Primary analysis population was reverted back to ITT (including lower risk patients). 2Reconsent process was implemented for all randomized patients in an attempt to collect extended follow-up data for 5- years post-randomization.
Primary analysis population was reverted back to ITT (including lower risk patients). 2<br><br>Reconsent process was implemented for all randomized patients in an attempt to collect extended follow-up data for 5- years post-randomization.