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Article History

Accepted: 10 August 2021

First Online: 7 October 2021

Declarations

:

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

: Wan-Yu Chu, Kim Annink, Laura Nijstad, Christian Maiwald, Michael Schroth, Loubna el Bakkali, Frank van Bel, Manon Benders, Mirjam van Weissenbruch, Anja Hagen, Axel Franz, Thomas Dorlo, Karel Allegaert, and Alwin Huitema have no conflicts of interest to declare.

: The data used in this study were performed in accordance with the Declaration of Helsinki and the guidelines of Good Clinical Practice (GCP). 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 PK substudy for The Netherlands (NL57237.041.16). The German Federal Authority (EudraCT 2016-000222-19), as well as the leading Ethics Committee 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 case 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.

: Protocol development and study conduct: KVA, MS, CM, LEB, FVB, MB, MVW, AH, AF, KA. Ethics and study registration: KVA, FVB, MB, AF. Study recruitment and data collection: KVA, MS, CM, LEB, FVB, MB, MVW, AH, AF. Modelling: WYC, LN, TD, ADRH. Drafting of the manuscript: WYC, KVA, LN, TD, KA, ADRH. All authors have read and commented on the manuscript and have approved the submitted version.