The most frequent clinical trial exclusion criteria present were hypoalbuminemia<3 g/dl (21.2%), BMI >40 kg/m2 (5.9%), thrombocytopenia<100,000/ul (7.6%), creatinine>2.5 mg/dl (5.1%), bilirubin>3 mg/dl (5.8%), elevated liver chemistries (ALT/AST; 5.4%/8.4%) and having required mechanical ventilation prior to implant (5.2%). The gene discussed is GPT; the disease is Hypoalbuminemia.