- Absense of clinically significant (i.e active) cardiovascular disease e.g. cerebrovascular accidents (<6 months prior to randomisation), myocardial infarction (< 1 year prior to randomisation), uncontrolled hypertension while receiving chronic medication, unstable angina, New York Hearth Association (NYHA) grade II or greater congestive heart failure, or serious cardiac arrhymia requiring medication.