Palevičiūtė, Eglė http://orcid.org/0000-0003-4758-7833
Čelutkienė, Jelena
Šimbelytė, Toma
Gumbienė, Lina
Jurevičienė, Elena
Zakarkaitė, Diana
Čėsna, Sigitas
Eichstaedt, Christina A.
Benjamin, Nicola
Grünig, Ekkehard
Article History
Received: 16 October 2022
Accepted: 5 April 2023
First Online: 19 April 2023
Declarations
:
: The study was approved by the ethics committee of the Medical Faculty of Heidelberg University, Germany (S-879/2019; Local project ID: 2019-04ET; version 1.0, 5 December 2019). All participating centers will submit the study protocol to their local ethics committees. The study will be carried out following applicable local laws and regulations. Any changes to the protocol that may impact the conduct of the study, may potentiate benefit, or may affect patient’s safety will require formal approval by the local ethics committees.Trained physicians will discuss the trial aspects with each patient, regarding its characteristics, consequences, potential impact on health issues, and benefit-risk ratio. Patients will have ample time and opportunity to ask questions and will be informed about the right to withdraw from the study at any time without any disadvantage and without having to provide reasons for this decision. Only patients who give their written, informed consent will be included in the study. The patient’s informed consent form is prepared in the native language. If needed for evaluation, it can be provided by the principal investigator of each center. The procedures set out in this protocol pertaining to the organization, evaluation, and documentation of this study will be conducted under Good Clinical Practice (GCP) guidelines and under the principles detailed in the Declaration of Helsinki. The data obtained during the trial will be treated pursuant to the General Data Protection Regulation (GDPR) (EU) 2016/679 and relevant national regulations.
: Not applicable.
: E.P. reports speaker honoraria fees from Johnson and Johnson and Medis Pharma outside this work.J.Č. reports personal fees from AstraZeneca, Boehringer Ingelheim, Pfizer, Bayer, and Novartis outside this work.E.G. reports research grants and speaker honoraria/consultancy fees from Actelion, Janssen, Bayer, MSD, Merck, and Ferrer and research grants to the institution from Acceleron, Actelion, Bayer, MSD, Janssen, Liquidia, United Therapeutics, and OMT outside the submitted work.L.G. has received speaker’s fees from Actelion, Johnson & Johnson, and Medis Pharma outside the submitted work.S.Č. reports honoraria fees from Medtronic, Bostopn Scientific, and Meril outside this work.T.Š., C.A.E, N.B., E.J., and D.Z. declare that they have no competing interests.