Funding for this research was provided by:
Received: 16 July 2018
Accepted: 15 May 2019
First Online: 21 June 2019
Ethics approval and consent to participate
: The study and all relevant documents have been approved by the following Ethics Committees.Table removedNovartis will provide to treating physicians or other involved medical professionals in a separate document a proposed informed consent form that complies with the Declaration of Helsinki principle and regulatory requirements and is considered appropriate for this study. The physician are instructed to keep the original informed consent form signed by the patient and a signed copy is also given to the patient.Eligible patients may only be included in the study after providing written (witnessed, where required by law or regulation), IRB/EC-approved informed consent, or, if incapable of doing so, after such consent has been provided by a legally acceptable representative of the patient. In cases where the patient’s representative gives consent, the patient should be informed about the study to the extent possible given his/her understanding. If the patient is capable of doing so, he/she should assent by personally signing and dating the written informed consent document or a separate assent form. Informed consent must be obtained before any data are collected. The process of obtaining informed consent should be documented in the patient source documents.
: Not applicable.
: In relation to this manuscript, we declare the following, real or perceived conflicts of interest: K. A. Papp, M. Gooderham, J. Beecker, C.W. Lynde, I. Dei-Cas, I. Delorme and L. Albrecht are advisors and investigators for Novartis. E. Rampakakis and J. Sampalis are third-party employees of Novartis for this study. A. Vieira, S. Hussein, O. Chambenoit and L. Rihakova are employees of Novartis.
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