 Safety evaluations included physical examinations, vital signs, ECGs, clinical laboratory assessments clinical chemistry, hematology, urinalysis, and serology, urine drug and alcohol screens, urine cotinine and exhaled CO screens, and pregnancy tests females only. Adverse events spontaneously reported by the subjects or observed by the Investigator or other study personnel were monitored from the time of Check-in until the End-of-Study or Early Termination. Any concomitant medications taken from 30 days prior to Check-in through the End-of-Study or Early Termination were recorded. 