- Patients with uncontrolled concurrent illness, including but not limited to: ongoing or active infection; uncontrolled arterial hypertension (>/= 140/90 mm of mercury on medications); uncontrolled endocrine diseases (e.g. diabetes mellitus, hypothyroidism or hyperthyroidism, adrenal disorder); altered mental status or psychiatric illness/social situations that would limit compliance with study requirements and/or obscure study results