 8. For female subjects: agrees to avoid pregnancy from 28 days prior to Study Day 0 and for the full duration of the study. Women physically capable of pregnancy not sterilized and still menstruating or within 1 year of the last menses if menopausal in sexual relationships with men must use an acceptable method of avoiding pregnancy during this period. Acceptable methods of avoiding pregnancy include a sterile sexual partner, sexual abstinence not engaging in sexual intercourse, hormonal contraceptives oral, injection, transdermal patch, or implant, vaginal ring, intrauterine device IUD, or the combination of a condom or diaphragm with spermicide. 