 - Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, congestive heart failure NYHA Class 3 or greater, cirrhosis with a Child-Pugh level of B or greater or evidence of cardiac dysfunction, unstable angina pectoris, cardiac arrhythmia, myocardial infarction within 6 months, hypotension defined by systolic blood pressure 86 mmHg at Screening visit, hypertension defined by systolic blood pressure 170 mmHg or diastolic blood pressure 105 mmHg at Screening visit, bradycardia defined by 50 beats per minute on ECG performed at screening, active peptic ulcer disease, clinically significant gastrointestinal conditions e.g. Crohns disease, ulcerative colitis, any seizure disorder or psychiatric illness, and social situations that would limit compliance with study requirements 