Table 1.

Standardised format for comparison of study populations across trials.

Phenotype	Disease activity	Disease stage	Aetiology/associations
Steatosis Steatohepatitis Indeterminate	NAS - Steatosis - Lobular inflammation - Ballooning SAF - Steatosis - Lobular inflammation - Ballooning - Fibrosis	Fibrosis - Stage 0: No fibrosis - Stage 1a: Mild perisinusoidal - Stage 1b: Moderate perisinusoidal - Stage 1c: Portal/periportal - Stage 2: Perisinusoidal and portal/periportal - Stage 3: Bridging - Stage 4: Cirrhosis	Insulin resistance Alcohol Lean NASH PNPLA3+ Drugs Inherited disorders (e.g., Weber-Christian, hypobetalipoproteinemia) Lipodystrophy Short bowel TPN Jejunoileal bypass

Copyright belongs to Siddiqui, M.S., et al., Case definitions for inclusion and analysis of endpoints in clinical trials for non-alcoholic steatohepatitis through the lens of regulatory science. Hepatology, 2018. 67(5): p. 2001-2012. No changes were made to this table. DOI: https://creativecommons.org/licenses/by-nc-nd/4.0/

PNPLA3, patatin-like phospholipase domain containing 3; TPN, total parenteral nutrition.