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Authors
Grasa, Carlos https://orcid.org/0000-0002-9323-2024
Salvadori, Nicolas https://orcid.org/0000-0002-0820-5305
Nardone, Alessandra
Than-in-at, Kanchana
Koblansky, Alicia
Parry, Chris
Thakkar, Nilay
Wang, Marcia
Giaquinto, Carlo
Rojo, Pablo https://orcid.org/0000-0002-0197-5462
Cressey, Tim R. https://orcid.org/0000-0002-8106-0974
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Article History
Received: 7 January 2026
Accepted: 2 February 2026
First Online: 24 February 2026
Declarations
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: This study is being carried out in accordance with the principles of GCP as laid down by the ICH topic E6 (R2), the Declaration of Helsinki 2013 and applicable national regulations. Last version of study protocol (version 6.0) has been approved by National Competent Authorities of participating sites and by local Ethics Committee of each participating site: South Africa: SAHPRA: TRIAL REFERENCE: 20210321; Ethics Committees: ZA11: Ethics Reference No: M21/03/008, ZA12: Ethics Reference No: 210312, ZA13: Ethics Reference No: 210323864, ZA14: Ethics Reference No: 210312, ZA15: Ethics Reference No: 210312, ZA16: Ethics Reference No: 110/2024 – Line 16; Brazil: CONEP: Número do Parecer: 7.762.961; United States of America: FDA: Reference Number: 00291534, CENTRAL IRB: Work Order Number: 1-1857484-1, US06: Work Order Number: 1-1874142-1, US07: Work Order Number: 1-1868821-1.
: Not applicable.
: The authors declare no competing interests.
