Ethics
ADVERSE REACTIONS
The study is being conducted in accordance with the Declaration of Helsinki on Ethical Principles for Medical Research Involving Human Patients, adopted by the General Assembly of the World Medical Association, Fortaleza, Brazil 2013, as well as with the valid national/local laws of the participating countries, with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Harmonised Tripartite Guideline for Good Clinical Practice (E6), and with the European Commission Directives 2001/20/EC and 2005/28/EC. The protocol was submitted to the responsible Independent Ethics Committees (IECs) and their written unconditional approval was obtained before the start of the study. IECs are informed of all subsequent protocol amendments that are likely to affect the safety of the patients or the conduct of the study, and of all suspected unexpected serious adverse reactions occurring during the study. The study is being conducted in 21 sites in seven European countries (Austria, Germany, Italy, Portugal, Spain, Sweden, and the United Kingdom) and Israel. The study is funded by Bial – Portela & Cª, S.A. and is registered on the European Union Drug Regulating Authorities Clinical Trials Database (EudraCT; number 2018‐002747).