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Article History

Received: 2 September 2018

Accepted: 23 November 2018

First Online: 20 December 2018

Ethics approval and consent to participate

: The CIS-PD study protocol and informed consent was approved by the local (Institutional Review Board) IRB committees at each site. The specific four IRBs were: University of Cincinnati Institutional Review Board, University of Alabama at Birmingham Institutional Review Board 01, University of Rochester Research Subjects Review Board, and the Northwestern University Institutional Review Board.The HD study protocol was approved by relevant site ethics committees and institutional review boards (Western IRB and Chairperson Bert Wilkins, JD, MHA IRB00000533, Puyallup, Washington US; Wake Forest University Health Sciences IRB and Chairperson Sally Bulla, PhD, RN FWA00001732, Winston-Salem, NC US; Georgetown University IRB and Chairperson Charbel Moussa, MD, PhD FWA00001080, Washington DC US; Columbia University IRB and Chairperson Elaine Larson, PhD, RN FWA00002636, New York NY US; Ethikkommission der Medizinischen Universitaet and Chairperson Reinhard Putz, Professor, Dr., Innsbruck Austria; East Midlands - Leicester South Research Ethics Committee and Chairperson John Aldridge, Nottingham UK; Ethik-Kommission der Ärztekammer Westfalen-Lippe und der medizinischen Fakultat der WWU and Chairperson Wolfgang E Berdel, Professor, Dr. med, Rechtsmedizin Germany). Written informed consent was obtained from each patient before any study procedures or assessments were done. These analyses were conducted in accordance with the protocol of the observational sub-study within Study TV7820-CNS-20016 (Open PRIDE-HD) and with the International Conference for Harmonisation Guidelines for Good Clinical Practice, the Declaration of Helsinki, and relevant national and local regulations.

: Not applicable.

: SC and ZW are Intel employees. MFG, IDG, LNP, SF, IG, SP, and J-MS are or were Teva Pharmaceuticals employees during the course of the study.

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