Funding for this research was provided by:
Novartis Pharma (NA)
Received: 22 August 2019
Accepted: 28 May 2020
First Online: 12 June 2020
Ethics approval and consent to participate
: The study design was approved by the independent ethics committee and institutional review boards (InternalRef removed); and was in accordance with the Declaration of Helsinki. Informed consent was obtained from each patient (or from parents for children < 16 years of age) in writing before randomization.
: Not applicable.
: SS has served as an investigator in clinical trials for Galapagos, Proteostasis, Celtaxsys, Flatley, Novartis Pharma GmbH and Vertex Pharmaceuticals Incorporated and has consulted for Teva GmbH, Novartis Pharma GmbH, Chiesi GmbH and Vertex Pharmaceuticals Incorporated. SN and UM have nothing to disclose. CS and JZ are employees of Novartis Pharma GmbH.