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Article History

Received: 2 December 2019

Accepted: 4 February 2020

First Online: 26 February 2020

Ethics approval and consent to participate

: The study (NCT02133001) that the patient in this case report participated in was conducted at 11 centers across the US between June 2014 and February 2016. The study protocol and its amendments were approved by the Sharp HealthCare Institutional Review Board (IRB), CA; Western IRB, WA; Hartford Hospital IRB, CT; University of Iowa IRB, IA; University of Michigan Medical School IRB, MI; Yale University School of Medicine, Human Investigation Committee, CT; Mayo Clinic IRB, MN; University of Pennsylvania, PA; Johns Hopkins Medicine IRB, MD; and Baylor College of Medical and Affiliated Hospitals IRB, TX. The study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki, consistent with Good Clinical Practice guidelines and applicable regulatory requirements. All participants provided written informed consent before participation.

: Not applicable as the information presented in this case report is fully anonymized.

: NB has been a consultant for Janssen Pharmaceuticals. RS has received grant support from the National Institutes of Health, Patient-Centered Outcomes Research Institute, Acadia Pharmaceuticals, Allergan Inc., Intracellular Therapies, Janssen Pharmaceuticals, Navitor Pharmaceuticals Inc., NeuroRx Inc., Novartis Inc., Otsuka Pharmaceuticals, and Sage Therapeutics. RS has been a consultant for Acadia Pharmaceuticals, Allergan Inc., Janssen Pharmaceuticals, and Lundbeck A/S.