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Article History

Received: 25 January 2024

Accepted: 1 October 2024

First Online: 14 October 2024

Declarations

:

: Both the phase 1 and phase 2 study protocols were approved by institutional boards (IRBs) before study commencement (CR845-CLIN 1005: Chesapeake IRB and Aspire IRB; CR845-CLIN 2005: Aspire IRB, Western IRBs, St Joseph Health IRB, Vanderbilt University IRB, Emory University IRB, Winthrop University Hospital IRB). Subjects provided written informed consent before any study-related procedures. Research was carried out in accordance with the protocols, US regulations, the ethical principles set forth in the Declaration of Helsinki, and Good Clinical Practice guidelines.

: Not applicable.

: RS: Cara Therapeutics, Inc. – employment. PN: Cara Therapeutics, Inc. – consultant. TM: Orlando Clinical Research Center – employment. FM: Cara Therapeutics, Inc. – employment.