 8. Females of child-bearing potential or male patients partners with child-bearing potential must use a highly effective method of contraception pearl index 1 such as complete sexual abstinence, combined oral contraceptive, hormone intrauterine contraceptive device IUCD, vaginal hormone ring, transdermal contraceptive patch, contraceptive implant or depot contraceptive injection in combination with a second method of contraception like a condom or a cervical cap diaphragm with spermicide or surgical sterilisation vasectomy in male patients or male partners during the study and at least 6 months thereafter. 