Fig. 1

Subject disposition. The full analysis set (FAS) consisted of all randomized subjects. The modified FAS (mFAS) consisted of all randomized subjects except those who dropped out for reasons unrelated to outcome as judged by an independent adjudication committee. The completers population included all subjects who had at least a 12-month visit. The per protocol population consisted of all subjects who had no major protocol violation between randomization and at least the 12-month visit. N is the number of subjects in each group