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Article History

Received: 8 March 2021

Accepted: 28 March 2022

First Online: 21 April 2022

Declarations

:

: The first version of the protocol was approved by the ethical commission (Kantonalen Ethikkommission Zürich) on 5 March 2020 (BASEC Nr. 2020-00080). The first amendment to the study protocol (v. 1.2; 12 April 2021) including minor changes of the components of the DSMB, the list of study investigators, the wording of the patient informed consent forms, and the final monitoring plan was approved by the ethical commission on 27 April 2021. The latest version of the study protocol (v. 2.0; second amendment; 1 Nov 2021) received approval from the Kantonalen Ethikkommission Zürich on 10 December 2020 and included details on the second study site, as well as updated definitions of adverse events as per national guidelines: this version of the study protocol is enclosed as .Written informed consent will be obtained from the participant or legal guardian prior to randomization; in patients requiring emergency interventional treatment who are temporarily not capable of providing informed consent, consent will be subsequently obtained after assessment of the presumed will and patient decree and allocation of an independent physician.

: The manuscript has been read and approved by all named authors.

: The authors declare that they have no competing interests.