{
  "schema_version": "chamgap-public-evidence-check-1.0",
  "public_id": "v2927-s0",
  "verdict_number": "2927",
  "title": "Adjunctive intravenous immunoglobulin × death or major disability at age 2 in neonates — composite outcome evidence sheet",
  "view_version": "1.0",
  "view_created_date": "2026-10-10",
  "criteria_version": "1.0",
  "criteria_date": "2026-10-06",
  "review_date": null,
  "legacy_evidence_date": "2026-08-26",
  "review_scope": {
    "materials_read": "Existing review summaries and stored records of methodological application",
    "clinical_papers_directly_read": false,
    "new_clinical_search": false,
    "limitation": "The complete stored review summary was read for production and the original URLs and identifiers were linked. External abstracts, full texts, registrations, protocols, SAPs and linked verdicts were not newly read or checked.",
    "date_meaning": "This is the date the stored materials were checked, not the date of a new search of the clinical literature."
  },
  "claim_context": {
    "population": "INIS neonates receiving antibiotics for suspected or confirmed sepsis; original eligibility and baseline details not read",
    "intervention": "Historical adjunctive exposure to IVIG added to antibiotics; no recommendation to select or use it",
    "dose": "The original 500mg/kg given twice 48 hours apart is preserved only as historical information; no individual administration, dosing or procedural guidance is created",
    "comparator": "Placebo and antibiotics common to both groups; product and actual concomitant treatment or exposure details not read",
    "endpoint": "Death or major disability at age 2 as a composite; distinguish its components, survivor assessment and deaths included in adverse events",
    "duration": "Composite assessment at age 2; age definition, follow-up and missing-data details not read; distinguish treatment exposure from follow-up",
    "excluded_extensions": [
      "Adding individual or composite events as new units, independent trials or participants",
      "Certifying a null result, confidence interval or nonreporting as an exact zero effect or absence of all harms",
      "Combining BBG-001 prevention with adjunctive IVIG treatment after infection",
      "Transferring effects to other strains, products, durations or populations",
      "Recommendations on neonatal product selection, use, suitability, administration or treatment"
    ]
  },
  "requirements": [
    {
      "item_id": "N01",
      "question_type": "Comparative efficacy",
      "question": "Have the original subclaim verdict and the parent values and context been distinguished?",
      "needed": "Separate preservation of the selected claim, grade and note and the parent grade, score and assessment axes",
      "role": "Required",
      "role_reason": "Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries",
      "application_exception": "Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.",
      "criterion": "Separate preservation of the selected claim, grade and note and the parent grade, score and assessment axes",
      "basis": "Reduction in death or major disability",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Link additional materials separately to the selected question and the parent context.",
      "current_reports": [
        "R01"
      ],
      "existence": "Material information recorded in the stored review summary",
      "acquired_read": "Summary read; external or linked material unread",
      "observation": "The selected verdict concerns 'reduction in death or major disability', with subclaim grade D and the note 'RR was 1.00.'; the parent is D34 with Caution.",
      "condition_status": "Partly verified",
      "status_reason": "Only the relevant information in the stored summary is recorded; detailed original materials and user review remain outstanding. Do not fill absent subclaim score, status or axes with parent values. There is no new grade, effect verdict or certification of independence.",
      "missingness": "Do not fill absent subclaim score, status or axes with parent values. There is no new grade, effect verdict or certification of independence.",
      "uncertainty": "Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Do not fill absent subclaim score, status or axes with parent values. There is no new grade, effect verdict or certification of independence."
    },
    {
      "item_id": "N02",
      "question_type": "Comparative efficacy",
      "question": "Who was the original population receiving antibiotics for suspected or confirmed sepsis?",
      "needed": "Original sepsis definition, eligibility, baseline, entry timing and denominators",
      "role": "Required",
      "role_reason": "Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries",
      "application_exception": "Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.",
      "criterion": "Original sepsis definition, eligibility, baseline, entry timing and denominators",
      "basis": "Reduction in death or major disability",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Obtain original population, diagnosis, eligibility, baseline and entry-timing materials.",
      "current_reports": [
        "R01"
      ],
      "existence": "Material information recorded in the stored review summary",
      "acquired_read": "Summary read; external or linked material unread",
      "observation": "INIS asks about adjunctive IVIG in neonates already receiving antibiotics for suspected or confirmed sepsis.",
      "condition_status": "Partly verified",
      "status_reason": "Only the relevant information in the stored summary is recorded; detailed original materials and user review remain outstanding. Do not combine this with trials of prevention before infection in extremely preterm infants. Original gestational age, birth weight, diagnostic or testing criteria and detailed eligibility have not been read.",
      "missingness": "Do not combine this with trials of prevention before infection in extremely preterm infants. Original gestational age, birth weight, diagnostic or testing criteria and detailed eligibility have not been read.",
      "uncertainty": "Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Do not combine this with trials of prevention before infection in extremely preterm infants. Original gestational age, birth weight, diagnostic or testing criteria and detailed eligibility have not been read."
    },
    {
      "item_id": "N03",
      "question_type": "Comparative efficacy",
      "question": "What was the actual comparison of added IVIG versus placebo with antibiotics common to both groups?",
      "needed": "Original IVIG identity, placebo, common antibiotics, concomitant treatment and actual exposure",
      "role": "Required",
      "role_reason": "Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries",
      "application_exception": "Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.",
      "criterion": "Original IVIG identity, placebo, common antibiotics, concomitant treatment and actual exposure",
      "basis": "Reduction in death or major disability",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Obtain original product, placebo, common treatment, concomitant treatment and changes.",
      "current_reports": [
        "R01"
      ],
      "existence": "Material information recorded in the stored review summary",
      "acquired_read": "Summary read; external or linked material unread",
      "observation": "All infants received antibiotics, and the international double-blind RCT compared added IVIG with placebo.",
      "condition_status": "Partly verified",
      "status_reason": "Only the relevant information in the stored summary is recorded; detailed original materials and user review remain outstanding. Do not turn this into IVIG alone, replacement of antibiotics or selection of a particular product. Placebo ingredients, the IVIG product and details of common antibiotics or treatment have not been read.",
      "missingness": "Do not turn this into IVIG alone, replacement of antibiotics or selection of a particular product. Placebo ingredients, the IVIG product and details of common antibiotics or treatment have not been read.",
      "uncertainty": "Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Do not turn this into IVIG alone, replacement of antibiotics or selection of a particular product. Placebo ingredients, the IVIG product and details of common antibiotics or treatment have not been read."
    },
    {
      "item_id": "N04",
      "question_type": "Comparative efficacy",
      "question": "Have the original administration exposure, actual completion and safety denominators been separated?",
      "needed": "Original study plan, actual administration, omissions, exposure and denominators",
      "role": "Required",
      "role_reason": "Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries",
      "application_exception": "Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.",
      "criterion": "Original study plan, actual administration, omissions, exposure and denominators",
      "basis": "Reduction in death or major disability",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Obtain original tables of planned and actual administration, omissions, discontinuation and exposure.",
      "current_reports": [
        "R01"
      ],
      "existence": "Material information recorded in the stored review summary",
      "acquired_read": "Summary read; external or linked material unread",
      "observation": "The historical regimen in the review summary is IVIG 500mg/kg given twice, 48 hours apart.",
      "condition_status": "Partly verified",
      "status_reason": "Only the relevant information in the stored summary is recorded; detailed original materials and user review remain outstanding. Do not create individual administration, dosing, infusion or suitability guidance. Detailed actual completion, placebo exposure, discontinuation and safety denominators have not been read.",
      "missingness": "Do not create individual administration, dosing, infusion or suitability guidance. Detailed actual completion, placebo exposure, discontinuation and safety denominators have not been read.",
      "uncertainty": "Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Do not create individual administration, dosing, infusion or suitability guidance. Detailed actual completion, placebo exposure, discontinuation and safety denominators have not been read."
    },
    {
      "item_id": "N05",
      "question_type": "Comparative efficacy",
      "question": "Have the 113 hospitals, 3,493 participants and analysis by assigned group been preserved?",
      "needed": "Original allocation, group denominators, analysis population, sites and missing data",
      "role": "Required",
      "role_reason": "Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries",
      "application_exception": "Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.",
      "criterion": "Original allocation, group denominators, analysis population, sites and missing data",
      "basis": "Reduction in death or major disability",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Obtain original participant flow, analysis population, group denominators, follow-up and missing-data handling.",
      "current_reports": [
        "R01"
      ],
      "existence": "Material information recorded in the stored review summary",
      "acquired_read": "Summary read; external or linked material unread",
      "observation": "The stored review summary states that 3,493 participants at 113 hospitals were randomized and analyzed by assigned group. Composite outcome denominators are 1,759/1,734.",
      "condition_status": "Partly verified",
      "status_reason": "Only the relevant information in the stored summary is recorded; detailed original materials and user review remain outstanding. Do not count multiple sites or denominators as independent trials. Do not invent group follow-up, omissions, imputation or exceptions, or certify completed disability assessment for everyone.",
      "missingness": "Do not count multiple sites or denominators as independent trials. Do not invent group follow-up, omissions, imputation or exceptions, or certify completed disability assessment for everyone.",
      "uncertainty": "Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Do not count multiple sites or denominators as independent trials. Do not invent group follow-up, omissions, imputation or exceptions, or certify completed disability assessment for everyone."
    },
    {
      "item_id": "N06",
      "question_type": "Comparative efficacy",
      "question": "What is the composite definition of death or major disability at age 2?",
      "needed": "Composite events, components, severity criteria, instruments, assessment timing and denominators",
      "role": "Required",
      "role_reason": "Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries",
      "application_exception": "Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.",
      "criterion": "Composite events, components, severity criteria, instruments, assessment timing and denominators",
      "basis": "Reduction in death or major disability",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Obtain the original composite definition, severity criteria, instruments, assessed population, timing and denominators.",
      "current_reports": [
        "R01"
      ],
      "existence": "Material information recorded in the stored review summary",
      "acquired_read": "Summary read; external or linked material unread",
      "observation": "The original endpoint is death or major disability at age 2. Preserve the composite result within one selected question.",
      "condition_status": "Partly verified",
      "status_reason": "Only the relevant information in the stored summary is recorded; detailed original materials and user review remain outstanding. Do not split components into new units or simply add them together. Details are absent on whether age 2 is corrected age, disability scales or criteria, assessors, methods and handling of overlap.",
      "missingness": "Do not split components into new units or simply add them together. Details are absent on whether age 2 is corrected age, disability scales or criteria, assessors, methods and handling of overlap.",
      "uncertainty": "Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Do not split components into new units or simply add them together. Details are absent on whether age 2 is corrected age, disability scales or criteria, assessors, methods and handling of overlap."
    },
    {
      "item_id": "N07",
      "question_type": "Comparative efficacy",
      "question": "Have 686/1759, 677/1734 and the original 39.0% been preserved?",
      "needed": "Original group order, composite events, original denominators, people versus events and proportions",
      "role": "Required",
      "role_reason": "Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries",
      "application_exception": "Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.",
      "criterion": "Original group order, composite events, original denominators, people versus events and proportions",
      "basis": "Reduction in death or major disability",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Obtain original composite event tables, denominators, components, overlap and missing data.",
      "current_reports": [
        "R01"
      ],
      "existence": "Material information recorded in the stored review summary",
      "acquired_read": "Summary read; external or linked material unread",
      "observation": "Death or major disability at age 2 was IVIG 686/1759 (39.0%) versus placebo 677/1734 (39.0%).",
      "condition_status": "Partly verified",
      "status_reason": "Only the relevant information in the stored summary is recorded; detailed original materials and user review remain outstanding. Do not turn equal rounded proportions into equality of every component or exact risks. Do not calculate event or participant totals, new proportions or group differences.",
      "missingness": "Do not turn equal rounded proportions into equality of every component or exact risks. Do not calculate event or participant totals, new proportions or group differences.",
      "uncertainty": "Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Do not turn equal rounded proportions into equality of every component or exact risks. Do not calculate event or participant totals, new proportions or group differences."
    },
    {
      "item_id": "N08",
      "question_type": "Comparative efficacy",
      "question": "Have RR 1.00, 95% CI 0.92~1.08 and the absolute difference of 0.0%p been distinguished?",
      "needed": "Original RR, comparison direction, CI, absolute difference, model and test",
      "role": "Required",
      "role_reason": "Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries",
      "application_exception": "Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.",
      "criterion": "Original RR, comparison direction, CI, absolute difference, model and test",
      "basis": "Reduction in death or major disability",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Obtain the original effect of interest, model, test, denominators and interval.",
      "current_reports": [
        "R01"
      ],
      "existence": "Material information recorded in the stored review summary",
      "acquired_read": "Summary read; external or linked material unread",
      "observation": "The original effect is RR 1.00 (95% CI 0.92~1.08), with an original absolute difference of 0.0%p.",
      "condition_status": "Partly verified",
      "status_reason": "Only the relevant information in the stored summary is recorded; detailed original materials and user review remain outstanding. Do not create a new P value, absolute-difference CI, reverse-direction effect, risk example, NNT or exact equivalence. Model, adjustment and original denominator details have not been read.",
      "missingness": "Do not create a new P value, absolute-difference CI, reverse-direction effect, risk example, NNT or exact equivalence. Model, adjustment and original denominator details have not been read.",
      "uncertainty": "Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Do not create a new P value, absolute-difference CI, reverse-direction effect, risk example, NNT or exact equivalence. Model, adjustment and original denominator details have not been read."
    },
    {
      "item_id": "N09",
      "question_type": "Comparative efficacy",
      "question": "Has a null result been distinguished from the CI tail that leaves a small benefit possible?",
      "needed": "Original interval, clinical importance, uncertainty and margin",
      "role": "Required",
      "role_reason": "Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries",
      "application_exception": "Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.",
      "criterion": "Original interval, clinical importance, uncertainty and margin",
      "basis": "Reduction in death or major disability",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Obtain original clinical boundaries, precision, analysis assumptions and interval.",
      "current_reports": [
        "R01"
      ],
      "existence": "Material information recorded in the stored review summary",
      "acquired_read": "Summary read; external or linked material unread",
      "observation": "The stored summary states that the CI lower bound of 0.92 leaves approximately 8% relative benefit possible, so absence of benefit is not established.",
      "condition_status": "Partly verified",
      "status_reason": "Only the relevant information in the stored summary is recorded; detailed original materials and user review remain outstanding. Preserve this wording as recorded; do not create new calculations, clinical margins, probabilities, an exact zero effect or an equivalence verdict.",
      "missingness": "Preserve this wording as recorded; do not create new calculations, clinical margins, probabilities, an exact zero effect or an equivalence verdict.",
      "uncertainty": "Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Preserve this wording as recorded; do not create new calculations, clinical margins, probabilities, an exact zero effect or an equivalence verdict."
    },
    {
      "item_id": "N10",
      "question_type": "Comparative efficacy",
      "question": "Have the death and major-disability components and survivor assessment been separated?",
      "needed": "Original events by component, people, survivor assessment, denominators and overlap",
      "role": "Required",
      "role_reason": "Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries",
      "application_exception": "Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.",
      "criterion": "Original events by component, people, survivor assessment, denominators and overlap",
      "basis": "Reduction in death or major disability",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Obtain original events by component, survivors to be assessed, denominators, overlap and plans.",
      "current_reports": [
        "R01"
      ],
      "existence": "Material information recorded in the stored review summary",
      "acquired_read": "Summary read; external or linked material unread",
      "observation": "The original materials provide the composite events and original proportions for death or major disability at age 2.",
      "condition_status": "Unverified",
      "status_reason": "Only the relevant information in the stored summary is recorded; detailed original materials and user review remain outstanding. Do not turn the composite effect into separate mortality reduction, disability improvement or assessment of all survivors. Detailed component effects, group denominators, overlap, criteria and tests are absent.",
      "missingness": "Do not turn the composite effect into separate mortality reduction, disability improvement or assessment of all survivors. Detailed component effects, group denominators, overlap, criteria and tests are absent.",
      "uncertainty": "Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Do not turn the composite effect into separate mortality reduction, disability improvement or assessment of all survivors. Detailed component effects, group denominators, overlap, criteria and tests are absent."
    },
    {
      "item_id": "N11",
      "question_type": "Comparative efficacy",
      "question": "What gaps remain in follow-up at age 2, age definition, missing data, loss to follow-up and proxy assessment?",
      "needed": "Assessment age, follow-up, visits, omissions, proxy or direct assessment and handling",
      "role": "Required",
      "role_reason": "Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries",
      "application_exception": "Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.",
      "criterion": "Assessment age, follow-up, visits, omissions, proxy or direct assessment and handling",
      "basis": "Reduction in death or major disability",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Obtain original follow-up flow, age definition, omissions, assessment methods, handling and sensitivity analyses.",
      "current_reports": [
        "R01"
      ],
      "existence": "Material information recorded in the stored review summary",
      "acquired_read": "Summary read; external or linked material unread",
      "observation": "The key outcome time is age 2. The stored summary preserves historical wording that evidence on assigned-group analysis and original missing data was reported.",
      "condition_status": "Partly verified",
      "status_reason": "Only the relevant information in the stored summary is recorded; detailed original materials and user review remain outstanding. Do not newly certify direct disability assessment of every infant, complete follow-up or absence of missing data solely from the total denominator. Original assessment-specific follow-up and handling details have not been read.",
      "missingness": "Do not newly certify direct disability assessment of every infant, complete follow-up or absence of missing data solely from the total denominator. Original assessment-specific follow-up and handling details have not been read.",
      "uncertainty": "Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Do not newly certify direct disability assessment of every infant, complete follow-up or absence of missing data solely from the total denominator. Original assessment-specific follow-up and handling details have not been read."
    },
    {
      "item_id": "N12",
      "question_type": "Comparative efficacy",
      "question": "Have allocation concealment, double blinding and the original listed-defect judgment been distinguished?",
      "needed": "Original allocation, concealment, blinding, assessment, analysis and reporting",
      "role": "Required",
      "role_reason": "Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries",
      "application_exception": "Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.",
      "criterion": "Original allocation, concealment, blinding, assessment, analysis and reporting",
      "basis": "Reduction in death or major disability",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Obtain original allocation, blinding, assessment, analysis, missing-data and reporting materials.",
      "current_reports": [
        "R01"
      ],
      "existence": "Material information recorded in the stored review summary",
      "acquired_read": "Summary read; external or linked material unread",
      "observation": "The stored summary preserves the history that listed defects were not counted because of original evidence on the international multicenter double-blind placebo control, allocation concealment, blinding, missing data and registration agreement.",
      "condition_status": "Partly verified",
      "status_reason": "Only the relevant information in the stored summary is recorded; detailed original materials and user review remain outstanding. Do not use this as certification that the present review passed or that no defects exist. Preserve parent B1 as recorded and do not reassess the axes.",
      "missingness": "Do not use this as certification that the present review passed or that no defects exist. Preserve parent B1 as recorded and do not reassess the axes.",
      "uncertainty": "Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Do not use this as certification that the present review passed or that no defects exist. Preserve parent B1 as recorded and do not reassess the axes."
    },
    {
      "item_id": "N13",
      "question_type": "Comparative efficacy",
      "question": "What has actually been accessed for registration, the prespecified composite endpoint, multiplicity and the analysis hierarchy?",
      "needed": "Original registration, protocol, SAP, hierarchy, changes and analysis",
      "role": "Required",
      "role_reason": "Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries",
      "application_exception": "Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.",
      "criterion": "Original registration, protocol, SAP, hierarchy, changes and analysis",
      "basis": "Reduction in death or major disability",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Obtain original registration, plans, hierarchy, changes and analysis-population materials.",
      "current_reports": [
        "R01"
      ],
      "existence": "Material information recorded in the stored review summary",
      "acquired_read": "Summary read; external or linked material unread",
      "observation": "The recorded registration identifier is ISRCTN94984750, and the stored summary describes historical evidence of registration agreement.",
      "condition_status": "Partly verified",
      "status_reason": "Only the relevant information in the stored summary is recorded; detailed original materials and user review remain outstanding. Registration, full text and plans have not been newly read. Do not invent alpha, test P values, component hierarchies, subgroups, missing-data plans or changes.",
      "missingness": "Registration, full text and plans have not been newly read. Do not invent alpha, test P values, component hierarchies, subgroups, missing-data plans or changes.",
      "uncertainty": "Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Registration, full text and plans have not been newly read. Do not invent alpha, test P values, component hierarchies, subgroups, missing-data plans or changes."
    },
    {
      "item_id": "N14",
      "question_type": "Comparative efficacy",
      "question": "Have subgroups, other outcomes or mechanisms replaced the direct composite effect?",
      "needed": "Prespecified subgroups, interactions, original denominators and clinical outcomes",
      "role": "Required",
      "role_reason": "Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries",
      "application_exception": "Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.",
      "criterion": "Prespecified subgroups, interactions, original denominators and clinical outcomes",
      "basis": "Reduction in death or major disability",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Obtain original prespecified subgroups, interactions, denominators and direct outcomes.",
      "current_reports": [
        "R01"
      ],
      "existence": "Material information recorded in the stored review summary",
      "acquired_read": "Summary read; external or linked material unread",
      "observation": "The stored summary records that the biological explanation of antibody deficiency did not translate into improved death or disability outcomes at age 2.",
      "condition_status": "Unverified",
      "status_reason": "Only the relevant information in the stored summary is recorded; detailed original materials and user review remain outstanding. Do not fill composite events with mechanisms, subgroups lacking detail, short-term responses or prevention of all infections. There are no individual effects or suitability assessments, or new CIs or P values.",
      "missingness": "Do not fill composite events with mechanisms, subgroups lacking detail, short-term responses or prevention of all infections. There are no individual effects or suitability assessments, or new CIs or P values.",
      "uncertainty": "Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Do not fill composite events with mechanisms, subgroups lacking detail, short-term responses or prevention of all infections. There are no individual effects or suitability assessments, or new CIs or P values."
    },
    {
      "item_id": "N15",
      "question_type": "Comparative efficacy",
      "question": "Have public funding, product provision, affiliations and external-analysis information been separated?",
      "needed": "Cash, IVIG or placebo provision, company affiliations, external analysis and study roles",
      "role": "Required",
      "role_reason": "Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries",
      "application_exception": "Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.",
      "criterion": "Cash, IVIG or placebo provision, company affiliations, external analysis and study roles",
      "basis": "Reduction in death or major disability",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Obtain original disclosures separately for funding, products or placebo, affiliations, design, analysis and writing.",
      "current_reports": [
        "R01"
      ],
      "existence": "Material information recorded in the stored review summary",
      "acquired_read": "Summary read; external or linked material unread",
      "observation": "Preserve support from the UK's MRC, Australia's NHMRC and New Zealand's HRC as stated in the stored review summary.",
      "condition_status": "Partly verified",
      "status_reason": "Only the relevant information in the stored summary is recorded; detailed original materials and user review remain outstanding. Do not newly extend public funding or original I2 into certification of no in-kind products, no company employees or independent analysis. Detailed roles and product supply have not been read.",
      "missingness": "Do not newly extend public funding or original I2 into certification of no in-kind products, no company employees or independent analysis. Detailed roles and product supply have not been read.",
      "uncertainty": "Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Do not newly extend public funding or original I2 into certification of no in-kind products, no company employees or independent analysis. Detailed roles and product supply have not been read."
    },
    {
      "item_id": "N16",
      "question_type": "Supplementary harm evidence",
      "question": "Have 12 versus 10 adverse events and the included 2 versus 4 deaths been separated?",
      "needed": "Adverse-event definitions, events versus people, relatedness, denominators and mapping of original deaths",
      "role": "Required",
      "role_reason": "Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries",
      "application_exception": "Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.",
      "criterion": "Adverse-event definitions, events versus people, relatedness, denominators and mapping of original deaths",
      "basis": "Reduction in death or major disability",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Obtain original adverse-event counts and people, included deaths, denominators, relatedness, exposure and component mapping.",
      "current_reports": [
        "R01"
      ],
      "existence": "Material information recorded in the stored review summary",
      "acquired_read": "Summary read; external or linked material unread",
      "observation": "The original full-text adverse-event description is IVIG 12 events (including 2 deaths) versus placebo 10 events (including 4 deaths). These are adverse-event counts.",
      "condition_status": "Partly verified",
      "status_reason": "Only the relevant information in the stored summary is recorded; detailed original materials and user review remain outstanding. Do not turn these into 12/10 people, total deaths, components of the 686/677 composite events or drug-related deaths. Numbers of people, denominators, relatedness, overlap and collection details have not been read.",
      "missingness": "Do not turn these into 12/10 people, total deaths, components of the 686/677 composite events or drug-related deaths. Numbers of people, denominators, relatedness, overlap and collection details have not been read.",
      "uncertainty": "Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Do not turn these into 12/10 people, total deaths, components of the 686/677 composite events or drug-related deaths. Numbers of people, denominators, relatedness, overlap and collection details have not been read."
    },
    {
      "item_id": "N17",
      "question_type": "Supplementary harm evidence",
      "question": "Has the absence of a reported adverse-event significance test been turned into a safety difference?",
      "needed": "Original adverse-event plan, comparison, test, interval and denominators",
      "role": "Required",
      "role_reason": "Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries",
      "application_exception": "Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.",
      "criterion": "Original adverse-event plan, comparison, test, interval and denominators",
      "basis": "Reduction in death or major disability",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Obtain original adverse-event plans, denominators, exposure, tests and intervals.",
      "current_reports": [
        "R01"
      ],
      "existence": "Material information recorded in the stored review summary",
      "acquired_read": "Summary read; external or linked material unread",
      "observation": "The stored review summary and safety description record that no original significance test was presented for the comparison of 12 versus 10 events.",
      "condition_status": "Partly verified",
      "status_reason": "Only the relevant information in the stored summary is recorded; detailed original materials and user review remain outstanding. Do not establish increased or decreased harm, equivalence or safety from the direction of event counts alone. There are no new P values, CIs, proportions, risk differences or hypothetical examples.",
      "missingness": "Do not establish increased or decreased harm, equivalence or safety from the direction of event counts alone. There are no new P values, CIs, proportions, risk differences or hypothetical examples.",
      "uncertainty": "Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Do not establish increased or decreased harm, equivalence or safety from the direction of event counts alone. There are no new P values, CIs, proportions, risk differences or hypothetical examples."
    },
    {
      "item_id": "N18",
      "question_type": "Supplementary harm evidence",
      "question": "Have exposure, discontinuation, rare or long-term harms and the age-2 outcome been separated?",
      "needed": "Harm collection, actual exposure, duration, denominators, relatedness and discontinuation",
      "role": "Required",
      "role_reason": "Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries",
      "application_exception": "Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.",
      "criterion": "Harm collection, actual exposure, duration, denominators, relatedness and discontinuation",
      "basis": "Reduction in death or major disability",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Obtain original safety-population, exposure, discontinuation, collection and long-term follow-up materials.",
      "current_reports": [
        "R01"
      ],
      "existence": "Material information recorded in the stored review summary",
      "acquired_read": "Summary read; external or linked material unread",
      "observation": "The original materials preserve study administration conditions, AE counts and death or major disability at age 2; the parent safety status is Caution.",
      "condition_status": "Unverified",
      "status_reason": "Only the relevant information in the stored summary is recorded; detailed original materials and user review remain outstanding. Do not replace missing AE collection, rare harms, long-term safety or administration completion with the original composite result. Do not create treatment, monitoring or administration instructions.",
      "missingness": "Do not replace missing AE collection, rare harms, long-term safety or administration completion with the original composite result. Do not create treatment, monitoring or administration instructions.",
      "uncertainty": "Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Do not replace missing AE collection, rare harms, long-term safety or administration completion with the original composite result. Do not create treatment, monitoring or administration instructions."
    },
    {
      "item_id": "N19",
      "question_type": "Supplementary harm evidence",
      "question": "Have prevention trials and other populations or products been distinguished from independent replication?",
      "needed": "Original question, timing, intervention, population and report or cohort relationships",
      "role": "Required",
      "role_reason": "Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries",
      "application_exception": "Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.",
      "criterion": "Original question, timing, intervention, population and report or cohort relationships",
      "basis": "Reduction in death or major disability",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Preserve direct outcomes for new populations, products or timing and the report or cohort relationships.",
      "current_reports": [
        "R01"
      ],
      "existence": "Material information recorded in the stored review summary",
      "acquired_read": "Summary read; external or linked material unread",
      "observation": "INIS concerns adjunctive treatment in neonates with sepsis receiving antibiotics, whereas verdict 2928 concerns preventing infection in extremely preterm infants using a different intervention.",
      "condition_status": "Unverified",
      "status_reason": "Only the relevant information in the stored summary is recorded; detailed original materials and user review remain outstanding. Do not combine the two sheets, sites or composite components as independent replications of the same trial, product superiority or the same effect in every population. Independent counts and participant totals are not recorded.",
      "missingness": "Do not combine the two sheets, sites or composite components as independent replications of the same trial, product superiority or the same effect in every population. Independent counts and participant totals are not recorded.",
      "uncertainty": "Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Do not combine the two sheets, sites or composite components as independent replications of the same trial, product superiority or the same effect in every population. Independent counts and participant totals are not recorded."
    },
    {
      "item_id": "N20",
      "question_type": "Comparative efficacy",
      "question": "Do gaps remain for outcomes beyond age 2 and applications to other indications?",
      "needed": "Direct comparisons of long-term components, other populations, other products and exposure",
      "role": "Required",
      "role_reason": "Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries",
      "application_exception": "Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.",
      "criterion": "Direct comparisons of long-term components, other populations, other products and exposure",
      "basis": "Reduction in death or major disability",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Obtain direct effect and harm materials by duration, population, product and exposure.",
      "current_reports": [
        "R01"
      ],
      "existence": "Material information recorded in the stored review summary",
      "acquired_read": "Summary read; external or linked material unread",
      "observation": "The direct key outcome in the currently designated stored review summary is death or major disability at age 2.",
      "condition_status": "Partly verified",
      "status_reason": "Only the relevant information in the stored summary is recorded; detailed original materials and user review remain outstanding. Do not extend this result to all IVIG indications, other ages or exposures, lifelong disability or survival, or prevention questions. There is no recommendation on use or suitability.",
      "missingness": "Do not extend this result to all IVIG indications, other ages or exposures, lifelong disability or survival, or prevention questions. There is no recommendation on use or suitability.",
      "uncertainty": "Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Do not extend this result to all IVIG indications, other ages or exposures, lifelong disability or survival, or prevention questions. There is no recommendation on use or suitability."
    },
    {
      "item_id": "N21",
      "question_type": "Comparative efficacy",
      "question": "Are the stored summary, original URLs, registration identifier and access to linked targets distinguished?",
      "needed": "Reports or cross-citations, URLs, identifiers and access by material",
      "role": "Required",
      "role_reason": "Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries",
      "application_exception": "Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.",
      "criterion": "Reports or cross-citations, URLs, identifiers and access by material",
      "basis": "Reduction in death or major disability",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Link user-provided original materials to each material type and access status.",
      "current_reports": [
        "R01"
      ],
      "existence": "Material information recorded in the stored review summary",
      "acquired_read": "Summary read; external or linked material unread",
      "observation": "The full stored summary of the designated parent verdict was read for preparation, and the original citation-list URLs and registration identifier are preserved.",
      "condition_status": "Partly verified",
      "status_reason": "Only the relevant information in the stored summary is recorded; detailed original materials and user review remain outstanding. External abstracts, full texts, registration, protocols, SAPs and targets of related-verdict links have not been read. Do not create new URLs or DOIs from identifiers or perform separate link tests.",
      "missingness": "External abstracts, full texts, registration, protocols, SAPs and targets of related-verdict links have not been read. Do not create new URLs or DOIs from identifiers or perform separate link tests.",
      "uncertainty": "Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "External abstracts, full texts, registration, protocols, SAPs and targets of related-verdict links have not been read. Do not create new URLs or DOIs from identifiers or perform separate link tests."
    },
    {
      "item_id": "N22",
      "question_type": "Comparative efficacy",
      "question": "Have the Korean and English manuscripts, original axes, dates, corrections, empty values, candidate history and preparation status been preserved?",
      "needed": "Distinguish the selected verdict record, complete parent, original languages and history from current preparation",
      "role": "Supplementary",
      "role_reason": "Case-specific production conditions recording the selected claim, endpoint, denominator, time, study identity and interpretation boundaries",
      "application_exception": "Unread material, other questions, other products and out-of-scope results do not stand in for fulfillment, zero effect or safety.",
      "criterion": "Distinguish the selected verdict record, complete parent, original languages and history from current preparation",
      "basis": "Reduction in death or major disability",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Preserve user materials and decisions in full, then link them as separate events.",
      "current_reports": [
        "R01"
      ],
      "existence": "Material information recorded in the stored review summary",
      "acquired_read": "Summary read; external or linked material unread",
      "observation": "Preserve 2026-08-26, empty correction and deliberation values, subclaim grade D and its note, and the actual parent grade, score, safety, assessment axes and Korean and English manuscripts.",
      "condition_status": "Partly verified",
      "status_reason": "Only the relevant information in the stored summary is recorded; detailed original materials and user review remain outstanding. Original verification, funding independence, design-defect and safety descriptions are historical, not certification of the present review. Do not fill absent subclaim fields; original review-pending and preparation-eligible indicators are candidate history.",
      "missingness": "Original verification, funding independence, design-defect and safety descriptions are historical, not certification of the present review. Do not fill absent subclaim fields; original review-pending and preparation-eligible indicators are candidate history.",
      "uncertainty": "Unread/unverified does not mean zero effect, zero events, safety or new clinical certification.",
      "review_date": null,
      "reading_status": "Full text not read · Stored summary read",
      "additional_material": "Original verification, funding independence, design-defect and safety descriptions are historical, not certification of the present review. Do not fill absent subclaim fields; original review-pending and preparation-eligible indicators are candidate history."
    }
  ],
  "reports": [
    {
      "report_id": "R01",
      "title": "INIS Collaborative Group. N Engl J Med. 2011;365:1201-1211. PMID: 21962214.",
      "url": "https://pubmed.ncbi.nlm.nih.gov/21962214/",
      "report_type": "Original trial paper report",
      "existence": "Preserved information from the existing citation and evidence lists",
      "acquired_read": "Summary read; external or linked material unread",
      "study_family": "F01",
      "independent_replication": false,
      "observed_result": "39.0% versus 39.0%; RR 1.00 (95% CI 0.92~1.08), absolute difference 0.0%p",
      "result_level": "Existing review summary; no comparison with the external original report",
      "source_evidence_date": "2026-08-26",
      "materials": [
        {
          "material_type": "local_summary",
          "public_status": "Original URL preserved",
          "access_status": "Summary read",
          "acquired": true,
          "actually_read": "Summary read",
          "as_of": "2026-08-26",
          "qualification": "Preserved parent verdict summary; report-specific links to the same stored summary copy"
        },
        {
          "material_type": "abstract",
          "public_status": "Original URL preserved",
          "access_status": "Not read",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-08-26",
          "qualification": "External or linked verdict material unread; a URL does not mean reading or review is complete"
        },
        {
          "material_type": "fulltext",
          "public_status": "No separate URL in the original material",
          "access_status": "Not read",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-08-26",
          "qualification": "External or linked verdict material unread; a URL does not mean reading or review is complete"
        },
        {
          "material_type": "registration",
          "public_status": "No separate URL in the original material",
          "access_status": "Not read",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-08-26",
          "qualification": "External or linked verdict material unread; a URL does not mean reading or review is complete"
        },
        {
          "material_type": "protocol_sap",
          "public_status": "No separate URL in the original material",
          "access_status": "Not read",
          "acquired": false,
          "actually_read": "Not read",
          "as_of": "2026-08-26",
          "qualification": "External or linked verdict material unread; a URL does not mean reading or review is complete"
        }
      ],
      "links": [
        {
          "label": "PubMed",
          "url": "https://pubmed.ncbi.nlm.nih.gov/21962214/"
        }
      ]
    }
  ],
  "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 stored methodological links reused for preparation; no current review, reassessment of methodological content or external-link testing"
    },
    {
      "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 stored methodological links reused for preparation; no current review, reassessment of methodological content or external-link testing"
    },
    {
      "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 stored methodological links reused for preparation; no current review, reassessment of methodological content or external-link testing"
    },
    {
      "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 stored methodological links reused for preparation; no current review, reassessment of methodological content or external-link testing"
    },
    {
      "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 stored methodological links reused for preparation; no current review, reassessment of methodological content or external-link testing"
    }
  ],
  "status_dictionary": {
    "Partly verified": "Some information is in the stored summary; detailed original material remains unverified. This does not certify passed review or clinical efficacy",
    "Unverified": "Detailed materials for the selected condition could not be established within the stored scope; this does not mean zero effect, zero studies or safety",
    "Review incomplete": "Review of existing content incomplete",
    "Met": "Use only within the relevant condition's scope after user review; no automatic display in this preparation",
    "Not reported": "Distinguish only within materials actually read; do not turn unread external materials into unreported findings",
    "Inaccessible": "Not applied during this preparation because actual access was not tested",
    "Not applicable": "Use with a reason for non-applicability based on an explicit question boundary",
    "Conflicting data": "Judge after actual material comparison; review was not performed during this preparation",
    "Insufficient evidence for the conditions": "Do not use as a clinical grade encompassing currently unread materials"
  },
  "study_overlap": {
    "state": "Unverified",
    "unique_trial_count": null,
    "unique_participant_count": null,
    "reason": "The same INIS age-2 composite outcome, original components and adverse events; the family ID for the same infant cohort links relationships and does not certify independent counts; do not newly add events, composite components, sites, cross-citations or the same participants as independent evidence"
  },
  "history": [
    {
      "date": "2026-10-10",
      "kind": "Separation of public-facing pages and materials",
      "view_version": "1.0",
      "change": "Reader pages and materials were prepared from the existing 22 items. No new clinical search, change in verification status or scoring was performed."
    }
  ],
  "language": "en",
  "translation_date": "2026-10-10"
}