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Article History

Received: 16 August 2018

Accepted: 27 November 2018

First Online: 7 January 2019

Ethics approval and consent to participate

: All participating centers obtained local ethics committee approvals to conduct the trial.The coordinating center approval was issued by Comitato Etico of A.O. San Paolo - Polo Universitario, Milano: Prot.34/Reg.delibere 2011/CE on 23 February 2011.The other ethics committees were:Written informed consent was mandatory for all able patients. When it could not be given, a written declaration of information received was collected from relatives, according to local ethics committee indications. As soon as patients’ neurological conditions improved, all enrolled patients were duly informed of the study and their written consent was obtained, both for the use of previously collected data, and for all prospective treatments and data collection. Patients or their next of kin could request withdrawal from the study at any time.

: Besides informed consent to participate, specific permission to use anonymized data for scientific purposes was collected from all patients.

: All the authors, the Steering Committee members, and the SedaEN investigators declare they have no competing interests.

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