CHAMGAP

LG2055 drinkable yogurt × Questionnaire symptom-days — PPS, day denominators and infection distinctions

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Required evidence, verification status and materials actually read
ItemAVerification statusBReading scopeCReview itemDCurrent findingsEWhy unverifiedFRequired materials and conditionsGFurther research
1 Partly verified Full text not readStored summary read N01 · Evidence conditionWhich existing questionnaire symptom-day claim is being transferred?Required
The selected claim is fewer questionnaire-recorded cold-like symptom-days, with original subclaim grade C and a note that several symptom-day proportions were lower but 95% CIs were not reported. Absent subclaim score/status/axes are distinguished from parent C50.
Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.
Selected wording, subclaim grade and parent results
Materials needed: Questionnaire symptom definitions, denominators, comparison/time points, estimand and user boundary review. The parent score is not used to fill subclaim values. Only material requests/research needs are recorded; no current lookup or research execution.
2 Partly verified Full text not readStored summary read N02 · Evidence conditionWhat cold risk and health status characterize the population?Required
The original trial involved 200 healthy Japanese people aged 20–64 prone to colds. Applicability is not expanded to children, older people, immunocompromised people/patients or every region/season.
Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.
Healthy Japanese adults aged 20–64 prone to colds
Materials needed: Original materials on cold susceptibility/eligibility, baseline health, comorbidities/medication and vaccination/contact exposure, plus direct results in other populations. Only material requests/research needs are recorded; no current lookup or research execution.
3 Partly verified Full text not readStored summary read N03 · Evidence conditionWhat is the study identity of the trial drink?Required
The original English text describes a drink containing Lactobacillus paragasseri SBT2055 (LG2055), the company-developed LG2055 drinkable yogurt. Organism count/CFU, drink volume, detailed composition and adherence are not established within the preserved scope. Equivalent effects of other strains/fermented milks are not assumed.
Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.
LG2055 drinkable yogurt versus other probiotics/products
Materials needed: Original strain, formulation/quantities, active product/manufacturing and actual exposure/adherence materials. No product/drink consumption or cold/infection-prevention instructions. Only material requests/research needs are recorded; no current lookup or research execution.
4 Partly verified Full text not readStored summary read N04 · Evidence conditionWhat does the actual identical-yogurt control compare?Required
The original materials explain that LG2055 yogurt was compared with identical yogurt lacking only LG2055 to ask about the added strain’s symptom-day effect. This is not changed into a comparison with no yogurt/intervention or an effect of yogurt in general.
Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.
Identical yogurt lacking only LG2055
Materials needed: Group composition, sensory properties/masking, actual product/exposure, concurrent diet/treatment and contact materials. Equality of all conditions is not certified through a new external comparison. Only material requests/research needs are recorded; no current lookup or research execution.
5 Partly verified Full text not readStored summary read N05 · Evidence conditionAre winter 12-week results separated from other durations?Required
The original trial observed participants for 12 weeks during winter. Actual intake/adherence, date/season distribution, missing symptom records and post-intervention follow-up remain unverified in detail. 12 weeks are not converted into a new total of days/person-days.
Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.
Observation duration, season and actual exposure
Materials needed: Original actual-exposure/recording duration, missingness/discontinuation, season/infection exposure and time-specific results. No long-term prevention/persistence effects or implementation instructions. Only material requests/research needs are recorded; no current lookup or research execution.
6 Partly verified Full text not readStored summary read N06 · Evidence conditionAre allocation, consumption completion and primary efficacy analyses separate?Required
The original materials report 200 randomized participants, 100/100 allocated, 198 completing consumption and, after five exclusions, a primary efficacy PPS of 193 (97/96). These original numbers describe separate stages; no new attrition counts/rates or group-specific exclusion counts are calculated.
Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.
200/198/193 participants and group-specific PPS
Materials needed: Flow diagrams, group-specific completion/exclusion reasons, endpoint-specific observations/analyses and missing-data handling. 200 randomized participants are not automatically repurposed as efficacy, harm or symptom-day denominators. Only material requests/research needs are recorded; no current lookup or research execution.
7 Partly verified Full text not readStored summary read N07 · Evidence conditionAre PPS results presented as ITT effects for everyone?Required
Primary efficacy used the PPS of 193 rather than all 200 participants. The original verdict records this limit; identical effects or sensitivity results for the full randomized ITT population are not established within the preserved scope.
Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.
Protocol-compliant completer analysis versus all randomized participants
Materials needed: Original ITT/other analysis populations, exclusions/missing data and results, and prespecified analysis plans. Positive PPS results are not certified as effects in all randomized participants. Only material requests/research needs are recorded; no current lookup or research execution.
8 Partly verified Full text not readStored summary read N08 · Evidence conditionHow are questionnaire symptom-days defined?Required
The original primary endpoint was days with questionnaire-recorded cold-like symptoms over 12 weeks. Detailed symptom items/frequency, recording methods, adjudication/severity criteria, concurrent treatment and missing-record rules remain unverified. This is preserved as a direct outcome distinct from confirmed infection.
Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.
Self-reported days with symptoms and measurement methods
Materials needed: Questionnaire tools, symptom-day criteria/concurrent symptoms, recording/missingness, measurement timing, advance plans and original tables. Symptom names are not newly designated as confirmed diagnoses. Only material requests/research needs are recorded; no current lookup or research execution.
9 Partly verified Full text not readStored summary read N09 · Evidence conditionWhat are the runny-nose numerator, denominator and effect?Required
Original runny-nose days were 2384/8148 days (29.3%) versus 2769/8066 days (34.3%), with original absolute difference −5.0 percentage points and P<.001. Only the original symptom-day values are preserved; they are not converted into individual infection risk, new RR/CI or an absolute reduction in days.
Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.
Original symptom-day proportions, absolute difference and P value
Materials needed: Original runny-nose symptom-day tables, group-specific denominator definitions, estimand, analysis model and 95% CI materials. No new recalculation or invented quantitative example. Only material requests/research needs are recorded; no current lookup or research execution.
10 Partly verified Full text not readStored summary read N10 · Evidence conditionAre people, person-days, repeated symptoms and events distinct?Required
2384/8148 and 2769/8066 are day numerators/denominators in the original wording, distinct from the person denominators of 193 (97/96). Overlapping symptoms within the same day/person remain unverified in detail. Symptom-specific days are not summed as unique people or infection events.
Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.
Symptom-day denominators versus 193-person denominators
Materials needed: Original recording/denominator units, participant-specific durations, concurrent/repeated symptoms, event definitions and missingness. No new person-day details/totals are calculated. Only material requests/research needs are recorded; no current lookup or research execution.
11 Unverified Full text not readStored summary read N11 · Evidence conditionHas the correlation structure of repeated records and analyses been verified?Required
The original materials provide symptom-day proportions and P values, but detailed handling of repeated/concurrent symptoms within participants, clustering/time series, missingness and models remains unverified. It is not asserted that repeated days were treated as independent participants, and no new error is judged.
Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.
Models/missing data for repeated symptom-days within people
Materials needed: Original estimand, within-participant repetition/correlation, missing observations, aggregation/testing methods and sensitivity analyses. No current model reanalysis or clinical calculation. Only material requests/research needs are recorded; no current lookup or research execution.
12 Partly verified Full text not readStored summary read N12 · Evidence conditionAre other questionnaire symptom results recorded separately?Required
The original narrative reports nasal congestion 17.7% versus 27.7%, sneezing 17.7% versus 20.2%, sore throat 6.3% versus 12.2% and hoarseness 3.5% versus 8.2%. Each original proportion is preserved; runny-nose P/CI limitations or denominators are not automatically copied to all symptoms, and no new difference/RR is calculated.
Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.
Nasal congestion, sneezing, sore throat and hoarseness
Materials needed: Original symptom-specific actual numerators/denominators, effects/CIs, models/time points and advance hierarchy. Symptoms are not added as a new composite score or infection event. Only material requests/research needs are recorded; no current lookup or research execution.
13 Partly verified Full text not readStored summary read N13 · Evidence conditionAre missing cough values being filled from its P value?Supplementary
The original counterview records that cough also had P<.001. Exact cough proportions, numerators/denominators and effects/CIs are not provided in the summary. Runny-nose 29.3/34.3% and −5.0 percentage points are not copied to cough.
Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.
Separate cough results and detailed gaps
Materials needed: Original cough tables, denominators, effects/CIs, tests/models and advance hierarchy. No new symptom values or CI estimates. Only material requests/research needs are recorded; no current lookup or research execution.
14 Partly verified Full text not readStored summary read N14 · Evidence conditionAre multiplicity and a composite score across symptoms verified?Required
The original materials record that the symptoms were not tested as one prespecified hierarchical composite score. Total test numbers, multiplicity adjustment/success criteria and advance plans remain unverified in detail. Original P values are not changed into adjusted P values or upgraded into whole-product cold prevention.
Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.
Prespecified hierarchical composite scores versus symptom-specific tests
Materials needed: Complete endpoint/test lists, registration/protocol/SAP, prespecification/multiple comparisons, selective reporting and original results. No new adjusted P value or grade. Only material requests/research needs are recorded; no current lookup or research execution.
15 Partly verified Full text not readStored summary read N15 · Evidence conditionIs the primary symptom-day specification distinct from the runny-nose example?Required
The original evidence narrative describes a primary questionnaire symptom-day endpoint, and the reader answer supplies a quantitative runny-nose example. Runny nose is not newly designated as the sole prespecified primary endpoint or as the same effect for all symptoms.
Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.
Primary questionnaire symptom-days versus selecting a specific symptom
Materials needed: Prespecified endpoints/priorities, symptom-specific analyses, complete results and plan/change materials. A selected symptom is not upgraded into a broad conclusion. Only material requests/research needs are recorded; no current lookup or research execution.
16 Unverified Full text not readStored summary read N16 · Evidence conditionWas laboratory-confirmed infection incidence directly measured?Required
The original crux/English text distinguishes this from a trial measuring infection incidence or laboratory-confirmed colds. The infection subclaim’s note also records that laboratory-confirmed incidence was not measured. Symptom-day reductions are not converted into infection prevention or fewer infected people/events.
Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.
Questionnaire symptoms versus pathogen-confirmed infection
Materials needed: Test/clinical-confirmation definitions, pathogens, direct group-specific infection events/denominators, follow-up and effects/CIs. Non-measurement is not changed into zero events or zero effect. Only material requests/research needs are recorded; no current lookup or research execution.
17 Unverified Full text not readStored summary read N17 · Evidence conditionAre severity, health-care use and other clinical outcomes being filled?Required
The preserved scope covers questionnaire-recorded symptom-days and symptom-specific proportions. Separate direct results for clinical severity, health-care use, hospitalization or absence from work are not provided in the current summary. Unread originals are not assumed to mean actual non-measurement.
Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.
Symptom-days versus severity, clinical visits/hospitalization and absence from work
Materials needed: Definitions, actual measurement/denominators, comparisons/durations, effects/CIs and originals for each clinical outcome. Symptom-days are not converted into clinical events or treatment effects. Only material requests/research needs are recorded; no current lookup or research execution.
18 Unverified Full text not readStored summary read N18 · Evidence conditionWhat gaps remain in 95% CIs and clinical effect size?Required
The original runny-nose absolute difference of −5.0 percentage points, P<.001 and several symptom-day proportions are preserved. The original report narrative says between-group 95% CIs were not presented. Clinical thresholds, person-specific effects and CIs are not newly derived from P values/denominators.
Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.
Original absolute difference/P value and unreported 95% CIs
Materials needed: Original effect estimates/precision, 95% CIs, prespecified clinical thresholds and denominator/correlation/model materials. Positive results are not expanded into long-term or infection effects. Only material requests/research needs are recorded; no current lookup or research execution.
19 Partly verified Full text not readStored summary read N19 · Evidence conditionAre symptom-days presented as a general immunity effect?Required
The original advertising interpretation explains an added-strain symptom-day effect versus identical yogurt, without establishing infection prevention or a general immune boost. New efficacy is not extended to mechanisms, other products/strains, populations or seasons.
Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.
The product’s added strain versus broad immunity claims
Materials needed: Direct endpoints, populations/interventions/comparators, durations, denominators and effects/CIs for each broad claim. No current mechanism, infection-prevention, cold-management or treatment-replacement instructions. Only material requests/research needs are recorded; no current lookup or research execution.
20 Partly verified Full text not readStored summary read N20 · Harm-information gaps supplementing the efficacy tableAre 12-week related safety signals distinct from all harms?Supplementary
The original materials contain the limited statement that no serious study-food-related safety signal was reported over 12 weeks, plus dairy-allergy/lactose-discomfort cautions. This is not extended into zero adverse events, safety in all populations or exclusion of long-term harms.
Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.
Serious study-food-related signals and dairy/lactose contexts
Materials needed: Group-specific AE/SAE collection, actual exposure/denominators, discontinuation/relatedness, allergy/lactose and long-term materials. No new harm rates or product-consumption/cold-management instructions. Only material requests/research needs are recorded; no current lookup or research execution.
21 Partly verified Full text not readStored summary read N21 · Evidence conditionWhat materials were actually read in this work?Required
The complete parent JSON was read for production and preserved in its original form. Summary reading concerns the preserved summary; external abstracts, full texts, registration and protocol/SAP remain unread in this work. URL/bibliography presence is not upgraded into external reading.
Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.
Preserved JSON summary and external-reading status
Materials needed: Materials for users to record actual external acquisition/reading scope, versions and timing. No current link/click/access tests. Only material requests/research needs are recorded; no current lookup or research execution.
22 Partly verified Full text not readStored summary read N22 · Evidence conditionAre registration, public dates, plans and current reading distinct?Required
The original evidence lists UMIN000045901. Although the paper stated registration preceded initiation, the preserved Korean/English narrative distinguishes public posting on 2022-09-08 after the planned 2021-10-30 start as retrospectively public registration. No current external comparison of actual start/version or plan agreement was performed, and no official URL is guessed.
Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.
Original registration information and detailed plans/access
Materials needed: Original registration texts/versions, public/start/change dates, endpoint/analysis and report-linkage materials. Only historical narratives are preserved; no current prespecification/access certification. Only material requests/research needs are recorded; no current lookup or research execution.
23 Unverified Full text not readStored summary read N23 · Evidence conditionWere protocol/SAP and endpoint/multiplicity plans acquired?Required
The original registration identifier, historical cross-checking and primary/secondary narratives are preserved. Individual protocol/SAP originals, versions/dates, complete endpoints/analyses/multiplicity and plan changes were not read in this work.
Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.
Advance plan, change and analysis materials
Materials needed: Protocol, SAP, revision history, complete endpoints/estimands/missingness, multiple comparisons, public dates and paper-comparison materials. Unread external materials are not assumed to mean absent documents. Only material requests/research needs are recorded; no current lookup or research execution.
24 Partly verified Full text not readStored summary read N24 · Evidence conditionAre company funding, product support, employee authors and research roles separate?Required
The original materials record four MEGMILK SNOW BRAND employee authors EK/TA/MK/TK, a company-developed LG2055 product and NS’s employment at the contract research organization KSO Corporation. The original limit that separate public cofunding, medical-writing and publication support were not identified is retained. Company cash funding, product manufacturing/provision and detailed design/analysis/data control remain separately unverified.
Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.
Four categories of company involvement and other support
Materials needed: Separate originals for company cash funding, product/food manufacturing support, author employment/contractor relationships, design/analysis/data control and other support/COI. The original independence axis is not used as new certification. Only material requests/research needs are recorded; no current lookup or research execution.
25 Partly verified Full text not readStored summary read N25 · Evidence conditionAre narrow positive results, broad-claim gaps and unverified materials distinct?Required
Positive questionnaire symptom-day results are distinguished from unmeasured laboratory-confirmed infections, originally unreported 95% CIs and unread detailed external materials.
Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.
Direct endpoints and access/reporting limitations
Materials needed: Materials verifying question-specific actual measurements/definitions, original tables/denominators, plans and actual access scope. Unread is not substituted for unreported, zero studies or zero effect. Only material requests/research needs are recorded; no current lookup or research execution.
26 Partly verified Full text not readStored summary read N26 · Evidence conditionAre reports, trials, people, repeated measures and sibling sheets distinct?Required
Parent 2977 and existing s0/s1 share the same Kobatake2022 report and 12-week trial context of 200 randomized participants/193 PPS participants. The same people, groups, days, symptoms, time points, bibliography and sibling sheets are not added as new independent trials/participants. One current report link is not a certified count of unique trials/participants.
Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.
Document linkage versus unique trials/participants
Materials needed: Original registration/report, actual cohort/analysis, endpoint/time-point and repeated-measure relationships. Unique trial counts and unique participant totals remain unrecorded. Only material requests/research needs are recorded; no current lookup or research execution.
27 Unverified Full text not readStored summary read N27 · Evidence conditionIs there evidence of separate independent confirmation?Supplementary
Parent replication R1 and independence I0 are preserved. The same report, subgroup, scale, repeated days or sibling sheets are not certified as new independent efficacy/harm replications.
Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.
Original R1/I0 versus independent replication
Materials needed: Confirmatory materials showing selected-question advance plans, separate populations/comparators, direct endpoints/denominators, effects/CIs, duration/funding and author relationships. No current search or independence judgment. Only material requests/research needs are recorded; no current lookup or research execution.
28 Partly verified Full text not readStored summary read N28 · Evidence conditionAre selected-subclaim and parent scores/axes preserved?Required
Selected grade/note and Korean/English claim wording are preserved, with absent subclaim score/status/axes left unrecorded. Parent C50, good safety and B/P/R1/I0/E+, bias axis and unrecorded precision are parent context, not a score for the selected row.
Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.
Subclaim grade/note, absent fields and parent context
Materials needed: User subclaim/parent-boundary review and actual correction materials. No new score/grade or official RoB 2/GRADE certification. Only material-request/research needs are recorded; no search/research was performed in this production.
29 Partly verified Full text not readStored summary read N29 · Evidence conditionAre Korean/English wording and absent structured fields preserved?Required
Parent Korean/English text, evidence/citation lists, axes and original selected-subclaim wording are preserved in the complete summary. Korean/English classification fields are absent; no new fields are filled in the original materials. External English papers were not compared.
Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.
Wording in both languages and absent classification fields
Materials needed: Materials for content review of bilingual terms, endpoints/durations, absent fields and selected scope. Production explanations remain distinct from original wording. Only material requests/research needs are recorded; no current lookup or research execution.
30 Partly verified Full text not readStored summary read N30 · Evidence conditionAre reference dates, corrections, historical cross-checking and production dates distinct?Required
Original reference date 2026-08-26, empty corrections/deliberation and grade-decision cross-check narratives are preserved. This history is not current condition freezing/application, production date or completed content review.
Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.
Original 2026-08-26 versus production/application events
Materials needed: When new materials/corrections arise, materials for separate updates to originals, events, conditions/observations and verdict decisions. Historical narratives are not used as new clinical review. Only material requests/research needs are recorded; no current lookup or research execution.
31 Unverified Full text not readStored summary read N31 · Evidence conditionWhat direct materials could fill the selected gaps?Supplementary
Original materials are needed to improve precision of symptom-day effects/CIs, repeated-record denominators, PPS/ITT and advance hierarchy. Infection prevention is a separate question requiring direct confirmed-infection data.
Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.
Definitions, direct endpoints, denominators/effects/CIs and plans
Materials needed: Question-matched advance direct comparisons, overall/symptom-specific denominators, estimands/CIs, measurement/missingness, multiplicity and separate confirmation/long-term harms. Only need is recorded; no current lookup or clinical study. Only material requests/research needs are recorded; no current lookup or research execution.
32 Partly verified Full text not readStored summary read N32 · Evidence conditionAre production, user review and implementation instructions distinct?Supplementary
This is table-content production from the preserved summary. Existing content and question-boundary review remain incomplete, and candidate pending/eligibility flags are preserved as history. Existing review status is recorded as it stands.
Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.
Production request, candidate history and content-review responsibility
Materials needed: Existing content review and later actual-material/correction work. The historical production record did not perform clinical-original comparison, external access, new calculations, grade changes or product/drink-consumption, sleep/cold-management, infection-prevention or treatment-replacement instructions. Only material requests/research needs are recorded; no current lookup or research execution.
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32 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
200 healthy Japanese adults aged 20–64 prone to colds; 100/100 allocated, 198 completers/five exclusions and a PPS of 193, with 97/96 per group
Ingredient, formulation and route
Company-developed drinkable yogurt containing Lactobacillus paragasseri SBT2055 (LG2055); actual quantities/CFU remain unverified in detail
Dose
Original study exposure: 12 weeks during winter; exact drink volume/organism count unverified. No product/drink-consumption or cold/infection-prevention instructions
Comparator
Identical yogurt lacking only LG2055, with 100 allocated; distinct from group-specific 97/96 in the primary efficacy PPS
Measured outcome
12-week questionnaire-recorded cold-like symptom-days and symptom-specific proportions; distinct from laboratory-confirmed infection incidence, severity and health-care use
Duration
12 weeks; actual exposure/adherence, endpoint-specific observations/analyses and persistence/long-term follow-up after completion remain unverified in detail
Questions outside this scope
Repurposing narrow morning-drowsiness/questionnaire symptom-day outcomes as general sleep, objective sleep, confirmed-infection prevention or clinical effects; Deriving new quantitative effects/CIs/adjusted values or invented examples from figure/text reporting limits, P values or denominators; Substituting FAS1/PPS, allocation/completion, people/days/symptoms/time points as the same denominator; Adding the same report, people, groups, time points, scales, bibliography or sibling sheets as new independent trials/participants; New grades/reassessment/independence certification or extract/product/drink-consumption, sleep/cold-management, infection-prevention or treatment-replacement instructions

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 · Kobatake E, et al. Intake of Lactobacillus paragasseri SBT2055 improves subjective symptoms of common cold during winter season in healthy adults. Front Nutr. 2022;9:1063584. PMID: 36570128.

PubMed

Material type
Double-blind randomized identical-yogurt placebo-controlled parallel trial
Materials actually read
Preserved summary read; external abstracts/full texts/registrations/plans remain unread
Findings recorded in the stored summary
Runny nose 29.3% versus 34.3%, absolute difference −5.0 percentage points, P<0.001; 95% CI not reported
Record level
Original evidence-list summary of the parent endpoint; boundaries between the selected direct question and other scales/symptoms/infection outcomes are distinguished in condition rows and roles
Study overlap and independent replication
Parent 2977 and existing s0/s1 share the same Kobatake2022 report and 12-week trial context of 200 randomized participants/193 PPS participants. The same people, groups, days, symptoms, time points, bibliography and sibling sheets are not added as new independent trials/participants. Bibliography/registration-based linkage is provisional, not certification of unique trials/participants or independence.
Public availability, access and reading status by material
MaterialPublic availabilityAccess statusActually readNotes
Stored summaryLocal preserved copy of the complete parent summaryStored summary readSummary readOnly original PubMed URLs/registration identifiers are preserved; no new certification of external reading, access, prespecification or condition fulfillment. No full-text/registration/plan URLs are guessed.
External abstractOriginal identifier/bibliography or required-material entry; public availability/access details remain unverifiedUnread; access testing not performedNot readOnly original PubMed URLs/registration identifiers are preserved; no new certification of external reading, access, prespecification or condition fulfillment. No full-text/registration/plan URLs are guessed.
External full textOriginal identifier/bibliography or required-material entry; public availability/access details remain unverifiedUnread; access testing not performedNot readOnly original PubMed URLs/registration identifiers are preserved; no new certification of external reading, access, prespecification or condition fulfillment. No full-text/registration/plan URLs are guessed.
Original registrationOriginal identifier/bibliography or required-material entry; public availability/access details remain unverifiedUnread; access testing not performedNot readOnly original PubMed URLs/registration identifiers are preserved; no new certification of external reading, access, prespecification or condition fulfillment. No full-text/registration/plan URLs are guessed.
Protocol/SAPOriginal identifier/bibliography or required-material entry; public availability/access details remain unverifiedUnread; access testing not performedNot readOnly original PubMed URLs/registration identifiers are preserved; no new certification of external reading, access, prespecification or condition fulfillment. No full-text/registration/plan URLs are guessed.

Report counts versus independent study counts

Parent 2977 and existing s0/s1 share the same Kobatake2022 report and 12-week trial context of 200 randomized participants/193 PPS participants. The same people, groups, days, symptoms, time points, bibliography and sibling sheets are not added as new independent trials/participants. Bibliography/registration-based linkage is provisional, not certification of unique trials/participants or independence.

Review criteria

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

N01 · Which existing questionnaire symptom-day claim is being transferred?
Required materials and conditions
Selected wording, subclaim grade and parent results
Conditions for verification
Show originals for selected wording, subclaim grade and parent results with selected-subclaim/parent boundaries, direct endpoints/estimand, denominators and external-reading scope.
Requirement and applicability
Required
Application exceptions
Distinguish self-reported symptom-days, people/person-days/repeated/concurrent symptoms and symptom-specific numerators/denominators/effects/CIs from confirmed infections/clinical outcomes; distinguish actual strain drink/identical yogurt, winter 12 weeks, allocation/completion/PPS/attrition, advance hierarchy/registration conflict, company involvement and harms. Preserve original numbers only; no new calculations, invented quantities, effects/CIs, grades/reassessment, independence certification or extract/product/drink-consumption, sleep/cold-management, infection-prevention or treatment-replacement instructions.
Why this condition is needed
Needed to connect selected wording, subclaim grade and parent results with the selected question, actual population/intervention/comparator, endpoints/hierarchy/estimand, denominators/duration and reports/harms.
Referenced methods
Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production
N02 · What cold risk and health status characterize the population?
Required materials and conditions
Healthy Japanese adults aged 20–64 prone to colds
Conditions for verification
Show originals for healthy Japanese adults aged 20–64 prone to colds with selected-subclaim/parent boundaries, direct endpoints/estimand, denominators and external-reading scope.
Requirement and applicability
Required
Application exceptions
Distinguish self-reported symptom-days, people/person-days/repeated/concurrent symptoms and symptom-specific numerators/denominators/effects/CIs from confirmed infections/clinical outcomes; distinguish actual strain drink/identical yogurt, winter 12 weeks, allocation/completion/PPS/attrition, advance hierarchy/registration conflict, company involvement and harms. Preserve original numbers only; no new calculations, invented quantities, effects/CIs, grades/reassessment, independence certification or extract/product/drink-consumption, sleep/cold-management, infection-prevention or treatment-replacement instructions.
Why this condition is needed
Needed to connect healthy Japanese adults aged 20–64 prone to colds with the selected question, actual population/intervention/comparator, endpoints/hierarchy/estimand, denominators/duration and reports/harms.
Referenced methods
Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production
N03 · What is the study identity of the trial drink?
Required materials and conditions
LG2055 drinkable yogurt versus other probiotics/products
Conditions for verification
Show originals for lG2055 drinkable yogurt versus other probiotics/products with selected-subclaim/parent boundaries, direct endpoints/estimand, denominators and external-reading scope.
Requirement and applicability
Required
Application exceptions
Distinguish self-reported symptom-days, people/person-days/repeated/concurrent symptoms and symptom-specific numerators/denominators/effects/CIs from confirmed infections/clinical outcomes; distinguish actual strain drink/identical yogurt, winter 12 weeks, allocation/completion/PPS/attrition, advance hierarchy/registration conflict, company involvement and harms. Preserve original numbers only; no new calculations, invented quantities, effects/CIs, grades/reassessment, independence certification or extract/product/drink-consumption, sleep/cold-management, infection-prevention or treatment-replacement instructions.
Why this condition is needed
Needed to connect lG2055 drinkable yogurt versus other probiotics/products with the selected question, actual population/intervention/comparator, endpoints/hierarchy/estimand, denominators/duration and reports/harms.
Referenced methods
Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production
N04 · What does the actual identical-yogurt control compare?
Required materials and conditions
Identical yogurt lacking only LG2055
Conditions for verification
Show originals for identical yogurt lacking only LG2055 with selected-subclaim/parent boundaries, direct endpoints/estimand, denominators and external-reading scope.
Requirement and applicability
Required
Application exceptions
Distinguish self-reported symptom-days, people/person-days/repeated/concurrent symptoms and symptom-specific numerators/denominators/effects/CIs from confirmed infections/clinical outcomes; distinguish actual strain drink/identical yogurt, winter 12 weeks, allocation/completion/PPS/attrition, advance hierarchy/registration conflict, company involvement and harms. Preserve original numbers only; no new calculations, invented quantities, effects/CIs, grades/reassessment, independence certification or extract/product/drink-consumption, sleep/cold-management, infection-prevention or treatment-replacement instructions.
Why this condition is needed
Needed to connect identical yogurt lacking only LG2055 with the selected question, actual population/intervention/comparator, endpoints/hierarchy/estimand, denominators/duration and reports/harms.
Referenced methods
Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production
N05 · Are winter 12-week results separated from other durations?
Required materials and conditions
Observation duration, season and actual exposure
Conditions for verification
Show originals for observation duration, season and actual exposure with selected-subclaim/parent boundaries, direct endpoints/estimand, denominators and external-reading scope.
Requirement and applicability
Required
Application exceptions
Distinguish self-reported symptom-days, people/person-days/repeated/concurrent symptoms and symptom-specific numerators/denominators/effects/CIs from confirmed infections/clinical outcomes; distinguish actual strain drink/identical yogurt, winter 12 weeks, allocation/completion/PPS/attrition, advance hierarchy/registration conflict, company involvement and harms. Preserve original numbers only; no new calculations, invented quantities, effects/CIs, grades/reassessment, independence certification or extract/product/drink-consumption, sleep/cold-management, infection-prevention or treatment-replacement instructions.
Why this condition is needed
Needed to connect observation duration, season and actual exposure with the selected question, actual population/intervention/comparator, endpoints/hierarchy/estimand, denominators/duration and reports/harms.
Referenced methods
Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production
N06 · Are allocation, consumption completion and primary efficacy analyses separate?
Required materials and conditions
200/198/193 participants and group-specific PPS
Conditions for verification
Show originals for 200/198/193 participants and group-specific PPS with selected-subclaim/parent boundaries, direct endpoints/estimand, denominators and external-reading scope.
Requirement and applicability
Required
Application exceptions
Distinguish self-reported symptom-days, people/person-days/repeated/concurrent symptoms and symptom-specific numerators/denominators/effects/CIs from confirmed infections/clinical outcomes; distinguish actual strain drink/identical yogurt, winter 12 weeks, allocation/completion/PPS/attrition, advance hierarchy/registration conflict, company involvement and harms. Preserve original numbers only; no new calculations, invented quantities, effects/CIs, grades/reassessment, independence certification or extract/product/drink-consumption, sleep/cold-management, infection-prevention or treatment-replacement instructions.
Why this condition is needed
Needed to connect 200/198/193 participants and group-specific PPS with the selected question, actual population/intervention/comparator, endpoints/hierarchy/estimand, denominators/duration and reports/harms.
Referenced methods
Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production
N07 · Are PPS results presented as ITT effects for everyone?
Required materials and conditions
Protocol-compliant completer analysis versus all randomized participants
Conditions for verification
Show originals for protocol-compliant completer analysis versus all randomized participants with selected-subclaim/parent boundaries, direct endpoints/estimand, denominators and external-reading scope.
Requirement and applicability
Required
Application exceptions
Distinguish self-reported symptom-days, people/person-days/repeated/concurrent symptoms and symptom-specific numerators/denominators/effects/CIs from confirmed infections/clinical outcomes; distinguish actual strain drink/identical yogurt, winter 12 weeks, allocation/completion/PPS/attrition, advance hierarchy/registration conflict, company involvement and harms. Preserve original numbers only; no new calculations, invented quantities, effects/CIs, grades/reassessment, independence certification or extract/product/drink-consumption, sleep/cold-management, infection-prevention or treatment-replacement instructions.
Why this condition is needed
Needed to connect protocol-compliant completer analysis versus all randomized participants with the selected question, actual population/intervention/comparator, endpoints/hierarchy/estimand, denominators/duration and reports/harms.
Referenced methods
Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production
N08 · How are questionnaire symptom-days defined?
Required materials and conditions
Self-reported days with symptoms and measurement methods
Conditions for verification
Show originals for self-reported days with symptoms and measurement methods with selected-subclaim/parent boundaries, direct endpoints/estimand, denominators and external-reading scope.
Requirement and applicability
Required
Application exceptions
Distinguish self-reported symptom-days, people/person-days/repeated/concurrent symptoms and symptom-specific numerators/denominators/effects/CIs from confirmed infections/clinical outcomes; distinguish actual strain drink/identical yogurt, winter 12 weeks, allocation/completion/PPS/attrition, advance hierarchy/registration conflict, company involvement and harms. Preserve original numbers only; no new calculations, invented quantities, effects/CIs, grades/reassessment, independence certification or extract/product/drink-consumption, sleep/cold-management, infection-prevention or treatment-replacement instructions.
Why this condition is needed
Needed to connect self-reported days with symptoms and measurement methods with the selected question, actual population/intervention/comparator, endpoints/hierarchy/estimand, denominators/duration and reports/harms.
Referenced methods
Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production
N09 · What are the runny-nose numerator, denominator and effect?
Required materials and conditions
Original symptom-day proportions, absolute difference and P value
Conditions for verification
Show originals for original symptom-day proportions, absolute difference and P value with selected-subclaim/parent boundaries, direct endpoints/estimand, denominators and external-reading scope.
Requirement and applicability
Required
Application exceptions
Distinguish self-reported symptom-days, people/person-days/repeated/concurrent symptoms and symptom-specific numerators/denominators/effects/CIs from confirmed infections/clinical outcomes; distinguish actual strain drink/identical yogurt, winter 12 weeks, allocation/completion/PPS/attrition, advance hierarchy/registration conflict, company involvement and harms. Preserve original numbers only; no new calculations, invented quantities, effects/CIs, grades/reassessment, independence certification or extract/product/drink-consumption, sleep/cold-management, infection-prevention or treatment-replacement instructions.
Why this condition is needed
Needed to connect original symptom-day proportions, absolute difference and P value with the selected question, actual population/intervention/comparator, endpoints/hierarchy/estimand, denominators/duration and reports/harms.
Referenced methods
Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production
N10 · Are people, person-days, repeated symptoms and events distinct?
Required materials and conditions
Symptom-day denominators versus 193-person denominators
Conditions for verification
Show originals for symptom-day denominators versus 193-person denominators with selected-subclaim/parent boundaries, direct endpoints/estimand, denominators and external-reading scope.
Requirement and applicability
Required
Application exceptions
Distinguish self-reported symptom-days, people/person-days/repeated/concurrent symptoms and symptom-specific numerators/denominators/effects/CIs from confirmed infections/clinical outcomes; distinguish actual strain drink/identical yogurt, winter 12 weeks, allocation/completion/PPS/attrition, advance hierarchy/registration conflict, company involvement and harms. Preserve original numbers only; no new calculations, invented quantities, effects/CIs, grades/reassessment, independence certification or extract/product/drink-consumption, sleep/cold-management, infection-prevention or treatment-replacement instructions.
Why this condition is needed
Needed to connect symptom-day denominators versus 193-person denominators with the selected question, actual population/intervention/comparator, endpoints/hierarchy/estimand, denominators/duration and reports/harms.
Referenced methods
Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production
N11 · Has the correlation structure of repeated records and analyses been verified?
Required materials and conditions
Models/missing data for repeated symptom-days within people
Conditions for verification
Show originals for models/missing data for repeated symptom-days within people with selected-subclaim/parent boundaries, direct endpoints/estimand, denominators and external-reading scope.
Requirement and applicability
Required
Application exceptions
Distinguish self-reported symptom-days, people/person-days/repeated/concurrent symptoms and symptom-specific numerators/denominators/effects/CIs from confirmed infections/clinical outcomes; distinguish actual strain drink/identical yogurt, winter 12 weeks, allocation/completion/PPS/attrition, advance hierarchy/registration conflict, company involvement and harms. Preserve original numbers only; no new calculations, invented quantities, effects/CIs, grades/reassessment, independence certification or extract/product/drink-consumption, sleep/cold-management, infection-prevention or treatment-replacement instructions.
Why this condition is needed
Needed to connect models/missing data for repeated symptom-days within people with the selected question, actual population/intervention/comparator, endpoints/hierarchy/estimand, denominators/duration and reports/harms.
Referenced methods
Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production
N12 · Are other questionnaire symptom results recorded separately?
Required materials and conditions
Nasal congestion, sneezing, sore throat and hoarseness
Conditions for verification
Show originals for nasal congestion, sneezing, sore throat and hoarseness with selected-subclaim/parent boundaries, direct endpoints/estimand, denominators and external-reading scope.
Requirement and applicability
Required
Application exceptions
Distinguish self-reported symptom-days, people/person-days/repeated/concurrent symptoms and symptom-specific numerators/denominators/effects/CIs from confirmed infections/clinical outcomes; distinguish actual strain drink/identical yogurt, winter 12 weeks, allocation/completion/PPS/attrition, advance hierarchy/registration conflict, company involvement and harms. Preserve original numbers only; no new calculations, invented quantities, effects/CIs, grades/reassessment, independence certification or extract/product/drink-consumption, sleep/cold-management, infection-prevention or treatment-replacement instructions.
Why this condition is needed
Needed to connect nasal congestion, sneezing, sore throat and hoarseness with the selected question, actual population/intervention/comparator, endpoints/hierarchy/estimand, denominators/duration and reports/harms.
Referenced methods
Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production
N13 · Are missing cough values being filled from its P value?
Required materials and conditions
Separate cough results and detailed gaps
Conditions for verification
Show originals for separate cough results and detailed gaps with selected-subclaim/parent boundaries, direct endpoints/estimand, denominators and external-reading scope.
Requirement and applicability
Supplementary
Application exceptions
Distinguish self-reported symptom-days, people/person-days/repeated/concurrent symptoms and symptom-specific numerators/denominators/effects/CIs from confirmed infections/clinical outcomes; distinguish actual strain drink/identical yogurt, winter 12 weeks, allocation/completion/PPS/attrition, advance hierarchy/registration conflict, company involvement and harms. Preserve original numbers only; no new calculations, invented quantities, effects/CIs, grades/reassessment, independence certification or extract/product/drink-consumption, sleep/cold-management, infection-prevention or treatment-replacement instructions.
Why this condition is needed
Needed to connect separate cough results and detailed gaps with the selected question, actual population/intervention/comparator, endpoints/hierarchy/estimand, denominators/duration and reports/harms.
Referenced methods
Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production
N14 · Are multiplicity and a composite score across symptoms verified?
Required materials and conditions
Prespecified hierarchical composite scores versus symptom-specific tests
Conditions for verification
Show originals for prespecified hierarchical composite scores versus symptom-specific tests with selected-subclaim/parent boundaries, direct endpoints/estimand, denominators and external-reading scope.
Requirement and applicability
Required
Application exceptions
Distinguish self-reported symptom-days, people/person-days/repeated/concurrent symptoms and symptom-specific numerators/denominators/effects/CIs from confirmed infections/clinical outcomes; distinguish actual strain drink/identical yogurt, winter 12 weeks, allocation/completion/PPS/attrition, advance hierarchy/registration conflict, company involvement and harms. Preserve original numbers only; no new calculations, invented quantities, effects/CIs, grades/reassessment, independence certification or extract/product/drink-consumption, sleep/cold-management, infection-prevention or treatment-replacement instructions.
Why this condition is needed
Needed to connect prespecified hierarchical composite scores versus symptom-specific tests with the selected question, actual population/intervention/comparator, endpoints/hierarchy/estimand, denominators/duration and reports/harms.
Referenced methods
Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production
N15 · Is the primary symptom-day specification distinct from the runny-nose example?
Required materials and conditions
Primary questionnaire symptom-days versus selecting a specific symptom
Conditions for verification
Show originals for primary questionnaire symptom-days versus selecting a specific symptom with selected-subclaim/parent boundaries, direct endpoints/estimand, denominators and external-reading scope.
Requirement and applicability
Required
Application exceptions
Distinguish self-reported symptom-days, people/person-days/repeated/concurrent symptoms and symptom-specific numerators/denominators/effects/CIs from confirmed infections/clinical outcomes; distinguish actual strain drink/identical yogurt, winter 12 weeks, allocation/completion/PPS/attrition, advance hierarchy/registration conflict, company involvement and harms. Preserve original numbers only; no new calculations, invented quantities, effects/CIs, grades/reassessment, independence certification or extract/product/drink-consumption, sleep/cold-management, infection-prevention or treatment-replacement instructions.
Why this condition is needed
Needed to connect primary questionnaire symptom-days versus selecting a specific symptom with the selected question, actual population/intervention/comparator, endpoints/hierarchy/estimand, denominators/duration and reports/harms.
Referenced methods
Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production
N16 · Was laboratory-confirmed infection incidence directly measured?
Required materials and conditions
Questionnaire symptoms versus pathogen-confirmed infection
Conditions for verification
Show originals for questionnaire symptoms versus pathogen-confirmed infection with selected-subclaim/parent boundaries, direct endpoints/estimand, denominators and external-reading scope.
Requirement and applicability
Required
Application exceptions
Distinguish self-reported symptom-days, people/person-days/repeated/concurrent symptoms and symptom-specific numerators/denominators/effects/CIs from confirmed infections/clinical outcomes; distinguish actual strain drink/identical yogurt, winter 12 weeks, allocation/completion/PPS/attrition, advance hierarchy/registration conflict, company involvement and harms. Preserve original numbers only; no new calculations, invented quantities, effects/CIs, grades/reassessment, independence certification or extract/product/drink-consumption, sleep/cold-management, infection-prevention or treatment-replacement instructions.
Why this condition is needed
Needed to connect questionnaire symptoms versus pathogen-confirmed infection with the selected question, actual population/intervention/comparator, endpoints/hierarchy/estimand, denominators/duration and reports/harms.
Referenced methods
Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production
N17 · Are severity, health-care use and other clinical outcomes being filled?
Required materials and conditions
Symptom-days versus severity, clinical visits/hospitalization and absence from work
Conditions for verification
Show originals for symptom-days versus severity, clinical visits/hospitalization and absence from work with selected-subclaim/parent boundaries, direct endpoints/estimand, denominators and external-reading scope.
Requirement and applicability
Required
Application exceptions
Distinguish self-reported symptom-days, people/person-days/repeated/concurrent symptoms and symptom-specific numerators/denominators/effects/CIs from confirmed infections/clinical outcomes; distinguish actual strain drink/identical yogurt, winter 12 weeks, allocation/completion/PPS/attrition, advance hierarchy/registration conflict, company involvement and harms. Preserve original numbers only; no new calculations, invented quantities, effects/CIs, grades/reassessment, independence certification or extract/product/drink-consumption, sleep/cold-management, infection-prevention or treatment-replacement instructions.
Why this condition is needed
Needed to connect symptom-days versus severity, clinical visits/hospitalization and absence from work with the selected question, actual population/intervention/comparator, endpoints/hierarchy/estimand, denominators/duration and reports/harms.
Referenced methods
Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production
N18 · What gaps remain in 95% CIs and clinical effect size?
Required materials and conditions
Original absolute difference/P value and unreported 95% CIs
Conditions for verification
Show originals for original absolute difference/P value and unreported 95% CIs with selected-subclaim/parent boundaries, direct endpoints/estimand, denominators and external-reading scope.
Requirement and applicability
Required
Application exceptions
Distinguish self-reported symptom-days, people/person-days/repeated/concurrent symptoms and symptom-specific numerators/denominators/effects/CIs from confirmed infections/clinical outcomes; distinguish actual strain drink/identical yogurt, winter 12 weeks, allocation/completion/PPS/attrition, advance hierarchy/registration conflict, company involvement and harms. Preserve original numbers only; no new calculations, invented quantities, effects/CIs, grades/reassessment, independence certification or extract/product/drink-consumption, sleep/cold-management, infection-prevention or treatment-replacement instructions.
Why this condition is needed
Needed to connect original absolute difference/P value and unreported 95% CIs with the selected question, actual population/intervention/comparator, endpoints/hierarchy/estimand, denominators/duration and reports/harms.
Referenced methods
Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production
N19 · Are symptom-days presented as a general immunity effect?
Required materials and conditions
The product’s added strain versus broad immunity claims
Conditions for verification
Show originals for the product’s added strain versus broad immunity claims with selected-subclaim/parent boundaries, direct endpoints/estimand, denominators and external-reading scope.
Requirement and applicability
Required
Application exceptions
Distinguish self-reported symptom-days, people/person-days/repeated/concurrent symptoms and symptom-specific numerators/denominators/effects/CIs from confirmed infections/clinical outcomes; distinguish actual strain drink/identical yogurt, winter 12 weeks, allocation/completion/PPS/attrition, advance hierarchy/registration conflict, company involvement and harms. Preserve original numbers only; no new calculations, invented quantities, effects/CIs, grades/reassessment, independence certification or extract/product/drink-consumption, sleep/cold-management, infection-prevention or treatment-replacement instructions.
Why this condition is needed
Needed to connect the product’s added strain versus broad immunity claims with the selected question, actual population/intervention/comparator, endpoints/hierarchy/estimand, denominators/duration and reports/harms.
Referenced methods
Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production
N20 · Are 12-week related safety signals distinct from all harms?
Required materials and conditions
Serious study-food-related signals and dairy/lactose contexts
Conditions for verification
Show originals for serious study-food-related signals and dairy/lactose contexts with selected-subclaim/parent boundaries, direct endpoints/estimand, denominators and external-reading scope.
Requirement and applicability
Supplementary
Application exceptions
Distinguish self-reported symptom-days, people/person-days/repeated/concurrent symptoms and symptom-specific numerators/denominators/effects/CIs from confirmed infections/clinical outcomes; distinguish actual strain drink/identical yogurt, winter 12 weeks, allocation/completion/PPS/attrition, advance hierarchy/registration conflict, company involvement and harms. Preserve original numbers only; no new calculations, invented quantities, effects/CIs, grades/reassessment, independence certification or extract/product/drink-consumption, sleep/cold-management, infection-prevention or treatment-replacement instructions.
Why this condition is needed
Needed to connect serious study-food-related signals and dairy/lactose contexts with the selected question, actual population/intervention/comparator, endpoints/hierarchy/estimand, denominators/duration and reports/harms.
Referenced methods
Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production
N21 · What materials were actually read in this work?
Required materials and conditions
Preserved JSON summary and external-reading status
Conditions for verification
Show originals for preserved JSON summary and external-reading status with selected-subclaim/parent boundaries, direct endpoints/estimand, denominators and external-reading scope.
Requirement and applicability
Required
Application exceptions
Distinguish self-reported symptom-days, people/person-days/repeated/concurrent symptoms and symptom-specific numerators/denominators/effects/CIs from confirmed infections/clinical outcomes; distinguish actual strain drink/identical yogurt, winter 12 weeks, allocation/completion/PPS/attrition, advance hierarchy/registration conflict, company involvement and harms. Preserve original numbers only; no new calculations, invented quantities, effects/CIs, grades/reassessment, independence certification or extract/product/drink-consumption, sleep/cold-management, infection-prevention or treatment-replacement instructions.
Why this condition is needed
Needed to connect preserved JSON summary and external-reading status with the selected question, actual population/intervention/comparator, endpoints/hierarchy/estimand, denominators/duration and reports/harms.
Referenced methods
Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production
N22 · Are registration, public dates, plans and current reading distinct?
Required materials and conditions
Original registration information and detailed plans/access
Conditions for verification
Show originals for original registration information and detailed plans/access with selected-subclaim/parent boundaries, direct endpoints/estimand, denominators and external-reading scope.
Requirement and applicability
Required
Application exceptions
Distinguish self-reported symptom-days, people/person-days/repeated/concurrent symptoms and symptom-specific numerators/denominators/effects/CIs from confirmed infections/clinical outcomes; distinguish actual strain drink/identical yogurt, winter 12 weeks, allocation/completion/PPS/attrition, advance hierarchy/registration conflict, company involvement and harms. Preserve original numbers only; no new calculations, invented quantities, effects/CIs, grades/reassessment, independence certification or extract/product/drink-consumption, sleep/cold-management, infection-prevention or treatment-replacement instructions.
Why this condition is needed
Needed to connect original registration information and detailed plans/access with the selected question, actual population/intervention/comparator, endpoints/hierarchy/estimand, denominators/duration and reports/harms.
Referenced methods
Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production
N23 · Were protocol/SAP and endpoint/multiplicity plans acquired?
Required materials and conditions
Advance plan, change and analysis materials
Conditions for verification
Show originals for advance plan, change and analysis materials with selected-subclaim/parent boundaries, direct endpoints/estimand, denominators and external-reading scope.
Requirement and applicability
Required
Application exceptions
Distinguish self-reported symptom-days, people/person-days/repeated/concurrent symptoms and symptom-specific numerators/denominators/effects/CIs from confirmed infections/clinical outcomes; distinguish actual strain drink/identical yogurt, winter 12 weeks, allocation/completion/PPS/attrition, advance hierarchy/registration conflict, company involvement and harms. Preserve original numbers only; no new calculations, invented quantities, effects/CIs, grades/reassessment, independence certification or extract/product/drink-consumption, sleep/cold-management, infection-prevention or treatment-replacement instructions.
Why this condition is needed
Needed to connect advance plan, change and analysis materials with the selected question, actual population/intervention/comparator, endpoints/hierarchy/estimand, denominators/duration and reports/harms.
Referenced methods
Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production
N24 · Are company funding, product support, employee authors and research roles separate?
Required materials and conditions
Four categories of company involvement and other support
Conditions for verification
Show originals for four categories of company involvement and other support with selected-subclaim/parent boundaries, direct endpoints/estimand, denominators and external-reading scope.
Requirement and applicability
Required
Application exceptions
Distinguish self-reported symptom-days, people/person-days/repeated/concurrent symptoms and symptom-specific numerators/denominators/effects/CIs from confirmed infections/clinical outcomes; distinguish actual strain drink/identical yogurt, winter 12 weeks, allocation/completion/PPS/attrition, advance hierarchy/registration conflict, company involvement and harms. Preserve original numbers only; no new calculations, invented quantities, effects/CIs, grades/reassessment, independence certification or extract/product/drink-consumption, sleep/cold-management, infection-prevention or treatment-replacement instructions.
Why this condition is needed
Needed to connect four categories of company involvement and other support with the selected question, actual population/intervention/comparator, endpoints/hierarchy/estimand, denominators/duration and reports/harms.
Referenced methods
Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production
N25 · Are narrow positive results, broad-claim gaps and unverified materials distinct?
Required materials and conditions
Direct endpoints and access/reporting limitations
Conditions for verification
Show originals for direct endpoints and access/reporting limitations with selected-subclaim/parent boundaries, direct endpoints/estimand, denominators and external-reading scope.
Requirement and applicability
Required
Application exceptions
Distinguish self-reported symptom-days, people/person-days/repeated/concurrent symptoms and symptom-specific numerators/denominators/effects/CIs from confirmed infections/clinical outcomes; distinguish actual strain drink/identical yogurt, winter 12 weeks, allocation/completion/PPS/attrition, advance hierarchy/registration conflict, company involvement and harms. Preserve original numbers only; no new calculations, invented quantities, effects/CIs, grades/reassessment, independence certification or extract/product/drink-consumption, sleep/cold-management, infection-prevention or treatment-replacement instructions.
Why this condition is needed
Needed to connect direct endpoints and access/reporting limitations with the selected question, actual population/intervention/comparator, endpoints/hierarchy/estimand, denominators/duration and reports/harms.
Referenced methods
Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production
N26 · Are reports, trials, people, repeated measures and sibling sheets distinct?
Required materials and conditions
Document linkage versus unique trials/participants
Conditions for verification
Show originals for document linkage versus unique trials/participants with selected-subclaim/parent boundaries, direct endpoints/estimand, denominators and external-reading scope.
Requirement and applicability
Required
Application exceptions
Distinguish self-reported symptom-days, people/person-days/repeated/concurrent symptoms and symptom-specific numerators/denominators/effects/CIs from confirmed infections/clinical outcomes; distinguish actual strain drink/identical yogurt, winter 12 weeks, allocation/completion/PPS/attrition, advance hierarchy/registration conflict, company involvement and harms. Preserve original numbers only; no new calculations, invented quantities, effects/CIs, grades/reassessment, independence certification or extract/product/drink-consumption, sleep/cold-management, infection-prevention or treatment-replacement instructions.
Why this condition is needed
Needed to connect document linkage versus unique trials/participants with the selected question, actual population/intervention/comparator, endpoints/hierarchy/estimand, denominators/duration and reports/harms.
Referenced methods
Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production
N27 · Is there evidence of separate independent confirmation?
Required materials and conditions
Original R1/I0 versus independent replication
Conditions for verification
Show originals for original R1/I0 versus independent replication with selected-subclaim/parent boundaries, direct endpoints/estimand, denominators and external-reading scope.
Requirement and applicability
Supplementary
Application exceptions
Distinguish self-reported symptom-days, people/person-days/repeated/concurrent symptoms and symptom-specific numerators/denominators/effects/CIs from confirmed infections/clinical outcomes; distinguish actual strain drink/identical yogurt, winter 12 weeks, allocation/completion/PPS/attrition, advance hierarchy/registration conflict, company involvement and harms. Preserve original numbers only; no new calculations, invented quantities, effects/CIs, grades/reassessment, independence certification or extract/product/drink-consumption, sleep/cold-management, infection-prevention or treatment-replacement instructions.
Why this condition is needed
Needed to connect original R1/I0 versus independent replication with the selected question, actual population/intervention/comparator, endpoints/hierarchy/estimand, denominators/duration and reports/harms.
Referenced methods
Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production
N28 · Are selected-subclaim and parent scores/axes preserved?
Required materials and conditions
Subclaim grade/note, absent fields and parent context
Conditions for verification
Show originals for subclaim grade/note, absent fields and parent context with selected-subclaim/parent boundaries, direct endpoints/estimand, denominators and external-reading scope.
Requirement and applicability
Required
Application exceptions
Distinguish self-reported symptom-days, people/person-days/repeated/concurrent symptoms and symptom-specific numerators/denominators/effects/CIs from confirmed infections/clinical outcomes; distinguish actual strain drink/identical yogurt, winter 12 weeks, allocation/completion/PPS/attrition, advance hierarchy/registration conflict, company involvement and harms. Preserve original numbers only; no new calculations, invented quantities, effects/CIs, grades/reassessment, independence certification or extract/product/drink-consumption, sleep/cold-management, infection-prevention or treatment-replacement instructions.
Why this condition is needed
Needed to connect subclaim grade/note, absent fields and parent context with the selected question, actual population/intervention/comparator, endpoints/hierarchy/estimand, denominators/duration and reports/harms.
Referenced methods
Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production
N29 · Are Korean/English wording and absent structured fields preserved?
Required materials and conditions
Wording in both languages and absent classification fields
Conditions for verification
Show originals for wording in both languages and absent classification fields with selected-subclaim/parent boundaries, direct endpoints/estimand, denominators and external-reading scope.
Requirement and applicability
Required
Application exceptions
Distinguish self-reported symptom-days, people/person-days/repeated/concurrent symptoms and symptom-specific numerators/denominators/effects/CIs from confirmed infections/clinical outcomes; distinguish actual strain drink/identical yogurt, winter 12 weeks, allocation/completion/PPS/attrition, advance hierarchy/registration conflict, company involvement and harms. Preserve original numbers only; no new calculations, invented quantities, effects/CIs, grades/reassessment, independence certification or extract/product/drink-consumption, sleep/cold-management, infection-prevention or treatment-replacement instructions.
Why this condition is needed
Needed to connect wording in both languages and absent classification fields with the selected question, actual population/intervention/comparator, endpoints/hierarchy/estimand, denominators/duration and reports/harms.
Referenced methods
Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production
N30 · Are reference dates, corrections, historical cross-checking and production dates distinct?
Required materials and conditions
Original 2026-08-26 versus production/application events
Conditions for verification
Show originals for original 2026-08-26 versus production/application events with selected-subclaim/parent boundaries, direct endpoints/estimand, denominators and external-reading scope.
Requirement and applicability
Required
Application exceptions
Distinguish self-reported symptom-days, people/person-days/repeated/concurrent symptoms and symptom-specific numerators/denominators/effects/CIs from confirmed infections/clinical outcomes; distinguish actual strain drink/identical yogurt, winter 12 weeks, allocation/completion/PPS/attrition, advance hierarchy/registration conflict, company involvement and harms. Preserve original numbers only; no new calculations, invented quantities, effects/CIs, grades/reassessment, independence certification or extract/product/drink-consumption, sleep/cold-management, infection-prevention or treatment-replacement instructions.
Why this condition is needed
Needed to connect original 2026-08-26 versus production/application events with the selected question, actual population/intervention/comparator, endpoints/hierarchy/estimand, denominators/duration and reports/harms.
Referenced methods
Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production
N31 · What direct materials could fill the selected gaps?
Required materials and conditions
Definitions, direct endpoints, denominators/effects/CIs and plans
Conditions for verification
Show originals for definitions, direct endpoints, denominators/effects/CIs and plans with selected-subclaim/parent boundaries, direct endpoints/estimand, denominators and external-reading scope.
Requirement and applicability
Supplementary
Application exceptions
Distinguish self-reported symptom-days, people/person-days/repeated/concurrent symptoms and symptom-specific numerators/denominators/effects/CIs from confirmed infections/clinical outcomes; distinguish actual strain drink/identical yogurt, winter 12 weeks, allocation/completion/PPS/attrition, advance hierarchy/registration conflict, company involvement and harms. Preserve original numbers only; no new calculations, invented quantities, effects/CIs, grades/reassessment, independence certification or extract/product/drink-consumption, sleep/cold-management, infection-prevention or treatment-replacement instructions.
Why this condition is needed
Needed to connect definitions, direct endpoints, denominators/effects/CIs and plans with the selected question, actual population/intervention/comparator, endpoints/hierarchy/estimand, denominators/duration and reports/harms.
Referenced methods
Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production
N32 · Are production, user review and implementation instructions distinct?
Required materials and conditions
Production request, candidate history and content-review responsibility
Conditions for verification
Show originals for production request, candidate history and content-review responsibility with selected-subclaim/parent boundaries, direct endpoints/estimand, denominators and external-reading scope.
Requirement and applicability
Supplementary
Application exceptions
Distinguish self-reported symptom-days, people/person-days/repeated/concurrent symptoms and symptom-specific numerators/denominators/effects/CIs from confirmed infections/clinical outcomes; distinguish actual strain drink/identical yogurt, winter 12 weeks, allocation/completion/PPS/attrition, advance hierarchy/registration conflict, company involvement and harms. Preserve original numbers only; no new calculations, invented quantities, effects/CIs, grades/reassessment, independence certification or extract/product/drink-consumption, sleep/cold-management, infection-prevention or treatment-replacement instructions.
Why this condition is needed
Needed to connect production request, candidate history and content-review responsibility with the selected question, actual population/intervention/comparator, endpoints/hierarchy/estimand, denominators/duration and reports/harms.
Referenced methods
Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production
Referenced methods and the sections actually reviewed

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

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

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

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

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

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

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

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

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

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

Official methodology · §15.2.4, §15.3.1–15.3.3

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

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

Official methodology · §19.1.2, §19.2.1–19.2.4

Referenced principle
Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.
Extent of review
Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed.
What the statuses mean
Partly verified
Some information exists in the preserved review summary; detailed original materials remain unverified. This does not certify a passed review or clinical efficacy.
Unverified
Detailed materials for the selected condition could not be established within the stored scope; this does not mean zero effect, zero studies or safety
Review incomplete
Review of existing content incomplete
Met
Use only within the relevant conditions after existing content review; no automatic designation in this preparation
Not reported
Distinguish only within materials actually read; do not turn unread external materials into unreported findings
Inaccessible
Not applied during this preparation because actual access was not tested
Not applicable
Use with a reason for non-applicability based on an explicit question boundary
Conflicting data
Judge after actual material comparison; review was not performed during this preparation
Insufficient evidence for the conditions
Do not use as a clinical grade encompassing currently unread materials

Change history

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

Public pages and materials were prepared from the existing 32 items. No new clinical search, verification-status change or scoring was performed.

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

Researcher downloads

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

View all item details

N01 · Which existing questionnaire symptom-day claim is being transferred?

Current findings
The selected claim is fewer questionnaire-recorded cold-like symptom-days, with original subclaim grade C and a note that several symptom-day proportions were lower but 95% CIs were not reported. Absent subclaim score/status/axes are distinguished from parent C50.
Verification status
Partly verified
Materials actually read
Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
Why unverified
Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.
Reason for missing information
Questionnaire symptom definitions, denominators, comparison/time points, estimand and user boundary review. The parent score is not used to fill subclaim values.
Required materials and conditions
Selected wording, subclaim grade and parent results
Materials to obtain first
Questionnaire symptom definitions, denominators, comparison/time points, estimand and user boundary review. The parent score is not used to fill subclaim values.
Further research
Materials needed: Questionnaire symptom definitions, denominators, comparison/time points, estimand and user boundary review. The parent score is not used to fill subclaim values. Only material requests/research needs are recorded; no current lookup or research execution.
Remaining uncertainty
External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.
Conditions for verification
Show originals for selected wording, subclaim grade and parent results with selected-subclaim/parent boundaries, direct endpoints/estimand, denominators and external-reading scope.
Why this condition is needed
Needed to connect selected wording, subclaim grade and parent results with the selected question, actual population/intervention/comparator, endpoints/hierarchy/estimand, denominators/duration and reports/harms.
Application exceptions
Distinguish self-reported symptom-days, people/person-days/repeated/concurrent symptoms and symptom-specific numerators/denominators/effects/CIs from confirmed infections/clinical outcomes; distinguish actual strain drink/identical yogurt, winter 12 weeks, allocation/completion/PPS/attrition, advance hierarchy/registration conflict, company involvement and harms. Preserve original numbers only; no new calculations, invented quantities, effects/CIs, grades/reassessment, independence certification or extract/product/drink-consumption, sleep/cold-management, infection-prevention or treatment-replacement instructions.
Referenced methods
Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

Related sources R01

N02 · What cold risk and health status characterize the population?

Current findings
The original trial involved 200 healthy Japanese people aged 20–64 prone to colds. Applicability is not expanded to children, older people, immunocompromised people/patients or every region/season.
Verification status
Partly verified
Materials actually read
Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
Why unverified
Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.
Reason for missing information
Original materials on cold susceptibility/eligibility, baseline health, comorbidities/medication and vaccination/contact exposure, plus direct results in other populations.
Required materials and conditions
Healthy Japanese adults aged 20–64 prone to colds
Materials to obtain first
Original materials on cold susceptibility/eligibility, baseline health, comorbidities/medication and vaccination/contact exposure, plus direct results in other populations.
Further research
Materials needed: Original materials on cold susceptibility/eligibility, baseline health, comorbidities/medication and vaccination/contact exposure, plus direct results in other populations. Only material requests/research needs are recorded; no current lookup or research execution.
Remaining uncertainty
External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.
Conditions for verification
Show originals for healthy Japanese adults aged 20–64 prone to colds with selected-subclaim/parent boundaries, direct endpoints/estimand, denominators and external-reading scope.
Why this condition is needed
Needed to connect healthy Japanese adults aged 20–64 prone to colds with the selected question, actual population/intervention/comparator, endpoints/hierarchy/estimand, denominators/duration and reports/harms.
Application exceptions
Distinguish self-reported symptom-days, people/person-days/repeated/concurrent symptoms and symptom-specific numerators/denominators/effects/CIs from confirmed infections/clinical outcomes; distinguish actual strain drink/identical yogurt, winter 12 weeks, allocation/completion/PPS/attrition, advance hierarchy/registration conflict, company involvement and harms. Preserve original numbers only; no new calculations, invented quantities, effects/CIs, grades/reassessment, independence certification or extract/product/drink-consumption, sleep/cold-management, infection-prevention or treatment-replacement instructions.
Referenced methods
Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

Related sources R01

N03 · What is the study identity of the trial drink?

Current findings
The original English text describes a drink containing Lactobacillus paragasseri SBT2055 (LG2055), the company-developed LG2055 drinkable yogurt. Organism count/CFU, drink volume, detailed composition and adherence are not established within the preserved scope. Equivalent effects of other strains/fermented milks are not assumed.
Verification status
Partly verified
Materials actually read
Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
Why unverified
Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.
Reason for missing information
Original strain, formulation/quantities, active product/manufacturing and actual exposure/adherence materials. No product/drink consumption or cold/infection-prevention instructions.
Required materials and conditions
LG2055 drinkable yogurt versus other probiotics/products
Materials to obtain first
Original strain, formulation/quantities, active product/manufacturing and actual exposure/adherence materials. No product/drink consumption or cold/infection-prevention instructions.
Further research
Materials needed: Original strain, formulation/quantities, active product/manufacturing and actual exposure/adherence materials. No product/drink consumption or cold/infection-prevention instructions. Only material requests/research needs are recorded; no current lookup or research execution.
Remaining uncertainty
External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.
Conditions for verification
Show originals for lG2055 drinkable yogurt versus other probiotics/products with selected-subclaim/parent boundaries, direct endpoints/estimand, denominators and external-reading scope.
Why this condition is needed
Needed to connect lG2055 drinkable yogurt versus other probiotics/products with the selected question, actual population/intervention/comparator, endpoints/hierarchy/estimand, denominators/duration and reports/harms.
Application exceptions
Distinguish self-reported symptom-days, people/person-days/repeated/concurrent symptoms and symptom-specific numerators/denominators/effects/CIs from confirmed infections/clinical outcomes; distinguish actual strain drink/identical yogurt, winter 12 weeks, allocation/completion/PPS/attrition, advance hierarchy/registration conflict, company involvement and harms. Preserve original numbers only; no new calculations, invented quantities, effects/CIs, grades/reassessment, independence certification or extract/product/drink-consumption, sleep/cold-management, infection-prevention or treatment-replacement instructions.
Referenced methods
Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

Related sources R01

N04 · What does the actual identical-yogurt control compare?

Current findings
The original materials explain that LG2055 yogurt was compared with identical yogurt lacking only LG2055 to ask about the added strain’s symptom-day effect. This is not changed into a comparison with no yogurt/intervention or an effect of yogurt in general.
Verification status
Partly verified
Materials actually read
Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
Why unverified
Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.
Reason for missing information
Group composition, sensory properties/masking, actual product/exposure, concurrent diet/treatment and contact materials. Equality of all conditions is not certified through a new external comparison.
Required materials and conditions
Identical yogurt lacking only LG2055
Materials to obtain first
Group composition, sensory properties/masking, actual product/exposure, concurrent diet/treatment and contact materials. Equality of all conditions is not certified through a new external comparison.
Further research
Materials needed: Group composition, sensory properties/masking, actual product/exposure, concurrent diet/treatment and contact materials. Equality of all conditions is not certified through a new external comparison. Only material requests/research needs are recorded; no current lookup or research execution.
Remaining uncertainty
External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.
Conditions for verification
Show originals for identical yogurt lacking only LG2055 with selected-subclaim/parent boundaries, direct endpoints/estimand, denominators and external-reading scope.
Why this condition is needed
Needed to connect identical yogurt lacking only LG2055 with the selected question, actual population/intervention/comparator, endpoints/hierarchy/estimand, denominators/duration and reports/harms.
Application exceptions
Distinguish self-reported symptom-days, people/person-days/repeated/concurrent symptoms and symptom-specific numerators/denominators/effects/CIs from confirmed infections/clinical outcomes; distinguish actual strain drink/identical yogurt, winter 12 weeks, allocation/completion/PPS/attrition, advance hierarchy/registration conflict, company involvement and harms. Preserve original numbers only; no new calculations, invented quantities, effects/CIs, grades/reassessment, independence certification or extract/product/drink-consumption, sleep/cold-management, infection-prevention or treatment-replacement instructions.
Referenced methods
Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

Related sources R01

N05 · Are winter 12-week results separated from other durations?

Current findings
The original trial observed participants for 12 weeks during winter. Actual intake/adherence, date/season distribution, missing symptom records and post-intervention follow-up remain unverified in detail. 12 weeks are not converted into a new total of days/person-days.
Verification status
Partly verified
Materials actually read
Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
Why unverified
Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.
Reason for missing information
Original actual-exposure/recording duration, missingness/discontinuation, season/infection exposure and time-specific results. No long-term prevention/persistence effects or implementation instructions.
Required materials and conditions
Observation duration, season and actual exposure
Materials to obtain first
Original actual-exposure/recording duration, missingness/discontinuation, season/infection exposure and time-specific results. No long-term prevention/persistence effects or implementation instructions.
Further research
Materials needed: Original actual-exposure/recording duration, missingness/discontinuation, season/infection exposure and time-specific results. No long-term prevention/persistence effects or implementation instructions. Only material requests/research needs are recorded; no current lookup or research execution.
Remaining uncertainty
External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.
Conditions for verification
Show originals for observation duration, season and actual exposure with selected-subclaim/parent boundaries, direct endpoints/estimand, denominators and external-reading scope.
Why this condition is needed
Needed to connect observation duration, season and actual exposure with the selected question, actual population/intervention/comparator, endpoints/hierarchy/estimand, denominators/duration and reports/harms.
Application exceptions
Distinguish self-reported symptom-days, people/person-days/repeated/concurrent symptoms and symptom-specific numerators/denominators/effects/CIs from confirmed infections/clinical outcomes; distinguish actual strain drink/identical yogurt, winter 12 weeks, allocation/completion/PPS/attrition, advance hierarchy/registration conflict, company involvement and harms. Preserve original numbers only; no new calculations, invented quantities, effects/CIs, grades/reassessment, independence certification or extract/product/drink-consumption, sleep/cold-management, infection-prevention or treatment-replacement instructions.
Referenced methods
Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

Related sources R01

N06 · Are allocation, consumption completion and primary efficacy analyses separate?

Current findings
The original materials report 200 randomized participants, 100/100 allocated, 198 completing consumption and, after five exclusions, a primary efficacy PPS of 193 (97/96). These original numbers describe separate stages; no new attrition counts/rates or group-specific exclusion counts are calculated.
Verification status
Partly verified
Materials actually read
Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
Why unverified
Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.
Reason for missing information
Flow diagrams, group-specific completion/exclusion reasons, endpoint-specific observations/analyses and missing-data handling. 200 randomized participants are not automatically repurposed as efficacy, harm or symptom-day denominators.
Required materials and conditions
200/198/193 participants and group-specific PPS
Materials to obtain first
Flow diagrams, group-specific completion/exclusion reasons, endpoint-specific observations/analyses and missing-data handling. 200 randomized participants are not automatically repurposed as efficacy, harm or symptom-day denominators.
Further research
Materials needed: Flow diagrams, group-specific completion/exclusion reasons, endpoint-specific observations/analyses and missing-data handling. 200 randomized participants are not automatically repurposed as efficacy, harm or symptom-day denominators. Only material requests/research needs are recorded; no current lookup or research execution.
Remaining uncertainty
External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.
Conditions for verification
Show originals for 200/198/193 participants and group-specific PPS with selected-subclaim/parent boundaries, direct endpoints/estimand, denominators and external-reading scope.
Why this condition is needed
Needed to connect 200/198/193 participants and group-specific PPS with the selected question, actual population/intervention/comparator, endpoints/hierarchy/estimand, denominators/duration and reports/harms.
Application exceptions
Distinguish self-reported symptom-days, people/person-days/repeated/concurrent symptoms and symptom-specific numerators/denominators/effects/CIs from confirmed infections/clinical outcomes; distinguish actual strain drink/identical yogurt, winter 12 weeks, allocation/completion/PPS/attrition, advance hierarchy/registration conflict, company involvement and harms. Preserve original numbers only; no new calculations, invented quantities, effects/CIs, grades/reassessment, independence certification or extract/product/drink-consumption, sleep/cold-management, infection-prevention or treatment-replacement instructions.
Referenced methods
Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

Related sources R01

N07 · Are PPS results presented as ITT effects for everyone?

Current findings
Primary efficacy used the PPS of 193 rather than all 200 participants. The original verdict records this limit; identical effects or sensitivity results for the full randomized ITT population are not established within the preserved scope.
Verification status
Partly verified
Materials actually read
Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
Why unverified
Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.
Reason for missing information
Original ITT/other analysis populations, exclusions/missing data and results, and prespecified analysis plans. Positive PPS results are not certified as effects in all randomized participants.
Required materials and conditions
Protocol-compliant completer analysis versus all randomized participants
Materials to obtain first
Original ITT/other analysis populations, exclusions/missing data and results, and prespecified analysis plans. Positive PPS results are not certified as effects in all randomized participants.
Further research
Materials needed: Original ITT/other analysis populations, exclusions/missing data and results, and prespecified analysis plans. Positive PPS results are not certified as effects in all randomized participants. Only material requests/research needs are recorded; no current lookup or research execution.
Remaining uncertainty
External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.
Conditions for verification
Show originals for protocol-compliant completer analysis versus all randomized participants with selected-subclaim/parent boundaries, direct endpoints/estimand, denominators and external-reading scope.
Why this condition is needed
Needed to connect protocol-compliant completer analysis versus all randomized participants with the selected question, actual population/intervention/comparator, endpoints/hierarchy/estimand, denominators/duration and reports/harms.
Application exceptions
Distinguish self-reported symptom-days, people/person-days/repeated/concurrent symptoms and symptom-specific numerators/denominators/effects/CIs from confirmed infections/clinical outcomes; distinguish actual strain drink/identical yogurt, winter 12 weeks, allocation/completion/PPS/attrition, advance hierarchy/registration conflict, company involvement and harms. Preserve original numbers only; no new calculations, invented quantities, effects/CIs, grades/reassessment, independence certification or extract/product/drink-consumption, sleep/cold-management, infection-prevention or treatment-replacement instructions.
Referenced methods
Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

Related sources R01

N08 · How are questionnaire symptom-days defined?

Current findings
The original primary endpoint was days with questionnaire-recorded cold-like symptoms over 12 weeks. Detailed symptom items/frequency, recording methods, adjudication/severity criteria, concurrent treatment and missing-record rules remain unverified. This is preserved as a direct outcome distinct from confirmed infection.
Verification status
Partly verified
Materials actually read
Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
Why unverified
Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.
Reason for missing information
Questionnaire tools, symptom-day criteria/concurrent symptoms, recording/missingness, measurement timing, advance plans and original tables. Symptom names are not newly designated as confirmed diagnoses.
Required materials and conditions
Self-reported days with symptoms and measurement methods
Materials to obtain first
Questionnaire tools, symptom-day criteria/concurrent symptoms, recording/missingness, measurement timing, advance plans and original tables. Symptom names are not newly designated as confirmed diagnoses.
Further research
Materials needed: Questionnaire tools, symptom-day criteria/concurrent symptoms, recording/missingness, measurement timing, advance plans and original tables. Symptom names are not newly designated as confirmed diagnoses. Only material requests/research needs are recorded; no current lookup or research execution.
Remaining uncertainty
External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.
Conditions for verification
Show originals for self-reported days with symptoms and measurement methods with selected-subclaim/parent boundaries, direct endpoints/estimand, denominators and external-reading scope.
Why this condition is needed
Needed to connect self-reported days with symptoms and measurement methods with the selected question, actual population/intervention/comparator, endpoints/hierarchy/estimand, denominators/duration and reports/harms.
Application exceptions
Distinguish self-reported symptom-days, people/person-days/repeated/concurrent symptoms and symptom-specific numerators/denominators/effects/CIs from confirmed infections/clinical outcomes; distinguish actual strain drink/identical yogurt, winter 12 weeks, allocation/completion/PPS/attrition, advance hierarchy/registration conflict, company involvement and harms. Preserve original numbers only; no new calculations, invented quantities, effects/CIs, grades/reassessment, independence certification or extract/product/drink-consumption, sleep/cold-management, infection-prevention or treatment-replacement instructions.
Referenced methods
Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

Related sources R01

N09 · What are the runny-nose numerator, denominator and effect?

Current findings
Original runny-nose days were 2384/8148 days (29.3%) versus 2769/8066 days (34.3%), with original absolute difference −5.0 percentage points and P<.001. Only the original symptom-day values are preserved; they are not converted into individual infection risk, new RR/CI or an absolute reduction in days.
Verification status
Partly verified
Materials actually read
Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
Why unverified
Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.
Reason for missing information
Original runny-nose symptom-day tables, group-specific denominator definitions, estimand, analysis model and 95% CI materials. No new recalculation or invented quantitative example.
Required materials and conditions
Original symptom-day proportions, absolute difference and P value
Materials to obtain first
Original runny-nose symptom-day tables, group-specific denominator definitions, estimand, analysis model and 95% CI materials. No new recalculation or invented quantitative example.
Further research
Materials needed: Original runny-nose symptom-day tables, group-specific denominator definitions, estimand, analysis model and 95% CI materials. No new recalculation or invented quantitative example. Only material requests/research needs are recorded; no current lookup or research execution.
Remaining uncertainty
External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.
Conditions for verification
Show originals for original symptom-day proportions, absolute difference and P value with selected-subclaim/parent boundaries, direct endpoints/estimand, denominators and external-reading scope.
Why this condition is needed
Needed to connect original symptom-day proportions, absolute difference and P value with the selected question, actual population/intervention/comparator, endpoints/hierarchy/estimand, denominators/duration and reports/harms.
Application exceptions
Distinguish self-reported symptom-days, people/person-days/repeated/concurrent symptoms and symptom-specific numerators/denominators/effects/CIs from confirmed infections/clinical outcomes; distinguish actual strain drink/identical yogurt, winter 12 weeks, allocation/completion/PPS/attrition, advance hierarchy/registration conflict, company involvement and harms. Preserve original numbers only; no new calculations, invented quantities, effects/CIs, grades/reassessment, independence certification or extract/product/drink-consumption, sleep/cold-management, infection-prevention or treatment-replacement instructions.
Referenced methods
Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

Related sources R01

N10 · Are people, person-days, repeated symptoms and events distinct?

Current findings
2384/8148 and 2769/8066 are day numerators/denominators in the original wording, distinct from the person denominators of 193 (97/96). Overlapping symptoms within the same day/person remain unverified in detail. Symptom-specific days are not summed as unique people or infection events.
Verification status
Partly verified
Materials actually read
Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
Why unverified
Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.
Reason for missing information
Original recording/denominator units, participant-specific durations, concurrent/repeated symptoms, event definitions and missingness. No new person-day details/totals are calculated.
Required materials and conditions
Symptom-day denominators versus 193-person denominators
Materials to obtain first
Original recording/denominator units, participant-specific durations, concurrent/repeated symptoms, event definitions and missingness. No new person-day details/totals are calculated.
Further research
Materials needed: Original recording/denominator units, participant-specific durations, concurrent/repeated symptoms, event definitions and missingness. No new person-day details/totals are calculated. Only material requests/research needs are recorded; no current lookup or research execution.
Remaining uncertainty
External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.
Conditions for verification
Show originals for symptom-day denominators versus 193-person denominators with selected-subclaim/parent boundaries, direct endpoints/estimand, denominators and external-reading scope.
Why this condition is needed
Needed to connect symptom-day denominators versus 193-person denominators with the selected question, actual population/intervention/comparator, endpoints/hierarchy/estimand, denominators/duration and reports/harms.
Application exceptions
Distinguish self-reported symptom-days, people/person-days/repeated/concurrent symptoms and symptom-specific numerators/denominators/effects/CIs from confirmed infections/clinical outcomes; distinguish actual strain drink/identical yogurt, winter 12 weeks, allocation/completion/PPS/attrition, advance hierarchy/registration conflict, company involvement and harms. Preserve original numbers only; no new calculations, invented quantities, effects/CIs, grades/reassessment, independence certification or extract/product/drink-consumption, sleep/cold-management, infection-prevention or treatment-replacement instructions.
Referenced methods
Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

Related sources R01

N11 · Has the correlation structure of repeated records and analyses been verified?

Current findings
The original materials provide symptom-day proportions and P values, but detailed handling of repeated/concurrent symptoms within participants, clustering/time series, missingness and models remains unverified. It is not asserted that repeated days were treated as independent participants, and no new error is judged.
Verification status
Unverified
Materials actually read
Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
Why unverified
Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.
Reason for missing information
Original estimand, within-participant repetition/correlation, missing observations, aggregation/testing methods and sensitivity analyses. No current model reanalysis or clinical calculation.
Required materials and conditions
Models/missing data for repeated symptom-days within people
Materials to obtain first
Original estimand, within-participant repetition/correlation, missing observations, aggregation/testing methods and sensitivity analyses. No current model reanalysis or clinical calculation.
Further research
Materials needed: Original estimand, within-participant repetition/correlation, missing observations, aggregation/testing methods and sensitivity analyses. No current model reanalysis or clinical calculation. Only material requests/research needs are recorded; no current lookup or research execution.
Remaining uncertainty
External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.
Conditions for verification
Show originals for models/missing data for repeated symptom-days within people with selected-subclaim/parent boundaries, direct endpoints/estimand, denominators and external-reading scope.
Why this condition is needed
Needed to connect models/missing data for repeated symptom-days within people with the selected question, actual population/intervention/comparator, endpoints/hierarchy/estimand, denominators/duration and reports/harms.
Application exceptions
Distinguish self-reported symptom-days, people/person-days/repeated/concurrent symptoms and symptom-specific numerators/denominators/effects/CIs from confirmed infections/clinical outcomes; distinguish actual strain drink/identical yogurt, winter 12 weeks, allocation/completion/PPS/attrition, advance hierarchy/registration conflict, company involvement and harms. Preserve original numbers only; no new calculations, invented quantities, effects/CIs, grades/reassessment, independence certification or extract/product/drink-consumption, sleep/cold-management, infection-prevention or treatment-replacement instructions.
Referenced methods
Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

Related sources R01

N12 · Are other questionnaire symptom results recorded separately?

Current findings
The original narrative reports nasal congestion 17.7% versus 27.7%, sneezing 17.7% versus 20.2%, sore throat 6.3% versus 12.2% and hoarseness 3.5% versus 8.2%. Each original proportion is preserved; runny-nose P/CI limitations or denominators are not automatically copied to all symptoms, and no new difference/RR is calculated.
Verification status
Partly verified
Materials actually read
Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
Why unverified
Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.
Reason for missing information
Original symptom-specific actual numerators/denominators, effects/CIs, models/time points and advance hierarchy. Symptoms are not added as a new composite score or infection event.
Required materials and conditions
Nasal congestion, sneezing, sore throat and hoarseness
Materials to obtain first
Original symptom-specific actual numerators/denominators, effects/CIs, models/time points and advance hierarchy. Symptoms are not added as a new composite score or infection event.
Further research
Materials needed: Original symptom-specific actual numerators/denominators, effects/CIs, models/time points and advance hierarchy. Symptoms are not added as a new composite score or infection event. Only material requests/research needs are recorded; no current lookup or research execution.
Remaining uncertainty
External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.
Conditions for verification
Show originals for nasal congestion, sneezing, sore throat and hoarseness with selected-subclaim/parent boundaries, direct endpoints/estimand, denominators and external-reading scope.
Why this condition is needed
Needed to connect nasal congestion, sneezing, sore throat and hoarseness with the selected question, actual population/intervention/comparator, endpoints/hierarchy/estimand, denominators/duration and reports/harms.
Application exceptions
Distinguish self-reported symptom-days, people/person-days/repeated/concurrent symptoms and symptom-specific numerators/denominators/effects/CIs from confirmed infections/clinical outcomes; distinguish actual strain drink/identical yogurt, winter 12 weeks, allocation/completion/PPS/attrition, advance hierarchy/registration conflict, company involvement and harms. Preserve original numbers only; no new calculations, invented quantities, effects/CIs, grades/reassessment, independence certification or extract/product/drink-consumption, sleep/cold-management, infection-prevention or treatment-replacement instructions.
Referenced methods
Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

Related sources R01

N13 · Are missing cough values being filled from its P value?

Current findings
The original counterview records that cough also had P<.001. Exact cough proportions, numerators/denominators and effects/CIs are not provided in the summary. Runny-nose 29.3/34.3% and −5.0 percentage points are not copied to cough.
Verification status
Partly verified
Materials actually read
Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
Why unverified
Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.
Reason for missing information
Original cough tables, denominators, effects/CIs, tests/models and advance hierarchy. No new symptom values or CI estimates.
Required materials and conditions
Separate cough results and detailed gaps
Materials to obtain first
Original cough tables, denominators, effects/CIs, tests/models and advance hierarchy. No new symptom values or CI estimates.
Further research
Materials needed: Original cough tables, denominators, effects/CIs, tests/models and advance hierarchy. No new symptom values or CI estimates. Only material requests/research needs are recorded; no current lookup or research execution.
Remaining uncertainty
External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.
Conditions for verification
Show originals for separate cough results and detailed gaps with selected-subclaim/parent boundaries, direct endpoints/estimand, denominators and external-reading scope.
Why this condition is needed
Needed to connect separate cough results and detailed gaps with the selected question, actual population/intervention/comparator, endpoints/hierarchy/estimand, denominators/duration and reports/harms.
Application exceptions
Distinguish self-reported symptom-days, people/person-days/repeated/concurrent symptoms and symptom-specific numerators/denominators/effects/CIs from confirmed infections/clinical outcomes; distinguish actual strain drink/identical yogurt, winter 12 weeks, allocation/completion/PPS/attrition, advance hierarchy/registration conflict, company involvement and harms. Preserve original numbers only; no new calculations, invented quantities, effects/CIs, grades/reassessment, independence certification or extract/product/drink-consumption, sleep/cold-management, infection-prevention or treatment-replacement instructions.
Referenced methods
Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

Related sources R01

N14 · Are multiplicity and a composite score across symptoms verified?

Current findings
The original materials record that the symptoms were not tested as one prespecified hierarchical composite score. Total test numbers, multiplicity adjustment/success criteria and advance plans remain unverified in detail. Original P values are not changed into adjusted P values or upgraded into whole-product cold prevention.
Verification status
Partly verified
Materials actually read
Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
Why unverified
Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.
Reason for missing information
Complete endpoint/test lists, registration/protocol/SAP, prespecification/multiple comparisons, selective reporting and original results. No new adjusted P value or grade.
Required materials and conditions
Prespecified hierarchical composite scores versus symptom-specific tests
Materials to obtain first
Complete endpoint/test lists, registration/protocol/SAP, prespecification/multiple comparisons, selective reporting and original results. No new adjusted P value or grade.
Further research
Materials needed: Complete endpoint/test lists, registration/protocol/SAP, prespecification/multiple comparisons, selective reporting and original results. No new adjusted P value or grade. Only material requests/research needs are recorded; no current lookup or research execution.
Remaining uncertainty
External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.
Conditions for verification
Show originals for prespecified hierarchical composite scores versus symptom-specific tests with selected-subclaim/parent boundaries, direct endpoints/estimand, denominators and external-reading scope.
Why this condition is needed
Needed to connect prespecified hierarchical composite scores versus symptom-specific tests with the selected question, actual population/intervention/comparator, endpoints/hierarchy/estimand, denominators/duration and reports/harms.
Application exceptions
Distinguish self-reported symptom-days, people/person-days/repeated/concurrent symptoms and symptom-specific numerators/denominators/effects/CIs from confirmed infections/clinical outcomes; distinguish actual strain drink/identical yogurt, winter 12 weeks, allocation/completion/PPS/attrition, advance hierarchy/registration conflict, company involvement and harms. Preserve original numbers only; no new calculations, invented quantities, effects/CIs, grades/reassessment, independence certification or extract/product/drink-consumption, sleep/cold-management, infection-prevention or treatment-replacement instructions.
Referenced methods
Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

Related sources R01

N15 · Is the primary symptom-day specification distinct from the runny-nose example?

Current findings
The original evidence narrative describes a primary questionnaire symptom-day endpoint, and the reader answer supplies a quantitative runny-nose example. Runny nose is not newly designated as the sole prespecified primary endpoint or as the same effect for all symptoms.
Verification status
Partly verified
Materials actually read
Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
Why unverified
Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.
Reason for missing information
Prespecified endpoints/priorities, symptom-specific analyses, complete results and plan/change materials. A selected symptom is not upgraded into a broad conclusion.
Required materials and conditions
Primary questionnaire symptom-days versus selecting a specific symptom
Materials to obtain first
Prespecified endpoints/priorities, symptom-specific analyses, complete results and plan/change materials. A selected symptom is not upgraded into a broad conclusion.
Further research
Materials needed: Prespecified endpoints/priorities, symptom-specific analyses, complete results and plan/change materials. A selected symptom is not upgraded into a broad conclusion. Only material requests/research needs are recorded; no current lookup or research execution.
Remaining uncertainty
External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.
Conditions for verification
Show originals for primary questionnaire symptom-days versus selecting a specific symptom with selected-subclaim/parent boundaries, direct endpoints/estimand, denominators and external-reading scope.
Why this condition is needed
Needed to connect primary questionnaire symptom-days versus selecting a specific symptom with the selected question, actual population/intervention/comparator, endpoints/hierarchy/estimand, denominators/duration and reports/harms.
Application exceptions
Distinguish self-reported symptom-days, people/person-days/repeated/concurrent symptoms and symptom-specific numerators/denominators/effects/CIs from confirmed infections/clinical outcomes; distinguish actual strain drink/identical yogurt, winter 12 weeks, allocation/completion/PPS/attrition, advance hierarchy/registration conflict, company involvement and harms. Preserve original numbers only; no new calculations, invented quantities, effects/CIs, grades/reassessment, independence certification or extract/product/drink-consumption, sleep/cold-management, infection-prevention or treatment-replacement instructions.
Referenced methods
Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

Related sources R01

N16 · Was laboratory-confirmed infection incidence directly measured?

Current findings
The original crux/English text distinguishes this from a trial measuring infection incidence or laboratory-confirmed colds. The infection subclaim’s note also records that laboratory-confirmed incidence was not measured. Symptom-day reductions are not converted into infection prevention or fewer infected people/events.
Verification status
Unverified
Materials actually read
Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
Why unverified
Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.
Reason for missing information
Test/clinical-confirmation definitions, pathogens, direct group-specific infection events/denominators, follow-up and effects/CIs. Non-measurement is not changed into zero events or zero effect.
Required materials and conditions
Questionnaire symptoms versus pathogen-confirmed infection
Materials to obtain first
Test/clinical-confirmation definitions, pathogens, direct group-specific infection events/denominators, follow-up and effects/CIs. Non-measurement is not changed into zero events or zero effect.
Further research
Materials needed: Test/clinical-confirmation definitions, pathogens, direct group-specific infection events/denominators, follow-up and effects/CIs. Non-measurement is not changed into zero events or zero effect. Only material requests/research needs are recorded; no current lookup or research execution.
Remaining uncertainty
External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.
Conditions for verification
Show originals for questionnaire symptoms versus pathogen-confirmed infection with selected-subclaim/parent boundaries, direct endpoints/estimand, denominators and external-reading scope.
Why this condition is needed
Needed to connect questionnaire symptoms versus pathogen-confirmed infection with the selected question, actual population/intervention/comparator, endpoints/hierarchy/estimand, denominators/duration and reports/harms.
Application exceptions
Distinguish self-reported symptom-days, people/person-days/repeated/concurrent symptoms and symptom-specific numerators/denominators/effects/CIs from confirmed infections/clinical outcomes; distinguish actual strain drink/identical yogurt, winter 12 weeks, allocation/completion/PPS/attrition, advance hierarchy/registration conflict, company involvement and harms. Preserve original numbers only; no new calculations, invented quantities, effects/CIs, grades/reassessment, independence certification or extract/product/drink-consumption, sleep/cold-management, infection-prevention or treatment-replacement instructions.
Referenced methods
Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

Related sources R01

N17 · Are severity, health-care use and other clinical outcomes being filled?

Current findings
The preserved scope covers questionnaire-recorded symptom-days and symptom-specific proportions. Separate direct results for clinical severity, health-care use, hospitalization or absence from work are not provided in the current summary. Unread originals are not assumed to mean actual non-measurement.
Verification status
Unverified
Materials actually read
Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
Why unverified
Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.
Reason for missing information
Definitions, actual measurement/denominators, comparisons/durations, effects/CIs and originals for each clinical outcome. Symptom-days are not converted into clinical events or treatment effects.
Required materials and conditions
Symptom-days versus severity, clinical visits/hospitalization and absence from work
Materials to obtain first
Definitions, actual measurement/denominators, comparisons/durations, effects/CIs and originals for each clinical outcome. Symptom-days are not converted into clinical events or treatment effects.
Further research
Materials needed: Definitions, actual measurement/denominators, comparisons/durations, effects/CIs and originals for each clinical outcome. Symptom-days are not converted into clinical events or treatment effects. Only material requests/research needs are recorded; no current lookup or research execution.
Remaining uncertainty
External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.
Conditions for verification
Show originals for symptom-days versus severity, clinical visits/hospitalization and absence from work with selected-subclaim/parent boundaries, direct endpoints/estimand, denominators and external-reading scope.
Why this condition is needed
Needed to connect symptom-days versus severity, clinical visits/hospitalization and absence from work with the selected question, actual population/intervention/comparator, endpoints/hierarchy/estimand, denominators/duration and reports/harms.
Application exceptions
Distinguish self-reported symptom-days, people/person-days/repeated/concurrent symptoms and symptom-specific numerators/denominators/effects/CIs from confirmed infections/clinical outcomes; distinguish actual strain drink/identical yogurt, winter 12 weeks, allocation/completion/PPS/attrition, advance hierarchy/registration conflict, company involvement and harms. Preserve original numbers only; no new calculations, invented quantities, effects/CIs, grades/reassessment, independence certification or extract/product/drink-consumption, sleep/cold-management, infection-prevention or treatment-replacement instructions.
Referenced methods
Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

Related sources R01

N18 · What gaps remain in 95% CIs and clinical effect size?

Current findings
The original runny-nose absolute difference of −5.0 percentage points, P<.001 and several symptom-day proportions are preserved. The original report narrative says between-group 95% CIs were not presented. Clinical thresholds, person-specific effects and CIs are not newly derived from P values/denominators.
Verification status
Unverified
Materials actually read
Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
Why unverified
Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.
Reason for missing information
Original effect estimates/precision, 95% CIs, prespecified clinical thresholds and denominator/correlation/model materials. Positive results are not expanded into long-term or infection effects.
Required materials and conditions
Original absolute difference/P value and unreported 95% CIs
Materials to obtain first
Original effect estimates/precision, 95% CIs, prespecified clinical thresholds and denominator/correlation/model materials. Positive results are not expanded into long-term or infection effects.
Further research
Materials needed: Original effect estimates/precision, 95% CIs, prespecified clinical thresholds and denominator/correlation/model materials. Positive results are not expanded into long-term or infection effects. Only material requests/research needs are recorded; no current lookup or research execution.
Remaining uncertainty
External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.
Conditions for verification
Show originals for original absolute difference/P value and unreported 95% CIs with selected-subclaim/parent boundaries, direct endpoints/estimand, denominators and external-reading scope.
Why this condition is needed
Needed to connect original absolute difference/P value and unreported 95% CIs with the selected question, actual population/intervention/comparator, endpoints/hierarchy/estimand, denominators/duration and reports/harms.
Application exceptions
Distinguish self-reported symptom-days, people/person-days/repeated/concurrent symptoms and symptom-specific numerators/denominators/effects/CIs from confirmed infections/clinical outcomes; distinguish actual strain drink/identical yogurt, winter 12 weeks, allocation/completion/PPS/attrition, advance hierarchy/registration conflict, company involvement and harms. Preserve original numbers only; no new calculations, invented quantities, effects/CIs, grades/reassessment, independence certification or extract/product/drink-consumption, sleep/cold-management, infection-prevention or treatment-replacement instructions.
Referenced methods
Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

Related sources R01

N19 · Are symptom-days presented as a general immunity effect?

Current findings
The original advertising interpretation explains an added-strain symptom-day effect versus identical yogurt, without establishing infection prevention or a general immune boost. New efficacy is not extended to mechanisms, other products/strains, populations or seasons.
Verification status
Partly verified
Materials actually read
Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
Why unverified
Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.
Reason for missing information
Direct endpoints, populations/interventions/comparators, durations, denominators and effects/CIs for each broad claim. No current mechanism, infection-prevention, cold-management or treatment-replacement instructions.
Required materials and conditions
The product’s added strain versus broad immunity claims
Materials to obtain first
Direct endpoints, populations/interventions/comparators, durations, denominators and effects/CIs for each broad claim. No current mechanism, infection-prevention, cold-management or treatment-replacement instructions.
Further research
Materials needed: Direct endpoints, populations/interventions/comparators, durations, denominators and effects/CIs for each broad claim. No current mechanism, infection-prevention, cold-management or treatment-replacement instructions. Only material requests/research needs are recorded; no current lookup or research execution.
Remaining uncertainty
External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.
Conditions for verification
Show originals for the product’s added strain versus broad immunity claims with selected-subclaim/parent boundaries, direct endpoints/estimand, denominators and external-reading scope.
Why this condition is needed
Needed to connect the product’s added strain versus broad immunity claims with the selected question, actual population/intervention/comparator, endpoints/hierarchy/estimand, denominators/duration and reports/harms.
Application exceptions
Distinguish self-reported symptom-days, people/person-days/repeated/concurrent symptoms and symptom-specific numerators/denominators/effects/CIs from confirmed infections/clinical outcomes; distinguish actual strain drink/identical yogurt, winter 12 weeks, allocation/completion/PPS/attrition, advance hierarchy/registration conflict, company involvement and harms. Preserve original numbers only; no new calculations, invented quantities, effects/CIs, grades/reassessment, independence certification or extract/product/drink-consumption, sleep/cold-management, infection-prevention or treatment-replacement instructions.
Referenced methods
Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

Related sources R01

N20 · Are 12-week related safety signals distinct from all harms?

Current findings
The original materials contain the limited statement that no serious study-food-related safety signal was reported over 12 weeks, plus dairy-allergy/lactose-discomfort cautions. This is not extended into zero adverse events, safety in all populations or exclusion of long-term harms.
Verification status
Partly verified
Materials actually read
Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
Why unverified
Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.
Reason for missing information
Group-specific AE/SAE collection, actual exposure/denominators, discontinuation/relatedness, allergy/lactose and long-term materials. No new harm rates or product-consumption/cold-management instructions.
Required materials and conditions
Serious study-food-related signals and dairy/lactose contexts
Materials to obtain first
Group-specific AE/SAE collection, actual exposure/denominators, discontinuation/relatedness, allergy/lactose and long-term materials. No new harm rates or product-consumption/cold-management instructions.
Further research
Materials needed: Group-specific AE/SAE collection, actual exposure/denominators, discontinuation/relatedness, allergy/lactose and long-term materials. No new harm rates or product-consumption/cold-management instructions. Only material requests/research needs are recorded; no current lookup or research execution.
Remaining uncertainty
External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.
Conditions for verification
Show originals for serious study-food-related signals and dairy/lactose contexts with selected-subclaim/parent boundaries, direct endpoints/estimand, denominators and external-reading scope.
Why this condition is needed
Needed to connect serious study-food-related signals and dairy/lactose contexts with the selected question, actual population/intervention/comparator, endpoints/hierarchy/estimand, denominators/duration and reports/harms.
Application exceptions
Distinguish self-reported symptom-days, people/person-days/repeated/concurrent symptoms and symptom-specific numerators/denominators/effects/CIs from confirmed infections/clinical outcomes; distinguish actual strain drink/identical yogurt, winter 12 weeks, allocation/completion/PPS/attrition, advance hierarchy/registration conflict, company involvement and harms. Preserve original numbers only; no new calculations, invented quantities, effects/CIs, grades/reassessment, independence certification or extract/product/drink-consumption, sleep/cold-management, infection-prevention or treatment-replacement instructions.
Referenced methods
Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

Related sources R01

N21 · What materials were actually read in this work?

Current findings
The complete parent JSON was read for production and preserved in its original form. Summary reading concerns the preserved summary; external abstracts, full texts, registration and protocol/SAP remain unread in this work. URL/bibliography presence is not upgraded into external reading.
Verification status
Partly verified
Materials actually read
Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
Why unverified
Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.
Reason for missing information
Materials for users to record actual external acquisition/reading scope, versions and timing. No current link/click/access tests.
Required materials and conditions
Preserved JSON summary and external-reading status
Materials to obtain first
Materials for users to record actual external acquisition/reading scope, versions and timing. No current link/click/access tests.
Further research
Materials needed: Materials for users to record actual external acquisition/reading scope, versions and timing. No current link/click/access tests. Only material requests/research needs are recorded; no current lookup or research execution.
Remaining uncertainty
External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.
Conditions for verification
Show originals for preserved JSON summary and external-reading status with selected-subclaim/parent boundaries, direct endpoints/estimand, denominators and external-reading scope.
Why this condition is needed
Needed to connect preserved JSON summary and external-reading status with the selected question, actual population/intervention/comparator, endpoints/hierarchy/estimand, denominators/duration and reports/harms.
Application exceptions
Distinguish self-reported symptom-days, people/person-days/repeated/concurrent symptoms and symptom-specific numerators/denominators/effects/CIs from confirmed infections/clinical outcomes; distinguish actual strain drink/identical yogurt, winter 12 weeks, allocation/completion/PPS/attrition, advance hierarchy/registration conflict, company involvement and harms. Preserve original numbers only; no new calculations, invented quantities, effects/CIs, grades/reassessment, independence certification or extract/product/drink-consumption, sleep/cold-management, infection-prevention or treatment-replacement instructions.
Referenced methods
Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

Related sources R01

N22 · Are registration, public dates, plans and current reading distinct?

Current findings
The original evidence lists UMIN000045901. Although the paper stated registration preceded initiation, the preserved Korean/English narrative distinguishes public posting on 2022-09-08 after the planned 2021-10-30 start as retrospectively public registration. No current external comparison of actual start/version or plan agreement was performed, and no official URL is guessed.
Verification status
Partly verified
Materials actually read
Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
Why unverified
Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.
Reason for missing information
Original registration texts/versions, public/start/change dates, endpoint/analysis and report-linkage materials. Only historical narratives are preserved; no current prespecification/access certification.
Required materials and conditions
Original registration information and detailed plans/access
Materials to obtain first
Original registration texts/versions, public/start/change dates, endpoint/analysis and report-linkage materials. Only historical narratives are preserved; no current prespecification/access certification.
Further research
Materials needed: Original registration texts/versions, public/start/change dates, endpoint/analysis and report-linkage materials. Only historical narratives are preserved; no current prespecification/access certification. Only material requests/research needs are recorded; no current lookup or research execution.
Remaining uncertainty
External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.
Conditions for verification
Show originals for original registration information and detailed plans/access with selected-subclaim/parent boundaries, direct endpoints/estimand, denominators and external-reading scope.
Why this condition is needed
Needed to connect original registration information and detailed plans/access with the selected question, actual population/intervention/comparator, endpoints/hierarchy/estimand, denominators/duration and reports/harms.
Application exceptions
Distinguish self-reported symptom-days, people/person-days/repeated/concurrent symptoms and symptom-specific numerators/denominators/effects/CIs from confirmed infections/clinical outcomes; distinguish actual strain drink/identical yogurt, winter 12 weeks, allocation/completion/PPS/attrition, advance hierarchy/registration conflict, company involvement and harms. Preserve original numbers only; no new calculations, invented quantities, effects/CIs, grades/reassessment, independence certification or extract/product/drink-consumption, sleep/cold-management, infection-prevention or treatment-replacement instructions.
Referenced methods
Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

Related sources R01

N23 · Were protocol/SAP and endpoint/multiplicity plans acquired?

Current findings
The original registration identifier, historical cross-checking and primary/secondary narratives are preserved. Individual protocol/SAP originals, versions/dates, complete endpoints/analyses/multiplicity and plan changes were not read in this work.
Verification status
Unverified
Materials actually read
Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
Why unverified
Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.
Reason for missing information
Protocol, SAP, revision history, complete endpoints/estimands/missingness, multiple comparisons, public dates and paper-comparison materials. Unread external materials are not assumed to mean absent documents.
Required materials and conditions
Advance plan, change and analysis materials
Materials to obtain first
Protocol, SAP, revision history, complete endpoints/estimands/missingness, multiple comparisons, public dates and paper-comparison materials. Unread external materials are not assumed to mean absent documents.
Further research
Materials needed: Protocol, SAP, revision history, complete endpoints/estimands/missingness, multiple comparisons, public dates and paper-comparison materials. Unread external materials are not assumed to mean absent documents. Only material requests/research needs are recorded; no current lookup or research execution.
Remaining uncertainty
External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.
Conditions for verification
Show originals for advance plan, change and analysis materials with selected-subclaim/parent boundaries, direct endpoints/estimand, denominators and external-reading scope.
Why this condition is needed
Needed to connect advance plan, change and analysis materials with the selected question, actual population/intervention/comparator, endpoints/hierarchy/estimand, denominators/duration and reports/harms.
Application exceptions
Distinguish self-reported symptom-days, people/person-days/repeated/concurrent symptoms and symptom-specific numerators/denominators/effects/CIs from confirmed infections/clinical outcomes; distinguish actual strain drink/identical yogurt, winter 12 weeks, allocation/completion/PPS/attrition, advance hierarchy/registration conflict, company involvement and harms. Preserve original numbers only; no new calculations, invented quantities, effects/CIs, grades/reassessment, independence certification or extract/product/drink-consumption, sleep/cold-management, infection-prevention or treatment-replacement instructions.
Referenced methods
Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

Related sources R01

N24 · Are company funding, product support, employee authors and research roles separate?

Current findings
The original materials record four MEGMILK SNOW BRAND employee authors EK/TA/MK/TK, a company-developed LG2055 product and NS’s employment at the contract research organization KSO Corporation. The original limit that separate public cofunding, medical-writing and publication support were not identified is retained. Company cash funding, product manufacturing/provision and detailed design/analysis/data control remain separately unverified.
Verification status
Partly verified
Materials actually read
Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
Why unverified
Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.
Reason for missing information
Separate originals for company cash funding, product/food manufacturing support, author employment/contractor relationships, design/analysis/data control and other support/COI. The original independence axis is not used as new certification.
Required materials and conditions
Four categories of company involvement and other support
Materials to obtain first
Separate originals for company cash funding, product/food manufacturing support, author employment/contractor relationships, design/analysis/data control and other support/COI. The original independence axis is not used as new certification.
Further research
Materials needed: Separate originals for company cash funding, product/food manufacturing support, author employment/contractor relationships, design/analysis/data control and other support/COI. The original independence axis is not used as new certification. Only material requests/research needs are recorded; no current lookup or research execution.
Remaining uncertainty
External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.
Conditions for verification
Show originals for four categories of company involvement and other support with selected-subclaim/parent boundaries, direct endpoints/estimand, denominators and external-reading scope.
Why this condition is needed
Needed to connect four categories of company involvement and other support with the selected question, actual population/intervention/comparator, endpoints/hierarchy/estimand, denominators/duration and reports/harms.
Application exceptions
Distinguish self-reported symptom-days, people/person-days/repeated/concurrent symptoms and symptom-specific numerators/denominators/effects/CIs from confirmed infections/clinical outcomes; distinguish actual strain drink/identical yogurt, winter 12 weeks, allocation/completion/PPS/attrition, advance hierarchy/registration conflict, company involvement and harms. Preserve original numbers only; no new calculations, invented quantities, effects/CIs, grades/reassessment, independence certification or extract/product/drink-consumption, sleep/cold-management, infection-prevention or treatment-replacement instructions.
Referenced methods
Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

Related sources R01

N25 · Are narrow positive results, broad-claim gaps and unverified materials distinct?

Current findings
Positive questionnaire symptom-day results are distinguished from unmeasured laboratory-confirmed infections, originally unreported 95% CIs and unread detailed external materials.
Verification status
Partly verified
Materials actually read
Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
Why unverified
Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.
Reason for missing information
Materials verifying question-specific actual measurements/definitions, original tables/denominators, plans and actual access scope. Unread is not substituted for unreported, zero studies or zero effect.
Required materials and conditions
Direct endpoints and access/reporting limitations
Materials to obtain first
Materials verifying question-specific actual measurements/definitions, original tables/denominators, plans and actual access scope. Unread is not substituted for unreported, zero studies or zero effect.
Further research
Materials needed: Materials verifying question-specific actual measurements/definitions, original tables/denominators, plans and actual access scope. Unread is not substituted for unreported, zero studies or zero effect. Only material requests/research needs are recorded; no current lookup or research execution.
Remaining uncertainty
External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.
Conditions for verification
Show originals for direct endpoints and access/reporting limitations with selected-subclaim/parent boundaries, direct endpoints/estimand, denominators and external-reading scope.
Why this condition is needed
Needed to connect direct endpoints and access/reporting limitations with the selected question, actual population/intervention/comparator, endpoints/hierarchy/estimand, denominators/duration and reports/harms.
Application exceptions
Distinguish self-reported symptom-days, people/person-days/repeated/concurrent symptoms and symptom-specific numerators/denominators/effects/CIs from confirmed infections/clinical outcomes; distinguish actual strain drink/identical yogurt, winter 12 weeks, allocation/completion/PPS/attrition, advance hierarchy/registration conflict, company involvement and harms. Preserve original numbers only; no new calculations, invented quantities, effects/CIs, grades/reassessment, independence certification or extract/product/drink-consumption, sleep/cold-management, infection-prevention or treatment-replacement instructions.
Referenced methods
Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

Related sources R01

N26 · Are reports, trials, people, repeated measures and sibling sheets distinct?

Current findings
Parent 2977 and existing s0/s1 share the same Kobatake2022 report and 12-week trial context of 200 randomized participants/193 PPS participants. The same people, groups, days, symptoms, time points, bibliography and sibling sheets are not added as new independent trials/participants. One current report link is not a certified count of unique trials/participants.
Verification status
Partly verified
Materials actually read
Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
Why unverified
Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.
Reason for missing information
Original registration/report, actual cohort/analysis, endpoint/time-point and repeated-measure relationships. Unique trial counts and unique participant totals remain unrecorded.
Required materials and conditions
Document linkage versus unique trials/participants
Materials to obtain first
Original registration/report, actual cohort/analysis, endpoint/time-point and repeated-measure relationships. Unique trial counts and unique participant totals remain unrecorded.
Further research
Materials needed: Original registration/report, actual cohort/analysis, endpoint/time-point and repeated-measure relationships. Unique trial counts and unique participant totals remain unrecorded. Only material requests/research needs are recorded; no current lookup or research execution.
Remaining uncertainty
External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.
Conditions for verification
Show originals for document linkage versus unique trials/participants with selected-subclaim/parent boundaries, direct endpoints/estimand, denominators and external-reading scope.
Why this condition is needed
Needed to connect document linkage versus unique trials/participants with the selected question, actual population/intervention/comparator, endpoints/hierarchy/estimand, denominators/duration and reports/harms.
Application exceptions
Distinguish self-reported symptom-days, people/person-days/repeated/concurrent symptoms and symptom-specific numerators/denominators/effects/CIs from confirmed infections/clinical outcomes; distinguish actual strain drink/identical yogurt, winter 12 weeks, allocation/completion/PPS/attrition, advance hierarchy/registration conflict, company involvement and harms. Preserve original numbers only; no new calculations, invented quantities, effects/CIs, grades/reassessment, independence certification or extract/product/drink-consumption, sleep/cold-management, infection-prevention or treatment-replacement instructions.
Referenced methods
Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

Related sources R01

N27 · Is there evidence of separate independent confirmation?

Current findings
Parent replication R1 and independence I0 are preserved. The same report, subgroup, scale, repeated days or sibling sheets are not certified as new independent efficacy/harm replications.
Verification status
Unverified
Materials actually read
Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
Why unverified
Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.
Reason for missing information
Confirmatory materials showing selected-question advance plans, separate populations/comparators, direct endpoints/denominators, effects/CIs, duration/funding and author relationships. No current search or independence judgment.
Required materials and conditions
Original R1/I0 versus independent replication
Materials to obtain first
Confirmatory materials showing selected-question advance plans, separate populations/comparators, direct endpoints/denominators, effects/CIs, duration/funding and author relationships. No current search or independence judgment.
Further research
Materials needed: Confirmatory materials showing selected-question advance plans, separate populations/comparators, direct endpoints/denominators, effects/CIs, duration/funding and author relationships. No current search or independence judgment. Only material requests/research needs are recorded; no current lookup or research execution.
Remaining uncertainty
External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.
Conditions for verification
Show originals for original R1/I0 versus independent replication with selected-subclaim/parent boundaries, direct endpoints/estimand, denominators and external-reading scope.
Why this condition is needed
Needed to connect original R1/I0 versus independent replication with the selected question, actual population/intervention/comparator, endpoints/hierarchy/estimand, denominators/duration and reports/harms.
Application exceptions
Distinguish self-reported symptom-days, people/person-days/repeated/concurrent symptoms and symptom-specific numerators/denominators/effects/CIs from confirmed infections/clinical outcomes; distinguish actual strain drink/identical yogurt, winter 12 weeks, allocation/completion/PPS/attrition, advance hierarchy/registration conflict, company involvement and harms. Preserve original numbers only; no new calculations, invented quantities, effects/CIs, grades/reassessment, independence certification or extract/product/drink-consumption, sleep/cold-management, infection-prevention or treatment-replacement instructions.
Referenced methods
Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

Related sources R01

N28 · Are selected-subclaim and parent scores/axes preserved?

Current findings
Selected grade/note and Korean/English claim wording are preserved, with absent subclaim score/status/axes left unrecorded. Parent C50, good safety and B/P/R1/I0/E+, bias axis and unrecorded precision are parent context, not a score for the selected row.
Verification status
Partly verified
Materials actually read
Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
Why unverified
Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.
Reason for missing information
User subclaim/parent-boundary review and actual correction materials. No new score/grade or official RoB 2/GRADE certification.
Required materials and conditions
Subclaim grade/note, absent fields and parent context
Materials to obtain first
User subclaim/parent-boundary review and actual correction materials. No new score/grade or official RoB 2/GRADE certification.
Further research
Materials needed: User subclaim/parent-boundary review and actual correction materials. No new score/grade or official RoB 2/GRADE certification. Only material-request/research needs are recorded; no search/research was performed in this production.
Remaining uncertainty
External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.
Conditions for verification
Show originals for subclaim grade/note, absent fields and parent context with selected-subclaim/parent boundaries, direct endpoints/estimand, denominators and external-reading scope.
Why this condition is needed
Needed to connect subclaim grade/note, absent fields and parent context with the selected question, actual population/intervention/comparator, endpoints/hierarchy/estimand, denominators/duration and reports/harms.
Application exceptions
Distinguish self-reported symptom-days, people/person-days/repeated/concurrent symptoms and symptom-specific numerators/denominators/effects/CIs from confirmed infections/clinical outcomes; distinguish actual strain drink/identical yogurt, winter 12 weeks, allocation/completion/PPS/attrition, advance hierarchy/registration conflict, company involvement and harms. Preserve original numbers only; no new calculations, invented quantities, effects/CIs, grades/reassessment, independence certification or extract/product/drink-consumption, sleep/cold-management, infection-prevention or treatment-replacement instructions.
Referenced methods
Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

Related sources R01

N29 · Are Korean/English wording and absent structured fields preserved?

Current findings
Parent Korean/English text, evidence/citation lists, axes and original selected-subclaim wording are preserved in the complete summary. Korean/English classification fields are absent; no new fields are filled in the original materials. External English papers were not compared.
Verification status
Partly verified
Materials actually read
Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
Why unverified
Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.
Reason for missing information
Materials for content review of bilingual terms, endpoints/durations, absent fields and selected scope. Production explanations remain distinct from original wording.
Required materials and conditions
Wording in both languages and absent classification fields
Materials to obtain first
Materials for content review of bilingual terms, endpoints/durations, absent fields and selected scope. Production explanations remain distinct from original wording.
Further research
Materials needed: Materials for content review of bilingual terms, endpoints/durations, absent fields and selected scope. Production explanations remain distinct from original wording. Only material requests/research needs are recorded; no current lookup or research execution.
Remaining uncertainty
External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.
Conditions for verification
Show originals for wording in both languages and absent classification fields with selected-subclaim/parent boundaries, direct endpoints/estimand, denominators and external-reading scope.
Why this condition is needed
Needed to connect wording in both languages and absent classification fields with the selected question, actual population/intervention/comparator, endpoints/hierarchy/estimand, denominators/duration and reports/harms.
Application exceptions
Distinguish self-reported symptom-days, people/person-days/repeated/concurrent symptoms and symptom-specific numerators/denominators/effects/CIs from confirmed infections/clinical outcomes; distinguish actual strain drink/identical yogurt, winter 12 weeks, allocation/completion/PPS/attrition, advance hierarchy/registration conflict, company involvement and harms. Preserve original numbers only; no new calculations, invented quantities, effects/CIs, grades/reassessment, independence certification or extract/product/drink-consumption, sleep/cold-management, infection-prevention or treatment-replacement instructions.
Referenced methods
Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

Related sources R01

N30 · Are reference dates, corrections, historical cross-checking and production dates distinct?

Current findings
Original reference date 2026-08-26, empty corrections/deliberation and grade-decision cross-check narratives are preserved. This history is not current condition freezing/application, production date or completed content review.
Verification status
Partly verified
Materials actually read
Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
Why unverified
Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.
Reason for missing information
When new materials/corrections arise, materials for separate updates to originals, events, conditions/observations and verdict decisions. Historical narratives are not used as new clinical review.
Required materials and conditions
Original 2026-08-26 versus production/application events
Materials to obtain first
When new materials/corrections arise, materials for separate updates to originals, events, conditions/observations and verdict decisions. Historical narratives are not used as new clinical review.
Further research
Materials needed: When new materials/corrections arise, materials for separate updates to originals, events, conditions/observations and verdict decisions. Historical narratives are not used as new clinical review. Only material requests/research needs are recorded; no current lookup or research execution.
Remaining uncertainty
External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.
Conditions for verification
Show originals for original 2026-08-26 versus production/application events with selected-subclaim/parent boundaries, direct endpoints/estimand, denominators and external-reading scope.
Why this condition is needed
Needed to connect original 2026-08-26 versus production/application events with the selected question, actual population/intervention/comparator, endpoints/hierarchy/estimand, denominators/duration and reports/harms.
Application exceptions
Distinguish self-reported symptom-days, people/person-days/repeated/concurrent symptoms and symptom-specific numerators/denominators/effects/CIs from confirmed infections/clinical outcomes; distinguish actual strain drink/identical yogurt, winter 12 weeks, allocation/completion/PPS/attrition, advance hierarchy/registration conflict, company involvement and harms. Preserve original numbers only; no new calculations, invented quantities, effects/CIs, grades/reassessment, independence certification or extract/product/drink-consumption, sleep/cold-management, infection-prevention or treatment-replacement instructions.
Referenced methods
Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

Related sources R01

N31 · What direct materials could fill the selected gaps?

Current findings
Original materials are needed to improve precision of symptom-day effects/CIs, repeated-record denominators, PPS/ITT and advance hierarchy. Infection prevention is a separate question requiring direct confirmed-infection data.
Verification status
Unverified
Materials actually read
Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
Why unverified
Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.
Reason for missing information
Question-matched advance direct comparisons, overall/symptom-specific denominators, estimands/CIs, measurement/missingness, multiplicity and separate confirmation/long-term harms. Only need is recorded; no current lookup or clinical study.
Required materials and conditions
Definitions, direct endpoints, denominators/effects/CIs and plans
Materials to obtain first
Question-matched advance direct comparisons, overall/symptom-specific denominators, estimands/CIs, measurement/missingness, multiplicity and separate confirmation/long-term harms. Only need is recorded; no current lookup or clinical study.
Further research
Materials needed: Question-matched advance direct comparisons, overall/symptom-specific denominators, estimands/CIs, measurement/missingness, multiplicity and separate confirmation/long-term harms. Only need is recorded; no current lookup or clinical study. Only material requests/research needs are recorded; no current lookup or research execution.
Remaining uncertainty
External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.
Conditions for verification
Show originals for definitions, direct endpoints, denominators/effects/CIs and plans with selected-subclaim/parent boundaries, direct endpoints/estimand, denominators and external-reading scope.
Why this condition is needed
Needed to connect definitions, direct endpoints, denominators/effects/CIs and plans with the selected question, actual population/intervention/comparator, endpoints/hierarchy/estimand, denominators/duration and reports/harms.
Application exceptions
Distinguish self-reported symptom-days, people/person-days/repeated/concurrent symptoms and symptom-specific numerators/denominators/effects/CIs from confirmed infections/clinical outcomes; distinguish actual strain drink/identical yogurt, winter 12 weeks, allocation/completion/PPS/attrition, advance hierarchy/registration conflict, company involvement and harms. Preserve original numbers only; no new calculations, invented quantities, effects/CIs, grades/reassessment, independence certification or extract/product/drink-consumption, sleep/cold-management, infection-prevention or treatment-replacement instructions.
Referenced methods
Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

Related sources R01

N32 · Are production, user review and implementation instructions distinct?

Current findings
This is table-content production from the preserved summary. Existing content and question-boundary review remain incomplete, and candidate pending/eligibility flags are preserved as history. Existing review status is recorded as it stands.
Verification status
Partly verified
Materials actually read
Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread
Why unverified
Production observation distinguishing selected/parent, report and endpoint materials in the preserved summary. Detailed original materials remain unverified and existing content review is incomplete; this does not establish completed clinical review or certification.
Reason for missing information
Existing content review and later actual-material/correction work. The historical production record did not perform clinical-original comparison, external access, new calculations, grade changes or product/drink-consumption, sleep/cold-management, infection-prevention or treatment-replacement instructions.
Required materials and conditions
Production request, candidate history and content-review responsibility
Materials to obtain first
Existing content review and later actual-material/correction work. The historical production record did not perform clinical-original comparison, external access, new calculations, grade changes or product/drink-consumption, sleep/cold-management, infection-prevention or treatment-replacement instructions.
Further research
Materials needed: Existing content review and later actual-material/correction work. The historical production record did not perform clinical-original comparison, external access, new calculations, grade changes or product/drink-consumption, sleep/cold-management, infection-prevention or treatment-replacement instructions. Only material requests/research needs are recorded; no current lookup or research execution.
Remaining uncertainty
External original materials remain unread and existing content review is incomplete. Original grades/scores/axes and historical verification/independence descriptions are not upgraded to new verdicts/certification.
Conditions for verification
Show originals for production request, candidate history and content-review responsibility with selected-subclaim/parent boundaries, direct endpoints/estimand, denominators and external-reading scope.
Why this condition is needed
Needed to connect production request, candidate history and content-review responsibility with the selected question, actual population/intervention/comparator, endpoints/hierarchy/estimand, denominators/duration and reports/harms.
Application exceptions
Distinguish self-reported symptom-days, people/person-days/repeated/concurrent symptoms and symptom-specific numerators/denominators/effects/CIs from confirmed infections/clinical outcomes; distinguish actual strain drink/identical yogurt, winter 12 weeks, allocation/completion/PPS/attrition, advance hierarchy/registration conflict, company involvement and harms. Preserve original numbers only; no new calculations, invented quantities, effects/CIs, grades/reassessment, independence certification or extract/product/drink-consumption, sleep/cold-management, infection-prevention or treatment-replacement instructions.
Referenced methods
Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production

Related sources R01