These data, taken together with our previous work showing no evidence of genotoxicity of in vivo LV-FAH in an HCC-prone mouse model68 and GSEA showing only enrichment of the PI3K-Akt and TGFb signaling pathways in one animal, establish a favorable safety profile, particularly since hepatocytes have been shown to be susceptible to insertional mutagenesis69,70. The gene discussed is TGFB1; the disease is hepatocellular carcinoma.