First study subject approvals package

Task 25 Inclusion of patients in the study M16M33The clinical study will run at the five study sites UK Bonn Radboudumc UNAV Palermo KU Leuven Patients who fulfill the submission criteria will be asked for informed consent and will be included in the study Patients will remain in the study for the duration of sedation or until death For more details about the study design see methodology section Part B 13 and Template for the clinical study Interim reports to EU will be provided