 - women of childbearing potential must be excluded if:Subject is pregnant does not have negative pregnancy tests at screening and at D-2 or breastfeeding subject does not agree to use an acceptable method of effective contraception: intrauterine device, intrauterine system, established use of oralinjectableimplantable transdermal hormonal methods, barrier methods of contraception condoms, occlusive caps with spermicidal foamgelfilmsuppository, vasectomised partner or true abstinence periodic abstinence and withdrawal are not effective methods until the end of the safety follow-up period. 