 - Male subjects who are not surgically sterilised vasectomy and are sexually active with female partners who are not using a highly effective method of contraception such as condom with spermicide combined with a highly effective method of contraception for their non-pregnant female partners Pearl Index 1, such as implants, injectables, oral contraceptives, intrauterine devices, diaphragm or cervical capspermicide, andor intend to donate sperm in the period from screening until 3 months following administration of the investigational medical product 