 - Significant cardiovascular disease New York Heart Association Class III or IV cardiac disease, myocardial infarction within the past 6 months, unstable angina, unstable arrhythmia or a need for anti-arrhythmic therapy use of medication to control heart rate in patients with atrial fibrillation was allowed, if on stable medication for at least the last month prior to randomization and the medication not listed as causing Torsade de Points Section 13.2, Appendix B, protocol version 1.0, Appendix 16.1.1, or evidence of acute ischemia on ECG. 