{
  "schema_version": "chamgap-public-criteria-1.0",
  "title": "Oral aqueous Nigella sativa seed extract as adjunctive therapy × Reduced seizure frequency in pediatric refractory epilepsy",
  "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": "What is the selected claim?",
      "needed": "The exact question on aqueous seed extract, pediatric refractory epilepsy, seizure frequency, continued antiseizure medication and added placebo",
      "role": "Required",
      "role_reason": "Material on The exact question on aqueous seed extract, pediatric refractory epilepsy, seizure frequency, continued antiseizure medication and added placebo is needed to connect the pediatric population to formulation, dose, background treatment, placebo, seizure recording, crossover periods and sequences, denominators, intervals or harms.",
      "application_exception": "The records of 23 enrolled participants and 20 completers are not converted into randomized, period-specific analysis or safety denominators, and no new dropout count is calculated. Crossover periods are not pooled as independent trials or new participants, and an overall test is not converted into an effect between treatment periods.",
      "criterion": "Original records on The exact question on aqueous seed extract, pediatric refractory epilepsy, seizure frequency, continued antiseizure medication and added placebo must link to the relevant report, crossover design, concomitant medication, measurement, timing and denominator, distinguishing recorded information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, population, background antiseizure medication, placebo, seizure recording, crossover periods and sequences, denominators, effect intervals, support and harms for adjunctive aqueous seed extract in children.",
      "condition_origin": "These existing conditions are linked to the crossover comparison of aqueous seed extract and placebo in children continuing antiseizure medication. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Original material specifying formulation, population, comparison and duration for this question This records needed materials; no new research was executed."
    },
    {
      "item_id": "N02",
      "question_type": "Evidence condition",
      "question": "Which materials were actually read here?",
      "needed": "Separate reading levels for the stored JSON summary and external articles, registration and plans",
      "role": "Required",
      "role_reason": "Material on Separate reading levels for the stored JSON summary and external articles, registration and plans is needed to connect the pediatric population to formulation, dose, background treatment, placebo, seizure recording, crossover periods and sequences, denominators, intervals or harms.",
      "application_exception": "The records of 23 enrolled participants and 20 completers are not converted into randomized, period-specific analysis or safety denominators, and no new dropout count is calculated. Crossover periods are not pooled as independent trials or new participants, and an overall test is not converted into an effect between treatment periods.",
      "criterion": "Original records on Separate reading levels for the stored JSON summary and external articles, registration and plans must link to the relevant report, crossover design, concomitant medication, measurement, timing and denominator, distinguishing recorded information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, population, background antiseizure medication, placebo, seizure recording, crossover periods and sequences, denominators, effect intervals, support and harms for adjunctive aqueous seed extract in children.",
      "condition_origin": "These existing conditions are linked to the crossover comparison of aqueous seed extract and placebo in children continuing antiseizure medication. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Original material and access histories supplied by the user or obtained in subsequent work This records needed materials; no new research was executed."
    },
    {
      "item_id": "N03",
      "question_type": "Evidence condition",
      "question": "What is the identity of the report?",
      "needed": "Link authors, year, title and PMID to the direct report",
      "role": "Required",
      "role_reason": "Material on Link authors, year, title and PMID to the direct report is needed to connect the pediatric population to formulation, dose, background treatment, placebo, seizure recording, crossover periods and sequences, denominators, intervals or harms.",
      "application_exception": "The records of 23 enrolled participants and 20 completers are not converted into randomized, period-specific analysis or safety denominators, and no new dropout count is calculated. Crossover periods are not pooled as independent trials or new participants, and an overall test is not converted into an effect between treatment periods.",
      "criterion": "Original records on Link authors, year, title and PMID to the direct report must link to the relevant report, crossover design, concomitant medication, measurement, timing and denominator, distinguishing recorded information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, population, background antiseizure medication, placebo, seizure recording, crossover periods and sequences, denominators, effect intervals, support and harms for adjunctive aqueous seed extract in children.",
      "condition_origin": "These existing conditions are linked to the crossover comparison of aqueous seed extract and placebo in children continuing antiseizure medication. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Full article bibliography and lists of related registrations and reports This records needed materials; no new research was executed."
    },
    {
      "item_id": "N04",
      "question_type": "Evidence condition",
      "question": "Are crossover periods kept distinct from independent studies or people?",
      "needed": "Relationships among the single trial, its sequences/periods, participants and reports",
      "role": "Required",
      "role_reason": "Material on Relationships among the single trial, its sequences/periods, participants and reports is needed to connect the pediatric population to formulation, dose, background treatment, placebo, seizure recording, crossover periods and sequences, denominators, intervals or harms.",
      "application_exception": "The records of 23 enrolled participants and 20 completers are not converted into randomized, period-specific analysis or safety denominators, and no new dropout count is calculated. Crossover periods are not pooled as independent trials or new participants, and an overall test is not converted into an effect between treatment periods.",
      "criterion": "Original records on Relationships among the single trial, its sequences/periods, participants and reports must link to the relevant report, crossover design, concomitant medication, measurement, timing and denominator, distinguishing recorded information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, population, background antiseizure medication, placebo, seizure recording, crossover periods and sequences, denominators, effect intervals, support and harms for adjunctive aqueous seed extract in children.",
      "condition_origin": "These existing conditions are linked to the crossover comparison of aqueous seed extract and placebo in children continuing antiseizure medication. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Participant flow, sequence/period tables and related report lists This records needed materials; no new research was executed."
    },
    {
      "item_id": "N05",
      "question_type": "Evidence condition",
      "question": "Which children does the record concern?",
      "needed": "Refractory diagnosis, age, seizure type, baseline severity and inclusion/exclusion criteria",
      "role": "Required",
      "role_reason": "Material on Refractory diagnosis, age, seizure type, baseline severity and inclusion/exclusion criteria is needed to connect the pediatric population to formulation, dose, background treatment, placebo, seizure recording, crossover periods and sequences, denominators, intervals or harms.",
      "application_exception": "The records of 23 enrolled participants and 20 completers are not converted into randomized, period-specific analysis or safety denominators, and no new dropout count is calculated. Crossover periods are not pooled as independent trials or new participants, and an overall test is not converted into an effect between treatment periods.",
      "criterion": "Original records on Refractory diagnosis, age, seizure type, baseline severity and inclusion/exclusion criteria must link to the relevant report, crossover design, concomitant medication, measurement, timing and denominator, distinguishing recorded information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, population, background antiseizure medication, placebo, seizure recording, crossover periods and sequences, denominators, effect intervals, support and harms for adjunctive aqueous seed extract in children.",
      "condition_origin": "These existing conditions are linked to the crossover comparison of aqueous seed extract and placebo in children continuing antiseizure medication. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Eligibility tables, baseline characteristics and seizure-type-specific material This records needed materials; no new research was executed."
    },
    {
      "item_id": "N06",
      "question_type": "Evidence condition",
      "question": "Which extract was used?",
      "needed": "Identity of the seed, Soxhlet aqueous extraction, composition/batch and formulation",
      "role": "Required",
      "role_reason": "Material on Identity of the seed, Soxhlet aqueous extraction, composition/batch and formulation is needed to connect the pediatric population to formulation, dose, background treatment, placebo, seizure recording, crossover periods and sequences, denominators, intervals or harms.",
      "application_exception": "The records of 23 enrolled participants and 20 completers are not converted into randomized, period-specific analysis or safety denominators, and no new dropout count is calculated. Crossover periods are not pooled as independent trials or new participants, and an overall test is not converted into an effect between treatment periods.",
      "criterion": "Original records on Identity of the seed, Soxhlet aqueous extraction, composition/batch and formulation must link to the relevant report, crossover design, concomitant medication, measurement, timing and denominator, distinguishing recorded information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, population, background antiseizure medication, placebo, seizure recording, crossover periods and sequences, denominators, effect intervals, support and harms for adjunctive aqueous seed extract in children.",
      "condition_origin": "These existing conditions are linked to the crossover comparison of aqueous seed extract and placebo in children continuing antiseizure medication. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Extraction, quality, constituent-amount and trial-preparation specifications This records needed materials; no new research was executed."
    },
    {
      "item_id": "N07",
      "question_type": "Evidence condition",
      "question": "What record specifies the dose and frequency?",
      "needed": "Weight-based amount per 1 administration, interval, actual dosing and adherence",
      "role": "Required",
      "role_reason": "Material on Weight-based amount per 1 administration, interval, actual dosing and adherence is needed to connect the pediatric population to formulation, dose, background treatment, placebo, seizure recording, crossover periods and sequences, denominators, intervals or harms.",
      "application_exception": "The records of 23 enrolled participants and 20 completers are not converted into randomized, period-specific analysis or safety denominators, and no new dropout count is calculated. Crossover periods are not pooled as independent trials or new participants, and an overall test is not converted into an effect between treatment periods.",
      "criterion": "Original records on Weight-based amount per 1 administration, interval, actual dosing and adherence must link to the relevant report, crossover design, concomitant medication, measurement, timing and denominator, distinguishing recorded information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, population, background antiseizure medication, placebo, seizure recording, crossover periods and sequences, denominators, effect intervals, support and harms for adjunctive aqueous seed extract in children.",
      "condition_origin": "These existing conditions are linked to the crossover comparison of aqueous seed extract and placebo in children continuing antiseizure medication. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Dosing schedules, adherence and adjustment records This records needed materials; no new research was executed."
    },
    {
      "item_id": "N08",
      "question_type": "Evidence condition",
      "question": "Is this an adjunctive effect above background antiseizure medication?",
      "needed": "Background drugs, maintenance, changes and attribution of concomitant treatment by group/period",
      "role": "Required",
      "role_reason": "Material on Background drugs, maintenance, changes and attribution of concomitant treatment by group/period is needed to connect the pediatric population to formulation, dose, background treatment, placebo, seizure recording, crossover periods and sequences, denominators, intervals or harms.",
      "application_exception": "The records of 23 enrolled participants and 20 completers are not converted into randomized, period-specific analysis or safety denominators, and no new dropout count is calculated. Crossover periods are not pooled as independent trials or new participants, and an overall test is not converted into an effect between treatment periods.",
      "criterion": "Original records on Background drugs, maintenance, changes and attribution of concomitant treatment by group/period must link to the relevant report, crossover design, concomitant medication, measurement, timing and denominator, distinguishing recorded information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, population, background antiseizure medication, placebo, seizure recording, crossover periods and sequences, denominators, effect intervals, support and harms for adjunctive aqueous seed extract in children.",
      "condition_origin": "These existing conditions are linked to the crossover comparison of aqueous seed extract and placebo in children continuing antiseizure medication. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Background drug lists, changes and rescue-treatment tables This records needed materials; no new research was executed."
    },
    {
      "item_id": "N09",
      "question_type": "Evidence condition",
      "question": "How was placebo actually compared?",
      "needed": "Placebo composition, appearance, administration and adjunctive-treatment conditions",
      "role": "Required",
      "role_reason": "Material on Placebo composition, appearance, administration and adjunctive-treatment conditions is needed to connect the pediatric population to formulation, dose, background treatment, placebo, seizure recording, crossover periods and sequences, denominators, intervals or harms.",
      "application_exception": "The records of 23 enrolled participants and 20 completers are not converted into randomized, period-specific analysis or safety denominators, and no new dropout count is calculated. Crossover periods are not pooled as independent trials or new participants, and an overall test is not converted into an effect between treatment periods.",
      "criterion": "Original records on Placebo composition, appearance, administration and adjunctive-treatment conditions must link to the relevant report, crossover design, concomitant medication, measurement, timing and denominator, distinguishing recorded information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, population, background antiseizure medication, placebo, seizure recording, crossover periods and sequences, denominators, effect intervals, support and harms for adjunctive aqueous seed extract in children.",
      "condition_origin": "These existing conditions are linked to the crossover comparison of aqueous seed extract and placebo in children continuing antiseizure medication. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Placebo specifications, preparation images/descriptions and administration records This records needed materials; no new research was executed."
    },
    {
      "item_id": "N10",
      "question_type": "Evidence condition",
      "question": "What was the allocation process in the crossover design?",
      "needed": "Sequence allocation, concealment, randomization methods and baseline balance",
      "role": "Required",
      "role_reason": "Material on Sequence allocation, concealment, randomization methods and baseline balance is needed to connect the pediatric population to formulation, dose, background treatment, placebo, seizure recording, crossover periods and sequences, denominators, intervals or harms.",
      "application_exception": "The records of 23 enrolled participants and 20 completers are not converted into randomized, period-specific analysis or safety denominators, and no new dropout count is calculated. Crossover periods are not pooled as independent trials or new participants, and an overall test is not converted into an effect between treatment periods.",
      "criterion": "Original records on Sequence allocation, concealment, randomization methods and baseline balance must link to the relevant report, crossover design, concomitant medication, measurement, timing and denominator, distinguishing recorded information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, population, background antiseizure medication, placebo, seizure recording, crossover periods and sequences, denominators, effect intervals, support and harms for adjunctive aqueous seed extract in children.",
      "condition_origin": "These existing conditions are linked to the crossover comparison of aqueous seed extract and placebo in children continuing antiseizure medication. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Original methods, sequence-allocation tables and baseline tables This records needed materials; no new research was executed."
    },
    {
      "item_id": "N11",
      "question_type": "Evidence condition",
      "question": "Was masking maintained for parents and assessors?",
      "needed": "Masking of parents, participants, administrators and assessors, and unmasking",
      "role": "Required",
      "role_reason": "Material on Masking of parents, participants, administrators and assessors, and unmasking is needed to connect the pediatric population to formulation, dose, background treatment, placebo, seizure recording, crossover periods and sequences, denominators, intervals or harms.",
      "application_exception": "The records of 23 enrolled participants and 20 completers are not converted into randomized, period-specific analysis or safety denominators, and no new dropout count is calculated. Crossover periods are not pooled as independent trials or new participants, and an overall test is not converted into an effect between treatment periods.",
      "criterion": "Original records on Masking of parents, participants, administrators and assessors, and unmasking must link to the relevant report, crossover design, concomitant medication, measurement, timing and denominator, distinguishing recorded information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, population, background antiseizure medication, placebo, seizure recording, crossover periods and sequences, denominators, effect intervals, support and harms for adjunctive aqueous seed extract in children.",
      "condition_origin": "These existing conditions are linked to the crossover comparison of aqueous seed extract and placebo in children continuing antiseizure medication. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Records of masking targets, procedures and unmasking This records needed materials; no new research was executed."
    },
    {
      "item_id": "N12",
      "question_type": "Evidence condition",
      "question": "How was observation time divided?",
      "needed": "The 4-week intervention periods, 2-week washout and period-specific measurement schedules",
      "role": "Required",
      "role_reason": "Material on The 4-week intervention periods, 2-week washout and period-specific measurement schedules is needed to connect the pediatric population to formulation, dose, background treatment, placebo, seizure recording, crossover periods and sequences, denominators, intervals or harms.",
      "application_exception": "The records of 23 enrolled participants and 20 completers are not converted into randomized, period-specific analysis or safety denominators, and no new dropout count is calculated. Crossover periods are not pooled as independent trials or new participants, and an overall test is not converted into an effect between treatment periods.",
      "criterion": "Original records on The 4-week intervention periods, 2-week washout and period-specific measurement schedules must link to the relevant report, crossover design, concomitant medication, measurement, timing and denominator, distinguishing recorded information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, population, background antiseizure medication, placebo, seizure recording, crossover periods and sequences, denominators, effect intervals, support and harms for adjunctive aqueous seed extract in children.",
      "condition_origin": "These existing conditions are linked to the crossover comparison of aqueous seed extract and placebo in children continuing antiseizure medication. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Schedules, period-specific diaries and washout records This records needed materials; no new research was executed."
    },
    {
      "item_id": "N13",
      "question_type": "Evidence condition",
      "question": "Were carryover, period and sequence effects addressed?",
      "needed": "Prospective assumptions and analyses for carryover, period and sequence",
      "role": "Required",
      "role_reason": "Material on Prospective assumptions and analyses for carryover, period and sequence is needed to connect the pediatric population to formulation, dose, background treatment, placebo, seizure recording, crossover periods and sequences, denominators, intervals or harms.",
      "application_exception": "The records of 23 enrolled participants and 20 completers are not converted into randomized, period-specific analysis or safety denominators, and no new dropout count is calculated. Crossover periods are not pooled as independent trials or new participants, and an overall test is not converted into an effect between treatment periods.",
      "criterion": "Original records on Prospective assumptions and analyses for carryover, period and sequence must link to the relevant report, crossover design, concomitant medication, measurement, timing and denominator, distinguishing recorded information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, population, background antiseizure medication, placebo, seizure recording, crossover periods and sequences, denominators, effect intervals, support and harms for adjunctive aqueous seed extract in children.",
      "condition_origin": "These existing conditions are linked to the crossover comparison of aqueous seed extract and placebo in children continuing antiseizure medication. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Crossover analysis methods, period/sequence results and sensitivity analyses This records needed materials; no new research was executed."
    },
    {
      "item_id": "N14",
      "question_type": "Evidence condition",
      "question": "How were seizures measured?",
      "needed": "Parent recording, daily units, seizure identification and diary completeness",
      "role": "Required",
      "role_reason": "Material on Parent recording, daily units, seizure identification and diary completeness is needed to connect the pediatric population to formulation, dose, background treatment, placebo, seizure recording, crossover periods and sequences, denominators, intervals or harms.",
      "application_exception": "The records of 23 enrolled participants and 20 completers are not converted into randomized, period-specific analysis or safety denominators, and no new dropout count is calculated. Crossover periods are not pooled as independent trials or new participants, and an overall test is not converted into an effect between treatment periods.",
      "criterion": "Original records on Parent recording, daily units, seizure identification and diary completeness must link to the relevant report, crossover design, concomitant medication, measurement, timing and denominator, distinguishing recorded information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, population, background antiseizure medication, placebo, seizure recording, crossover periods and sequences, denominators, effect intervals, support and harms for adjunctive aqueous seed extract in children.",
      "condition_origin": "These existing conditions are linked to the crossover comparison of aqueous seed extract and placebo in children continuing antiseizure medication. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Diary forms, seizure-identification rules and measurement methods This records needed materials; no new research was executed."
    },
    {
      "item_id": "N15",
      "question_type": "Evidence condition",
      "question": "What was the prospective endpoint hierarchy for seizure counts?",
      "needed": "Primary/secondary endpoints, time points and analyses in registration, protocol and SAP",
      "role": "Required",
      "role_reason": "Material on Primary/secondary endpoints, time points and analyses in registration, protocol and SAP is needed to connect the pediatric population to formulation, dose, background treatment, placebo, seizure recording, crossover periods and sequences, denominators, intervals or harms.",
      "application_exception": "The records of 23 enrolled participants and 20 completers are not converted into randomized, period-specific analysis or safety denominators, and no new dropout count is calculated. Crossover periods are not pooled as independent trials or new participants, and an overall test is not converted into an effect between treatment periods.",
      "criterion": "Original records on Primary/secondary endpoints, time points and analyses in registration, protocol and SAP must link to the relevant report, crossover design, concomitant medication, measurement, timing and denominator, distinguishing recorded information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, population, background antiseizure medication, placebo, seizure recording, crossover periods and sequences, denominators, effect intervals, support and harms for adjunctive aqueous seed extract in children.",
      "condition_origin": "These existing conditions are linked to the crossover comparison of aqueous seed extract and placebo in children continuing antiseizure medication. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Registration histories, protocol and SAP This records needed materials; no new research was executed."
    },
    {
      "item_id": "N16",
      "question_type": "Evidence condition",
      "question": "What are the enrollment, completion and period-specific analysis denominators?",
      "needed": "The 23 enrolled participants, 20 completers and analysis denominators by period/endpoint",
      "role": "Required",
      "role_reason": "Material on The 23 enrolled participants, 20 completers and analysis denominators by period/endpoint is needed to connect the pediatric population to formulation, dose, background treatment, placebo, seizure recording, crossover periods and sequences, denominators, intervals or harms.",
      "application_exception": "The records of 23 enrolled participants and 20 completers are not converted into randomized, period-specific analysis or safety denominators, and no new dropout count is calculated. Crossover periods are not pooled as independent trials or new participants, and an overall test is not converted into an effect between treatment periods.",
      "criterion": "Original records on The 23 enrolled participants, 20 completers and analysis denominators by period/endpoint must link to the relevant report, crossover design, concomitant medication, measurement, timing and denominator, distinguishing recorded information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, population, background antiseizure medication, placebo, seizure recording, crossover periods and sequences, denominators, effect intervals, support and harms for adjunctive aqueous seed extract in children.",
      "condition_origin": "These existing conditions are linked to the crossover comparison of aqueous seed extract and placebo in children continuing antiseizure medication. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Participant flow and period-/endpoint-specific analysis tables This records needed materials; no new research was executed."
    },
    {
      "item_id": "N17",
      "question_type": "Evidence condition",
      "question": "How were noncompletion and missing records handled?",
      "needed": "Reasons for discontinuation, sequence/period, missing-data handling and analysis sets",
      "role": "Required",
      "role_reason": "Material on Reasons for discontinuation, sequence/period, missing-data handling and analysis sets is needed to connect the pediatric population to formulation, dose, background treatment, placebo, seizure recording, crossover periods and sequences, denominators, intervals or harms.",
      "application_exception": "The records of 23 enrolled participants and 20 completers are not converted into randomized, period-specific analysis or safety denominators, and no new dropout count is calculated. Crossover periods are not pooled as independent trials or new participants, and an overall test is not converted into an effect between treatment periods.",
      "criterion": "Original records on Reasons for discontinuation, sequence/period, missing-data handling and analysis sets must link to the relevant report, crossover design, concomitant medication, measurement, timing and denominator, distinguishing recorded information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, population, background antiseizure medication, placebo, seizure recording, crossover periods and sequences, denominators, effect intervals, support and harms for adjunctive aqueous seed extract in children.",
      "condition_origin": "These existing conditions are linked to the crossover comparison of aqueous seed extract and placebo in children continuing antiseizure medication. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Discontinuation reasons, missing-data/analysis-set records and sensitivity analyses This records needed materials; no new research was executed."
    },
    {
      "item_id": "N18",
      "question_type": "Evidence condition",
      "question": "Which results do the retained mean seizure counts represent?",
      "needed": "Baseline, extract and placebo daily seizure counts, corresponding dispersion and denominators",
      "role": "Required",
      "role_reason": "Material on Baseline, extract and placebo daily seizure counts, corresponding dispersion and denominators is needed to connect the pediatric population to formulation, dose, background treatment, placebo, seizure recording, crossover periods and sequences, denominators, intervals or harms.",
      "application_exception": "The records of 23 enrolled participants and 20 completers are not converted into randomized, period-specific analysis or safety denominators, and no new dropout count is calculated. Crossover periods are not pooled as independent trials or new participants, and an overall test is not converted into an effect between treatment periods.",
      "criterion": "Original records on Baseline, extract and placebo daily seizure counts, corresponding dispersion and denominators must link to the relevant report, crossover design, concomitant medication, measurement, timing and denominator, distinguishing recorded information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, population, background antiseizure medication, placebo, seizure recording, crossover periods and sequences, denominators, effect intervals, support and harms for adjunctive aqueous seed extract in children.",
      "condition_origin": "These existing conditions are linked to the crossover comparison of aqueous seed extract and placebo in children continuing antiseizure medication. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Period-specific result tables, dispersion definitions and paired analyses This records needed materials; no new research was executed."
    },
    {
      "item_id": "N19",
      "question_type": "Evidence condition",
      "question": "What question does the overall Friedman test answer?",
      "needed": "Distinguish the overall test from the selected between-treatment-period contrast",
      "role": "Required",
      "role_reason": "Material on Distinguish the overall test from the selected between-treatment-period contrast is needed to connect the pediatric population to formulation, dose, background treatment, placebo, seizure recording, crossover periods and sequences, denominators, intervals or harms.",
      "application_exception": "The records of 23 enrolled participants and 20 completers are not converted into randomized, period-specific analysis or safety denominators, and no new dropout count is calculated. Crossover periods are not pooled as independent trials or new participants, and an overall test is not converted into an effect between treatment periods.",
      "criterion": "Original records on Distinguish the overall test from the selected between-treatment-period contrast must link to the relevant report, crossover design, concomitant medication, measurement, timing and denominator, distinguishing recorded information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, population, background antiseizure medication, placebo, seizure recording, crossover periods and sequences, denominators, effect intervals, support and harms for adjunctive aqueous seed extract in children.",
      "condition_origin": "These existing conditions are linked to the crossover comparison of aqueous seed extract and placebo in children continuing antiseizure medication. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Statistical methods, prospective contrasts and result tables This records needed materials; no new research was executed."
    },
    {
      "item_id": "N20",
      "question_type": "Evidence condition",
      "question": "What does 65% versus 20% improvement mean?",
      "needed": "Improvement/responder criteria, participant counts, periods/sequences and denominators",
      "role": "Required",
      "role_reason": "Material on Improvement/responder criteria, participant counts, periods/sequences and denominators is needed to connect the pediatric population to formulation, dose, background treatment, placebo, seizure recording, crossover periods and sequences, denominators, intervals or harms.",
      "application_exception": "The records of 23 enrolled participants and 20 completers are not converted into randomized, period-specific analysis or safety denominators, and no new dropout count is calculated. Crossover periods are not pooled as independent trials or new participants, and an overall test is not converted into an effect between treatment periods.",
      "criterion": "Original records on Improvement/responder criteria, participant counts, periods/sequences and denominators must link to the relevant report, crossover design, concomitant medication, measurement, timing and denominator, distinguishing recorded information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, population, background antiseizure medication, placebo, seizure recording, crossover periods and sequences, denominators, effect intervals, support and harms for adjunctive aqueous seed extract in children.",
      "condition_origin": "These existing conditions are linked to the crossover comparison of aqueous seed extract and placebo in children continuing antiseizure medication. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Responder definitions, period-specific participant counts/denominators and intervals This records needed materials; no new research was executed."
    },
    {
      "item_id": "N21",
      "question_type": "Evidence condition",
      "question": "What are the exact effect magnitude and interval?",
      "needed": "Effect size, CI and important difference for the prospective treatment contrast",
      "role": "Required",
      "role_reason": "Material on Effect size, CI and important difference for the prospective treatment contrast is needed to connect the pediatric population to formulation, dose, background treatment, placebo, seizure recording, crossover periods and sequences, denominators, intervals or harms.",
      "application_exception": "The records of 23 enrolled participants and 20 completers are not converted into randomized, period-specific analysis or safety denominators, and no new dropout count is calculated. Crossover periods are not pooled as independent trials or new participants, and an overall test is not converted into an effect between treatment periods.",
      "criterion": "Original records on Effect size, CI and important difference for the prospective treatment contrast must link to the relevant report, crossover design, concomitant medication, measurement, timing and denominator, distinguishing recorded information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, population, background antiseizure medication, placebo, seizure recording, crossover periods and sequences, denominators, effect intervals, support and harms for adjunctive aqueous seed extract in children.",
      "condition_origin": "These existing conditions are linked to the crossover comparison of aqueous seed extract and placebo in children continuing antiseizure medication. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Treatment contrasts, dispersion, CIs and evidence for an important difference This records needed materials; no new research was executed."
    },
    {
      "item_id": "N22",
      "question_type": "Evidence condition",
      "question": "How were tests across periods, seizures and responders planned?",
      "needed": "Prospective planning for seizure-count/responder, time-point and subgroup tests",
      "role": "Required",
      "role_reason": "Material on Prospective planning for seizure-count/responder, time-point and subgroup tests is needed to connect the pediatric population to formulation, dose, background treatment, placebo, seizure recording, crossover periods and sequences, denominators, intervals or harms.",
      "application_exception": "The records of 23 enrolled participants and 20 completers are not converted into randomized, period-specific analysis or safety denominators, and no new dropout count is calculated. Crossover periods are not pooled as independent trials or new participants, and an overall test is not converted into an effect between treatment periods.",
      "criterion": "Original records on Prospective planning for seizure-count/responder, time-point and subgroup tests must link to the relevant report, crossover design, concomitant medication, measurement, timing and denominator, distinguishing recorded information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, population, background antiseizure medication, placebo, seizure recording, crossover periods and sequences, denominators, effect intervals, support and harms for adjunctive aqueous seed extract in children.",
      "condition_origin": "These existing conditions are linked to the crossover comparison of aqueous seed extract and placebo in children continuing antiseizure medication. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Registration, SAP and complete endpoint tables This records needed materials; no new research was executed."
    },
    {
      "item_id": "N23",
      "question_type": "Evidence condition",
      "question": "Could adherence and rescue treatment affect the results?",
      "needed": "Extract/placebo adherence, missed doses, medication changes and emergency treatment",
      "role": "Required",
      "role_reason": "Material on Extract/placebo adherence, missed doses, medication changes and emergency treatment is needed to connect the pediatric population to formulation, dose, background treatment, placebo, seizure recording, crossover periods and sequences, denominators, intervals or harms.",
      "application_exception": "The records of 23 enrolled participants and 20 completers are not converted into randomized, period-specific analysis or safety denominators, and no new dropout count is calculated. Crossover periods are not pooled as independent trials or new participants, and an overall test is not converted into an effect between treatment periods.",
      "criterion": "Original records on Extract/placebo adherence, missed doses, medication changes and emergency treatment must link to the relevant report, crossover design, concomitant medication, measurement, timing and denominator, distinguishing recorded information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, population, background antiseizure medication, placebo, seizure recording, crossover periods and sequences, denominators, effect intervals, support and harms for adjunctive aqueous seed extract in children.",
      "condition_origin": "These existing conditions are linked to the crossover comparison of aqueous seed extract and placebo in children continuing antiseizure medication. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Administration/rescue-treatment records and prospective handling rules This records needed materials; no new research was executed."
    },
    {
      "item_id": "N24",
      "question_type": "Evidence condition",
      "question": "What is known about independent repetition or other formulations?",
      "needed": "Unique trial relationships for the same aqueous extract, pediatric population, comparison and duration",
      "role": "Required",
      "role_reason": "Material on Unique trial relationships for the same aqueous extract, pediatric population, comparison and duration is needed to connect the pediatric population to formulation, dose, background treatment, placebo, seizure recording, crossover periods and sequences, denominators, intervals or harms.",
      "application_exception": "The records of 23 enrolled participants and 20 completers are not converted into randomized, period-specific analysis or safety denominators, and no new dropout count is calculated. Crossover periods are not pooled as independent trials or new participants, and an overall test is not converted into an effect between treatment periods.",
      "criterion": "Original records on Unique trial relationships for the same aqueous extract, pediatric population, comparison and duration must link to the relevant report, crossover design, concomitant medication, measurement, timing and denominator, distinguishing recorded information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, population, background antiseizure medication, placebo, seizure recording, crossover periods and sequences, denominators, effect intervals, support and harms for adjunctive aqueous seed extract in children.",
      "condition_origin": "These existing conditions are linked to the crossover comparison of aqueous seed extract and placebo in children continuing antiseizure medication. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Direct studies of the same formulation/population and related report lists This records needed materials; no new research was executed."
    },
    {
      "item_id": "N25",
      "question_type": "Evidence condition",
      "question": "Does the short signal answer long-term seizure-control questions?",
      "needed": "Long-term persistence, effects after discontinuation, follow-up and dose questions",
      "role": "Required",
      "role_reason": "Material on Long-term persistence, effects after discontinuation, follow-up and dose questions is needed to connect the pediatric population to formulation, dose, background treatment, placebo, seizure recording, crossover periods and sequences, denominators, intervals or harms.",
      "application_exception": "The records of 23 enrolled participants and 20 completers are not converted into randomized, period-specific analysis or safety denominators, and no new dropout count is calculated. Crossover periods are not pooled as independent trials or new participants, and an overall test is not converted into an effect between treatment periods.",
      "criterion": "Original records on Long-term persistence, effects after discontinuation, follow-up and dose questions must link to the relevant report, crossover design, concomitant medication, measurement, timing and denominator, distinguishing recorded information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, population, background antiseizure medication, placebo, seizure recording, crossover periods and sequences, denominators, effect intervals, support and harms for adjunctive aqueous seed extract in children.",
      "condition_origin": "These existing conditions are linked to the crossover comparison of aqueous seed extract and placebo in children continuing antiseizure medication. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Long-term follow-up, post-discontinuation records and direct dose material This records needed materials; no new research was executed."
    },
    {
      "item_id": "N26",
      "question_type": "Evidence condition",
      "question": "Can the finding extend to outcomes beyond seizure frequency?",
      "needed": "Separate evidence for durable remission, medication withdrawal, development/quality of life and severe events",
      "role": "Required",
      "role_reason": "Material on Separate evidence for durable remission, medication withdrawal, development/quality of life and severe events is needed to connect the pediatric population to formulation, dose, background treatment, placebo, seizure recording, crossover periods and sequences, denominators, intervals or harms.",
      "application_exception": "The records of 23 enrolled participants and 20 completers are not converted into randomized, period-specific analysis or safety denominators, and no new dropout count is calculated. Crossover periods are not pooled as independent trials or new participants, and an overall test is not converted into an effect between treatment periods.",
      "criterion": "Original records on Separate evidence for durable remission, medication withdrawal, development/quality of life and severe events must link to the relevant report, crossover design, concomitant medication, measurement, timing and denominator, distinguishing recorded information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, population, background antiseizure medication, placebo, seizure recording, crossover periods and sequences, denominators, effect intervals, support and harms for adjunctive aqueous seed extract in children.",
      "condition_origin": "These existing conditions are linked to the crossover comparison of aqueous seed extract and placebo in children continuing antiseizure medication. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Direct measurements, durations and denominators for separate clinical outcomes This records needed materials; no new research was executed."
    },
    {
      "item_id": "N27",
      "question_type": "Evidence condition",
      "question": "What was reported about research funding?",
      "needed": "Funding sources, support amounts and roles",
      "role": "Required",
      "role_reason": "Material on Funding sources, support amounts and roles is needed to connect the pediatric population to formulation, dose, background treatment, placebo, seizure recording, crossover periods and sequences, denominators, intervals or harms.",
      "application_exception": "The records of 23 enrolled participants and 20 completers are not converted into randomized, period-specific analysis or safety denominators, and no new dropout count is calculated. Crossover periods are not pooled as independent trials or new participants, and an overall test is not converted into an effect between treatment periods.",
      "criterion": "Original records on Funding sources, support amounts and roles must link to the relevant report, crossover design, concomitant medication, measurement, timing and denominator, distinguishing recorded information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, population, background antiseizure medication, placebo, seizure recording, crossover periods and sequences, denominators, effect intervals, support and harms for adjunctive aqueous seed extract in children.",
      "condition_origin": "These existing conditions are linked to the crossover comparison of aqueous seed extract and placebo in children continuing antiseizure medication. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Funding sources, sponsor roles and support specifications This records needed materials; no new research was executed."
    },
    {
      "item_id": "N28",
      "question_type": "Evidence condition",
      "question": "Are product provision, employee authorship and COI distinguished?",
      "needed": "Separate original records of product/free support, employment, patents and COI",
      "role": "Required",
      "role_reason": "Material on Separate original records of product/free support, employment, patents and COI is needed to connect the pediatric population to formulation, dose, background treatment, placebo, seizure recording, crossover periods and sequences, denominators, intervals or harms.",
      "application_exception": "The records of 23 enrolled participants and 20 completers are not converted into randomized, period-specific analysis or safety denominators, and no new dropout count is calculated. Crossover periods are not pooled as independent trials or new participants, and an overall test is not converted into an effect between treatment periods.",
      "criterion": "Original records on Separate original records of product/free support, employment, patents and COI must link to the relevant report, crossover design, concomitant medication, measurement, timing and denominator, distinguishing recorded information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, population, background antiseizure medication, placebo, seizure recording, crossover periods and sequences, denominators, effect intervals, support and harms for adjunctive aqueous seed extract in children.",
      "condition_origin": "These existing conditions are linked to the crossover comparison of aqueous seed extract and placebo in children continuing antiseizure medication. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Original disclosures of product provision, employment, patents and COI This records needed materials; no new research was executed."
    },
    {
      "item_id": "N29",
      "question_type": "Evidence condition",
      "question": "How were harms collected during the same pediatric exposure?",
      "needed": "Adverse-event definitions, collection, discontinuation, people/events and period-specific denominators",
      "role": "Supplementary",
      "role_reason": "Material on Adverse-event definitions, collection, discontinuation, people/events and period-specific denominators is needed to connect the pediatric population to formulation, dose, background treatment, placebo, seizure recording, crossover periods and sequences, denominators, intervals or harms.",
      "application_exception": "The records of 23 enrolled participants and 20 completers are not converted into randomized, period-specific analysis or safety denominators, and no new dropout count is calculated. Crossover periods are not pooled as independent trials or new participants, and an overall test is not converted into an effect between treatment periods.",
      "criterion": "Original records on Adverse-event definitions, collection, discontinuation, people/events and period-specific denominators must link to the relevant report, crossover design, concomitant medication, measurement, timing and denominator, distinguishing recorded information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, population, background antiseizure medication, placebo, seizure recording, crossover periods and sequences, denominators, effect intervals, support and harms for adjunctive aqueous seed extract in children.",
      "condition_origin": "These existing conditions are linked to the crossover comparison of aqueous seed extract and placebo in children continuing antiseizure medication. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Period-specific adverse events, discontinuation and collection methods This records needed materials; no new research was executed."
    },
    {
      "item_id": "N30",
      "question_type": "Evidence condition",
      "question": "What are the timing, concomitant-drug and attribution limits for harms?",
      "needed": "Period-specific occurrence, discontinuation/recovery, background drugs, baseline seizures and alternative explanations",
      "role": "Supplementary",
      "role_reason": "Material on Period-specific occurrence, discontinuation/recovery, background drugs, baseline seizures and alternative explanations is needed to connect the pediatric population to formulation, dose, background treatment, placebo, seizure recording, crossover periods and sequences, denominators, intervals or harms.",
      "application_exception": "The records of 23 enrolled participants and 20 completers are not converted into randomized, period-specific analysis or safety denominators, and no new dropout count is calculated. Crossover periods are not pooled as independent trials or new participants, and an overall test is not converted into an effect between treatment periods.",
      "criterion": "Original records on Period-specific occurrence, discontinuation/recovery, background drugs, baseline seizures and alternative explanations must link to the relevant report, crossover design, concomitant medication, measurement, timing and denominator, distinguishing recorded information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, population, background antiseizure medication, placebo, seizure recording, crossover periods and sequences, denominators, effect intervals, support and harms for adjunctive aqueous seed extract in children.",
      "condition_origin": "These existing conditions are linked to the crossover comparison of aqueous seed extract and placebo in children continuing antiseizure medication. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Original concomitant-drug, timeline, discontinuation/recovery and alternative-explanation records This records needed materials; no new research was executed."
    },
    {
      "item_id": "N31",
      "question_type": "Evidence condition",
      "question": "What is known about long-term/rare harms and other vulnerable groups?",
      "needed": "Direct safety material for long-term exposure, rare events and special populations",
      "role": "Supplementary",
      "role_reason": "Material on Direct safety material for long-term exposure, rare events and special populations is needed to connect the pediatric population to formulation, dose, background treatment, placebo, seizure recording, crossover periods and sequences, denominators, intervals or harms.",
      "application_exception": "The records of 23 enrolled participants and 20 completers are not converted into randomized, period-specific analysis or safety denominators, and no new dropout count is calculated. Crossover periods are not pooled as independent trials or new participants, and an overall test is not converted into an effect between treatment periods.",
      "criterion": "Original records on Direct safety material for long-term exposure, rare events and special populations must link to the relevant report, crossover design, concomitant medication, measurement, timing and denominator, distinguishing recorded information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, population, background antiseizure medication, placebo, seizure recording, crossover periods and sequences, denominators, effect intervals, support and harms for adjunctive aqueous seed extract in children.",
      "condition_origin": "These existing conditions are linked to the crossover comparison of aqueous seed extract and placebo in children continuing antiseizure medication. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Long-term safety material and population-specific exposure/event records This records needed materials; no new research was executed."
    },
    {
      "item_id": "N32",
      "question_type": "Evidence condition",
      "question": "What do the original grade, axes and historical independent cross-check mean?",
      "needed": "Retain the original C54, axes, inactive/empty records and verdict history",
      "role": "Required",
      "role_reason": "Material on Retain the original C54, axes, inactive/empty records and verdict history is needed to connect the pediatric population to formulation, dose, background treatment, placebo, seizure recording, crossover periods and sequences, denominators, intervals or harms.",
      "application_exception": "The records of 23 enrolled participants and 20 completers are not converted into randomized, period-specific analysis or safety denominators, and no new dropout count is calculated. Crossover periods are not pooled as independent trials or new participants, and an overall test is not converted into an effect between treatment periods.",
      "criterion": "Original records on Retain the original C54, axes, inactive/empty records and verdict history must link to the relevant report, crossover design, concomitant medication, measurement, timing and denominator, distinguishing recorded information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, population, background antiseizure medication, placebo, seizure recording, crossover periods and sequences, denominators, effect intervals, support and harms for adjunctive aqueous seed extract in children.",
      "condition_origin": "These existing conditions are linked to the crossover comparison of aqueous seed extract and placebo in children continuing antiseizure medication. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Clear histories of the original verdict and change events This records needed materials; no new research was executed."
    },
    {
      "item_id": "N33",
      "question_type": "Evidence condition",
      "question": "What do current English wording, corrections and dates mean?",
      "needed": "Distinguish Korean/English text, the original evidence date, correction events and current preparation date",
      "role": "Required",
      "role_reason": "Material on Distinguish Korean/English text, the original evidence date, correction events and current preparation date is needed to connect the pediatric population to formulation, dose, background treatment, placebo, seizure recording, crossover periods and sequences, denominators, intervals or harms.",
      "application_exception": "The records of 23 enrolled participants and 20 completers are not converted into randomized, period-specific analysis or safety denominators, and no new dropout count is calculated. Crossover periods are not pooled as independent trials or new participants, and an overall test is not converted into an effect between treatment periods.",
      "criterion": "Original records on Distinguish Korean/English text, the original evidence date, correction events and current preparation date must link to the relevant report, crossover design, concomitant medication, measurement, timing and denominator, distinguishing recorded information from what remains unverified.",
      "basis": "Existing principles distinguish formulation, population, background antiseizure medication, placebo, seizure recording, crossover periods and sequences, denominators, effect intervals, support and harms for adjunctive aqueous seed extract in children.",
      "condition_origin": "These existing conditions are linked to the crossover comparison of aqueous seed extract and placebo in children continuing antiseizure medication. They explain stored summaries and material gaps without establishing new preregistration, official assessment or independent clinical validation.",
      "proposed_research": "Material needed: Before/after correction material, subsequent original material and user comments This records needed materials; no new research was executed."
    }
  ]
}