Received: 28 May 2021
Accepted: 5 January 2022
First Online: 25 January 2022
: The MORA study received ethical review board approval in all participating countries (Commissie Medische Ethiek UZ Leuven, 20 October 2014; Comité de Protection des Personnes Ile-de-France X, 4 November 2014; Ethik-Kommission der Medizinischen Fakultät der Universität Würzburg, 15 October 2014; Komisja Bioetyczna przy Dolnośląskiej Izbie Lekarskiej we Wrocławiu, 12 October 2014; Hospital Clínico San Carlos Comité Ético de Investigación Clínica, 6 November 2014; NRES Committee West Midlands – Coventry and Warwickshire, 15 September 2014). The study was approved by all Italian ehical review boards on 20 November 2014. The NOCT study received United States ethical review board approval on 21 August 2014. Both studies were conducted in accordance with the Declaration of Helsinki. Patients provided written informed consent.
: Not applicable.
: The authors declared the following potential conflicts of interest with respect to the research, authorship and/or publication of this article: JM has received honoraria from Norgine Ltd for speaking and investigator advisory board attendance. JH and SJC are employees of Norgine Ltd. MAA-G has received honoraria from Norgine Ltd for advisory board attendance and from Casen-Recordati for speaking and teaching.