End Points Must Be Clinically Meaningful for Drug Development in Nonalcoholic Fatty Liver Disease

Nonalcoholic fatty liver disease (NAFLD) has emerged as a major cause of chronic liver disease in many parts of the world. It is associated with increased mortality owing to cardiovascular and liver disease and is also associated with an increased risk of several types of cancer including hepatocellular cancer, which can develop even in the absence of cirrhosis.1–3 It is projected to surpass hepatitis C virus infection as an etiology for end-stage liver disease as well as hepatocellular cancer requiring liver transplantation.

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