a Two infants started feeding prior to randomization; 1 infant’s condition worsened prior to randomization resulting in loss of vascular access required for drug administration.
b Two infants identified as ineligible post-randomization (1 had < 600 grams birth weight, 1 developed severe IVH post-consent)
c One infant received placebo in error, samples included as placebo in the pharmacokinetic (PK) analyses, however clinical outcomes included as intention to treat.