 4. Willing and able to provide written informed consent after having been informed of the requirements and the restrictions of the study. Female subjects of childbearing potential must agree to use a highly effective method of birth control defined as those which result in a low failure rate i.e. less than 1 per year when used consistently and correctly such as sexual abstinence, vasectomised partner, non hormonal IUDs, double barrier methods, for instance, e.g. condom and spermicide cream. 