 Procedures for assessing, recording and reporting AEs Throughout the duration of the study, the investigator will closely monitor each subject for clinical evidence of drug intolerance and monitor all clinically obtained laboratory values for laboratory evidence of AEs. AEs not explained by the infants underlying illness which occur during the course of the study will be reported in detail on the appropriate CRFs and followed until resolution or until it becomes stable. All SAEs will be reported to studys medical monitor within 24 hours. 