 - Any disease e. g. active infection, uncontrolled hypertension, clinically significant cardiovascular disease for example CVA 6 months before study start, myocardial infarction 6 months before study start, unstable angina, NYHA grade 2 CHF, arrhythmia requiring medication, metabolic dysfunction giving reasonable suspicion of a disease or condition that contra-indicates the use of the study drugs or puts the patient at high risk for treatment-related complications 