 - Females of childbearing potential FCBP - A female of childbearing potential is a sexually mature woman who: 1 has not undergone a hysterectomy or bilateral oophorectomy; or 2 has not been naturally postmenopausal for at least 24 consecutive months may be included if the patient is not pregnant by a negative serum β-human chorionic gonadotropin β-hCG pregnancy test result obtained during screening. Pregnancy testing is not required for post-menopausal or surgically sterilized women. FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy. Females must agree to avoid pregnancy during the study and must agree to use a medically acceptable method of birth control as determined by the study doctor while participating in the study and for at least 12 weeks after the last dose of study medication. 