Exclusion criteria: 1) subject is pregnant; 2) subject has history of surgical revision or conversion of bariatric procedure; 3) subject has a history of hospitalization for acute illness in the previous 3 months; 4) subject has current active malignant neoplasm; or history of malignancy other than localized basal cell cancer of skin during previous 5 years; 5) subject has current history type 1 or type 2 diabetes mellitus.