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Authors
Müller, Amke https://orcid.org/0000-0003-4136-2326
Konigorski, Stefan
Meißner, Carina
Fadai, Tahmine
Warren, Claire V.
Falkenberg, Irina
Kircher, Tilo
Nestoriuc, Yvonne
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Funding
Funding for this research was provided by:
Deutsche Forschungsgemeinschaft (422744262, 422744262)
Helmut-Schmidt-Universität Universität der Bundeswehr Hamburg
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Article History
Received: 17 August 2023
Accepted: 12 September 2023
First Online: 13 October 2023
Declarations
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: This trial has been reviewed and approved by the ethics committee of the ‘Ärztekammer’ of Hamburg, Germany (approval number: PV7151; first approval (version 2), 16th December 2019), based on the last protocol amendment (version 3, 30th March 2021). In this amendment the protocol was extended by the FAB-study piloting the main study (PHEA) while adding a series of N-of-1 trials assessing the effect of OLP on discontinuation symptoms. The trial has been registered at clinicaltrials.gov (ClinicalTrials.gov ID: NCT05051995). Patients will be fully informed about the study procedure and provide written informed consent to participate.
: The authors declare no competing interests.
