Ethics approval and consent to participate
der, Ethik-Kommission der
DEL, DER, POLAND
The study was conducted in compliance with the Declaration of Helsinki, the International Council on Harmonisation Guidance for Good Clinical Practice, and applicable regulatory requirements, and was approved by the institutional review board/ethics committee of each study site, including: Canada: Mount Sinai Hospital Research Ethic Board, Toronto, Canada; IRB Services, Aurora, Canada; Western University Health Science Research Ethics Board, Western University, London, ON, Canada; Ottawa Health Science Network Research Ethics Board, Ottawa Hospital, Ottawa, Canada; University of Alberta Health Research Ethics Board, Health Research Ethics Board Biomedical Research, Edmonton, Canada; Queens University Health Sciences and Affiliated Teaching Hospitals Research Ethics Board, Queen’s University Research Services, Ontario, Canada. Czech Republic: Central Ethics Committee (CEC): Ethics Committee FN Hradec Kralove, Czech Republic; Local Ethics Committee (LEC): Eticka komise ISCARE, Praha 7, Czech Republic; LEC: Eticka komise Fakultni nemocnice Kralovske Vinohrady, Praha 10, Czech Republic; LEC: Eticka komise mestske nemocnice, Ostrava, Czech Republic. France: Comité de Protection des Personnes Nord Ouest II, Amiens, France. Germany: EC Ethik-Kommission der Ärztekammer, Hamburg, Germany; Ethikkommission der Landesärztekammer, Cottbus, Germany. Hungary: Ethics Committee of Hungary—Central, Budapest, Hungary. Italy: Comitato Etico Indipendente Fondazione PTV, Roma, Italy; Comitato Etico A.O. Universitaria, Firenze, Italy; Comitato Etico Area Vasta Centro, Firenze, Italy; Comitato Etico A. O. Della, Napoli, Italy; Ce Seconda Univerità Sun—Aorn Ospe, Degli Studi di Napoli, Aou Sun—Aorn Ospedali Dei Colli, Napoli, Italy; Comitato Etico Dell’IRCCS Istituto Clinico Humanitas, Rozzano, Italy; Comiatato Etico A. O. Policlinico S. Orsola Malpighi, Bologna, Italy; Comitato Etico Indipendente AOU Bologna, Dell'Azienda Ospedaliero Universitaria di Bologna, Bologna, Italy; Comitato Etico Dell’universita’ Cattolica Del Sacro Cuore, E Annesso Policlinico “A. Gemelli,” Roma, Italy; Comitato Etico Universita’ Cattolica—Policlinico Gemelli, Roma, Italy. Poland: Komisja ds. Etyki i Nadzoru nad Badaniami na Ludziach i Zwierzętach, Warszawa, Poland. Spain: CEC: Ciudad Sanitaria i Universitaria de Bellvitge, Comité Ético de Investigación Clínica, Feixa, Barcelona, Spain; LEC: Comité Ético de Investigación Clínica del Hospital de la Santa Creu i Sant Pau, Barcelona, Spain; LEC: Hospital Universitario Germans Trias i Pujol, Comité Ético de Investigación Clínica, Ctra, Badalona, Spain; LEC: Comité Ético de Investigación Clínica, Hospital Universitario Virgen Macarena, Sevilla, Spain; Regional EC: Comité Autonómico de Ensayos Clínicos de Andalucía CAEC, Sevilla, Spain; LEC: Corporacio Sanitaria Parc Tauli, Comité Ético de Investigación Clínica, Barcelona, Spain. United States of America: Icahn School of Medicine at Mount Sinai, New York, NY, USA; Schulman Associates Institutional Review Board, Cincinnati, OH, USA; University of Miami, Miami, FL, USA; University of Chicago Medical Center, Chicago, IL, USA; University of Michigan Health System, Ann Arbor, MI, USA; Weill Cornell Medical College, New York, NY, USA. All patients provided written informed consent.