Interim analyses This trial will follow a group sequential design, with 2 stop-points (interim and final analysis). The trial will stop if efficacy rules are met. The endpoints assessed at the first stop-point will be based on primary outcomes and adverse events. The first will be the interim analysis will occur after the accrual of 50 patients in each arm (100 total) thus representing approximately 1/3 of trial accrual. For the efficacy stop-point, a p-value of 0.001 at interim and 0.05 at final analysis will be used.