Creatinine =< 1.5 mg/dL OR calculated (calc.) creatinine clearance >= 30 mL/minXx_NEWLINE_xXCreatinine =< 1.5 x upper limit of normal (ULN) mg/dL OR calculated (calc.) creatinine clearance >= 60 mL/minXx_NEWLINE_xXCreatinine =< 1.5 mg/dL x upper limits of normal (ULN) OR calculated (calc.) creatinine clearance >= 30 mL/minXx_NEWLINE_xXCreatinine =< 1.5 x upper limit of normal (ULN) OR calculated (calc.) creatinine clearance > 45 mL/min using the lean body mass formula onlyXx_NEWLINE_xXRe-registration: creatinine =< 1.5 ULN OR calc. creatinine clearance > 45 mL/min (using lean body mass formula only)Xx_NEWLINE_xXWithin 14 days of registration: Calculated (calc.) creatinine clearance > 50 mL/minXx_NEWLINE_xXCreatinine OR =< 1.5 mg/dl x upper limit of normal (ULN) OR calculated (calc.) creatinine clearance > 45 mL/minXx_NEWLINE_xXCreatinine =< 1.5 x upper limit of normal (ULN) OR calculated (calc.) creatinine clearance >= 30 mL/minXx_NEWLINE_xXCalculated (calc.) creatinine clearance > 45 mL/minXx_NEWLINE_xXCalculated (calc.) creatinine clearance >= 50 mL/min by Cockcroft-GaultXx_NEWLINE_xX