Only material needs are recorded; no research or retrieval is performed.
Required materials and conditions: Prespecified questions, direct effects, CIs, plans and follow-up
Materials to obtain first: Question-specific prespecified direct effects and CIs, denominators, missingness, measurement, effects of interest, clinical thresholds, multiplicity, separate confirmation, longer-term clinical outcomes and harms. Only material needs are recorded; no research or retrieval is performed.
Further research: Material needed: Question-specific prespecified direct effects and CIs, denominators, missingness, measurement, effects of interest, clinical thresholds, multiplicity, separate confirmation, longer-term clinical outcomes and harms. Only material needs are recorded; no research or retrieval is performed. Only material requests and research needs are recorded; no retrieval or research is performed in this work.
Remaining uncertainty: External original material has not been read and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.
Conditions for verification: Show source material and scope for the following evidence need, including the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope: Prespecified questions, direct effects, CIs, plans and follow-up.
Why this condition is needed: This condition links the evidence need with the selected question, actual population, intervention and control, total score and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms: Prespecified questions, direct effects, CIs, plans and follow-up.
Application exceptions: Distinguish the secondary Orientation P value from unverified group-specific values, effects, CIs, comparison models, prespecified or exploratory hierarchy and multiplicity; also distinguish the null primary total score, other tests, daily function, baseline cognition, population, intervention, control, duration, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

Related sources R01

N31 · Are production, existing content review and practical instructions separated?

Current findings: This is an application-condition record based on the preserved summary. Existing content and question-boundary review are incomplete; historical candidate pending and eligibility labels are retained as history. Existing review status is recorded as it stands.
Verification status: Partly verified
Materials actually read: Stored summary read; external abstract, full text, registration, protocol and SAP unread
Why unverified: An observation from the preserved summary that distinguishes selected and parent claims, paper and registration, and endpoint information. Detailed original data are unverified and review of existing content is incomplete; this is not a passed content review or clinical certification.
Reason for missing information: Existing content review and subsequent actual material and correction records. The original production performed no comparison of clinical source material, external reading, new calculations, grade changes or advice on MKP, milk or products, cognition or dementia care, or treatment replacement.
Required materials and conditions: Production request, historical candidate record and responsibility for existing content review
Materials to obtain first: Existing content review and subsequent actual material and correction records. The original production performed no comparison of clinical source material, external reading, new calculations, grade changes or advice on MKP, milk or products, cognition or dementia care, or treatment replacement.
Further research: Material needed: Existing content review and subsequent actual material and correction records. The original production performed no comparison of clinical source material, external reading, new calculations, grade changes or advice on MKP, milk or products, cognition or dementia care, or treatment replacement. Only material requests and research needs are recorded; no retrieval or research is performed in this work.
Remaining uncertainty: External original material has not been read and review of existing content is incomplete. Original grades, scores, axes and historical verification or independence statements are not promoted into a new verdict or certification.
Conditions for verification: Show source material and scope for the following evidence need, including the selected-subclaim and parent boundary, reports and endpoints, effect of interest, denominators and external reading scope: Production request, historical candidate record and responsibility for existing content review.
Why this condition is needed: This condition links the evidence need with the selected question, actual population, intervention and control, total score and subscales, hierarchy and effect of interest, denominators and follow-up, reports and harms: Production request, historical candidate record and responsibility for existing content review.
Application exceptions: Distinguish the secondary Orientation P value from unverified group-specific values, effects, CIs, comparison models, prespecified or exploratory hierarchy and multiplicity; also distinguish the null primary total score, other tests, daily function, baseline cognition, population, intervention, control, duration, denominators and harms. Only original numbers are retained. No new calculations, effects, CIs, hypothetical quantities, rejudging, grades, independence certification, consumption advice for MKP, milk or products, cognition or dementia care, or treatment-replacement instructions are produced.
Referenced methods: Existing C/E/H distinctions concerning questions, populations, interventions, comparisons, reports and trials, outcomes and denominators, and harms are referenced for production.

Related sources R01