Study design
This phase 3, double-blind, randomized, placebo-controlled study was conducted at 111 sites in 21 countries. The protocol was approved by appropriate local and national institutional review boards or independent ethics committees, and the trial was conducted in accordance with the Declaration of Helsinki and Good Clinical Practice guidelines. All patients provided written informed consent. The trial was preregistered (www.clinicaltrials.gov; NCT03602560). Pol Boudes, Christopher L. Bowlus, Gideon M. Hirschfield, Cynthia Levy, Marlyn J. Mayo, Alexandra Steinberg, John M. Vierling, Charles A. McWherter, and Yun-Jung Choi provided input to study design that led to the protocol. Gideon M. Hirschfield, Charles McWherter, and Yun-Jung Choi had access to all data and reviewed and can vouch for the integrity of the data analyses.