5. The subject has an abnormality in medical history, physical examination, biochemistry, hematology, coagulation, serology, or urinalysis at the screening or admission visit that is considered clinically significant by the investigator or meets grades 2-4 Common Terminology Criteria for Adverse Events (CTCAE) v.4 criteria, or in the opinion of the investigator, could interfere with the objective of the study or the safety of the subject. Notwithstanding, the following values must remain within the normal range values (as determined by the Physician Reference Laboratory [PRL]) in order for a subject to be eligible for the study: calcium, magnesium, potassium, creatinine, ALT, AST, GGT, hemoglobin, absolute lymphocyte count, absolute 50 mg/dL in asymptomatic subjects and absolute leukocyte count values as low as 3.1x109/L in African American subjects will be considered for enrollment at the investigator's discretion. Lastly, the upper limit value for exclusion is modified for the following values and is as follows: INR>1.2, total bilirubin>1.2 mg/dL, serum amylase >143 U/L, LDH>261 U/L, and CPK>367 U/L, which do not normalize upon repeat testing, will be exclusionary.