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Article History

Received: 8 January 2026

Accepted: 16 March 2026

First Online: 24 March 2026

Declarations

:

: No ethical approval was required for this current study since the data used in this study were obtained from clinical trials that already had ethical approval. Ethical approval for clinical studies was obtained from the Biomedical Research Ethics Committee of the University of KwaZulu-Natal (UKZN-BREC), and studies were registered on clintrials.gov with the following reference and NCT numbers: Prox-BF005/09; PRAXIS-BE242/16 and BFC613/17, NCT03162107 and NCT04032730; InDEX-BFC584/16, NCT03237182; and TRiAD-BREC/00002654/2021, NCT05175794. All studies were conducted in accordance with national regulations and institutional ethical standards. Written informed consent was obtained from participants at the time of enrolment into the parent trials. All biological sample collection and study-related investigations conducted during the parent clinical studies were carried out in accordance with the South African Good Clinical Practice guidelines and the National Department of Health Ethics in Health Research: Principles, Processes and Structures guidelines (2015).

: Written informed consent was obtained from all participants at the time of enrolment in the parent clinical studies. This manuscript reports a retrospective secondary analysis of anonymized data; additional consent was not required in accordance with the South African Department of Health Ethics in Health Research: Principles, Processes and Structures (2015, 2nd ed., Sect.  3.3.7).

: As this was a retrospective review that presented anonymous data from clinical trials only, written informed consent was obtained from all participants within the relevant studies. No individual-level patient data was being presented; hence, additional informed consent for publication was deemed not necessary.

: The authors declare no competing interests.