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Article History

Received: 15 August 2022

Accepted: 19 December 2022

First Online: 16 January 2023

Declarations

:

: This trial was conducted in accordance with the International Council on Harmonisation for Good Clinical Practice and the Declaration of Helsinki. Institutional review board or independent ethics committee approval was obtained at all trial sites. Patients or guardians provided informed consent. Patient confidentiality was maintained.

: Not applicable.

: EF has received consulting fees from Rhythm Pharmaceuticals, Inc., and participated in the BBS advisory board for Rhythm Pharmaceuticals, Inc., and she is a clinical investigator for clinical trials of setmelanotide in BBS for Rhythm Pharmaceuticals, Inc. RMH has received study drugs, grant support for clinical trials of setmelanotide in obesity, payments for lectures, and support for attending meetings from Rhythm Pharmaceuticals, Inc., as well as consulting fees from Rhythm Pharmaceuticals, Inc., and Axovia Therapeutics, LLC, and he participated in the data safety monitoring board for setmelanotide clinical trials for Rhythm Pharmaceuticals, Inc. JA has received payment for lectures from and participated in the BBS advisory board for Rhythm Pharmaceuticals, Inc. PB is an NIHR senior investigator. GÁMM has received payment for lectures from and participated in the BBS advisory board for Rhythm Pharmaceuticals, Inc. HD received consulting fees once from Rhythm Pharmaceuticals, Inc, and she has participated in the BBS advisory board for Rhythm Pharmaceuticals, Inc. CC’s institution received funding for this research from Rhythm Pharmaceuticals. AG’s institution received funding for this research from Rhythm Pharmaceuticals. BCB is an employee of and stockholder in Rhythm Pharmaceuticals, Inc. UGM is an employee of and stockholder in Rhythm Pharmaceuticals, Inc. KC has received grant funding from Ysopia Bioscience, Integrative Phenomics, and Confo Therapeutics and is a clinical investigator for clinical trials of setmelanotide in BBS for Rhythm Pharmaceuticals, Inc. AMH has received grant funding from the Weston Family Microbiome Initiative and Canadian Institutes of Health Research, has received payment as a speaker for Pfizer Canada, Inc., is a member of the BBS advisory board for Rhythm Pharmaceuticals, Inc., and is a member of the 2022 somatrogon advisory board for Pfizer, Inc.