 - Females who are breastfeeding or pregnant at Screening or Baseline as documented by a positive beta human chorionic gonadotropin ß-hCG with a minimum sensitivity of 25 International Units per Liter IUL or equivalent units of ß-hCG or hCG. A separate baseline assessment is required if a negative screening pregnancy test was obtained more than 72 hours before the first dose of study drug. 