 4. All male subjects must practice effective contraception during the study. Females of childbearing potential must use a medically accepted form of birth control, unless postmenopausal for 1 year as documented by elevated follicle-stimulating hormone FSH or surgically sterile. All females of childbearing potential must have a negative serum pregnancy test human chorionic gonadotropin beta hCGβ at screening and a negative urine pregnancy test on Day 1 pre-dose. 