{
  "schema_version": "chamgap-public-criteria-1.0",
  "title": "Oral whole Nigella sativa seed powder capsules × Improvement in TSH and anti-TPO in Hashimoto thyroiditis",
  "language": "en",
  "translation_date": "2026-10-24",
  "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": "Which Hashimoto thyroiditis question is addressed?",
      "needed": "Oral seed powder over 8 weeks and TSH/anti-TPO in adults continuing stable levothyroxine",
      "role": "Required",
      "role_reason": "Material on Oral seed powder over 8 weeks and TSH/anti-TPO in adults continuing stable levothyroxine is needed to connect adjunctive whole-seed powder to its population, formulation, concomitant treatment, comparison, laboratory marker, timing, denominator or harms.",
      "application_exception": "The records of 47 randomized participants and 40 completers/analyzed participants are not converted into arm-specific analysis sets or safety denominators, and withdrawals are not calculated. Marker values are not used to create new differences, units, dispersion definitions or CIs; registration bibliography is not converted into actual reading or confirmation of prospective plans.",
      "criterion": "Original records on Oral seed powder over 8 weeks and TSH/anti-TPO in adults continuing stable levothyroxine must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.",
      "basis": "Existing principles distinguish the population, formulation, continued levothyroxine, placebo, thyroid markers, timing, denominators, related reports, company involvement and harms of adjunctive whole-seed powder.",
      "condition_origin": "These existing conditions are linked to adjunctive whole-seed powder and laboratory markers in adults with Hashimoto thyroiditis. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Original eligibility criteria and results tables linking population, continued standard treatment, comparator and each endpoint are needed. Symptoms, medication withdrawal and cure are excluded. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N02",
      "question_type": "Evidence condition",
      "question": "Are whole-seed-powder capsules distinguished from other Nigella formulations?",
      "needed": "Product and constituent details for ground whole Nigella sativa L. seed powder in 1 g capsules",
      "role": "Required",
      "role_reason": "Material on Product and constituent details for ground whole Nigella sativa L. seed powder in 1 g capsules is needed to connect adjunctive whole-seed powder to its population, formulation, concomitant treatment, comparison, laboratory marker, timing, denominator or harms.",
      "application_exception": "The records of 47 randomized participants and 40 completers/analyzed participants are not converted into arm-specific analysis sets or safety denominators, and withdrawals are not calculated. Marker values are not used to create new differences, units, dispersion definitions or CIs; registration bibliography is not converted into actual reading or confirmation of prospective plans.",
      "criterion": "Original records on Product and constituent details for ground whole Nigella sativa L. seed powder in 1 g capsules must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.",
      "basis": "Existing principles distinguish the population, formulation, continued levothyroxine, placebo, thyroid markers, timing, denominators, related reports, company involvement and harms of adjunctive whole-seed powder.",
      "condition_origin": "These existing conditions are linked to adjunctive whole-seed powder and laboratory markers in adults with Hashimoto thyroiditis. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Original manufacturing, constituent-content, standardization and lot records are needed. No efficacy or equivalence of other formulations is added. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N03",
      "question_type": "Evidence condition",
      "question": "How are the original dose and dosing times retained?",
      "needed": "1 g before lunch and dinner, 2 g/day total, and actual adherence",
      "role": "Required",
      "role_reason": "Material on 1 g before lunch and dinner, 2 g/day total, and actual adherence is needed to connect adjunctive whole-seed powder to its population, formulation, concomitant treatment, comparison, laboratory marker, timing, denominator or harms.",
      "application_exception": "The records of 47 randomized participants and 40 completers/analyzed participants are not converted into arm-specific analysis sets or safety denominators, and withdrawals are not calculated. Marker values are not used to create new differences, units, dispersion definitions or CIs; registration bibliography is not converted into actual reading or confirmation of prospective plans.",
      "criterion": "Original records on 1 g before lunch and dinner, 2 g/day total, and actual adherence must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.",
      "basis": "Existing principles distinguish the population, formulation, continued levothyroxine, placebo, thyroid markers, timing, denominators, related reports, company involvement and harms of adjunctive whole-seed powder.",
      "condition_origin": "These existing conditions are linked to adjunctive whole-seed powder and laboratory markers in adults with Hashimoto thyroiditis. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Original dosing/adherence, actual exposure, concomitant-medication timing and product-constituent records are needed. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N04",
      "question_type": "Evidence condition",
      "question": "Are the 8-week treatment/follow-up period and later course distinguished?",
      "needed": "8-week exposure and test timing, with longer-term and post-discontinuation follow-up",
      "role": "Required",
      "role_reason": "Material on 8-week exposure and test timing, with longer-term and post-discontinuation follow-up is needed to connect adjunctive whole-seed powder to its population, formulation, concomitant treatment, comparison, laboratory marker, timing, denominator or harms.",
      "application_exception": "The records of 47 randomized participants and 40 completers/analyzed participants are not converted into arm-specific analysis sets or safety denominators, and withdrawals are not calculated. Marker values are not used to create new differences, units, dispersion definitions or CIs; registration bibliography is not converted into actual reading or confirmation of prospective plans.",
      "criterion": "Original records on 8-week exposure and test timing, with longer-term and post-discontinuation follow-up must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.",
      "basis": "Existing principles distinguish the population, formulation, continued levothyroxine, placebo, thyroid markers, timing, denominators, related reports, company involvement and harms of adjunctive whole-seed powder.",
      "condition_origin": "These existing conditions are linked to adjunctive whole-seed powder and laboratory markers in adults with Hashimoto thyroiditis. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Original test schedules, exposure/discontinuation records and longer follow-up material are needed. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N05",
      "question_type": "Evidence condition",
      "question": "What are the diagnosis and baseline characteristics of the population?",
      "needed": "Hashimoto diagnosis, baseline TSH/antibodies, levothyroxine dose and eligibility criteria",
      "role": "Required",
      "role_reason": "Material on Hashimoto diagnosis, baseline TSH/antibodies, levothyroxine dose and eligibility criteria is needed to connect adjunctive whole-seed powder to its population, formulation, concomitant treatment, comparison, laboratory marker, timing, denominator or harms.",
      "application_exception": "The records of 47 randomized participants and 40 completers/analyzed participants are not converted into arm-specific analysis sets or safety denominators, and withdrawals are not calculated. Marker values are not used to create new differences, units, dispersion definitions or CIs; registration bibliography is not converted into actual reading or confirmation of prospective plans.",
      "criterion": "Original records on Hashimoto diagnosis, baseline TSH/antibodies, levothyroxine dose and eligibility criteria must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.",
      "basis": "Existing principles distinguish the population, formulation, continued levothyroxine, placebo, thyroid markers, timing, denominators, related reports, company involvement and harms of adjunctive whole-seed powder.",
      "condition_origin": "These existing conditions are linked to adjunctive whole-seed powder and laboratory markers in adults with Hashimoto thyroiditis. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Original diagnosis, baseline tests, dose/maintenance period, age, comorbidities and arm-specific eligibility tables are needed. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N06",
      "question_type": "Evidence condition",
      "question": "Is adjunctive use with continued levothyroxine distinguished from replacement?",
      "needed": "Continued or changed standard treatment, medication use and the adjunctive-intervention specification in both arms",
      "role": "Required",
      "role_reason": "Material on Continued or changed standard treatment, medication use and the adjunctive-intervention specification in both arms is needed to connect adjunctive whole-seed powder to its population, formulation, concomitant treatment, comparison, laboratory marker, timing, denominator or harms.",
      "application_exception": "The records of 47 randomized participants and 40 completers/analyzed participants are not converted into arm-specific analysis sets or safety denominators, and withdrawals are not calculated. Marker values are not used to create new differences, units, dispersion definitions or CIs; registration bibliography is not converted into actual reading or confirmation of prospective plans.",
      "criterion": "Original records on Continued or changed standard treatment, medication use and the adjunctive-intervention specification in both arms must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.",
      "basis": "Existing principles distinguish the population, formulation, continued levothyroxine, placebo, thyroid markers, timing, denominators, related reports, company involvement and harms of adjunctive whole-seed powder.",
      "condition_origin": "These existing conditions are linked to adjunctive whole-seed powder and laboratory markers in adults with Hashimoto thyroiditis. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Original medication dose/change, adherence, diet/other-treatment and common-care records are needed. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N07",
      "question_type": "Evidence condition",
      "question": "Are the starch placebo and masking specification known?",
      "needed": "Starch-placebo composition/appearance, equal care and masking in both arms",
      "role": "Required",
      "role_reason": "Material on Starch-placebo composition/appearance, equal care and masking in both arms is needed to connect adjunctive whole-seed powder to its population, formulation, concomitant treatment, comparison, laboratory marker, timing, denominator or harms.",
      "application_exception": "The records of 47 randomized participants and 40 completers/analyzed participants are not converted into arm-specific analysis sets or safety denominators, and withdrawals are not calculated. Marker values are not used to create new differences, units, dispersion definitions or CIs; registration bibliography is not converted into actual reading or confirmation of prospective plans.",
      "criterion": "Original records on Starch-placebo composition/appearance, equal care and masking in both arms must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.",
      "basis": "Existing principles distinguish the population, formulation, continued levothyroxine, placebo, thyroid markers, timing, denominators, related reports, company involvement and harms of adjunctive whole-seed powder.",
      "condition_origin": "These existing conditions are linked to adjunctive whole-seed powder and laboratory markers in adults with Hashimoto thyroiditis. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Original placebo composition, packaging, allocation/masking, adherence and equal-care records are needed. Successful masking is not certified. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N08",
      "question_type": "Evidence condition",
      "question": "Are trial design and completer analysis retained separately?",
      "needed": "Analysis populations in the randomized double-blind placebo-controlled trial",
      "role": "Required",
      "role_reason": "Material on Analysis populations in the randomized double-blind placebo-controlled trial is needed to connect adjunctive whole-seed powder to its population, formulation, concomitant treatment, comparison, laboratory marker, timing, denominator or harms.",
      "application_exception": "The records of 47 randomized participants and 40 completers/analyzed participants are not converted into arm-specific analysis sets or safety denominators, and withdrawals are not calculated. Marker values are not used to create new differences, units, dispersion definitions or CIs; registration bibliography is not converted into actual reading or confirmation of prospective plans.",
      "criterion": "Original records on Analysis populations in the randomized double-blind placebo-controlled trial must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.",
      "basis": "Existing principles distinguish the population, formulation, continued levothyroxine, placebo, thyroid markers, timing, denominators, related reports, company involvement and harms of adjunctive whole-seed powder.",
      "condition_origin": "These existing conditions are linked to adjunctive whole-seed powder and laboratory markers in adults with Hashimoto thyroiditis. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Original sequence, concealment, allocation, analysis-plan and ITT/completer-population material is needed. No new official risk assessment is produced. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N09",
      "question_type": "Evidence condition",
      "question": "What do the denominators of 47 and 40 represent?",
      "needed": "Total allocation, completion/analysis and arm-specific/endpoint-specific denominators",
      "role": "Required",
      "role_reason": "Material on Total allocation, completion/analysis and arm-specific/endpoint-specific denominators is needed to connect adjunctive whole-seed powder to its population, formulation, concomitant treatment, comparison, laboratory marker, timing, denominator or harms.",
      "application_exception": "The records of 47 randomized participants and 40 completers/analyzed participants are not converted into arm-specific analysis sets or safety denominators, and withdrawals are not calculated. Marker values are not used to create new differences, units, dispersion definitions or CIs; registration bibliography is not converted into actual reading or confirmation of prospective plans.",
      "criterion": "Original records on Total allocation, completion/analysis and arm-specific/endpoint-specific denominators must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.",
      "basis": "Existing principles distinguish the population, formulation, continued levothyroxine, placebo, thyroid markers, timing, denominators, related reports, company involvement and harms of adjunctive whole-seed powder.",
      "condition_origin": "These existing conditions are linked to adjunctive whole-seed powder and laboratory markers in adults with Hashimoto thyroiditis. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Arm-specific allocation, completion, TSH/anti-TPO analysis denominators and the original participant flow diagram are needed. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N10",
      "question_type": "Evidence condition",
      "question": "What are the limitations of completer analysis and missing-data handling?",
      "needed": "Analysis exclusions, missing tests, reasons for attrition and sensitivity analyses",
      "role": "Required",
      "role_reason": "Material on Analysis exclusions, missing tests, reasons for attrition and sensitivity analyses is needed to connect adjunctive whole-seed powder to its population, formulation, concomitant treatment, comparison, laboratory marker, timing, denominator or harms.",
      "application_exception": "The records of 47 randomized participants and 40 completers/analyzed participants are not converted into arm-specific analysis sets or safety denominators, and withdrawals are not calculated. Marker values are not used to create new differences, units, dispersion definitions or CIs; registration bibliography is not converted into actual reading or confirmation of prospective plans.",
      "criterion": "Original records on Analysis exclusions, missing tests, reasons for attrition and sensitivity analyses must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.",
      "basis": "Existing principles distinguish the population, formulation, continued levothyroxine, placebo, thyroid markers, timing, denominators, related reports, company involvement and harms of adjunctive whole-seed powder.",
      "condition_origin": "These existing conditions are linked to adjunctive whole-seed powder and laboratory markers in adults with Hashimoto thyroiditis. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Original arm-specific missing/exclusion reasons, missing-data handling, analysis against the plan and sensitivity material are needed. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N11",
      "question_type": "Evidence condition",
      "question": "Are withdrawals with itching and nausea retained separately?",
      "needed": "Events, timing, denominators and missing outcomes linked to active-arm harm-related attrition",
      "role": "Supplementary",
      "role_reason": "Material on Events, timing, denominators and missing outcomes linked to active-arm harm-related attrition is needed to connect adjunctive whole-seed powder to its population, formulation, concomitant treatment, comparison, laboratory marker, timing, denominator or harms.",
      "application_exception": "The records of 47 randomized participants and 40 completers/analyzed participants are not converted into arm-specific analysis sets or safety denominators, and withdrawals are not calculated. Marker values are not used to create new differences, units, dispersion definitions or CIs; registration bibliography is not converted into actual reading or confirmation of prospective plans.",
      "criterion": "Original records on Events, timing, denominators and missing outcomes linked to active-arm harm-related attrition must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.",
      "basis": "Existing principles distinguish the population, formulation, continued levothyroxine, placebo, thyroid markers, timing, denominators, related reports, company involvement and harms of adjunctive whole-seed powder.",
      "condition_origin": "These existing conditions are linked to adjunctive whole-seed powder and laboratory markers in adults with Hashimoto thyroiditis. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Original adverse-event, attrition/discontinuation, missing-measurement, control-arm and event-course material is needed, linking safety to missing efficacy data. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N12",
      "question_type": "Evidence condition",
      "question": "What are the original reported TSH values?",
      "needed": "8-week TSH arm-specific values, original dispersion and adjusted analysis",
      "role": "Required",
      "role_reason": "Material on 8-week TSH arm-specific values, original dispersion and adjusted analysis is needed to connect adjunctive whole-seed powder to its population, formulation, concomitant treatment, comparison, laboratory marker, timing, denominator or harms.",
      "application_exception": "The records of 47 randomized participants and 40 completers/analyzed participants are not converted into arm-specific analysis sets or safety denominators, and withdrawals are not calculated. Marker values are not used to create new differences, units, dispersion definitions or CIs; registration bibliography is not converted into actual reading or confirmation of prospective plans.",
      "criterion": "Original records on 8-week TSH arm-specific values, original dispersion and adjusted analysis must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.",
      "basis": "Existing principles distinguish the population, formulation, continued levothyroxine, placebo, thyroid markers, timing, denominators, related reports, company involvement and harms of adjunctive whole-seed powder.",
      "condition_origin": "These existing conditions are linked to adjunctive whole-seed powder and laboratory markers in adults with Hashimoto thyroiditis. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Original results tables defining laboratory units, group matching, dispersion, baseline/final values, covariates and denominators are needed. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N13",
      "question_type": "Evidence condition",
      "question": "What are the original reported anti-TPO values?",
      "needed": "8-week anti-TPO arm-specific values, original dispersion and P/analysis specification",
      "role": "Required",
      "role_reason": "Material on 8-week anti-TPO arm-specific values, original dispersion and P/analysis specification is needed to connect adjunctive whole-seed powder to its population, formulation, concomitant treatment, comparison, laboratory marker, timing, denominator or harms.",
      "application_exception": "The records of 47 randomized participants and 40 completers/analyzed participants are not converted into arm-specific analysis sets or safety denominators, and withdrawals are not calculated. Marker values are not used to create new differences, units, dispersion definitions or CIs; registration bibliography is not converted into actual reading or confirmation of prospective plans.",
      "criterion": "Original records on 8-week anti-TPO arm-specific values, original dispersion and P/analysis specification must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.",
      "basis": "Existing principles distinguish the population, formulation, continued levothyroxine, placebo, thyroid markers, timing, denominators, related reports, company involvement and harms of adjunctive whole-seed powder.",
      "condition_origin": "These existing conditions are linked to adjunctive whole-seed powder and laboratory markers in adults with Hashimoto thyroiditis. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Original antibody units, arms/timepoints, dispersion, denominators and adjusted-analysis tables are needed. TSH P values or numbers are not copied into the antibody result. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N14",
      "question_type": "Evidence condition",
      "question": "Are adjusted effects and 95% CIs available?",
      "needed": "Marker-specific adjusted between-group effects and 95% CIs",
      "role": "Required",
      "role_reason": "Material on Marker-specific adjusted between-group effects and 95% CIs is needed to connect adjunctive whole-seed powder to its population, formulation, concomitant treatment, comparison, laboratory marker, timing, denominator or harms.",
      "application_exception": "The records of 47 randomized participants and 40 completers/analyzed participants are not converted into arm-specific analysis sets or safety denominators, and withdrawals are not calculated. Marker values are not used to create new differences, units, dispersion definitions or CIs; registration bibliography is not converted into actual reading or confirmation of prospective plans.",
      "criterion": "Original records on Marker-specific adjusted between-group effects and 95% CIs must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.",
      "basis": "Existing principles distinguish the population, formulation, continued levothyroxine, placebo, thyroid markers, timing, denominators, related reports, company involvement and harms of adjunctive whole-seed powder.",
      "condition_origin": "These existing conditions are linked to adjunctive whole-seed powder and laboratory markers in adults with Hashimoto thyroiditis. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Original adjusted between-group estimates, variances, CIs and models are needed. Nonreporting in the original summary remains distinct from unread external text; no back-calculation is performed. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N15",
      "question_type": "Evidence condition",
      "question": "Are original ± notation, units and final values versus changes distinguished?",
      "needed": "Measurement units, means/dispersion, estimands and timing",
      "role": "Required",
      "role_reason": "Material on Measurement units, means/dispersion, estimands and timing is needed to connect adjunctive whole-seed powder to its population, formulation, concomitant treatment, comparison, laboratory marker, timing, denominator or harms.",
      "application_exception": "The records of 47 randomized participants and 40 completers/analyzed participants are not converted into arm-specific analysis sets or safety denominators, and withdrawals are not calculated. Marker values are not used to create new differences, units, dispersion definitions or CIs; registration bibliography is not converted into actual reading or confirmation of prospective plans.",
      "criterion": "Original records on Measurement units, means/dispersion, estimands and timing must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.",
      "basis": "Existing principles distinguish the population, formulation, continued levothyroxine, placebo, thyroid markers, timing, denominators, related reports, company involvement and harms of adjunctive whole-seed powder.",
      "condition_origin": "These existing conditions are linked to adjunctive whole-seed powder and laboratory markers in adults with Hashimoto thyroiditis. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Original laboratory/statistical tables, baseline values, units and dispersion definitions are needed. The ± notation is not arbitrarily relabeled as a CI or SE. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N16",
      "question_type": "Evidence condition",
      "question": "What is the specification for baseline adjustment and multiple comparisons?",
      "needed": "Adjustment variables, test timepoints, estimands and multiplicity",
      "role": "Required",
      "role_reason": "Material on Adjustment variables, test timepoints, estimands and multiplicity is needed to connect adjunctive whole-seed powder to its population, formulation, concomitant treatment, comparison, laboratory marker, timing, denominator or harms.",
      "application_exception": "The records of 47 randomized participants and 40 completers/analyzed participants are not converted into arm-specific analysis sets or safety denominators, and withdrawals are not calculated. Marker values are not used to create new differences, units, dispersion definitions or CIs; registration bibliography is not converted into actual reading or confirmation of prospective plans.",
      "criterion": "Original records on Adjustment variables, test timepoints, estimands and multiplicity must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.",
      "basis": "Existing principles distinguish the population, formulation, continued levothyroxine, placebo, thyroid markers, timing, denominators, related reports, company involvement and harms of adjunctive whole-seed powder.",
      "condition_origin": "These existing conditions are linked to adjunctive whole-seed powder and laboratory markers in adults with Hashimoto thyroiditis. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Original SAPs, models, covariates, all markers/timepoints and analysis-population material are needed. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N17",
      "question_type": "Evidence condition",
      "question": "Has the prospective hierarchy of principal TSH and related anti-TPO been confirmed?",
      "needed": "Prospective endpoint hierarchy for 8-week TSH and the antibody reported alongside it",
      "role": "Required",
      "role_reason": "Material on Prospective endpoint hierarchy for 8-week TSH and the antibody reported alongside it is needed to connect adjunctive whole-seed powder to its population, formulation, concomitant treatment, comparison, laboratory marker, timing, denominator or harms.",
      "application_exception": "The records of 47 randomized participants and 40 completers/analyzed participants are not converted into arm-specific analysis sets or safety denominators, and withdrawals are not calculated. Marker values are not used to create new differences, units, dispersion definitions or CIs; registration bibliography is not converted into actual reading or confirmation of prospective plans.",
      "criterion": "Original records on Prospective endpoint hierarchy for 8-week TSH and the antibody reported alongside it must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.",
      "basis": "Existing principles distinguish the population, formulation, continued levothyroxine, placebo, thyroid markers, timing, denominators, related reports, company involvement and harms of adjunctive whole-seed powder.",
      "condition_origin": "These existing conditions are linked to adjunctive whole-seed powder and laboratory markers in adults with Hashimoto thyroiditis. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Registration, protocol/SAP and a complete endpoint/timepoint table are needed. No new co-primary (1st) status, splitting or regrading is declared. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N18",
      "question_type": "Evidence condition",
      "question": "What are the assay and assessor procedures?",
      "needed": "TSH/anti-TPO assays, blood-sampling timepoints and laboratory/assessor masking",
      "role": "Required",
      "role_reason": "Material on TSH/anti-TPO assays, blood-sampling timepoints and laboratory/assessor masking is needed to connect adjunctive whole-seed powder to its population, formulation, concomitant treatment, comparison, laboratory marker, timing, denominator or harms.",
      "application_exception": "The records of 47 randomized participants and 40 completers/analyzed participants are not converted into arm-specific analysis sets or safety denominators, and withdrawals are not calculated. Marker values are not used to create new differences, units, dispersion definitions or CIs; registration bibliography is not converted into actual reading or confirmation of prospective plans.",
      "criterion": "Original records on TSH/anti-TPO assays, blood-sampling timepoints and laboratory/assessor masking must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.",
      "basis": "Existing principles distinguish the population, formulation, continued levothyroxine, placebo, thyroid markers, timing, denominators, related reports, company involvement and harms of adjunctive whole-seed powder.",
      "condition_origin": "These existing conditions are linked to adjunctive whole-seed powder and laboratory markers in adults with Hashimoto thyroiditis. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Original assay/laboratory methods, repeated measurements, units and assessor-masking material are needed. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N19",
      "question_type": "Evidence condition",
      "question": "What are the original randomization, concealment and masking methods?",
      "needed": "Allocation sequence, concealment and participant/assessor masking",
      "role": "Required",
      "role_reason": "Material on Allocation sequence, concealment and participant/assessor masking is needed to connect adjunctive whole-seed powder to its population, formulation, concomitant treatment, comparison, laboratory marker, timing, denominator or harms.",
      "application_exception": "The records of 47 randomized participants and 40 completers/analyzed participants are not converted into arm-specific analysis sets or safety denominators, and withdrawals are not calculated. Marker values are not used to create new differences, units, dispersion definitions or CIs; registration bibliography is not converted into actual reading or confirmation of prospective plans.",
      "criterion": "Original records on Allocation sequence, concealment and participant/assessor masking must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.",
      "basis": "Existing principles distinguish the population, formulation, continued levothyroxine, placebo, thyroid markers, timing, denominators, related reports, company involvement and harms of adjunctive whole-seed powder.",
      "condition_origin": "These existing conditions are linked to adjunctive whole-seed powder and laboratory markers in adults with Hashimoto thyroiditis. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Original methods, registration/plans and arm-specific follow-up/assessment records are needed. No official RoB2/GRADE assessment is produced. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N20",
      "question_type": "Evidence condition",
      "question": "Are the IRCT registration record and actual reading distinguished?",
      "needed": "Original registration/version and timing for IRCT2015021719082N4",
      "role": "Required",
      "role_reason": "Material on Original registration/version and timing for IRCT2015021719082N4 is needed to connect adjunctive whole-seed powder to its population, formulation, concomitant treatment, comparison, laboratory marker, timing, denominator or harms.",
      "application_exception": "The records of 47 randomized participants and 40 completers/analyzed participants are not converted into arm-specific analysis sets or safety denominators, and withdrawals are not calculated. Marker values are not used to create new differences, units, dispersion definitions or CIs; registration bibliography is not converted into actual reading or confirmation of prospective plans.",
      "criterion": "Original records on Original registration/version and timing for IRCT2015021719082N4 must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.",
      "basis": "Existing principles distinguish the population, formulation, continued levothyroxine, placebo, thyroid markers, timing, denominators, related reports, company involvement and harms of adjunctive whole-seed powder.",
      "condition_origin": "These existing conditions are linked to adjunctive whole-seed powder and laboratory markers in adults with Hashimoto thyroiditis. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Original registration, revision history, protocol/SAP and matching with the paper are needed. Identifier presence is not promoted into prospective registration or completed content verification. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N21",
      "question_type": "Evidence condition",
      "question": "Are T3 and T4 kept separate from the principal claim?",
      "needed": "Separate T3/T4 results, timing, denominators and hierarchy",
      "role": "Supplementary",
      "role_reason": "Material on Separate T3/T4 results, timing, denominators and hierarchy is needed to connect adjunctive whole-seed powder to its population, formulation, concomitant treatment, comparison, laboratory marker, timing, denominator or harms.",
      "application_exception": "The records of 47 randomized participants and 40 completers/analyzed participants are not converted into arm-specific analysis sets or safety denominators, and withdrawals are not calculated. Marker values are not used to create new differences, units, dispersion definitions or CIs; registration bibliography is not converted into actual reading or confirmation of prospective plans.",
      "criterion": "Original records on Separate T3/T4 results, timing, denominators and hierarchy must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.",
      "basis": "Existing principles distinguish the population, formulation, continued levothyroxine, placebo, thyroid markers, timing, denominators, related reports, company involvement and harms of adjunctive whole-seed powder.",
      "condition_origin": "These existing conditions are linked to adjunctive whole-seed powder and laboratory markers in adults with Hashimoto thyroiditis. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Original results, CIs, denominators and hierarchy for each marker are needed. No new separate efficacy grade is created. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N22",
      "question_type": "Evidence condition",
      "question": "Are weight, VEGF and Nesfatin-1 kept separate?",
      "needed": "Separate results, denominators and prospective hierarchy for body weight/mechanistic markers",
      "role": "Supplementary",
      "role_reason": "Material on Separate results, denominators and prospective hierarchy for body weight/mechanistic markers is needed to connect adjunctive whole-seed powder to its population, formulation, concomitant treatment, comparison, laboratory marker, timing, denominator or harms.",
      "application_exception": "The records of 47 randomized participants and 40 completers/analyzed participants are not converted into arm-specific analysis sets or safety denominators, and withdrawals are not calculated. Marker values are not used to create new differences, units, dispersion definitions or CIs; registration bibliography is not converted into actual reading or confirmation of prospective plans.",
      "criterion": "Original records on Separate results, denominators and prospective hierarchy for body weight/mechanistic markers must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.",
      "basis": "Existing principles distinguish the population, formulation, continued levothyroxine, placebo, thyroid markers, timing, denominators, related reports, company involvement and harms of adjunctive whole-seed powder.",
      "condition_origin": "These existing conditions are linked to adjunctive whole-seed powder and laboratory markers in adults with Hashimoto thyroiditis. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Original separate-endpoint tables and links to the same participants/denominators are needed. Mechanistic or weight changes are not converted into cure or symptom effects. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N23",
      "question_type": "Evidence condition",
      "question": "Are symptom improvement and laboratory results distinguished?",
      "needed": "Direct results for patient symptoms, quality of life and function",
      "role": "Supplementary",
      "role_reason": "Material on Direct results for patient symptoms, quality of life and function is needed to connect adjunctive whole-seed powder to its population, formulation, concomitant treatment, comparison, laboratory marker, timing, denominator or harms.",
      "application_exception": "The records of 47 randomized participants and 40 completers/analyzed participants are not converted into arm-specific analysis sets or safety denominators, and withdrawals are not calculated. Marker values are not used to create new differences, units, dispersion definitions or CIs; registration bibliography is not converted into actual reading or confirmation of prospective plans.",
      "criterion": "Original records on Direct results for patient symptoms, quality of life and function must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.",
      "basis": "Existing principles distinguish the population, formulation, continued levothyroxine, placebo, thyroid markers, timing, denominators, related reports, company involvement and harms of adjunctive whole-seed powder.",
      "condition_origin": "These existing conditions are linked to adjunctive whole-seed powder and laboratory markers in adults with Hashimoto thyroiditis. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Original material on prespecified patient outcomes, symptoms and quality of life is needed. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N24",
      "question_type": "Evidence condition",
      "question": "Are medication reduction, withdrawal and cure excluded from the claim?",
      "needed": "Direct comparisons for levothyroxine reduction/withdrawal and autoimmune cure",
      "role": "Supplementary",
      "role_reason": "Material on Direct comparisons for levothyroxine reduction/withdrawal and autoimmune cure is needed to connect adjunctive whole-seed powder to its population, formulation, concomitant treatment, comparison, laboratory marker, timing, denominator or harms.",
      "application_exception": "The records of 47 randomized participants and 40 completers/analyzed participants are not converted into arm-specific analysis sets or safety denominators, and withdrawals are not calculated. Marker values are not used to create new differences, units, dispersion definitions or CIs; registration bibliography is not converted into actual reading or confirmation of prospective plans.",
      "criterion": "Original records on Direct comparisons for levothyroxine reduction/withdrawal and autoimmune cure must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.",
      "basis": "Existing principles distinguish the population, formulation, continued levothyroxine, placebo, thyroid markers, timing, denominators, related reports, company involvement and harms of adjunctive whole-seed powder.",
      "condition_origin": "These existing conditions are linked to adjunctive whole-seed powder and laboratory markers in adults with Hashimoto thyroiditis. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Direct studies of medication reduction/discontinuation and clinical course are needed. These outcomes are not added here. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N25",
      "question_type": "Evidence condition",
      "question": "Are long-term thyroid function and persistent effects known?",
      "needed": "Laboratory/clinical course beyond 8 weeks and after discontinuation",
      "role": "Supplementary",
      "role_reason": "Material on Laboratory/clinical course beyond 8 weeks and after discontinuation is needed to connect adjunctive whole-seed powder to its population, formulation, concomitant treatment, comparison, laboratory marker, timing, denominator or harms.",
      "application_exception": "The records of 47 randomized participants and 40 completers/analyzed participants are not converted into arm-specific analysis sets or safety denominators, and withdrawals are not calculated. Marker values are not used to create new differences, units, dispersion definitions or CIs; registration bibliography is not converted into actual reading or confirmation of prospective plans.",
      "criterion": "Original records on Laboratory/clinical course beyond 8 weeks and after discontinuation must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.",
      "basis": "Existing principles distinguish the population, formulation, continued levothyroxine, placebo, thyroid markers, timing, denominators, related reports, company involvement and harms of adjunctive whole-seed powder.",
      "condition_origin": "These existing conditions are linked to adjunctive whole-seed powder and laboratory markers in adults with Hashimoto thyroiditis. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Longer follow-up, post-discontinuation course and repeated material for the same formulation are needed. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N26",
      "question_type": "Evidence condition",
      "question": "Is a single report distinguished from independent replication?",
      "needed": "Trial families, shared participants and independent teams using the same formulation",
      "role": "Required",
      "role_reason": "Material on Trial families, shared participants and independent teams using the same formulation is needed to connect adjunctive whole-seed powder to its population, formulation, concomitant treatment, comparison, laboratory marker, timing, denominator or harms.",
      "application_exception": "The records of 47 randomized participants and 40 completers/analyzed participants are not converted into arm-specific analysis sets or safety denominators, and withdrawals are not calculated. Marker values are not used to create new differences, units, dispersion definitions or CIs; registration bibliography is not converted into actual reading or confirmation of prospective plans.",
      "criterion": "Original records on Trial families, shared participants and independent teams using the same formulation must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.",
      "basis": "Existing principles distinguish the population, formulation, continued levothyroxine, placebo, thyroid markers, timing, denominators, related reports, company involvement and harms of adjunctive whole-seed powder.",
      "condition_origin": "These existing conditions are linked to adjunctive whole-seed powder and laboratory markers in adults with Hashimoto thyroiditis. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Team, product, funding, additional-report/registration links and replication material for the same question are needed. Final unique-trial/participant totals remain unverified. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N27",
      "question_type": "Evidence condition",
      "question": "Are university support, product manufacture and company-involvement routes distinguished?",
      "needed": "Original records of funding, product support, employee authorship and conflicts of interest",
      "role": "Required",
      "role_reason": "Material on Original records of funding, product support, employee authorship and conflicts of interest is needed to connect adjunctive whole-seed powder to its population, formulation, concomitant treatment, comparison, laboratory marker, timing, denominator or harms.",
      "application_exception": "The records of 47 randomized participants and 40 completers/analyzed participants are not converted into arm-specific analysis sets or safety denominators, and withdrawals are not calculated. Marker values are not used to create new differences, units, dispersion definitions or CIs; registration bibliography is not converted into actual reading or confirmation of prospective plans.",
      "criterion": "Original records on Original records of funding, product support, employee authorship and conflicts of interest must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.",
      "basis": "Existing principles distinguish the population, formulation, continued levothyroxine, placebo, thyroid markers, timing, denominators, related reports, company involvement and harms of adjunctive whole-seed powder.",
      "condition_origin": "These existing conditions are linked to adjunctive whole-seed powder and laboratory markers in adults with Hashimoto thyroiditis. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Original support/manufacturing contracts, product provision, author affiliations and COI text are needed. University support alone is not labeled as absence of all company involvement. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N28",
      "question_type": "Evidence condition",
      "question": "What are the harm-collection procedures and course of itching/nausea?",
      "needed": "Harm definitions, active ascertainment, events/discontinuation and severity",
      "role": "Supplementary",
      "role_reason": "Material on Harm definitions, active ascertainment, events/discontinuation and severity is needed to connect adjunctive whole-seed powder to its population, formulation, concomitant treatment, comparison, laboratory marker, timing, denominator or harms.",
      "application_exception": "The records of 47 randomized participants and 40 completers/analyzed participants are not converted into arm-specific analysis sets or safety denominators, and withdrawals are not calculated. Marker values are not used to create new differences, units, dispersion definitions or CIs; registration bibliography is not converted into actual reading or confirmation of prospective plans.",
      "criterion": "Original records on Harm definitions, active ascertainment, events/discontinuation and severity must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.",
      "basis": "Existing principles distinguish the population, formulation, continued levothyroxine, placebo, thyroid markers, timing, denominators, related reports, company involvement and harms of adjunctive whole-seed powder.",
      "condition_origin": "These existing conditions are linked to adjunctive whole-seed powder and laboratory markers in adults with Hashimoto thyroiditis. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Original harm tables, ascertainment/discontinuation, arm-specific course and missing-material records are needed. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N29",
      "question_type": "Evidence condition",
      "question": "Are safety denominators, exposure and controls separately known?",
      "needed": "Arm-specific safety populations, actual dosing and 8-week exposure/events",
      "role": "Supplementary",
      "role_reason": "Material on Arm-specific safety populations, actual dosing and 8-week exposure/events is needed to connect adjunctive whole-seed powder to its population, formulation, concomitant treatment, comparison, laboratory marker, timing, denominator or harms.",
      "application_exception": "The records of 47 randomized participants and 40 completers/analyzed participants are not converted into arm-specific analysis sets or safety denominators, and withdrawals are not calculated. Marker values are not used to create new differences, units, dispersion definitions or CIs; registration bibliography is not converted into actual reading or confirmation of prospective plans.",
      "criterion": "Original records on Arm-specific safety populations, actual dosing and 8-week exposure/events must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.",
      "basis": "Existing principles distinguish the population, formulation, continued levothyroxine, placebo, thyroid markers, timing, denominators, related reports, company involvement and harms of adjunctive whole-seed powder.",
      "condition_origin": "These existing conditions are linked to adjunctive whole-seed powder and laboratory markers in adults with Hashimoto thyroiditis. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Original safety denominators, events, controls, exposure time and attrition records are needed. Incidence is not calculated. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N30",
      "question_type": "Evidence condition",
      "question": "Are concomitant levothyroxine and alternative causes distinguished?",
      "needed": "Concomitant medication/dosing times, changes, baseline conditions and event timing",
      "role": "Supplementary",
      "role_reason": "Material on Concomitant medication/dosing times, changes, baseline conditions and event timing is needed to connect adjunctive whole-seed powder to its population, formulation, concomitant treatment, comparison, laboratory marker, timing, denominator or harms.",
      "application_exception": "The records of 47 randomized participants and 40 completers/analyzed participants are not converted into arm-specific analysis sets or safety denominators, and withdrawals are not calculated. Marker values are not used to create new differences, units, dispersion definitions or CIs; registration bibliography is not converted into actual reading or confirmation of prospective plans.",
      "criterion": "Original records on Concomitant medication/dosing times, changes, baseline conditions and event timing must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.",
      "basis": "Existing principles distinguish the population, formulation, continued levothyroxine, placebo, thyroid markers, timing, denominators, related reports, company involvement and harms of adjunctive whole-seed powder.",
      "condition_origin": "These existing conditions are linked to adjunctive whole-seed powder and laboratory markers in adults with Hashimoto thyroiditis. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Medication/timing, changes, baseline conditions, controls, post-discontinuation course and alternative-cause material are needed. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N31",
      "question_type": "Evidence condition",
      "question": "Were long-term, rare and vulnerable-population harms verified?",
      "needed": "Longer follow-up, independent harm reports, vulnerable populations and exposure/denominators",
      "role": "Supplementary",
      "role_reason": "Material on Longer follow-up, independent harm reports, vulnerable populations and exposure/denominators is needed to connect adjunctive whole-seed powder to its population, formulation, concomitant treatment, comparison, laboratory marker, timing, denominator or harms.",
      "application_exception": "The records of 47 randomized participants and 40 completers/analyzed participants are not converted into arm-specific analysis sets or safety denominators, and withdrawals are not calculated. Marker values are not used to create new differences, units, dispersion definitions or CIs; registration bibliography is not converted into actual reading or confirmation of prospective plans.",
      "criterion": "Original records on Longer follow-up, independent harm reports, vulnerable populations and exposure/denominators must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.",
      "basis": "Existing principles distinguish the population, formulation, continued levothyroxine, placebo, thyroid markers, timing, denominators, related reports, company involvement and harms of adjunctive whole-seed powder.",
      "condition_origin": "These existing conditions are linked to adjunctive whole-seed powder and laboratory markers in adults with Hashimoto thyroiditis. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Longer follow-up, vulnerable-population material, independent reports and exposure/denominators are needed. Unverified status is retained without a new harm investigation or judgment. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N32",
      "question_type": "Evidence condition",
      "question": "Are summary reading, PubMed, PMCID and registration distinguished?",
      "needed": "An access table for stored JSON, external abstracts, full text, IRCT and protocols/SAPs",
      "role": "Required",
      "role_reason": "Material on An access table for stored JSON, external abstracts, full text, IRCT and protocols/SAPs is needed to connect adjunctive whole-seed powder to its population, formulation, concomitant treatment, comparison, laboratory marker, timing, denominator or harms.",
      "application_exception": "The records of 47 randomized participants and 40 completers/analyzed participants are not converted into arm-specific analysis sets or safety denominators, and withdrawals are not calculated. Marker values are not used to create new differences, units, dispersion definitions or CIs; registration bibliography is not converted into actual reading or confirmation of prospective plans.",
      "criterion": "Original records on An access table for stored JSON, external abstracts, full text, IRCT and protocols/SAPs must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.",
      "basis": "Existing principles distinguish the population, formulation, continued levothyroxine, placebo, thyroid markers, timing, denominators, related reports, company involvement and harms of adjunctive whole-seed powder.",
      "condition_origin": "These existing conditions are linked to adjunctive whole-seed powder and laboratory markers in adults with Hashimoto thyroiditis. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: External material remains unread pending actual acquisition and review. Identifiers or URLs are not labeled as reading, accessibility or fulfilled conditions. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N33",
      "question_type": "Evidence condition",
      "question": "Are generic English wording and historical corrections preserved?",
      "needed": "Original Korean/English text and limits of the 2026-09-14 correction",
      "role": "Supplementary",
      "role_reason": "Material on Original Korean/English text and limits of the 2026-09-14 correction is needed to connect adjunctive whole-seed powder to its population, formulation, concomitant treatment, comparison, laboratory marker, timing, denominator or harms.",
      "application_exception": "The records of 47 randomized participants and 40 completers/analyzed participants are not converted into arm-specific analysis sets or safety denominators, and withdrawals are not calculated. Marker values are not used to create new differences, units, dispersion definitions or CIs; registration bibliography is not converted into actual reading or confirmation of prospective plans.",
      "criterion": "Original records on Original Korean/English text and limits of the 2026-09-14 correction must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.",
      "basis": "Existing principles distinguish the population, formulation, continued levothyroxine, placebo, thyroid markers, timing, denominators, related reports, company involvement and harms of adjunctive whole-seed powder.",
      "condition_origin": "These existing conditions are linked to adjunctive whole-seed powder and laboratory markers in adults with Hashimoto thyroiditis. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: External English text and historical correction targets remain uncompared here. Historical verification wording is not converted into newly completed content verification. This records needed materials; no new research was executed."
    },
    {
      "item_id": "N34",
      "question_type": "Evidence condition",
      "question": "Are original grade, axes, evidence date and preparation kept separate?",
      "needed": "Original C54, Caution, axes, evidence date and correction values",
      "role": "Required",
      "role_reason": "Material on Original C54, Caution, axes, evidence date and correction values is needed to connect adjunctive whole-seed powder to its population, formulation, concomitant treatment, comparison, laboratory marker, timing, denominator or harms.",
      "application_exception": "The records of 47 randomized participants and 40 completers/analyzed participants are not converted into arm-specific analysis sets or safety denominators, and withdrawals are not calculated. Marker values are not used to create new differences, units, dispersion definitions or CIs; registration bibliography is not converted into actual reading or confirmation of prospective plans.",
      "criterion": "Original records on Original C54, Caution, axes, evidence date and correction values must link to the relevant report, design, formulation, background treatment, endpoint, timing and denominator, distinguishing recorded information from what remains unverified.",
      "basis": "Existing principles distinguish the population, formulation, continued levothyroxine, placebo, thyroid markers, timing, denominators, related reports, company involvement and harms of adjunctive whole-seed powder.",
      "condition_origin": "These existing conditions are linked to adjunctive whole-seed powder and laboratory markers in adults with Hashimoto thyroiditis. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: New evidence, condition revisions and verdict changes are separate events following content review. The original date is not used as a current search or external-reading date. This records needed materials; no new research was executed."
    }
  ]
}