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Article History

Received: 14 June 2020

Accepted: 13 October 2020

First Online: 27 October 2020

Ethics approval and consent to participate

: The study was approved by the local Ethics Committee (Medisch Ethische Toetsings Commissie, Assen, The Netherlands). Written informed consent was obtained from each subject prior to enrolment in the study, which was conducted at QPS Netherlands B.V. (Groningen, The Netherlands), in accordance with the revised Declaration of Helsinki principles, International Council for Harmonization Good Clinical Practice guidelines, and applicable laws and regulations.

: Not applicable.

: Idorsia Pharmaceuticals Ltd (Allschwil, Switzerland) sponsored this study. All authors had support from Idorsia for the submitted work; MSM, PNS, and JD are full-time employees of Idorsia and owners of stock units and/or restricted stock units from Idorsia. CV-P is a full-time employee of the clinical research organization QPS Netherlands B.V. (Groningen, The Netherlands) contracted to conduct the study; no other competing interests have been raised. HX is a full-time employee of the ECG service provider eResearch Technology Inc. (ERT®, Rochester, NY, USA) contracted for the evaluation of cardiac safety and statistical analysis of Holter ECG data; BD is a consultant for ERT® and owns stock and is eligible for stock options in the company. No other competing interests have been raised.