 - Female subjects who are of child bearing potential pre-menopausal and not surgically sterilised and are sexually active with male partners who are not surgically sterilised vasectomy and are not using highly effective contraceptive methods Pearl Index 1,such as implants, injectables, oral contraceptives, intrauterine devices, diaphragm or cervical capspermicide combined with a highly effective method of contraception for their male partners e.g. condom with spermicide, andor are pregnant, breast-feeding or intend to become pregnant applicable to Part II MD only 