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Article History

Accepted: 1 December 2022

First Online: 9 December 2022

Declarations

:

: This study was supported by Idorsia Pharmaceuticals Ltd, Allschwil, Switzerland. Idorsia Idorsia Pharmaceuticals Ltd funded the manuscript writing support (manuscript preparation) and the open access fee.

: DK has participated in advisory boards from Idorsia; DGB has participated in advisory boards from Idorsia, Roche and received a research grant from MSD; GP has participated in advisory boards from Takeda, Bioprojet, Jazz, Fidia and Idorsia; HB has participated in advisory boards from UCB, Jazz and Idorsia; ST has nothing to disclose; YD participated in advisory boards from UCB, Takeda, Bioprojet, Jazz, Orexia, Avadel and Idorsia; DSK, PC, MR and MS-S are employees of Idorsia Pharmaceuticals Ltd. The IDSIQ was developed by Buysse DJ, Thompson W, Scott J and Franzen PL. Germain A, Hall M, Moul, DE, Nofzinger , EA and Kupfer DJ of the University of Pittsburgh and as amended by Idorsia Pharmaceuticals Ltd. IDSIQ© 2020, University of Pittsburg. All rights reserved. IDSIQ-14 derivative created 2020 by Idorsia Pharmaceuticals Ltd under license and distributed by Idorsia Pharmaceuticals Ltd under license.

: The study protocol was approved by the appropriate institutional review boards or independent ethics committees and the study was performed in accordance with the ethical standards as laid down in the 1964 Declaration of Helsinki and its later amendments or comparable ethical standards.

: All patients provided written informed consent.

: Not applicable.

: The study sponsor will receive requests for individual participant data that underlie the results reported in this article, after deidentification, from researchers who provide a methodologically sound proposal. Please direct any requests to medicalinformationus@idorsia.com.

: Not applicable.

: Dalma Seboek Kinter was involved in the study conception and design. Dalma Seboek Kinter, Magdalene Rausch, Dieter Kunz, Yves Dauvilliers, Heike Benes, Diego García-Borreguero, Giuselle Plazzi and Stephen Thein were all involved in data acquisition. Mouna Sassi-Sayadi was involved in the data analysis, validation and visualisation. All authors were involved in interpretation of the data. Dieter Kunz, Yves Dauvilliers, Heike Benes, Diego García-Borreguero, Giuseppe Plazzi and Stephen Thein were trial investigators or participated in the conduct of the study. All authors had full access to the data, were involved with review and editing of the manuscript for important intellectual content, approved the final version of the manuscript and had final responsibility for the decision to submit for publication and agreed to be accountable for the work.