Author contributions
X.K. (first author) participated in all aspects of the study including funding for the trial, protocol design, trial execution, data collection and analysis, and manuscript preparation. S.B. (senior author) obtained funding for the trial, critically contributed to protocol design, provided supervision and revision of the manuscript. The order of authorship has been a joint decision of the co-authors based on substantial contribution to conception and design, execution, analysis and interpretation of data.