Document is current

Article History

Received: 10 November 2023

Accepted: 21 March 2024

First Online: 13 April 2024

Competing interests

: The following authors declare they have no conflicts of interest: Lisa Derendorf, Stephanie Stock, Dusan Simic, Dirk Müller, Arim Shukri, Christine Zelenak, Jonas Nagel, Birgit Herbeck Belnap and Jan Sørensen have no competing interests. The following authors declare conflicts of interest: Christoph Herrmann-Lingen declares that he is receiving royalties from Hogrefe Publishers for the German version of the Hospital Anxiety and Depression Scale. During the last 3 years, he has received a lecture honorarium from Novartis. His research is funded by the German Ministry of Education and Research, the German Research Foundation, and the EU Commission. Susanne S. Pedersen has received a lecture honorarium from Bayer in 2021, and consultancy fees from ReCor Medical (Ultrasound Denervation Therapies), Boston Scientific, Medtronic, St. Jude Medical, Sanofi-Aventis, Astra-Zeneca, Servier and the Lundbeck Foundation in the past. Tim Friede reports personal fees from Actimed, Bayer, BiosenseWebster, Bristol Myers Squibb, Cardior, CSL Behring, Enanta, Fresenius Kabi, Galapagos, IQVIA, Janssen, KyowaKirin, Lilly, LivaNova, Minoryx, Novartis, r-connect, Recardio, Recordati, Relaxera, Roche, Servier, Viatris and Vifor for statistical consultancies including data monitoring committees, all outside the submitted work.

: The study has been registered and approved at the University Medical Centre Göttingen (UMG Reg. No 02853) and the German Clinical Trials Register (DRKS00025120). The informed consent forms and the study protocol (current version in Göttingen V1.2/16 February 2022) have been approved by the responsible ethics committees of all participating study sites before inclusion of the first patient. The findings of this study will be disseminated in national and international peer-reviewed journals and conferences.

: The following authors declare they have no conflicts of interest: Lisa Derendorf, Stephanie Stock, Dusan Simic, Dirk Müller, Arim Shukri, Christine Zelenak, Jonas Nagel, Birgit Herbeck Belnap and Jan Sørensen have no competing interests. The following authors declare conflicts of interest: <b>Christoph Herrmann-Lingen</b> declares that he is receiving royalties from Hogrefe Publishers for the German version of the Hospital Anxiety and Depression Scale. During the last 3 years, he has received a lecture honorarium from Novartis. His research is funded by the German Ministry of Education and Research, the German Research Foundation, and the EU Commission. <b>Susanne S. Pedersen</b> has received a lecture honorarium from Bayer in 2021, and consultancy fees from ReCor Medical (Ultrasound Denervation Therapies), Boston Scientific, Medtronic, St. Jude Medical, Sanofi-Aventis, Astra-Zeneca, Servier and the Lundbeck Foundation in the past. <b>Tim Friede</b> reports personal fees from Actimed, Bayer, BiosenseWebster, Bristol Myers Squibb, Cardior, CSL Behring, Enanta, Fresenius Kabi, Galapagos, IQVIA, Janssen, KyowaKirin, Lilly, LivaNova, Minoryx, Novartis, r-connect, Recardio, Recordati, Relaxera, Roche, Servier, Viatris and Vifor for statistical consultancies including data monitoring committees, all outside the submitted work.