{ "schema_version": "chamgap-public-evidence-check-1.0", "public_id": "v2972-s0", "verdict_number": "2972", "title": "Cod liver oil × PCR-confirmed SARS-CoV-2 — Null coprimary outcome, testing and applicability gaps", "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": "34,601 Norwegian adults not taking vitamin D supplements daily, 17,278/17,323; baseline vitamin D/age and PCR observation/testing-denominator details unverified", "intervention": "Orkla Health AS Möller's Tran combination cod-liver-oil study product", "dose": "Original study exposure: 5 mL/day, vitamin D 10 µg, about 1 g n-3 and a median 164 days; no new cumulative amount or product/vitamin intake guidance", "comparator": "Flavour-matched corn-oil placebo, 17,323 adults; actual composition/concomitant exposures unverified", "endpoint": "Selected PCR-confirmed SARS-CoV-2 infection; separated from the other coprimary serious-outcome/negative-test/self-reported-ARI endpoints", "duration": "About six winter months, a median 164 days; original registration posted 2020-10-30/start 2020-11-10 descriptions; individual observation/period details unverified", "excluded_extensions": [ "Repurposing effects during use as continued protection after stopping or using PCR/other coprimary outcomes as effects on each other", "Adding the same reports/people/arms/periods/events/endpoints, citations, related sheets as new independent trials or participants", "Mixing randomized/ITT denominators, endpoint-specific observation/testing, person/time/event denominators and other cohorts", "New effects/CI/invented quantities, equivalence/zero effects, reassessment/grades or independence certification from original numbers", "Cod-liver-oil/vitamin/product-use, infection-prevention/COVID-19 management or treatment-replacement instructions" ] }, "requirements": [ { "item_id": "N01", "question_type": "Evidence condition", "question": "Which existing PCR-infection claim is being presented?", "needed": "Selected wording, subclaim grade and parent context", "role": "Required", "role_reason": "Needed to connect selected wording, subclaim grade and parent context with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.", "application_exception": "Distinguish PCR-confirmed infection, testing selection/repetition, serious outcomes/negative tests/self-reported ARI, four coprimary endpoints/fallback, all randomized participants in ITT/missingness/denominators, winter/period/population, combination product/comparator/exposure, sponsorship/company involvement and harms. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or cod-liver-oil/vitamin/product-use/infection-prevention/COVID-19 management/treatment-replacement instructions.", "criterion": "Show original materials for selected wording, subclaim grade and parent context together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.", "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: PCR-infection definition, population/exposure, prespecified endpoint/estimand, period/denominator and existing question-boundary review. Parent values are not used to fill missing subclaim fields. Only the material request/research need is recorded; no lookup or research is performed now.", "current_reports": [ "R01" ], "existence": "Original parent-summary records preserved; external detailed-material acquisition/reading remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "The selected claim is reduced PCR-confirmed SARS-CoV-2 infection. Its original subclaim grade is D and its note records a null result, RR 1.00 (CI 0.82–1.22). Missing subclaim score/status/axes are distinguished from the parent D with 34 points and its axes.", "condition_status": "Partly verified", "status_reason": "Production observation distinguishing selected/parent, report and interval/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": "PCR-infection definition, population/exposure, prespecified endpoint/estimand, period/denominator and existing question-boundary review. Parent values are not used to fill missing subclaim fields.", "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": "PCR-infection definition, population/exposure, prespecified endpoint/estimand, period/denominator and existing question-boundary review. Parent values are not used to fill missing subclaim fields." }, { "item_id": "N02", "question_type": "Evidence condition", "question": "Which adults were studied during winter?", "needed": "Norwegian adults not taking vitamin D daily", "role": "Required", "role_reason": "Needed to connect norwegian adults not taking vitamin D daily with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.", "application_exception": "Distinguish PCR-confirmed infection, testing selection/repetition, serious outcomes/negative tests/self-reported ARI, four coprimary endpoints/fallback, all randomized participants in ITT/missingness/denominators, winter/period/population, combination product/comparator/exposure, sponsorship/company involvement and harms. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or cod-liver-oil/vitamin/product-use/infection-prevention/COVID-19 management/treatment-replacement instructions.", "criterion": "Show original materials for norwegian adults not taking vitamin D daily together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.", "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: Eligibility/exclusions, baseline vitamin D/health, vaccination/infection history and actual exposure/behaviour/medication data. Do not extend to deficient patients or populations in every period. Only the material request/research need is recorded; no lookup or research is performed now.", "current_reports": [ "R01" ], "existence": "Original parent-summary records preserved; external detailed-material acquisition/reading remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "The original population was 34,601 Norwegian adults not taking vitamin D supplements daily. Exact age range, baseline vitamin D status/deficiency, conditions, testing/vaccination and concomitant exposures are not established from the summary.", "condition_status": "Partly verified", "status_reason": "Production observation distinguishing selected/parent, report and interval/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": "Eligibility/exclusions, baseline vitamin D/health, vaccination/infection history and actual exposure/behaviour/medication data. Do not extend to deficient patients or populations in every period.", "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": "Eligibility/exclusions, baseline vitamin D/health, vaccination/infection history and actual exposure/behaviour/medication data. Do not extend to deficient patients or populations in every period." }, { "item_id": "N03", "question_type": "Evidence condition", "question": "What is known about winter, the period and duration?", "needed": "About six winter months, a median 164 days and the stated start", "role": "Required", "role_reason": "Needed to connect about six winter months, a median 164 days and the stated start with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.", "application_exception": "Distinguish PCR-confirmed infection, testing selection/repetition, serious outcomes/negative tests/self-reported ARI, four coprimary endpoints/fallback, all randomized participants in ITT/missingness/denominators, winter/period/population, combination product/comparator/exposure, sponsorship/company involvement and harms. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or cod-liver-oil/vitamin/product-use/infection-prevention/COVID-19 management/treatment-replacement instructions.", "criterion": "Show original materials for about six winter months, a median 164 days and the stated start together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.", "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: Actual recruitment/exposure/follow-up dates, season/variant/vaccination/testing policies and discontinuation/loss data. Do not turn this into current COVID-19 or other-period prevention guidance. Only the material request/research need is recorded; no lookup or research is performed now.", "current_reports": [ "R01" ], "existence": "Original parent-summary records preserved; external detailed-material acquisition/reading remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "The original materials record about six winter months, a median 164 days of use, registration posted 2020-10-30 and start 2020-11-10. Actual end/individual follow-up and variant/vaccination/testing-policy details remain unverified. No new end date or observation time is calculated.", "condition_status": "Partly verified", "status_reason": "Production observation distinguishing selected/parent, report and interval/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": "Actual recruitment/exposure/follow-up dates, season/variant/vaccination/testing policies and discontinuation/loss data. Do not turn this into current COVID-19 or other-period prevention guidance.", "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": "Actual recruitment/exposure/follow-up dates, season/variant/vaccination/testing policies and discontinuation/loss data. Do not turn this into current COVID-19 or other-period prevention guidance." }, { "item_id": "N04", "question_type": "Evidence condition", "question": "Was the study product vitamin D or omega-3 alone?", "needed": "Möller's Tran combination cod liver oil", "role": "Required", "role_reason": "Needed to connect möller's Tran combination cod liver oil with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.", "application_exception": "Distinguish PCR-confirmed infection, testing selection/repetition, serious outcomes/negative tests/self-reported ARI, four coprimary endpoints/fallback, all randomized participants in ITT/missingness/denominators, winter/period/population, combination product/comparator/exposure, sponsorship/company involvement and harms. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or cod-liver-oil/vitamin/product-use/infection-prevention/COVID-19 management/treatment-replacement instructions.", "criterion": "Show original materials for möller's Tran combination cod liver oil together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.", "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: Exact product/composition/manufacture, actual intake/adherence and concomitant supplement source data. No cod-liver-oil/vitamin/product-use or treatment-replacement instructions. Only the material request/research need is recorded; no lookup or research is performed now.", "current_reports": [ "R01" ], "existence": "Original parent-summary records preserved; external detailed-material acquisition/reading remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "The original study used cod liver oil 5 mL/day, supplying vitamin D 10 µg and about 1 g of n-3 fatty acids. This was a combination product; it does not extend to deficiency treatment, high-dose vitamin D or omega-3 alone. No new total ingredient amounts or other vitamin values are created.", "condition_status": "Partly verified", "status_reason": "Production observation distinguishing selected/parent, report and interval/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": "Exact product/composition/manufacture, actual intake/adherence and concomitant supplement source data. No cod-liver-oil/vitamin/product-use 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": "Exact product/composition/manufacture, actual intake/adherence and concomitant supplement source data. No cod-liver-oil/vitamin/product-use or treatment-replacement instructions." }, { "item_id": "N05", "question_type": "Evidence condition", "question": "Is the flavour-matched corn-oil comparator preserved?", "needed": "17,278 assigned cod liver oil versus 17,323 assigned corn oil", "role": "Required", "role_reason": "Needed to connect 17,278 assigned cod liver oil versus 17,323 assigned corn oil with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.", "application_exception": "Distinguish PCR-confirmed infection, testing selection/repetition, serious outcomes/negative tests/self-reported ARI, four coprimary endpoints/fallback, all randomized participants in ITT/missingness/denominators, winter/period/population, combination product/comparator/exposure, sponsorship/company involvement and harms. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or cod-liver-oil/vitamin/product-use/infection-prevention/COVID-19 management/treatment-replacement instructions.", "criterion": "Show original materials for 17,278 assigned cod liver oil versus 17,323 assigned corn oil together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.", "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: Actual active/placebo products, contact/sensory features, concomitant intake, adherence and exposure data. Do not generalize this particular comparison to all cod-liver-oil/vitamin effects. Only the material request/research need is recorded; no lookup or research is performed now.", "current_reports": [ "R01" ], "existence": "Original parent-summary records preserved; external detailed-material acquisition/reading remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "The original 34,601 adults were assigned to cod liver oil, 17,278, or flavour-matched corn-oil placebo, 17,323. Actual placebo composition, sensory features/masking, other supplements/diet and concomitant exposures remain unverified. Do not substitute no intervention or a different oil product.", "condition_status": "Partly verified", "status_reason": "Production observation distinguishing selected/parent, report and interval/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": "Actual active/placebo products, contact/sensory features, concomitant intake, adherence and exposure data. Do not generalize this particular comparison to all cod-liver-oil/vitamin 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": "Actual active/placebo products, contact/sensory features, concomitant intake, adherence and exposure data. Do not generalize this particular comparison to all cod-liver-oil/vitamin effects." }, { "item_id": "N06", "question_type": "Evidence condition", "question": "Are a median 164 days and complete observation/adherence distinguished?", "needed": "Duration distribution and actual exposure/discontinuation", "role": "Required", "role_reason": "Needed to connect duration distribution and actual exposure/discontinuation with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.", "application_exception": "Distinguish PCR-confirmed infection, testing selection/repetition, serious outcomes/negative tests/self-reported ARI, four coprimary endpoints/fallback, all randomized participants in ITT/missingness/denominators, winter/period/population, combination product/comparator/exposure, sponsorship/company involvement and harms. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or cod-liver-oil/vitamin/product-use/infection-prevention/COVID-19 management/treatment-replacement instructions.", "criterion": "Show original materials for duration distribution and actual exposure/discontinuation together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.", "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: Actual exposure/adherence, discontinuation, follow-up distributions by arm and endpoint-specific observation periods/missing data. No product-use or COVID-19 management guidance. Only the material request/research need is recorded; no lookup or research is performed now.", "current_reports": [ "R01" ], "existence": "Original parent-summary records preserved; external detailed-material acquisition/reading remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "The original duration of use was a median 164 days. This does not mean identical duration/exposure or complete adherence for everyone. Distributions, discontinuation/withdrawal and observation by time remain unverified; cumulative amounts/person-time are not calculated.", "condition_status": "Partly verified", "status_reason": "Production observation distinguishing selected/parent, report and interval/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": "Actual exposure/adherence, discontinuation, follow-up distributions by arm and endpoint-specific observation periods/missing data. No product-use or COVID-19 management guidance.", "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": "Actual exposure/adherence, discontinuation, follow-up distributions by arm and endpoint-specific observation periods/missing data. No product-use or COVID-19 management guidance." }, { "item_id": "N07", "question_type": "Evidence condition", "question": "What were the original PCR-infection events and effect?", "needed": "227 versus 228, RR 1.00 and adjusted 95% CI", "role": "Required", "role_reason": "Needed to connect 227 versus 228, RR 1.00 and adjusted 95% CI with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.", "application_exception": "Distinguish PCR-confirmed infection, testing selection/repetition, serious outcomes/negative tests/self-reported ARI, four coprimary endpoints/fallback, all randomized participants in ITT/missingness/denominators, winter/period/population, combination product/comparator/exposure, sponsorship/company involvement and harms. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or cod-liver-oil/vitamin/product-use/infection-prevention/COVID-19 management/treatment-replacement instructions.", "criterion": "Show original materials for 227 versus 228, RR 1.00 and adjusted 95% CI together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.", "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 PCR events/denominators, estimand/test, adjusted interval/plan and clinical threshold. No new calculations or invented examples beyond the original effect/CI. Only the material request/research need is recorded; no lookup or research is performed now.", "current_reports": [ "R01" ], "existence": "Original parent-summary records preserved; external detailed-material acquisition/reading remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "Selected PCR infection was null: 227 versus 228, RR 1.00 (adjusted 95% CI 0.82–1.22). No new proportions, risk differences, NNT or P values are calculated from randomized arm sizes; no new verdict of exactly zero effect, equivalence or exclusion of every benefit is made.", "condition_status": "Partly verified", "status_reason": "Production observation distinguishing selected/parent, report and interval/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 PCR events/denominators, estimand/test, adjusted interval/plan and clinical threshold. No new calculations or invented examples beyond the original effect/CI.", "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 PCR events/denominators, estimand/test, adjusted interval/plan and clinical threshold. No new calculations or invented examples beyond the original effect/CI." }, { "item_id": "N08", "question_type": "Evidence condition", "question": "What is the exact event unit for a positive PCR result?", "needed": "Confirmed infection, people/tests and repeated events", "role": "Required", "role_reason": "Needed to connect confirmed infection, people/tests and repeated events with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.", "application_exception": "Distinguish PCR-confirmed infection, testing selection/repetition, serious outcomes/negative tests/self-reported ARI, four coprimary endpoints/fallback, all randomized participants in ITT/missingness/denominators, winter/period/population, combination product/comparator/exposure, sponsorship/company involvement and harms. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or cod-liver-oil/vitamin/product-use/infection-prevention/COVID-19 management/treatment-replacement instructions.", "criterion": "Show original materials for confirmed infection, people/tests and repeated events together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.", "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 test/event definitions, person identifiers, first/repeated positives, baseline infection/diagnosis and aggregation/timing data. No new unique-infection or test totals. Only the material request/research need is recorded; no lookup or research is performed now.", "current_reports": [ "R01" ], "existence": "Original parent-summary records preserved; external detailed-material acquisition/reading remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "The original endpoint was PCR-confirmed SARS-CoV-2 infection with 227/228 events. Positive tests, people with a first infection, repeated infections/tests, specimens and confirmation rules remain unverified. Tests/repeated time points are not added as new participants/events.", "condition_status": "Partly verified", "status_reason": "Production observation distinguishing selected/parent, report and interval/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 test/event definitions, person identifiers, first/repeated positives, baseline infection/diagnosis and aggregation/timing data. No new unique-infection or test totals.", "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 test/event definitions, person identifiers, first/repeated positives, baseline infection/diagnosis and aggregation/timing data. No new unique-infection or test totals." }, { "item_id": "N09", "question_type": "Evidence condition", "question": "How do testing selection and opportunities affect the comparison?", "needed": "Detailed gaps in access, symptoms/screening and missed testing", "role": "Required", "role_reason": "Needed to connect detailed gaps in access, symptoms/screening and missed testing with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.", "application_exception": "Distinguish PCR-confirmed infection, testing selection/repetition, serious outcomes/negative tests/self-reported ARI, four coprimary endpoints/fallback, all randomized participants in ITT/missingness/denominators, winter/period/population, combination product/comparator/exposure, sponsorship/company involvement and harms. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or cod-liver-oil/vitamin/product-use/infection-prevention/COVID-19 management/treatment-replacement instructions.", "criterion": "Show original materials for detailed gaps in access, symptoms/screening and missed testing together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.", "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: Testing/selection criteria, policies/access, opportunities in both arms, missingness/confirmation and prespecified analysis/sensitivity data. Do not repurpose negative tests as absence of infection or a prevention effect. Only the material request/research need is recorded; no lookup or research is performed now.", "current_reports": [ "R01" ], "existence": "Original parent-summary records preserved; external detailed-material acquisition/reading remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "The original materials record PCR-confirmed infection and negative SARS-CoV-2 tests as separate coprimary outcomes. Testing selection, frequency, access, omissions, asymptomatic testing and opportunities/behaviour by arm are not established from the summary.", "condition_status": "Unverified", "status_reason": "Production observation distinguishing selected/parent, report and interval/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": "Testing/selection criteria, policies/access, opportunities in both arms, missingness/confirmation and prespecified analysis/sensitivity data. Do not repurpose negative tests as absence of infection or a prevention 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": "Testing/selection criteria, policies/access, opportunities in both arms, missingness/confirmation and prespecified analysis/sensitivity data. Do not repurpose negative tests as absence of infection or a prevention effect." }, { "item_id": "N10", "question_type": "Evidence condition", "question": "Are ITT for 34,601 adults and endpoint-specific observation denominators separated?", "needed": "All randomized adults in ITT and the scope of 0.05% missingness", "role": "Required", "role_reason": "Needed to connect all randomized adults in ITT and the scope of 0.05% missingness with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.", "application_exception": "Distinguish PCR-confirmed infection, testing selection/repetition, serious outcomes/negative tests/self-reported ARI, four coprimary endpoints/fallback, all randomized participants in ITT/missingness/denominators, winter/period/population, combination product/comparator/exposure, sponsorship/company involvement and harms. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or cod-liver-oil/vitamin/product-use/infection-prevention/COVID-19 management/treatment-replacement instructions.", "criterion": "Show original materials for all randomized adults in ITT and the scope of 0.05% missingness together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.", "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 participant flow by arm, PCR observation/analysis/testing denominators, missing variables/handling and duration/withdrawal/censoring data. No new missing counts/rates or confirmation that everyone completed follow-up. Only the material request/research need is recorded; no lookup or research is performed now.", "current_reports": [ "R01" ], "existence": "Original parent-summary records preserved; external detailed-material acquisition/reading remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "All original 34,601 randomized adults were included in ITT; missingness in key variables was 0.05%. This does not establish identical denominators for all PCR observations/tests/analyses or zero missingness in every variable. Actual missing/observed/censored counts remain unverified.", "condition_status": "Partly verified", "status_reason": "Production observation distinguishing selected/parent, report and interval/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 participant flow by arm, PCR observation/analysis/testing denominators, missing variables/handling and duration/withdrawal/censoring data. No new missing counts/rates or confirmation that everyone completed follow-up.", "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 participant flow by arm, PCR observation/analysis/testing denominators, missing variables/handling and duration/withdrawal/censoring data. No new missing counts/rates or confirmation that everyone completed follow-up." }, { "item_id": "N11", "question_type": "Evidence condition", "question": "Are the four coprimary outcomes and multiplicity plan preserved?", "needed": "Prespecified fallback, adjusted intervals and null outcomes", "role": "Required", "role_reason": "Needed to connect prespecified fallback, adjusted intervals and null outcomes with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.", "application_exception": "Distinguish PCR-confirmed infection, testing selection/repetition, serious outcomes/negative tests/self-reported ARI, four coprimary endpoints/fallback, all randomized participants in ITT/missingness/denominators, winter/period/population, combination product/comparator/exposure, sponsorship/company involvement and harms. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or cod-liver-oil/vitamin/product-use/infection-prevention/COVID-19 management/treatment-replacement instructions.", "criterion": "Show original materials for prespecified fallback, adjusted intervals and null outcomes together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.", "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: Exact endpoints, fallback procedure/intervals/significance levels, amendments/hierarchy in registration/protocol/SAP and original results. No new adjusted P values, calculations or grades. Only the material request/research need is recorded; no lookup or research is performed now.", "current_reports": [ "R01" ], "existence": "Original parent-summary records preserved; external detailed-material acquisition/reading remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "The original materials record four prespecified coprimary outcomes—PCR infection, serious COVID-19, negative tests and self-reported ARI—and fallback multiplicity control. Plan details, allocation and decision rules were not confirmed through new registration/SAP reading.", "condition_status": "Partly verified", "status_reason": "Production observation distinguishing selected/parent, report and interval/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": "Exact endpoints, fallback procedure/intervals/significance levels, amendments/hierarchy in registration/protocol/SAP and original results. No new adjusted P values, calculations or grades.", "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": "Exact endpoints, fallback procedure/intervals/significance levels, amendments/hierarchy in registration/protocol/SAP and original results. No new adjusted P values, calculations or grades." }, { "item_id": "N12", "question_type": "Evidence condition", "question": "Is serious COVID-19 distinguished from the overall PCR-infection effect?", "needed": "121 versus 101, RR 1.20 and CI 0.87–1.65", "role": "Required", "role_reason": "Needed to connect 121 versus 101, RR 1.20 and CI 0.87–1.65 with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.", "application_exception": "Distinguish PCR-confirmed infection, testing selection/repetition, serious outcomes/negative tests/self-reported ARI, four coprimary endpoints/fallback, all randomized participants in ITT/missingness/denominators, winter/period/population, combination product/comparator/exposure, sponsorship/company involvement and harms. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or cod-liver-oil/vitamin/product-use/infection-prevention/COVID-19 management/treatment-replacement instructions.", "criterion": "Show original materials for 121 versus 101, RR 1.20 and CI 0.87–1.65 together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.", "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: Serious-outcome definition, relation to test-confirmed infection, denominators/timing/follow-up, original effect/CI and aggregation data. No new clinical components/event totals or effects. Only the material request/research need is recorded; no lookup or research is performed now.", "current_reports": [ "R01" ], "existence": "Original parent-summary records preserved; external detailed-material acquisition/reading remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "Original serious COVID-19 was null: 121 versus 101, RR 1.20 (CI 0.87–1.65). The exact serious-outcome definition, overlap/denominators and model remain unverified; PCR numerators 227/228 or RR 1.00 are not copied here. No new verdict of a confirmed risk increase is made.", "condition_status": "Partly verified", "status_reason": "Production observation distinguishing selected/parent, report and interval/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": "Serious-outcome definition, relation to test-confirmed infection, denominators/timing/follow-up, original effect/CI and aggregation data. No new clinical components/event totals or 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": "Serious-outcome definition, relation to test-confirmed infection, denominators/timing/follow-up, original effect/CI and aggregation data. No new clinical components/event totals or effects." }, { "item_id": "N13", "question_type": "Evidence condition", "question": "Does a negative test independently establish infection prevention?", "needed": "8,546 versus 8,565, RR 1.00 and CI 0.97–1.04", "role": "Required", "role_reason": "Needed to connect 8,546 versus 8,565, RR 1.00 and CI 0.97–1.04 with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.", "application_exception": "Distinguish PCR-confirmed infection, testing selection/repetition, serious outcomes/negative tests/self-reported ARI, four coprimary endpoints/fallback, all randomized participants in ITT/missingness/denominators, winter/period/population, combination product/comparator/exposure, sponsorship/company involvement and harms. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or cod-liver-oil/vitamin/product-use/infection-prevention/COVID-19 management/treatment-replacement instructions.", "criterion": "Show original materials for 8,546 versus 8,565, RR 1.00 and CI 0.97–1.04 together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.", "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: Negative-test definition, aggregation/repetition, denominators, testing opportunities, prespecified model and original results. Positives/negatives are not summed into new test totals or unique people. Only the material request/research need is recorded; no lookup or research is performed now.", "current_reports": [ "R01" ], "existence": "Original parent-summary records preserved; external detailed-material acquisition/reading remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "Original negative SARS-CoV-2 tests were null: 8,546 versus 8,565, RR 1.00 (CI 0.97–1.04). Testing selection/negative-event definition and person/test overlap remain unverified. Do not repurpose this as people with negative PCR/no infection or a reduction in all infection incidence.", "condition_status": "Partly verified", "status_reason": "Production observation distinguishing selected/parent, report and interval/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": "Negative-test definition, aggregation/repetition, denominators, testing opportunities, prespecified model and original results. Positives/negatives are not summed into new test totals or unique people.", "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": "Negative-test definition, aggregation/repetition, denominators, testing opportunities, prespecified model and original results. Positives/negatives are not summed into new test totals or unique people." }, { "item_id": "N14", "question_type": "Evidence condition", "question": "Is self-reported ARI confirmed SARS-CoV-2 infection?", "needed": "3,964 versus 3,834, RR 1.04 and CI 0.97–1.11", "role": "Required", "role_reason": "Needed to connect 3,964 versus 3,834, RR 1.04 and CI 0.97–1.11 with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.", "application_exception": "Distinguish PCR-confirmed infection, testing selection/repetition, serious outcomes/negative tests/self-reported ARI, four coprimary endpoints/fallback, all randomized participants in ITT/missingness/denominators, winter/period/population, combination product/comparator/exposure, sponsorship/company involvement and harms. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or cod-liver-oil/vitamin/product-use/infection-prevention/COVID-19 management/treatment-replacement instructions.", "criterion": "Show original materials for 3,964 versus 3,834, RR 1.04 and CI 0.97–1.11 together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.", "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 ARI questions/definition, people/repeated symptoms, actual testing/timing, denominators/model. Do not upgrade self-reports to pathogen-confirmed infection. Only the material request/research need is recorded; no lookup or research is performed now.", "current_reports": [ "R01" ], "existence": "Original parent-summary records preserved; external detailed-material acquisition/reading remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "Original self-reported acute respiratory infection was null: 3,964 versus 3,834, RR 1.04 (CI 0.97–1.11). Questionnaire/period/definition, other pathogens and test-confirmation details remain unverified. Do not combine this with PCR-confirmed infection/serious events.", "condition_status": "Partly verified", "status_reason": "Production observation distinguishing selected/parent, report and interval/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 ARI questions/definition, people/repeated symptoms, actual testing/timing, denominators/model. Do not upgrade self-reports to pathogen-confirmed infection.", "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 ARI questions/definition, people/repeated symptoms, actual testing/timing, denominators/model. Do not upgrade self-reports to pathogen-confirmed infection." }, { "item_id": "N15", "question_type": "Evidence condition", "question": "Were coprimary outcomes or repeated tests in the same people added together?", "needed": "Endpoint/event overlap and unique people", "role": "Required", "role_reason": "Needed to connect endpoint/event overlap and unique people with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.", "application_exception": "Distinguish PCR-confirmed infection, testing selection/repetition, serious outcomes/negative tests/self-reported ARI, four coprimary endpoints/fallback, all randomized participants in ITT/missingness/denominators, winter/period/population, combination product/comparator/exposure, sponsorship/company involvement and harms. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or cod-liver-oil/vitamin/product-use/infection-prevention/COVID-19 management/treatment-replacement instructions.", "criterion": "Show original materials for endpoint/event overlap and unique people together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.", "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: Person/test/event identifiers, overlap/repetition handling and endpoint-specific denominator/observation data. Overall unique-trial/participant totals remain unrecorded. Only the material request/research need is recorded; no lookup or research is performed now.", "current_reports": [ "R01" ], "existence": "Original parent-summary records preserved; external detailed-material acquisition/reading remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "Original event counts for all four endpoints are preserved separately. The overlap between PCR/serious outcomes/negative tests/ARI and repeated time points in the same people remains unverified. Events/denominators are not added into new participant counts, independent trials or infection totals.", "condition_status": "Partly verified", "status_reason": "Production observation distinguishing selected/parent, report and interval/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": "Person/test/event identifiers, overlap/repetition handling and endpoint-specific denominator/observation data. Overall unique-trial/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": "Person/test/event identifiers, overlap/repetition handling and endpoint-specific denominator/observation data. Overall unique-trial/participant totals remain unrecorded." }, { "item_id": "N16", "question_type": "Evidence condition", "question": "Were between-arm estimates replaced by within-arm changes?", "needed": "Randomized between-arm RRs and exposure/testing changes", "role": "Required", "role_reason": "Needed to connect randomized between-arm RRs and exposure/testing changes with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.", "application_exception": "Distinguish PCR-confirmed infection, testing selection/repetition, serious outcomes/negative tests/self-reported ARI, four coprimary endpoints/fallback, all randomized participants in ITT/missingness/denominators, winter/period/population, combination product/comparator/exposure, sponsorship/company involvement and harms. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or cod-liver-oil/vitamin/product-use/infection-prevention/COVID-19 management/treatment-replacement instructions.", "criterion": "Show original materials for randomized between-arm RRs and exposure/testing changes together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.", "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/denominators, between-arm model, period/testing/concomitant exposures and variable/missing-data handling. No new differences, ratios or time-series effects. Only the material request/research need is recorded; no lookup or research is performed now.", "current_reports": [ "R01" ], "existence": "Original parent-summary records preserved; external detailed-material acquisition/reading remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "Original effects are endpoint-specific randomized between-arm RRs/intervals. Individual/within-arm changes in infection exposure, testing behaviour and model adjustment remain unverified. Changes across periods within an arm are not newly calculated as product-specific effects.", "condition_status": "Partly verified", "status_reason": "Production observation distinguishing selected/parent, report and interval/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/denominators, between-arm model, period/testing/concomitant exposures and variable/missing-data handling. No new differences, ratios or time-series 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 estimand/denominators, between-arm model, period/testing/concomitant exposures and variable/missing-data handling. No new differences, ratios or time-series effects." }, { "item_id": "N17", "question_type": "Evidence condition", "question": "Were original allocation and masking descriptions treated as certification?", "needed": "Independent research-support allocation and masked roles", "role": "Required", "role_reason": "Needed to connect independent research-support allocation and masked roles with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.", "application_exception": "Distinguish PCR-confirmed infection, testing selection/repetition, serious outcomes/negative tests/self-reported ARI, four coprimary endpoints/fallback, all randomized participants in ITT/missingness/denominators, winter/period/population, combination product/comparator/exposure, sponsorship/company involvement and harms. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or cod-liver-oil/vitamin/product-use/infection-prevention/COVID-19 management/treatment-replacement instructions.", "criterion": "Show original materials for independent research-support allocation and masked roles together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.", "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: Actual concealment/implementation, masking success/unmasking, exposure/deviations and measurement/missing-data source materials. Design strengths and manufacturer support are recorded separately. Only the material request/research need is recorded; no lookup or research is performed now.", "current_reports": [ "R01" ], "existence": "Original parent-summary records preserved; external detailed-material acquisition/reading remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "Original materials record allocation by the hospital research-support department without investigator involvement, and masking of participants, investigators, care providers, collectors, assessors and analysts. The original term quadruple-blinded and parent B0 are retained; no new procedural comparison or formal risk-of-bias assessment was performed.", "condition_status": "Partly verified", "status_reason": "Production observation distinguishing selected/parent, report and interval/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": "Actual concealment/implementation, masking success/unmasking, exposure/deviations and measurement/missing-data source materials. Design strengths and manufacturer support are recorded separately.", "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": "Actual concealment/implementation, masking success/unmasking, exposure/deviations and measurement/missing-data source materials. Design strengths and manufacturer support are recorded separately." }, { "item_id": "N18", "question_type": "Evidence condition", "question": "Was the CI range or null result extended into a clinical-threshold conclusion?", "needed": "PCR RR/adjusted CI and unverified clinical importance", "role": "Required", "role_reason": "Needed to connect pCR RR/adjusted CI and unverified clinical importance with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.", "application_exception": "Distinguish PCR-confirmed infection, testing selection/repetition, serious outcomes/negative tests/self-reported ARI, four coprimary endpoints/fallback, all randomized participants in ITT/missingness/denominators, winter/period/population, combination product/comparator/exposure, sponsorship/company involvement and harms. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or cod-liver-oil/vitamin/product-use/infection-prevention/COVID-19 management/treatment-replacement instructions.", "criterion": "Show original materials for pCR RR/adjusted CI and unverified clinical importance together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.", "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, adjusted CI/plan, clinical threshold, scope and question-specific direct materials. No new precision/efficacy verdict based only on sample size. Only the material request/research need is recorded; no lookup or research is performed now.", "current_reports": [ "R01" ], "existence": "Original parent-summary records preserved; external detailed-material acquisition/reading remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "Original PCR RR 1.00 (CI 0.82–1.22) and subclaim grade D are preserved. No new confirmation is made of a prespecified clinical threshold, exclusion of every benefit, equivalence, high-dose single-ingredient effects or deficiency treatment.", "condition_status": "Partly verified", "status_reason": "Production observation distinguishing selected/parent, report and interval/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, adjusted CI/plan, clinical threshold, scope and question-specific direct materials. No new precision/efficacy verdict based only on sample size.", "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, adjusted CI/plan, clinical threshold, scope and question-specific direct materials. No new precision/efficacy verdict based only on sample size." }, { "item_id": "N19", "question_type": "Evidence condition", "question": "Was the result generalized to current prevention or other ingredients?", "needed": "Combination-product, period and population boundaries", "role": "Required", "role_reason": "Needed to connect combination-product, period and population boundaries with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.", "application_exception": "Distinguish PCR-confirmed infection, testing selection/repetition, serious outcomes/negative tests/self-reported ARI, four coprimary endpoints/fallback, all randomized participants in ITT/missingness/denominators, winter/period/population, combination product/comparator/exposure, sponsorship/company involvement and harms. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or cod-liver-oil/vitamin/product-use/infection-prevention/COVID-19 management/treatment-replacement instructions.", "criterion": "Show original materials for combination-product, period and population boundaries together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.", "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 population/period/ingredient/dose, intervention/comparator, PCR/clinical endpoint, duration/effect/CI and harm materials. No recommendations or intake guidance. Only the material request/research need is recorded; no lookup or research is performed now.", "current_reports": [ "R01" ], "existence": "Original parent-summary records preserved; external detailed-material acquisition/reading remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "The existing counterview/ad interpretation limits scope to about six winter months of combination cod liver oil in adults not taking vitamin D daily. It does not address deficiency treatment, high-dose vitamin D or omega-3 alone. Do not turn it into current COVID-19 prevention/management or treatment-replacement instructions.", "condition_status": "Partly verified", "status_reason": "Production observation distinguishing selected/parent, report and interval/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 population/period/ingredient/dose, intervention/comparator, PCR/clinical endpoint, duration/effect/CI and harm materials. No recommendations or intake guidance.", "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 population/period/ingredient/dose, intervention/comparator, PCR/clinical endpoint, duration/effect/CI and harm materials. No recommendations or intake guidance." }, { "item_id": "N20", "question_type": "Harm-information gaps supplementing the efficacy table", "question": "What is the scope of the low-grade side-effect description?", "needed": "Reports in both arms and tested dose/population safety", "role": "Supplementary", "role_reason": "Needed to connect reports in both arms and tested dose/population safety with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.", "application_exception": "Distinguish PCR-confirmed infection, testing selection/repetition, serious outcomes/negative tests/self-reported ARI, four coprimary endpoints/fallback, all randomized participants in ITT/missingness/denominators, winter/period/population, combination product/comparator/exposure, sponsorship/company involvement and harms. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or cod-liver-oil/vitamin/product-use/infection-prevention/COVID-19 management/treatment-replacement instructions.", "criterion": "Show original materials for reports in both arms and tested dose/population safety together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.", "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: Adverse-event collection/grading, events/exposure/harm denominators by arm, discontinuation/causality and long-term materials. No cod-liver-oil/vitamin/infection-management instructions. Only the material request/research need is recorded; no lookup or research is performed now.", "current_reports": [ "R01" ], "existence": "Original parent-summary records preserved; external detailed-material acquisition/reading remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "The existing safety description records only low-grade side effects in both arms and limits scope to the tested dose/participants. Event types/counts by arm, actual exposure/denominators, discontinuation and causality remain unverified. Do not extend to zero adverse events or long-term safety.", "condition_status": "Partly verified", "status_reason": "Production observation distinguishing selected/parent, report and interval/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": "Adverse-event collection/grading, events/exposure/harm denominators by arm, discontinuation/causality and long-term materials. No cod-liver-oil/vitamin/infection-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": "Adverse-event collection/grading, events/exposure/harm denominators by arm, discontinuation/causality and long-term materials. No cod-liver-oil/vitamin/infection-management instructions." }, { "item_id": "N21", "question_type": "Evidence condition", "question": "What materials were actually read or acquired?", "needed": "Preserved summary and external original materials", "role": "Required", "role_reason": "Needed to connect preserved summary and external original materials with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.", "application_exception": "Distinguish PCR-confirmed infection, testing selection/repetition, serious outcomes/negative tests/self-reported ARI, four coprimary endpoints/fallback, all randomized participants in ITT/missingness/denominators, winter/period/population, combination product/comparator/exposure, sponsorship/company involvement and harms. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or cod-liver-oil/vitamin/product-use/infection-prevention/COVID-19 management/treatment-replacement instructions.", "criterion": "Show original materials for preserved summary and external original materials together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.", "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: Records of actual acquisition/reading scope, versions and dates. No external-link/click/access testing. Only material requests/research needs are recorded; no search or research was performed in that production.", "current_reports": [ "R01" ], "existence": "Original parent-summary records preserved; external detailed-material acquisition/reading remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "The complete parent summary was read for production and preserved in its original form. Summary reading concerns preserved materials; external abstracts/full texts/registrations/protocols/SAP remain unread. Original citations/URLs do not establish external reading here.", "condition_status": "Partly verified", "status_reason": "Production observation distinguishing selected/parent, report and interval/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": "Records of actual acquisition/reading scope, versions and dates. No external-link/click/access testing.", "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": "Records of actual acquisition/reading scope, versions and dates. No external-link/click/access testing." }, { "item_id": "N22", "question_type": "Evidence condition", "question": "Are historical registration/plans distinguished from current reading?", "needed": "Original registration identifier and detailed comparison", "role": "Required", "role_reason": "Needed to connect original registration identifier and detailed comparison with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.", "application_exception": "Distinguish PCR-confirmed infection, testing selection/repetition, serious outcomes/negative tests/self-reported ARI, four coprimary endpoints/fallback, all randomized participants in ITT/missingness/denominators, winter/period/population, combination product/comparator/exposure, sponsorship/company involvement and harms. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or cod-liver-oil/vitamin/product-use/infection-prevention/COVID-19 management/treatment-replacement instructions.", "criterion": "Show original materials for original registration identifier and detailed comparison together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.", "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: Actual registration versions/publication, recruitment/start/amendments, endpoints/models/analysis intervals and original report links. Preserve historical descriptions without new certification of plans or prospective specification. Only the material request/research need is recorded; no lookup or research is performed now.", "current_reports": [ "R01" ], "existence": "Original parent-summary records preserved; external detailed-material acquisition/reading remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "Existing evidence/Korean text records NCT04609423, posted 2020-10-30 before the 2020-11-10 start, as prospective registration with four matching coprimary endpoints. Official registration URL/version/plan were not newly compared externally; URLs are not guessed.", "condition_status": "Partly verified", "status_reason": "Production observation distinguishing selected/parent, report and interval/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": "Actual registration versions/publication, recruitment/start/amendments, endpoints/models/analysis intervals and original report links. Preserve historical descriptions without new certification of plans or prospective specification.", "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": "Actual registration versions/publication, recruitment/start/amendments, endpoints/models/analysis intervals and original report links. Preserve historical descriptions without new certification of plans or prospective specification." }, { "item_id": "N23", "question_type": "Evidence condition", "question": "Have protocol/SAP and analysis/missing-data plans been acquired?", "needed": "Separate materials for prespecified plans/changes", "role": "Required", "role_reason": "Needed to connect separate prespecified-plan and amendment materials with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.", "application_exception": "Distinguish PCR-confirmed infection, testing selection/repetition, serious outcomes/negative tests/self-reported ARI, four coprimary endpoints/fallback, all randomized participants in ITT/missingness/denominators, winter/period/population, combination product/comparator/exposure, sponsorship/company involvement and harms. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or cod-liver-oil/vitamin/product-use/infection-prevention/COVID-19 management/treatment-replacement instructions.", "criterion": "Show original materials for separate prespecified-plan and amendment materials together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.", "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, amendments, estimands/denominators/analyses, all endpoints and publication timing. Unread materials are not assumed absent. Only the material request/research need is recorded; no lookup or research is performed now.", "current_reports": [ "R01" ], "existence": "Original parent-summary records preserved; external detailed-material acquisition/reading remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "Original primary-outcome/ITT/registration descriptions and historical cross-checking are preserved. Actual protocol/SAP versions/timing, interval/endpoint-specific models/censoring/missingness and hierarchy/multiplicity were not newly read.", "condition_status": "Unverified", "status_reason": "Production observation distinguishing selected/parent, report and interval/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, amendments, estimands/denominators/analyses, all endpoints and publication timing. Unread materials are not assumed absent.", "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, amendments, estimands/denominators/analyses, all endpoints and publication timing. Unread materials are not assumed absent." }, { "item_id": "N24", "question_type": "Evidence condition", "question": "Are sponsorship, funding, products, authors and research involvement separated?", "needed": "Four company-involvement items and nonprofit/public/academic support", "role": "Required", "role_reason": "Needed to connect four company-involvement items and nonprofit/public/academic support with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.", "application_exception": "Distinguish PCR-confirmed infection, testing selection/repetition, serious outcomes/negative tests/self-reported ARI, four coprimary endpoints/fallback, all randomized participants in ITT/missingness/denominators, winter/period/population, combination product/comparator/exposure, sponsorship/company involvement and harms. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or cod-liver-oil/vitamin/product-use/infection-prevention/COVID-19 management/treatment-replacement instructions.", "criterion": "Show original materials for four company-involvement items and nonprofit/public/academic support together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.", "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 original materials on company cash funding, product support, employee authors/outside relationships, design/analysis/data control and nonprofit/institutional support. Original independence-axis values are not new certification of all items or independence. Only the material request/research need is recorded; no lookup or research is performed now.", "current_reports": [ "R01" ], "existence": "Original parent-summary records preserved; external detailed-material acquisition/reading remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "Orkla Health AS funding and cod-liver-oil/placebo supply, plus Oslo University Hospital/University of Oslo support, are preserved. Outside relationships of KBH with Olympic Seafood/Amgen/Sanofi and SMU with Olympic Seafood, and AS/KTK employment at Age Laboratories AS, are separately recorded. Do not confuse these with newly confirmed product-manufacturer employee authors or design/analysis roles.", "condition_status": "Partly verified", "status_reason": "Production observation distinguishing selected/parent, report and interval/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 original materials on company cash funding, product support, employee authors/outside relationships, design/analysis/data control and nonprofit/institutional support. Original independence-axis values are not new certification of all items or independence.", "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 original materials on company cash funding, product support, employee authors/outside relationships, design/analysis/data control and nonprofit/institutional support. Original independence-axis values are not new certification of all items or independence." }, { "item_id": "N25", "question_type": "Evidence condition", "question": "Are results by interval/endpoint distinguished from information gaps?", "needed": "Direct results, unverified details and access status", "role": "Required", "role_reason": "Needed to connect direct results, unverified details and access status with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.", "application_exception": "Distinguish PCR-confirmed infection, testing selection/repetition, serious outcomes/negative tests/self-reported ARI, four coprimary endpoints/fallback, all randomized participants in ITT/missingness/denominators, winter/period/population, combination product/comparator/exposure, sponsorship/company involvement and harms. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or cod-liver-oil/vitamin/product-use/infection-prevention/COVID-19 management/treatment-replacement instructions.", "criterion": "Show original materials for direct results, unverified details and access status together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.", "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 measurements, original interval/endpoint tables, plans, observations/denominators and actual access records. Do not substitute unread with unreported or null with exactly zero effect/equivalence. Only the material request/research need is recorded; no lookup or research is performed now.", "current_reports": [ "R01" ], "existence": "Original parent-summary records preserved; external detailed-material acquisition/reading remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "Null findings for PCR infection, serious outcomes, negative tests and self-reported ARI are distinguished from unverified event definitions/testing opportunities/denominators and unread details.", "condition_status": "Partly verified", "status_reason": "Production observation distinguishing selected/parent, report and interval/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 measurements, original interval/endpoint tables, plans, observations/denominators and actual access records. Do not substitute unread with unreported or null with exactly zero effect/equivalence.", "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 measurements, original interval/endpoint tables, plans, observations/denominators and actual access records. Do not substitute unread with unreported or null with exactly zero effect/equivalence." }, { "item_id": "N26", "question_type": "Evidence condition", "question": "Are reports, trials, people, intervals, events and related sheets separated?", "needed": "Linked records versus unique trials/participants", "role": "Required", "role_reason": "Needed to connect linked records and unique trials/participants with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.", "application_exception": "Distinguish PCR-confirmed infection, testing selection/repetition, serious outcomes/negative tests/self-reported ARI, four coprimary endpoints/fallback, all randomized participants in ITT/missingness/denominators, winter/period/population, combination product/comparator/exposure, sponsorship/company involvement and harms. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or cod-liver-oil/vitamin/product-use/infection-prevention/COVID-19 management/treatment-replacement instructions.", "criterion": "Show original materials for linked records and unique trials/participants together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.", "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 reports/registration, cohorts/intervals, events/repetition/observation and overlap relationships. Unique-trial/participant totals remain unrecorded. Only the material request/research need is recorded; no lookup or research is performed now.", "current_reports": [ "R01" ], "existence": "Original parent-summary records preserved; external detailed-material acquisition/reading remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "Parent 2972 and existing s0/s1/s2 share the same Brunvoll 2022 report, trial of 34,601 people and four-coprimary-outcome context. The same people/arms/periods/tests/events/endpoints, citations, related sheets are not added as new independent trials or participants. Linked-report counts do not certify unique-trial/participant totals.", "condition_status": "Partly verified", "status_reason": "Production observation distinguishing selected/parent, report and interval/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 reports/registration, cohorts/intervals, events/repetition/observation and overlap relationships. Unique-trial/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 reports/registration, cohorts/intervals, events/repetition/observation and overlap relationships. Unique-trial/participant totals remain unrecorded." }, { "item_id": "N27", "question_type": "Evidence condition", "question": "Are the original single trial and separate independent replication distinguished?", "needed": "Parent R1, independence axis and direct replication", "role": "Supplementary", "role_reason": "Needed to connect parent R1, independence axis and direct replication with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.", "application_exception": "Distinguish PCR-confirmed infection, testing selection/repetition, serious outcomes/negative tests/self-reported ARI, four coprimary endpoints/fallback, all randomized participants in ITT/missingness/denominators, winter/period/population, combination product/comparator/exposure, sponsorship/company involvement and harms. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or cod-liver-oil/vitamin/product-use/infection-prevention/COVID-19 management/treatment-replacement instructions.", "criterion": "Show original materials for parent R1, independence axis and direct replication together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.", "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 prespecified confirmation matching the question, with direct population/intervention/comparator/endpoint/duration, denominators/effects/CI and funding/author relationships. No new search or independence verdict. Only the material request/research need is recorded; no lookup or research is performed now.", "current_reports": [ "R01" ], "existence": "Original parent-summary records preserved; external detailed-material acquisition/reading remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "Parent R1/I0 are preserved. Intervals/endpoints/related sheets for the same participants are not certified as new independent replication; researcher relationships and manufacturer support remain separately recorded.", "condition_status": "Unverified", "status_reason": "Production observation distinguishing selected/parent, report and interval/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 prespecified confirmation matching the question, with direct population/intervention/comparator/endpoint/duration, denominators/effects/CI and funding/author relationships. No new search or independence verdict.", "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 prespecified confirmation matching the question, with direct population/intervention/comparator/endpoint/duration, denominators/effects/CI and funding/author relationships. No new search or independence verdict." }, { "item_id": "N28", "question_type": "Evidence condition", "question": "Are the subclaim grade and parent score/axes preserved?", "needed": "Selected D, missing score/status/axes and parent context", "role": "Required", "role_reason": "Needed to connect selected D, missing score/status/axes and parent context with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.", "application_exception": "Distinguish PCR-confirmed infection, testing selection/repetition, serious outcomes/negative tests/self-reported ARI, four coprimary endpoints/fallback, all randomized participants in ITT/missingness/denominators, winter/period/population, combination product/comparator/exposure, sponsorship/company involvement and harms. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or cod-liver-oil/vitamin/product-use/infection-prevention/COVID-19 management/treatment-replacement instructions.", "criterion": "Show original materials for selected D, missing score/status/axes and parent context together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.", "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 subclaim/parent-boundary review and actual correction materials. Distinguish absent/original axis values and their history. Only the material request/research need is recorded; no lookup or research is performed now.", "current_reports": [ "R01" ], "existence": "Original parent-summary records preserved; external detailed-material acquisition/reading remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "The selected grade/note and bilingual question are preserved; absent subclaim score/status/axes remain unrecorded. Parent D with 34 points, safety and axes remain parent context. They are not repurposed as the selected score and no new grade/RoB2/GRADE certification is created.", "condition_status": "Partly verified", "status_reason": "Production observation distinguishing selected/parent, report and interval/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 subclaim/parent-boundary review and actual correction materials. Distinguish absent/original axis values and their history.", "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 subclaim/parent-boundary review and actual correction materials. Distinguish absent/original axis values and their history." }, { "item_id": "N29", "question_type": "Evidence condition", "question": "Are both languages, citations and absent fields preserved?", "needed": "Both original languages and absent separate classification information", "role": "Required", "role_reason": "Needed to connect both original languages and absent classification fields with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.", "application_exception": "Distinguish PCR-confirmed infection, testing selection/repetition, serious outcomes/negative tests/self-reported ARI, four coprimary endpoints/fallback, all randomized participants in ITT/missingness/denominators, winter/period/population, combination product/comparator/exposure, sponsorship/company involvement and harms. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or cod-liver-oil/vitamin/product-use/infection-prevention/COVID-19 management/treatment-replacement instructions.", "criterion": "Show original materials for both original languages and absent classification fields together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.", "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 reviewing bilingual terminology, time/event/effect units, selected scope and absent fields. Production explanations are distinguished from original records. Only the material request/research need is recorded; no lookup or research is performed now.", "current_reports": [ "R01" ], "existence": "Original parent-summary records preserved; external detailed-material acquisition/reading remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "Preserve parent Korean/English citations/descriptions, evidence/citation lists, axes and selected-subclaim records in the complete summary. Separate classification information in both languages is absent; originals are not filled with new fields. No external English full-text comparison.", "condition_status": "Partly verified", "status_reason": "Production observation distinguishing selected/parent, report and interval/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 reviewing bilingual terminology, time/event/effect units, selected scope and absent fields. Production explanations are distinguished from original records.", "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 reviewing bilingual terminology, time/event/effect units, selected scope and absent fields. Production explanations are distinguished from original records." }, { "item_id": "N30", "question_type": "Evidence condition", "question": "Are source dates/corrections/history separated from production dates?", "needed": "Original 2026-08-26 and new conditions/application", "role": "Required", "role_reason": "Needed to connect original 2026-08-26 and new conditions/application with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.", "application_exception": "Distinguish PCR-confirmed infection, testing selection/repetition, serious outcomes/negative tests/self-reported ARI, four coprimary endpoints/fallback, all randomized participants in ITT/missingness/denominators, winter/period/population, combination product/comparator/exposure, sponsorship/company involvement and harms. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or cod-liver-oil/vitamin/product-use/infection-prevention/COVID-19 management/treatment-replacement instructions.", "criterion": "Show original materials for original 2026-08-26 and new conditions/application together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.", "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: Update materials separating originals, events, conditions/observations and verdict decisions when new evidence/corrections arise. Historical wording is not completed clinical content review here. Only material requests/research needs are recorded; no search or research was performed in that production.", "current_reports": [ "R01" ], "existence": "Original parent-summary records preserved; external detailed-material acquisition/reading remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "Original evidence date 2026-08-26, empty corrections/deliberation and grade-decision cross-checking are preserved. Historical citation/registration descriptions differ from current production, condition freezing/application and completed content review.", "condition_status": "Partly verified", "status_reason": "Production observation distinguishing selected/parent, report and interval/endpoint materials in the preserved summary. 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Historical wording is not completed clinical content review here." }, { "item_id": "N31", "question_type": "Evidence condition", "question": "What direct materials would fill the selected gaps?", "needed": "Direct interval/endpoint effects, denominators/CI and follow-up", "role": "Supplementary", "role_reason": "Needed to connect direct interval/endpoint effects, denominators/CI and follow-up with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.", "application_exception": "Distinguish PCR-confirmed infection, testing selection/repetition, serious outcomes/negative tests/self-reported ARI, four coprimary endpoints/fallback, all randomized participants in ITT/missingness/denominators, winter/period/population, combination product/comparator/exposure, sponsorship/company involvement and harms. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or cod-liver-oil/vitamin/product-use/infection-prevention/COVID-19 management/treatment-replacement instructions.", "criterion": "Show original materials for direct interval/endpoint effects, denominators/CI and follow-up together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.", "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 tables/plans, interval/endpoint definitions, estimands/CI, observation/censoring/denominators, exposure/adherence, independent confirmation and long-term harms. Only the need is recorded; no new lookup/research. Only the material request/research need is recorded; no lookup or research is performed now.", "current_reports": [ "R01" ], "existence": "Original parent-summary records preserved; external detailed-material acquisition/reading remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "PCR-infection accuracy/applicability could be clarified by direct testing selection/definition, endpoint denominator/model, adjustment-plan and winter/period/baseline-state materials. Do not extend to other-ingredient treatment or broad prevention.", "condition_status": "Unverified", "status_reason": "Production observation distinguishing selected/parent, report and interval/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 tables/plans, interval/endpoint definitions, estimands/CI, observation/censoring/denominators, exposure/adherence, independent confirmation and long-term harms. Only the need is recorded; no new lookup/research.", "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 tables/plans, interval/endpoint definitions, estimands/CI, observation/censoring/denominators, exposure/adherence, independent confirmation and long-term harms. Only the need is recorded; no new lookup/research." }, { "item_id": "N32", "question_type": "Evidence condition", "question": "Are applicability records separated from content review and instructions?", "needed": "Applicability records, existing candidate history and content review", "role": "Supplementary", "role_reason": "Needed to connect condition records, historical candidates and content review with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.", "application_exception": "Distinguish PCR-confirmed infection, testing selection/repetition, serious outcomes/negative tests/self-reported ARI, four coprimary endpoints/fallback, all randomized participants in ITT/missingness/denominators, winter/period/population, combination product/comparator/exposure, sponsorship/company involvement and harms. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or cod-liver-oil/vitamin/product-use/infection-prevention/COVID-19 management/treatment-replacement instructions.", "criterion": "Show original materials for condition records, historical candidates and content review together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.", "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 materials/corrections. The original production did not perform clinical-source comparisons, external access, new calculations, grade changes or product-use/COVID-19 management/infection-prevention/treatment-replacement instructions. Only the material request/research need is recorded; no lookup or research is performed now.", "current_reports": [ "R01" ], "existence": "Original parent-summary records preserved; external detailed-material acquisition/reading remain separately unverified", "acquired_read": "Preserved summary read; external abstracts/full texts/registrations/protocols/SAP remain unread", "observation": "These are summary-based applicability records. Existing content/question-boundary review remains incomplete; candidate pending/eligible markers are preserved as history.", "condition_status": "Partly verified", "status_reason": "Production observation distinguishing selected/parent, report and interval/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 materials/corrections. The original production did not perform clinical-source comparisons, external access, new calculations, grade changes or product-use/COVID-19 management/infection-prevention/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 materials/corrections. The original production did not perform clinical-source comparisons, external access, new calculations, grade changes or product-use/COVID-19 management/infection-prevention/treatment-replacement instructions." } ], "reports": [ { "report_id": "R01", "title": "Brunvoll SH, et al. Prevention of covid-19 and other acute respiratory infections with cod liver oil supplementation. BMJ. 2022;378:e071245. 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No new external reading/access or certification that conditions are met." }, { "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 URL/citation and registration identifier are preserved; absent full-text/registration/plan URLs or registration for other reports are not guessed. No new external reading/access or certification that conditions are met." }, { "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 URL/citation and registration identifier are preserved; absent full-text/registration/plan URLs or registration for other reports are not guessed. No new external reading/access or certification that conditions are met." }, { "material_type": "Registration material", "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 URL/citation and registration identifier are preserved; absent full-text/registration/plan URLs or registration for other reports are not guessed. No new external reading/access or certification that conditions are met." }, { "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 URL/citation and registration identifier are preserved; absent full-text/registration/plan URLs or registration for other reports are not guessed. No new external reading/access or certification that conditions are met." } ], "links": [ { "label": "PubMed", "url": "https://pubmed.ncbi.nlm.nih.gov/36215222/" } ] } ], "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. 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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": "Separate PCR/other coprimary results from the same Brunvoll trial; no extension to current/single-ingredient prevention. Parent 2972 and existing s0/s1/s2 share the Brunvoll 2022 report, trial of 34,601 people and four-coprimary-outcome context. The same people/arms/periods/tests/events/endpoints, citations, related sheets are not added as new independent trials/participants. Citation-based provisional links do not certify 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" }