Two interim and one final statistical analyses were planned for and conducted during this study:
* Interim Analysis 1 (futility analysis),
* Interim Analysis 2 (\~18 months into study): database cutoff date 12-May-2014, and
* Final Analysis (\~36 months into study): database cutoff date 16-Nov-2015. The End of Trial Analysis for the study was conducted at \~75 months into the study: database cutoff date 31-Jan-2019.