Funding for this research was provided by:
Norgine Ltd (N/A)
Received: 18 August 2018
Accepted: 11 April 2019
First Online: 30 May 2019
Ethics approval and consent to participate
: The study was approved by the Local Independent Ethics Committee Landesamt für Gesundheit und Soziales (LAGeSo, State Office of Health and Social Affairs), Ethics Committee of the Land Berlin (Reference number: 12/0362 ZS EK), and performed according to the principles of the Declaration of Helsinki, the Guidelines of the International Conference on Harmonization on Good Clinical Practice, and the European Union Clinical Trials Directive. All subjects provided written informed consent.
: Not applicable.
: LC is an employee of Norgine. BT was an employee of Norgine at the time the study was completed and the data analyzed. MH, now retired, was a Medical Consultant for Norgine. RK is a Senior Clinical Research Physician for PAREXEL, which performed the study on behalf of Norgine.
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