Patient characteristics
Eighty-six patients were screened for enrollment to this study. A total of 24 patients were excluded at the screening because of the surplus ofCYP3A5 non-expressors (as stated above, the target size of this group was defined as approximately 30). As another two patients were excluded due to overdose of tacrolimus after the conversion to the once-daily extended-release formulation, the study included 60 patients, 28 expressors and 32 non-expressors group among them (Figure 1). The full analysis set (FAS) included all eligible patients who received ≥1 dose of once-daily extended release tacrolimus, with the patients analyzed according to the treatment allocation. The per-protocol (PP) set included all patients who completed the study without a major protocol deviation.
The non-expressor group included a significantly higher proportion of men than the expressor group (77.4% vs. 42.9%, P = 0.008). The two study groups did not differ significantly in terms of other clinical characteristics or in the time elapsed from the liver transplantation to the study recruitment (Table 1).