An adverse event is defined as any unfavorable and unintended sign, including an abnormal laboratory finding, symptom, or disease temporally associated with the use of an investigational product, whether or not related to the investigational product. This includes any occurrence that was new in onset or aggravated in severity or frequency from the baseline condition. Adverse events (AEs) assessments will begin at time of signing of informed consent and will continue until 30 days following study treatment. AEs which are assessed as possibly, probably, or definitely related to study treatment must be followed until the AE is resolved or until the patient is clinically stable. Other safety assessments, including physical examinations, vital signs, hematology, clinical chemistry, and urinalysis, will be done through subject discontinuation or 12 months after initial study treatment, whichever occurs first.