Other illness that in the opinion of the investigator would exclude the patient from participating in this study, including uncontrolled diabetes mellitus, cardiac disease Uncontrolled diabetes mellitus Uncontrolled diabetes mellitus Uncontrolled diabetes mellitus Patients with serious, uncontrolled, concomitant disorder(s) such as diabetes mellitus Patients with uncontrolled arterial hypertension despite optimal medical management or uncontrolled type I or II diabetes mellitus; patients with well-controlled arterial hypertension or diabetes mellitus are eligible Uncontrolled hypertension or diabetes mellitus Uncontrolled diabetes mellitus Uncontrolled diabetes mellitus Uncontrolled diabetes mellitus Subject has uncontrolled diabetes mellitus Uncontrolled endocrine disorders including diabetes mellitus, hypothyroidism, or hyperthyroidism. Uncontrolled diabetes mellitus Uncontrolled hypertension or uncontrolled diabetes mellitus Patients with severe medical problems such as uncontrolled diabetes mellitus or cardiovascular disease or active infections are not eligible for this trial History of uncontrolled diabetes mellitus or diabetic neuropathy Uncontrolled hypertension, or uncontrolled diabetes mellitus Uncontrolled diabetes mellitus. Diabetes mellitus uncontrolled by medication Uncontrolled diabetes mellitus Any other severe, uncontrolled medical condition, including uncontrolled diabetes mellitus or unstable congestive heart failure. Uncontrolled diabetes mellitus. Uncontrolled diabetes mellitus or inadequately controlled hypertension Uncontrolled diabetes mellitus Diabetes mellitus uncontrolled Uncontrolled heart failure or hypertension or uncontrolled diabetes mellitus Uncontrolled heart failure or hypertension or uncontrolled diabetes mellitus Diabetes mellitus uncontrolled Uncontrolled diabetes mellitus Patients with uncontrolled diabetes mellitus The patient has uncontrolled diabetes mellitus (despite therapeutic intervention) and occurrence of more than episodes of ketoacidosis in the months prior to the first dose of study drug. Patients with uncontrolled diabetes mellitus Uncontrolled diabetes mellitus, hypothyroidism, or hyperthyroidism Have uncontrolled diabetes mellitus or uncontrolled hyperglycemia Uncontrolled diabetes mellitus Subject has uncontrolled diabetes mellitus, in the judgment of the Principal Investigator. Uncontrolled diabetes mellitus Uncontrolled diabetes mellitus