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Article History

Received: 4 April 2018

Accepted: 18 July 2018

First Online: 7 August 2018

Ethics approval and consent to participate

: This study was conducted in accordance with the study protocol, Good Clinical Practice (GCP), as defined in Title 21 of the US Code of Federal Regulations Parts 50, 54, 56, 312, and Part 11, and the International Conference on Harmonisation GCP consolidated guidelines (E6: Guideline for Good Clinical Practice) and applicable regulatory requirements. All aspects of the ethics review were conducted in accordance with the Declaration of Helsinki or local laws, whichever provided the greater level of protection for patients. The protocol and all amendments were reviewed and approved by qualified independent review boards (IRBs), including Quorum Review IRB, Avera IRB, University of Michigan IRB, Georgia Health Sciences University Human Assurance Committee, Human Research Protection Office at the University of Maryland School of Medicine, Western IRB, Emory University IRB, and Cleveland Clinic IRB, before enrollment of patients in the study at each site. Informed consent was obtained from each patient in writing before any protocol-specific screening tests were performed.

: Not applicable

: MT has participated as an investigator in clinical trials funded by Incyte Corporation, NS Pharma, CTI BioPharma, and Gilead. SE-V and KH are employees and stockholders of Incyte Corporation. SH is a member of the speaker’s bureau for Incyte Corporation. MRB has participated as an investigator in clinical trials funded by Incyte Corporation.

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