CONTINUING RETROSPECTIVE AND PROSPECTIVE STUDIES BASED ON DETAILED CLINICAL

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Our preliminary data addressed some of our short-term end-points. We plan long-term follow-up to determine the impact of each of these immunosuppressive protocols on long-term kidney function. We will continue to do intention-to-treat analyses. However, we will also analyze subgroups that remain in their original randomized arm. One of the unexpected limitations of this study has been the high number of recipients that have not continued on one or both of the original study drugs. The multiple reasons for changes include inability to achieve study drug levels, AR, side effects, changes in local physician, and patient preference. Of note, national data show that a high percentage of transplant recipients have one of more of their immunosuppressive medications changed in the first 2 transplant years (32).