Within 6 weeks prior to randomization: Aspartate aminotransferase (AST) must be =< 1.5 x ULN for the lab* Note: If alanine aminotransferase (ALT) is performed instead of AST (per institution's standard practice), the ALT value must be =< 1.5 x ULN; if both were performed, the AST must be =< 1.5 x ULNXx_NEWLINE_xXRe-registration: AST/ALT =< 3 x ULNXx_NEWLINE_xXAspartate aminotransferase (AST) must be =< 3 x ULN for the lab within 28 days before randomization;* Note: if alanine aminotransferase (ALT) is performed instead of AST (per institution's standard practice), the ALT value must be =< 3 x ULN; if both were performed, the AST must also be =< 3 x ULN; if AST and/or ALT is >= ULN but =< 3 x ULN, serologic testing for hepatitis B and C must be performed and results for viral infection must be negativeXx_NEWLINE_xX