Updates are available Correction dated 2020-05-20

Article History

Received: 22 March 2019

Accepted: 30 December 2019

First Online: 10 January 2020

Change Date: 20 May 2020

Change Type: Correction

Change Details: An amendment to this paper has been published and can be accessed via the original article.

Ethics approval and consent to participate

: All subjects signed an informed consent form prior to enrollment to the study. The study was approved by the IRB of each participating site.• Fox Chase Cancer Center IRB, 50 Huntingdon Pike, Rockledge, PA 19046• The Methodist Hospital Research Institute IRB, 6565 Fannin Street, MGJ4-010, Houston, TX 77030• University of Kansas Medical Center, Human Subjects Committee, 3901 Rainbow Boulevard, Kansas City, KS 66205• Western Institutional Review Board, 1019 39th Avenue SE Suite 120, Puyallup, WA 98374-2115 (and previously at 3535 Seventh Avenue Southwest, Olympia, WA 98502-5010)• Indiana University IRB, c/o Office of Research Administration, 980 Indiana Avenue, Room 3315, IN 46202• Biomedical Research Alliance of New York, Suite 210, 1981 Marcus Avenue, Lake Success, NY 11042• Weill Cornell Medical College Institutional Review Board, 407 East 61st Street, RR 110, New York 10065The study was performed in accordance with the Declaration of Helsinki (Seoul, October 2008). The IND number is 112502.

: Not applicable.

: PAR, SMC, and BB are full-time employees of Dompé farmaceutici S.p.A. All other authors declare that they have no competing interests.