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

Verdict 2977 · Evidence Check

Stored-material review date: Not recorded  
Original evidence cut-off: 2026-08-26  
Review-criteria version: 1.0  
Public page/material preparation date: 2026-10-14

Clinical papers were not read directly; existing review summaries were checked. No new clinical-literature search was performed. Unverified does not mean that research is absent or that there is no effect.

## Assessment scope

- 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

## Checklist items

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

Verification status: Partly verified  
Reading scope: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread

- 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.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread

- 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.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread

- 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.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread

- 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.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread

- 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.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread

- 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.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread

- 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.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread

- 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.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread

- 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.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread

- 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.
- 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.
- 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.
- 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.
- 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?

Verification status: Unverified  
Reading scope: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread

- 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.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread

- 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.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread

- 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.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread

- 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.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread

- 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.
- 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.
- 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.
- 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.
- 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?

Verification status: Unverified  
Reading scope: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread

- 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.
- 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.
- 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.
- 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.
- 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?

Verification status: Unverified  
Reading scope: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread

- 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.
- 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.
- 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.
- 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.
- 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?

Verification status: Unverified  
Reading scope: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread

- 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.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread

- 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.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread

- 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.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread

- 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.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread

- 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.
- 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.
- 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.
- 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.
- 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?

Verification status: Unverified  
Reading scope: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread

- 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.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread

- 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.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread

- Current findings: Positive questionnaire symptom-day results are distinguished from unmeasured laboratory-confirmed infections, originally unreported 95% CIs and unread detailed external materials.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread

- 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.
- 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.
- 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.
- 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.
- 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?

Verification status: Unverified  
Reading scope: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread

- 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.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread

- 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.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread

- 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.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread

- 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.
- 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.
- 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.
- 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.
- 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?

Verification status: Unverified  
Reading scope: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread

- 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.
- 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.
- 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.
- 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.
- 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?

Verification status: Partly verified  
Reading scope: Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread

- 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.
- 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.
- 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.
- 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.
- Referenced methods: Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production
- Related sources: R01

## Evidence and sources

### 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](https://pubmed.ncbi.nlm.nih.gov/36570128/)

Materials actually read: Preserved summary read; external abstracts/full texts/registrations/plans remain unread  
Findings recorded in the 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  
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.

| Material | Public availability | Access status | Actually read | Notes |
|---|---|---|---|---|
| Stored summary | Local preserved copy of the complete parent summary | Stored summary read | Summary read | Only 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 abstract | Original identifier/bibliography or required-material entry; public availability/access details remain unverified | Unread; access testing not performed | Not read | Only 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 text | Original identifier/bibliography or required-material entry; public availability/access details remain unverified | Unread; access testing not performed | Not read | Only 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 registration | Original identifier/bibliography or required-material entry; public availability/access details remain unverified | Unread; access testing not performed | Not read | Only 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/SAP | Original identifier/bibliography or required-material entry; public availability/access details remain unverified | Unread; access testing not performed | Not read | Only 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. |

## Review criteria and methods

These are Chamgap's own application conditions, informed by the relevant sections of official methodological guidance. They do not constitute official assessment-tool certification or a new efficacy score.

- M03 [Cochrane Handbook 6.5 (2024), chapter updated 2023-08](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03) · §3.1, §3.2.1–3.2.3, MECIR C5/C7/C13 · Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions. · 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](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04) · §4.5, §4.6.1–4.6.3, MECIR C42 · Distinguish studies from reports and link them; do not omit a study solely because results are unreported. · 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](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08) · §8.1–8.2.3, Table 8.2.a · Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting. · 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](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15) · §15.2.4, §15.3.1–15.3.3 · Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision. · 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](https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19) · §19.1.2, §19.2.1–19.2.4 · Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates. · 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/materials 1.0. Public pages and materials were prepared from the existing 32 items. No new clinical search, verification-status change or scoring was performed.
