 - Sexually active females, unless surgically sterile or at least two years post-menopausal or an FSH40 mIumL, must use an effective method of avoiding pregnancy including oral, injectable, transdermal, abstinence, use of a condom by the sexual partner or sterile sexual partner for 3 months before the first dose of study drug, and must agree to continue using such precautions through the study period of 84 days. Cessation of birth control after this point should be discussed with a responsible physician. Sexually active males, unless surgically sterile, must likewise use an effective method of birth control condom or abstinence and must agree to continue using such precautions through Study Day 84 after their dose of study drug. 