 6. Female patients of reproductive potential will have a negative urine β-hCG test at screening and prior to drug administration. If sexually active, female participant agrees to use andor have their partner use two acceptable methods of birth control beginning at least 2 weeks prior to administration of study drug and throughout the study. Acceptable methods of birth control are abstinence, or 2 of the following: intrauterine device IUD, diaphragm, spermicides, cervical cap, contraceptive sponge, and condoms 