 - Willingness of women of child-bearing potential WOCBP and male subjects whose sexual partners are WOCBP, to use an effective form of contraception pearl index 1, such as complete sexual abstinence, combined oral contraceptive, hormone 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. WOCBP are defined as sexually mature women who have not undergone a hysterectomy or surgical sterilization or who have not been naturally postmenopausal for at least 12 consecutive months i.e., who has had menses any time in the preceding 12 consecutive months. 