 13. Subject is pregnant positive serum beta human chorionic gonadotropin b-HCG test at screening or is currently breast-feeding, anticipates becoming pregnantimpregnating their partner during the study or within 6 months after study participation, or subject does not agree to follow acceptable methods of birth control, such as hormonal contraception, intra-uterine pessar, condoms or sterilization, to avoid conception during the study and for at least 6 months after receiving the last dose of study treatment 