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Article History

Accepted: 24 July 2022

First Online: 30 August 2022

Declarations

:

: The ALBINO study is funded under the Horizon 2020 Framework EU Program call H2020-PHC-2015-two-stage grant 667224. The research on the pharmacokinetics during whole body hypothermia (KA) is further supported by the iPREDICT project (FWO Senior research project, fundamental research, G0D0520N).

: All authors have no conflicts of interest to declare.

: The data used in this study were acquired in accordance with the Declaration of Helsinki and the guidelines of Good Clinical Practice. The ALBINO study was granted by institutional review boards and independent ethics committees. The Medical Ethics Committee of the University Medical Centre Utrecht and the Central Committee on Human Research approved the study including the specific pharmacokinetic sub-study for the Netherlands (NL57237.041.16). The German Federal Authority (EudraCT 2016-000222-19) as well as the leading Ethics Committee of Tübingen approved the study for Germany.

: Short oral consent was obtained from at least one parent before administering the study medication. After the first dose, but before the (potential) second dose, full written parental consent was obtained. In the case where parents did not sign the informed consent, blood samples already collected shortly after birth were destroyed.

: The raw data are available upon reasonable request by an e-mail to the corresponding author, while blinding for group allocation should be respected until the primary outcome analysis has been finalized.

: Not applicable.

: KA and the ALBINO study group were responsible for protocol development, study conduct, study registration, study recruitment, and data collection. Population pharmacokinetic-pharmacodynamic modeling was performed by WC, TD, and AH. The draft of the manuscript was written and reviewed by WC, KA, TD, and AH. All authors and contributors have read and commented on the manuscript and have approved the submitted version.