Each patient will provide written dated informed consent prior to undergoing eligibility screening for entry into the study. Screening evaluations will be performed within 21 days prior to scheduled study drug administration. If all eligibility criteria are met, the patient will be enrolled and will be scheduled for placement of the IP catheter at least 7 days prior to the scheduled dosing (Day -7) to allow adequate time for healing around the catheter insertion site. Baseline evaluations will be performed prior to dosing. At that time the investigator will ensure that the patient remains eligible for participation.