Fig 1. CONSORT flow diagram of randomized 2x2 trial of rATG induction dosing and delayed CNI withdrawal [52].

The study statisticians provided computer-generated randomized assignments in sequentially-numbered, sealed opaque envelopes opened after obtaining consent for trial participation. Randomization included stratification by race (Caucasian/Asian vs. non-Caucasian/Asian), donor type (living vs. deceased), and whether listed for eventual pancreas transplantation. Study patients were identified and enrolled by attending transplant physicians and study coordinators. The integrity of the treatment arm assignments made by this system was monitored and confirmed by the study statisticians. Two patients not meeting enrollment criteria were consented and randomized in error, but were identified before transplantation and removed from participation in the trial.