Adjudication results of events of interest.

Abbreviations: AST, aspartate aminotransferase; ALT, alanine aminotransferase; CK, creatinine phosphokinase. *Potential cases were those with abnormal post-dose laboratory test results regardless of the baseline level. †Definition for baseline and post-dose laboratory test results in Table 1. ‡Alternative cause was evaluated for possible cases with adverse events that met definition in Table 1 by the review committee. §Insertion of an indwelling urethral catheter.