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Authors
Skerrett, Donna L. https://orcid.org/0000-0001-9398-1327
Stapledon, Catherine J. M. https://orcid.org/0000-0002-2827-2396
Ahuja, Mukesh https://orcid.org/0009-0006-3147-1288
Navuru, Divya R. https://orcid.org/0009-0008-6666-5618
Duiker, Melanie J. https://orcid.org/0009-0005-2358-3776
Krishnan, Ravi https://orcid.org/0009-0006-9502-7469
Schnitzer, Thomas J. https://orcid.org/0000-0002-4048-5431
Peat, Rachel A. https://orcid.org/0000-0002-3180-439X
Bloom, Philip D. https://orcid.org/0009-0004-2441-6956
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Article History
Received: 8 October 2025
Accepted: 13 January 2026
First Online: 26 January 2026
Declarations
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: The study was conducted in accordance with international guidelines (Declaration of Helsinki, ICH, and GCP guidelines) and applicable local laws and regulations. The Bellberry ethics committee approved the study and it was registered on the Australian New Zealand Clinical Trials Registry at anzctr.org.au (ACTRN12621000136808) prior to screening. All participants provided informed consent.
: Not applicable.
: DL Skerrett: Paradigm Biopharmaceuticals Ltd., Employee and Shareholder.CJM Stapledon: Paradigm Biopharmaceuticals Ltd. Employee and Shareholder.M Ahuja: Prior Paradigm Biopharmaceuticals Ltd. Employee and Shareholder; Rush University Medical Center Consultant; ChitogenX Investor and Shareholder; Shareholder for Pfizer, Bristol Myers Squibb, and Orthofix.DR Navuru: Paradigm Biopharmaceuticals Ltd. Employee and Shareholder.MJ Duiker: Paradigm Biopharmaceuticals Ltd. Employee and Shareholder.R Krishnan: Prior Paradigm Biopharmaceuticals Ltd. Employee and Current Shareholder.TJ Schnitzer: Consultant for AstraZeneca, Eli Lilly, GlaxoSmithKline, Horizon, IBSA Group, Merck, Moebius Medical, Orion, Regeneron, Xalud Therapeutics, Pfizer. Research grants from Paradigm Biopharmaceuticals Ltd. Pfizer.RA Peat: Paradigm Biopharmaceuticals Ltd. Employee and Shareholder.PD Bloom: Sportsmed Biologic. Research Grants from Paradigm Biopharmaceuticals Ltd and Shareholder.
