 2. Postmenopausal, surgically sterile, or willing to use acceptable means of contraception for at least 30 days after surgery including any of the following: hormonal contraceptives e.g., oral, injectable, implantable starting at least 30 days before study administration, effective double-barrier methods e.g., condoms with spermicide, intrauterine device, lifestyle with a personal choice of abstinence, nonheterosexual lifestyle, or a strictly monogamous relationship with a partner who has had a vasectomy. 