 12. Clinically significant ie, active cardiovascular disease. This includes, but is not limited to, the following examples: cerebrovascular accidents 6 months prior to randomization, myocardial infarction 1 year prior to randomization, uncontrolled hypertension 150100 mmHg while receiving chronic medication, unstable angina, New York Heart Association NYHA Grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication, clinically significant electrocardiogram ECG findings e.g. QTc 440 msecs male 460 msecs female or 2o atrioventricular block, etc.. 