Lipase < 2.0 x ULN and no radiologic or clinical evidence of pancreatitis Lipase < 2.0 x ULN and no radiologic or clinical evidence of pancreatitis Lipase < 2.0 x ULN; no radiologic/clinical evidence of pancreatitis Serum lipase =< ULN at baseline; patients with glucose intolerance should be on a stable regimen and be monitored Lipase < 2.0 x ULN and no radiologic or clinical evidence of pancreatitis Amylase and lipase =< 1.5 x ULN without any symptoms of pancreatitis Lipase and amylase =< 2.0 x ULN and no radiologic or clinical evidence of pancreatitis Serum lipase =< 1.5 x ULN Patients must have a lipase, amylase, TSH with reflex free T3/T4 performed within 7 days prior to sub-study registration; (Note: For the Canadian sites, testing for lipase only is acceptable) Patients must have amylase or lipase within =< 1.5 x IULN without symptoms of pancreatitis at registration, within 28 days prior to registration Serum lipase =< 1.5 ULN