 - Myocardial infarction within 6 months prior to enrollment or has New York Heart Association NYHA class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities not including 1st degree atrioventricular AV-block, Wenckebach type 2nd degree heart block, or left bundle branch block; prior to study entry, any electrocardiogram ECG abnormality at screening has to be documented by the investigator as not medically relevant; note: there is no lower limit of left ventricular ejection fraction below which patients are excluded from participation 