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Article History

Received: 14 July 2023

Accepted: 13 October 2023

First Online: 21 October 2023

Declarations

:

: This study has been designed and will be conducted in accordance with the principles set in the Declaration of Helsinki, 2008. The study is approved by the Central Denmark Region Committee on Health Research Ethics (registration number 1–10-72–36-21) and is registered at Clinicaltrials.gov (NCT05023460, registered in July 2021). Signed informed consent is obtained from all study participants at enrollment.Any modification of the protocol that may affect the conduction of the study, the potential benefit for the participating patients, or the safety of treatment needs to be approved by the Central Denmark Region Committee on Health Research Ethics before implementation. The investigators have no financial or other competing interests in the trial's outcome. The results of the study will be submitted for publication in an international journal. Positive as well as negative and inconclusive results will be published. After completing their participation in the study, participants are offered to continue ONS treatment following the standard clinical follow-up outpatient program at the Department of Neurosurgery, Aarhus University Hospital.

: Not applicable.

: KM and JCHS have received lecture fees and travel support from Abbott, and their institution (Aarhus University Hospital) has received research support from Abbott. KM has received teaching fees from Medtronic and consulting fees from Salvia BioElectronics. KM and JCHS are co-owners and co-founders of the neuromodulation database company Neurizon. RJ has given lectures for Pfizer, Eli-Lilly, Merck, TEVA, Novartis, Lundbeck, and Allergan. Investigator in clinical trials with Eli-Lilly, Novartis, and Lundbeck. ASP has been a sub-investigator in trials for Eli-Lilly and Lundbeck Pharma. ISFA has nothing to declare.