Study design and treatments
ICH
FLIGHT-FXR (Study design and number of patients per treatment group are shown in Extended Data Fig. The study protocol and all amendments were reviewed by the Independent Ethics Committee or Institutional Review Board for each center. The study was conducted according to the principles of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) E6 Guideline for Good Clinical Practice, which have their origin in the Declaration of Helsinki. Written, informed consent was obtained from each patient at screening before any study-specific procedure was performed.