 - For women of childbearing potential; negative pregnancy testing within 72 hours prior to or on study visit 1 day 0 and willingness to use adequate contraception during the study intervention; OR post-menopausal defined as any one of the following 1 prior hysterectomy, 2 absence of menstrual period for 1 year in the absence of prior chemotherapy or 3 absence of menstrual period for 2 years in women with a prior history of chemotherapy exposure who were pre-menopausal prior to chemotherapy; in women of childbearing potential, effective contraception must be used for one month prior to the initiation of therapy, during therapy, and for at least one month following discontinuation of therapy; it is recommended that two reliable forms of contraception be used simultaneously 