11. Subjects who have a cardiovascular condition such as, but not limited to unstable ischemic heart disease, NYHA Class III/IV left ventricular failure, acute ischemic heart disease in the last year prior to study screening, which may impact the safety of the subject or the evaluation of the result of the study according to the Investigator's judgment; history of atrial fibrillation, history of sustained and non sustained cardiac arrhythmias diagnosed within 24 weeks prior to study entry not controlled with therapy.