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Article History

Received: 23 October 2020

Accepted: 14 March 2021

First Online: 23 March 2021

Declarations

:

: The study protocol was approved by the Ethics Committee of the Erasmus MC University Medical Center (MEC-2018-004, NL96196.078.17, May 16th, 2018) and registered in the European drug regulatory affairs Clinical Trials database (Eudra-CT 2017–002036-17, March 6, 2018). The study is approved by each participating institution’s Institutional Review Board. This study will be conducted according to the principles of the Declaration of Helsinki (version October 2013) and in accordance with the Medical Research Involving Human Subjects Act (WMO). The patients treating physicians, local investigator, or research nurse of the participating centers follow Good Clinical Practice (GCP) and other applicable regulations in informing the patient and obtaining consent. Before informed consent may be obtained, the investigator should provide the patient ample time and opportunity to inquire about details of the trial and to decide whether or not to participate in the trial. All questions about the trial should be answered to the satisfaction of the patient. Patients are well informed that participation in voluntary and that they may withdraw at any point during the study. Informed consent includes consent for collection and use of biological specimens (i.e. blood and tissue). Written informed consent of patients is required before enrolment in the trial or study related procedures take place. All data are handled with strict confidentiality, assuring anonymity of patients.

: Not applicable.

: The authors declare that they have no competing interests.