Is minimal, [almost] steroid-free immunosuppression a safe approach in adult liver transplantation? Long-term outcome of a prospective, double blind, placebo-controlled, randomized, investigator-driven study.

Objective: To investigate the safety of minimal immunosuppression (IS) in liver transplantation (LT).

Background: The lack of long-term follow-up studies, including pathologic data, has led to a protean handling of IS in LT.

Methods: Between February 2000 and September 2004, 156 adults were enrolled in a prospective, randomized, double-blind, placebo-controlled minimization trial comparing tacrolimus placebo (TAC-PLAC) and TAC short-term steroid (TAC-STER) IS.