Received: 15 January 2020
Accepted: 19 May 2020
First Online: 12 June 2020
Ethics approval and consent to participate
: After institutional review board approval was provided at each institution, written informed consent was obtained from each patient or the patient’s legally authorized surrogate prior to conduct of study-specific procedures.<b>Australia:</b> Monash Medical Centre, 246 Clayton Road, Clayton, 3168; Bellberry Limited, 129 Glen Osmond Road, Eastwood, South Australia,<b>Canada:</b> Institutional Review Board Services, Suite 300, 372 Hollandview Trail, Aurora, Ontario, L4G 0A5; Concordia Hospital Ethics Committee, 1095 Concordia Avenue, Winnipeg, Manitoba, R2K 3S8; Comité d’éthique de la recherche de l’Institut universitaire de cardiologie et de pneumologie de Qué, 2725 Chemin Ste-Foy, Quebec, Québec, G1V 4G5.<b>Germany:</b> Ethikkommission Schleswig-Holstein, Bismarckallee 8–12, Bad Segeberg, 23795.<b>Republic of Korea:</b> Incheon Saint Mary’s Hospital, 56, Dongsu-ro, Bupyeong-gu, Incheon, 021431; Seoul National University Boramae Medical center, 20, Boramae-ro 5-gil, Dongjak-gu, Seoul, 156–707; Soon Chun Hyang University Bucheon Hospital, 170 Jomaru-ro, Wonmi-Gu, Bucheon-Si, Gyeonggi-Do, 420–767; Chung-Ang University Hospital, 102, Heukseok-ro, Dongjak-gu, Seoul, 06973; St. Paul’s Hospital, 180, Wangsan-ro, Dongdaemun-gu, Seoul, 02559; Asan Mecial Center, Institutional Review Board, #388–1 Pungnap 2-dong, Songpa-gu, Seoul, 138–736; Kyung Hee University Medical Center, #1 Hoegi-dong, Dondaemeun-gu, Seoul, 130–702; Yonsei University, Wonju Severance Christian Hospital, 20, Ilsan-ro, Wonju, Gangwon-do, 26426.<b>Netherlands:</b> St. Antonius Ziekenhuis, Koekoekslaan 1, Nieuwegein, 3435 CM, Netherlands.<b>Poland:</b> Komisja Bioetyczna, ulica Sklodowskiej-Curie 11, Szczecin, 71–332.<b>Romania:</b> Comisia Nationala de Bioetica a medicamentelor si a Dispozitivelor Medicale, Pavilion K, Spitalul Clinic Colentina, Sos. Stefan cel Mare nr. 19–21, Bucuresti, 20125.<b>Spain:</b> Fundación Jiménez Díaz, Avenue Reyes Católicos, 2, Madrid, 28040.<b>United States:</b> Advarra Institutional Review Board, Suite 110, 6940 Columbia Gateway Drive, Columbia, Maryland, 21046–3431; Western Institutional Review Board, 1019 39th Avenue South East, Suite 120, Puyallup, Washington, 98374–2115.
: Not applicable.
: ALL, BEM, AD, TK, CA and JR are employees of GSK and own shares in the company. RTS is a former employee of GSK and hold shares in the company. HW reports support from GSK related to the conduct of the study.