Serum lipase and amylase =< . x ULN Amylase and lipase =< x ULN Amylase and lipase < . x ULN obtained ? days prior to randomization Amylase and lipase =< . ULN; subjects with amylase or lipase > . ULN may enroll if there are neither clinical nor radiographic signs of pancreatitis Serum lipase and amylase =< . x ULN. Serum lipase and amylase =< . x ULN. Serum amylase/lipase =< . x ULN FULL STUDY INCLUSION CRITERIA: Amylase and lipase =< . x ULN Serum amylase and lipase =< x ULN Serum amylase and lipase =< . x ULN Serum amylase and lipase =< . x institutional ULN Normal serum lipase and amylase (per institutional normal values) Have normal pancreatic status as defined by the following criterion: a. Serum lipase and amylase ? . ULN Serum lipase and amylase =< . x ULN Serum lipase and amylase =< . x ULN Within days prior to first dose of study drug treatment: Amylase and lipase =< . x ULN Serum amylase and lipase within normal limits Amylase and/or lipase =< . x ULN, obtained =< days prior to registration Patients must have a lipase and amylase performed within days prior to sub-study registration Serum amylase and lipase =< . x the ULN Within days of subject registration: Serum amylase =< x ULN and serum lipase within normal limits Amylase (- U/L) and lipase (- U/L) levels within . times the range of normal Amylase and lipase =< . x the upper limit of normal Patients must have a lipase, amylase, TSH with reflex free T/T performed within days prior to sub-study registration; (Note: For the Canadian sites, testing for lipase only is acceptable) Amylase and lipase <=ULN [Applies to Phase ]. Amylase and lipase ? X upper limit of normal Asymptomatic serum amylase or lipase > Grade Serum lipase and amylase =< . x ULN; NOTE: if subject has tumor involvement in the liver =< x ULN Serum lipase/amylase ?. x ULN Serum amylase > . x ULN or serum lipase > . x ULN. Amylase and lipase levels =< ULN Amylase and lipase =< . x ULN Amylase and lipase < . x of ULN Serum amylase or lipase <. x ULN; Amylase and lipase =< x ULN Amylase and lipase ? . x ULN (? x ULN for subjects with pancreas involvement with tumor) Serum lipase ? x ULN and serum amylase within the normal range Serum lipase ? x ULN and serum amylase within the normal range Lipase and amylase =< . x ULN Serum amylase =< upper limit of normal (ULN) (if > ULN, confirm pancreatic amylase < .ukat/L and serum lipase < ULN) Serum amylase and lipase within normal limits Amylase and lipase ? . x ULN Amylase and Lipase < . x normal for age.