Williams, Jason H.
Udata, Chandrasekhar
Ganguly, Bishu J.
Bucktrout, Samantha L.
Joh, Tenshang
Shannon, Megan
Wong, Gilbert Y.
Levisetti, Matteo
Garzone, Pamela D.
Meng, Xu
Article History
Received: 24 July 2019
Accepted: 21 November 2019
First Online: 3 January 2020
Compliance with Ethical Standards
: The study, registered at ClinicalTrials.gov (NCT02038764), was conducted in compliance with the Declaration of Helsinki and with all International Conference on Harmonization Good Clinical Practice guidelines. In addition, all local regulatory requirements were followed, in particular, those affording greater protection to the safety of trial participants. The final protocol, amendments, and informed consent documentation were reviewed and approved by Institutional Review Boards and/or Independent Ethics Committees at each participating center. A signed and dated informed consent was required from each subject before any screening procedures were conducted.