The PRAGUE-19 study is a prospective multicenter open-label single arm study. The design and short-term results of the pilot study phase have been published previously.
This article describes a 2 year clinical follow-up of patients included in the pilot phase between December 2012 and August 2013. The study was approved by the local ethical committee at each centre as well as by the national multicentric ethical committee and written informed consent was obtained from all study patients.