Study assessments will occur in both the inpatient (observation) and outpatient (clinic) setting. A total of four observational inpatient days (Days 7, 12, 18, and 29) will be required throughout the study. Serum, saliva, and urine specimens will be collected at specified time-points beginning at the Day 1 visit and concluding at the Day 36 Follow-Up visit. During the inpatient study visits, blood, urine, and salivary samples will be collected every 4 hours.