 Female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence for the duration of the study. Female subject is not pregnant or breast-feeding. Confirmation that the subject is not pregnant must be established by a negative serum beta-human chorionic gonadotropin beta-hCG pregnancy test result obtained during screening. Pregnancy testing is not required for post-menopausal or surgically sterilized women 