{
  "schema_version": "chamgap-public-criteria-1.0",
  "title": "Oral vitamin C × first gout diagnosis in men without gout",
  "language": "en",
  "translation_date": "2026-10-22",
  "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": "Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed."
    },
    {
      "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": "Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed."
    },
    {
      "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": "Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed."
    },
    {
      "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": "Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed."
    },
    {
      "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": "Existing methodological links were reused for production. External originals were not reread and methodological content was not reassessed."
    }
  ],
  "status_dictionary": {
    "Partly verified": "Partial information from the stored summary is linked; detailed originals and content review remain incomplete.",
    "Unverified": "Required details cannot be established within the preserved scope. This does not establish absence of effects or studies, or safety.",
    "Review incomplete": "Review of existing content remains incomplete.",
    "Met": "This state is used only within the relevant conditions after material verification and content review. It was not automatically assigned in this work.",
    "Not reported": "Unreported within material actually read. Unread external material is not relabeled as unreported.",
    "Inaccessible": "This means actual access failure. External access was not attempted in this work, so this state was not assigned.",
    "Not applicable": "Used only with an application exception and reason based on the question scope.",
    "Conflicting data": "This requires actual comparison of materials; no new conflict judgment was made in this work.",
    "Insufficient evidence for the conditions": "This indicates gaps in additional material for the selected conditions. Unread material as a whole is not converted into an efficacy grade."
  },
  "requirements": [
    {
      "item_id": "N01",
      "question_type": "Evidence condition",
      "question": "What is the selected question?",
      "needed": "Existing subclaim and verdict record, and the parent-question boundary",
      "role": "Required",
      "role_reason": "Material on Existing subclaim and verdict record, and the parent-question boundary is needed to connect prior history, sex, oral exposure, comparisons, first diagnosis reports, denominators, precision and harms.",
      "application_exception": "The existing selected D30 verdict is preserved separately from the parent’s deferred verdict, empty score and assessment axes. Full-cohort and prior-gout-excluded analyses, first diagnoses, recurrent attacks and urate are distinguished. No new incidence rates, effects, intervals, person-years, participant totals or dosing guidance are created.",
      "criterion": "Original records on Existing subclaim and verdict record, and the parent-question boundary must link to the same population, exposure, comparison, event, time point and denominator, distinguishing full-cohort and prior-gout-excluded analyses and diagnoses from attacks.",
      "basis": "Existing principles distinguish questions, direct comparisons, reports and trials, populations and events, denominators, precision and harms.",
      "condition_origin": "These evidence conditions concern the existing question of oral single-ingredient vitamin C and first gout diagnosis in men without gout. They do not establish new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: The parent question on recurrent-flare prevention in established gout is not repurposed as this question or made into a new claim. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N02",
      "question_type": "Evidence condition",
      "question": "What do selected D30 and parent deferral mean?",
      "needed": "Distinguishing selected D30 from parent deferral and empty score",
      "role": "Required",
      "role_reason": "Material on Distinguishing selected D30 from parent deferral and empty score is needed to connect prior history, sex, oral exposure, comparisons, first diagnosis reports, denominators, precision and harms.",
      "application_exception": "The existing selected D30 verdict is preserved separately from the parent’s deferred verdict, empty score and assessment axes. Full-cohort and prior-gout-excluded analyses, first diagnoses, recurrent attacks and urate are distinguished. No new incidence rates, effects, intervals, person-years, participant totals or dosing guidance are created.",
      "criterion": "Original records on Distinguishing selected D30 from parent deferral and empty score must link to the same population, exposure, comparison, event, time point and denominator, distinguishing full-cohort and prior-gout-excluded analyses and diagnoses from attacks.",
      "basis": "Existing principles distinguish questions, direct comparisons, reports and trials, populations and events, denominators, precision and harms.",
      "condition_origin": "These evidence conditions concern the existing question of oral single-ingredient vitamin C and first gout diagnosis in men without gout. They do not establish new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: The verdicts are not overwritten by each other or changed into a new verdict or fulfilled condition. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N03",
      "question_type": "Evidence condition",
      "question": "What materials were read in this work?",
      "needed": "Complete parent summary, subclaims, historical checks and unread external materials",
      "role": "Required",
      "role_reason": "Material on Complete parent summary, subclaims, historical checks and unread external materials is needed to connect prior history, sex, oral exposure, comparisons, first diagnosis reports, denominators, precision and harms.",
      "application_exception": "The existing selected D30 verdict is preserved separately from the parent’s deferred verdict, empty score and assessment axes. Full-cohort and prior-gout-excluded analyses, first diagnoses, recurrent attacks and urate are distinguished. No new incidence rates, effects, intervals, person-years, participant totals or dosing guidance are created.",
      "criterion": "Original records on Complete parent summary, subclaims, historical checks and unread external materials must link to the same population, exposure, comparison, event, time point and denominator, distinguishing full-cohort and prior-gout-excluded analyses and diagnoses from attacks.",
      "basis": "Existing principles distinguish questions, direct comparisons, reports and trials, populations and events, denominators, precision and harms.",
      "condition_origin": "These evidence conditions concern the existing question of oral single-ingredient vitamin C and first gout diagnosis in men without gout. They do not establish new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: External abstracts, full text, registration, protocols and analysis plans are unread and access was not attempted. Historical checks are not inherited as current content review. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N04",
      "question_type": "Evidence condition",
      "question": "What is the post hoc PHS II report?",
      "needed": "Juraschek2022, PMID/PMCID/DOI and original-trial registration",
      "role": "Required",
      "role_reason": "Material on Juraschek2022, PMID/PMCID/DOI and original-trial registration is needed to connect prior history, sex, oral exposure, comparisons, first diagnosis reports, denominators, precision and harms.",
      "application_exception": "The existing selected D30 verdict is preserved separately from the parent’s deferred verdict, empty score and assessment axes. Full-cohort and prior-gout-excluded analyses, first diagnoses, recurrent attacks and urate are distinguished. No new incidence rates, effects, intervals, person-years, participant totals or dosing guidance are created.",
      "criterion": "Original records on Juraschek2022, PMID/PMCID/DOI and original-trial registration must link to the same population, exposure, comparison, event, time point and denominator, distinguishing full-cohort and prior-gout-excluded analyses and diagnoses from attacks.",
      "basis": "Existing principles distinguish questions, direct comparisons, reports and trials, populations and events, denominators, precision and harms.",
      "condition_origin": "These evidence conditions concern the existing question of oral single-ingredient vitamin C and first gout diagnosis in men without gout. They do not establish new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: The identifier belongs to the original cardiovascular/cancer trial. Gout prespecification is unverified; the original text and registration remain unread in this work. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N05",
      "question_type": "Evidence condition",
      "question": "Are the original trial and subgroup analyses counted twice?",
      "needed": "Original factorial trial, full-cohort and prior-gout-excluded analyses, and shared participants",
      "role": "Required",
      "role_reason": "Material on Original factorial trial, full-cohort and prior-gout-excluded analyses, and shared participants is needed to connect prior history, sex, oral exposure, comparisons, first diagnosis reports, denominators, precision and harms.",
      "application_exception": "The existing selected D30 verdict is preserved separately from the parent’s deferred verdict, empty score and assessment axes. Full-cohort and prior-gout-excluded analyses, first diagnoses, recurrent attacks and urate are distinguished. No new incidence rates, effects, intervals, person-years, participant totals or dosing guidance are created.",
      "criterion": "Original records on Original factorial trial, full-cohort and prior-gout-excluded analyses, and shared participants must link to the same population, exposure, comparison, event, time point and denominator, distinguishing full-cohort and prior-gout-excluded analyses and diagnoses from attacks.",
      "basis": "Existing principles distinguish questions, direct comparisons, reports and trials, populations and events, denominators, precision and harms.",
      "condition_origin": "These evidence conditions concern the existing question of oral single-ingredient vitamin C and first gout diagnosis in men without gout. They do not establish new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: They are not added as independent trials or new participants. Unique trial, participant and replication totals remain unverified. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N06",
      "question_type": "Evidence condition",
      "question": "Who are the men without prior gout?",
      "needed": "Male physicians≥50 years, prior-gout exclusion, selection and baseline",
      "role": "Required",
      "role_reason": "Material on Male physicians≥50 years, prior-gout exclusion, selection and baseline is needed to connect prior history, sex, oral exposure, comparisons, first diagnosis reports, denominators, precision and harms.",
      "application_exception": "The existing selected D30 verdict is preserved separately from the parent’s deferred verdict, empty score and assessment axes. Full-cohort and prior-gout-excluded analyses, first diagnoses, recurrent attacks and urate are distinguished. No new incidence rates, effects, intervals, person-years, participant totals or dosing guidance are created.",
      "criterion": "Original records on Male physicians≥50 years, prior-gout exclusion, selection and baseline must link to the same population, exposure, comparison, event, time point and denominator, distinguishing full-cohort and prior-gout-excluded analyses and diagnoses from attacks.",
      "basis": "Existing principles distinguish questions, direct comparisons, reports and trials, populations and events, denominators, precision and harms.",
      "condition_origin": "These evidence conditions concern the existing question of oral single-ingredient vitamin C and first gout diagnosis in men without gout. They do not establish new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Results are not extended to women, the general population or recurrent attacks in established gout. History ascertainment, detailed selection and baseline balance remain unverified. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N07",
      "question_type": "Evidence condition",
      "question": "Are full-cohort diagnosis reports the same as first diagnoses?",
      "needed": "Event definitions in the full cohort including prior gout and the prior-gout-excluded analysis",
      "role": "Required",
      "role_reason": "Material on Event definitions in the full cohort including prior gout and the prior-gout-excluded analysis is needed to connect prior history, sex, oral exposure, comparisons, first diagnosis reports, denominators, precision and harms.",
      "application_exception": "The existing selected D30 verdict is preserved separately from the parent’s deferred verdict, empty score and assessment axes. Full-cohort and prior-gout-excluded analyses, first diagnoses, recurrent attacks and urate are distinguished. No new incidence rates, effects, intervals, person-years, participant totals or dosing guidance are created.",
      "criterion": "Original records on Event definitions in the full cohort including prior gout and the prior-gout-excluded analysis must link to the same population, exposure, comparison, event, time point and denominator, distinguishing full-cohort and prior-gout-excluded analyses and diagnoses from attacks.",
      "basis": "Existing principles distinguish questions, direct comparisons, reports and trials, populations and events, denominators, precision and harms.",
      "condition_origin": "These evidence conditions concern the existing question of oral single-ingredient vitamin C and first gout diagnosis in men without gout. They do not establish new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: The positive full-cohort HR is not repurposed as the selected first-diagnosis effect. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N08",
      "question_type": "Evidence condition",
      "question": "What is the selected analysis result?",
      "needed": "Prior-gout-excluded events, denominators, HR,95%CI, P and rates",
      "role": "Required",
      "role_reason": "Material on Prior-gout-excluded events, denominators, HR,95%CI, P and rates is needed to connect prior history, sex, oral exposure, comparisons, first diagnosis reports, denominators, precision and harms.",
      "application_exception": "The existing selected D30 verdict is preserved separately from the parent’s deferred verdict, empty score and assessment axes. Full-cohort and prior-gout-excluded analyses, first diagnoses, recurrent attacks and urate are distinguished. No new incidence rates, effects, intervals, person-years, participant totals or dosing guidance are created.",
      "criterion": "Original records on Prior-gout-excluded events, denominators, HR,95%CI, P and rates must link to the same population, exposure, comparison, event, time point and denominator, distinguishing full-cohort and prior-gout-excluded analyses and diagnoses from attacks.",
      "basis": "Existing principles distinguish questions, direct comparisons, reports and trials, populations and events, denominators, precision and harms.",
      "condition_origin": "These evidence conditions concern the existing question of oral single-ingredient vitamin C and first gout diagnosis in men without gout. They do not establish new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: No new incidence rate, HR, difference or CI is calculated. Nonsignificance is not judged as an effect of0 or equivalence. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N09",
      "question_type": "Evidence condition",
      "question": "Which analysis produced the positive full-cohort result?",
      "needed": "Full-cohort454/7329 versus517/7312, HR, P and inclusion of prior gout",
      "role": "Required",
      "role_reason": "Material on Full-cohort454/7329 versus517/7312, HR, P and inclusion of prior gout is needed to connect prior history, sex, oral exposure, comparisons, first diagnosis reports, denominators, precision and harms.",
      "application_exception": "The existing selected D30 verdict is preserved separately from the parent’s deferred verdict, empty score and assessment axes. Full-cohort and prior-gout-excluded analyses, first diagnoses, recurrent attacks and urate are distinguished. No new incidence rates, effects, intervals, person-years, participant totals or dosing guidance are created.",
      "criterion": "Original records on Full-cohort454/7329 versus517/7312, HR, P and inclusion of prior gout must link to the same population, exposure, comparison, event, time point and denominator, distinguishing full-cohort and prior-gout-excluded analyses and diagnoses from attacks.",
      "basis": "Existing principles distinguish questions, direct comparisons, reports and trials, populations and events, denominators, precision and harms.",
      "condition_origin": "These evidence conditions concern the existing question of oral single-ingredient vitamin C and first gout diagnosis in men without gout. They do not establish new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: The positive full-cohort result including prior gout does not replace uncertainty in the selected analysis or establish attack prevention in established gout. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N10",
      "question_type": "Evidence condition",
      "question": "What does self-reported diagnosis measure?",
      "needed": "Annual diagnosis reports, first-event ascertainment and date imputation",
      "role": "Required",
      "role_reason": "Material on Annual diagnosis reports, first-event ascertainment and date imputation is needed to connect prior history, sex, oral exposure, comparisons, first diagnosis reports, denominators, precision and harms.",
      "application_exception": "The existing selected D30 verdict is preserved separately from the parent’s deferred verdict, empty score and assessment axes. Full-cohort and prior-gout-excluded analyses, first diagnoses, recurrent attacks and urate are distinguished. No new incidence rates, effects, intervals, person-years, participant totals or dosing guidance are created.",
      "criterion": "Original records on Annual diagnosis reports, first-event ascertainment and date imputation must link to the same population, exposure, comparison, event, time point and denominator, distinguishing full-cohort and prior-gout-excluded analyses and diagnoses from attacks.",
      "basis": "Existing principles distinguish questions, direct comparisons, reports and trials, populations and events, denominators, precision and harms.",
      "condition_origin": "These evidence conditions concern the existing question of oral single-ingredient vitamin C and first gout diagnosis in men without gout. They do not establish new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Medical records, classification criteria, first-diagnosis ascertainment, missing reports, imputation methods and group-specific measurement differences remain unverified. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N11",
      "question_type": "Evidence condition",
      "question": "Are randomized allocation and the post hoc outcome distinguished?",
      "needed": "Original factorial trial, exposure allocation, post hoc gout outcome and selection",
      "role": "Required",
      "role_reason": "Material on Original factorial trial, exposure allocation, post hoc gout outcome and selection is needed to connect prior history, sex, oral exposure, comparisons, first diagnosis reports, denominators, precision and harms.",
      "application_exception": "The existing selected D30 verdict is preserved separately from the parent’s deferred verdict, empty score and assessment axes. Full-cohort and prior-gout-excluded analyses, first diagnoses, recurrent attacks and urate are distinguished. No new incidence rates, effects, intervals, person-years, participant totals or dosing guidance are created.",
      "criterion": "Original records on Original factorial trial, exposure allocation, post hoc gout outcome and selection must link to the same population, exposure, comparison, event, time point and denominator, distinguishing full-cohort and prior-gout-excluded analyses and diagnoses from attacks.",
      "basis": "Existing principles distinguish questions, direct comparisons, reports and trials, populations and events, denominators, precision and harms.",
      "condition_origin": "These evidence conditions concern the existing question of oral single-ingredient vitamin C and first gout diagnosis in men without gout. They do not establish new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Randomized exposure is not elevated to a prespecified primary gout outcome or confirmatory prevention trial. Details of post hoc analysis and selection remain unverified. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N12",
      "question_type": "Evidence condition",
      "question": "What are the oral formulation and actual dose?",
      "needed": "Oral C product, dose, ingredients and actual exposure in the selected analysis",
      "role": "Required",
      "role_reason": "Material on Oral C product, dose, ingredients and actual exposure in the selected analysis is needed to connect prior history, sex, oral exposure, comparisons, first diagnosis reports, denominators, precision and harms.",
      "application_exception": "The existing selected D30 verdict is preserved separately from the parent’s deferred verdict, empty score and assessment axes. Full-cohort and prior-gout-excluded analyses, first diagnoses, recurrent attacks and urate are distinguished. No new incidence rates, effects, intervals, person-years, participant totals or dosing guidance are created.",
      "criterion": "Original records on Oral C product, dose, ingredients and actual exposure in the selected analysis must link to the same population, exposure, comparison, event, time point and denominator, distinguishing full-cohort and prior-gout-excluded analyses and diagnoses from attacks.",
      "basis": "Existing principles distinguish questions, direct comparisons, reports and trials, populations and events, denominators, precision and harms.",
      "condition_origin": "These evidence conditions concern the existing question of oral single-ingredient vitamin C and first gout diagnosis in men without gout. They do not establish new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: The parent’s not-applicable dose for absent eligible studies is not transferred to this question or filled using external knowledge. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N13",
      "question_type": "Evidence condition",
      "question": "What is known about dosing, follow-up and person-years?",
      "needed": "Long-term factorial trial, annual reports, exact exposure, follow-up and attrition",
      "role": "Required",
      "role_reason": "Material on Long-term factorial trial, annual reports, exact exposure, follow-up and attrition is needed to connect prior history, sex, oral exposure, comparisons, first diagnosis reports, denominators, precision and harms.",
      "application_exception": "The existing selected D30 verdict is preserved separately from the parent’s deferred verdict, empty score and assessment axes. Full-cohort and prior-gout-excluded analyses, first diagnoses, recurrent attacks and urate are distinguished. No new incidence rates, effects, intervals, person-years, participant totals or dosing guidance are created.",
      "criterion": "Original records on Long-term factorial trial, annual reports, exact exposure, follow-up and attrition must link to the same population, exposure, comparison, event, time point and denominator, distinguishing full-cohort and prior-gout-excluded analyses and diagnoses from attacks.",
      "basis": "Existing principles distinguish questions, direct comparisons, reports and trials, populations and events, denominators, precision and harms.",
      "condition_origin": "These evidence conditions concern the existing question of oral single-ingredient vitamin C and first gout diagnosis in men without gout. They do not establish new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Exact dosing and follow-up duration, person-year denominators, exposure changes, stopping and date-imputation details remain unverified. The parent’s not-applicable duration is not transferred here. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N14",
      "question_type": "Evidence condition",
      "question": "What comparisons involve placebo and concurrent factorial interventions?",
      "needed": "C, placebo, concurrent randomized factors, adherence, drugs and additional supplements",
      "role": "Required",
      "role_reason": "Material on C, placebo, concurrent randomized factors, adherence, drugs and additional supplements is needed to connect prior history, sex, oral exposure, comparisons, first diagnosis reports, denominators, precision and harms.",
      "application_exception": "The existing selected D30 verdict is preserved separately from the parent’s deferred verdict, empty score and assessment axes. Full-cohort and prior-gout-excluded analyses, first diagnoses, recurrent attacks and urate are distinguished. No new incidence rates, effects, intervals, person-years, participant totals or dosing guidance are created.",
      "criterion": "Original records on C, placebo, concurrent randomized factors, adherence, drugs and additional supplements must link to the same population, exposure, comparison, event, time point and denominator, distinguishing full-cohort and prior-gout-excluded analyses and diagnoses from attacks.",
      "basis": "Existing principles distinguish questions, direct comparisons, reports and trials, populations and events, denominators, precision and harms.",
      "condition_origin": "These evidence conditions concern the existing question of oral single-ingredient vitamin C and first gout diagnosis in men without gout. They do not establish new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Other factors, drugs, diet, supplements, urate medication, adherence, crossover and adjustment remain unverified. This is not a standard gout-drug replacement trial. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N15",
      "question_type": "Evidence condition",
      "question": "What are the selected denominators, missingness and censoring?",
      "needed": "Total14641, allocation, prior-gout-excluded6865/6823, events and analysis",
      "role": "Required",
      "role_reason": "Material on Total14641, allocation, prior-gout-excluded6865/6823, events and analysis is needed to connect prior history, sex, oral exposure, comparisons, first diagnosis reports, denominators, precision and harms.",
      "application_exception": "The existing selected D30 verdict is preserved separately from the parent’s deferred verdict, empty score and assessment axes. Full-cohort and prior-gout-excluded analyses, first diagnoses, recurrent attacks and urate are distinguished. No new incidence rates, effects, intervals, person-years, participant totals or dosing guidance are created.",
      "criterion": "Original records on Total14641, allocation, prior-gout-excluded6865/6823, events and analysis must link to the same population, exposure, comparison, event, time point and denominator, distinguishing full-cohort and prior-gout-excluded analyses and diagnoses from attacks.",
      "basis": "Existing principles distinguish questions, direct comparisons, reports and trials, populations and events, denominators, precision and harms.",
      "condition_origin": "These evidence conditions concern the existing question of oral single-ingredient vitamin C and first gout diagnosis in men without gout. They do not establish new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Subgroup denominators are not relabeled as new allocation. Exclusion, missingness, annual responses, censoring and ITT/PP remain unverified. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N16",
      "question_type": "Evidence condition",
      "question": "What are the HR model and clinically important effect?",
      "needed": "Adjustment, time, proportional hazards, original95%CI and important difference",
      "role": "Required",
      "role_reason": "Material on Adjustment, time, proportional hazards, original95%CI and important difference is needed to connect prior history, sex, oral exposure, comparisons, first diagnosis reports, denominators, precision and harms.",
      "application_exception": "The existing selected D30 verdict is preserved separately from the parent’s deferred verdict, empty score and assessment axes. Full-cohort and prior-gout-excluded analyses, first diagnoses, recurrent attacks and urate are distinguished. No new incidence rates, effects, intervals, person-years, participant totals or dosing guidance are created.",
      "criterion": "Original records on Adjustment, time, proportional hazards, original95%CI and important difference must link to the same population, exposure, comparison, event, time point and denominator, distinguishing full-cohort and prior-gout-excluded analyses and diagnoses from attacks.",
      "basis": "Existing principles distinguish questions, direct comparisons, reports and trials, populations and events, denominators, precision and harms.",
      "condition_origin": "These evidence conditions concern the existing question of oral single-ingredient vitamin C and first gout diagnosis in men without gout. They do not establish new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Exact model, adjustment, proportional hazards, clinically important difference and power are not newly verified or calculated. This is not converted into complete absence of effect. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N17",
      "question_type": "Evidence condition",
      "question": "Was the gout outcome preregistered?",
      "needed": "Original NCT00270647 trial, cardiovascular/cancer outcomes, gout prespecification and analysis plans",
      "role": "Required",
      "role_reason": "Material on Original NCT00270647 trial, cardiovascular/cancer outcomes, gout prespecification and analysis plans is needed to connect prior history, sex, oral exposure, comparisons, first diagnosis reports, denominators, precision and harms.",
      "application_exception": "The existing selected D30 verdict is preserved separately from the parent’s deferred verdict, empty score and assessment axes. Full-cohort and prior-gout-excluded analyses, first diagnoses, recurrent attacks and urate are distinguished. No new incidence rates, effects, intervals, person-years, participant totals or dosing guidance are created.",
      "criterion": "Original records on Original NCT00270647 trial, cardiovascular/cancer outcomes, gout prespecification and analysis plans must link to the same population, exposure, comparison, event, time point and denominator, distinguishing full-cohort and prior-gout-excluded analyses and diagnoses from attacks.",
      "basis": "Existing principles distinguish questions, direct comparisons, reports and trials, populations and events, denominators, precision and harms.",
      "condition_origin": "These evidence conditions concern the existing question of oral single-ingredient vitamin C and first gout diagnosis in men without gout. They do not establish new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: The identifier alone does not establish a prespecified prevention outcome or fulfilled analysis condition. Registration, protocols and analysis plans remain unread in this work. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N18",
      "question_type": "Evidence condition",
      "question": "Is the chronic-gout review direct evidence for this question?",
      "needed": "Citation-only Cochrane2021, unmeasured attacks and population differences",
      "role": "Required",
      "role_reason": "Material on Citation-only Cochrane2021, unmeasured attacks and population differences is needed to connect prior history, sex, oral exposure, comparisons, first diagnosis reports, denominators, precision and harms.",
      "application_exception": "The existing selected D30 verdict is preserved separately from the parent’s deferred verdict, empty score and assessment axes. Full-cohort and prior-gout-excluded analyses, first diagnoses, recurrent attacks and urate are distinguished. No new incidence rates, effects, intervals, person-years, participant totals or dosing guidance are created.",
      "criterion": "Original records on Citation-only Cochrane2021, unmeasured attacks and population differences must link to the same population, exposure, comparison, event, time point and denominator, distinguishing full-cohort and prior-gout-excluded analyses and diagnoses from attacks.",
      "basis": "Existing principles distinguish questions, direct comparisons, reports and trials, populations and events, denominators, precision and harms.",
      "condition_origin": "These evidence conditions concern the existing question of oral single-ingredient vitamin C and first gout diagnosis in men without gout. They do not establish new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: The review is not repurposed as a new direct trial, new participants or a urate value for first diagnosis in men without gout. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N19",
      "question_type": "Evidence condition",
      "question": "Are independent replication and the3019 urate verdict distinguished?",
      "needed": "PHS II subgroup analyses, the separate3019 surrogate and report relationships",
      "role": "Required",
      "role_reason": "Material on PHS II subgroup analyses, the separate3019 surrogate and report relationships is needed to connect prior history, sex, oral exposure, comparisons, first diagnosis reports, denominators, precision and harms.",
      "application_exception": "The existing selected D30 verdict is preserved separately from the parent’s deferred verdict, empty score and assessment axes. Full-cohort and prior-gout-excluded analyses, first diagnoses, recurrent attacks and urate are distinguished. No new incidence rates, effects, intervals, person-years, participant totals or dosing guidance are created.",
      "criterion": "Original records on PHS II subgroup analyses, the separate3019 surrogate and report relationships must link to the same population, exposure, comparison, event, time point and denominator, distinguishing full-cohort and prior-gout-excluded analyses and diagnoses from attacks.",
      "basis": "Existing principles distinguish questions, direct comparisons, reports and trials, populations and events, denominators, precision and harms.",
      "condition_origin": "These evidence conditions concern the existing question of oral single-ingredient vitamin C and first gout diagnosis in men without gout. They do not establish new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Trials, reports and participants from other verdicts are not combined. Unique clinical totals and independent replication for the selected question remain unverified. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N20",
      "question_type": "Evidence condition",
      "question": "What can be extended across history, sex, dose and duration?",
      "needed": "Prior-gout exclusion, male physicians, prespecified subgroups, interactions and other doses",
      "role": "Required",
      "role_reason": "Material on Prior-gout exclusion, male physicians, prespecified subgroups, interactions and other doses is needed to connect prior history, sex, oral exposure, comparisons, first diagnosis reports, denominators, precision and harms.",
      "application_exception": "The existing selected D30 verdict is preserved separately from the parent’s deferred verdict, empty score and assessment axes. Full-cohort and prior-gout-excluded analyses, first diagnoses, recurrent attacks and urate are distinguished. No new incidence rates, effects, intervals, person-years, participant totals or dosing guidance are created.",
      "criterion": "Original records on Prior-gout exclusion, male physicians, prespecified subgroups, interactions and other doses must link to the same population, exposure, comparison, event, time point and denominator, distinguishing full-cohort and prior-gout-excluded analyses and diagnoses from attacks.",
      "basis": "Existing principles distinguish questions, direct comparisons, reports and trials, populations and events, denominators, precision and harms.",
      "condition_origin": "These evidence conditions concern the existing question of oral single-ingredient vitamin C and first gout diagnosis in men without gout. They do not establish new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: No new generalization is made to women, the general population, established gout, other doses, sustained prevention or subgroup interactions. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N21",
      "question_type": "Evidence condition",
      "question": "Are diagnoses, attacks, urate and drug replacement different questions?",
      "needed": "Selected diagnoses, clinical attacks, surrogate outcomes and standard-drug replacement",
      "role": "Required",
      "role_reason": "Material on Selected diagnoses, clinical attacks, surrogate outcomes and standard-drug replacement is needed to connect prior history, sex, oral exposure, comparisons, first diagnosis reports, denominators, precision and harms.",
      "application_exception": "The existing selected D30 verdict is preserved separately from the parent’s deferred verdict, empty score and assessment axes. Full-cohort and prior-gout-excluded analyses, first diagnoses, recurrent attacks and urate are distinguished. No new incidence rates, effects, intervals, person-years, participant totals or dosing guidance are created.",
      "criterion": "Original records on Selected diagnoses, clinical attacks, surrogate outcomes and standard-drug replacement must link to the same population, exposure, comparison, event, time point and denominator, distinguishing full-cohort and prior-gout-excluded analyses and diagnoses from attacks.",
      "basis": "Existing principles distinguish questions, direct comparisons, reports and trials, populations and events, denominators, precision and harms.",
      "condition_origin": "These evidence conditions concern the existing question of oral single-ingredient vitamin C and first gout diagnosis in men without gout. They do not establish new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: First-diagnosis reports are not repurposed as direct attack frequency, urate reduction or replacement of treatment for established gout. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N22",
      "question_type": "Evidence condition",
      "question": "What is known about NIH and industry study-agent support?",
      "needed": "NIH, BASF/Pfizer/DSM, study agents, packaging, employment and interests",
      "role": "Required",
      "role_reason": "Material on NIH, BASF/Pfizer/DSM, study agents, packaging, employment and interests is needed to connect prior history, sex, oral exposure, comparisons, first diagnosis reports, denominators, precision and harms.",
      "application_exception": "The existing selected D30 verdict is preserved separately from the parent’s deferred verdict, empty score and assessment axes. Full-cohort and prior-gout-excluded analyses, first diagnoses, recurrent attacks and urate are distinguished. No new incidence rates, effects, intervals, person-years, participant totals or dosing guidance are created.",
      "criterion": "Original records on NIH, BASF/Pfizer/DSM, study agents, packaging, employment and interests must link to the same population, exposure, comparison, event, time point and denominator, distinguishing full-cohort and prior-gout-excluded analyses and diagnoses from attacks.",
      "basis": "Existing principles distinguish questions, direct comparisons, reports and trials, populations and events, denominators, precision and harms.",
      "condition_origin": "These evidence conditions concern the existing question of oral single-ingredient vitamin C and first gout diagnosis in men without gout. They do not establish new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Funding and product support alone do not verify employee authorship, patents, interests, absence of bias or new independent certification. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N23",
      "question_type": "Evidence condition",
      "question": "How were oral C harms actually collected?",
      "needed": "Events, collection, stopping, denominators and duration for the selected exposure",
      "role": "Supplementary",
      "role_reason": "Material on Events, collection, stopping, denominators and duration for the selected exposure is needed to connect prior history, sex, oral exposure, comparisons, first diagnosis reports, denominators, precision and harms.",
      "application_exception": "The existing selected D30 verdict is preserved separately from the parent’s deferred verdict, empty score and assessment axes. Full-cohort and prior-gout-excluded analyses, first diagnoses, recurrent attacks and urate are distinguished. No new incidence rates, effects, intervals, person-years, participant totals or dosing guidance are created.",
      "criterion": "Original records on Events, collection, stopping, denominators and duration for the selected exposure must link to the same population, exposure, comparison, event, time point and denominator, distinguishing full-cohort and prior-gout-excluded analyses and diagnoses from attacks.",
      "basis": "Existing principles distinguish questions, direct comparisons, reports and trials, populations and events, denominators, precision and harms.",
      "condition_origin": "These evidence conditions concern the existing question of oral single-ingredient vitamin C and first gout diagnosis in men without gout. They do not establish new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Group-specific harms, stopping, exposure denominators and collection in PHS II and the selected analysis remain unverified. Diagnosis results are not used to judge safety. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N24",
      "question_type": "Evidence condition",
      "question": "What is known about concomitant exposures, predisposition and long-term harms?",
      "needed": "Kidney disease, stones, iron overload, concurrent factors, drugs, timelines, long-term and rare events",
      "role": "Supplementary",
      "role_reason": "Material on Kidney disease, stones, iron overload, concurrent factors, drugs, timelines, long-term and rare events is needed to connect prior history, sex, oral exposure, comparisons, first diagnosis reports, denominators, precision and harms.",
      "application_exception": "The existing selected D30 verdict is preserved separately from the parent’s deferred verdict, empty score and assessment axes. Full-cohort and prior-gout-excluded analyses, first diagnoses, recurrent attacks and urate are distinguished. No new incidence rates, effects, intervals, person-years, participant totals or dosing guidance are created.",
      "criterion": "Original records on Kidney disease, stones, iron overload, concurrent factors, drugs, timelines, long-term and rare events must link to the same population, exposure, comparison, event, time point and denominator, distinguishing full-cohort and prior-gout-excluded analyses and diagnoses from attacks.",
      "basis": "Existing principles distinguish questions, direct comparisons, reports and trials, populations and events, denominators, precision and harms.",
      "condition_origin": "These evidence conditions concern the existing question of oral single-ingredient vitamin C and first gout diagnosis in men without gout. They do not establish new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Specific interactions, between-group risks, causality, recovery after stopping and absence of long-term or rare harms remain unverified. No new incidence rate or verdict is created. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N25",
      "question_type": "Evidence condition",
      "question": "Do the parent’s human-study indicator and narrative agree?",
      "needed": "Disagreement between parent indicator and narrative, and absent selected-subclaim axes",
      "role": "Required",
      "role_reason": "Material on Disagreement between parent indicator and narrative, and absent selected-subclaim axes is needed to connect prior history, sex, oral exposure, comparisons, first diagnosis reports, denominators, precision and harms.",
      "application_exception": "The existing selected D30 verdict is preserved separately from the parent’s deferred verdict, empty score and assessment axes. Full-cohort and prior-gout-excluded analyses, first diagnoses, recurrent attacks and urate are distinguished. No new incidence rates, effects, intervals, person-years, participant totals or dosing guidance are created.",
      "criterion": "Original records on Disagreement between parent indicator and narrative, and absent selected-subclaim axes must link to the same population, exposure, comparison, event, time point and denominator, distinguishing full-cohort and prior-gout-excluded analyses and diagnoses from attacks.",
      "basis": "Existing principles distinguish questions, direct comparisons, reports and trials, populations and events, denominators, precision and harms.",
      "condition_origin": "These evidence conditions concern the existing question of oral single-ingredient vitamin C and first gout diagnosis in men without gout. They do not establish new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Neither is corrected as the right answer or inherited as a selected-subclaim axis in this production. Parent axes remain separate from selected D30. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N26",
      "question_type": "Evidence condition",
      "question": "What do Korean/English text, parent dates and empty corrections mean?",
      "needed": "Korean/English subclaim text, parent account,2026-09-07 and historical records",
      "role": "Required",
      "role_reason": "Material on Korean/English subclaim text, parent account,2026-09-07 and historical records is needed to connect prior history, sex, oral exposure, comparisons, first diagnosis reports, denominators, precision and harms.",
      "application_exception": "The existing selected D30 verdict is preserved separately from the parent’s deferred verdict, empty score and assessment axes. Full-cohort and prior-gout-excluded analyses, first diagnoses, recurrent attacks and urate are distinguished. No new incidence rates, effects, intervals, person-years, participant totals or dosing guidance are created.",
      "criterion": "Original records on Korean/English subclaim text, parent account,2026-09-07 and historical records must link to the same population, exposure, comparison, event, time point and denominator, distinguishing full-cohort and prior-gout-excluded analyses and diagnoses from attacks.",
      "basis": "Existing principles distinguish questions, direct comparisons, reports and trials, populations and events, denominators, precision and harms.",
      "condition_origin": "These evidence conditions concern the existing question of oral single-ingredient vitamin C and first gout diagnosis in men without gout. They do not establish new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Historical independent checks and the original verdict date are not inherited as current content review or new literature reading. Empty corrections do not establish integrity of all literature. This records needed materials; no new research was executed."
    }
  ]
}