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Authors
Stoica, Robert https://orcid.org/0000-0002-3895-3574
Medina-Polo, Jose https://orcid.org/0000-0003-3626-8669
Manecksha, Rustom P. https://orcid.org/0000-0003-3437-744X
Kolb, Christine https://orcid.org/0009-0003-2249-3459
Emmeluth, Melanie
Kuhl, Hans Christian https://orcid.org/0009-0001-2696-1358
Hassan, Tarek https://orcid.org/0000-0001-9427-363X
Riedl, Claus R. https://orcid.org/0000-0001-5544-9540
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Article History
Received: 11 December 2025
Accepted: 26 January 2026
First Online: 5 February 2026
Declarations
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: MEDA Pharma GmbH & Co. KG (A Viatris Company) sponsored this study. CRR received consulting fees from MEDA Pharma GmbH & Co. KG (a Viatris company) and holds a fiduciary role in ESSIC. JMP, RPM, and RS report no conflicts. CK, ME, and HCK are employees of MEDA Pharma, a subsidiary of Viatris Inc., Canonsburg, USA; TK is employed directly by Viatris Inc.
: The study was approved by local research ethics committees at all participating sites and countries and adhered to the Declaration of Helsinki and the DIN ISO 14155 standard for clinical investigations of medical devices. All patients were required to provide written informed consent before study entry, and study participation was voluntary.
: Not applicable.
