a) they are documented to be surgically sterile or post-menopausal [amenorrhea >1 year and FSH >30mU/mL]; --OR-- b) they are using a hormonal birth control method (oral contraceptives, contraceptive implants); --OR-- c) they are using a barrier method of contraception (male or female condoms, diaphragm, cervical cap) with a spermicide.