- Male and female patients will be eligible for enrollment. Females should be either of non-childbearing potential as a result of surgery, radiational therapy, menopause (one year post onset), or of childbearing potential and practicing a medically acceptable method of contraception (eg, abstinence, a barrier method plus spermicide, or intrauterine device [IUD]) for at least three months before Visit 1 (Screening) and for two months after the end of the study. They must also have a negative serum beta-human chorionic gonadotropin (beta-hCG) at Screening. Pregnant and/or lactating females are excluded. Those women using an oral contraceptive must also be using an additional approved method of contraception (eg, a barrier method plus spermicide, or IUD) starting with the Baseline Phase and continuing throughout the entire study period.