Trial design
NCT02932436
-11
The EmDia trial is a randomized, double-blind, two-armed, placebo-controlled, parallel group, investigator-initiated study of phase IV. The University Medical Center of the Johannes Gutenberg-University Mainz conducted the single-center trial as study sponsor. All study documents were approved by the local ethics committee and the data protection officer prior to study initiation. All study participants provided informed written consent, and study procedures have been performed in line with the principles outlined in the Declaration of Helsinki and the recommendations for Good Clinical Practice. The trial was registered at clinicaltrials.gov with the unique identifier: NCT02932436 (EudraCT number: 2016-001264-11). The rationale and design of the trial have been described in detail recently [