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Article History

Received: 7 July 2021

Accepted: 24 October 2021

First Online: 2 February 2022

Declarations

:

: LC is a current employee of Bayer AG, Germany and SS is a former employee of Bayer AG. All other authors declare no competing interests.

: The Food and Drug Administration, Department of Health, Republic of the Philippines approved the study protocol and all relevant study documents prior to study start. Ethical approval was obtained from each participating site of the Philippines (St. Luke’s Medical Center; University of the East Ramon Magsaysay Memorial Medical Center; University of Santo Tomas Hospital), Thailand (Faculty of Medicine Siriraj Hospital; Faculty of Medicine Vajra Hospital; Faculty of Medicine Chiang Mai University; Faculty of Medicine Ramathibodi Hospital, Mahidol University; Maharat Nakhon Ratchasima Hospital) and Korea (CHA Gangnam Medical Center, CHA University; Keimyung University Dongsan Hospital; ChungNam National University Hospital; Inha University Hospital; The Catholic University Of Korea, Seoul St. Mary’s Hospital; Seoul National University Hospital; Korea University Anam Hospital Clinical Trial Center; Ajou University Hospital; Severance Hospital Clinical Trial Center; ChonNam National University Hospital; Pusan National University Yangsan Hospital; GangNam Severance Hospital). Centralized ethical approval for participating sites was obtained for Singapore (SingHealth), Malaysia (Ministry of Health) and Indonesia (Faculty of Medicine University of Indonesia).

: All enrolled patients gave written informed consent prior to any study-related procedure.

: Not applicable.