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Article History

Received: 17 September 2020

Accepted: 15 December 2020

First Online: 22 January 2021

Ethics approval and consent to participate

: This trial is conducted in full compliance with Good Clinical Practice and according to the local law and regulatory requirements at each participating centre.<i>Switzerland:</i> Ethical Committee Bern, Murtenstrasse 31, 3010 Bern, Switzerland (lead ethical committee in Switzerland) and Ethical Committee EKOS (local ethical committee in Switzerland), Oberer Graben 32, 9001 St. Gallen, Switzerland (ethical number: PB_2016-01494, date of approval: 25.03.2015/, date of approval of last amended protocol version 4.1 dated 07.02.2017: 23.02.2017).<i>Germany:</i> Ethik-Kommission, Landesärztekammer Rheinland-Pfalz, Postfach 29 26, 55019 Mainz (ethical number: 837.250.17 (11084), date of approval 30.01.2018).<i>France, Grenoble</i>: CPP Sud-Est VI – CHU – Administration Centrale – 58 rue Montalembert – BP.69 – 63003 Clermont Ferrand Cedex 1 (Ref. CPP: AU1392; Ref. ID-RCB 2017-A02877-46, date of approval 03.04.2018).<i>Russia:</i> Ethical Committee of the Almazov National Medical Research Centre, 2 Akkuratov str., St. Petersburg, 197341 Russia (Ethical approval number 7 dated 15.01.2018 and number 88-A dated 14.05.2018).Any protocol modifications will be communicated to the responsible ethical committees. Written, informed consent to participate is obtained from all participants prior to their inclusion in the study.

: Consent for publication is obtained for every participant included in the study. The results of the eSATIS trial will be presented at national and international conferences and will be published in peer-reviewed journals. Additionally, a summary of the study’s findings will be posted on the eSATIS website (). Patients’ confidentiality will be strictly guaranteed. Only the sites’ study teams know patients’ identity.

: The authors declare that they have no competing interests.