Ethics approval and consent to participate
The study was conducted according to the principles defined in the Declaration of Helsinki and Good Clinical Practices. All participating investigators obtained full ethics or institutional review board approval according to their local regulations. The Ethik-Kommission des Landes Berlin, Landesamt für Gesundheit und Soziales, Berlin, provided approval for the lead site in Germany (reference# 18/0339 – EK 12/15). Written informed consent was obtained from all participating patients.