Author contributions:
All authors made substantial contributions to conception and design of,
or acquisition of data or analysis and interpretation of data. All
authors gave input to the manuscript and revised the manuscript
critically for important intellectual content. All authors gave final
approval of the version to be published. Tilo Biedermann, Peter Couroux
and Mika Mäkelä were signatory investigators in the trials and Tina
Maria Greve was responsible for analsis and reporting of the trial
safety data.