CONSORT 2010 flow diagram of the study population.

<p>One hundred and four patients were screened, of whom 85 were included in the study. One patient was mistakenly treated with MVC instead of placebo during the entire study and an intention-to-treat analysis was performed. One participant deceased (in the placebo arm) whereas 5 participants prematurely discontinued the study (at week 2, 13, 18, 29 and 42); 79 study participants finished the complete study protocol. Data of all participants were included in the analysis of the primary endpoint.