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First Online: 23 September 2020

Declarations

:

: No specific funding was received for the preparation of this article.

: The authors declared no competing interest for this work.

: The protocol (Eudract 2020-001434-35) was approved by the local ethical committee.

: A written informed consent was obtained from each patient taking part to the study, in compliance with the International Council for Harmonisation (ICH) Good Clinical Practice (GCP) Guideline,

: Patients expressed no objection for the publication of the results.

: The datasets generated during and/or analyzed during the current study are not publicly available due to confidentiality reasons but are available from the corresponding author on reasonable request.

: Custom NONMEM and R codes used for model building, simulations and computation/representation of pcVPC are available on the DDMoRe Model Repository .

: Not applicable.

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