 - Use of prescription or non-prescription drugs including CYP 3A4 inhibitors and inducers, vitamins and dietary or herbal supplements, from 14 days before screening until the follow-up visit, unless in the opinion of the Investigator and sponsor the medication will not interfere with the study. Inhaled beta-2 agonists and acetaminophen up to 4 g per day for the treatment of minor ailments, eg headache, are permitted. Hormone replacement therapy HRT is also permitted for post-menopausal females. 