Received: 24 November 2020
Accepted: 7 May 2021
First Online: 8 September 2021
: Approved by the Institutional Review Board (IRB) at the University of Alabama at Birmingham (UAB – IRB approval number 130408004). Oversight was provided by a Data Safety Monitoring Board. The trial was conducted in accordance with the provisions of the Declaration of Helsinki and the International Conference on Harmonization Good Clinical Practice Guidelines and registered in ExternalRef removed (NCT02038179). Written informed consent was obtained from all participants.
: Not applicable.
: Kenneth G Saag reports the following: Consultant for Arthrosi, Atom Bioscience, Horizon, Inflazome, LG Pharma, Mallinkrodt, SOBI, Takeda; research grants from Horizon, SOBI, and Shanton. No other authors report conflicts of interests.