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. 2025 Feb 24;10(3):e01032-24. doi: 10.1128/msphere.01032-24

Fig 1.

Flowchart depicts clinical trial screening of 2252 infants: 1733 were ineligible or eligible but not enrolled, and 519 were randomized into one of five groups. Safety/tolerability and primary analyses were conducted after exclusions for incomplete data.

Trial CONSORT flow diagram. aExclusions due to the administration or prescription of parenteral antibiotics or due to neonates not orally feeding were based on criteria documented at the last available screening visit, irrespective of the infant’s age when they were last screened. bAll infants who received zero doses of investigational product also had zero post-intervention stool samples collected between days 14 and 60, inclusive, and thus were not included in the safety and tolerability analyses or in the primary outcome analysis.