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[Correspondence] Trials of obeticholic acid for non-alcoholic steatohepatitis

Timely recruitment to multicentre randomised-controlled trials is of paramount importance for non-alcoholic steatohepatitisis, and the investigators of the FLINT study were able to enrol 283 patients in just 20 months.1 For trials of non-alcoholic steatohepatitis, this approach has led to challenges in the interpretation of the uniformity and reproducibility of the therapeutic effect. In the FLINT study, for example, drug efficacy varied noticeably between trial sites, with the odds of a patient achieving histological improvement ranging from 0·6 (in favour of placebo) to 12·4, while placebo response ranged from 0% to 44%.