3 results
The purpose of this clinical investigation is to verify the efficacy and safety of the CVRx Neo System in subjects who qualify for the implantation for a Baroreflex Activation Therapy System compared with subjects who do not receive this device.
Main Objective: To assess the effects of OCA in patients with PBC on: -Serum alkaline phosphatase (ALP) and total bilirubin, together as a composite endpoint -SafetySecondary Objectives:To assess the effects of OCA in patients with PBC on:-…
The primary objective is to minimize the occurrence of sub-therapeutic and supra-therapeutic C0 of tacrolimus on day 3 after transplantation by basing the starting dose of tacrolimus on a dosing algorithm, rather than the standard bodyweight-only-…