This committee will have three responsibilities: 1) monitor identification, enrollment, and randomization procedures to detect any evidence of bias; 2) monitor adverse events to determine if they occur disproportionately in one group, and 3) monitor key clinical outcomes to determine if one group does significantly better than the other. To assist the DSMB in its work, our statistician, Vicki Hertzberg, will monitor the progress of the study on a monthly basis. The DSMB will have no role in the day-to-day conduct of the trial. The study statistician will report to the DSMB at quarterly meetings.