{ "schema_version": "chamgap-public-evidence-check-1.0", "public_id": "v2972-s1", "verdict_number": "2972", "title": "Winter cod liver oil · Original null result for reduced serious COVID-19", "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": "Norwegian adults not taking vitamin D supplements daily; original 34,601 randomized; direct serious-outcome risk/infected-population denominators unverified", "intervention": "Winter cod liver oil 5 mL/day in adults not taking vitamin D supplements daily", "dose": "Original combination-study exposure preserved: cod liver oil 5 mL/day, vitamin D 10 µg/about 1 g n-3; no intake/conversion/management guidance", "comparator": "Flavour-matched corn-oil placebo; original randomized arm sizes 17,278/17,323", "endpoint": "Selected serious COVID-19: original 121/101, RR 1.20/interval 0.87–1.65; exact composite/components/confirmation/denominator unverified", "duration": "Original about six winter months, median 164 days of use; distinguished from individual/event/risk periods, long-term follow-up and treatment scope", "excluded_extensions": [ "Repurposing serious events 121/101/RR as individual hospitalization/death components or treatment after infection", "Adding PCR/negative tests/ARI or related claims as serious outcomes or independent trials", "Copying full arm sizes/infection events as every risk-population/component denominator", "Extending a null combination product to deficiency/high-dose/single ingredients, all current periods or treatment", "Cod-liver-oil/vitamin/product-use, infection-prevention/COVID-19 management/serious-disease treatment or treatment-replacement instructions" ] }, "requirements": [ { "item_id": "N01", "question_type": "Serious COVID-19, component/denominator gaps", "question": "How is the selected serious-COVID-19 claim distinguished from infection/respiratory claims?", "needed": "Selected serious-outcome question/record and parent/infection/other respiratory endpoints", "role": "Required", "role_reason": "Distinguish original product/population, serious outcome/components/denominators and unverified scope for this question: How is the selected serious-COVID-19 claim distinguished from infection/respiratory claims?", "application_exception": "Do not repurpose PCR/symptom results as direct effects on the selected serious outcome or add new related units.", "criterion": "For Selected serious-outcome question/record and parent/infection/other respiratory endpoints, separate original information from unverified details and boundaries on extension to infection/other respiratory outcomes, individual components/harms or current treatment.", "basis": "M03 §3.1, §3.2.1–3.2.4 principles for clarifying questions; Detailed separation rules are a custom design; M04 §4.6.1–4.6.2 distinction between studies and reports; Cohort/outcome linkage is a custom application; M03 §3.2.4; Custom extension boundary", "condition_origin": "Individual records based on preserved original materials; existing content review incomplete", "proposed_research": "A plan distinguishing infection, serious outcomes and other respiratory results", "current_reports": [ "R01" ], "existence": "Cod-liver-oil trial summary exists; external serious-outcome/component/harm details remain unread and needed", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "The selected existing question is reduced serious COVID-19. Its subclaim record is linked; PCR infection and other acute respiratory infection remain original context. No new question, split or trial is created.", "condition_status": "Partly verified", "status_reason": "Some original summary information is linked for production; this does not establish clinical verification/completed content review. No new certification of clinical independence was made.", "missingness": "No new certification of clinical independence was made.", "uncertainty": "No new certification of clinical independence was made.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original question/event definitions, population/comparator and scope-change records" }, { "item_id": "N02", "question_type": "Serious COVID-19, component/denominator gaps", "question": "What are the selected D/note and absent score/status/axes?", "needed": "Subclaim D, RR 1.20 (0.87–1.65) and parent history", "role": "Required", "role_reason": "Distinguish original product/population, serious outcome/components/denominators and unverified scope for this question: What are the selected D/note and absent score/status/axes?", "application_exception": "Do not repurpose parent 34 points or H/E0/C0/B0 axes as subclaim values or current clinical review/efficacy certification.", "criterion": "For Subclaim D, RR 1.20 (0.87–1.65) and parent history, separate original information from unverified details and boundaries on extension to infection/other respiratory outcomes, individual components/harms or current treatment.", "basis": "M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed separation rules are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design", "condition_origin": "Individual records based on preserved original materials; existing content review incomplete", "proposed_research": "Separate original grades from new evidence/changes", "current_reports": [ "R01" ], "existence": "Cod-liver-oil trial summary exists; external serious-outcome/component/harm details remain unread and needed", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "Selected D and the note “Null, RR 1.20 (0.87–1.65)” are preserved. Subclaim score/status/axes are absent; parent D with 34 points and its axes remain separate historical context.", "condition_status": "Partly verified", "status_reason": "Some original summary information is linked for production; this does not establish clinical verification/completed content review. Subclaim score/status/axes are absent from the original.", "missingness": "Subclaim score/status/axes are absent from the original.", "uncertainty": "Subclaim score/status/axes are absent from the original.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original subclaim and explicit change events" }, { "item_id": "N03", "question_type": "Serious COVID-19, component/denominator gaps", "question": "What are the population and routine vitamin-D supplementation boundaries?", "needed": "Norwegian adults, no routine daily supplements, selection/baseline", "role": "Required", "role_reason": "Distinguish original product/population, serious outcome/components/denominators and unverified scope for this question: What are the population and routine vitamin-D supplementation boundaries?", "application_exception": "Do not extend to deficiency treatment, specific risk groups/every adult or intake guidance.", "criterion": "For Norwegian adults, no routine daily supplements, selection/baseline, separate original information from unverified details and boundaries on extension to infection/other respiratory outcomes, individual components/harms or current treatment.", "basis": "M03 §3.2.1; detailed population conditions are internally designed; M04 §4.6.1–4.6.2, M15 §15.3.1; internal application", "condition_origin": "Individual records based on preserved original materials; existing content review incomplete", "proposed_research": "Research specifying the population and routine-supplement scope", "current_reports": [ "R01" ], "existence": "Cod-liver-oil trial summary exists; external serious-outcome/component/harm details remain unread and needed", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "The original concerns winter cod liver oil in adults not taking vitamin D supplements daily and records 34,601 Norwegian adults. It does not directly establish results for deficiency treatment or every adult.", "condition_status": "Partly verified", "status_reason": "Some original summary information is linked for production; this does not establish clinical verification/completed content review. Age/sex, selection/exclusions, baseline conditions/vitamin status and infection risk remain unverified.", "missingness": "Age/sex, selection/exclusions, baseline conditions/vitamin status and infection risk remain unverified.", "uncertainty": "Age/sex, selection/exclusions, baseline conditions/vitamin status and infection risk remain unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Selection criteria and baseline/vitamin-status tables" }, { "item_id": "N04", "question_type": "Serious COVID-19, component/denominator gaps", "question": "What separates winter/the trial period from current variants, vaccination and treatment?", "needed": "Original winter period, stated 2020 start and baseline/period exposures", "role": "Required", "role_reason": "Distinguish original product/population, serious outcome/components/denominators and unverified scope for this question: What separates winter/the trial period from current variants, vaccination and treatment?", "application_exception": "Do not newly establish the winter result for all current variants/vaccination states or serious-COVID-19 treatment efficacy.", "criterion": "For Original winter period, stated 2020 start and baseline/period exposures, separate original information from unverified details and boundaries on extension to infection/other respiratory outcomes, individual components/harms or current treatment.", "basis": "M03 §3.2.1; detailed population conditions are internally designed; M04 §4.6.1–4.6.2, M15 §15.3.1; internal application; M03 §3.2.3, M08 §8.2.2–8.2.3; internal application", "condition_origin": "Individual records based on preserved original materials; existing content review incomplete", "proposed_research": "Research distinguishing period/population boundaries", "current_reports": [ "R01" ], "existence": "Cod-liver-oil trial summary exists; external serious-outcome/component/harm details remain unread and needed", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "The original describes about six winter months, registration posted 2020-10-30 and start 2020-11-10. Details of variants, vaccination/previous infection and concurrent treatment are absent from the summary.", "condition_status": "Partly verified", "status_reason": "Some original summary information is linked for production; this does not establish clinical verification/completed content review. Period-specific pathogens/vaccination, previous infection, exposure/treatment and subgroups remain unverified.", "missingness": "Period-specific pathogens/vaccination, previous infection, exposure/treatment and subgroups remain unverified.", "uncertainty": "Period-specific pathogens/vaccination, previous infection, exposure/treatment and subgroups remain unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Actual period/baseline exposures and pathogen/treatment data" }, { "item_id": "N05", "question_type": "Serious COVID-19, component/denominator gaps", "question": "What was the original combination-product exposure at 5 mL/day?", "needed": "Cod liver oil, vitamin D 10 µg/about 1 g n-3 and original product identity", "role": "Required", "role_reason": "Distinguish original product/population, serious outcome/components/denominators and unverified scope for this question: What was the original combination-product exposure at 5 mL/day?", "application_exception": "No new dose conversion, cod-liver-oil/vitamin/product-use instructions, ingredient recommendations or treatment methods.", "criterion": "For Cod liver oil, vitamin D 10 µg/about 1 g n-3 and original product identity, separate original information from unverified details and boundaries on extension to infection/other respiratory outcomes, individual components/harms or current treatment.", "basis": "M03 §§3.2.2–3.2.3; reverse-direction labels and assessment adaptation are Chamgap-designed; M03 §§3.2.1–3.2.4; dose, durability and effect-modification details are Chamgap-designed", "condition_origin": "Individual records based on preserved original materials; existing content review incomplete", "proposed_research": "Research specifying combination product/population exposure", "current_reports": [ "R01" ], "existence": "Cod-liver-oil trial summary exists; external serious-outcome/component/harm details remain unread and needed", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "Original cod liver oil 5 mL/day contained vitamin D 10 µg and about 1 g of n-3 fatty acids. The original Möller’s Tran manufacturer-product description is preserved; the combination is not split into single-ingredient effects.", "condition_status": "Partly verified", "status_reason": "Some original summary information is linked for production; this does not establish clinical verification/completed content review. Composition/manufacture/quality, other ingredients and actual adherence/exposure specifications remain unverified.", "missingness": "Composition/manufacture/quality, other ingredients and actual adherence/exposure specifications remain unverified.", "uncertainty": "Composition/manufacture/quality, other ingredients and actual adherence/exposure specifications remain unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Study-product specifications and actual exposure/adherence records" }, { "item_id": "N06", "question_type": "Serious COVID-19, component/denominator gaps", "question": "What does the flavour-matched corn-oil comparator answer?", "needed": "Original corn-oil placebo, sensory features/composition/common conditions", "role": "Required", "role_reason": "Distinguish original product/population, serious outcome/components/denominators and unverified scope for this question: What does the flavour-matched corn-oil comparator answer?", "application_exception": "Do not turn the combination-product comparison into new superiority claims for single ingredients, all products or other treatments.", "criterion": "For Original corn-oil placebo, sensory features/composition/common conditions, separate original information from unverified details and boundaries on extension to infection/other respiratory outcomes, individual components/harms or current treatment.", "basis": "M03 §3.2.2–3.2.3; reverse-direction labels and testing adaptations are internally designed; M03 §3.2.3, M08 §8.2.2–8.2.3; internal application; M08 §8.1–8.2.3; internal application", "condition_origin": "Individual records based on preserved original materials; existing content review incomplete", "proposed_research": "A plan specifying the exact comparator and estimand", "current_reports": [ "R01" ], "existence": "Cod-liver-oil trial summary exists; external serious-outcome/component/harm details remain unread and needed", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "The original compares flavour-matched corn-oil placebo, 17,323 adults, with cod liver oil, 17,278. This was not a comparison with no treatment, high-dose vitamins or omega-3 alone.", "condition_status": "Partly verified", "status_reason": "Some original summary information is linked for production; this does not establish clinical verification/completed content review. Comparator composition/exposure, condition recognition/actual adherence and shared procedures remain unverified.", "missingness": "Comparator composition/exposure, condition recognition/actual adherence and shared procedures remain unverified.", "uncertainty": "Comparator composition/exposure, condition recognition/actual adherence and shared procedures remain unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Active/placebo specifications and masking/adherence data" }, { "item_id": "N07", "question_type": "Serious COVID-19, component/denominator gaps", "question": "How are a median 164 days/about six months separated from actual exposure/follow-up?", "needed": "Median 164 days of use, winter period, outcome observation/adherence", "role": "Required", "role_reason": "Distinguish original product/population, serious outcome/components/denominators and unverified scope for this question: How are a median 164 days/about six months separated from actual exposure/follow-up?", "application_exception": "Do not calculate 164 days as a fixed duration for everyone, total product amounts or person-time, or provide an intake schedule.", "criterion": "For Median 164 days of use, winter period, outcome observation/adherence, separate original information from unverified details and boundaries on extension to infection/other respiratory outcomes, individual components/harms or current treatment.", "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed; M03 §3.2.1–3.2.4; dose/duration/effect-modification details are internally designed; M08 §8.2.2, M15 §15.3.1; internal application", "condition_origin": "Individual records based on preserved original materials; existing content review incomplete", "proposed_research": "Research separating exposure from event-observation periods", "current_reports": [ "R01" ], "existence": "Cod-liver-oil trial summary exists; external serious-outcome/component/harm details remain unread and needed", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "The original records a median 164 days of use and about six winter months. Individual exposure durations, adherence/discontinuation and infection/serious-outcome follow-up times are not detailed in the summary.", "condition_status": "Partly verified", "status_reason": "Some original summary information is linked for production; this does not establish clinical verification/completed content review. Individual/arm-specific exposure, adherence/discontinuation, time at risk and outcome observation remain unverified.", "missingness": "Individual/arm-specific exposure, adherence/discontinuation, time at risk and outcome observation remain unverified.", "uncertainty": "Individual/arm-specific exposure, adherence/discontinuation, time at risk and outcome observation remain unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Exposure/outcome timing and adherence/follow-up records" }, { "item_id": "N08", "question_type": "Serious COVID-19, component/denominator gaps", "question": "What is the exact serious-COVID-19 event/composite definition?", "needed": "Serious-outcome definition, confirmation, composite/components and thresholds", "role": "Required", "role_reason": "Distinguish original product/population, serious outcome/components/denominators and unverified scope for this question: What is the exact serious-COVID-19 event/composite definition?", "application_exception": "Do not newly define severity using hospitalization/death alone or add symptoms/components absent from the original.", "criterion": "For Serious-outcome definition, confirmation, composite/components and thresholds, separate original information from unverified details and boundaries on extension to infection/other respiratory outcomes, individual components/harms or current treatment.", "basis": "M03 §3.2.4 and M15 §15.3.1–15.3.3; Question-specific outcome adaptation is Chamgap design; M08 Table 8.2.a and M03 §3.2.4; Chamgap application; M03 §3.2.4; Chamgap interpretation boundary", "condition_origin": "Individual records based on preserved original materials; existing content review incomplete", "proposed_research": "Research specifying the serious composite and individual components", "current_reports": [ "R01" ], "existence": "Cod-liver-oil trial summary exists; external serious-outcome/component/harm details remain unread and needed", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "The original records serious COVID-19 as one coprimary outcome. Exact severity criteria, composite components/adjudication and confirmation methods are not provided in the summary.", "condition_status": "Unverified", "status_reason": "Required direct materials were not verified within the current summary/unread-external-material scope. Composite definition/components, thresholds, testing/physician adjudication and confirmation timing remain unverified.", "missingness": "Composite definition/components, thresholds, testing/physician adjudication and confirmation timing remain unverified.", "uncertainty": "Composite definition/components, thresholds, testing/physician adjudication and confirmation timing remain unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Serious-outcome definitions, adjudication/confirmation plans and original component tables" }, { "item_id": "N09", "question_type": "Serious COVID-19, component/denominator gaps", "question": "What are the selected serious-outcome events, RR and adjusted interval?", "needed": "Serious outcomes: 121 versus 101, RR 1.20 (0.87–1.65)", "role": "Required", "role_reason": "Distinguish original product/population, serious outcome/components/denominators and unverified scope for this question: What are the selected serious-outcome events, RR and adjusted interval?", "application_exception": "Do not turn RR>1 into confirmed harm/a significant increase or certify the original null result as exactly zero effect/equivalence.", "criterion": "For Serious outcomes: 121 versus 101, RR 1.20 (0.87–1.65), separate original information from unverified details and boundaries on extension to infection/other respiratory outcomes, individual components/harms or current treatment.", "basis": "M08 Table 8.2.a, M15 §15.3 and M19 §19.1.2–19.2.4; Design-specific adaptation is Chamgap design; M08 §8.2.2 and M15 §15.3.1; Chamgap application; M15 §15.3.1–15.3.3; Chamgap application", "condition_origin": "Individual records based on preserved original materials; existing content review incomplete", "proposed_research": "Research specifying estimand, events/denominators and adjustment", "current_reports": [ "R01" ], "existence": "Cod-liver-oil trial summary exists; external serious-outcome/component/harm details remain unread and needed", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "Following the original endpoint order, serious outcomes were cod liver oil 121 versus placebo 101, RR 1.20 (0.87–1.65). Korean/English text describes adjusted 95% intervals and the original null result. No new RR/CI/P is calculated.", "condition_status": "Partly verified", "status_reason": "Some original summary information is linked for production; this does not establish clinical verification/completed content review. Whether events count people, first/repeated events or composite events, and the relevant denominator/model/adjustment method, remain unverified.", "missingness": "Whether events count people, first/repeated events or composite events, and the relevant denominator/model/adjustment method, remain unverified.", "uncertainty": "Whether events count people, first/repeated events or composite events, and the relevant denominator/model/adjustment method, remain unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Serious-outcome events/denominators and RR/interval/analysis tables" }, { "item_id": "N10", "question_type": "Serious COVID-19, component/denominator gaps", "question": "Is hospitalization the same as the individual effect of the serious composite?", "needed": "Hospitalization definition/confirmation, events/denominator and composite relationship", "role": "Required", "role_reason": "Distinguish original product/population, serious outcome/components/denominators and unverified scope for this question: Is hospitalization the same as the individual effect of the serious composite?", "application_exception": "Do not transfer 121/101 to hospitalization counts or create zero hospitalizations or reduction/increase effects.", "criterion": "For Hospitalization definition/confirmation, events/denominator and composite relationship, separate original information from unverified details and boundaries on extension to infection/other respiratory outcomes, individual components/harms or current treatment.", "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are internally designed; M03 §3.2.4; internal extension boundaries", "condition_origin": "Individual records based on preserved original materials; existing content review incomplete", "proposed_research": "A plan distinguishing the composite from individual hospitalization outcomes", "current_reports": [ "R01" ], "existence": "Cod-liver-oil trial summary exists; external serious-outcome/component/harm details remain unread and needed", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "Original serious-event totals 121/101 and RR exist, but hospitalization components/inclusion, original events/denominators and effect/CI are not separately available. The composite result is not copied as a hospitalization result.", "condition_status": "Unverified", "status_reason": "Required direct materials were not verified within the current summary/unread-external-material scope. Hospitalization components, definition/confirmation, events/denominators/time and effect intervals remain unverified.", "missingness": "Hospitalization components, definition/confirmation, events/denominators/time and effect intervals remain unverified.", "uncertainty": "Hospitalization components, definition/confirmation, events/denominators/time and effect intervals remain unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original hospitalization/serious-component tables and direct definitions" }, { "item_id": "N11", "question_type": "Serious COVID-19, component/denominator gaps", "question": "Is death the same as the individual effect of the serious composite?", "needed": "Death definition/period, components/individual events and denominator", "role": "Required", "role_reason": "Distinguish original product/population, serious outcome/components/denominators and unverified scope for this question: Is death the same as the individual effect of the serious composite?", "application_exception": "Do not add zero deaths or sparse-event counts absent from the original, or judge null serious outcomes as mortality equivalence/no harm.", "criterion": "For Death definition/period, components/individual events and denominator, separate original information from unverified details and boundaries on extension to infection/other respiratory outcomes, individual components/harms or current treatment.", "basis": "M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are internally designed; M03 §3.2.4; internal extension boundaries", "condition_origin": "Individual records based on preserved original materials; existing content review incomplete", "proposed_research": "A plan separating serious composites from cause-specific/all-cause mortality", "current_reports": [ "R01" ], "existence": "Cod-liver-oil trial summary exists; external serious-outcome/component/harm details remain unread and needed", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "The original summary lacks individual COVID-19/all-cause-death components, events/denominators and effect/CI. The serious-outcome RR is not transferred to a mortality RR.", "condition_status": "Unverified", "status_reason": "Required direct materials were not verified within the current summary/unread-external-material scope. Cause-specific/all-cause death, composite inclusion, events/denominators/time and estimates/CI remain unverified.", "missingness": "Cause-specific/all-cause death, composite inclusion, events/denominators/time and estimates/CI remain unverified.", "uncertainty": "Cause-specific/all-cause death, composite inclusion, events/denominators/time and estimates/CI remain unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original mortality/serious-component tables and definitions/follow-up" }, { "item_id": "N12", "question_type": "Serious COVID-19, component/denominator gaps", "question": "Are randomized, infected and at-risk population denominators distinguished?", "needed": "34,601/arm sizes versus serious-outcome/infected/event-risk denominators", "role": "Required", "role_reason": "Distinguish original product/population, serious outcome/components/denominators and unverified scope for this question: Are randomized, infected and at-risk population denominators distinguished?", "application_exception": "Do not use PCR 227/228 as serious-outcome denominators or copy full arm sizes to every component/subgroup.", "criterion": "For 34,601/arm sizes versus serious-outcome/infected/event-risk denominators, separate original information from unverified details and boundaries on extension to infection/other respiratory outcomes, individual components/harms or current treatment.", "basis": "M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are internally designed; M03 §3.2.1; detailed population conditions are internally designed; M08 §8.2.2, M15 §15.3.1; internal application", "condition_origin": "Individual records based on preserved original materials; existing content review incomplete", "proposed_research": "Research distinguishing populations, denominators and conditional estimands", "current_reports": [ "R01" ], "existence": "Cod-liver-oil trial summary exists; external serious-outcome/component/harm details remain unread and needed", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "Original randomization of 34,601 adults (17,278/17,323) is preserved. The exact serious-event risk denominator, conditional serious-outcome denominator among PCR-infected participants and risk subgroups are not separately available.", "condition_status": "Partly verified", "status_reason": "Some original summary information is linked for production; this does not establish clinical verification/completed content review. Outcome-specific effective denominators/infection conditions, time/subgroups and event aggregation remain unverified.", "missingness": "Outcome-specific effective denominators/infection conditions, time/subgroups and event aggregation remain unverified.", "uncertainty": "Outcome-specific effective denominators/infection conditions, time/subgroups and event aggregation remain unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Randomized/infected/at-risk population flow and outcome-specific denominators" }, { "item_id": "N13", "question_type": "Serious COVID-19, component/denominator gaps", "question": "What is the uncertainty in serious/component events and intervals?", "needed": "Original events/intervals, component sparsity/precision and importance", "role": "Required", "role_reason": "Distinguish original product/population, serious outcome/components/denominators and unverified scope for this question: What is the uncertainty in serious/component events and intervals?", "application_exception": "Do not calculate new P/CI where original intervals/P are absent or newly conclude that all important benefits/harms are excluded.", "criterion": "For Original events/intervals, component sparsity/precision and importance, separate original information from unverified details and boundaries on extension to infection/other respiratory outcomes, individual components/harms or current treatment.", "basis": "M15 §15.3.1–15.3.3; Chamgap adaptation; M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptations are Chamgap design", "condition_origin": "Individual records based on preserved original materials; existing content review incomplete", "proposed_research": "A plan distinguishing overall sample size from outcome-specific precision", "current_reports": [ "R01" ], "existence": "Cod-liver-oil trial summary exists; external serious-outcome/component/harm details remain unread and needed", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "Original serious events 121/101, RR 1.20, interval 0.87–1.65 and parent C0 are preserved. A large overall sample does not guarantee precision, exclusion of small differences or equivalence for each component.", "condition_status": "Partly verified", "status_reason": "Some original summary information is linked for production; this does not establish clinical verification/completed content review. Component events/denominators, estimates/CI, power/importance and sparse-event handling remain unverified.", "missingness": "Component events/denominators, estimates/CI, power/importance and sparse-event handling remain unverified.", "uncertainty": "Component events/denominators, estimates/CI, power/importance and sparse-event handling remain unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Component-specific events/estimates/intervals and SAP" }, { "item_id": "N14", "question_type": "Serious COVID-19, component/denominator gaps", "question": "How are PCR infection, negative tests and other ARI different endpoints?", "needed": "Original order of four results, related outcomes, negative tests and questionnaire ARI", "role": "Supplementary", "role_reason": "Distinguish original product/population, serious outcome/components/denominators and unverified scope for this question: How are PCR infection, negative tests and other ARI different endpoints?", "application_exception": "Do not turn negative tests into other confirmed infections or sum the four event counts/related claims into serious outcomes or independent trials.", "criterion": "For Original order of four results, related outcomes, negative tests and questionnaire ARI, separate original information from unverified details and boundaries on extension to infection/other respiratory outcomes, individual components/harms or current treatment.", "basis": "M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed splitting rules are internally designed; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed; M03 §3.2.4; internal extension boundaries", "condition_origin": "Individual records based on preserved original materials; existing content review incomplete", "proposed_research": "A plan separating infection, tests, symptoms and serious outcomes", "current_reports": [ "R01" ], "existence": "Cod-liver-oil trial summary exists; external serious-outcome/component/harm details remain unread and needed", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "Original PCR 227/228, RR 1.00 (0.82–1.22); negative tests 8,546/8,565, RR 1.00 (0.97–1.04); and self-reported ARI 3,964/3,834, RR 1.04 (0.97–1.11), are preserved as other-endpoint context.", "condition_status": "Partly verified", "status_reason": "Some original summary information is linked for production; this does not establish clinical verification/completed content review. Event definitions/confirmation, people/tests/repetition and denominators/models for each endpoint remain unverified.", "missingness": "Event definitions/confirmation, people/tests/repetition and denominators/models for each endpoint remain unverified.", "uncertainty": "Event definitions/confirmation, people/tests/repetition and denominators/models for each endpoint remain unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Each endpoint definition/denominator and original result tables" }, { "item_id": "N15", "question_type": "Serious COVID-19, component/denominator gaps", "question": "What was the original scope of four coprimary outcomes, fallback and adjusted intervals?", "needed": "Coprimary hierarchy, multiplicity/fallback and interval adjustment", "role": "Required", "role_reason": "Distinguish original product/population, serious outcome/components/denominators and unverified scope for this question: What was the original scope of four coprimary outcomes, fallback and adjusted intervals?", "application_exception": "Do not create current prospective-specification certification from four endpoint names/original B0 quotations or arbitrarily interpret interval adjustment as baseline-covariate adjustment.", "criterion": "For Coprimary hierarchy, multiplicity/fallback and interval adjustment, separate original information from unverified details and boundaries on extension to infection/other respiratory outcomes, individual components/harms or current treatment.", "basis": "M08 Table 8.2.a, M04 §4.6.3; internal application; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptations are internally designed; M15 §15.3.1–15.3.3; internal application", "condition_origin": "Individual records based on preserved original materials; existing content review incomplete", "proposed_research": "Research specifying coprimary outcomes, estimands and multiplicity", "current_reports": [ "R01" ], "existence": "Cod-liver-oil trial summary exists; external serious-outcome/component/harm details remain unread and needed", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "The original describes all four coprimary outcomes as null and multiplicity control through prespecified fallback. Original adjusted 95% intervals are preserved; exact rules/adjustments/original plans remain externally unread.", "condition_status": "Partly verified", "status_reason": "Some original summary information is linked for production; this does not establish clinical verification/completed content review. Fallback allocation/success rules, interval/model adjustment and plan versions remain unverified.", "missingness": "Fallback allocation/success rules, interval/model adjustment and plan versions remain unverified.", "uncertainty": "Fallback allocation/success rules, interval/model adjustment and plan versions remain unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Registration/protocol/SAP and multiplicity/interval plans" }, { "item_id": "N16", "question_type": "Serious COVID-19, component/denominator gaps", "question": "What is known from the registration ID/posting/start versus current plan reading?", "needed": "NCT04609423, original 2020-10-30/11-10 and prospective description", "role": "Required", "role_reason": "Distinguish original product/population, serious outcome/components/denominators and unverified scope for this question: What is known from the registration ID/posting/start versus current plan reading?", "application_exception": "Do not upgrade original prospective/matching quotations to current registration verification or completed plan review, or calculate date differences.", "criterion": "For NCT04609423, original 2020-10-30/11-10 and prospective description, separate original information from unverified details and boundaries on extension to infection/other respiratory outcomes, individual components/harms or current treatment.", "basis": "M04 §4.5–4.6 material collection/selection principles; acquisition/reading separation and hyperlink specifications are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design; M08 Table 8.2.a, M04 §4.6.3; internal application", "condition_origin": "Individual records based on preserved original materials; existing content review incomplete", "proposed_research": "Records preserving prespecified plans and amendment events", "current_reports": [ "R01" ], "existence": "Cod-liver-oil trial summary exists; external serious-outcome/component/harm details remain unread and needed", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "Original NCT04609423 and prospective registration posted 2020-10-30 before start 2020-11-10 are preserved. External registration, protocol and SAP were not queried/read this time.", "condition_status": "Partly verified", "status_reason": "Some original summary information is linked for production; this does not establish clinical verification/completed content review. Registration content/versions, prespecified outcomes/analyses and amendment/posting records remain unread.", "missingness": "Registration content/versions, prespecified outcomes/analyses and amendment/posting records remain unread.", "uncertainty": "Registration content/versions, prespecified outcomes/analyses and amendment/posting records remain unread.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Registration versions/timing, protocol/SAP and result comparisons" }, { "item_id": "N17", "question_type": "Serious COVID-19, component/denominator gaps", "question": "What do the original concealment/quadruple-masking quotations record?", "needed": "Allocation without investigator involvement and masked participant/research/collection/assessment/analysis roles", "role": "Required", "role_reason": "Distinguish original product/population, serious outcome/components/denominators and unverified scope for this question: What do the original concealment/quadruple-masking quotations record?", "application_exception": "Do not inherit original B0/quadruple masking as current completed risk-of-bias/content review or independence certification.", "criterion": "For Allocation without investigator involvement and masked participant/research/collection/assessment/analysis roles, separate original information from unverified details and boundaries on extension to infection/other respiratory outcomes, individual components/harms or current treatment.", "basis": "M08 §8.1–8.2.3; internal application; M08 Table 8.2.a, M03 §3.2.4; internal application", "condition_origin": "Individual records based on preserved original materials; existing content review incomplete", "proposed_research": "Research specifying exact allocation and masking roles", "current_reports": [ "R01" ], "existence": "Cod-liver-oil trial summary exists; external serious-outcome/component/harm details remain unread and needed", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "The original research explanation preserves quotations on hospital research-support allocation without investigator involvement and masking of participants, researchers, care, collection, assessment and analysis personnel. Actual procedures/condition recognition were not newly reviewed externally.", "condition_status": "Partly verified", "status_reason": "Some original summary information is linked for production; this does not establish clinical verification/completed content review. Allocation/concealment, maintained masking/condition comparability and baseline-balance details remain unread.", "missingness": "Allocation/concealment, maintained masking/condition comparability and baseline-balance details remain unread.", "uncertainty": "Allocation/concealment, maintained masking/condition comparability and baseline-balance details remain unread.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Allocation/masking/condition-recognition and baseline/protocol data" }, { "item_id": "N18", "question_type": "Serious COVID-19, component/denominator gaps", "question": "Is 0.05% key-variable missingness the same as missing events/components?", "needed": "Randomized/arm sizes, 0.05% key variables and outcome-specific denominators/flow", "role": "Required", "role_reason": "Distinguish original product/population, serious outcome/components/denominators and unverified scope for this question: Is 0.05% key-variable missingness the same as missing events/components?", "application_exception": "Do not convert 0.05% to a person count or copy it to missingness rates for every endpoint/harm.", "criterion": "For Randomized/arm sizes, 0.05% key variables and outcome-specific denominators/flow, separate original information from unverified details and boundaries on extension to infection/other respiratory outcomes, individual components/harms or current treatment.", "basis": "M08 Table 8.2.a, M15 §15.3, M19 §19.1.2–19.2.4; design-specific adaptation is our own design; M08 §8.2.2, M15 §15.3.1; own application; M19 §19.1.2–19.2.4, M04 §4.6.3; own application", "condition_origin": "Individual records based on preserved original materials; existing content review incomplete", "proposed_research": "A plan distinguishing all participants/key variables from outcome-specific completeness", "current_reports": [ "R01" ], "existence": "Cod-liver-oil trial summary exists; external serious-outcome/component/harm details remain unread and needed", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "Original 34,601/17,278/17,323 and 0.05% key-variable missingness are preserved. Endpoint/serious-component omissions, risk denominators and completed withdrawal/infection follow-up are not separately available.", "condition_status": "Partly verified", "status_reason": "Some original summary information is linked for production; this does not establish clinical verification/completed content review. Missingness by arm/endpoint/component, reasons for withdrawal/discontinuation and missing-data handling remain unverified.", "missingness": "Missingness by arm/endpoint/component, reasons for withdrawal/discontinuation and missing-data handling remain unverified.", "uncertainty": "Missingness by arm/endpoint/component, reasons for withdrawal/discontinuation and missing-data handling remain unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Each flow/missingness table, SAP and collection materials" }, { "item_id": "N19", "question_type": "Serious COVID-19, component/denominator gaps", "question": "What separates original ITT from adherence/infection-conditioned estimands?", "needed": "All randomized adults in ITT, actual exposure/infected participants and serious-outcome estimand", "role": "Required", "role_reason": "Distinguish original product/population, serious outcome/components/denominators and unverified scope for this question: What separates original ITT from adherence/infection-conditioned estimands?", "application_exception": "Do not repurpose a preventive assignment trial’s serious-outcome RR as treatment after infection or newly calculate absent denominators.", "criterion": "For All randomized adults in ITT, actual exposure/infected participants and serious-outcome estimand, separate original information from unverified details and boundaries on extension to infection/other respiratory outcomes, individual components/harms or current treatment.", "basis": "M08 §8.2.2, M15 §15.3.1; own application; M03 §3.2.3, M08 §8.2.2–8.2.3; own application; M08 Table 8.2.a, M04 §4.6.3; own application", "condition_origin": "Individual records based on preserved original materials; existing content review incomplete", "proposed_research": "A plan distinguishing assigned prevention effects from serious-outcome effects among infected participants", "current_reports": [ "R01" ], "existence": "Cod-liver-oil trial summary exists; external serious-outcome/component/harm details remain unread and needed", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "The original records an ITT quotation for all randomized participants. Adherer/infection-conditioned analyses, actual exposure and model/adjustment/missing-data details are absent from the summary.", "condition_status": "Partly verified", "status_reason": "Some original summary information is linked for production; this does not establish clinical verification/completed content review. Estimands/analysis populations, adherence/missingness and covariate/conditional models remain unverified.", "missingness": "Estimands/analysis populations, adherence/missingness and covariate/conditional models remain unverified.", "uncertainty": "Estimands/analysis populations, adherence/missingness and covariate/conditional models remain unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "SAP, analysis populations/models and exposure/denominator materials" }, { "item_id": "N20", "question_type": "Serious COVID-19, component/denominator gaps", "question": "Were baseline vitamins/conditions, vaccination and concurrent exposures verified?", "needed": "Baseline/medications, other supplements/exposures and arm differences", "role": "Required", "role_reason": "Distinguish original product/population, serious outcome/components/denominators and unverified scope for this question: Were baseline vitamins/conditions, vaccination and concurrent exposures verified?", "application_exception": "Do not add deficiency diagnoses, high-dose/single-ingredient effects or infection-prevention/treatment methods without original materials.", "criterion": "For Baseline/medications, other supplements/exposures and arm differences, separate original information from unverified details and boundaries on extension to infection/other respiratory outcomes, individual components/harms or current treatment.", "basis": "M03 §3.2.3, M08 §8.2.2–8.2.3; internal application; M03 §3.2.1; detailed population conditions are internally designed; M19 §19.2.2–19.2.4 design considerations; detailed confounding records are internally designed", "condition_origin": "Individual records based on preserved original materials; existing content review incomplete", "proposed_research": "Research specifying population and shared exposures", "current_reports": [ "R01" ], "existence": "Cod-liver-oil trial summary exists; external serious-outcome/component/harm details remain unread and needed", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "The original specifies no routine daily supplements and the winter/combination-product scope. Baseline vitamin status, comorbidities/medications, vaccination/exposure and other supplement/treatment details are absent.", "condition_status": "Unverified", "status_reason": "Required direct materials were not verified within the current summary/unread-external-material scope. Baseline/changed conditions/medications, supplements/vaccination/infection exposures and arm differences remain unverified.", "missingness": "Baseline/changed conditions/medications, supplements/vaccination/infection exposures and arm differences remain unverified.", "uncertainty": "Baseline/changed conditions/medications, supplements/vaccination/infection exposures and arm differences remain unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Baseline/concurrent exposures and subgroup/protocol materials" }, { "item_id": "N21", "question_type": "Serious COVID-19, component/denominator gaps", "question": "What are the original manufacturer/institution support and outside/diagnostics-author relationships?", "needed": "Orkla supply/funding, Oslo support and disclosed relationships/employees", "role": "Required", "role_reason": "Distinguish original product/population, serious outcome/components/denominators and unverified scope for this question: What are the original manufacturer/institution support and outside/diagnostics-author relationships?", "application_exception": "Do not combine diagnostics-company employees with manufacturer employees or turn manufacturer null reporting into independence/content-review certification or invalidation of the numbers.", "criterion": "For Orkla supply/funding, Oslo support and disclosed relationships/employees, separate original information from unverified details and boundaries on extension to infection/other respiratory outcomes, individual components/harms or current treatment.", "basis": "Chamgap’s own independence/attribution conditions. The official methodological sections used in this pilot do not guarantee every detailed item; M08 §8.1–8.2.3; internal application", "condition_origin": "Individual records based on preserved original materials; existing content review incomplete", "proposed_research": "Specify funding and research-decision/analysis roles", "current_reports": [ "R01" ], "existence": "Cod-liver-oil trial summary exists; external serious-outcome/component/harm details remain unread and needed", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "The original records Orkla Health AS funding/products/placebo, Oslo hospital/university support, KBH’s outside relationships with Olympic Seafood/Amgen/Sanofi, SMU’s with Olympic Seafood, and AS/KTK employment at Age Laboratories.", "condition_status": "Partly verified", "status_reason": "Some original summary information is linked for production; this does not establish clinical verification/completed content review. Original disclosures/supporters and current design/analysis/data-access role details remain unread.", "missingness": "Original disclosures/supporters and current design/analysis/data-access role details remain unread.", "uncertainty": "Original disclosures/supporters and current design/analysis/data-access role details remain unread.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original support/product-supply and author-relationship disclosures" }, { "item_id": "N22", "question_type": "Serious COVID-19, component/denominator gaps", "question": "How are the same trial/people/composite components and related claims connected?", "needed": "Single Brunvoll 2022 citation, four outcomes/arms/period and overlap", "role": "Required", "role_reason": "Distinguish original product/population, serious outcome/components/denominators and unverified scope for this question: How are the same trial/people/composite components and related claims connected?", "application_exception": "One report or four outcomes do not certify the total independent-trial count or final independence count.", "criterion": "For Single Brunvoll 2022 citation, four outcomes/arms/period and overlap, separate original information from unverified details and boundaries on extension to infection/other respiratory outcomes, individual components/harms or current treatment.", "basis": "Study/report distinction in M04 §4.6.1–4.6.2; Cohort/outcome linkage is Chamgap application; M04 §4.6.1–4.6.2 and M15 §15.3.1; Chamgap application", "condition_origin": "Individual records based on preserved original materials; existing content review incomplete", "proposed_research": "Records distinguishing reports from trial families/components", "current_reports": [ "R01" ], "existence": "Cod-liver-oil trial summary exists; external serious-outcome/component/harm details remain unread and needed", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "The existing single evidence/citation report links four outcomes, the same people/arms/period and related claims. Composite components, tests/symptoms/events are not added as new independent trials/participants.", "condition_status": "Partly verified", "status_reason": "Some original summary information is linked for production; this does not establish clinical verification/completed content review. Individual overlap/component relationships, related reports and unique-trial/participant totals remain unverified.", "missingness": "Individual overlap/component relationships, related reports and unique-trial/participant totals remain unverified.", "uncertainty": "Individual overlap/component relationships, related reports and unique-trial/participant totals remain unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Trial/report identities and event/component/observation-unit data" }, { "item_id": "N23", "question_type": "Serious COVID-19, component/denominator gaps", "question": "What separates direct independent serious-outcome confirmation from the single-trial history?", "needed": "Selected product/population and independent reports of the same serious outcome", "role": "Required", "role_reason": "Distinguish original product/population, serious outcome/components/denominators and unverified scope for this question: What separates direct independent serious-outcome confirmation from the single-trial history?", "application_exception": "Do not extend the original single trial into a current claim of no worldwide studies or count related outcomes as independent replication.", "criterion": "For Selected product/population and independent reports of the same serious outcome, separate original information from unverified details and boundaries on extension to infection/other respiratory outcomes, individual components/harms or current treatment.", "basis": "Study/report distinction in M04 §4.6.1–4.6.2; Cohort/outcome linkage is Chamgap application; M04 §4.6.1–4.6.2 and M15 §15.3.1; Chamgap application", "condition_origin": "Individual records based on preserved original materials; existing content review incomplete", "proposed_research": "Separate research specifying the same product/population/serious-outcome definition", "current_reports": [ "R01" ], "existence": "Cod-liver-oil trial summary exists; external serious-outcome/component/harm details remain unread and needed", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "Parent R1/I0 and the single large manufacturer-supported trial description are preserved as history. Other independent serious-outcome source materials were not newly searched for/acquired.", "condition_status": "Unverified", "status_reason": "Required direct materials were not verified within the current summary/unread-external-material scope. Populations/products/serious-outcome definitions and overlap/independence in separate direct reports remain unverified.", "missingness": "Populations/products/serious-outcome definitions and overlap/independence in separate direct reports remain unverified.", "uncertainty": "Populations/products/serious-outcome definitions and overlap/independence in separate direct reports remain unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct confirmation/trial-identity materials" }, { "item_id": "N24", "question_type": "Serious COVID-19, component/denominator gaps", "question": "What separates a null combination product from deficiency/high-dose/single-ingredient effects?", "needed": "Original product versus deficiency treatment/high-dose vitamin D/n-3 alone", "role": "Supplementary", "role_reason": "Distinguish original product/population, serious outcome/components/denominators and unverified scope for this question: What separates a null combination product from deficiency/high-dose/single-ingredient effects?", "application_exception": "No new vitamin-use/deficiency-treatment guidance, product/ingredient recommendations or high-dose/treatment-replacement methods.", "criterion": "For Original product versus deficiency treatment/high-dose vitamin D/n-3 alone, separate original information from unverified details and boundaries on extension to infection/other respiratory outcomes, individual components/harms or current treatment.", "basis": "M03 §3.2.2–3.2.3; reverse-direction labels and testing adaptations are internally designed; M04 §4.6.1–4.6.2, M15 §15.3.1; internal application; M03 §3.2.1–3.2.4; dose/duration/effect-modification details are internally designed", "condition_origin": "Individual records based on preserved original materials; existing content review incomplete", "proposed_research": "A plan separating the combination product from other questions", "current_reports": [ "R01" ], "existence": "Cod-liver-oil trial summary exists; external serious-outcome/component/harm details remain unread and needed", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "Original counterview/ad interpretation explicitly excludes deficiency treatment, high-dose vitamin D and omega-3 alone. Combination-product results are not turned into individual-ingredient conclusions.", "condition_status": "Partly verified", "status_reason": "Some original summary information is linked for production; this does not establish clinical verification/completed content review. Direct serious-outcome data for single/other exposures or deficient/at-risk populations remain unverified.", "missingness": "Direct serious-outcome data for single/other exposures or deficient/at-risk populations remain unverified.", "uncertainty": "Direct serious-outcome data for single/other exposures or deficient/at-risk populations remain unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Exact ingredient/population/exposure-specific materials" }, { "item_id": "N25", "question_type": "Serious COVID-19, component/denominator gaps", "question": "Which serious, hospitalization/death, symptom/quality-of-life outcomes can be answered?", "needed": "Original serious-outcome name, individual/patient-important outcomes and treatment questions", "role": "Supplementary", "role_reason": "Distinguish original product/population, serious outcome/components/denominators and unverified scope for this question: Which serious, hospitalization/death, symptom/quality-of-life outcomes can be answered?", "application_exception": "Do not extend the original prevention null result to current serious-disease treatment failure or alternative-treatment selection.", "criterion": "For Original serious-outcome name, individual/patient-important outcomes and treatment questions, separate original information from unverified details and boundaries on extension to infection/other respiratory outcomes, individual components/harms or current treatment.", "basis": "M03 §3.2.4; internally defined extension boundary; M03 §3.2.4, M15 §15.3.1–15.3.3; question-specific outcome adaptation is internally designed", "condition_origin": "Individual records based on preserved original materials; existing content review incomplete", "proposed_research": "Research distinguishing prevention/serious outcomes/treatment and component-specific estimands", "current_reports": [ "R01" ], "existence": "Cod-liver-oil trial summary exists; external serious-outcome/component/harm details remain unread and needed", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "Original serious-event totals and infection/questionnaire ARI are different outcomes. Direct values for individual hospitalization/death, quality of life/symptom severity or treating serious disease after infection are not separately available.", "condition_status": "Partly verified", "status_reason": "Some original summary information is linked for production; this does not establish clinical verification/completed content review. Clinical components/important outcomes and direct definitions/denominators/effects/periods remain unverified.", "missingness": "Clinical components/important outcomes and direct definitions/denominators/effects/periods remain unverified.", "uncertainty": "Clinical components/important outcomes and direct definitions/denominators/effects/periods remain unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct individual clinical/patient-important outcome materials" }, { "item_id": "N26", "question_type": "Serious COVID-19, component/denominator gaps", "question": "What is the scope of summary reading, unread external materials and original links?", "needed": "Entire summary, abstract/full text/registration/plans/disclosures", "role": "Required", "role_reason": "Distinguish original product/population, serious outcome/components/denominators and unverified scope for this question: What is the scope of summary reading, unread external materials and original links?", "application_exception": "Preserve absent DOI/PMCID and unread status; a URL/ID alone does not establish acquisition or access success/failure.", "criterion": "For Entire summary, abstract/full text/registration/plans/disclosures, separate original information from unverified details and boundaries on extension to infection/other respiratory outcomes, individual components/harms or current treatment.", "basis": "M04 §4.5–4.6 material collection/selection principles; acquisition/reading separation and hyperlink specifications are internally designed; M04 §4.5, §4.6.3; limits of this material conversion follow the review scope and internal design", "condition_origin": "Individual records based on preserved original materials; existing content review incomplete", "proposed_research": "Records separating summaries/identities from new acquisition", "current_reports": [ "R01" ], "existence": "Cod-liver-oil trial summary exists; external serious-outcome/component/harm details remain unread and needed", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "The entire preserved 2972 summary was read and saved for production. PubMed URL/NCT are original source links; external content/link access, clicks and tests were not performed.", "condition_status": "Partly verified", "status_reason": "Some original summary information is linked for production; this does not establish clinical verification/completed content review. Current verification of external serious-outcome definitions/methods/results and registration/plan/disclosure details remains incomplete.", "missingness": "Current verification of external serious-outcome definitions/methods/results and registration/plan/disclosure details remains incomplete.", "uncertainty": "Current verification of external serious-outcome definitions/methods/results and registration/plan/disclosure details remains incomplete.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Acquired original materials and actual reading/addition events" }, { "item_id": "N27", "question_type": "Serious COVID-19, component/denominator gaps", "question": "What are the bilingual text, dates/corrections, original axes/absences and history?", "needed": "Parent D with 34 points, languages/dates/empty values and B0 quotations/axes", "role": "Required", "role_reason": "Distinguish original product/population, serious outcome/components/denominators and unverified scope for this question: What are the bilingual text, dates/corrections, original axes/absences and history?", "application_exception": "Do not inherit B0/prespecification/ITT quotations or cross-checking as current clinical-content review or independence certification.", "criterion": "For Parent D with 34 points, languages/dates/empty values and B0 quotations/axes, separate original information from unverified details and boundaries on extension to infection/other respiratory outcomes, individual components/harms or current treatment.", "basis": "M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed splitting rules are internally designed; M04 §4.5, §4.6.3; current material-conversion limits follow review scope and internal design; Chamgap’s own independence/attribution conditions. The official methodological sections used in this pilot do not guarantee every detailed item", "condition_origin": "Individual records based on preserved original materials; existing content review incomplete", "proposed_research": "Separate original values/absences from new updates", "current_reports": [ "R01" ], "existence": "Cod-liver-oil trial summary exists; external serious-outcome/component/harm details remain unread and needed", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "Bilingual text, original evidence date 2026-08-26 and empty corrections/deliberation are preserved. Parent B/H/R1/I0/E0/B0/C0, the true large-hard-endpoint-RCT indicator, two false indicators and empty grade-override reasons remain historical context. Separate classification fields and the primary-failed/secondary-positive indicator are unrecorded.", "condition_status": "Partly verified", "status_reason": "Some original summary information is linked for production; this does not establish clinical verification/completed content review. External original quotations/translations and detailed registration/correction comparisons were not performed this time.", "missingness": "External original quotations/translations and detailed registration/correction comparisons were not performed this time.", "uncertainty": "External original quotations/translations and detailed registration/correction comparisons were not performed this time.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Original text, language-specific changes and date/correction events" }, { "item_id": "N28", "question_type": "Serious COVID-19, component/denominator gaps", "question": "What was the original scope of harm collection and low-grade side effects?", "needed": "Side-effect definitions/grading, collection/causality and arm events", "role": "Supplementary", "role_reason": "Distinguish original product/population, serious outcome/components/denominators and unverified scope for this question: What was the original scope of harm collection and low-grade side effects?", "application_exception": "Do not turn the original low-grade-only description into zero side effects, long-term no harm or equivalent safety.", "criterion": "For Side-effect definitions/grading, collection/causality and arm events, separate original information from unverified details and boundaries on extension to infection/other respiratory outcomes, individual components/harms or current treatment.", "basis": "M19 §19.1.2–19.2.4; Detailed distinctions are designed by CHAMGAP", "condition_origin": "Individual records based on preserved original materials; existing content review incomplete", "proposed_research": "Research specifying harm collection separately from efficacy", "current_reports": [ "R01" ], "existence": "Cod-liver-oil trial summary exists; external serious-outcome/component/harm details remain unread and needed", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "The original safety description states that only low-grade side effects were reported in both arms. All event definitions, collection/grading methods and serious/related-event/arm-count details are absent from the summary.", "condition_status": "Partly verified", "status_reason": "Some original summary information is linked for production; this does not establish clinical verification/completed content review. Harm collection/grading, all events and original causality/discontinuation tables remain unverified.", "missingness": "Harm collection/grading, all events and original causality/discontinuation tables remain unverified.", "uncertainty": "Harm collection/grading, all events and original causality/discontinuation tables remain unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Harm plans and event/grading/discontinuation materials" }, { "item_id": "N29", "question_type": "Serious COVID-19, component/denominator gaps", "question": "Are side effects, serious COVID-19 and hospitalization/death categories distinguished?", "needed": "Exposure harms, trial-efficacy serious outcomes and other-event causality", "role": "Supplementary", "role_reason": "Distinguish original product/population, serious outcome/components/denominators and unverified scope for this question: Are side effects, serious COVID-19 and hospitalization/death categories distinguished?", "application_exception": "Do not make new product-caused-harm or guaranteed-safety verdicts from RR 1.20 or low-grade descriptions.", "criterion": "For Exposure harms, trial-efficacy serious outcomes and other-event causality, separate original information from unverified details and boundaries on extension to infection/other respiratory outcomes, individual components/harms or current treatment.", "basis": "M19 §19.1.2–19.2.4; detailed discrimination is internally designed; Chamgap’s own interpretation boundaries. M19 principles are referenced; no official causality tool was run; M03 §3.2.4; internal extension boundaries", "condition_origin": "Individual records based on preserved original materials; existing content review incomplete", "proposed_research": "A plan separating infection severity from exposure harms", "current_reports": [ "R01" ], "existence": "Cod-liver-oil trial summary exists; external serious-outcome/component/harm details remain unread and needed", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "The serious-COVID-19 RR and low-grade side-effect descriptions in both arms concern different outcomes. Serious-event counts 121/101 are not transferred to product-side-effect counts.", "condition_status": "Partly verified", "status_reason": "Some original summary information is linked for production; this does not establish clinical verification/completed content review. Definitions, causality/components and denominators for efficacy events/exposure harms remain unverified.", "missingness": "Definitions, causality/components and denominators for efficacy events/exposure harms remain unverified.", "uncertainty": "Definitions, causality/components and denominators for efficacy events/exposure harms remain unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Efficacy/harm categories and causality/event materials" }, { "item_id": "N30", "question_type": "Serious COVID-19, component/denominator gaps", "question": "Are overall/arm-specific harm denominators the same as key-variable missingness?", "needed": "17,278/17,323, key-variable 0.05% and harm-observation populations", "role": "Supplementary", "role_reason": "Distinguish original product/population, serious outcome/components/denominators and unverified scope for this question: Are overall/arm-specific harm denominators the same as key-variable missingness?", "application_exception": "Do not copy all-participant/0.05% information into complete harm observation or calculate new incidence/differences/CI.", "criterion": "For 17,278/17,323, key-variable 0.05% and harm-observation populations, separate original information from unverified details and boundaries on extension to infection/other respiratory outcomes, individual components/harms or current treatment.", "basis": "M19 §19.2.2–19.2.4, M03 §3.2.3; internal application; M19 §19.1.2–19.2.4; internal application", "condition_origin": "Individual records based on preserved original materials; existing content review incomplete", "proposed_research": "Research distinguishing efficacy analyses from harm-observation populations", "current_reports": [ "R01" ], "existence": "Cod-liver-oil trial summary exists; external serious-outcome/component/harm details remain unread and needed", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "Randomized arm sizes and key-variable missingness are described, but collection/denominators/exposure time and CI for each side effect are not separately available.", "condition_status": "Unverified", "status_reason": "Required direct materials were not verified within the current summary/unread-external-material scope. Harm denominators by arm/event/period and comparative effects/CI remain unverified.", "missingness": "Harm denominators by arm/event/period and comparative effects/CI remain unverified.", "uncertainty": "Harm denominators by arm/event/period and comparative effects/CI remain unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Harm flow and events/denominator tables by arm" }, { "item_id": "N31", "question_type": "Serious COVID-19, component/denominator gaps", "question": "What is known about harm timing, after stopping, delayed and long-term observation?", "needed": "Original median 164 days and side-effect timing/exposure/follow-up", "role": "Supplementary", "role_reason": "Distinguish original product/population, serious outcome/components/denominators and unverified scope for this question: What is known about harm timing, after stopping, delayed and long-term observation?", "application_exception": "Do not convert winter exposure into confirmed safety for all long-term/repeated use.", "criterion": "For Original median 164 days and side-effect timing/exposure/follow-up, separate original information from unverified details and boundaries on extension to infection/other respiratory outcomes, individual components/harms or current treatment.", "basis": "M19 §19.2 design-specific harm questions; temporal-relationship details are internally designed; M19 §19.1.2–19.2.4; internal application", "condition_origin": "Individual records based on preserved original materials; existing content review incomplete", "proposed_research": "A plan distinguishing timing and delayed harms", "current_reports": [ "R01" ], "existence": "Cod-liver-oil trial summary exists; external serious-outcome/component/harm details remain unread and needed", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "The original has a median 164 days of use and low-grade descriptions in both arms, but no side-effect timing or post-discontinuation/delayed/longer observation details.", "condition_status": "Unverified", "status_reason": "Required direct materials were not verified within the current summary/unread-external-material scope. Exposure/event timing and direct post-study/long-term harms remain unverified.", "missingness": "Exposure/event timing and direct post-study/long-term harms remain unverified.", "uncertainty": "Exposure/event timing and direct post-study/long-term harms remain unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Exposure/harm timing and follow-up materials" }, { "item_id": "N32", "question_type": "Serious COVID-19, component/denominator gaps", "question": "What alternative causes involve combination product/placebo, medical history and medications?", "needed": "Vitamin/n-3 combination, shared exposures and event causality", "role": "Supplementary", "role_reason": "Distinguish original product/population, serious outcome/components/denominators and unverified scope for this question: What alternative causes involve combination product/placebo, medical history and medications?", "application_exception": "Do not add unreported ingredients/invented harms or new medication/product stopping/substitution/management instructions.", "criterion": "For Vitamin/n-3 combination, shared exposures and event causality, separate original information from unverified details and boundaries on extension to infection/other respiratory outcomes, individual components/harms or current treatment.", "basis": "M19 §19.2.2–19.2.4 design considerations; detailed confounding records are Chamgap design; M03 §3.2.3, M08 §8.2.2–8.2.3; Chamgap adaptation", "condition_origin": "Individual records based on preserved original materials; existing content review incomplete", "proposed_research": "A harm plan distinguishing relevant exposure from alternative causes", "current_reports": [ "R01" ], "existence": "Cod-liver-oil trial summary exists; external serious-outcome/component/harm details remain unread and needed", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "The original product is a combination and placebo flavour-matched corn oil. Detailed source materials attributing events to product/individual ingredients, baseline status or concurrent medications are absent.", "condition_status": "Unverified", "status_reason": "Required direct materials were not verified within the current summary/unread-external-material scope. Baseline/concurrent medications, actual exposure and event-specific causality/alternative causes remain unverified.", "missingness": "Baseline/concurrent medications, actual exposure and event-specific causality/alternative causes remain unverified.", "uncertainty": "Baseline/concurrent medications, actual exposure and event-specific causality/alternative causes remain unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Medical history/medications/exposure and event-causality records" }, { "item_id": "N33", "question_type": "Serious COVID-19, component/denominator gaps", "question": "Are key-variable missingness, serious-outcome confirmation and harm-related stopping distinguished?", "needed": "0.05% missingness, event confirmation/collection and stopping reasons", "role": "Supplementary", "role_reason": "Distinguish original product/population, serious outcome/components/denominators and unverified scope for this question: Are key-variable missingness, serious-outcome confirmation and harm-related stopping distinguished?", "application_exception": "Do not declare zero omissions in all harms/components from a small key-variable missingness rate or fill unverified events with zero.", "criterion": "For 0.05% missingness, event confirmation/collection and stopping reasons, separate original information from unverified details and boundaries on extension to infection/other respiratory outcomes, individual components/harms or current treatment.", "basis": "M19 §19.1.2–19.2.4, M04 §4.6.3; internal application; M08 §8.2.2, M15 §15.3.1; internal application", "condition_origin": "Individual records based on preserved original materials; existing content review incomplete", "proposed_research": "A plan distinguishing missing efficacy data from harm-related stopping", "current_reports": [ "R01" ], "existence": "Cod-liver-oil trial summary exists; external serious-outcome/component/harm details remain unread and needed", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "Original 0.05% key-variable missingness and ITT are preserved. Serious-event confirmation/component omissions, side-effect-related stopping and complete harm collection are not detailed.", "condition_status": "Unverified", "status_reason": "Required direct materials were not verified within the current summary/unread-external-material scope. Event/harm omissions, arm-specific stopping reasons/causality and handling remain unverified.", "missingness": "Event/harm omissions, arm-specific stopping reasons/causality and handling remain unverified.", "uncertainty": "Event/harm omissions, arm-specific stopping reasons/causality and handling remain unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Outcome/harm flow, omissions/discontinuation and SAP" }, { "item_id": "N34", "question_type": "Serious COVID-19, component/denominator gaps", "question": "How do independent harm materials differ from the same trial/components/related claims?", "needed": "Separate safety-material identities and overlap in the same people/components", "role": "Supplementary", "role_reason": "Distinguish original product/population, serious outcome/components/denominators and unverified scope for this question: How do independent harm materials differ from the same trial/components/related claims?", "application_exception": "Do not extend the current absence of a separate slot into a claim that all external safety materials are absent.", "criterion": "For Separate safety-material identities and overlap in the same people/components, separate original information from unverified details and boundaries on extension to infection/other respiratory outcomes, individual components/harms or current treatment.", "basis": "M04 §§4.6.1–4.6.2; harm-material adaptation is Chamgap-designed; M04 §§4.6.1–4.6.2 distinction between studies and reports; cohort/outcome links are Chamgap adaptations", "condition_origin": "Individual records based on preserved original materials; existing content review incomplete", "proposed_research": "Records distinguishing the same trial from independent harms", "current_reports": [ "R01" ], "existence": "Cod-liver-oil trial summary exists; external serious-outcome/component/harm details remain unread and needed", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "The current list contains this large efficacy report. Separate original harm materials were not newly searched for/acquired; the same trial/people, composite components and related claims are not counted as independent harm trials.", "condition_status": "Unverified", "status_reason": "Required direct materials were not verified within the current summary/unread-external-material scope. Independent harm-material identities, population/product/exposure and overlap remain unverified.", "missingness": "Independent harm-material identities, population/product/exposure and overlap remain unverified.", "uncertainty": "Independent harm-material identities, population/product/exposure and overlap remain unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Separate harm/surveillance and event materials" }, { "item_id": "N35", "question_type": "Serious COVID-19, component/denominator gaps", "question": "What are the boundaries for deficient/at-risk/vulnerable populations, current periods and long-term safety?", "needed": "Original winter product/population versus other risks/exposures/periods", "role": "Supplementary", "role_reason": "Distinguish original product/population, serious outcome/components/denominators and unverified scope for this question: What are the boundaries for deficient/at-risk/vulnerable populations, current periods and long-term safety?", "application_exception": "No new cod-liver-oil/vitamin/product-use, infection-prevention/COVID-19 management or serious-COVID-19 treatment guidance.", "criterion": "For Original winter product/population versus other risks/exposures/periods, separate original information from unverified details and boundaries on extension to infection/other respiratory outcomes, individual components/harms or current treatment.", "basis": "M19 §19.1.2–19.2.4; internal application; M03 §3.2.1; detailed population conditions are internally designed; M03 §3.2.1–3.2.4; dose/duration/effect-modification details are internally designed", "condition_origin": "Individual records based on preserved original materials; existing content review incomplete", "proposed_research": "Research separating population and long-term safety questions", "current_reports": [ "R01" ], "existence": "Cod-liver-oil trial summary exists; external serious-outcome/component/harm details remain unread and needed", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "The original limits scope to the tested dose/participants. It does not judge direct safety in deficient/high-risk/other-condition populations, current periods, long-term exposure or different products.", "condition_status": "Unverified", "status_reason": "Required direct materials were not verified within the current summary/unread-external-material scope. Direct events, medications and long-term follow-up by population/period/exposure remain unverified.", "missingness": "Direct events, medications and long-term follow-up by population/period/exposure remain unverified.", "uncertainty": "Direct events, medications and long-term follow-up by population/period/exposure remain unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Direct harms for at-risk/vulnerable populations and specific products/periods" }, { "item_id": "N36", "question_type": "Serious COVID-19, component/denominator gaps", "question": "Are the causal scopes of null serious outcomes, other endpoints and good safety separated?", "needed": "Serious-outcome RR/interval, efficacy/harms and parent safety", "role": "Supplementary", "role_reason": "Distinguish original product/population, serious outcome/components/denominators and unverified scope for this question: Are the causal scopes of null serious outcomes, other endpoints and good safety separated?", "application_exception": "Do not turn the original product null result into null effects for all vitamins/treatment replacement, guaranteed safety or a new grade.", "criterion": "For Serious-outcome RR/interval, efficacy/harms and parent safety, separate original information from unverified details and boundaries on extension to infection/other respiratory outcomes, individual components/harms or current treatment.", "basis": "Chamgap’s own interpretation boundaries. M19 principles are referenced; no official causality tool was run; M03 §3.2.4; internal extension boundaries; M15 §15.3.1–15.3.3; internal application", "condition_origin": "Individual records based on preserved original materials; existing content review incomplete", "proposed_research": "A plan separating different estimands/outcomes", "current_reports": [ "R01" ], "existence": "Cod-liver-oil trial summary exists; external serious-outcome/component/harm details remain unread and needed", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "Original null serious outcomes, null findings for the other three endpoints, low-grade side effects and parent good safety are preserved separately. The serious-outcome interval/null result is not confirmed harm, equivalence/no-harm certification or separate hospitalization/death conclusions.", "condition_status": "Partly verified", "status_reason": "Some original summary information is linked for production; this does not establish clinical verification/completed content review. Direct component/comparative harms, causality/importance and long-term precision remain unverified.", "missingness": "Direct component/comparative harms, causality/importance and long-term precision remain unverified.", "uncertainty": "Direct component/comparative harms, causality/importance and long-term precision remain unverified.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Component-specific efficacy/harms and direct estimates/follow-up materials" }, { "item_id": "N37", "question_type": "Serious COVID-19, component/denominator gaps", "question": "How are follow-up materials, historical candidates, versions and incomplete content review linked?", "needed": "Preserved summary, conditions, units, denominators, components, original values and addition events", "role": "Supplementary", "role_reason": "Distinguish original product/population, serious outcome/components/denominators and unverified scope for this question: How are follow-up materials, historical candidates, versions and incomplete content review linked?", "application_exception": "Do not invent current completed clinical-content review/publication from historical cross-checking or original production completion.", "criterion": "For Preserved summary, conditions, units, denominators, components, original values and addition events, separate original information from unverified details and boundaries on extension to infection/other respiratory outcomes, individual components/harms or current treatment.", "basis": "M03 §3.1, §3.2.1–3.2.4 question-clarification principles; detailed splitting rules are internally designed; M04 §4.6.3, M15 §15.3.1–15.3.3; status separation is internally designed; M04 §4.5, §4.6.3; current material-conversion limits follow review scope and internal design; M08 Table 8.2.a, M04 §4.6.3; internal application", "condition_origin": "Individual records based on preserved original materials; existing content review incomplete", "proposed_research": "Research addressing direct gaps in the selected serious-COVID-19 question", "current_reports": [ "R01" ], "existence": "Cod-liver-oil trial summary exists; external serious-outcome/component/harm details remain unread and needed", "acquired_read": "Summary read; external materials unread, access not attempted", "observation": "Conditions were preserved/frozen before separate application. Candidate review-pending/production-eligibility labels remain historical records; current content/question-boundary review is incomplete. Zero new units and unrecorded confirmed independent totals are retained.", "condition_status": "Partly verified", "status_reason": "Some original summary information is linked for production; this does not establish clinical verification/completed content review. Follow-up original materials, actual reading, changes, content review and independence decisions do not yet exist.", "missingness": "Follow-up original materials, actual reading, changes, content review and independence decisions do not yet exist.", "uncertainty": "Follow-up original materials, actual reading, changes, content review and independence decisions do not yet exist.", "review_date": null, "reading_status": "Full text not read · Stored summary read", "additional_material": "Additional original materials, before/after values, versions and change-decision records" } ], "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. PMID: 36215222.", "url": "https://pubmed.ncbi.nlm.nih.gov/36215222/", "report_type": "Brunvoll 2022 winter cod-liver-oil report: selected serious outcome among four coprimary endpoints, with other results preserved", "existence": "Citation and preserved summary exist; external original text/registration and serious-component/denominator details unread", "acquired_read": "Summary read; external materials unread, access not attempted", "study_family": "SF01", "independent_replication": "The same people/arms/period, serious components/other endpoints, related claims and citations are not added as new independent trials/participants.", "observed_result": "Original serious outcomes: 121 versus 101, RR 1.20 (0.87–1.65); the other three endpoints remain separate context in the full original evidence-result record.", "result_level": "Selected original serious-outcome RR/adjusted 95% interval and null result. Exact serious composite/components, hospitalization/death/confirmation/risk denominators unverified. A preventive assignment trial is not repurposed as treatment effects after infection.", "source_evidence_date": "2026-08-26", "materials": [ { "material_type": "Stored summary", "public_status": "Local preserved summary", "access_status": "Summary read", "acquired": true, "actually_read": "Summary read", "as_of": "2026-08-26", "qualification": "Only acquisition/reading of the entire parent summary. Original paper/registration or serious-component result tables were not acquired." }, { "material_type": "Abstract", "public_status": "External materials unread/needed", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Only the original citation URL is linked. External content/access and link tests were not attempted." }, { "material_type": "Full paper", "public_status": "External materials unread/needed", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Original DOI/PMCID not provided. No new acquisition/reading of the full text/content." }, { "material_type": "Registration material", "public_status": "External materials unread/needed", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "NCT04609423 and original posting/start/prospective descriptions preserved. Actual versions/content unread." }, { "material_type": "Protocol", "public_status": "External materials unread/needed", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Original plans for product/population, serious composite/components/confirmation, risk denominators, four primary outcomes and harms are needed. Existence/publication status unverified." }, { "material_type": "Statistical analysis plan", "public_status": "External materials unread/needed", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Original plans for ITT/at-risk populations, RR/intervals, fallback/adjustment and sparse-event/missingness/component analyses are needed." }, { "material_type": "Result tables and serious-component/denominator/harm materials", "public_status": "External materials unread/needed", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Details needed for serious events 121/101/original RR, components/infected/at-risk populations, repetition/omissions and harms. No new event/CI calculation." }, { "material_type": "Funding/conflict-of-interest disclosures", "public_status": "External materials unread/needed", "access_status": "Unread; access not attempted", "acquired": false, "actually_read": "Not read", "as_of": null, "qualification": "Original disclosures on Orkla/Oslo support, products/placebo, outside relationships/diagnostics-company employees and roles are currently unread." } ], "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": "Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work." }, { "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": "Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work." }, { "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": "Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work." }, { "id": "M15", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15", "section": "§15.2.4, §15.3.1–15.3.3", "official_principle": "Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.", "review_level": "Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work." }, { "id": "M19", "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10", "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19", "section": "§19.1.2, §19.2.1–19.2.4", "official_principle": "Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.", "review_level": "Methodological principles stated in existing pilot materials and condition templates were referenced. The methodological text was not reviewed again in this work." } ], "status_dictionary": { "Met": "The original content has been reviewed as meeting the conditions. This status is not used in this preparation.", "Partly verified": "Some information in the stored summary was linked during preparation; clinical verification or review is not complete.", "Unverified": "Required direct values, definitions or materials have not been established within the current storage and reading scope. This does not mean zero effect, no papers or failed access.", "Review incomplete": "Review of existing content or actual review incomplete.", "Not reported": "Used only when original materials were actually read and the outcome was judged unreported. Not used for external materials unread in this work.", "Inaccessible": "Used only when an actual access attempt has a recorded failure. Not used for access that was not attempted in this work.", "Insufficient evidence for the conditions": "Indicates insufficient direct materials for the relevant scope or conditions; it is not a new grade.", "Not applicable": "Used when the reason it does not apply to the original question is stated.", "Conflicting data": "Retains the scope of conflicting statements in original materials; it is not an arbitrary reassessment." }, "study_overlap": { "state": "Unverified", "unique_trial_count": null, "unique_participant_count": null, "reason": "Brunvoll 2022 links the same trial/citation, two assigned arms, four endpoints/serious components, people/period and parent/PCR/serious/other-respiratory claims. No new totals of independent trials/participants/events." }, "history": [ { "date": "2026-10-14", "kind": "Separation of public-facing pages and materials", "view_version": "1.0", "change": "Public-facing pages and materials were prepared from the existing 37 items. No new clinical search, verification-status changes or scoring." } ], "language": "en", "translation_date": "2026-10-14" }