ETHICS STATEMENT
This study is a sub analysis of the BATTLE study. The BATTLE study protocol was reviewed and approved by independent ethics committees and institutional review boards from all the six participating centres. The study was performed in accordance with the Good Clinical Practice guidelines, the International Conference on Harmonization guidelines and the most recent version of the Declaration of Helsinki. Written informed consent for participation and publication of our results was obtained from all the participants at the screenings visit. The BATTLE study is registered on Clinical trials.gov number: NCT02 657473.