Funding for this research was provided by:
Nichi Iko (Not applicable)
Received: 20 November 2018
Accepted: 20 July 2019
First Online: 14 August 2019
Ethics approval and consent to participate
: The study protocol has been reviewed and approved by Copernicus Group, Independent Review Board (IRB), IRB tracking number SYN3–15-614, and was approved by each participating center’s IRB. The IRB approval for the phase I study was granted 9 November 2015 and the IRB approval for the phase II study was granted on 18 January 2016. Written informed consent for study participation and use of collected data and biologic specimens for ancillary studies will be obtained from subjects or authorized surrogates by study site personnel.
: Not applicable.
: MR has no disclosures.JN is employed by Kangen Pharmaceuticals America, LLC.PH has served as a consultant for Abbvie, Inc. and Kangen Pharmaceuticals America, LLC (formerly KC Specialty Therapeutics, LLC).