An NAS ≥ 5 correlated with the diagnosis of NASH (n = 137), patients with scores <3 were diagnosed as not having NASH (n = 1), and patients with scores of 3 and 4 were diagnosed as having borderline NASH (n = 48; Fig. 1). The follow-up, symptoms, and adverse effects were assessed as described previously. Biochemical measurements were conducted at the Central Laboratories of Dr. Spranger and Partner (Ingolstadt, Germany). Data were selleck chemicals llc evaluated with SAS version 9.1 statistical software. Statistical analysis was performed by Sonja Kaftan at the Institute for Research and Development (IFE Europe GmbH, Essen, Germany). Fisher’s exact test with a two-sided significance level

of 0.050 is 80% capable of detecting a difference between a selleckchem group 1 proportion of 0.3 and a group 2 proportion of 0.1 when the sample size in each group is 69. With a protocol violation rate of approximately 15% taken into account, 170 patients should be enrolled. Pre-post differences between the histology sum scores at the baseline and at the study end were calculated for each group by the two-sided Wilcoxon rank sum test with an α-level of 5%. Pre-post differences between each of the histological criteria and pre-post differences between each

of the liver function tests and the other clinical parameters were compared with the Wilcoxon rank sum test. For the comparison of each of the parameters between the treatment groups, Fisher’s exact test was used. UDCA (500-mg Ursofalk tablets) and placebo were provided by Dr. Falk Pharma GmbH (Freiburg, 上海皓元医药股份有限公司 Germany). The placebo was identical in shape, color, and size. The patient information leaflet for study participation was prepared by IFE Europe. Before enrollment into the study, written, informed consent was obtained from each patient. The study was approved by the ethics committee of the University of Frankfurt (Frankfurt,

Germany) on June 4, 2002 and by Landesärztekammer (LAEK) Hessen on June 25, 2002 according to §40 Arzneimittelgesetz (AMG), and it was in compliance with the Declaration of Helsinki. The first patient entered the study in August 2002, and the last one completed it in April 2008. Thirty-nine of the 186 patients were removed from the ITT set because of major protocol violations. Opening of the emergency code envelope occurred for two patients. For six patients, the first biopsy sample was older than 1 month, and two patients had antinuclear antibody/smooth muscle antibody titers >1:160. For seven patients, the aspartate aminotransferase (AST) or ALT level was less than 1.5 times the upper limit of normal, and they did not have simultaneous findings indicative of metabolic syndrome. In one patient, type 2 diabetes could not be controlled sufficiently. One patient had concomitant medication (bezafibrate) for more than 48 days. In 9 patients, the date of the final visit was later than 90 days, and 11 patients were not compliant.