 - Uncontrolled or severe cardiovascular disease, including myocardial infarction, unstable angina, or atrial fibrillation AFib within 6 months prior to study treatment, New York Heart Association NYHA Class II or greater congestive heart failure, serious arrhythmias requiring medication for treatment, clinically significant pericardial disease, cardiac amyloidosis, or QTc with Fridericia s QTcF correction that is unmeasurable or greater than or equal to 480 msec on screening ECG. Note: for QTcF greater than or equal to 480 sec on the screening ECG, the ECG may be repeated twice at least 24 hours apart; the mean QTcF from the three screening ECGs must be 480 msec in order to meet eligibility for trial participation. 