Efficacy measurements Ultrasonographic nevertheless assessment All patients underwent ultrasonography for liver steatosis after fasting for 10 to 12 hours. Ultrasound scans were performed by a trained operator who was blind to participants’ group allocations. Steatosis severity was scored using the following scale: 0 (normal echogenicity), 1 (mild), 2 (moderate), 3 (severe) [28]. Liver fat infiltration was considered mild when increased echogenicity plus augmented liver size was present, moderate if these two features were present plus sound attenuation, and severe if the walls of the portal vessels and the diaphragm were unseen. Clinical evaluation Patients were questioned about the evolution of their symptoms, such as abdominal discomfort or pain, abdominal bloating, and/or nausea.

The changes were classified as follows: improved, worsened or unchanged. Safety and tolerability Data from the physical examination (determination of bodyweight, BMI, pulse rate, and arterial pressure), laboratory tests and requests for AE were used for the safety and tolerability analysis. AE was predefined as mild when it did not require the withdrawal of study medication, moderate when it required therapy discontinuation according to physicians’ criteria and/or specific treatment of the AE, and serious when it led to or prolonged hospitalization, which could be fatal or nonfatal. Laboratory analysis Blood samples were drawn from 8:00 to 8:30 AM. After an overnight fasting of 12 hours, and aliquots were obtained for laboratory determinations.

Liver enzymes (ALT, aspartate aminotransferase [AST], �� glutamyl transferase [GGT], alkaline phosphatase [ALP]), serum glucose, creatinine, bilirubin, TC, high density lipoprotein cholesterol (HDL-C), and TG were determined AV-951 by enzymatic methods using reagent kits (Roche, Basel, Switzerland). LDL-C values were calculated using the Friedewald equation [29]. Insulin levels were determined using radioimmunoassay and the prothrombin time with the routine laboratory method. The HOMA index was calculated as follows: HOMA = [fasting glucose (in mg/dL) / 18] �� [fasting insulin (in ��UI/mL) / 22.5]. Plasma TAS was assessed by using a reagent kit from Randox (NX2332, Randox, Antrim, UK) and values were reported in mmol/L. Statistical analyses Analyses were conducted in accordance with the intention to treat principle. The data of all randomized patients were analyzed. Sample size was calculated by assuming that the mean reduction from baseline of liver fat infiltration should be greater than 25% with respect to the change in the placebo recipients. A sample size of 25 subjects per group was estimated to be sufficient to detect such differences at a 5% level of significance with 80% power. The data are presented as means �� SD.