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Funding for this research was provided by:
1998 Society
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Article History
Accepted: 10 June 2025
First Online: 23 June 2025
Declarations
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: This single-center study was prospectively registered (NCT06034340, ClinicalTrials.gov), approved by the Institutional Review Board at Emory University School of Medicine (IRB #00002928), as a non-significant risk study with an Abbreviated Investigational Device Exemption, and conducted at the ECCRU in accordance with the principles of the Declaration of Helsinki (from March 1, 2023 to September 30, 2023). All participants and parents gave written informed assent and consent.
: The authors have read the manuscript and given their consent for publication.
: ART and MRP are inventors of patents and founders and shareholder of companies developing STAR particles, including Alys Pharmaceuticals, Aldena Therapeutics, Vimela Therapeutics, and Microstar Biotech. The associated conflicts of interest have been disclosed and are being managed by the Georgia Institute of Technology and the Johns Hopkins University. EIF has no conflicts of interest to disclose.
