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Article History

Accepted: 5 May 2022

First Online: 13 June 2022

Declarations

:

: This study was sponsored by SocraTec R&D GmbH, Esteve Pharmaceuticals is the MAH of this product in Spain and Luye Pharma AG developed and manufactures the product.

: Marcos Iniesta, Adelaida Morte and Anna Vaqué are full-time employees of ESTEVE Pharmaceuticals. Cornelius Koch was a full-time employee of SocraTec at the time of the study; currently he is a full-time employee of Luye. Bjoern Schurad is full-time employee of Luye and Barbara Schug is an employee of SocraTec. Rafael De la Torre reports consulting fees for Esteve Pharmaceuticals.

: Ethics Committee of the Landesärztekammer Thüringen (trial number: 1351riv18ct and date of EC approval: 2018-05-15). Informed consent was obtained from all subjects involved in the study. The trial is registered in ClinicalTrials.gov: NCT03573050 and EudraCT: 2018-000968-28

: Written informed consent was obtained from all participants prior to enrolment.

: Not applicable.

: The data presented in this study are available on request to the corresponding author.

: Not applicable.

: Marcos Iniesta, Adelaida Morte, Rafael de la Torre and Anna Vaqué reviewed the results and critically discussed, drafted, edited and reviewed all versions of the manuscript and approved the final version. Barbara Schug, Cornelius Koch and Bjoern Schurad conceived or designed the study, contributed to data collection and analysed and interpreted data. All authors have read and agreed to the published version of the manuscript.