TACROLlMUS (Tac) was approved by the FDA for clinical use in liver transplantation in 1993 and .mycophenolate mofetil (MMF) was approved in 1995 for use in kidney transplantation with cyclosporine. The aim of the present study was to compare the combination of Tac and steroids (double therapy, group D) versus tacrolimus, steroids, and MMF (triple therapy, group T) in primary adult (age> IS years) liver transplantation (LTx). An interim report was published on the first 200 patients with a mean follow-up of 12.7 ::': 0.4 months. l The present report includes the entire study population of 350 consenting patients enrolled between August 1995 and May 1995. All patients were followed until January 2000 with a mean follow-up of 33.S ::': 9.1 months (range 20 to 53). Patient and donor characteristics were similar in both groups.