 - Female participants must be: postmenopausal for at least one year, surgically sterile, or practicing an effective method of birth control e.g., prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch, male partner sterilization, abstinence and agreeing to continue abstinence or to use one of the acceptable methods of contraception just enumerated should sexual activity commence before entry and throughout the study; and have a negative serum pregnancy test at the screening visit. 