{
  "schema_version": "chamgap-public-evidence-check-1.0",
  "public_id": "v2928-s0",
  "verdict_number": "2928",
  "title": "BBG-001 × prevention of NEC, sepsis and death in very preterm infants — three primary outcomes 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": "PiPS prevention in very preterm infants; detailed eligibility and baseline information not read",
    "intervention": "Historical exposure in a prevention trial of the specific BBG-001 strain; no recommendation for use",
    "dose": "Only the original daily administration condition is preserved; no dosing, duration or procedural guidance is created",
    "comparator": "Placebo; detailed actual concomitant exposures not read",
    "endpoint": "Distinguish sepsis, Bell stage 2 or greater NEC and death before discharge by their individual definitions and original results within one existing question",
    "duration": "Apart from death before discharge, exact observation windows by event and actual administration duration have not been read in detail",
    "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": "Prevention of NEC, sepsis and death",
      "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 preserved review summary",
      "acquired_read": "Summary read; external or linked material unread",
      "observation": "The selected original claim is 'prevention of NEC, sepsis and death', with subclaim grade D and the note 'All were null.'; the parent is D34 with Good safety status.",
      "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": "Have the population and eligibility for prevention in very preterm infants been distinguished from adjunctive treatment?",
      "needed": "Gestational age, birth, recruitment, eligibility, baseline 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": "Gestational age, birth, recruitment, eligibility, baseline and denominators",
      "basis": "Prevention of NEC, sepsis and death",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Obtain original eligibility, baseline, recruitment, timing and concomitant-exposure materials.",
      "current_reports": [
        "R01"
      ],
      "existence": "Material information recorded in the preserved review summary",
      "acquired_read": "Summary read; external or linked material unread",
      "observation": "PiPS is a BBG-001 trial to prevent NEC, sepsis and death in very preterm infants; it differs from adding IVIG as adjunctive treatment after 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. Detailed gestational-age and birth-weight criteria, baseline risk, recruitment timing and nutrition or antibiotic conditions are absent from the summary. Do not create new eligibility or product-selection instructions.",
      "missingness": "Detailed gestational-age and birth-weight criteria, baseline risk, recruitment timing and nutrition or antibiotic conditions are absent from the summary. Do not create new eligibility or product-selection 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": "Detailed gestational-age and birth-weight criteria, baseline risk, recruitment timing and nutrition or antibiotic conditions are absent from the summary. Do not create new eligibility or product-selection instructions."
    },
    {
      "item_id": "N03",
      "question_type": "Comparative efficacy",
      "question": "What are the BBG-001 strain identity, placebo and actual exposure?",
      "needed": "Original strain, formulation, quality, control, administration duration 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 strain, formulation, quality, control, administration duration and actual exposure",
      "basis": "Prevention of NEC, sepsis and death",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Obtain original strain, product, placebo, quality, duration and actual-exposure tables.",
      "current_reports": [
        "R01"
      ],
      "existence": "Material information recorded in the preserved review summary",
      "acquired_read": "Summary read; external or linked material unread",
      "observation": "The study condition was daily administration of the specific Bifidobacterium breve BBG-001 strain or 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 transfer this to other strains, mixtures or probiotics in general. Detailed dose, formulation, manufacturing criteria, start and stop times and actual adherence are absent from the summary. Do not create intake or use instructions.",
      "missingness": "Do not transfer this to other strains, mixtures or probiotics in general. Detailed dose, formulation, manufacturing criteria, start and stop times and actual adherence are absent from the summary. Do not create intake or use 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 transfer this to other strains, mixtures or probiotics in general. Detailed dose, formulation, manufacturing criteria, start and stop times and actual adherence are absent from the summary. Do not create intake or use instructions."
    },
    {
      "item_id": "N04",
      "question_type": "Comparative efficacy",
      "question": "Have the 1,315 participants and group denominators for the three outcomes been distinguished?",
      "needed": "Original allocation, group analyses, missing data and event-specific 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 allocation, group analyses, missing data and event-specific denominators",
      "basis": "Prevention of NEC, sepsis and death",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Obtain original participant flow, group denominators for each outcome, omissions and event mapping.",
      "current_reports": [
        "R01"
      ],
      "existence": "Material information recorded in the preserved review summary",
      "acquired_read": "Summary read; external or linked material unread",
      "observation": "The stored summary records 1,315 PiPS participants and the proportions for three events in each group.",
      "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 calculate original group sizes, outcome-specific event counts, denominators or missing-data rates. Do not add participants or events as independent evidence when the same infant appears in different events.",
      "missingness": "Do not newly calculate original group sizes, outcome-specific event counts, denominators or missing-data rates. Do not add participants or events as independent evidence when the same infant appears in different events.",
      "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 calculate original group sizes, outcome-specific event counts, denominators or missing-data rates. Do not add participants or events as independent evidence when the same infant appears in different events."
    },
    {
      "item_id": "N05",
      "question_type": "Comparative efficacy",
      "question": "Are sepsis, NEC and death before discharge a single composite event?",
      "needed": "Three co-primary outcomes, original definitions, individual people or events and time",
      "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": "Three co-primary outcomes, original definitions, individual people or events and time",
      "basis": "Prevention of NEC, sepsis and death",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Obtain the original definition of each endpoint, prespecified hierarchy, overlap, denominators and timing.",
      "current_reports": [
        "R01"
      ],
      "existence": "Material information recorded in the preserved review summary",
      "acquired_read": "Summary read; external or linked material unread",
      "observation": "The evidence list records sepsis, Bell stage 2 or greater NEC and death before discharge as endpoints. The original grade decision records three co-primary outcomes.",
      "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 the three outcomes into a newly summed composite event or new structural units. Do not arbitrarily change the existing false indicator for splitting co-primary outcomes.",
      "missingness": "Do not turn the three outcomes into a newly summed composite event or new structural units. Do not arbitrarily change the existing false indicator for splitting co-primary outcomes.",
      "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 three outcomes into a newly summed composite event or new structural units. Do not arbitrarily change the existing false indicator for splitting co-primary outcomes."
    },
    {
      "item_id": "N06",
      "question_type": "Comparative efficacy",
      "question": "What are the actual sepsis definition, confirmation and observation period?",
      "needed": "Sepsis definition, testing, confirmation, timing, people or events 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": "Sepsis definition, testing, confirmation, timing, people or events and denominators",
      "basis": "Prevention of NEC, sepsis and death",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Obtain original sepsis definition, confirmation, timing, denominators and repeated-event tables.",
      "current_reports": [
        "R01"
      ],
      "existence": "Material information recorded in the preserved review summary",
      "acquired_read": "Summary read; external or linked material unread",
      "observation": "The original evidence list records sepsis as a primary outcome.",
      "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 invent details of culture confirmation, clinical diagnosis, timing criteria, repeated events or sepsis categories. The exact observation window and denominators have not been read.",
      "missingness": "Do not invent details of culture confirmation, clinical diagnosis, timing criteria, repeated events or sepsis categories. The exact observation window and 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 invent details of culture confirmation, clinical diagnosis, timing criteria, repeated events or sepsis categories. The exact observation window and denominators have not been read."
    },
    {
      "item_id": "N07",
      "question_type": "Comparative efficacy",
      "question": "Are the sepsis proportions, adjusted RR, 95% CI and original absolute difference preserved?",
      "needed": "Original group order, proportions, adjustment model, effect, CI 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 group order, proportions, adjustment model, effect, CI and denominators",
      "basis": "Prevention of NEC, sepsis and death",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Obtain original event tables, group denominators, adjustment model, tests and CIs.",
      "current_reports": [
        "R01"
      ],
      "existence": "Material information recorded in the preserved review summary",
      "acquired_read": "Summary read; external or linked material unread",
      "observation": "BBG-001 11.2% versus placebo 11.7%, adjusted RR 0.97 (95% CI 0.73~1.29), with an original absolute difference of −0.5%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 calculate new event counts, RRs, absolute differences, P values or NNTs from the original proportions. Adjustment variables, missing data and model details have not been read.",
      "missingness": "Do not calculate new event counts, RRs, absolute differences, P values or NNTs from the original proportions. Adjustment variables, missing data and model 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 calculate new event counts, RRs, absolute differences, P values or NNTs from the original proportions. Adjustment variables, missing data and model details have not been read."
    },
    {
      "item_id": "N08",
      "question_type": "Comparative efficacy",
      "question": "What are the definition, classification and verification scope for Bell stage 2 or greater NEC?",
      "needed": "Original NEC classification, adjudication, 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 NEC classification, adjudication, timing and denominators",
      "basis": "Prevention of NEC, sepsis and death",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Obtain original Bell definitions, adjudication, results by stage or timing and denominators.",
      "current_reports": [
        "R01"
      ],
      "existence": "Material information recorded in the preserved review summary",
      "acquired_read": "Summary read; external or linked material unread",
      "observation": "The evidence list records Bell stage 2 or greater NEC.",
      "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 replace this definition with other stages, suspected diagnosis, surgical NEC or nutritional indicators. Detailed adjudication, observation windows and group denominators have not been read.",
      "missingness": "Do not replace this definition with other stages, suspected diagnosis, surgical NEC or nutritional indicators. Detailed adjudication, observation windows and group 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 replace this definition with other stages, suspected diagnosis, surgical NEC or nutritional indicators. Detailed adjudication, observation windows and group denominators have not been read."
    },
    {
      "item_id": "N09",
      "question_type": "Comparative efficacy",
      "question": "Have the original NEC proportions, RR, interval and absolute difference been preserved exactly?",
      "needed": "Original group proportions, effects, intervals, denominators and tests",
      "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 proportions, effects, intervals, denominators and tests",
      "basis": "Prevention of NEC, sepsis and death",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Obtain original NEC events, denominators, RR, interval, model and tests.",
      "current_reports": [
        "R01"
      ],
      "existence": "Material information recorded in the preserved review summary",
      "acquired_read": "Summary read; external or linked material unread",
      "observation": "The original main-text NEC result is 9.4% versus 10.0%, RR 0.93, interval 0.68~1.27 and original absolute difference −0.6%p. The 95% CI context in the original reader answer is preserved in the full 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 arbitrarily fill event counts, new CIs, P values, interval levels or model details absent from the original evidence list.",
      "missingness": "Do not arbitrarily fill event counts, new CIs, P values, interval levels or model details absent from the original evidence list.",
      "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 arbitrarily fill event counts, new CIs, P values, interval levels or model details absent from the original evidence list."
    },
    {
      "item_id": "N10",
      "question_type": "Comparative efficacy",
      "question": "Has death before discharge been distinguished from deaths in other periods or from other causes?",
      "needed": "Death definition, time, cause, denominators and follow-up",
      "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": "Death definition, time, cause, denominators and follow-up",
      "basis": "Prevention of NEC, sepsis and death",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Obtain original death definitions, timing, causes, group denominators and follow-up materials.",
      "current_reports": [
        "R01"
      ],
      "existence": "Material information recorded in the preserved review summary",
      "acquired_read": "Summary read; external or linked material unread",
      "observation": "The evidence list records death before discharge.",
      "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 the pre-discharge outcome to prevention of death at age 2, throughout life or by other causes. Original cause, duration, denominator and follow-up procedures have not been read in detail.",
      "missingness": "Do not extend the pre-discharge outcome to prevention of death at age 2, throughout life or by other causes. Original cause, duration, denominator and follow-up procedures have not been read in detail.",
      "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 the pre-discharge outcome to prevention of death at age 2, throughout life or by other causes. Original cause, duration, denominator and follow-up procedures have not been read in detail."
    },
    {
      "item_id": "N11",
      "question_type": "Comparative efficacy",
      "question": "Are the original death proportions, RR, interval and absolute difference preserved?",
      "needed": "Original group proportions, original effects, intervals, denominators and tests",
      "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 proportions, original effects, intervals, denominators and tests",
      "basis": "Prevention of NEC, sepsis and death",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Obtain original death tables, denominators, effects, intervals, adjustment and tests.",
      "current_reports": [
        "R01"
      ],
      "existence": "Material information recorded in the preserved review summary",
      "acquired_read": "Summary read; external or linked material unread",
      "observation": "The original main-text death result is 8.3% versus 8.5%, RR 0.93, interval 0.67~1.30 and original absolute difference −0.2%p. The 95% CI context in the original reader answer is preserved 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 calculate new death counts, RRs, risk differences or P values from the original proportions. Do not mix the death RR with the same RR or CI for NEC.",
      "missingness": "Do not calculate new death counts, RRs, risk differences or P values from the original proportions. Do not mix the death RR with the same RR or CI for NEC.",
      "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 calculate new death counts, RRs, risk differences or P values from the original proportions. Do not mix the death RR with the same RR or CI for NEC."
    },
    {
      "item_id": "N12",
      "question_type": "Comparative efficacy",
      "question": "Has the original null result been distinguished from CIs that leave both benefit and harm possible?",
      "needed": "Original intervals, precision and clinical importance for each outcome",
      "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 intervals, precision and clinical importance for each outcome",
      "basis": "Prevention of NEC, sepsis and death",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Obtain original effects, precision, clinical boundaries and denominators for each outcome.",
      "current_reports": [
        "R01"
      ],
      "existence": "Material information recorded in the preserved review summary",
      "acquired_read": "Summary read; external or linked material unread",
      "observation": "The stored summary records null results for the three primary outcomes and the limitation that CIs leave both potentially meaningful benefit and harm possible.",
      "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 a null result as an exact zero effect, equivalence or absence of all harms. There are no new MCIDs, power calculations, sample sizes or hypothetical numerical examples.",
      "missingness": "Do not newly certify a null result as an exact zero effect, equivalence or absence of all harms. There are no new MCIDs, power calculations, sample sizes or hypothetical numerical 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 newly certify a null result as an exact zero effect, equivalence or absence of all harms. There are no new MCIDs, power calculations, sample sizes or hypothetical numerical examples."
    },
    {
      "item_id": "N13",
      "question_type": "Comparative efficacy",
      "question": "Have cross-colonization, within-group colonization and actual event effects been distinguished?",
      "needed": "Placebo-group colonization, timing, confirmation, actual exposure and prespecified analyses",
      "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": "Placebo-group colonization, timing, confirmation, actual exposure and prespecified analyses",
      "basis": "Prevention of NEC, sepsis and death",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Obtain original colonization confirmation, exposure, timing, denominators, prespecified analyses and sensitivity analyses.",
      "current_reports": [
        "R01"
      ],
      "existence": "Material information recorded in the preserved review summary",
      "acquired_read": "Summary read; external or linked material unread",
      "observation": "The stored summary records BBG-001 colonization in the placebo group and states that prespecified analyses did not explain the null result.",
      "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 colonization as clinical prevention efficacy or an independent trial. Do not add cross-colonization as a new axis defect or certify the original analysis as newly reviewed.",
      "missingness": "Do not count colonization as clinical prevention efficacy or an independent trial. Do not add cross-colonization as a new axis defect or certify the original analysis as newly reviewed.",
      "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 colonization as clinical prevention efficacy or an independent trial. Do not add cross-colonization as a new axis defect or certify the original analysis as newly reviewed."
    },
    {
      "item_id": "N14",
      "question_type": "Comparative efficacy",
      "question": "What gaps remain in double blinding, placebo and actual adjudication and analysis procedures?",
      "needed": "Original allocation, concealment, blinding, adjudicators and analysts",
      "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, adjudicators and analysts",
      "basis": "Prevention of NEC, sepsis and death",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Obtain original allocation, blinding, confirmation, analysis and missing-data procedures.",
      "current_reports": [
        "R01"
      ],
      "existence": "Material information recorded in the preserved review summary",
      "acquired_read": "Summary read; external or linked material unread",
      "observation": "The original evidence list describes PiPS as a multicenter double-blind placebo-controlled RCT.",
      "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 invent detailed allocation concealment, blinding checks, event adjudication or analyst procedures. Do not certify nominal blinding as absence of all bias.",
      "missingness": "Do not invent detailed allocation concealment, blinding checks, event adjudication or analyst procedures. Do not certify nominal blinding as absence of all bias.",
      "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 invent detailed allocation concealment, blinding checks, event adjudication or analyst procedures. Do not certify nominal blinding as absence of all bias."
    },
    {
      "item_id": "N15",
      "question_type": "Comparative efficacy",
      "question": "What gaps remain in the prespecified hierarchy, multiple primary outcomes and registration access?",
      "needed": "Original registration, protocol, SAP, multiplicity, changes and analysis population",
      "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, multiplicity, changes and analysis population",
      "basis": "Prevention of NEC, sepsis and death",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Obtain original registration, plans, hierarchy, multiplicity, analysis populations and changes.",
      "current_reports": [
        "R01"
      ],
      "existence": "Material information recorded in the preserved review summary",
      "acquired_read": "Summary read; external or linked material unread",
      "observation": "The registration identifier is ISRCTN05511098, and the stored review summary preserves wording about three co-primary outcomes and prespecified colonization analyses.",
      "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 read registration, full text or plans. Exact alpha, test P values, multiplicity, ITT or missing-data handling and changes have not been read in detail.",
      "missingness": "Do not newly read registration, full text or plans. Exact alpha, test P values, multiplicity, ITT or missing-data handling and changes have not been read in detail.",
      "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 read registration, full text or plans. Exact alpha, test P values, multiplicity, ITT or missing-data handling and changes have not been read in detail."
    },
    {
      "item_id": "N16",
      "question_type": "Comparative efficacy",
      "question": "Have the single PiPS trial, multiple outcomes and related-verdict links been kept from being added as independent evidence?",
      "needed": "Relationships among the same trial, reports, cohort, outcomes and cross-citations",
      "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": "Relationships among the same trial, reports, cohort, outcomes and cross-citations",
      "basis": "Prevention of NEC, sepsis and death",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Link additional reports by original identifiers, participants, outcomes and strain relationships.",
      "current_reports": [
        "R01",
        "R02"
      ],
      "existence": "Material information recorded in the preserved review summary",
      "acquired_read": "Summary read; external or linked material unread",
      "observation": "NEC, sepsis and death before discharge concern the same PiPS report and infant cohort. Verdict 1503 is a cross-citation of an existing verdict on a different strain combination.",
      "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 add the three outcomes or related links as new independent trials or participants. The verdict 1503 target and included trials have not been newly read; final independent counts and participant totals are null.",
      "missingness": "Do not add the three outcomes or related links as new independent trials or participants. The verdict 1503 target and included trials have not been newly read; final independent counts and participant totals are null.",
      "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 add the three outcomes or related links as new independent trials or participants. The verdict 1503 target and included trials have not been newly read; final independent counts and participant totals are null."
    },
    {
      "item_id": "N17",
      "question_type": "Comparative efficacy",
      "question": "Have the original cross-citation of the verdict 1503 strain combination and new direct evidence been separated?",
      "needed": "Existing related-verdict record, strains, population, trials 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": "Existing related-verdict record, strains, population, trials and denominators",
      "basis": "Prevention of NEC, sepsis and death",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Link relevant original materials provided by the user by strain, comparison and cohort.",
      "current_reports": [
        "R01",
        "R02"
      ],
      "existence": "Material information recorded in the preserved review summary",
      "acquired_read": "Summary read; external or linked material unread",
      "observation": "The stored summary cross-cites verdict 1503, where a Bifidobacterium plus Lactobacillus combination had NEC and total-mortality benefit, B77, in the same preterm prevention indication.",
      "condition_status": "Partly verified",
      "status_reason": "Only the relevant information in the stored summary is recorded; detailed original materials and user review remain outstanding. That verdict and its original trials have not been read or reassessed in this preparation. Do not transfer effects of another combination to BBG-001 or create a direct product-superiority comparison.",
      "missingness": "That verdict and its original trials have not been read or reassessed in this preparation. Do not transfer effects of another combination to BBG-001 or create a direct product-superiority comparison.",
      "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": "That verdict and its original trials have not been read or reassessed in this preparation. Do not transfer effects of another combination to BBG-001 or create a direct product-superiority comparison."
    },
    {
      "item_id": "N18",
      "question_type": "Comparative efficacy",
      "question": "Have NIHR cash funding, Yakult in-kind provision and study roles each been preserved?",
      "needed": "Funding, product or placebo manufacture, transport, affiliations, 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": "Funding, product or placebo manufacture, transport, affiliations, analysis and study roles",
      "basis": "Prevention of NEC, sepsis and death",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Obtain original disclosures on funding, in-kind provision, affiliations, design, conduct, analysis and writing.",
      "current_reports": [
        "R01"
      ],
      "existence": "Material information recorded in the preserved review summary",
      "acquired_read": "Summary read; external or linked material unread",
      "observation": "Preserve the NIHR HTA research funding and Yakult Honsha's free manufacture and transport to the UK of probiotic and placebo products. The stored summary records no company involvement in design, conduct or analysis.",
      "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 absence of in-kind provision or complete independence solely from public support. Employee authors and other writing roles have not been separately read; preserve original I1.",
      "missingness": "Do not newly certify absence of in-kind provision or complete independence solely from public support. Employee authors and other writing roles have not been separately read; preserve original I1.",
      "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 absence of in-kind provision or complete independence solely from public support. Employee authors and other writing roles have not been separately read; preserve original I1."
    },
    {
      "item_id": "N19",
      "question_type": "Supplementary harm evidence",
      "question": "Have nonreporting of a probiotic-bacteremia signal and the original event intervals been separated?",
      "needed": "Harm definition, collection, people or events, exposure, denominators and relatedness",
      "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 definition, collection, people or events, exposure, denominators and relatedness",
      "basis": "Prevention of NEC, sepsis and death",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Obtain original harm collection, group events or people, denominators, relatedness, exposure and CIs.",
      "current_reports": [
        "R01"
      ],
      "existence": "Material information recorded in the preserved review summary",
      "acquired_read": "Summary read; external or linked material unread",
      "observation": "The original safety description states that no major safety signal, including probiotic bacteremia, was reported and that the three primary events did not increase.",
      "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 nonreporting into zero bacteremia events, absence of harm or certification of long-term safety. Preserve as historical both the possibility of harm within the original effect CIs and the original Good safety verdict.",
      "missingness": "Do not turn nonreporting into zero bacteremia events, absence of harm or certification of long-term safety. Preserve as historical both the possibility of harm within the original effect CIs and the original Good safety 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": "Do not turn nonreporting into zero bacteremia events, absence of harm or certification of long-term safety. Preserve as historical both the possibility of harm within the original effect CIs and the original Good safety verdict."
    },
    {
      "item_id": "N20",
      "question_type": "Supplementary harm evidence",
      "question": "What gaps remain in exposure duration, missing data, safety-analysis populations and rare harms?",
      "needed": "Actual exposure, harm denominators, observation windows, 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": "Actual exposure, harm denominators, observation windows, relatedness and discontinuation",
      "basis": "Prevention of NEC, sepsis and death",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Obtain original exposure, safety-analysis population, discontinuation, missing-data, follow-up and relatedness materials.",
      "current_reports": [
        "R01"
      ],
      "existence": "Material information recorded in the preserved review summary",
      "acquired_read": "Summary read; external or linked material unread",
      "observation": "The stored summary preserves daily study-product administration and descriptions of primary events and safety signals.",
      "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 newly calculate specific administration durations, safety populations, repeated events, rare-harm rates, discontinuation or long-term follow-up.",
      "missingness": "Do not newly calculate specific administration durations, safety populations, repeated events, rare-harm rates, discontinuation or long-term follow-up.",
      "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 calculate specific administration durations, safety populations, repeated events, rare-harm rates, discontinuation or long-term follow-up."
    },
    {
      "item_id": "N21",
      "question_type": "Supplementary harm evidence",
      "question": "Do gaps remain when applying effects or harms to other populations, strains, combinations or durations?",
      "needed": "Direct comparisons and independent relationships by population, strain, formulation and duration",
      "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 and independent relationships by population, strain, formulation and duration",
      "basis": "Prevention of NEC, sepsis and death",
      "condition_origin": "Individual production conditions; not completed review or automatic satisfaction of common definitions",
      "proposed_research": "Obtain direct effect and harm materials by population, strain, combination and duration.",
      "current_reports": [
        "R01",
        "R02"
      ],
      "existence": "Material information recorded in the preserved review summary",
      "acquired_read": "Summary read; external or linked material unread",
      "observation": "The stored summary distinguishes prevention with the specific BBG-001 strain in very preterm infants from results for other combination products.",
      "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 treat all probiotics as ineffective or safe, or equate their effects with those of other strains. There are no neonatal product-selection, use or suitability instructions.",
      "missingness": "Do not treat all probiotics as ineffective or safe, or equate their effects with those of other strains. There are no neonatal product-selection, use or suitability 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 treat all probiotics as ineffective or safe, or equate their effects with those of other strains. There are no neonatal product-selection, use or suitability instructions."
    },
    {
      "item_id": "N22",
      "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": "Prevention of NEC, sepsis and death",
      "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",
        "R02"
      ],
      "existence": "Material information recorded in the preserved 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": "N23",
      "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": "Prevention of NEC, sepsis and death",
      "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 preserved 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": "Costeloe K, et al. Lancet. 2016;387:649-660. PMID: 26628328.",
      "url": "https://pubmed.ncbi.nlm.nih.gov/26628328/",
      "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": "Sepsis: BBG-001 11.2% versus placebo 11.7%, absolute difference -0.5%p, adjusted RR 0.97 (95% CI 0.73~1.29); NEC 9.4% versus 10.0%; death 8.3% versus 8.5%",
      "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/26628328/"
        }
      ]
    },
    {
      "report_id": "R02",
      "title": "Verdict 1503: Bifidobacterium plus Lactobacillus combination probiotics × prevention of NEC and total mortality in preterm infants (B 77)",
      "url": "https://chamgap.com/verdicts/gut/bifidobacterium-lactobacillus-probiotics-preterm-nec-mortality/",
      "report_type": "Cross-citation to an existing verdict; original trial report/bibliography not acquired",
      "existence": "Only the cross-citation in the parent review summary exists; linked target not read",
      "acquired_read": "Summary read; external or linked material unread",
      "study_family": "F02",
      "independent_replication": false,
      "observed_result": "Outcomes differ by strain and combination within the same indication.",
      "result_level": "Only the original cross-citation summary is preserved; no new clinical evidence on other strains has been read",
      "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": "source_link",
          "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": "Official source",
          "url": "https://chamgap.com/verdicts/gut/bifidobacterium-lactobacillus-probiotics-preterm-nec-mortality/"
        }
      ]
    }
  ],
  "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 exists in the preserved review summary, with detailed original materials still unverified; no certification of a passed review or clinical efficacy",
    "Unverified": "Detailed materials for the selected condition could not be established within the stored scope; this does not mean zero effect, zero studies or safety",
    "Review incomplete": "Review of existing content incomplete",
    "Met": "Use only within the relevant 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": "Three co-primary outcomes in the same PiPS trial and infant cohort; a cross-citation of existing verdict 1503 on a different strain combination, whose linked target and included trials have not been read and which does not certify independent replication of BBG-001; family IDs link relationships and do 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 23 items. No new clinical search, change in verification status or scoring was performed."
    }
  ],
  "language": "en",
  "translation_date": "2026-10-10"
}