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Authors
Boesing, Maria https://orcid.org/0000-0001-8605-1893
Abig, Kristin
Brändle, Michael
Brutsche, Martin
Burri, Emanuel
Frye, Björn C.
Giezendanner, Stéphanie
Grutters, Jan C.
Haas, Philippe
Heisler, Justian
Jaun, Fabienne
Leuppi-Taegtmeyer, Anne B.
Lüthi-Corridori, Giorgia
Müller-Quernheim, Joachim
Nüesch, Reto
Pohl, Wolfgang
Rassouli, Frank
Leuppi, Jörg D.
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Funding
Funding for this research was provided by:
Advita LifeSciences
Schweizerische Akademie der Medizinischen Wissenschaften (YTCR 18/20)
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Article History
Received: 30 March 2022
Accepted: 8 September 2022
First Online: 20 September 2022
Declarations
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: Ethics approval to conduct this trial has been first granted for the sites Baselland and St. Gallen by the Ethics Commission for North-Western and Central Switzerland (EKNZ) and the Ethics Commission for Eastern Switzerland (EKOS) on December 3, 2020 (Project-ID: 2020-01902). Six amendments regarding additional study sites (Schwyz, Vienna, and Nieuwegein), eligibility criteria, structural changes of the CRF, study duration, and sample size have been approved by the EKNZ and EKOS between December 2020 and July 2022. Furthermore, we are currently awaiting ethics approval from the local ethics committees for the study sites in Vienna (Austria) and Nieuwegein (Netherlands).The trial meets the criteria and principles of the Declaration of Helsinki and has been registered in the Clinicaltrials.gov database (Trial registration number: NCT04536350).Informed consent to participate in the trial is obtained by the recruiting study physicians from all patients prior to study entry. Each patient will be informed that participation in the study is voluntary, that he/she may withdraw from the study at any time with no need for justification, and that withdrawal of consent will not affect his/her subsequent medical assistance and treatment. On the consent form, participants are asked for permission to use of their data should they choose to withdraw from the trial. Participants are also asked for permission for personal data being shared with regulatory authorities, when relevant. Furthermore, the patient will be informed on an obligatory basis that his/her medical records may be examined by authorized individuals other than their treating physician. All patients are covered by liability insurance for the total study duration.
: No personal data of any patient is used in this manuscript, therefore a consent for publication is not needed.
: The authors declare that they have no competing interests.
