 - Poorly controlled hypertension at the physicians discretion or clinically significant i.e. active cardiovascular disease: cerebrovascular accident CVA stroke within 6 months prior to the first study treatment, myocardial infarction within 6 months prior to the first study treatment, unstable angina, New York Heart Association NYHA grade II or greater congestive heart failure CHF, or serious cardiac arrhythmia requiring medication. 