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Article History

Accepted: 17 July 2023

First Online: 21 August 2023

Declarations

:

: The IMPAACT P1093 and ODYSSEY (PENTA 20) studies were funded by ViiV Healthcare. Diana M. Gibb, Anna Turkova, and Deborah Ford receive support from the Medical Research Council Program MC_UU_00004/03.

: Anna Turkova is an employer of MRC CTU at UCL and a paid consultant for the VH Global Paediatrics Advisory Board (Long-Acting Agents/New Delivery Methods/New Technologies) with fees paid to MRC CTU at UCL. Ann Buchanan and Mark Baker are employees of ViiV HC; Hardik Chandasana is an employee of GSK and Rajendra Singh was an employee of GSK at the time of this research; all authors are eligible for stock/stock options in GSK.

: The P1093 and ODYSSEY studies were designed in accordance with the International Council for Harmonization, Good Clinical Practice guidelines, and applicable country-specific requirements and abided by the ethical principles of the Declaration of Helsinki. The trial protocol, amendments, and informed consent forms were reviewed and approved by institutional review boards and national authorities.

: Informed consent was obtained from all participants prior to screening.

: Not applicable.

: Anonymized individual participant data and study documents can be requested for further research from .

: The final PK model code is available in ESM.

: HC, MB, DMG, AT, DF, TR, AW, CA, RH, ET, AB, EPA, and RS contributed to the conception of the study. HC, MB, TR, AW, EPA, and RS contributed to the design of the study. DF, LF, MB-D, HM, CA, and MF contributed to the acquisition of the data. HC, MT, SH, and RS contributed to the analysis of the data. HC, MT, SH, MB, DMG, AT, DF, TR, AW, CA, MF, AB, PB, HW, AC, DB, EPA, and RS contributed to the interpretation of the data. HC, AB, and RS contributed to drafting the manuscript. All authors contributed to critically revising the manuscript for important intellectual content and approve the manuscript for publication.