{
  "schema_version": "chamgap-public-criteria-1.0",
  "title": "Cod liver oil × PCR-confirmed SARS-CoV-2 — Null coprimary outcome, testing and applicability gaps",
  "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": "Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed."
    },
    {
      "id": "M04",
      "version": "Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04",
      "section": "§4.5, §4.6.1–4.6.3, MECIR C42",
      "official_principle": "Distinguish studies from reports and link them; do not omit a study solely because results are unreported.",
      "review_level": "Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed."
    },
    {
      "id": "M08",
      "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-08",
      "section": "§8.1–8.2.3, Table 8.2.a",
      "official_principle": "Define the outcome and effect of interest, then examine randomization, deviations, missing data, measurement and selective reporting.",
      "review_level": "Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed."
    },
    {
      "id": "M15",
      "version": "Cochrane Handbook 6.5 (2024), chapter updated 2023-08",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-15",
      "section": "§15.2.4, §15.3.1–15.3.3",
      "official_principle": "Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.",
      "review_level": "Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed."
    },
    {
      "id": "M19",
      "version": "Cochrane Handbook 6.5 (2024), chapter updated 2019-10",
      "url": "https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-19",
      "section": "§19.1.2, §19.2.1–19.2.4",
      "official_principle": "Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence rates.",
      "review_level": "Link preserved methodological application records; no current clinical-content reassessment or external-link verification was performed."
    }
  ],
  "status_dictionary": {
    "Partly verified": "Some information exists in the preserved review summary; detailed original materials remain unverified. This does not certify a passed review or clinical efficacy.",
    "Unverified": "Detailed materials for the selected condition could not be established within the stored scope; this does not mean zero effect, zero studies or safety",
    "Review incomplete": "Review of existing content incomplete",
    "Met": "Use only within the relevant conditions after existing content review; no automatic designation in this preparation",
    "Not reported": "Distinguish only within materials actually read; do not turn unread external materials into unreported findings",
    "Inaccessible": "Not applied during this preparation because actual access was not tested",
    "Not applicable": "Use with a reason for non-applicability based on an explicit question boundary",
    "Conflicting data": "Judge after actual material comparison; review was not performed during this preparation",
    "Insufficient evidence for the conditions": "Do not use as a clinical grade encompassing currently unread materials"
  },
  "requirements": [
    {
      "item_id": "N01",
      "question_type": "Evidence condition",
      "question": "Which existing PCR-infection claim is being presented?",
      "needed": "Selected wording, subclaim grade and parent context",
      "role": "Required",
      "role_reason": "Needed to connect selected wording, subclaim grade and parent context with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.",
      "application_exception": "Distinguish PCR-confirmed infection, testing selection/repetition, serious outcomes/negative tests/self-reported ARI, four coprimary endpoints/fallback, all randomized participants in ITT/missingness/denominators, winter/period/population, combination product/comparator/exposure, sponsorship/company involvement and harms. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or cod-liver-oil/vitamin/product-use/infection-prevention/COVID-19 management/treatment-replacement instructions.",
      "criterion": "Show original materials for selected wording, subclaim grade and parent context together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.",
      "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production",
      "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review",
      "proposed_research": "Materials needed: PCR-infection definition, population/exposure, prespecified endpoint/estimand, period/denominator and existing question-boundary review. Parent values are not used to fill missing subclaim fields. Only the material request/research need is recorded; no lookup or research is performed now."
    },
    {
      "item_id": "N02",
      "question_type": "Evidence condition",
      "question": "Which adults were studied during winter?",
      "needed": "Norwegian adults not taking vitamin D daily",
      "role": "Required",
      "role_reason": "Needed to connect norwegian adults not taking vitamin D daily with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.",
      "application_exception": "Distinguish PCR-confirmed infection, testing selection/repetition, serious outcomes/negative tests/self-reported ARI, four coprimary endpoints/fallback, all randomized participants in ITT/missingness/denominators, winter/period/population, combination product/comparator/exposure, sponsorship/company involvement and harms. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or cod-liver-oil/vitamin/product-use/infection-prevention/COVID-19 management/treatment-replacement instructions.",
      "criterion": "Show original materials for norwegian adults not taking vitamin D daily together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.",
      "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production",
      "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review",
      "proposed_research": "Materials needed: Eligibility/exclusions, baseline vitamin D/health, vaccination/infection history and actual exposure/behaviour/medication data. Do not extend to deficient patients or populations in every period. Only the material request/research need is recorded; no lookup or research is performed now."
    },
    {
      "item_id": "N03",
      "question_type": "Evidence condition",
      "question": "What is known about winter, the period and duration?",
      "needed": "About six winter months, a median 164 days and the stated start",
      "role": "Required",
      "role_reason": "Needed to connect about six winter months, a median 164 days and the stated start with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.",
      "application_exception": "Distinguish PCR-confirmed infection, testing selection/repetition, serious outcomes/negative tests/self-reported ARI, four coprimary endpoints/fallback, all randomized participants in ITT/missingness/denominators, winter/period/population, combination product/comparator/exposure, sponsorship/company involvement and harms. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or cod-liver-oil/vitamin/product-use/infection-prevention/COVID-19 management/treatment-replacement instructions.",
      "criterion": "Show original materials for about six winter months, a median 164 days and the stated start together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.",
      "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production",
      "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review",
      "proposed_research": "Materials needed: Actual recruitment/exposure/follow-up dates, season/variant/vaccination/testing policies and discontinuation/loss data. Do not turn this into current COVID-19 or other-period prevention guidance. Only the material request/research need is recorded; no lookup or research is performed now."
    },
    {
      "item_id": "N04",
      "question_type": "Evidence condition",
      "question": "Was the study product vitamin D or omega-3 alone?",
      "needed": "Möller's Tran combination cod liver oil",
      "role": "Required",
      "role_reason": "Needed to connect möller's Tran combination cod liver oil with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.",
      "application_exception": "Distinguish PCR-confirmed infection, testing selection/repetition, serious outcomes/negative tests/self-reported ARI, four coprimary endpoints/fallback, all randomized participants in ITT/missingness/denominators, winter/period/population, combination product/comparator/exposure, sponsorship/company involvement and harms. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or cod-liver-oil/vitamin/product-use/infection-prevention/COVID-19 management/treatment-replacement instructions.",
      "criterion": "Show original materials for möller's Tran combination cod liver oil together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.",
      "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production",
      "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review",
      "proposed_research": "Materials needed: Exact product/composition/manufacture, actual intake/adherence and concomitant supplement source data. No cod-liver-oil/vitamin/product-use or treatment-replacement instructions. Only the material request/research need is recorded; no lookup or research is performed now."
    },
    {
      "item_id": "N05",
      "question_type": "Evidence condition",
      "question": "Is the flavour-matched corn-oil comparator preserved?",
      "needed": "17,278 assigned cod liver oil versus 17,323 assigned corn oil",
      "role": "Required",
      "role_reason": "Needed to connect 17,278 assigned cod liver oil versus 17,323 assigned corn oil with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.",
      "application_exception": "Distinguish PCR-confirmed infection, testing selection/repetition, serious outcomes/negative tests/self-reported ARI, four coprimary endpoints/fallback, all randomized participants in ITT/missingness/denominators, winter/period/population, combination product/comparator/exposure, sponsorship/company involvement and harms. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or cod-liver-oil/vitamin/product-use/infection-prevention/COVID-19 management/treatment-replacement instructions.",
      "criterion": "Show original materials for 17,278 assigned cod liver oil versus 17,323 assigned corn oil together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.",
      "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production",
      "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review",
      "proposed_research": "Materials needed: Actual active/placebo products, contact/sensory features, concomitant intake, adherence and exposure data. Do not generalize this particular comparison to all cod-liver-oil/vitamin effects. Only the material request/research need is recorded; no lookup or research is performed now."
    },
    {
      "item_id": "N06",
      "question_type": "Evidence condition",
      "question": "Are a median 164 days and complete observation/adherence distinguished?",
      "needed": "Duration distribution and actual exposure/discontinuation",
      "role": "Required",
      "role_reason": "Needed to connect duration distribution and actual exposure/discontinuation with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.",
      "application_exception": "Distinguish PCR-confirmed infection, testing selection/repetition, serious outcomes/negative tests/self-reported ARI, four coprimary endpoints/fallback, all randomized participants in ITT/missingness/denominators, winter/period/population, combination product/comparator/exposure, sponsorship/company involvement and harms. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or cod-liver-oil/vitamin/product-use/infection-prevention/COVID-19 management/treatment-replacement instructions.",
      "criterion": "Show original materials for duration distribution and actual exposure/discontinuation together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.",
      "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production",
      "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review",
      "proposed_research": "Materials needed: Actual exposure/adherence, discontinuation, follow-up distributions by arm and endpoint-specific observation periods/missing data. No product-use or COVID-19 management guidance. Only the material request/research need is recorded; no lookup or research is performed now."
    },
    {
      "item_id": "N07",
      "question_type": "Evidence condition",
      "question": "What were the original PCR-infection events and effect?",
      "needed": "227 versus 228, RR 1.00 and adjusted 95% CI",
      "role": "Required",
      "role_reason": "Needed to connect 227 versus 228, RR 1.00 and adjusted 95% CI with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.",
      "application_exception": "Distinguish PCR-confirmed infection, testing selection/repetition, serious outcomes/negative tests/self-reported ARI, four coprimary endpoints/fallback, all randomized participants in ITT/missingness/denominators, winter/period/population, combination product/comparator/exposure, sponsorship/company involvement and harms. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or cod-liver-oil/vitamin/product-use/infection-prevention/COVID-19 management/treatment-replacement instructions.",
      "criterion": "Show original materials for 227 versus 228, RR 1.00 and adjusted 95% CI together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.",
      "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production",
      "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review",
      "proposed_research": "Materials needed: Original PCR events/denominators, estimand/test, adjusted interval/plan and clinical threshold. No new calculations or invented examples beyond the original effect/CI. Only the material request/research need is recorded; no lookup or research is performed now."
    },
    {
      "item_id": "N08",
      "question_type": "Evidence condition",
      "question": "What is the exact event unit for a positive PCR result?",
      "needed": "Confirmed infection, people/tests and repeated events",
      "role": "Required",
      "role_reason": "Needed to connect confirmed infection, people/tests and repeated events with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.",
      "application_exception": "Distinguish PCR-confirmed infection, testing selection/repetition, serious outcomes/negative tests/self-reported ARI, four coprimary endpoints/fallback, all randomized participants in ITT/missingness/denominators, winter/period/population, combination product/comparator/exposure, sponsorship/company involvement and harms. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or cod-liver-oil/vitamin/product-use/infection-prevention/COVID-19 management/treatment-replacement instructions.",
      "criterion": "Show original materials for confirmed infection, people/tests and repeated events together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.",
      "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production",
      "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review",
      "proposed_research": "Materials needed: Original test/event definitions, person identifiers, first/repeated positives, baseline infection/diagnosis and aggregation/timing data. No new unique-infection or test totals. Only the material request/research need is recorded; no lookup or research is performed now."
    },
    {
      "item_id": "N09",
      "question_type": "Evidence condition",
      "question": "How do testing selection and opportunities affect the comparison?",
      "needed": "Detailed gaps in access, symptoms/screening and missed testing",
      "role": "Required",
      "role_reason": "Needed to connect detailed gaps in access, symptoms/screening and missed testing with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.",
      "application_exception": "Distinguish PCR-confirmed infection, testing selection/repetition, serious outcomes/negative tests/self-reported ARI, four coprimary endpoints/fallback, all randomized participants in ITT/missingness/denominators, winter/period/population, combination product/comparator/exposure, sponsorship/company involvement and harms. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or cod-liver-oil/vitamin/product-use/infection-prevention/COVID-19 management/treatment-replacement instructions.",
      "criterion": "Show original materials for detailed gaps in access, symptoms/screening and missed testing together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.",
      "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production",
      "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review",
      "proposed_research": "Materials needed: Testing/selection criteria, policies/access, opportunities in both arms, missingness/confirmation and prespecified analysis/sensitivity data. Do not repurpose negative tests as absence of infection or a prevention effect. Only the material request/research need is recorded; no lookup or research is performed now."
    },
    {
      "item_id": "N10",
      "question_type": "Evidence condition",
      "question": "Are ITT for 34,601 adults and endpoint-specific observation denominators separated?",
      "needed": "All randomized adults in ITT and the scope of 0.05% missingness",
      "role": "Required",
      "role_reason": "Needed to connect all randomized adults in ITT and the scope of 0.05% missingness with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.",
      "application_exception": "Distinguish PCR-confirmed infection, testing selection/repetition, serious outcomes/negative tests/self-reported ARI, four coprimary endpoints/fallback, all randomized participants in ITT/missingness/denominators, winter/period/population, combination product/comparator/exposure, sponsorship/company involvement and harms. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or cod-liver-oil/vitamin/product-use/infection-prevention/COVID-19 management/treatment-replacement instructions.",
      "criterion": "Show original materials for all randomized adults in ITT and the scope of 0.05% missingness together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.",
      "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production",
      "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review",
      "proposed_research": "Materials needed: Original participant flow by arm, PCR observation/analysis/testing denominators, missing variables/handling and duration/withdrawal/censoring data. No new missing counts/rates or confirmation that everyone completed follow-up. Only the material request/research need is recorded; no lookup or research is performed now."
    },
    {
      "item_id": "N11",
      "question_type": "Evidence condition",
      "question": "Are the four coprimary outcomes and multiplicity plan preserved?",
      "needed": "Prespecified fallback, adjusted intervals and null outcomes",
      "role": "Required",
      "role_reason": "Needed to connect prespecified fallback, adjusted intervals and null outcomes with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.",
      "application_exception": "Distinguish PCR-confirmed infection, testing selection/repetition, serious outcomes/negative tests/self-reported ARI, four coprimary endpoints/fallback, all randomized participants in ITT/missingness/denominators, winter/period/population, combination product/comparator/exposure, sponsorship/company involvement and harms. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or cod-liver-oil/vitamin/product-use/infection-prevention/COVID-19 management/treatment-replacement instructions.",
      "criterion": "Show original materials for prespecified fallback, adjusted intervals and null outcomes together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.",
      "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production",
      "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review",
      "proposed_research": "Materials needed: Exact endpoints, fallback procedure/intervals/significance levels, amendments/hierarchy in registration/protocol/SAP and original results. No new adjusted P values, calculations or grades. Only the material request/research need is recorded; no lookup or research is performed now."
    },
    {
      "item_id": "N12",
      "question_type": "Evidence condition",
      "question": "Is serious COVID-19 distinguished from the overall PCR-infection effect?",
      "needed": "121 versus 101, RR 1.20 and CI 0.87–1.65",
      "role": "Required",
      "role_reason": "Needed to connect 121 versus 101, RR 1.20 and CI 0.87–1.65 with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.",
      "application_exception": "Distinguish PCR-confirmed infection, testing selection/repetition, serious outcomes/negative tests/self-reported ARI, four coprimary endpoints/fallback, all randomized participants in ITT/missingness/denominators, winter/period/population, combination product/comparator/exposure, sponsorship/company involvement and harms. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or cod-liver-oil/vitamin/product-use/infection-prevention/COVID-19 management/treatment-replacement instructions.",
      "criterion": "Show original materials for 121 versus 101, RR 1.20 and CI 0.87–1.65 together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.",
      "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production",
      "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review",
      "proposed_research": "Materials needed: Serious-outcome definition, relation to test-confirmed infection, denominators/timing/follow-up, original effect/CI and aggregation data. No new clinical components/event totals or effects. Only the material request/research need is recorded; no lookup or research is performed now."
    },
    {
      "item_id": "N13",
      "question_type": "Evidence condition",
      "question": "Does a negative test independently establish infection prevention?",
      "needed": "8,546 versus 8,565, RR 1.00 and CI 0.97–1.04",
      "role": "Required",
      "role_reason": "Needed to connect 8,546 versus 8,565, RR 1.00 and CI 0.97–1.04 with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.",
      "application_exception": "Distinguish PCR-confirmed infection, testing selection/repetition, serious outcomes/negative tests/self-reported ARI, four coprimary endpoints/fallback, all randomized participants in ITT/missingness/denominators, winter/period/population, combination product/comparator/exposure, sponsorship/company involvement and harms. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or cod-liver-oil/vitamin/product-use/infection-prevention/COVID-19 management/treatment-replacement instructions.",
      "criterion": "Show original materials for 8,546 versus 8,565, RR 1.00 and CI 0.97–1.04 together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.",
      "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production",
      "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review",
      "proposed_research": "Materials needed: Negative-test definition, aggregation/repetition, denominators, testing opportunities, prespecified model and original results. Positives/negatives are not summed into new test totals or unique people. Only the material request/research need is recorded; no lookup or research is performed now."
    },
    {
      "item_id": "N14",
      "question_type": "Evidence condition",
      "question": "Is self-reported ARI confirmed SARS-CoV-2 infection?",
      "needed": "3,964 versus 3,834, RR 1.04 and CI 0.97–1.11",
      "role": "Required",
      "role_reason": "Needed to connect 3,964 versus 3,834, RR 1.04 and CI 0.97–1.11 with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.",
      "application_exception": "Distinguish PCR-confirmed infection, testing selection/repetition, serious outcomes/negative tests/self-reported ARI, four coprimary endpoints/fallback, all randomized participants in ITT/missingness/denominators, winter/period/population, combination product/comparator/exposure, sponsorship/company involvement and harms. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or cod-liver-oil/vitamin/product-use/infection-prevention/COVID-19 management/treatment-replacement instructions.",
      "criterion": "Show original materials for 3,964 versus 3,834, RR 1.04 and CI 0.97–1.11 together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.",
      "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production",
      "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review",
      "proposed_research": "Materials needed: Original ARI questions/definition, people/repeated symptoms, actual testing/timing, denominators/model. Do not upgrade self-reports to pathogen-confirmed infection. Only the material request/research need is recorded; no lookup or research is performed now."
    },
    {
      "item_id": "N15",
      "question_type": "Evidence condition",
      "question": "Were coprimary outcomes or repeated tests in the same people added together?",
      "needed": "Endpoint/event overlap and unique people",
      "role": "Required",
      "role_reason": "Needed to connect endpoint/event overlap and unique people with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.",
      "application_exception": "Distinguish PCR-confirmed infection, testing selection/repetition, serious outcomes/negative tests/self-reported ARI, four coprimary endpoints/fallback, all randomized participants in ITT/missingness/denominators, winter/period/population, combination product/comparator/exposure, sponsorship/company involvement and harms. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or cod-liver-oil/vitamin/product-use/infection-prevention/COVID-19 management/treatment-replacement instructions.",
      "criterion": "Show original materials for endpoint/event overlap and unique people together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.",
      "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production",
      "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review",
      "proposed_research": "Materials needed: Person/test/event identifiers, overlap/repetition handling and endpoint-specific denominator/observation data. Overall unique-trial/participant totals remain unrecorded. Only the material request/research need is recorded; no lookup or research is performed now."
    },
    {
      "item_id": "N16",
      "question_type": "Evidence condition",
      "question": "Were between-arm estimates replaced by within-arm changes?",
      "needed": "Randomized between-arm RRs and exposure/testing changes",
      "role": "Required",
      "role_reason": "Needed to connect randomized between-arm RRs and exposure/testing changes with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.",
      "application_exception": "Distinguish PCR-confirmed infection, testing selection/repetition, serious outcomes/negative tests/self-reported ARI, four coprimary endpoints/fallback, all randomized participants in ITT/missingness/denominators, winter/period/population, combination product/comparator/exposure, sponsorship/company involvement and harms. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or cod-liver-oil/vitamin/product-use/infection-prevention/COVID-19 management/treatment-replacement instructions.",
      "criterion": "Show original materials for randomized between-arm RRs and exposure/testing changes together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.",
      "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production",
      "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review",
      "proposed_research": "Materials needed: Original estimand/denominators, between-arm model, period/testing/concomitant exposures and variable/missing-data handling. No new differences, ratios or time-series effects. Only the material request/research need is recorded; no lookup or research is performed now."
    },
    {
      "item_id": "N17",
      "question_type": "Evidence condition",
      "question": "Were original allocation and masking descriptions treated as certification?",
      "needed": "Independent research-support allocation and masked roles",
      "role": "Required",
      "role_reason": "Needed to connect independent research-support allocation and masked roles with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.",
      "application_exception": "Distinguish PCR-confirmed infection, testing selection/repetition, serious outcomes/negative tests/self-reported ARI, four coprimary endpoints/fallback, all randomized participants in ITT/missingness/denominators, winter/period/population, combination product/comparator/exposure, sponsorship/company involvement and harms. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or cod-liver-oil/vitamin/product-use/infection-prevention/COVID-19 management/treatment-replacement instructions.",
      "criterion": "Show original materials for independent research-support allocation and masked roles together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.",
      "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production",
      "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review",
      "proposed_research": "Materials needed: Actual concealment/implementation, masking success/unmasking, exposure/deviations and measurement/missing-data source materials. Design strengths and manufacturer support are recorded separately. Only the material request/research need is recorded; no lookup or research is performed now."
    },
    {
      "item_id": "N18",
      "question_type": "Evidence condition",
      "question": "Was the CI range or null result extended into a clinical-threshold conclusion?",
      "needed": "PCR RR/adjusted CI and unverified clinical importance",
      "role": "Required",
      "role_reason": "Needed to connect pCR RR/adjusted CI and unverified clinical importance with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.",
      "application_exception": "Distinguish PCR-confirmed infection, testing selection/repetition, serious outcomes/negative tests/self-reported ARI, four coprimary endpoints/fallback, all randomized participants in ITT/missingness/denominators, winter/period/population, combination product/comparator/exposure, sponsorship/company involvement and harms. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or cod-liver-oil/vitamin/product-use/infection-prevention/COVID-19 management/treatment-replacement instructions.",
      "criterion": "Show original materials for pCR RR/adjusted CI and unverified clinical importance together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.",
      "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production",
      "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review",
      "proposed_research": "Materials needed: Original estimand, adjusted CI/plan, clinical threshold, scope and question-specific direct materials. No new precision/efficacy verdict based only on sample size. Only the material request/research need is recorded; no lookup or research is performed now."
    },
    {
      "item_id": "N19",
      "question_type": "Evidence condition",
      "question": "Was the result generalized to current prevention or other ingredients?",
      "needed": "Combination-product, period and population boundaries",
      "role": "Required",
      "role_reason": "Needed to connect combination-product, period and population boundaries with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.",
      "application_exception": "Distinguish PCR-confirmed infection, testing selection/repetition, serious outcomes/negative tests/self-reported ARI, four coprimary endpoints/fallback, all randomized participants in ITT/missingness/denominators, winter/period/population, combination product/comparator/exposure, sponsorship/company involvement and harms. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or cod-liver-oil/vitamin/product-use/infection-prevention/COVID-19 management/treatment-replacement instructions.",
      "criterion": "Show original materials for combination-product, period and population boundaries together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.",
      "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production",
      "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review",
      "proposed_research": "Materials needed: Direct population/period/ingredient/dose, intervention/comparator, PCR/clinical endpoint, duration/effect/CI and harm materials. No recommendations or intake guidance. Only the material request/research need is recorded; no lookup or research is performed now."
    },
    {
      "item_id": "N20",
      "question_type": "Harm-information gaps supplementing the efficacy table",
      "question": "What is the scope of the low-grade side-effect description?",
      "needed": "Reports in both arms and tested dose/population safety",
      "role": "Supplementary",
      "role_reason": "Needed to connect reports in both arms and tested dose/population safety with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.",
      "application_exception": "Distinguish PCR-confirmed infection, testing selection/repetition, serious outcomes/negative tests/self-reported ARI, four coprimary endpoints/fallback, all randomized participants in ITT/missingness/denominators, winter/period/population, combination product/comparator/exposure, sponsorship/company involvement and harms. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or cod-liver-oil/vitamin/product-use/infection-prevention/COVID-19 management/treatment-replacement instructions.",
      "criterion": "Show original materials for reports in both arms and tested dose/population safety together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.",
      "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production",
      "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review",
      "proposed_research": "Materials needed: Adverse-event collection/grading, events/exposure/harm denominators by arm, discontinuation/causality and long-term materials. No cod-liver-oil/vitamin/infection-management instructions. Only the material request/research need is recorded; no lookup or research is performed now."
    },
    {
      "item_id": "N21",
      "question_type": "Evidence condition",
      "question": "What materials were actually read or acquired?",
      "needed": "Preserved summary and external original materials",
      "role": "Required",
      "role_reason": "Needed to connect preserved summary and external original materials with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.",
      "application_exception": "Distinguish PCR-confirmed infection, testing selection/repetition, serious outcomes/negative tests/self-reported ARI, four coprimary endpoints/fallback, all randomized participants in ITT/missingness/denominators, winter/period/population, combination product/comparator/exposure, sponsorship/company involvement and harms. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or cod-liver-oil/vitamin/product-use/infection-prevention/COVID-19 management/treatment-replacement instructions.",
      "criterion": "Show original materials for preserved summary and external original materials together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.",
      "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production",
      "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review",
      "proposed_research": "Materials needed: Records of actual acquisition/reading scope, versions and dates. No external-link/click/access testing. Only material requests/research needs are recorded; no search or research was performed in that production."
    },
    {
      "item_id": "N22",
      "question_type": "Evidence condition",
      "question": "Are historical registration/plans distinguished from current reading?",
      "needed": "Original registration identifier and detailed comparison",
      "role": "Required",
      "role_reason": "Needed to connect original registration identifier and detailed comparison with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.",
      "application_exception": "Distinguish PCR-confirmed infection, testing selection/repetition, serious outcomes/negative tests/self-reported ARI, four coprimary endpoints/fallback, all randomized participants in ITT/missingness/denominators, winter/period/population, combination product/comparator/exposure, sponsorship/company involvement and harms. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or cod-liver-oil/vitamin/product-use/infection-prevention/COVID-19 management/treatment-replacement instructions.",
      "criterion": "Show original materials for original registration identifier and detailed comparison together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.",
      "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production",
      "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review",
      "proposed_research": "Materials needed: Actual registration versions/publication, recruitment/start/amendments, endpoints/models/analysis intervals and original report links. Preserve historical descriptions without new certification of plans or prospective specification. Only the material request/research need is recorded; no lookup or research is performed now."
    },
    {
      "item_id": "N23",
      "question_type": "Evidence condition",
      "question": "Have protocol/SAP and analysis/missing-data plans been acquired?",
      "needed": "Separate materials for prespecified plans/changes",
      "role": "Required",
      "role_reason": "Needed to connect separate prespecified-plan and amendment materials with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.",
      "application_exception": "Distinguish PCR-confirmed infection, testing selection/repetition, serious outcomes/negative tests/self-reported ARI, four coprimary endpoints/fallback, all randomized participants in ITT/missingness/denominators, winter/period/population, combination product/comparator/exposure, sponsorship/company involvement and harms. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or cod-liver-oil/vitamin/product-use/infection-prevention/COVID-19 management/treatment-replacement instructions.",
      "criterion": "Show original materials for separate prespecified-plan and amendment materials together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.",
      "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production",
      "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review",
      "proposed_research": "Materials needed: Protocol, SAP, amendments, estimands/denominators/analyses, all endpoints and publication timing. Unread materials are not assumed absent. Only the material request/research need is recorded; no lookup or research is performed now."
    },
    {
      "item_id": "N24",
      "question_type": "Evidence condition",
      "question": "Are sponsorship, funding, products, authors and research involvement separated?",
      "needed": "Four company-involvement items and nonprofit/public/academic support",
      "role": "Required",
      "role_reason": "Needed to connect four company-involvement items and nonprofit/public/academic support with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.",
      "application_exception": "Distinguish PCR-confirmed infection, testing selection/repetition, serious outcomes/negative tests/self-reported ARI, four coprimary endpoints/fallback, all randomized participants in ITT/missingness/denominators, winter/period/population, combination product/comparator/exposure, sponsorship/company involvement and harms. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or cod-liver-oil/vitamin/product-use/infection-prevention/COVID-19 management/treatment-replacement instructions.",
      "criterion": "Show original materials for four company-involvement items and nonprofit/public/academic support together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.",
      "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production",
      "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review",
      "proposed_research": "Materials needed: Separate original materials on company cash funding, product support, employee authors/outside relationships, design/analysis/data control and nonprofit/institutional support. Original independence-axis values are not new certification of all items or independence. Only the material request/research need is recorded; no lookup or research is performed now."
    },
    {
      "item_id": "N25",
      "question_type": "Evidence condition",
      "question": "Are results by interval/endpoint distinguished from information gaps?",
      "needed": "Direct results, unverified details and access status",
      "role": "Required",
      "role_reason": "Needed to connect direct results, unverified details and access status with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.",
      "application_exception": "Distinguish PCR-confirmed infection, testing selection/repetition, serious outcomes/negative tests/self-reported ARI, four coprimary endpoints/fallback, all randomized participants in ITT/missingness/denominators, winter/period/population, combination product/comparator/exposure, sponsorship/company involvement and harms. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or cod-liver-oil/vitamin/product-use/infection-prevention/COVID-19 management/treatment-replacement instructions.",
      "criterion": "Show original materials for direct results, unverified details and access status together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.",
      "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production",
      "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review",
      "proposed_research": "Materials needed: Direct measurements, original interval/endpoint tables, plans, observations/denominators and actual access records. Do not substitute unread with unreported or null with exactly zero effect/equivalence. Only the material request/research need is recorded; no lookup or research is performed now."
    },
    {
      "item_id": "N26",
      "question_type": "Evidence condition",
      "question": "Are reports, trials, people, intervals, events and related sheets separated?",
      "needed": "Linked records versus unique trials/participants",
      "role": "Required",
      "role_reason": "Needed to connect linked records and unique trials/participants with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.",
      "application_exception": "Distinguish PCR-confirmed infection, testing selection/repetition, serious outcomes/negative tests/self-reported ARI, four coprimary endpoints/fallback, all randomized participants in ITT/missingness/denominators, winter/period/population, combination product/comparator/exposure, sponsorship/company involvement and harms. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or cod-liver-oil/vitamin/product-use/infection-prevention/COVID-19 management/treatment-replacement instructions.",
      "criterion": "Show original materials for linked records and unique trials/participants together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.",
      "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production",
      "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review",
      "proposed_research": "Materials needed: Original reports/registration, cohorts/intervals, events/repetition/observation and overlap relationships. Unique-trial/participant totals remain unrecorded. Only the material request/research need is recorded; no lookup or research is performed now."
    },
    {
      "item_id": "N27",
      "question_type": "Evidence condition",
      "question": "Are the original single trial and separate independent replication distinguished?",
      "needed": "Parent R1, independence axis and direct replication",
      "role": "Supplementary",
      "role_reason": "Needed to connect parent R1, independence axis and direct replication with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.",
      "application_exception": "Distinguish PCR-confirmed infection, testing selection/repetition, serious outcomes/negative tests/self-reported ARI, four coprimary endpoints/fallback, all randomized participants in ITT/missingness/denominators, winter/period/population, combination product/comparator/exposure, sponsorship/company involvement and harms. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or cod-liver-oil/vitamin/product-use/infection-prevention/COVID-19 management/treatment-replacement instructions.",
      "criterion": "Show original materials for parent R1, independence axis and direct replication together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.",
      "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production",
      "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review",
      "proposed_research": "Materials needed: Separate prespecified confirmation matching the question, with direct population/intervention/comparator/endpoint/duration, denominators/effects/CI and funding/author relationships. No new search or independence verdict. Only the material request/research need is recorded; no lookup or research is performed now."
    },
    {
      "item_id": "N28",
      "question_type": "Evidence condition",
      "question": "Are the subclaim grade and parent score/axes preserved?",
      "needed": "Selected D, missing score/status/axes and parent context",
      "role": "Required",
      "role_reason": "Needed to connect selected D, missing score/status/axes and parent context with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.",
      "application_exception": "Distinguish PCR-confirmed infection, testing selection/repetition, serious outcomes/negative tests/self-reported ARI, four coprimary endpoints/fallback, all randomized participants in ITT/missingness/denominators, winter/period/population, combination product/comparator/exposure, sponsorship/company involvement and harms. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or cod-liver-oil/vitamin/product-use/infection-prevention/COVID-19 management/treatment-replacement instructions.",
      "criterion": "Show original materials for selected D, missing score/status/axes and parent context together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.",
      "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production",
      "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review",
      "proposed_research": "Materials needed: Existing subclaim/parent-boundary review and actual correction materials. Distinguish absent/original axis values and their history. Only the material request/research need is recorded; no lookup or research is performed now."
    },
    {
      "item_id": "N29",
      "question_type": "Evidence condition",
      "question": "Are both languages, citations and absent fields preserved?",
      "needed": "Both original languages and absent separate classification information",
      "role": "Required",
      "role_reason": "Needed to connect both original languages and absent classification fields with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.",
      "application_exception": "Distinguish PCR-confirmed infection, testing selection/repetition, serious outcomes/negative tests/self-reported ARI, four coprimary endpoints/fallback, all randomized participants in ITT/missingness/denominators, winter/period/population, combination product/comparator/exposure, sponsorship/company involvement and harms. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or cod-liver-oil/vitamin/product-use/infection-prevention/COVID-19 management/treatment-replacement instructions.",
      "criterion": "Show original materials for both original languages and absent classification fields together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.",
      "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production",
      "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review",
      "proposed_research": "Materials needed: Materials for reviewing bilingual terminology, time/event/effect units, selected scope and absent fields. Production explanations are distinguished from original records. Only the material request/research need is recorded; no lookup or research is performed now."
    },
    {
      "item_id": "N30",
      "question_type": "Evidence condition",
      "question": "Are source dates/corrections/history separated from production dates?",
      "needed": "Original 2026-08-26 and new conditions/application",
      "role": "Required",
      "role_reason": "Needed to connect original 2026-08-26 and new conditions/application with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.",
      "application_exception": "Distinguish PCR-confirmed infection, testing selection/repetition, serious outcomes/negative tests/self-reported ARI, four coprimary endpoints/fallback, all randomized participants in ITT/missingness/denominators, winter/period/population, combination product/comparator/exposure, sponsorship/company involvement and harms. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or cod-liver-oil/vitamin/product-use/infection-prevention/COVID-19 management/treatment-replacement instructions.",
      "criterion": "Show original materials for original 2026-08-26 and new conditions/application together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.",
      "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production",
      "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review",
      "proposed_research": "Materials needed: Update materials separating originals, events, conditions/observations and verdict decisions when new evidence/corrections arise. Historical wording is not completed clinical content review here. Only material requests/research needs are recorded; no search or research was performed in that production."
    },
    {
      "item_id": "N31",
      "question_type": "Evidence condition",
      "question": "What direct materials would fill the selected gaps?",
      "needed": "Direct interval/endpoint effects, denominators/CI and follow-up",
      "role": "Supplementary",
      "role_reason": "Needed to connect direct interval/endpoint effects, denominators/CI and follow-up with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.",
      "application_exception": "Distinguish PCR-confirmed infection, testing selection/repetition, serious outcomes/negative tests/self-reported ARI, four coprimary endpoints/fallback, all randomized participants in ITT/missingness/denominators, winter/period/population, combination product/comparator/exposure, sponsorship/company involvement and harms. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or cod-liver-oil/vitamin/product-use/infection-prevention/COVID-19 management/treatment-replacement instructions.",
      "criterion": "Show original materials for direct interval/endpoint effects, denominators/CI and follow-up together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.",
      "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production",
      "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review",
      "proposed_research": "Materials needed: Original tables/plans, interval/endpoint definitions, estimands/CI, observation/censoring/denominators, exposure/adherence, independent confirmation and long-term harms. Only the need is recorded; no new lookup/research. Only the material request/research need is recorded; no lookup or research is performed now."
    },
    {
      "item_id": "N32",
      "question_type": "Evidence condition",
      "question": "Are applicability records separated from content review and instructions?",
      "needed": "Applicability records, existing candidate history and content review",
      "role": "Supplementary",
      "role_reason": "Needed to connect condition records, historical candidates and content review with the selected question, actual population/intervention/comparator, endpoints/estimands, denominators/tests/follow-up and reports/harms.",
      "application_exception": "Distinguish PCR-confirmed infection, testing selection/repetition, serious outcomes/negative tests/self-reported ARI, four coprimary endpoints/fallback, all randomized participants in ITT/missingness/denominators, winter/period/population, combination product/comparator/exposure, sponsorship/company involvement and harms. Only original numbers are preserved; no new calculations, invented quantities, effects/CI, grades/reassessment, independence certification or cod-liver-oil/vitamin/product-use/infection-prevention/COVID-19 management/treatment-replacement instructions.",
      "criterion": "Show original materials for condition records, historical candidates and content review together with selected-subclaim/parent boundaries, direct endpoints/estimands/denominators and the scope of external reading.",
      "basis": "Existing C/E/H distinctions of questions, populations, interventions, comparisons, reports/trials, endpoints/denominators and harms referenced for production",
      "condition_origin": "Applicability conditions for preserved existing subclaims; not prespecified registration, official-tool execution or completed review",
      "proposed_research": "Materials needed: Existing content review and later actual materials/corrections. The original production did not perform clinical-source comparisons, external access, new calculations, grade changes or product-use/COVID-19 management/infection-prevention/treatment-replacement instructions. Only the material request/research need is recorded; no lookup or research is performed now."
    }
  ]
}