Stache, Stephen
Furey, Gabriel
Mehallo, Christopher J.
Article History
Received: 5 August 2025
Accepted: 6 July 2026
First Online: 13 July 2026
Declarations
:
: The study was approved by Pearl IRB and conducted in accordance with the Declaration of Helsinki. The committee approved the protocol as an exempt research determination in accordance with the applicable federal regulations and determined the study noted above to be Exempt according to 45 CFR 46.104(d)(4) Secondary Research Uses of Data or Specimens 45 CFR 46.104(d)(4)(ii). Pearl IRB is in full compliance with good clinical practice as defined under the U.S. Food and Drug Administration (FDA) regulations, U.S. Department of Health and Human Services (HHS) regulations, and the International Conference on Harmonization (ICH) guidelines. All patients signed Informed consent acknowledging that their data might be used anonymously for research purposes.
: Not applicable.
: The authors declare no competing interests.