- for females, the following conditions are to be met: all female subjects must be confirmed as not pregnant via serum pregnancy test; females must be of non-childbearing potential (defined as either surgically sterile or at least 1 year postmenopausal); or female subjects of childbearing potential must use 2 of the 3 following acceptable birth control methods from the time specified prior to the study through 60 days following the last dose of study drug: intrauterine contraceptive device (IUD) in place for at least 2 months prior to study; barrier method (condom or diaphragm) with spermicide for at least 14 days prior to screening; stable hormonal contraceptive for at least 3 months prior to study;