 - Females of childbearing potential FCBP must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIUmL prior to starting therapy and prior to beginning another cycle if applicable; women of child-bearing potential and men must agree to use adequate contraception hormonal or barrier method of birth control; abstinence prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately; a female of childbearing potential FCBP 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 i.e., has had menses at any time in the preceding 24 consecutive months 