Double-Blind, Placebo-Controlled Study of Two Doses of EPA-E in Patients With Non Alcoholic Steatohepatitis (NASH)

Histological Response Defined by Change From Baseline in Standardized Scoring of Liver Biopsies

Patient is considered a responder if histological examination shows: Composite NAS of \<=3 AND no worsening in Fibrosis OR Improvement in NAS by \>=2 across at least 2 of the NAS components AND no worsening in fibrosis A priori threshold for statistical significance is p\<0.05, 1-sided

Time frame: 12 months

Alanine Transaminase (ALT) Levels

Mean change from baseline at month 3 analyzed by Analysis of Covariance (ANCOVA) in the efficacy evaluable analysis set with treatment group as a factor and baseline ALT as a covariate. Principal comparisons were the response between; 1. EPA-E 2700 mg and Placebo groups 2. EPA-E 1800 mg and Placebo groups

Time frame: 3 month endpoint

Alanine Transaminase (ALT) Levels

Mean change from baseline at month 6 analyzed by Analysis of Covariance (ANCOVA) in the efficacy analysis set with treatment group as a factor and baseline ALT as a covariate. Principal comparisons were the response between; 1. EPA-E 2700 mg and Placebo groups 2. EPA-E 1800 mg and Placebo groups

Time frame: 6 months