{ "schema_version": "chamgap-public-evidence-check-1.0", "public_id": "v2977-s0", "verdict_number": "2977", "title": "LG2055 drinkable yogurt × Questionnaire symptom-days — PPS, day denominators and infection distinctions", "view_version": "1.0", "view_created_date": "2026-10-14", "criteria_version": "1.0", "criteria_date": "2026-10-06", "review_date": null, "legacy_evidence_date": "2026-08-26", "review_scope": { "materials_read": "Existing review summaries and stored records of methodological application", "clinical_papers_directly_read": false, "new_clinical_search": false, "limitation": "The whole stored parent-verdict summary and selected subclaim were read for production. External papers, abstracts, full texts, registry, protocol, SAP and funding disclosures were not separately read or accessed. Historical review records are not inherited as current clinical verification or a new verdict.", "date_meaning": "This is the date the stored materials were checked, not the date of a new search of the clinical literature." }, "claim_context": { "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", "intervention": "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", "endpoint": "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", "excluded_extensions": [ "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" ] }, "requirements": [ { "item_id": "N01", "question_type": "Evidence condition", "question": "Which existing questionnaire symptom-day claim is being transferred?", "needed": "Selected wording, subclaim grade and parent results", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "Show originals for selected wording, subclaim grade and parent results with selected-subclaim/parent boundaries, direct endpoints/estimand, denominators and external-reading scope.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_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.", "current_reports": [ "R01" ], "existence": "The original parent-summary display record is preserved; public availability, acquisition and actual reading of detailed external materials remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Questionnaire symptom definitions, denominators, comparison/time points, estimand and user boundary review. The parent score is not used to fill subclaim values.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Questionnaire symptom definitions, denominators, comparison/time points, estimand and user boundary review. The parent score is not used to fill subclaim values." }, { "item_id": "N02", "question_type": "Evidence condition", "question": "What cold risk and health status characterize the population?", "needed": "Healthy Japanese adults aged 20–64 prone to colds", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_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.", "current_reports": [ "R01" ], "existence": "The original parent-summary display record is preserved; public availability, acquisition and actual reading of detailed external materials remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Original materials on cold susceptibility/eligibility, baseline health, comorbidities/medication and vaccination/contact exposure, plus direct results in other populations.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original materials on cold susceptibility/eligibility, baseline health, comorbidities/medication and vaccination/contact exposure, plus direct results in other populations." }, { "item_id": "N03", "question_type": "Evidence condition", "question": "What is the study identity of the trial drink?", "needed": "LG2055 drinkable yogurt versus other probiotics/products", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "Show originals for lG2055 drinkable yogurt versus other probiotics/products with selected-subclaim/parent boundaries, direct endpoints/estimand, denominators and external-reading scope.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_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.", "current_reports": [ "R01" ], "existence": "The original parent-summary display record is preserved; public availability, acquisition and actual reading of detailed external materials remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Original strain, formulation/quantities, active product/manufacturing and actual exposure/adherence materials. No product/drink consumption or cold/infection-prevention instructions.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original strain, formulation/quantities, active product/manufacturing and actual exposure/adherence materials. No product/drink consumption or cold/infection-prevention instructions." }, { "item_id": "N04", "question_type": "Evidence condition", "question": "What does the actual identical-yogurt control compare?", "needed": "Identical yogurt lacking only LG2055", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "Show originals for identical yogurt lacking only LG2055 with selected-subclaim/parent boundaries, direct endpoints/estimand, denominators and external-reading scope.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_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.", "current_reports": [ "R01" ], "existence": "The original parent-summary display record is preserved; public availability, acquisition and actual reading of detailed external materials remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "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.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "item_id": "N05", "question_type": "Evidence condition", "question": "Are winter 12-week results separated from other durations?", "needed": "Observation duration, season and actual exposure", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "Show originals for observation duration, season and actual exposure with selected-subclaim/parent boundaries, direct endpoints/estimand, denominators and external-reading scope.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_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.", "current_reports": [ "R01" ], "existence": "The original parent-summary display record is preserved; public availability, acquisition and actual reading of detailed external materials remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Original actual-exposure/recording duration, missingness/discontinuation, season/infection exposure and time-specific results. No long-term prevention/persistence effects or implementation instructions.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original actual-exposure/recording duration, missingness/discontinuation, season/infection exposure and time-specific results. No long-term prevention/persistence effects or implementation instructions." }, { "item_id": "N06", "question_type": "Evidence condition", "question": "Are allocation, consumption completion and primary efficacy analyses separate?", "needed": "200/198/193 participants and group-specific PPS", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "Show originals for 200/198/193 participants and group-specific PPS with selected-subclaim/parent boundaries, direct endpoints/estimand, denominators and external-reading scope.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_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.", "current_reports": [ "R01" ], "existence": "The original parent-summary display record is preserved; public availability, acquisition and actual reading of detailed external materials remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "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.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "item_id": "N07", "question_type": "Evidence condition", "question": "Are PPS results presented as ITT effects for everyone?", "needed": "Protocol-compliant completer analysis versus all randomized participants", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "Show originals for protocol-compliant completer analysis versus all randomized participants with selected-subclaim/parent boundaries, direct endpoints/estimand, denominators and external-reading scope.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_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.", "current_reports": [ "R01" ], "existence": "The original parent-summary display record is preserved; public availability, acquisition and actual reading of detailed external materials remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "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.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "item_id": "N08", "question_type": "Evidence condition", "question": "How are questionnaire symptom-days defined?", "needed": "Self-reported days with symptoms and measurement methods", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "Show originals for self-reported days with symptoms and measurement methods with selected-subclaim/parent boundaries, direct endpoints/estimand, denominators and external-reading scope.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_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.", "current_reports": [ "R01" ], "existence": "The original parent-summary display record is preserved; public availability, acquisition and actual reading of detailed external materials remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "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.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "item_id": "N09", "question_type": "Evidence condition", "question": "What are the runny-nose numerator, denominator and effect?", "needed": "Original symptom-day proportions, absolute difference and P value", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_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.", "current_reports": [ "R01" ], "existence": "The original parent-summary display record is preserved; public availability, acquisition and actual reading of detailed external materials remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Original runny-nose symptom-day tables, group-specific denominator definitions, estimand, analysis model and 95% CI materials. No new recalculation or invented quantitative example.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original runny-nose symptom-day tables, group-specific denominator definitions, estimand, analysis model and 95% CI materials. No new recalculation or invented quantitative example." }, { "item_id": "N10", "question_type": "Evidence condition", "question": "Are people, person-days, repeated symptoms and events distinct?", "needed": "Symptom-day denominators versus 193-person denominators", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "Show originals for symptom-day denominators versus 193-person denominators with selected-subclaim/parent boundaries, direct endpoints/estimand, denominators and external-reading scope.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_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.", "current_reports": [ "R01" ], "existence": "The original parent-summary display record is preserved; public availability, acquisition and actual reading of detailed external materials remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Original recording/denominator units, participant-specific durations, concurrent/repeated symptoms, event definitions and missingness. No new person-day details/totals are calculated.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original recording/denominator units, participant-specific durations, concurrent/repeated symptoms, event definitions and missingness. No new person-day details/totals are calculated." }, { "item_id": "N11", "question_type": "Evidence condition", "question": "Has the correlation structure of repeated records and analyses been verified?", "needed": "Models/missing data for repeated symptom-days within people", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_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.", "current_reports": [ "R01" ], "existence": "The original parent-summary display record is preserved; public availability, acquisition and actual reading of detailed external materials remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "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.", "condition_status": "Unverified", "status_reason": "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.", "missingness": "Original estimand, within-participant repetition/correlation, missing observations, aggregation/testing methods and sensitivity analyses. No current model reanalysis or clinical calculation.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original estimand, within-participant repetition/correlation, missing observations, aggregation/testing methods and sensitivity analyses. No current model reanalysis or clinical calculation." }, { "item_id": "N12", "question_type": "Evidence condition", "question": "Are other questionnaire symptom results recorded separately?", "needed": "Nasal congestion, sneezing, sore throat and hoarseness", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "Show originals for nasal congestion, sneezing, sore throat and hoarseness with selected-subclaim/parent boundaries, direct endpoints/estimand, denominators and external-reading scope.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_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.", "current_reports": [ "R01" ], "existence": "The original parent-summary display record is preserved; public availability, acquisition and actual reading of detailed external materials remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "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.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "item_id": "N13", "question_type": "Evidence condition", "question": "Are missing cough values being filled from its P value?", "needed": "Separate cough results and detailed gaps", "role": "Supplementary", "role_reason": "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_exception": "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.", "criterion": "Show originals for separate cough results and detailed gaps with selected-subclaim/parent boundaries, direct endpoints/estimand, denominators and external-reading scope.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_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.", "current_reports": [ "R01" ], "existence": "The original parent-summary display record is preserved; public availability, acquisition and actual reading of detailed external materials remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Original cough tables, denominators, effects/CIs, tests/models and advance hierarchy. No new symptom values or CI estimates.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original cough tables, denominators, effects/CIs, tests/models and advance hierarchy. No new symptom values or CI estimates." }, { "item_id": "N14", "question_type": "Evidence condition", "question": "Are multiplicity and a composite score across symptoms verified?", "needed": "Prespecified hierarchical composite scores versus symptom-specific tests", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "Show originals for prespecified hierarchical composite scores versus symptom-specific tests with selected-subclaim/parent boundaries, direct endpoints/estimand, denominators and external-reading scope.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_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.", "current_reports": [ "R01" ], "existence": "The original parent-summary display record is preserved; public availability, acquisition and actual reading of detailed external materials remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Complete endpoint/test lists, registration/protocol/SAP, prespecification/multiple comparisons, selective reporting and original results. No new adjusted P value or grade.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Complete endpoint/test lists, registration/protocol/SAP, prespecification/multiple comparisons, selective reporting and original results. No new adjusted P value or grade." }, { "item_id": "N15", "question_type": "Evidence condition", "question": "Is the primary symptom-day specification distinct from the runny-nose example?", "needed": "Primary questionnaire symptom-days versus selecting a specific symptom", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_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.", "current_reports": [ "R01" ], "existence": "The original parent-summary display record is preserved; public availability, acquisition and actual reading of detailed external materials remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Prespecified endpoints/priorities, symptom-specific analyses, complete results and plan/change materials. A selected symptom is not upgraded into a broad conclusion.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Prespecified endpoints/priorities, symptom-specific analyses, complete results and plan/change materials. A selected symptom is not upgraded into a broad conclusion." }, { "item_id": "N16", "question_type": "Evidence condition", "question": "Was laboratory-confirmed infection incidence directly measured?", "needed": "Questionnaire symptoms versus pathogen-confirmed infection", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "Show originals for questionnaire symptoms versus pathogen-confirmed infection with selected-subclaim/parent boundaries, direct endpoints/estimand, denominators and external-reading scope.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_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.", "current_reports": [ "R01" ], "existence": "The original parent-summary display record is preserved; public availability, acquisition and actual reading of detailed external materials remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "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.", "condition_status": "Unverified", "status_reason": "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.", "missingness": "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.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "item_id": "N17", "question_type": "Evidence condition", "question": "Are severity, health-care use and other clinical outcomes being filled?", "needed": "Symptom-days versus severity, clinical visits/hospitalization and absence from work", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_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.", "current_reports": [ "R01" ], "existence": "The original parent-summary display record is preserved; public availability, acquisition and actual reading of detailed external materials remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "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.", "condition_status": "Unverified", "status_reason": "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.", "missingness": "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.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "item_id": "N18", "question_type": "Evidence condition", "question": "What gaps remain in 95% CIs and clinical effect size?", "needed": "Original absolute difference/P value and unreported 95% CIs", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_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.", "current_reports": [ "R01" ], "existence": "The original parent-summary display record is preserved; public availability, acquisition and actual reading of detailed external materials remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "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.", "condition_status": "Unverified", "status_reason": "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.", "missingness": "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.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "item_id": "N19", "question_type": "Evidence condition", "question": "Are symptom-days presented as a general immunity effect?", "needed": "The product’s added strain versus broad immunity claims", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_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.", "current_reports": [ "R01" ], "existence": "The original parent-summary display record is preserved; public availability, acquisition and actual reading of detailed external materials remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "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.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "item_id": "N20", "question_type": "Harm-information gaps supplementing the efficacy table", "question": "Are 12-week related safety signals distinct from all harms?", "needed": "Serious study-food-related signals and dairy/lactose contexts", "role": "Supplementary", "role_reason": "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_exception": "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.", "criterion": "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.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_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.", "current_reports": [ "R01" ], "existence": "The original parent-summary display record is preserved; public availability, acquisition and actual reading of detailed external materials remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "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.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "item_id": "N21", "question_type": "Evidence condition", "question": "What materials were actually read in this work?", "needed": "Preserved JSON summary and external-reading status", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "Show originals for preserved JSON summary and external-reading status with selected-subclaim/parent boundaries, direct endpoints/estimand, denominators and external-reading scope.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_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.", "current_reports": [ "R01" ], "existence": "The original parent-summary display record is preserved; public availability, acquisition and actual reading of detailed external materials remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Materials for users to record actual external acquisition/reading scope, versions and timing. No current link/click/access tests.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Materials for users to record actual external acquisition/reading scope, versions and timing. No current link/click/access tests." }, { "item_id": "N22", "question_type": "Evidence condition", "question": "Are registration, public dates, plans and current reading distinct?", "needed": "Original registration information and detailed plans/access", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "Show originals for original registration information and detailed plans/access with selected-subclaim/parent boundaries, direct endpoints/estimand, denominators and external-reading scope.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_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.", "current_reports": [ "R01" ], "existence": "The original parent-summary display record is preserved; public availability, acquisition and actual reading of detailed external materials remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Original registration texts/versions, public/start/change dates, endpoint/analysis and report-linkage materials. Only historical narratives are preserved; no current prespecification/access certification.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original registration texts/versions, public/start/change dates, endpoint/analysis and report-linkage materials. Only historical narratives are preserved; no current prespecification/access certification." }, { "item_id": "N23", "question_type": "Evidence condition", "question": "Were protocol/SAP and endpoint/multiplicity plans acquired?", "needed": "Advance plan, change and analysis materials", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "Show originals for advance plan, change and analysis materials with selected-subclaim/parent boundaries, direct endpoints/estimand, denominators and external-reading scope.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_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.", "current_reports": [ "R01" ], "existence": "The original parent-summary display record is preserved; public availability, acquisition and actual reading of detailed external materials remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "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.", "condition_status": "Unverified", "status_reason": "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.", "missingness": "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.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "item_id": "N24", "question_type": "Evidence condition", "question": "Are company funding, product support, employee authors and research roles separate?", "needed": "Four categories of company involvement and other support", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "Show originals for four categories of company involvement and other support with selected-subclaim/parent boundaries, direct endpoints/estimand, denominators and external-reading scope.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_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.", "current_reports": [ "R01" ], "existence": "The original parent-summary display record is preserved; public availability, acquisition and actual reading of detailed external materials remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "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.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "item_id": "N25", "question_type": "Evidence condition", "question": "Are narrow positive results, broad-claim gaps and unverified materials distinct?", "needed": "Direct endpoints and access/reporting limitations", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "Show originals for direct endpoints and access/reporting limitations with selected-subclaim/parent boundaries, direct endpoints/estimand, denominators and external-reading scope.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_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.", "current_reports": [ "R01" ], "existence": "The original parent-summary display record is preserved; public availability, acquisition and actual reading of detailed external materials remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "Positive questionnaire symptom-day results are distinguished from unmeasured laboratory-confirmed infections, originally unreported 95% CIs and unread detailed external materials.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "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.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "item_id": "N26", "question_type": "Evidence condition", "question": "Are reports, trials, people, repeated measures and sibling sheets distinct?", "needed": "Document linkage versus unique trials/participants", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "Show originals for document linkage versus unique trials/participants with selected-subclaim/parent boundaries, direct endpoints/estimand, denominators and external-reading scope.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_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.", "current_reports": [ "R01" ], "existence": "The original parent-summary display record is preserved; public availability, acquisition and actual reading of detailed external materials remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Original registration/report, actual cohort/analysis, endpoint/time-point and repeated-measure relationships. Unique trial counts and unique participant totals remain unrecorded.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original registration/report, actual cohort/analysis, endpoint/time-point and repeated-measure relationships. Unique trial counts and unique participant totals remain unrecorded." }, { "item_id": "N27", "question_type": "Evidence condition", "question": "Is there evidence of separate independent confirmation?", "needed": "Original R1/I0 versus independent replication", "role": "Supplementary", "role_reason": "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_exception": "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.", "criterion": "Show originals for original R1/I0 versus independent replication with selected-subclaim/parent boundaries, direct endpoints/estimand, denominators and external-reading scope.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_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.", "current_reports": [ "R01" ], "existence": "The original parent-summary display record is preserved; public availability, acquisition and actual reading of detailed external materials remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "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.", "condition_status": "Unverified", "status_reason": "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.", "missingness": "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.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "item_id": "N28", "question_type": "Evidence condition", "question": "Are selected-subclaim and parent scores/axes preserved?", "needed": "Subclaim grade/note, absent fields and parent context", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "Show originals for subclaim grade/note, absent fields and parent context with selected-subclaim/parent boundaries, direct endpoints/estimand, denominators and external-reading scope.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_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.", "current_reports": [ "R01" ], "existence": "The original parent-summary display record is preserved; public availability, acquisition and actual reading of detailed external materials remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "User subclaim/parent-boundary review and actual correction materials. No new score/grade or official RoB 2/GRADE certification.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "User subclaim/parent-boundary review and actual correction materials. No new score/grade or official RoB 2/GRADE certification." }, { "item_id": "N29", "question_type": "Evidence condition", "question": "Are Korean/English wording and absent structured fields preserved?", "needed": "Wording in both languages and absent classification fields", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "Show originals for wording in both languages and absent classification fields with selected-subclaim/parent boundaries, direct endpoints/estimand, denominators and external-reading scope.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_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.", "current_reports": [ "R01" ], "existence": "The original parent-summary display record is preserved; public availability, acquisition and actual reading of detailed external materials remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "Materials for content review of bilingual terms, endpoints/durations, absent fields and selected scope. Production explanations remain distinct from original wording.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Materials for content review of bilingual terms, endpoints/durations, absent fields and selected scope. Production explanations remain distinct from original wording." }, { "item_id": "N30", "question_type": "Evidence condition", "question": "Are reference dates, corrections, historical cross-checking and production dates distinct?", "needed": "Original 2026-08-26 versus production/application events", "role": "Required", "role_reason": "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_exception": "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.", "criterion": "Show originals for original 2026-08-26 versus production/application events with selected-subclaim/parent boundaries, direct endpoints/estimand, denominators and external-reading scope.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_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.", "current_reports": [ "R01" ], "existence": "The original parent-summary display record is preserved; public availability, acquisition and actual reading of detailed external materials remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "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.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "item_id": "N31", "question_type": "Evidence condition", "question": "What direct materials could fill the selected gaps?", "needed": "Definitions, direct endpoints, denominators/effects/CIs and plans", "role": "Supplementary", "role_reason": "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_exception": "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.", "criterion": "Show originals for definitions, direct endpoints, denominators/effects/CIs and plans with selected-subclaim/parent boundaries, direct endpoints/estimand, denominators and external-reading scope.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_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.", "current_reports": [ "R01" ], "existence": "The original parent-summary display record is preserved; public availability, acquisition and actual reading of detailed external materials remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "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.", "condition_status": "Unverified", "status_reason": "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.", "missingness": "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.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "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." }, { "item_id": "N32", "question_type": "Evidence condition", "question": "Are production, user review and implementation instructions distinct?", "needed": "Production request, candidate history and content-review responsibility", "role": "Supplementary", "role_reason": "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_exception": "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.", "criterion": "Show originals for production request, candidate history and content-review responsibility with selected-subclaim/parent boundaries, direct endpoints/estimand, denominators and external-reading scope.", "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production", "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review", "proposed_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.", "current_reports": [ "R01" ], "existence": "The original parent-summary display record is preserved; public availability, acquisition and actual reading of detailed external materials remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "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.", "condition_status": "Partly verified", "status_reason": "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.", "missingness": "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.", "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.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "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." } ], "reports": [ { "report_id": "R01", "title": "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.", "url": "https://pubmed.ncbi.nlm.nih.gov/36570128/", "report_type": "Double-blind randomized identical-yogurt placebo-controlled parallel trial", "existence": "Report bibliography exists in original citations; external availability/access remain unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/plans remain unread", "study_family": "F01", "independent_replication": "Provisional linkage of the same report/sibling sheets; not certification of separate independent trials or efficacy replication", "observed_result": "Runny nose 29.3% versus 34.3%, absolute difference −5.0 percentage points, P<0.001; 95% CI not reported", "result_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", "source_evidence_date": "2026-08-26", "materials": [ { "material_type": "Stored summary", "public_status": "Local preserved copy of the complete parent summary", "access_status": "Stored summary read", "acquired": true, "actually_read": "Summary read", "as_of": "2026-08-26", "qualification": "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." }, { "material_type": "External abstract", "public_status": "Original identifier/bibliography or required-material entry; public availability/access details remain unverified", "access_status": "Unread; access testing not performed", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "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." }, { "material_type": "External full text", "public_status": "Original identifier/bibliography or required-material entry; public availability/access details remain unverified", "access_status": "Unread; access testing not performed", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "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." }, { "material_type": "Original registration", "public_status": "Original identifier/bibliography or required-material entry; public availability/access details remain unverified", "access_status": "Unread; access testing not performed", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "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." }, { "material_type": "Protocol/SAP", "public_status": "Original identifier/bibliography or required-material entry; public availability/access details remain unverified", "access_status": "Unread; access testing not performed", "acquired": false, "actually_read": "Not read", "as_of": "2026-08-26", "qualification": "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." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/36570128/" } ] } ], "method_sources": [ { "id": "M03", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-03", "section": "§3.1, §3.2.1–3.2.3, MECIR C5/C7/C13", "official_principle": "Clearly record the question, eligibility conditions and reasons for changes, and distinguish variations in interventions.", "review_level": "Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed." }, { "id": "M04", "version": "Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04", "section": "§4.5, §4.6.1–4.6.3, MECIR C42", "official_principle": "Distinguish studies from reports and link them; do not omit a study solely because results are unreported.", "review_level": "Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed." }, { "id": "M08", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08", "section": "§8.1–8.2.3, Table 8.2.a", "official_principle": "Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.", "review_level": "Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed." }, { "id": "M15", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15", "section": "§15.2.4, §15.3.1–15.3.3", "official_principle": "Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.", "review_level": "Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed." }, { "id": "M19", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19", "section": "§19.1.2, §19.2.1–19.2.4", "official_principle": "Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.", "review_level": "Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed." } ], "status_dictionary": { "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" }, "study_overlap": { "state": "Unverified", "unique_trial_count": null, "unique_participant_count": null, "reason": "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." }, "history": [ { "date": "2026-10-14", "kind": "Separation of public-facing pages and materials", "view_version": "1.0", "change": "Public pages and materials were prepared from the existing 32 items. No new clinical search, verification-status change or scoring was performed." } ], "language": "en", "translation_date": "2026-10-14" }