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Article History

Accepted: 23 June 2024

First Online: 3 August 2024

Funding

: This research was sponsored by Relmada Therapeutics, Inc., Coral Gables, FL, USA.

: Sara De Martin received personal fees from Relmada Therapeutics and from Aesculapius Farmaceutici. Marco Pappagallo received personal fees from Relmada Therapeutics during this study, he holds stock ownership with Acadia, and he has received personal fees from Overlook Medical Center. Nicola Ferri, Andrea Mattarei and Franco Folli received personal fees from Relmada Therapeutics. Sergio Traversa, Charles E. Inturrisi, and Paolo L. Manfredi received personal fees and or held stock ownership from Relmada Therapeutics. Sergio Traversa is an employee of Relmada Therapeutics. Paolo L. Manfredi and Charles E. Inturrisi are inventors on patents related to esmethadone. Clotilde Guidetti has received personal fees from MGGM Therapeutics. James Stuart received fees from Relmada as a paid consultant.

: The datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.

: Writing—Original Draft Preparation: N.F. and S.D.M.; Conceptualization: P.M., M.P., C.G., C.E.I. F.F.; Funding Acquisition: S.T.; Methodology: J.S., A.M., S.C.

: A central institutional review board (Advarra, 6100 Mer[1]riweather Drive, Columbia, MD) was used for the review and approval of the protocol.

: All subjects signed an approved informed consent forms prior to any procedures being performed.

: All patients provided consent.

: Not applicable.