Randomization
In each cohort, subjects who had signed informed consent and met all eligibility criteria were randomized to receive active treatment or placebo according to their assigned unique subject randomization number. The randomization scheme was devised by an unblinded statistician (who had no other involvement in the study and was considered blinded) using statistical computer software suitable for generating randomizations, such as SAS PROC PLAN. The randomization codes were made available in a secure electronic format only to the site pharmacy staff administering the study drug who were not involved in any other aspect of the study. The codes were not made available to the Sponsor, study subjects, or staff members responsible for the monitoring and evaluation of safety assessments.