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Article History

Received: 10 August 2018

Accepted: 9 November 2018

First Online: 27 December 2018

Ethics approval and consent to participate

: As previously provided [], the study was approved by “regulatory authorities and ethics committees in 11 countries: the UK, Germany, Switzerland, Estonia, France, Italy, Latvia, Lithuania, Romania, South Africa and Spain.” In addition, as previously reported [], the phase IIa “study protocol, patient information, informed consent forms, and amendments were reviewed and approved by relevant independent ethics committees and institutional review board.”

: Not applicable.

: JMZ is supported by the National Institute for Health Research University College London Hospitals Biomedical Research Centre, and has received consulting fees from Convergence Pharmaceuticals Ltd, a Biogen company. JP, VM, and ST were employees of and shareholders in Convergence Pharmaceuticals Ltd, a Biogen company, at the time of the study, and hold stock in Biogen. LB’s institution received payment for conducting the study; however, LB had no personal financial interest and has no other competing interests to declare with regard to this study. GDS and SM have no competing interests to declare. DAE has received financial support from Convergence Pharmaceuticals Ltd, a Biogen company, and Merz. MO has received scientific support and/or honoraria from Biogen, Convergence Pharmaceuticals Ltd, a Biogen company, Eli Lilly, Genzyme, Heel, Johnson & Johnson, Novartis, Pfizer, Sanofi-Aventis, and Teva; and research grants from Allergan, Electrocore, the German Ministry for Education and Research (BMBF), and Heel. DS was an employee of Biogen at the time of data analysis and manuscript generation and holds stock in Biogen. GC has received financial support and honoraria from Alfasigma, Angelini, and Convergence Pharmaceuticals Ltd, a Biogen company; and has received a research grant from Alfasigma.

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