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.