Visit 1/Day -3 (-1 day) to Day 1 Screening Visit 2/Day 1 Randomization (Start of Treatment) Visit 3/Day 8 (-1/+3 days) Interim Visit 4/Day 15 (-1/+3 days) End of Treatment / Early Termination Visit 5/ Day 28 (-1/+3 days)* 2 Weeks Post-Treatment/Follow-Up Phone Contact Safety will be assessed by monitoring adverse events (AEs) and clinically significant changes from Visit 1/Screening in laboratory values.