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Article History

Received: 10 December 2024

Accepted: 27 February 2025

First Online: 4 March 2025

Declarations

:

: K.B. is a founder and board member at OASIS Diagnostics, an author of the related patent and R&D strategy, independent consultant, and trainer of Takeda.M.M., M.R., K.K., and P.I. are researchers at OASIS Diagnostics. A.S. is an independent consultant of Ethicon, Takeda, Pfizer, Sofar. M.UM. is an independent consultant of Regen Lab.H.H., P.J., M.UM., E.D., and E.GD. received remuneration as a study investigator.H.H., C.R., and A.S. are independent consultants and members of the OASIS Diagnostics’ Scientific Advisory Board. Others declare no conflicts of interest.

: The study was approved by the ethics committees respective for each study site: on 19 March 2021 by Ethics Committee of the Institute for Maternal and Child Care (no. 1/19.03.2021), on 27 April 2021 by Ethics Committee for Research with Medicines of the Health Areas of León and Bierzo (no. 2186), on 9 June 2021 by Ethics Committee of the University Hospital of Brno (no. 47/21Zdrav.), on 14 October 2021 by Ethics Committee at the Regional Medical Chamber in Warsaw (no. KB/1362/21) and on 25 July 2022 by Ethics Committee at AGEL Hospital Košice-Šaca (no. ONIRY 3/2/2020).