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Article History

Received: 29 July 2022

Accepted: 2 August 2022

First Online: 20 August 2022

Declarations

:

: Santiago  Lopez-Ben, Lukas Krska, Javier  Marquez-Rivas, Domenico Russello, Elisa York, and Mario Zacharias received honoraria from Baxter as advisors for interpreting the raw data and consulting in stratification and interpretation of data in post hoc analyses.

: This registry was conducted in compliance with applicable laws, regulations and guidance. We obtained an independent ethics committee review as well as written and dated approval/favorable opinion from the independent ethics committee (IEC) for the registry protocol/amendment(s). We also obtained written informed consent forms, pediatric assent forms, any consent/assent form updates, patient recruitment procedures (e.g. advertisements), and any written information to be provided to patients with a statement from the IEC that it complies with Good Pharmacoepidemiology Practices requirements and (when applicable) International Conference on Harmonisation Good Clinical Practices. The study was performed in accordance with the tenets of the Declaration of Helsinki.

: All patients provided written informed consent to participate in the study within 72 h post-surgery.

: Not applicable.