Document is current

Article History

Received: 31 July 2019

Accepted: 5 August 2019

First Online: 15 October 2019

Ethics approval and consent to participate

: The study will be performed according to good clinical practice guidelines and in full conformity with the Declaration of Helsinki and the national or local laws and regulations of each participating site. The study was approved by the appropriate institutional review boards in Germany (ethical board of the Medical Faculty, RWTH Aachen University, Germany [EK 021/18], Federal Institute for Drugs and Medical Devices [BfArM 61-3910-4042490, ) and will a seek ethical and regulatory approval from all participating sites across Europe prior to study start at each site. Before enrolment, all patients will provide written informed consent. We initiated a Data Monitoring Committee (DMC) of an independent group of experts that advises NICOFA and the study investigators. The DMC will periodically review and evaluate the accumulated study data for participant safety, study conduct and progress, and, when appropriate, efficacy, and make recommendations to NICOFA concerning the continuation, modification, or termination of the trial. The study is registered (EudraCT-No.: 2017-002163-17, ClinicalTrials.gov NCT03761511). The sponsor is the RWTH Aachen University, Germany represented by the Dean of the Medical Faculty.

: Not applicable.

: The authors declare that they have no competing interests.