DDMP lactic-acid-bacteria beverage × Original null finding for stratum-corneum moisture at 12 weeks

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 · 12-week stratum-corneum moisture and evidence gapsHow is the selected 12-week question distinguished from intermediate-time sibling findings?Required	The selected original question is increased stratum-corneum moisture at 12 weeks. Its subclaim record is linked, while changes at weeks 4 and 8 remain original context. No new question, split or trial is created. R01	Some original summary information was linked for production; clinical verification/review is incomplete. Clinical independence was not newly certified.	12-week question/verdict connection and parent/intermediate scope	A plan distinguishing final 12-week and intermediate estimands
2	Partly verified	Full text not readStored summary read	N02 · 12-week stratum-corneum moisture and evidence gapsWhat are the subclaim D grade/note and absent values?Required	The selected D grade and note, 29.7 versus 29.7 a.u., P=0.985, are preserved. Subclaim score/status/axes are absent; parent D28 and axes are separate historical context. R01	Some original summary information is linked for production; this does not establish clinical verification/completed content review. Subclaim score/status/axes are absent in the original.	Subclaim grade/note, absent score/status/axes and parent history	Separate original-grade preservation from additional evidence/corrections
3	Partly verified	Full text not readStored summary read	N03 · 12-week stratum-corneum moisture and evidence gapsWho was studied, and how are dry skin and disease distinguished?Required	The original records 220 healthy Japanese adults with dry skin. This is not direct treatment/moisturizing efficacy in skin-disease patients or all ages/regions. R01	Some original summary information was linked for production; clinical verification/review is incomplete. Age/sex, dry-skin criteria, baseline severity, eligibility/exclusions and illnesses/drugs are unverified.	Healthy Japanese adults with dry skin, eligibility and baseline scope	Research specifying the population and definition of dry skin
4	Partly verified	Full text not readStored summary read	N04 · 12-week stratum-corneum moisture and evidence gapsWhat is the studied identity of DDMP and the beverage?Required	The original intervention is a 65 mL lactic-acid-bacteria beverage containing 2.2 mg DDMP. The long chemical name remains in the original citation; DDMP is not replaced by a specific strain/organism count or all probiotics. R01	Some original summary information was linked for production; clinical verification/review is incomplete. Strains/counts, composition, manufacture, stability/assays and product specifications are unverified.	2.2 mg DDMP, 65 mL beverage and chemical/product specifications	Research specifying the precise DDMP/beverage scope
5	Partly verified	Full text not readStored summary read	N05 · 12-week stratum-corneum moisture and evidence gapsWhat comparison does the control beverage answer?Required	The original control is the same lactic-acid-bacteria beverage with only DDMP removed. It is not a comparison with no intake, another product or no lactic-acid bacteria. R01	Some original summary information was linked for production; clinical verification/review is incomplete. Equivalence specifications, sensory/compositional details and actual shared exposure/adherence are unverified.	Identical lactic-acid-bacteria beverage with only DDMP removed, differences/shared exposure	Research specifying the DDMP contrast on an identical-beverage background
6	Partly verified	Full text not readStored summary read	N06 · 12-week stratum-corneum moisture and evidence gapsWhat were original exposure, intake frequency and adherence?Required	The original gives a 65 mL beverage containing 2.2 mg and a 12-week duration. Intake frequency, daily total, timing and actual adherence quantities are not separately supplied in this summary. R01	Some original summary information was linked for production; clinical verification/review is incomplete. Frequency/timing, actual adherence, missing exposure and protocol deviations are unverified.	Original 2.2 mg/65 mL, frequency and actual exposure	A plan separating intended provision from actual exposure
7	Partly verified	Full text not readStored summary read	N07 · 12-week stratum-corneum moisture and evidence gapsHow are the 12-week endpoint, visits and persistence distinguished?Required	The original records 12-week follow-up, the final primary stratum-corneum moisture endpoint and intermediate weeks 4 and 8. Persistence after study completion and longer-use results are not supplied. R01	Some original summary information was linked for production; clinical verification/review is incomplete. Exact visit windows, post-completion/discontinuation follow-up and direct long-term results are unverified.	Final week 12, week 4/8 visits and post-discontinuation outcomes	Research separating final, intermediate and post-study questions
8	Partly verified	Full text not readStored summary read	N08 · 12-week stratum-corneum moisture and evidence gapsWhat were measurement sites, methods/environment and moisture units?Required	The original final 12-week unit is a.u. (arbitrary units). Measurement sites, equipment, temperature/humidity, acclimation, repetitions and formulas are absent from the summary. R01	Some original summary information was linked for production; clinical verification/review is incomplete. Sites, equipment/environment, standardization, a.u. derivation and measurement error are unverified.	Skin measurement sites, equipment/environment and a.u. definition	Research fixing site/environment and measurement definitions
9	Partly verified	Full text not readStored summary read	N09 · 12-week stratum-corneum moisture and evidence gapsWhat original comparison describes final absolute moisture at 12 weeks?Required	Original final 12-week values are 29.7±7.67 for the test beverage versus 29.7±6.19 a.u. for control, P=0.985. The original null narrative is preserved; no new difference, effect or CI is calculated. R01	Some original summary information was linked for production; clinical verification/review is incomplete. The meaning of ±, arm-specific denominators, models/adjustments and site-specific/repeated data are unverified.	29.7±7.67 versus 29.7±6.19 a.u. by condition, P=0.985	Research specifying the final-visit between-arm estimand
10	Partly verified	Full text not readStored summary read	N10 · 12-week stratum-corneum moisture and evidence gapsHow does change from baseline at 12 weeks differ from final values?Required	Original 12-week change from baseline is +8.05±6.85 versus +7.92±5.97, P=0.877. This remains a different result representation from final 29.7 a.u.; positive within-arm change does not mean between-arm benefit. R01	Some original summary information was linked for production; clinical verification/review is incomplete. Separate change-unit specification, baseline values, ± definition, denominators/CIs and models are unverified.	+8.05±6.85 versus +7.92±5.97, P=0.877	A plan separating final values from changes and within-arm from between-arm estimands
11	Partly verified	Full text not readStored summary read	N11 · 12-week stratum-corneum moisture and evidence gapsAre the original no-95%-CI narrative and uncertainty distinguished?Required	The original states that no 95% CI was reported and a meaningful benefit cannot be excluded. No external paper was newly read in this run to verify that reporting statement. R01	Some original summary information was linked for production; clinical verification/review is incomplete. The estimand's CI, variance definition/covariance and importance/equivalence criteria are unverified.	Original no-CI narrative, effect intervals/importance and meaning of ±	Research prespecifying effects, intervals and importance
12	Partly verified	Full text not readStored summary read	N12 · 12-week stratum-corneum moisture and evidence gapsWhich time points do positive week 4/8 findings describe?Supplementary	Original week 4 changes +4.28 versus −2.09 (P<0.001) and week 8 +8.47 versus +5.17 (P=0.002) are preserved. The sibling is C with a positive-intermediate/disappearing-final note; it does not replace the selected 12-week D result. R01	Some original summary information was linked for production; clinical verification/review is incomplete. Intermediate variance/CIs, denominators, units/hierarchy and multiplicity are unverified.	Intermediate changes/P values, sibling original grade and final-visit boundary	Research fixing visit-specific estimands and hierarchy
13	Partly verified	Full text not readStored summary read	N13 · 12-week stratum-corneum moisture and evidence gapsWhat does a positive whole-time mixed model mean?Supplementary	The original counterview records that whole-time mixed-model P<0.001 describes differing trajectories, not a 12-week effect. It does not replace final P=.985/.877. R01	Some original summary information was linked for production; clinical verification/review is incomplete. Models, interactions/effect definitions, covariates, results/denominators and multiplicity are unverified.	Whole-time P<0.001 versus final 12-week and change results	Research separating longitudinal estimands from final contrasts
14	Partly verified	Full text not readStored summary read	N14 · 12-week stratum-corneum moisture and evidence gapsWhat is known about prespecified final-primary versus intermediate/secondary hierarchy?Required	Original bilingual text/evidence records week 12 as the prespecified final primary endpoint. Exact prespecified secondary/exploratory hierarchy and success/multiplicity rules for intermediate visits are absent. R01	Some original summary information was linked for production; clinical verification/review is incomplete. Actual external planning versions, hierarchy/timing and testing rules remain unread.	Original final-primary narrative, registry/SAP and intermediate hierarchy	A plan separating final/intermediate and primary/secondary/exploratory outcomes
15	Partly verified	Full text not readStored summary read	N15 · 12-week stratum-corneum moisture and evidence gapsWhat registration and bibliographic identifiers are supplied or absent?Required	The original registration record contains UMIN000052867 and the citation supplies PMID40151405. It is linked as a UMIN ID, not NCT. DOI/PMCID are absent from the citation. R01	Some original summary information was linked for production; clinical verification/review is incomplete. DOI/PMCID, registry versions/content and protocol/SAP are currently unverified.	UMIN000052867, PMID40151405 and DOI/PMCID scope	Link identifiers, prespecified plans and published results
16	Partly verified	Full text not readStored summary read	N16 · 12-week stratum-corneum moisture and evidence gapsAre all 220 randomized participants distinguished from 213 protocol-compliant analyses?Required	Original 220 randomized and 213 protocol-compliant participants analyzed are preserved. Arm-specific randomized/analysis and valid outcome/visit denominators are not separately supplied. R01	Some original summary information was linked for production; clinical verification/review is incomplete. Arm/visit-specific analysis counts, PPS selection rules and exclusion reasons are unverified.	Randomized versus PPS populations and arm/outcome-specific denominators	Research prespecifying randomized versus analysis populations
17	Unverified	Full text not readStored summary read	N17 · 12-week stratum-corneum moisture and evidence gapsWhat were actual attrition, protocol-deviation and missing-measurement reasons?Required	PPS 213 alone does not establish whether exclusions reflect lost follow-up, exposure violations, missing measurements or other reasons. ITT, imputation and sensitivity analyses are absent. R01	Needed direct information was not verified within the current summary and unread-external-material scope. Arm-specific flow/reasons, missing-data handling, all-randomized analyses and sensitivities are unverified.	Not analyzed/missing, adherence deviations, discontinuation and handling	Research separating missingness/deviations from estimands
18	Unverified	Full text not readStored summary read	N18 · 12-week stratum-corneum moisture and evidence gapsHow do skin sites, repeated measurements and arms/visits differ from people?Required	Original samples are 220/213 people; measurement sites/repeated aggregation are unverified. The same people, arms, sites and weeks 4/8/12 are not added as new independent trials/participants. R01	Needed direct information was not verified within the current summary and unread-external-material scope. Site-specific observations, repetitions/aggregation, correlation handling and denominators are unverified.	Analysis units for people, multiple sites/measurements and visits	A plan separating people from repeated sites/time points
19	Unverified	Full text not readStored summary read	N19 · 12-week stratum-corneum moisture and evidence gapsWhat were baseline conditions, environment/season and concurrent moisturizing exposures?Required	The current summary has no detailed control or arm differences for baseline moisture, environment/season, skin care/diet or concurrent treatment. R01	Needed direct information was not verified within the current summary and unread-external-material scope. Baseline testing, environment/season, shared management/drugs and exposure records are unverified.	Arm-specific baseline moisture, environment/lifestyle and concurrent skin care	Research specifying measurement environment and shared exposures
20	Partly verified	Full text not readStored summary read	N20 · 12-week stratum-corneum moisture and evidence gapsWere randomization, allocation concealment and baseline balance verified?Required	The original design is a double-blind randomized identical-beverage placebo-controlled parallel trial. Allocation procedures, concealment and baseline balance are not detailed in the summary. R01	Some original summary information was linked for production; clinical verification/review is incomplete. Sequence generation, concealment, allocation responsibility and arm-specific baseline data are unverified.	Parallel randomization, sequence/concealment and baseline tables	An allocation plan for the identical-beverage comparison
21	Partly verified	Full text not readStored summary read	N21 · 12-week stratum-corneum moisture and evidence gapsWhat was the actual scope of double blinding, beverage equivalence and measurement procedures?Required	The original records double blinding and identical beverages. Who was blinded and how, equivalence/condition awareness and moisture-measurement standardization are absent. R01	Some original summary information was linked for production; clinical verification/review is incomplete. Blinded parties/procedures, sensory equivalence, condition awareness and measurement/analysis procedures are unverified.	Blinding of participants/measurers/analysts, equivalence and condition awareness	Research specifying measurement and condition awareness
22	Partly verified	Full text not readStored summary read	N22 · 12-week stratum-corneum moisture and evidence gapsWhat are PPS, absolute/change and within-/between-arm estimands?Required	Primary PPS 213 and original final 12-week/change-from-baseline contrasts are distinguished. Baseline/covariate adjustment, estimands and models are not detailed. R01	Some original summary information was linked for production; clinical verification/review is incomplete. Analysis populations/models, adjustments, absolute/change values and all-randomized contrasts are unverified.	Assignment/adherent-participant effects and original final/change analyses	Research specifying assignment/adherent and final/change estimands
23	Partly verified	Full text not readStored summary read	N23 · 12-week stratum-corneum moisture and evidence gapsWhat original information concerns manufacturers, contractors and provision/support?Required	The original states Nissin York supplied test/placebo beverages; T.S., M.T. and S.S. worked at its development institute, while M.M. worked at contract organization M&I Science. The original no-separate-public-funding/medical-writing/publication-fee narrative is preserved. R01	Some original summary information was linked for production; clinical verification/review is incomplete. Current detailed original disclosures, support and design/analysis/data-access roles remain unread.	Nissin York provision, employee authors, M&I Science and support scope	Specify support and decision/analysis roles
24	Partly verified	Full text not readStored summary read	N24 · 12-week stratum-corneum moisture and evidence gapsHow are the same citation, trial, time points and siblings linked?Required	Current evidence/citation lists each contain one Sato2025 record, linked as one report. Both identical-beverage arms, weeks 4/8/12, skin sites and siblings share this context; they are not newly added independent trials/participants. R01	Some original summary information was linked for production; clinical verification/review is incomplete. Related report/trial relationships and unique trial/participant totals are unverified.	The same Sato2025 report and observation/participant relationships	Records distinguishing reports from study families
25	Unverified	Full text not readStored summary read	N25 · 12-week stratum-corneum moisture and evidence gapsWhat direct independent replications or other manufacturer/product data exist?Required	The original records one manufacturer-linked trial and historical R1/I0 axes. Other direct studies/products were not searched for or verified in this run. R01	Needed direct information was not verified within the current summary and unread-external-material scope. Separate direct-report populations, beverages/endpoints, overlap and independence are unverified.	Separate independent reports for the same 12-week DDMP-beverage question	Separate research addressing the same question
26	Partly verified	Full text not readStored summary read	N26 · 12-week stratum-corneum moisture and evidence gapsWhat are extrapolation boundaries for other beverages/strains, populations and sites?Supplementary	Original scope is a DDMP-containing identical-beverage comparison in healthy Japanese adults with dry skin. Direct values for other bacteria/beverages, products, skin diseases/populations/sites are not supplied. R01	Some original summary information was linked for production; clinical verification/review is incomplete. Direct effects/CIs and interactions by population, product or site are unverified.	Studied identity versus direct comparisons for other formulations/populations/sites	Research specifying precise study identity and applicability
27	Partly verified	Full text not readStored summary read	N27 · 12-week stratum-corneum moisture and evidence gapsAre intermediate differences, final disappearance and persistence distinguished?Supplementary	The original states intermediate differences disappeared at week 12 and benefit did not persist. Post-week-12 persistence, repeated-use and recurrence data are absent. R01	Some original summary information was linked for production; clinical verification/review is incomplete. Direct post-discontinuation/longer-term effects, denominators and CIs are unverified.	Original week 4/8 positive findings, final week 12 null finding and longer term	Research distinguishing timing/persistence questions
28	Partly verified	Full text not readStored summary read	N28 · 12-week stratum-corneum moisture and evidence gapsWhat do stratum-corneum moisture versus symptom/clinical skin outcomes answer?Supplementary	The original endpoint is stratum-corneum moisture. Separate direct treatment effects on symptoms, quality of life or clinical skin-disease outcomes are absent. R01	Some original summary information was linked for production; clinical verification/review is incomplete. Patient-important/disease outcome definitions, effects, denominators and durations are unverified.	Measurement endpoints versus skin symptoms, quality of life and disease treatment	A plan separating moisture testing from patient-important outcomes
29	Partly verified	Full text not readStored summary read	N29 · 12-week stratum-corneum moisture and evidence gapsWhat was actually read, externally unread and linked?Required	The complete preserved 2979 summary was read and saved for production. Original PubMed and UMIN identifiers connect sources; external content/link access, clicks and tests were not performed in that production. R01	Some original summary information was linked for production; clinical verification/review is incomplete. Current external original methods/results and registry/plans remain unverified.	Complete preserved summary, abstract/full text/plans and source connections	Records separating preserved summaries from newly acquired materials
30	Partly verified	Full text not readStored summary read	N30 · 12-week stratum-corneum moisture and evidence gapsWhat are original bilingual text, dates, axes/absences, corrections and history?Required	Bilingual text, the original date 2026-08-26, empty correction/deliberation records and parent D28 are preserved. B/S/R1/I0/E0/B1/C0 axes, three false flags and empty override reasons are historical. Original detailed-classification and primary-failure/secondary-positive fields are absent. R01	Some original summary information was linked for production; clinical verification/review is incomplete. External detailed translation, original-text and correction comparisons were not performed in this run.	Original languages/dates, parent axes/score and empty/absent values	Separate original values/absences from new updates
31	Partly verified	Full text not readStored summary read	N31 · 12-week stratum-corneum moisture and evidence gapsWhat was the original scope of adverse-event collection and serious safety signals?Supplementary	The original records no reported serious safety signal related to the test beverage during 12-week intake. Collection methods, all-event/severity and relatedness-adjudication tables are absent. R01	Some original summary information was linked for production; clinical verification/review is incomplete. Adverse-event definitions/collection, all events and relatedness adjudication are unverified.	Collection methods/definitions, severity, relatedness and original narrative	Research specifying harm collection separately from efficacy
32	Partly verified	Full text not readStored summary read	N32 · 12-week stratum-corneum moisture and evidence gapsAre dairy-allergy/intolerance cautions actual events?Supplementary	The original separately mentions dairy-ingredient allergy/intolerance. This is not a count or causal result showing allergy events occurred in this trial. R01	Some original summary information was linked for production; clinical verification/review is incomplete. Eligibility/relevant populations and actual events/denominators/severity are unverified.	Original cautionary context and relevant populations/event data	Safety questions specifying vulnerable populations
33	Unverified	Full text not readStored summary read	N33 · 12-week stratum-corneum moisture and evidence gapsWere arm-specific harms and event/exposure denominators verified?Supplementary	It is unverified whether all 220/PPS 213 match the harm-collection population. Arm-specific events/denominators, effects and CIs are absent. R01	Needed direct information was not verified within the current summary and unread-external-material scope. Arm/period-specific harm denominators, events and comparative effects/CIs are unverified.	All-randomized/PPS populations versus harm collection and arm comparisons	A plan separating efficacy from harm-collection populations
34	Unverified	Full text not readStored summary read	N34 · 12-week stratum-corneum moisture and evidence gapsWhat were harm timing and on-/post-exposure follow-up?Supplementary	The original has a safety narrative for 12-week exposure but no separate event timing, period-specific observation or post-study/delayed-harm follow-up. R01	Needed direct information was not verified within the current summary and unread-external-material scope. Event timing and on-exposure/post-discontinuation/long-term observation are unverified.	12-week scope, event timing and post-discontinuation/delayed observation	Research prespecifying timing and delayed harms
35	Unverified	Full text not readStored summary read	N35 · 12-week stratum-corneum moisture and evidence gapsWhat alternative causes concern DDMP, shared beverage, illnesses or drugs?Supplementary	The context compares presence/absence of DDMP in identical beverages. Actual information attributing harm to DDMP, the shared beverage or other factors is absent. R01	Needed direct information was not verified within the current summary and unread-external-material scope. Medical history/drugs, actual exposures and event-specific alternative causes/relatedness are unverified.	Shared dairy/beverage, concurrent exposures and harm attribution	A harm plan separating the exposure of interest from alternative causes
36	Unverified	Full text not readStored summary read	N36 · 12-week stratum-corneum moisture and evidence gapsWere PPS exclusions, missingness and harm-related discontinuations verified?Supplementary	PPS 213 alone does not establish whether analysis exclusions were harm-related. Event collection/handling in omitted participants is also absent. R01	Needed direct information was not verified within the current summary and unread-external-material scope. Arm-specific exclusions/missingness/discontinuations, relatedness and collection/handling are unverified.	PPS populations, exclusion/discontinuation reasons and missing harm collection	A plan distinguishing missingness from harm-related discontinuation
37	Unverified	Full text not readStored summary read	N37 · 12-week stratum-corneum moisture and evidence gapsHow are independent harm reports distinguished from observations in the same trial?Supplementary	The current listing is this beverage efficacy report. Separate original harm materials were not searched for/acquired in this run; the same report, arms, visits and siblings are not independent harm trials. R01	Needed direct information was not verified within the current summary and unread-external-material scope. Independent harm-report identities, populations/exposures and overlap are unverified.	Separate harm identities, exposures/populations and overlap	Independent harm research with clear exposures/populations
38	Unverified	Full text not readStored summary read	N38 · 12-week stratum-corneum moisture and evidence gapsWhat is known about vulnerable populations, other illnesses/beverages and long-term safety?Supplementary	12-week data in healthy Japanese adults with dry skin do not establish safety for other beverages/populations, illnesses or longer repeated exposure. R01	Needed direct information was not verified within the current summary and unread-external-material scope. Population-specific histories/drugs and direct long-term/repeated harms are unverified.	Original healthy adults versus allergy/illness and repeated/long-term scope	Research separating population and long-term safety questions
39	Partly verified	Full text not readStored summary read	N39 · 12-week stratum-corneum moisture and evidence gapsWhat are the causal scopes of final null, intermediate positive and good safety findings?Supplementary	Original 12-week null findings, positive week 4/8 findings, no reported serious related safety signal and parent good safety status are preserved separately. Null efficacy does not establish harms or guarantee safety. R01	Some original summary information was linked for production; clinical verification/review is incomplete. Direct comparative/causal safety and long-term precision are unverified.	Separate efficacy/timing, original safety grade and comparative harms	Plan separating different outcomes/estimands
40	Partly verified	Full text not readStored summary read	N40 · 12-week stratum-corneum moisture and evidence gapsHow are follow-up materials, historical candidates, versions and incomplete content review linked?Supplementary	Criteria were saved and frozen before separate application. Original pending/eligible candidates remain history. Content/question-boundary review is incomplete; completion flags are false, new units are 0 and final independent counts remain unrecorded. R01	Some original summary information is linked for production; this does not establish clinical verification/completed content review. Follow-up original materials, actual reading, changes, content review and independence decisions do not yet exist.	Review summary/criteria, new materials/original values, historical candidates and user decisions	Research directly addressing gaps in selected 12-week moisture

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40 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: Healthy Japanese adults with dry skin; original 220 randomized/PPS 213 analyzed
Ingredient, formulation and route: A 65 mL lactic-acid-bacteria beverage containing 2.2 mg DDMP
Dose: Original 2.2 mg DDMP/65 mL beverage exposure is preserved; frequency/total intake are unverified. No intake/conversion instructions.
Comparator: The identical lactic-acid-bacteria beverage with only DDMP removed
Measured outcome: Final stratum-corneum moisture at 12 weeks (a.u.), distinguished from baseline change; site/environment/unit details are unverified
Duration: 12 weeks, distinguished from intermediate weeks 4/8 and post-study/long-term effects
Questions outside this scope: Replacing 12-week efficacy with positive intermediate week 4/8 or whole-time-model findings; Extending the DDMP identical-beverage contrast to all lactic-acid bacteria, other products or skin-disease effects; Converting final/change values, a.u. or ± into new effects, CIs or percentages; Adding people, arms, sites, visits, siblings or the same citation as independent trials/participants; Instructions for probiotic/product intake, skin/moisturizing management or treatment substitution

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 · Sato T, et al. Effect of 2,3-dihydro-3,5-dihydroxy-6-methyl-4H-pyran-4-one-containing lactic acid bacterial beverages on skin moisture. J Nutr Sci Vitaminol. 2025. PMID: 40151405.

PubMed

Material type: Preserved Sato2025 report of final 12-week and intermediate findings for identical beverages with/without DDMP
Materials actually read: Summary read; external materials unread, access not attempted
Findings recorded in the stored summary: 29.7±7.67 versus 29.7±6.19 a.u., P=0.985; change +8.05±6.85 versus +7.92±5.97, P=0.877; no 95% CI reported
Record level: Original null comparisons of final 12-week a.u. and baseline change, distinct from positive week 4/8/whole-time findings. ± definition, sites, environment, arm denominators and CIs are unverified; the original no-CI narrative is preserved.
Study overlap and independent replication: The same Sato2025 trial/citation links both beverage arms, 220/PPS 213, sites/visits/final/change results and parent/12-week/intermediate sheets. These are not newly added independent trials/participants.

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Stored summary	Local preserved summary	Summary read	Summary read	Only acquisition/reading of the complete parent summary is established, not original paper/registry acquisition.
Abstract	External materials unread/needed	Unread; access not attempted	Not read	Only the original citation link is connected. External access, content verification and link testing were not attempted.
Full paper	External materials unread/needed	Unread; access not attempted	Not read	DOI/PMCID are not supplied; no original full text or external content was newly acquired/read.
Registration material	External materials unread/needed	Unread; access not attempted	Not read	Original UMIN000052867 is preserved; it is not NCT. Registry versions/content remain unread and access was not attempted.
Protocol	External materials unread/needed	Unread; access not attempted	Not read	Original plans for identical beverages/exposure, sites/environment, final/intermediate outcomes and harms are needed. Existence/public availability are unverified.
Statistical analysis plan	External materials unread/needed	Unread; access not attempted	Not read	Original plans for PPS/assignment effects, final/change contrasts, time models/multiplicity and missingness are needed.
Outcome tables and site/denominator/harm records	External materials unread/needed	Unread; access not attempted	Not read	Arm/visit/site, baseline/change, ± definitions, denominators/missingness and detailed harms are needed. No new calculations.
Funding/conflict-of-interest disclosures	External materials unread/needed	Unread; access not attempted	Not read	Original disclosures about Nissin York provision, employee/contractor and support roles remain unread.

Report counts versus independent study counts

The same Sato2025 trial/citation links both beverage arms, 220/PPS 213, sites/visits/final/change results and parent/12-week/intermediate sheets. These are not newly added independent trials/participants.

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 · How is the selected 12-week question distinguished from intermediate-time sibling findings?

Required materials and conditions: 12-week question/verdict connection and parent/intermediate scope
Conditions for verification: Separate original information about 12-week question/verdict connection and parent/intermediate scope from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.
Requirement and applicability: Required
Application exceptions: Do not fill the selected 12-week claim or grade with positive intermediate findings.
Why this condition is needed: Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: How is the selected 12-week question distinguished from intermediate-time sibling findings?
Referenced methods: M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are internally designed; M04 §4.6.1–4.6.2 distinguishes studies from reports; cohort/outcome links are an internal application

N02 · What are the subclaim D grade/note and absent values?

Required materials and conditions: Subclaim grade/note, absent score/status/axes and parent history
Conditions for verification: Separate original information about Subclaim grade/note, absent score/status/axes and parent history from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.
Requirement and applicability: Required
Application exceptions: Do not transfer parent 28 points or its original C0 axis into subclaim values or current review approval.
Why this condition is needed: Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: What are the subclaim D grade/note and absent values?
Referenced methods: M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design

N03 · Who was studied, and how are dry skin and disease distinguished?

Required materials and conditions: Healthy Japanese adults with dry skin, eligibility and baseline scope
Conditions for verification: Separate original information about Healthy Japanese adults with dry skin, eligibility and baseline scope from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.
Requirement and applicability: Required
Application exceptions: Do not extend measurements in healthy adults into skin-disease treatment or effects in every population.
Why this condition is needed: Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: Who was studied, and how are dry skin and disease distinguished?
Referenced methods: M03 §3.2.1; detailed population conditions are internally designed; M04 §4.6.1–4.6.2, M15 §15.3.1; internal application

N04 · What is the studied identity of DDMP and the beverage?

Required materials and conditions: 2.2 mg DDMP, 65 mL beverage and chemical/product specifications
Conditions for verification: Separate original information about 2.2 mg DDMP, 65 mL beverage and chemical/product specifications from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.
Requirement and applicability: Required
Application exceptions: Do not newly add mechanisms, strains/counts, product names or dose conversions without original information.
Why this condition is needed: Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: What is the studied identity of DDMP and the beverage?
Referenced methods: M03 §§3.2.2–3.2.3; reverse-direction labels and assessment adaptation are Chamgap-designed; M03 §§3.2.1–3.2.4; dose, durability and effect-modification details are Chamgap-designed

N05 · What comparison does the control beverage answer?

Required materials and conditions: Identical lactic-acid-bacteria beverage with only DDMP removed, differences/shared exposure
Conditions for verification: Separate original information about Identical lactic-acid-bacteria beverage with only DDMP removed, differences/shared exposure from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.
Requirement and applicability: Required
Application exceptions: Do not extend the result into no benefit from all lactic-acid-bacteria beverages or the isolated effect of a particular strain.
Why this condition is needed: Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: What comparison does the control beverage answer?
Referenced methods: M03 §3.2.2–3.2.3; Reverse-direction labels and assessment adaptation are Chamgap design; M03 §3.2.3 and M08 §8.2.2–8.2.3; Chamgap application

N06 · What were original exposure, intake frequency and adherence?

Required materials and conditions: Original 2.2 mg/65 mL, frequency and actual exposure
Conditions for verification: Separate original information about Original 2.2 mg/65 mL, frequency and actual exposure from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.
Requirement and applicability: Required
Application exceptions: Do not create or convert daily intake, probiotic/product instructions or management methods.
Why this condition is needed: Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: What were original exposure, intake frequency and adherence?
Referenced methods: M03 §3.2.2–3.2.3; Reverse-direction labeling and test adaptations are internally designed; M08 §8.2.2, M15 §15.3.1; Internal application; M03 §3.2.1–3.2.4; Dose, persistence and effect-modification details are internally designed

N07 · How are the 12-week endpoint, visits and persistence distinguished?

Required materials and conditions: Final week 12, week 4/8 visits and post-discontinuation outcomes
Conditions for verification: Separate original information about Final week 12, week 4/8 visits and post-discontinuation outcomes from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.
Requirement and applicability: Required
Application exceptions: Do not establish sustained moisturizing benefit from positive intermediate findings or 12-week follow-up.
Why this condition is needed: Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: How are the 12-week endpoint, visits and persistence distinguished?
Referenced methods: M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed; M03 §3.2.1–3.2.4; dose, duration and effect-modification details are internally designed

N08 · What were measurement sites, methods/environment and moisture units?

Required materials and conditions: Skin measurement sites, equipment/environment and a.u. definition
Conditions for verification: Separate original information about Skin measurement sites, equipment/environment and a.u. definition from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.
Requirement and applicability: Required
Application exceptions: Do not turn a.u. into water-content percentages, site-specific effects or moisturizer/skin-care instructions.
Why this condition is needed: Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: What were measurement sites, methods/environment and moisture units?
Referenced methods: M03 §3.2.4, M15 §15.3.1–15.3.3; Question-specific outcome adaptations are internally designed; M08 Table 8.2.a, M03 §3.2.4; Internal application; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; Design-specific adaptations are internally designed

N09 · What original comparison describes final absolute moisture at 12 weeks?

Required materials and conditions: 29.7±7.67 versus 29.7±6.19 a.u. by condition, P=0.985
Conditions for verification: Separate original information about 29.7±7.67 versus 29.7±6.19 a.u. by condition, P=0.985 from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.
Requirement and applicability: Required
Application exceptions: Do not newly certify exactly zero effect, equivalence or no response in every person from equal displayed means.
Why this condition is needed: Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: What original comparison describes final absolute moisture at 12 weeks?
Referenced methods: M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; Design-specific adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap application; M15 §15.3.1–15.3.3; Chamgap application

N10 · How does change from baseline at 12 weeks differ from final values?

Required materials and conditions: +8.05±6.85 versus +7.92±5.97, P=0.877
Conditions for verification: Separate original information about +8.05±6.85 versus +7.92±5.97, P=0.877 from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.
Requirement and applicability: Required
Application exceptions: Do not calculate new net effects, baseline values or percentages from the two changes.
Why this condition is needed: Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: How does change from baseline at 12 weeks differ from final values?
Referenced methods: M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; Design-specific adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap application; M15 §15.3.1–15.3.3; Chamgap application

N11 · Are the original no-95%-CI narrative and uncertainty distinguished?

Required materials and conditions: Original no-CI narrative, effect intervals/importance and meaning of ±
Conditions for verification: Separate original information about Original no-CI narrative, effect intervals/importance and meaning of ± from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.
Requirement and applicability: Required
Application exceptions: Do not arbitrarily interpret ± as CI/SD or reconstruct CIs from the original numbers.
Why this condition is needed: Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: Are the original no-95%-CI narrative and uncertainty distinguished?
Referenced methods: M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; Design-specific adaptations are internally designed; M15 §15.3.1–15.3.3; Internal application; M04 §4.5, §4.6.3; Current conversion limits follow the review scope and internal design

N12 · Which time points do positive week 4/8 findings describe?

Required materials and conditions: Intermediate changes/P values, sibling original grade and final-visit boundary
Conditions for verification: Separate original information about Intermediate changes/P values, sibling original grade and final-visit boundary from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.
Requirement and applicability: Supplementary
Application exceptions: Do not copy week 4/8 numbers into week 12 or new independent trials/replications, or calculate new time-specific differences.
Why this condition is needed: Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: Which time points do positive week 4/8 findings describe?
Referenced methods: M04 §4.6.3, M15 §15.3.1–15.3.3; Status separation is internally designed; M08 Table 8.2.a, M04 §4.6.3; Internal application; M03 §3.2.1–3.2.4; Dose, persistence and effect-modification details are internally designed

N13 · What does a positive whole-time mixed model mean?

Required materials and conditions: Whole-time P<0.001 versus final 12-week and change results
Conditions for verification: Separate original information about Whole-time P<0.001 versus final 12-week and change results from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.
Requirement and applicability: Supplementary
Application exceptions: Do not newly grade whole-time significance as 12-week primary-efficacy success or persistent benefit.
Why this condition is needed: Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: What does a positive whole-time mixed model mean?
Referenced methods: M08 §8.2.2, M15 §15.3.1; Internal application; M08 Table 8.2.a, M04 §4.6.3; Internal application; M04 §4.6.3, M15 §15.3.1–15.3.3; Status separation is internally designed

N14 · What is known about prespecified final-primary versus intermediate/secondary hierarchy?

Required materials and conditions: Original final-primary narrative, registry/SAP and intermediate hierarchy
Conditions for verification: Separate original information about Original final-primary narrative, registry/SAP and intermediate hierarchy from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.
Requirement and applicability: Required
Application exceptions: Preserve the original prespecification narrative without inventing current external registry-content certification.
Why this condition is needed: Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: What is known about prespecified final-primary versus intermediate/secondary hierarchy?
Referenced methods: M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific result adaptation is our own design; M08 Table 8.2.a, M04 §4.6.3; own application

N15 · What registration and bibliographic identifiers are supplied or absent?

Required materials and conditions: UMIN000052867, PMID40151405 and DOI/PMCID scope
Conditions for verification: Separate original information about UMIN000052867, PMID40151405 and DOI/PMCID scope from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.
Requirement and applicability: Required
Application exceptions: Do not turn absent identifiers into actual non-registration, absent full text or failed access, or guess a DOI.
Why this condition is needed: Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: What registration and bibliographic identifiers are supplied or absent?
Referenced methods: M04 §4.5–4.6 material collection/selection principles; acquisition/reading separation and hyperlink specifications are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design; M08 Table 8.2.a, M04 §4.6.3; internal application

N16 · Are all 220 randomized participants distinguished from 213 protocol-compliant analyses?

Required materials and conditions: Randomized versus PPS populations and arm/outcome-specific denominators
Conditions for verification: Separate original information about Randomized versus PPS populations and arm/outcome-specific denominators from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.
Requirement and applicability: Required
Application exceptions: Do not newly calculate 220−213, arm samples or attrition rates.
Why this condition is needed: Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: Are all 220 randomized participants distinguished from 213 protocol-compliant analyses?
Referenced methods: M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; Design-specific adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap application

N17 · What were actual attrition, protocol-deviation and missing-measurement reasons?

Required materials and conditions: Not analyzed/missing, adherence deviations, discontinuation and handling
Conditions for verification: Separate original information about Not analyzed/missing, adherence deviations, discontinuation and handling from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.
Requirement and applicability: Required
Application exceptions: Do not turn every PPS exclusion into attrition/adverse effects or create new numbers or flaw grades.
Why this condition is needed: Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: What were actual attrition, protocol-deviation and missing-measurement reasons?
Referenced methods: M08 §8.2.2, M15 §15.3.1; internal application; M08 Table 8.2.a, M04 §4.6.3; internal application; M19 §19.1.2–19.2.4, M04 §4.6.3; internal application

N18 · How do skin sites, repeated measurements and arms/visits differ from people?

Required materials and conditions: Analysis units for people, multiple sites/measurements and visits
Conditions for verification: Separate original information about Analysis units for people, multiple sites/measurements and visits from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.
Requirement and applicability: Required
Application exceptions: Do not invent skin-site/night data or newly add visit-specific samples.
Why this condition is needed: Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: How do skin sites, repeated measurements and arms/visits differ from people?
Referenced methods: Distinguishing studies from reports in M04 §4.6.1–4.6.2; Cohort/outcome linkage is an internal application; M08 Table 8.2.a, M03 §3.2.4; Internal application; M08 §8.2.2, M15 §15.3.1; Internal application

N19 · What were baseline conditions, environment/season and concurrent moisturizing exposures?

Required materials and conditions: Arm-specific baseline moisture, environment/lifestyle and concurrent skin care
Conditions for verification: Separate original information about Arm-specific baseline moisture, environment/lifestyle and concurrent skin care from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.
Requirement and applicability: Required
Application exceptions: Do not newly add management methods, moisturizing products/treatments as actual study elements or implementation instructions.
Why this condition is needed: Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: What were baseline conditions, environment/season and concurrent moisturizing exposures?
Referenced methods: M03 §3.2.3, M08 §8.2.2–8.2.3; Internal application; M08 Table 8.2.a, M03 §3.2.4; Internal application; Design considerations in M19 §19.2.2–19.2.4; Detailed confounding records are internally designed

N20 · Were randomization, allocation concealment and baseline balance verified?

Required materials and conditions: Parallel randomization, sequence/concealment and baseline tables
Conditions for verification: Separate original information about Parallel randomization, sequence/concealment and baseline tables from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.
Requirement and applicability: Required
Application exceptions: Do not certify adequate allocation or no bias from the RCT label or original B1 axis alone.
Why this condition is needed: Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: Were randomization, allocation concealment and baseline balance verified?
Referenced methods: M08 §8.1–8.2.3; own application

N21 · What was the actual scope of double blinding, beverage equivalence and measurement procedures?

Required materials and conditions: Blinding of participants/measurers/analysts, equivalence and condition awareness
Conditions for verification: Separate original information about Blinding of participants/measurers/analysts, equivalence and condition awareness from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.
Requirement and applicability: Required
Application exceptions: Do not inherit the original double-blind design as current successful-blinding review or independence certification.
Why this condition is needed: Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: What was the actual scope of double blinding, beverage equivalence and measurement procedures?
Referenced methods: M08 §8.1–8.2.3; internal application; M08 Table 8.2.a, M03 §3.2.4; internal application

N22 · What are PPS, absolute/change and within-/between-arm estimands?

Required materials and conditions: Assignment/adherent-participant effects and original final/change analyses
Conditions for verification: Separate original information about Assignment/adherent-participant effects and original final/change analyses from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.
Requirement and applicability: Required
Application exceptions: Do not copy PPS results as all-randomized effects or turn within-arm changes into between-arm efficacy.
Why this condition is needed: Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: What are PPS, absolute/change and within-/between-arm estimands?
Referenced methods: M08 §8.2.2 and M15 §15.3.1: in-house application; M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4: design-specific adaptation is in-house.

N23 · What original information concerns manufacturers, contractors and provision/support?

Required materials and conditions: Nissin York provision, employee authors, M&I Science and support scope
Conditions for verification: Separate original information about Nissin York provision, employee authors, M&I Science and support scope from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.
Requirement and applicability: Required
Application exceptions: Do not combine the contractor author with company employee authors or turn original support narratives into current content-review/independence judgments.
Why this condition is needed: Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: What original information concerns manufacturers, contractors and provision/support?
Referenced methods: Chamgap’s own independence/attribution conditions. The official methodological sections used in this pilot do not guarantee every detailed item; M08 §8.1–8.2.3; internal application

N24 · How are the same citation, trial, time points and siblings linked?

Required materials and conditions: The same Sato2025 report and observation/participant relationships
Conditions for verification: Separate original information about The same Sato2025 report and observation/participant relationships from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.
Requirement and applicability: Required
Application exceptions: One report is not certification of the total independent-trial count or final clinical-independence count.
Why this condition is needed: Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: How are the same citation, trial, time points and siblings linked?
Referenced methods: Study/report distinction in M04 §4.6.1–4.6.2; Cohort/outcome linkage is Chamgap application; M04 §4.6.1–4.6.2 and M15 §15.3.1; Chamgap application

N25 · What direct independent replications or other manufacturer/product data exist?

Required materials and conditions: Separate independent reports for the same 12-week DDMP-beverage question
Conditions for verification: Separate original information about Separate independent reports for the same 12-week DDMP-beverage question from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.
Requirement and applicability: Required
Application exceptions: Do not extend the original single-trial narrative into a current absence of every study, or count sibling tables as independent replication.
Why this condition is needed: Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: What direct independent replications or other manufacturer/product data exist?
Referenced methods: Study/report distinction in M04 §4.6.1–4.6.2; Cohort/outcome linkage is Chamgap application; M04 §4.6.1–4.6.2 and M15 §15.3.1; Chamgap application

N26 · What are extrapolation boundaries for other beverages/strains, populations and sites?

Required materials and conditions: Studied identity versus direct comparisons for other formulations/populations/sites
Conditions for verification: Separate original information about Studied identity versus direct comparisons for other formulations/populations/sites from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.
Requirement and applicability: Supplementary
Application exceptions: Do not newly declare no benefit from all lactic-acid bacteria or create product recommendations/intake/skin-care instructions.
Why this condition is needed: Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: What are extrapolation boundaries for other beverages/strains, populations and sites?
Referenced methods: M03 §3.2.1; Detailed population conditions are internally designed; M03 §3.2.2–3.2.3; Reverse-direction labeling and test adaptations are internally designed; M04 §4.6.1–4.6.2, M15 §15.3.1; Internal application; M03 §3.2.1–3.2.4; Dose, persistence and effect-modification details are internally designed

N27 · Are intermediate differences, final disappearance and persistence distinguished?

Required materials and conditions: Original week 4/8 positive findings, final week 12 null finding and longer term
Conditions for verification: Separate original information about Original week 4/8 positive findings, final week 12 null finding and longer term from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.
Requirement and applicability: Supplementary
Application exceptions: Preserve the original conclusion without extending it into zero effect in every long-term situation or permanently no effect.
Why this condition is needed: Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: Are intermediate differences, final disappearance and persistence distinguished?
Referenced methods: M03 §3.2.1–3.2.4; Dose, persistence and effect-modification details are internally designed; M04 §4.6.3, M15 §15.3.1–15.3.3; Status separation is internally designed

N28 · What do stratum-corneum moisture versus symptom/clinical skin outcomes answer?

Required materials and conditions: Measurement endpoints versus skin symptoms, quality of life and disease treatment
Conditions for verification: Separate original information about Measurement endpoints versus skin symptoms, quality of life and disease treatment from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.
Requirement and applicability: Supplementary
Application exceptions: Do not turn null measurements into no benefit from every skin treatment, treatment substitution or moisturizing-management instructions.
Why this condition is needed: Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: What do stratum-corneum moisture versus symptom/clinical skin outcomes answer?
Referenced methods: M03 §3.2.4; internally defined extension boundary; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is internally designed

N29 · What was actually read, externally unread and linked?

Required materials and conditions: Complete preserved summary, abstract/full text/plans and source connections
Conditions for verification: Separate original information about Complete preserved summary, abstract/full text/plans and source connections from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.
Requirement and applicability: Required
Application exceptions: Do not declare external acquisition/reading, successful access or failed access based on a URL/ID.
Why this condition is needed: Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: What was actually read, externally unread and linked?
Referenced methods: M04 §4.5–4.6 material collection/selection principles; acquisition/reading separation and hyperlink specifications are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design

N30 · What are original bilingual text, dates, axes/absences, corrections and history?

Required materials and conditions: Original languages/dates, parent axes/score and empty/absent values
Conditions for verification: Separate original information about Original languages/dates, parent axes/score and empty/absent values from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.
Requirement and applicability: Required
Application exceptions: Do not inherit original flaw/size/duration scoring or cross-check wording as current review/rescoring, or invent absent fields.
Why this condition is needed: Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: What are original bilingual text, dates, axes/absences, corrections and history?
Referenced methods: M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed splitting rules are internally designed; M04 §4.5, §4.6.3; current material-conversion limits follow review scope and internal design; Chamgap’s own independence/attribution conditions. The official methodological sections used in this pilot do not guarantee every detailed item

N31 · What was the original scope of adverse-event collection and serious safety signals?

Required materials and conditions: Collection methods/definitions, severity, relatedness and original narrative
Conditions for verification: Separate original information about Collection methods/definitions, severity, relatedness and original narrative from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.
Requirement and applicability: Supplementary
Application exceptions: Do not turn no reported serious related signal into zero adverse events of all types or guaranteed absence of harm/safety.
Why this condition is needed: Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: What was the original scope of adverse-event collection and serious safety signals?
Referenced methods: M19 §19.1.2–19.2.4; Detailed distinctions are designed by CHAMGAP

N32 · Are dairy-allergy/intolerance cautions actual events?

Required materials and conditions: Original cautionary context and relevant populations/event data
Conditions for verification: Separate original information about Original cautionary context and relevant populations/event data from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.
Requirement and applicability: Supplementary
Application exceptions: Do not create new product-checking/avoidance, intake/treatment instructions or allergy counts absent from the original.
Why this condition is needed: Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: Are dairy-allergy/intolerance cautions actual events?
Referenced methods: M19 §19.1.2–19.2.4; Detailed distinctions are internally designed; M19 §19.1.2–19.2.4; Internal application; Chamgap internal interpretation boundaries, informed by M19 principles without running an official causality tool

N33 · Were arm-specific harms and event/exposure denominators verified?

Required materials and conditions: All-randomized/PPS populations versus harm collection and arm comparisons
Conditions for verification: Separate original information about All-randomized/PPS populations versus harm collection and arm comparisons from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.
Requirement and applicability: Supplementary
Application exceptions: Do not automatically apply PPS 213 as a harm denominator or calculate zero events, incidence, differences or CIs.
Why this condition is needed: Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: Were arm-specific harms and event/exposure denominators verified?
Referenced methods: M19 §19.2.2–19.2.4, M03 §3.2.3; internal application; M19 §19.1.2–19.2.4; internal application

N34 · What were harm timing and on-/post-exposure follow-up?

Required materials and conditions: 12-week scope, event timing and post-discontinuation/delayed observation
Conditions for verification: Separate original information about 12-week scope, event timing and post-discontinuation/delayed observation from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.
Requirement and applicability: Supplementary
Application exceptions: Do not turn 12-week efficacy duration into completed long-term safety verification.
Why this condition is needed: Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: What were harm timing and on-/post-exposure follow-up?
Referenced methods: M19 §19.2 design-specific harm questions; temporal-relationship details are internally designed; M19 §19.1.2–19.2.4; internal application

N35 · What alternative causes concern DDMP, shared beverage, illnesses or drugs?

Required materials and conditions: Shared dairy/beverage, concurrent exposures and harm attribution
Conditions for verification: Separate original information about Shared dairy/beverage, concurrent exposures and harm attribution from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.
Requirement and applicability: Supplementary
Application exceptions: Do not turn shared-ingredient cautions into established DDMP harms or new treatment/prevention instructions.
Why this condition is needed: Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: What alternative causes concern DDMP, shared beverage, illnesses or drugs?
Referenced methods: M19 §19.2.2–19.2.4 design considerations; detailed confounding records are Chamgap design; M03 §3.2.3, M08 §8.2.2–8.2.3; Chamgap adaptation

N36 · Were PPS exclusions, missingness and harm-related discontinuations verified?

Required materials and conditions: PPS populations, exclusion/discontinuation reasons and missing harm collection
Conditions for verification: Separate original information about PPS populations, exclusion/discontinuation reasons and missing harm collection from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.
Requirement and applicability: Supplementary
Application exceptions: Do not calculate new differences/ratios from 220/213 or turn exclusions into people with adverse effects.
Why this condition is needed: Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: Were PPS exclusions, missingness and harm-related discontinuations verified?
Referenced methods: M19 §19.1.2–19.2.4, M04 §4.6.3; internal application; M08 §8.2.2, M15 §15.3.1; internal application

N37 · How are independent harm reports distinguished from observations in the same trial?

Required materials and conditions: Separate harm identities, exposures/populations and overlap
Conditions for verification: Separate original information about Separate harm identities, exposures/populations and overlap from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.
Requirement and applicability: Supplementary
Application exceptions: No separate current slot does not establish absence of every external harm report.
Why this condition is needed: Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: How are independent harm reports distinguished from observations in the same trial?
Referenced methods: M04 §§4.6.1–4.6.2; harm-material adaptation is Chamgap-designed; M04 §§4.6.1–4.6.2 distinction between studies and reports; cohort/outcome links are Chamgap adaptations

N38 · What is known about vulnerable populations, other illnesses/beverages and long-term safety?

Required materials and conditions: Original healthy adults versus allergy/illness and repeated/long-term scope
Conditions for verification: Separate original information about Original healthy adults versus allergy/illness and repeated/long-term scope from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.
Requirement and applicability: Supplementary
Application exceptions: Do not newly propose probiotic/product intake, skin-care or treatment-substitution methods.
Why this condition is needed: Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: What is known about vulnerable populations, other illnesses/beverages and long-term safety?
Referenced methods: M19 §19.1.2–19.2.4; Internal application; Design considerations in M19 §19.2.2–19.2.4; Detailed confounding records are internally designed

N39 · What are the causal scopes of final null, intermediate positive and good safety findings?

Required materials and conditions: Separate efficacy/timing, original safety grade and comparative harms
Conditions for verification: Separate original information about Separate efficacy/timing, original safety grade and comparative harms from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.
Requirement and applicability: Supplementary
Application exceptions: Do not extend findings into certification of efficacy/safety for an entire device/ingredient or assign new grades/causality.
Why this condition is needed: Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: What are the causal scopes of final null, intermediate positive and good safety findings?
Referenced methods: Chamgap internal interpretation boundaries, informed by M19 principles without running an official causality tool; M03 §3.2.4; Internally defined extrapolation boundaries

N40 · How are follow-up materials, historical candidates, versions and incomplete content review linked?

Required materials and conditions: Review summary/criteria, new materials/original values, historical candidates and user decisions
Conditions for verification: Separate original information about Review summary/criteria, new materials/original values, historical candidates and user decisions from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.
Requirement and applicability: Supplementary
Application exceptions: Do not invent current clinical review or completed publication from historical cross-checks or completed production.
Why this condition is needed: Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: How are follow-up materials, historical candidates/versions and incomplete content review connected?
Referenced methods: M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed splitting rules are internally designed; M04 §4.6.3, M15 §15.3.1–15.3.3; status separation is internally designed; M04 §4.5, §4.6.3; current material-conversion limits follow review scope and internal design; M08 Table 8.2.a, M04 §4.6.3; internal application

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: Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work.

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: Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work.

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: Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work.

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: Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work.

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: Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work.

What the statuses mean

Met: The original content has been reviewed as meeting the conditions. This status is not used in this preparation.
Partly verified: Some information in the stored summary was linked during preparation; clinical verification or review is not complete.
Unverified: Required direct values, definitions or materials have not been established within the current storage and reading scope. This does not mean zero effect, no papers or failed access.
Review incomplete: Review of existing content or actual review incomplete.
Not reported: Used only when original materials were actually read and the outcome was judged unreported. Not used for external materials unread in this work.
Inaccessible: Used only when an actual access attempt has a recorded failure. Not used for access that was not attempted in this work.
Insufficient evidence for the conditions: Indicates insufficient direct materials for the relevant scope or conditions; it is not a new grade.
Not applicable: Used when the reason it does not apply to the original question is stated.
Conflicting data: Retains the scope of conflicting statements in original materials; it is not an arbitrary reassessment.

Change history

2026-10-14 · Public page/material version 1.0

The public page and data were prepared from the existing 40 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 · How is the selected 12-week question distinguished from intermediate-time sibling findings?

Current findings: The selected original question is increased stratum-corneum moisture at 12 weeks. Its subclaim record is linked, while changes at weeks 4 and 8 remain original context. No new question, split or trial is created.
Verification status: Partly verified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Some original summary information was linked for production; clinical verification/review is incomplete. Clinical independence was not newly certified.
Reason for missing information: Clinical independence was not newly certified.
Required materials and conditions: 12-week question/verdict connection and parent/intermediate scope
Materials to obtain first: Original question/time, measurement/comparison and scope-change records
Further research: A plan distinguishing final 12-week and intermediate estimands
Remaining uncertainty: Clinical independence was not newly certified.
Conditions for verification: Separate original information about 12-week question/verdict connection and parent/intermediate scope from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.
Why this condition is needed: Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: How is the selected 12-week question distinguished from intermediate-time sibling findings?
Application exceptions: Do not fill the selected 12-week claim or grade with positive intermediate findings.
Referenced methods: M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are internally designed; M04 §4.6.1–4.6.2 distinguishes studies from reports; cohort/outcome links are an internal application

Related sources R01

N02 · What are the subclaim D grade/note and absent values?

Current findings: The selected D grade and note, 29.7 versus 29.7 a.u., P=0.985, are preserved. Subclaim score/status/axes are absent; parent D28 and axes are separate historical context.
Verification status: Partly verified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Some original summary information is linked for production; this does not establish clinical verification/completed content review. Subclaim score/status/axes are absent in the original.
Reason for missing information: Subclaim score/status/axes are absent in the original.
Required materials and conditions: Subclaim grade/note, absent score/status/axes and parent history
Materials to obtain first: Subclaim original and explicit change events
Further research: Separate original-grade preservation from additional evidence/corrections
Remaining uncertainty: Subclaim score/status/axes are absent in the original.
Conditions for verification: Separate original information about Subclaim grade/note, absent score/status/axes and parent history from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.
Why this condition is needed: Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: What are the subclaim D grade/note and absent values?
Application exceptions: Do not transfer parent 28 points or its original C0 axis into subclaim values or current review approval.
Referenced methods: M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design

Related sources R01

N03 · Who was studied, and how are dry skin and disease distinguished?

Current findings: The original records 220 healthy Japanese adults with dry skin. This is not direct treatment/moisturizing efficacy in skin-disease patients or all ages/regions.
Verification status: Partly verified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Some original summary information was linked for production; clinical verification/review is incomplete. Age/sex, dry-skin criteria, baseline severity, eligibility/exclusions and illnesses/drugs are unverified.
Reason for missing information: Age/sex, dry-skin criteria, baseline severity, eligibility/exclusions and illnesses/drugs are unverified.
Required materials and conditions: Healthy Japanese adults with dry skin, eligibility and baseline scope
Materials to obtain first: Eligibility criteria and baseline/diagnostic tables
Further research: Research specifying the population and definition of dry skin
Remaining uncertainty: Age/sex, dry-skin criteria, baseline severity, eligibility/exclusions and illnesses/drugs are unverified.
Conditions for verification: Separate original information about Healthy Japanese adults with dry skin, eligibility and baseline scope from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.
Why this condition is needed: Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: Who was studied, and how are dry skin and disease distinguished?
Application exceptions: Do not extend measurements in healthy adults into skin-disease treatment or effects in every population.
Referenced methods: M03 §3.2.1; detailed population conditions are internally designed; M04 §4.6.1–4.6.2, M15 §15.3.1; internal application

Related sources R01

N04 · What is the studied identity of DDMP and the beverage?

Current findings: The original intervention is a 65 mL lactic-acid-bacteria beverage containing 2.2 mg DDMP. The long chemical name remains in the original citation; DDMP is not replaced by a specific strain/organism count or all probiotics.
Verification status: Partly verified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Some original summary information was linked for production; clinical verification/review is incomplete. Strains/counts, composition, manufacture, stability/assays and product specifications are unverified.
Reason for missing information: Strains/counts, composition, manufacture, stability/assays and product specifications are unverified.
Required materials and conditions: 2.2 mg DDMP, 65 mL beverage and chemical/product specifications
Materials to obtain first: Beverage/ingredient specifications and analysis of the actual test product
Further research: Research specifying the precise DDMP/beverage scope
Remaining uncertainty: Strains/counts, composition, manufacture, stability/assays and product specifications are unverified.
Conditions for verification: Separate original information about 2.2 mg DDMP, 65 mL beverage and chemical/product specifications from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.
Why this condition is needed: Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: What is the studied identity of DDMP and the beverage?
Application exceptions: Do not newly add mechanisms, strains/counts, product names or dose conversions without original information.
Referenced methods: M03 §§3.2.2–3.2.3; reverse-direction labels and assessment adaptation are Chamgap-designed; M03 §§3.2.1–3.2.4; dose, durability and effect-modification details are Chamgap-designed

Related sources R01

N05 · What comparison does the control beverage answer?

Current findings: The original control is the same lactic-acid-bacteria beverage with only DDMP removed. It is not a comparison with no intake, another product or no lactic-acid bacteria.
Verification status: Partly verified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Some original summary information was linked for production; clinical verification/review is incomplete. Equivalence specifications, sensory/compositional details and actual shared exposure/adherence are unverified.
Reason for missing information: Equivalence specifications, sensory/compositional details and actual shared exposure/adherence are unverified.
Required materials and conditions: Identical lactic-acid-bacteria beverage with only DDMP removed, differences/shared exposure
Materials to obtain first: Test/control composition, quality and blinding information
Further research: Research specifying the DDMP contrast on an identical-beverage background
Remaining uncertainty: Equivalence specifications, sensory/compositional details and actual shared exposure/adherence are unverified.
Conditions for verification: Separate original information about Identical lactic-acid-bacteria beverage with only DDMP removed, differences/shared exposure from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.
Why this condition is needed: Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: What comparison does the control beverage answer?
Application exceptions: Do not extend the result into no benefit from all lactic-acid-bacteria beverages or the isolated effect of a particular strain.
Referenced methods: M03 §3.2.2–3.2.3; Reverse-direction labels and assessment adaptation are Chamgap design; M03 §3.2.3 and M08 §8.2.2–8.2.3; Chamgap application

Related sources R01

N06 · What were original exposure, intake frequency and adherence?

Current findings: The original gives a 65 mL beverage containing 2.2 mg and a 12-week duration. Intake frequency, daily total, timing and actual adherence quantities are not separately supplied in this summary.
Verification status: Partly verified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Some original summary information was linked for production; clinical verification/review is incomplete. Frequency/timing, actual adherence, missing exposure and protocol deviations are unverified.
Reason for missing information: Frequency/timing, actual adherence, missing exposure and protocol deviations are unverified.
Required materials and conditions: Original 2.2 mg/65 mL, frequency and actual exposure
Materials to obtain first: Study exposure schedule and adherence/provision records
Further research: A plan separating intended provision from actual exposure
Remaining uncertainty: Frequency/timing, actual adherence, missing exposure and protocol deviations are unverified.
Conditions for verification: Separate original information about Original 2.2 mg/65 mL, frequency and actual exposure from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.
Why this condition is needed: Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: What were original exposure, intake frequency and adherence?
Application exceptions: Do not create or convert daily intake, probiotic/product instructions or management methods.
Referenced methods: M03 §3.2.2–3.2.3; Reverse-direction labeling and test adaptations are internally designed; M08 §8.2.2, M15 §15.3.1; Internal application; M03 §3.2.1–3.2.4; Dose, persistence and effect-modification details are internally designed

Related sources R01

N07 · How are the 12-week endpoint, visits and persistence distinguished?

Current findings: The original records 12-week follow-up, the final primary stratum-corneum moisture endpoint and intermediate weeks 4 and 8. Persistence after study completion and longer-use results are not supplied.
Verification status: Partly verified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Some original summary information was linked for production; clinical verification/review is incomplete. Exact visit windows, post-completion/discontinuation follow-up and direct long-term results are unverified.
Reason for missing information: Exact visit windows, post-completion/discontinuation follow-up and direct long-term results are unverified.
Required materials and conditions: Final week 12, week 4/8 visits and post-discontinuation outcomes
Materials to obtain first: Visit/exposure schedules and follow-up results
Further research: Research separating final, intermediate and post-study questions
Remaining uncertainty: Exact visit windows, post-completion/discontinuation follow-up and direct long-term results are unverified.
Conditions for verification: Separate original information about Final week 12, week 4/8 visits and post-discontinuation outcomes from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.
Why this condition is needed: Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: How are the 12-week endpoint, visits and persistence distinguished?
Application exceptions: Do not establish sustained moisturizing benefit from positive intermediate findings or 12-week follow-up.
Referenced methods: M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed; M03 §3.2.1–3.2.4; dose, duration and effect-modification details are internally designed

Related sources R01

N08 · What were measurement sites, methods/environment and moisture units?

Current findings: The original final 12-week unit is a.u. (arbitrary units). Measurement sites, equipment, temperature/humidity, acclimation, repetitions and formulas are absent from the summary.
Verification status: Partly verified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Some original summary information was linked for production; clinical verification/review is incomplete. Sites, equipment/environment, standardization, a.u. derivation and measurement error are unverified.
Reason for missing information: Sites, equipment/environment, standardization, a.u. derivation and measurement error are unverified.
Required materials and conditions: Skin measurement sites, equipment/environment and a.u. definition
Materials to obtain first: Measurement methods, environment/sites and original test tables
Further research: Research fixing site/environment and measurement definitions
Remaining uncertainty: Sites, equipment/environment, standardization, a.u. derivation and measurement error are unverified.
Conditions for verification: Separate original information about Skin measurement sites, equipment/environment and a.u. definition from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.
Why this condition is needed: Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: What were measurement sites, methods/environment and moisture units?
Application exceptions: Do not turn a.u. into water-content percentages, site-specific effects or moisturizer/skin-care instructions.
Referenced methods: M03 §3.2.4, M15 §15.3.1–15.3.3; Question-specific outcome adaptations are internally designed; M08 Table 8.2.a, M03 §3.2.4; Internal application; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; Design-specific adaptations are internally designed

Related sources R01

N09 · What original comparison describes final absolute moisture at 12 weeks?

Current findings: Original final 12-week values are 29.7±7.67 for the test beverage versus 29.7±6.19 a.u. for control, P=0.985. The original null narrative is preserved; no new difference, effect or CI is calculated.
Verification status: Partly verified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Some original summary information was linked for production; clinical verification/review is incomplete. The meaning of ±, arm-specific denominators, models/adjustments and site-specific/repeated data are unverified.
Reason for missing information: The meaning of ±, arm-specific denominators, models/adjustments and site-specific/repeated data are unverified.
Required materials and conditions: 29.7±7.67 versus 29.7±6.19 a.u. by condition, P=0.985
Materials to obtain first: Final-value, model/denominator and measurement result tables
Further research: Research specifying the final-visit between-arm estimand
Remaining uncertainty: The meaning of ±, arm-specific denominators, models/adjustments and site-specific/repeated data are unverified.
Conditions for verification: Separate original information about 29.7±7.67 versus 29.7±6.19 a.u. by condition, P=0.985 from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.
Why this condition is needed: Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: What original comparison describes final absolute moisture at 12 weeks?
Application exceptions: Do not newly certify exactly zero effect, equivalence or no response in every person from equal displayed means.
Referenced methods: M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; Design-specific adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap application; M15 §15.3.1–15.3.3; Chamgap application

Related sources R01

N10 · How does change from baseline at 12 weeks differ from final values?

Current findings: Original 12-week change from baseline is +8.05±6.85 versus +7.92±5.97, P=0.877. This remains a different result representation from final 29.7 a.u.; positive within-arm change does not mean between-arm benefit.
Verification status: Partly verified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Some original summary information was linked for production; clinical verification/review is incomplete. Separate change-unit specification, baseline values, ± definition, denominators/CIs and models are unverified.
Reason for missing information: Separate change-unit specification, baseline values, ± definition, denominators/CIs and models are unverified.
Required materials and conditions: +8.05±6.85 versus +7.92±5.97, P=0.877
Materials to obtain first: Baseline/change and denominator/model result tables
Further research: A plan separating final values from changes and within-arm from between-arm estimands
Remaining uncertainty: Separate change-unit specification, baseline values, ± definition, denominators/CIs and models are unverified.
Conditions for verification: Separate original information about +8.05±6.85 versus +7.92±5.97, P=0.877 from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.
Why this condition is needed: Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: How does change from baseline at 12 weeks differ from final values?
Application exceptions: Do not calculate new net effects, baseline values or percentages from the two changes.
Referenced methods: M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; Design-specific adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap application; M15 §15.3.1–15.3.3; Chamgap application

Related sources R01

N11 · Are the original no-95%-CI narrative and uncertainty distinguished?

Current findings: The original states that no 95% CI was reported and a meaningful benefit cannot be excluded. No external paper was newly read in this run to verify that reporting statement.
Verification status: Partly verified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Some original summary information was linked for production; clinical verification/review is incomplete. The estimand's CI, variance definition/covariance and importance/equivalence criteria are unverified.
Reason for missing information: The estimand's CI, variance definition/covariance and importance/equivalence criteria are unverified.
Required materials and conditions: Original no-CI narrative, effect intervals/importance and meaning of ±
Materials to obtain first: Original analysis results and precision/importance plans
Further research: Research prespecifying effects, intervals and importance
Remaining uncertainty: The estimand's CI, variance definition/covariance and importance/equivalence criteria are unverified.
Conditions for verification: Separate original information about Original no-CI narrative, effect intervals/importance and meaning of ± from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.
Why this condition is needed: Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: Are the original no-95%-CI narrative and uncertainty distinguished?
Application exceptions: Do not arbitrarily interpret ± as CI/SD or reconstruct CIs from the original numbers.
Referenced methods: M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; Design-specific adaptations are internally designed; M15 §15.3.1–15.3.3; Internal application; M04 §4.5, §4.6.3; Current conversion limits follow the review scope and internal design

Related sources R01

N12 · Which time points do positive week 4/8 findings describe?

Current findings: Original week 4 changes +4.28 versus −2.09 (P<0.001) and week 8 +8.47 versus +5.17 (P=0.002) are preserved. The sibling is C with a positive-intermediate/disappearing-final note; it does not replace the selected 12-week D result.
Verification status: Partly verified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Some original summary information was linked for production; clinical verification/review is incomplete. Intermediate variance/CIs, denominators, units/hierarchy and multiplicity are unverified.
Reason for missing information: Intermediate variance/CIs, denominators, units/hierarchy and multiplicity are unverified.
Required materials and conditions: Intermediate changes/P values, sibling original grade and final-visit boundary
Materials to obtain first: Intermediate/final results and protocol/SAP
Further research: Research fixing visit-specific estimands and hierarchy
Remaining uncertainty: Intermediate variance/CIs, denominators, units/hierarchy and multiplicity are unverified.
Conditions for verification: Separate original information about Intermediate changes/P values, sibling original grade and final-visit boundary from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.
Why this condition is needed: Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: Which time points do positive week 4/8 findings describe?
Application exceptions: Do not copy week 4/8 numbers into week 12 or new independent trials/replications, or calculate new time-specific differences.
Referenced methods: M04 §4.6.3, M15 §15.3.1–15.3.3; Status separation is internally designed; M08 Table 8.2.a, M04 §4.6.3; Internal application; M03 §3.2.1–3.2.4; Dose, persistence and effect-modification details are internally designed

Related sources R01

N13 · What does a positive whole-time mixed model mean?

Current findings: The original counterview records that whole-time mixed-model P<0.001 describes differing trajectories, not a 12-week effect. It does not replace final P=.985/.877.
Verification status: Partly verified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Some original summary information was linked for production; clinical verification/review is incomplete. Models, interactions/effect definitions, covariates, results/denominators and multiplicity are unverified.
Reason for missing information: Models, interactions/effect definitions, covariates, results/denominators and multiplicity are unverified.
Required materials and conditions: Whole-time P<0.001 versus final 12-week and change results
Materials to obtain first: Time-model/SAP and visit-specific analyses
Further research: Research separating longitudinal estimands from final contrasts
Remaining uncertainty: Models, interactions/effect definitions, covariates, results/denominators and multiplicity are unverified.
Conditions for verification: Separate original information about Whole-time P<0.001 versus final 12-week and change results from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.
Why this condition is needed: Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: What does a positive whole-time mixed model mean?
Application exceptions: Do not newly grade whole-time significance as 12-week primary-efficacy success or persistent benefit.
Referenced methods: M08 §8.2.2, M15 §15.3.1; Internal application; M08 Table 8.2.a, M04 §4.6.3; Internal application; M04 §4.6.3, M15 §15.3.1–15.3.3; Status separation is internally designed

Related sources R01

N14 · What is known about prespecified final-primary versus intermediate/secondary hierarchy?

Current findings: Original bilingual text/evidence records week 12 as the prespecified final primary endpoint. Exact prespecified secondary/exploratory hierarchy and success/multiplicity rules for intermediate visits are absent.
Verification status: Partly verified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Some original summary information was linked for production; clinical verification/review is incomplete. Actual external planning versions, hierarchy/timing and testing rules remain unread.
Reason for missing information: Actual external planning versions, hierarchy/timing and testing rules remain unread.
Required materials and conditions: Original final-primary narrative, registry/SAP and intermediate hierarchy
Materials to obtain first: Registry, protocol/SAP and outcome lists
Further research: A plan separating final/intermediate and primary/secondary/exploratory outcomes
Remaining uncertainty: Actual external planning versions, hierarchy/timing and testing rules remain unread.
Conditions for verification: Separate original information about Original final-primary narrative, registry/SAP and intermediate hierarchy from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.
Why this condition is needed: Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: What is known about prespecified final-primary versus intermediate/secondary hierarchy?
Application exceptions: Preserve the original prespecification narrative without inventing current external registry-content certification.
Referenced methods: M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific result adaptation is our own design; M08 Table 8.2.a, M04 §4.6.3; own application

Related sources R01

N15 · What registration and bibliographic identifiers are supplied or absent?

Current findings: The original registration record contains UMIN000052867 and the citation supplies PMID40151405. It is linked as a UMIN ID, not NCT. DOI/PMCID are absent from the citation.
Verification status: Partly verified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Some original summary information was linked for production; clinical verification/review is incomplete. DOI/PMCID, registry versions/content and protocol/SAP are currently unverified.
Reason for missing information: DOI/PMCID, registry versions/content and protocol/SAP are currently unverified.
Required materials and conditions: UMIN000052867, PMID40151405 and DOI/PMCID scope
Materials to obtain first: Original bibliography/registry and protocol/SAP
Further research: Link identifiers, prespecified plans and published results
Remaining uncertainty: DOI/PMCID, registry versions/content and protocol/SAP are currently unverified.
Conditions for verification: Separate original information about UMIN000052867, PMID40151405 and DOI/PMCID scope from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.
Why this condition is needed: Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: What registration and bibliographic identifiers are supplied or absent?
Application exceptions: Do not turn absent identifiers into actual non-registration, absent full text or failed access, or guess a DOI.
Referenced methods: M04 §4.5–4.6 material collection/selection principles; acquisition/reading separation and hyperlink specifications are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design; M08 Table 8.2.a, M04 §4.6.3; internal application

Related sources R01

N16 · Are all 220 randomized participants distinguished from 213 protocol-compliant analyses?

Current findings: Original 220 randomized and 213 protocol-compliant participants analyzed are preserved. Arm-specific randomized/analysis and valid outcome/visit denominators are not separately supplied.
Verification status: Partly verified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Some original summary information was linked for production; clinical verification/review is incomplete. Arm/visit-specific analysis counts, PPS selection rules and exclusion reasons are unverified.
Reason for missing information: Arm/visit-specific analysis counts, PPS selection rules and exclusion reasons are unverified.
Required materials and conditions: Randomized versus PPS populations and arm/outcome-specific denominators
Materials to obtain first: Participant flow, arm/visit denominators and PPS criteria
Further research: Research prespecifying randomized versus analysis populations
Remaining uncertainty: Arm/visit-specific analysis counts, PPS selection rules and exclusion reasons are unverified.
Conditions for verification: Separate original information about Randomized versus PPS populations and arm/outcome-specific denominators from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.
Why this condition is needed: Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: Are all 220 randomized participants distinguished from 213 protocol-compliant analyses?
Application exceptions: Do not newly calculate 220−213, arm samples or attrition rates.
Referenced methods: M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; Design-specific adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap application

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N17 · What were actual attrition, protocol-deviation and missing-measurement reasons?

Current findings: PPS 213 alone does not establish whether exclusions reflect lost follow-up, exposure violations, missing measurements or other reasons. ITT, imputation and sensitivity analyses are absent.
Verification status: Unverified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Needed direct information was not verified within the current summary and unread-external-material scope. Arm-specific flow/reasons, missing-data handling, all-randomized analyses and sensitivities are unverified.
Reason for missing information: Arm-specific flow/reasons, missing-data handling, all-randomized analyses and sensitivities are unverified.
Required materials and conditions: Not analyzed/missing, adherence deviations, discontinuation and handling
Materials to obtain first: Participant flow, deviation/missingness records and SAP
Further research: Research separating missingness/deviations from estimands
Remaining uncertainty: Arm-specific flow/reasons, missing-data handling, all-randomized analyses and sensitivities are unverified.
Conditions for verification: Separate original information about Not analyzed/missing, adherence deviations, discontinuation and handling from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.
Why this condition is needed: Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: What were actual attrition, protocol-deviation and missing-measurement reasons?
Application exceptions: Do not turn every PPS exclusion into attrition/adverse effects or create new numbers or flaw grades.
Referenced methods: M08 §8.2.2, M15 §15.3.1; internal application; M08 Table 8.2.a, M04 §4.6.3; internal application; M19 §19.1.2–19.2.4, M04 §4.6.3; internal application

Related sources R01

N18 · How do skin sites, repeated measurements and arms/visits differ from people?

Current findings: Original samples are 220/213 people; measurement sites/repeated aggregation are unverified. The same people, arms, sites and weeks 4/8/12 are not added as new independent trials/participants.
Verification status: Unverified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Needed direct information was not verified within the current summary and unread-external-material scope. Site-specific observations, repetitions/aggregation, correlation handling and denominators are unverified.
Reason for missing information: Site-specific observations, repetitions/aggregation, correlation handling and denominators are unverified.
Required materials and conditions: Analysis units for people, multiple sites/measurements and visits
Materials to obtain first: Site/visit data and analysis-unit/SAP information
Further research: A plan separating people from repeated sites/time points
Remaining uncertainty: Site-specific observations, repetitions/aggregation, correlation handling and denominators are unverified.
Conditions for verification: Separate original information about Analysis units for people, multiple sites/measurements and visits from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.
Why this condition is needed: Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: How do skin sites, repeated measurements and arms/visits differ from people?
Application exceptions: Do not invent skin-site/night data or newly add visit-specific samples.
Referenced methods: Distinguishing studies from reports in M04 §4.6.1–4.6.2; Cohort/outcome linkage is an internal application; M08 Table 8.2.a, M03 §3.2.4; Internal application; M08 §8.2.2, M15 §15.3.1; Internal application

Related sources R01

N19 · What were baseline conditions, environment/season and concurrent moisturizing exposures?

Current findings: The current summary has no detailed control or arm differences for baseline moisture, environment/season, skin care/diet or concurrent treatment.
Verification status: Unverified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Needed direct information was not verified within the current summary and unread-external-material scope. Baseline testing, environment/season, shared management/drugs and exposure records are unverified.
Reason for missing information: Baseline testing, environment/season, shared management/drugs and exposure records are unverified.
Required materials and conditions: Arm-specific baseline moisture, environment/lifestyle and concurrent skin care
Materials to obtain first: Baseline/measurement environment, concurrent exposures and protocol
Further research: Research specifying measurement environment and shared exposures
Remaining uncertainty: Baseline testing, environment/season, shared management/drugs and exposure records are unverified.
Conditions for verification: Separate original information about Arm-specific baseline moisture, environment/lifestyle and concurrent skin care from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.
Why this condition is needed: Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: What were baseline conditions, environment/season and concurrent moisturizing exposures?
Application exceptions: Do not newly add management methods, moisturizing products/treatments as actual study elements or implementation instructions.
Referenced methods: M03 §3.2.3, M08 §8.2.2–8.2.3; Internal application; M08 Table 8.2.a, M03 §3.2.4; Internal application; Design considerations in M19 §19.2.2–19.2.4; Detailed confounding records are internally designed

Related sources R01

N20 · Were randomization, allocation concealment and baseline balance verified?

Current findings: The original design is a double-blind randomized identical-beverage placebo-controlled parallel trial. Allocation procedures, concealment and baseline balance are not detailed in the summary.
Verification status: Partly verified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Some original summary information was linked for production; clinical verification/review is incomplete. Sequence generation, concealment, allocation responsibility and arm-specific baseline data are unverified.
Reason for missing information: Sequence generation, concealment, allocation responsibility and arm-specific baseline data are unverified.
Required materials and conditions: Parallel randomization, sequence/concealment and baseline tables
Materials to obtain first: Allocation procedures, baseline tables and protocol
Further research: An allocation plan for the identical-beverage comparison
Remaining uncertainty: Sequence generation, concealment, allocation responsibility and arm-specific baseline data are unverified.
Conditions for verification: Separate original information about Parallel randomization, sequence/concealment and baseline tables from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.
Why this condition is needed: Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: Were randomization, allocation concealment and baseline balance verified?
Application exceptions: Do not certify adequate allocation or no bias from the RCT label or original B1 axis alone.
Referenced methods: M08 §8.1–8.2.3; own application

Related sources R01

N21 · What was the actual scope of double blinding, beverage equivalence and measurement procedures?

Current findings: The original records double blinding and identical beverages. Who was blinded and how, equivalence/condition awareness and moisture-measurement standardization are absent.
Verification status: Partly verified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Some original summary information was linked for production; clinical verification/review is incomplete. Blinded parties/procedures, sensory equivalence, condition awareness and measurement/analysis procedures are unverified.
Reason for missing information: Blinded parties/procedures, sensory equivalence, condition awareness and measurement/analysis procedures are unverified.
Required materials and conditions: Blinding of participants/measurers/analysts, equivalence and condition awareness
Materials to obtain first: Blinding/equivalence and measurement-standardization information
Further research: Research specifying measurement and condition awareness
Remaining uncertainty: Blinded parties/procedures, sensory equivalence, condition awareness and measurement/analysis procedures are unverified.
Conditions for verification: Separate original information about Blinding of participants/measurers/analysts, equivalence and condition awareness from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.
Why this condition is needed: Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: What was the actual scope of double blinding, beverage equivalence and measurement procedures?
Application exceptions: Do not inherit the original double-blind design as current successful-blinding review or independence certification.
Referenced methods: M08 §8.1–8.2.3; internal application; M08 Table 8.2.a, M03 §3.2.4; internal application

Related sources R01

N22 · What are PPS, absolute/change and within-/between-arm estimands?

Current findings: Primary PPS 213 and original final 12-week/change-from-baseline contrasts are distinguished. Baseline/covariate adjustment, estimands and models are not detailed.
Verification status: Partly verified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Some original summary information was linked for production; clinical verification/review is incomplete. Analysis populations/models, adjustments, absolute/change values and all-randomized contrasts are unverified.
Reason for missing information: Analysis populations/models, adjustments, absolute/change values and all-randomized contrasts are unverified.
Required materials and conditions: Assignment/adherent-participant effects and original final/change analyses
Materials to obtain first: SAP and results/denominators for each estimand
Further research: Research specifying assignment/adherent and final/change estimands
Remaining uncertainty: Analysis populations/models, adjustments, absolute/change values and all-randomized contrasts are unverified.
Conditions for verification: Separate original information about Assignment/adherent-participant effects and original final/change analyses from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.
Why this condition is needed: Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: What are PPS, absolute/change and within-/between-arm estimands?
Application exceptions: Do not copy PPS results as all-randomized effects or turn within-arm changes into between-arm efficacy.
Referenced methods: M08 §8.2.2 and M15 §15.3.1: in-house application; M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4: design-specific adaptation is in-house.

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N23 · What original information concerns manufacturers, contractors and provision/support?

Current findings: The original states Nissin York supplied test/placebo beverages; T.S., M.T. and S.S. worked at its development institute, while M.M. worked at contract organization M&I Science. The original no-separate-public-funding/medical-writing/publication-fee narrative is preserved.
Verification status: Partly verified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Some original summary information was linked for production; clinical verification/review is incomplete. Current detailed original disclosures, support and design/analysis/data-access roles remain unread.
Reason for missing information: Current detailed original disclosures, support and design/analysis/data-access roles remain unread.
Required materials and conditions: Nissin York provision, employee authors, M&I Science and support scope
Materials to obtain first: Original support/provision, author relationships/roles and disclosures
Further research: Specify support and decision/analysis roles
Remaining uncertainty: Current detailed original disclosures, support and design/analysis/data-access roles remain unread.
Conditions for verification: Separate original information about Nissin York provision, employee authors, M&I Science and support scope from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.
Why this condition is needed: Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: What original information concerns manufacturers, contractors and provision/support?
Application exceptions: Do not combine the contractor author with company employee authors or turn original support narratives into current content-review/independence judgments.
Referenced methods: Chamgap’s own independence/attribution conditions. The official methodological sections used in this pilot do not guarantee every detailed item; M08 §8.1–8.2.3; internal application

Related sources R01

N24 · How are the same citation, trial, time points and siblings linked?

Current findings: Current evidence/citation lists each contain one Sato2025 record, linked as one report. Both identical-beverage arms, weeks 4/8/12, skin sites and siblings share this context; they are not newly added independent trials/participants.
Verification status: Partly verified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Some original summary information was linked for production; clinical verification/review is incomplete. Related report/trial relationships and unique trial/participant totals are unverified.
Reason for missing information: Related report/trial relationships and unique trial/participant totals are unverified.
Required materials and conditions: The same Sato2025 report and observation/participant relationships
Materials to obtain first: Trial/related-report identities and observation units
Further research: Records distinguishing reports from study families
Remaining uncertainty: Related report/trial relationships and unique trial/participant totals are unverified.
Conditions for verification: Separate original information about The same Sato2025 report and observation/participant relationships from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.
Why this condition is needed: Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: How are the same citation, trial, time points and siblings linked?
Application exceptions: One report is not certification of the total independent-trial count or final clinical-independence count.
Referenced methods: Study/report distinction in M04 §4.6.1–4.6.2; Cohort/outcome linkage is Chamgap application; M04 §4.6.1–4.6.2 and M15 §15.3.1; Chamgap application

Related sources R01

N25 · What direct independent replications or other manufacturer/product data exist?

Current findings: The original records one manufacturer-linked trial and historical R1/I0 axes. Other direct studies/products were not searched for or verified in this run.
Verification status: Unverified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Needed direct information was not verified within the current summary and unread-external-material scope. Separate direct-report populations, beverages/endpoints, overlap and independence are unverified.
Reason for missing information: Separate direct-report populations, beverages/endpoints, overlap and independence are unverified.
Required materials and conditions: Separate independent reports for the same 12-week DDMP-beverage question
Materials to obtain first: Direct confirmatory/replication reports and trial identities
Further research: Separate research addressing the same question
Remaining uncertainty: Separate direct-report populations, beverages/endpoints, overlap and independence are unverified.
Conditions for verification: Separate original information about Separate independent reports for the same 12-week DDMP-beverage question from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.
Why this condition is needed: Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: What direct independent replications or other manufacturer/product data exist?
Application exceptions: Do not extend the original single-trial narrative into a current absence of every study, or count sibling tables as independent replication.
Referenced methods: Study/report distinction in M04 §4.6.1–4.6.2; Cohort/outcome linkage is Chamgap application; M04 §4.6.1–4.6.2 and M15 §15.3.1; Chamgap application

Related sources R01

N26 · What are extrapolation boundaries for other beverages/strains, populations and sites?

Current findings: Original scope is a DDMP-containing identical-beverage comparison in healthy Japanese adults with dry skin. Direct values for other bacteria/beverages, products, skin diseases/populations/sites are not supplied.
Verification status: Partly verified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Some original summary information was linked for production; clinical verification/review is incomplete. Direct effects/CIs and interactions by population, product or site are unverified.
Reason for missing information: Direct effects/CIs and interactions by population, product or site are unverified.
Required materials and conditions: Studied identity versus direct comparisons for other formulations/populations/sites
Materials to obtain first: Direct formulation/population/measurement-site data
Further research: Research specifying precise study identity and applicability
Remaining uncertainty: Direct effects/CIs and interactions by population, product or site are unverified.
Conditions for verification: Separate original information about Studied identity versus direct comparisons for other formulations/populations/sites from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.
Why this condition is needed: Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: What are extrapolation boundaries for other beverages/strains, populations and sites?
Application exceptions: Do not newly declare no benefit from all lactic-acid bacteria or create product recommendations/intake/skin-care instructions.
Referenced methods: M03 §3.2.1; Detailed population conditions are internally designed; M03 §3.2.2–3.2.3; Reverse-direction labeling and test adaptations are internally designed; M04 §4.6.1–4.6.2, M15 §15.3.1; Internal application; M03 §3.2.1–3.2.4; Dose, persistence and effect-modification details are internally designed

Related sources R01

N27 · Are intermediate differences, final disappearance and persistence distinguished?

Current findings: The original states intermediate differences disappeared at week 12 and benefit did not persist. Post-week-12 persistence, repeated-use and recurrence data are absent.
Verification status: Partly verified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Some original summary information was linked for production; clinical verification/review is incomplete. Direct post-discontinuation/longer-term effects, denominators and CIs are unverified.
Reason for missing information: Direct post-discontinuation/longer-term effects, denominators and CIs are unverified.
Required materials and conditions: Original week 4/8 positive findings, final week 12 null finding and longer term
Materials to obtain first: Time-specific/post-study results and plans
Further research: Research distinguishing timing/persistence questions
Remaining uncertainty: Direct post-discontinuation/longer-term effects, denominators and CIs are unverified.
Conditions for verification: Separate original information about Original week 4/8 positive findings, final week 12 null finding and longer term from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.
Why this condition is needed: Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: Are intermediate differences, final disappearance and persistence distinguished?
Application exceptions: Preserve the original conclusion without extending it into zero effect in every long-term situation or permanently no effect.
Referenced methods: M03 §3.2.1–3.2.4; Dose, persistence and effect-modification details are internally designed; M04 §4.6.3, M15 §15.3.1–15.3.3; Status separation is internally designed

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N28 · What do stratum-corneum moisture versus symptom/clinical skin outcomes answer?

Current findings: The original endpoint is stratum-corneum moisture. Separate direct treatment effects on symptoms, quality of life or clinical skin-disease outcomes are absent.
Verification status: Partly verified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Some original summary information was linked for production; clinical verification/review is incomplete. Patient-important/disease outcome definitions, effects, denominators and durations are unverified.
Reason for missing information: Patient-important/disease outcome definitions, effects, denominators and durations are unverified.
Required materials and conditions: Measurement endpoints versus skin symptoms, quality of life and disease treatment
Materials to obtain first: Direct symptom/clinical-outcome information
Further research: A plan separating moisture testing from patient-important outcomes
Remaining uncertainty: Patient-important/disease outcome definitions, effects, denominators and durations are unverified.
Conditions for verification: Separate original information about Measurement endpoints versus skin symptoms, quality of life and disease treatment from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.
Why this condition is needed: Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: What do stratum-corneum moisture versus symptom/clinical skin outcomes answer?
Application exceptions: Do not turn null measurements into no benefit from every skin treatment, treatment substitution or moisturizing-management instructions.
Referenced methods: M03 §3.2.4; internally defined extension boundary; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is internally designed

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N29 · What was actually read, externally unread and linked?

Current findings: The complete preserved 2979 summary was read and saved for production. Original PubMed and UMIN identifiers connect sources; external content/link access, clicks and tests were not performed in that production.
Verification status: Partly verified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Some original summary information was linked for production; clinical verification/review is incomplete. Current external original methods/results and registry/plans remain unverified.
Reason for missing information: Current external original methods/results and registry/plans remain unverified.
Required materials and conditions: Complete preserved summary, abstract/full text/plans and source connections
Materials to obtain first: Acquired original materials and actual reading/addition events
Further research: Records separating preserved summaries from newly acquired materials
Remaining uncertainty: Current external original methods/results and registry/plans remain unverified.
Conditions for verification: Separate original information about Complete preserved summary, abstract/full text/plans and source connections from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.
Why this condition is needed: Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: What was actually read, externally unread and linked?
Application exceptions: Do not declare external acquisition/reading, successful access or failed access based on a URL/ID.
Referenced methods: M04 §4.5–4.6 material collection/selection principles; acquisition/reading separation and hyperlink specifications are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design

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N30 · What are original bilingual text, dates, axes/absences, corrections and history?

Current findings: Bilingual text, the original date 2026-08-26, empty correction/deliberation records and parent D28 are preserved. B/S/R1/I0/E0/B1/C0 axes, three false flags and empty override reasons are historical. Original detailed-classification and primary-failure/secondary-positive fields are absent.
Verification status: Partly verified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Some original summary information was linked for production; clinical verification/review is incomplete. External detailed translation, original-text and correction comparisons were not performed in this run.
Reason for missing information: External detailed translation, original-text and correction comparisons were not performed in this run.
Required materials and conditions: Original languages/dates, parent axes/score and empty/absent values
Materials to obtain first: Language-specific originals/revisions and dated correction events
Further research: Separate original values/absences from new updates
Remaining uncertainty: External detailed translation, original-text and correction comparisons were not performed in this run.
Conditions for verification: Separate original information about Original languages/dates, parent axes/score and empty/absent values from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.
Why this condition is needed: Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: What are original bilingual text, dates, axes/absences, corrections and history?
Application exceptions: Do not inherit original flaw/size/duration scoring or cross-check wording as current review/rescoring, or invent absent fields.
Referenced methods: M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed splitting rules are internally designed; M04 §4.5, §4.6.3; current material-conversion limits follow review scope and internal design; Chamgap’s own independence/attribution conditions. The official methodological sections used in this pilot do not guarantee every detailed item

Related sources R01

N31 · What was the original scope of adverse-event collection and serious safety signals?

Current findings: The original records no reported serious safety signal related to the test beverage during 12-week intake. Collection methods, all-event/severity and relatedness-adjudication tables are absent.
Verification status: Partly verified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Some original summary information was linked for production; clinical verification/review is incomplete. Adverse-event definitions/collection, all events and relatedness adjudication are unverified.
Reason for missing information: Adverse-event definitions/collection, all events and relatedness adjudication are unverified.
Required materials and conditions: Collection methods/definitions, severity, relatedness and original narrative
Materials to obtain first: Harm plans, event/discontinuation and relatedness tables
Further research: Research specifying harm collection separately from efficacy
Remaining uncertainty: Adverse-event definitions/collection, all events and relatedness adjudication are unverified.
Conditions for verification: Separate original information about Collection methods/definitions, severity, relatedness and original narrative from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.
Why this condition is needed: Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: What was the original scope of adverse-event collection and serious safety signals?
Application exceptions: Do not turn no reported serious related signal into zero adverse events of all types or guaranteed absence of harm/safety.
Referenced methods: M19 §19.1.2–19.2.4; Detailed distinctions are designed by CHAMGAP

Related sources R01

N32 · Are dairy-allergy/intolerance cautions actual events?

Current findings: The original separately mentions dairy-ingredient allergy/intolerance. This is not a count or causal result showing allergy events occurred in this trial.
Verification status: Partly verified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Some original summary information was linked for production; clinical verification/review is incomplete. Eligibility/relevant populations and actual events/denominators/severity are unverified.
Reason for missing information: Eligibility/relevant populations and actual events/denominators/severity are unverified.
Required materials and conditions: Original cautionary context and relevant populations/event data
Materials to obtain first: Population/event and exposure/relatedness data
Further research: Safety questions specifying vulnerable populations
Remaining uncertainty: Eligibility/relevant populations and actual events/denominators/severity are unverified.
Conditions for verification: Separate original information about Original cautionary context and relevant populations/event data from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.
Why this condition is needed: Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: Are dairy-allergy/intolerance cautions actual events?
Application exceptions: Do not create new product-checking/avoidance, intake/treatment instructions or allergy counts absent from the original.
Referenced methods: M19 §19.1.2–19.2.4; Detailed distinctions are internally designed; M19 §19.1.2–19.2.4; Internal application; Chamgap internal interpretation boundaries, informed by M19 principles without running an official causality tool

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N33 · Were arm-specific harms and event/exposure denominators verified?

Current findings: It is unverified whether all 220/PPS 213 match the harm-collection population. Arm-specific events/denominators, effects and CIs are absent.
Verification status: Unverified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Needed direct information was not verified within the current summary and unread-external-material scope. Arm/period-specific harm denominators, events and comparative effects/CIs are unverified.
Reason for missing information: Arm/period-specific harm denominators, events and comparative effects/CIs are unverified.
Required materials and conditions: All-randomized/PPS populations versus harm collection and arm comparisons
Materials to obtain first: Harm flow and events/denominator tables by arm
Further research: A plan separating efficacy from harm-collection populations
Remaining uncertainty: Arm/period-specific harm denominators, events and comparative effects/CIs are unverified.
Conditions for verification: Separate original information about All-randomized/PPS populations versus harm collection and arm comparisons from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.
Why this condition is needed: Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: Were arm-specific harms and event/exposure denominators verified?
Application exceptions: Do not automatically apply PPS 213 as a harm denominator or calculate zero events, incidence, differences or CIs.
Referenced methods: M19 §19.2.2–19.2.4, M03 §3.2.3; internal application; M19 §19.1.2–19.2.4; internal application

Related sources R01

N34 · What were harm timing and on-/post-exposure follow-up?

Current findings: The original has a safety narrative for 12-week exposure but no separate event timing, period-specific observation or post-study/delayed-harm follow-up.
Verification status: Unverified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Needed direct information was not verified within the current summary and unread-external-material scope. Event timing and on-exposure/post-discontinuation/long-term observation are unverified.
Reason for missing information: Event timing and on-exposure/post-discontinuation/long-term observation are unverified.
Required materials and conditions: 12-week scope, event timing and post-discontinuation/delayed observation
Materials to obtain first: Harm/exposure timing and follow-up information
Further research: Research prespecifying timing and delayed harms
Remaining uncertainty: Event timing and on-exposure/post-discontinuation/long-term observation are unverified.
Conditions for verification: Separate original information about 12-week scope, event timing and post-discontinuation/delayed observation from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.
Why this condition is needed: Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: What were harm timing and on-/post-exposure follow-up?
Application exceptions: Do not turn 12-week efficacy duration into completed long-term safety verification.
Referenced methods: M19 §19.2 design-specific harm questions; temporal-relationship details are internally designed; M19 §19.1.2–19.2.4; internal application

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N35 · What alternative causes concern DDMP, shared beverage, illnesses or drugs?

Current findings: The context compares presence/absence of DDMP in identical beverages. Actual information attributing harm to DDMP, the shared beverage or other factors is absent.
Verification status: Unverified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Needed direct information was not verified within the current summary and unread-external-material scope. Medical history/drugs, actual exposures and event-specific alternative causes/relatedness are unverified.
Reason for missing information: Medical history/drugs, actual exposures and event-specific alternative causes/relatedness are unverified.
Required materials and conditions: Shared dairy/beverage, concurrent exposures and harm attribution
Materials to obtain first: History/exposure and event/relatedness records
Further research: A harm plan separating the exposure of interest from alternative causes
Remaining uncertainty: Medical history/drugs, actual exposures and event-specific alternative causes/relatedness are unverified.
Conditions for verification: Separate original information about Shared dairy/beverage, concurrent exposures and harm attribution from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.
Why this condition is needed: Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: What alternative causes concern DDMP, shared beverage, illnesses or drugs?
Application exceptions: Do not turn shared-ingredient cautions into established DDMP harms or new treatment/prevention instructions.
Referenced methods: M19 §19.2.2–19.2.4 design considerations; detailed confounding records are Chamgap design; M03 §3.2.3, M08 §8.2.2–8.2.3; Chamgap adaptation

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N36 · Were PPS exclusions, missingness and harm-related discontinuations verified?

Current findings: PPS 213 alone does not establish whether analysis exclusions were harm-related. Event collection/handling in omitted participants is also absent.
Verification status: Unverified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Needed direct information was not verified within the current summary and unread-external-material scope. Arm-specific exclusions/missingness/discontinuations, relatedness and collection/handling are unverified.
Reason for missing information: Arm-specific exclusions/missingness/discontinuations, relatedness and collection/handling are unverified.
Required materials and conditions: PPS populations, exclusion/discontinuation reasons and missing harm collection
Materials to obtain first: Flow/exclusions, harm-related discontinuations and missing data
Further research: A plan distinguishing missingness from harm-related discontinuation
Remaining uncertainty: Arm-specific exclusions/missingness/discontinuations, relatedness and collection/handling are unverified.
Conditions for verification: Separate original information about PPS populations, exclusion/discontinuation reasons and missing harm collection from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.
Why this condition is needed: Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: Were PPS exclusions, missingness and harm-related discontinuations verified?
Application exceptions: Do not calculate new differences/ratios from 220/213 or turn exclusions into people with adverse effects.
Referenced methods: M19 §19.1.2–19.2.4, M04 §4.6.3; internal application; M08 §8.2.2, M15 §15.3.1; internal application

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N37 · How are independent harm reports distinguished from observations in the same trial?

Current findings: The current listing is this beverage efficacy report. Separate original harm materials were not searched for/acquired in this run; the same report, arms, visits and siblings are not independent harm trials.
Verification status: Unverified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Needed direct information was not verified within the current summary and unread-external-material scope. Independent harm-report identities, populations/exposures and overlap are unverified.
Reason for missing information: Independent harm-report identities, populations/exposures and overlap are unverified.
Required materials and conditions: Separate harm identities, exposures/populations and overlap
Materials to obtain first: Separate harm/surveillance and event materials
Further research: Independent harm research with clear exposures/populations
Remaining uncertainty: Independent harm-report identities, populations/exposures and overlap are unverified.
Conditions for verification: Separate original information about Separate harm identities, exposures/populations and overlap from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.
Why this condition is needed: Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: How are independent harm reports distinguished from observations in the same trial?
Application exceptions: No separate current slot does not establish absence of every external harm report.
Referenced methods: M04 §§4.6.1–4.6.2; harm-material adaptation is Chamgap-designed; M04 §§4.6.1–4.6.2 distinction between studies and reports; cohort/outcome links are Chamgap adaptations

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N38 · What is known about vulnerable populations, other illnesses/beverages and long-term safety?

Current findings: 12-week data in healthy Japanese adults with dry skin do not establish safety for other beverages/populations, illnesses or longer repeated exposure.
Verification status: Unverified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Needed direct information was not verified within the current summary and unread-external-material scope. Population-specific histories/drugs and direct long-term/repeated harms are unverified.
Reason for missing information: Population-specific histories/drugs and direct long-term/repeated harms are unverified.
Required materials and conditions: Original healthy adults versus allergy/illness and repeated/long-term scope
Materials to obtain first: Direct harm data by vulnerable/disease population and exposure duration
Further research: Research separating population and long-term safety questions
Remaining uncertainty: Population-specific histories/drugs and direct long-term/repeated harms are unverified.
Conditions for verification: Separate original information about Original healthy adults versus allergy/illness and repeated/long-term scope from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.
Why this condition is needed: Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: What is known about vulnerable populations, other illnesses/beverages and long-term safety?
Application exceptions: Do not newly propose probiotic/product intake, skin-care or treatment-substitution methods.
Referenced methods: M19 §19.1.2–19.2.4; Internal application; Design considerations in M19 §19.2.2–19.2.4; Detailed confounding records are internally designed

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N39 · What are the causal scopes of final null, intermediate positive and good safety findings?

Current findings: Original 12-week null findings, positive week 4/8 findings, no reported serious related safety signal and parent good safety status are preserved separately. Null efficacy does not establish harms or guarantee safety.
Verification status: Partly verified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Some original summary information was linked for production; clinical verification/review is incomplete. Direct comparative/causal safety and long-term precision are unverified.
Reason for missing information: Direct comparative/causal safety and long-term precision are unverified.
Required materials and conditions: Separate efficacy/timing, original safety grade and comparative harms
Materials to obtain first: Separate comparative-harm/follow-up data alongside efficacy
Further research: Plan separating different outcomes/estimands
Remaining uncertainty: Direct comparative/causal safety and long-term precision are unverified.
Conditions for verification: Separate original information about Separate efficacy/timing, original safety grade and comparative harms from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.
Why this condition is needed: Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: What are the causal scopes of final null, intermediate positive and good safety findings?
Application exceptions: Do not extend findings into certification of efficacy/safety for an entire device/ingredient or assign new grades/causality.
Referenced methods: Chamgap internal interpretation boundaries, informed by M19 principles without running an official causality tool; M03 §3.2.4; Internally defined extrapolation boundaries

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N40 · How are follow-up materials, historical candidates, versions and incomplete content review linked?

Current findings: Criteria were saved and frozen before separate application. Original pending/eligible candidates remain history. Content/question-boundary review is incomplete; completion flags are false, new units are 0 and final independent counts remain unrecorded.
Verification status: Partly verified
Materials actually read: Summary read; external materials unread, access not attempted
Why unverified: Some original summary information is linked for production; this does not establish clinical verification/completed content review. Follow-up original materials, actual reading, changes, content review and independence decisions do not yet exist.
Reason for missing information: Follow-up original materials, actual reading, changes, content review and independence decisions do not yet exist.
Required materials and conditions: Review summary/criteria, new materials/original values, historical candidates and user decisions
Materials to obtain first: Additional original materials, before/after values, versions and change-decision records
Further research: Research directly addressing gaps in selected 12-week moisture
Remaining uncertainty: Follow-up original materials, actual reading, changes, content review and independence decisions do not yet exist.
Conditions for verification: Separate original information about Review summary/criteria, new materials/original values, historical candidates and user decisions from unverified information and extrapolation boundaries for intermediate visits, other products, clinical outcomes and harms.
Why this condition is needed: Needed to distinguish the original beverage/population, timing/measurement and unverified scope for: How are follow-up materials, historical candidates/versions and incomplete content review connected?
Application exceptions: Do not invent current clinical review or completed publication from historical cross-checks or completed production.
Referenced methods: M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed splitting rules are internally designed; M04 §4.6.3, M15 §15.3.1–15.3.3; status separation is internally designed; M04 §4.5, §4.6.3; current material-conversion limits follow review scope and internal design; M08 Table 8.2.a, M04 §4.6.3; internal application

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