{
  "schema_version": "chamgap-public-criteria-1.0",
  "title": "Winter cod liver oil · Original null result for reduced serious COVID-19",
  "language": "en",
  "translation_date": "2026-10-14",
  "criteria_version": "1.0",
  "criteria_date": "2026-10-06",
  "condition_origin": "Chamgap's own application conditions",
  "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."
  },
  "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"
    },
    {
      "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"
    },
    {
      "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"
    },
    {
      "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"
    },
    {
      "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"
    },
    {
      "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"
    },
    {
      "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"
    },
    {
      "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"
    },
    {
      "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"
    },
    {
      "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"
    },
    {
      "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"
    },
    {
      "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"
    },
    {
      "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"
    },
    {
      "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"
    },
    {
      "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"
    },
    {
      "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"
    },
    {
      "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"
    },
    {
      "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"
    },
    {
      "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"
    },
    {
      "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"
    },
    {
      "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"
    },
    {
      "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"
    },
    {
      "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"
    },
    {
      "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"
    },
    {
      "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"
    },
    {
      "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"
    },
    {
      "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"
    },
    {
      "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"
    },
    {
      "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"
    },
    {
      "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"
    },
    {
      "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"
    },
    {
      "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"
    },
    {
      "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"
    },
    {
      "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"
    },
    {
      "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"
    },
    {
      "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"
    },
    {
      "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"
    }
  ]
}