3. Women of child-bearing potential must have a negative serum pregnancy test at screening and negative urine pregnancy at check-in, and must agree to avoid pregnancy during study. Pregnancy is tested at screening, during check-in, and at any given time if deemed necessary by the PI or designate. During the study, women of child-bearing potential must use two acceptable methods of contraception at the same time. Medically acceptable contraceptives include: (1) documented surgical sterilization (such as a hysterectomy), (2) barrier methods (such as a condom or diaphragm) used with a spermicide, or the use of a condom with a spermicide and (3) hormonal contraception (combination oral contraceptives, transdermal patch, injectables, implantables or vaginal ring) or (4) an intrauterine device (IUD) or intrauterine system (IUS). Abstinence is not an acceptable form of contraception in this study.