Figure 1. Consort Flow Sheet of Study Subjects.
1Reason unknown. 2One infant identified as ineligible post-randomization; two infants died. 3One placebo subject incorrectly received 10mg/kg/day of inositol for 7 days before it was discovered and stopped and is considered to be part of the 10m/kg/day group only for the PK analysis. However, other data from this subject are analyzed, as randomized, with the placebo infants.