Shisha, Tamas
Posch, Maximilian G.
Lehmann, Jeanette
Feifel, Roland
Junt, Tobias
Hawtin, Stuart
Schuemann, Jens
Avrameas, Alexandre
Danekula, Rambabu
Misiolek, Patrycja
Siegel, Richard
Gergely, Peter
Funding for this research was provided by:
Novartis
Article History
Accepted: 16 July 2023
First Online: 2 August 2023
Declarations
:
: Conception and design: TS, SH, PG, RF, TJ, AA. Collection of data: TS, RF, MGP, JL, AA. Data analysis and interpretation: TS, SH, RF, TJ, PG, RD, RS. Manuscript writing and reviewing: TS, JS, SH, RF, TJ, MGP, JL, RS. Final approval of manuscript: all authors.
: The study was funded by Novartis Pharma AG.
: Novartis is committed to sharing with qualified external researchers access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided are anonymised to respect the privacy of participants who have participated in the trial in line with applicable laws and regulations.
: TS, RF, TJ, SH, JS, AA, RD, PM, RS and PG are currently employees of Novartis Pharma AG. MGP and JL were employees of Charité Research Organisation GmbH. MGP is currently an employee of Scirent Clinical Research and Science. JL is currently an employee of Pfizer.
: The study was registered on EudraCT (EudraCT number: 2017-004559-21).
: The study protocol was reviewed and approved by the independent ethics committee (Landesamt für Gesundheit und Soziales (LAGeSo); Geschäftsstelle der Ethik-Kommission des Landes, Berlin) (approval date: 17 May 2018).
: The study was conducted at a single clinical site (Charité Research Organization, Berlin, Germany) in accordance with the ethical principles of the Declaration of Helsinki, Good Clinical Practice standards, and applicable regulatory requirements. All participants provided written informed consent before the study initiation.
: Not applicable.
: Not applicable.