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516 In parallel, TGR5 activation in LSECs triggers NO production, which enhances hepatocyte sensitivity to HGF, further supporting liver regeneration

While safety monitoring was comprehensive, the trials were not specifically designed to detect rare adverse effects that might occur at rates lower than 1-2%, which would require much larger participant numbers

The FDA's guidance on combination product devices notes that needle gauge selection for SQ delivery should prioritize the smallest gauge that delivers the full dose within 10 seconds of pressure [2]

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