Ethics approval and consent to participate
HLP, comatose
COMATOSE
The Danish Regional Committee on Health and Research Ethics approved the protocol (MICA-S-20150173 HLP, 01/01/2017). Danish legislation permits immediate inclusion of patients who are unable to provide consent in nonpharmaceutical trials and mandates that consent should be obtained at the first given opportunity after inclusion in the trial. Consent for the inclusion of comatose patients was obtained from a legal representative and a physician with expertise in the clinical area but no affiliation with the trial. A physician obtained proxy consent at the earliest possible opportunity. Informed consent from the patient was obtained if the patient regained consciousness.