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Article History

Received: 28 September 2024

Accepted: 13 March 2025

First Online: 25 April 2025

Declarations

:

: The authors declare no competing interests.

: Our research methods adhered to all applicable guidelines and regulations. The data used in this study was obtained from the NPDS in a de-identified format. The Colorado Multiple Institutional Review Board on Human Subjects Protection has established guidelines for determining whether a study qualifies as human subjects research. According to these guidelines, our analysis of NPDS data does not meet the criteria outlined in 45 Code of Federal Regulations (CFR) 46.101(b) for human subjects research. Consequently, formal IRB approval was optional for this study. It is important to note that certain research categories, classified as exempt research, are not subject to federal regulations and can proceed without formal IRB review and approval. To qualify for this exemption, research activities must involve minimal risk and meet specific criteria defined in federal regulations 45 CFR 46.101(b). In our case, the Colorado Multiple Institutional Review Board on Human Subjects Protection reviewed our study protocol and determined that it met the criteria for exemption. This decision is documented under COMIRB#22-1088. This exemption status indicates that while our research involves human data, it poses minimal risk and falls within the parameters that allow for streamlined ethical review processes.