Funding for this research was provided by:
Bayer Pharmaceuticals (no award number)
Received: 10 August 2020
Accepted: 6 May 2021
First Online: 17 May 2021
: The study was approved by French regulatory authorities (Agence nationale de sécurité du médicament et des produits de santé) on Jan 24th 2019, received a favorable opinion by the “Comité de Protection des Personnes EST III” (Dec 6th, 2018) and complies with the Helsinki declaration and French laws and regulations, and follows the International Conference on Harmonisation E6 (R2) Guideline for Good Clinical Practice. Written informed consent will be obtained from each patient before any screening and inclusion procedure. The trial results, even inconclusive, will be submitted in a peer-reviewed journal. Trial registration numbers are the following: EudraCT number: 2018–003541-42; ClinicalTrials.gov number: NCT03828799.
: Not Applicable.
: The authors declare that they have no competing interests.