Text and Data Mining valid from 2019-12-01
Received: 12 June 2019
Accepted: 29 October 2019
First Online: 10 December 2019
Ethics approval and consent to participate
: The Dex-CSDH trial protocol version 3 (27 April 2017), informed consent forms, and all other relevant trial documents have been approved by the North West-Haydock Research and Ethics Committee (REC), reference 15/NW/0171.All correspondence with the REC will be retained in the Trial Master File and Investigator Site File. Annual reports will be submitted to the REC in accordance with national requirements. The trial will be performed in accordance with the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guidelines and the letter of the Declaration of Helsinki, the conditions and principles of Good Clinical Practice (GCP), the protocol, and applicable local regulatory requirements and laws.Protocol violations, deviations, non-compliances, or breaches are departures from the approved protocol and must be adequately documented and reported to the Chief Investigator and Sponsor immediately. Any potential/suspected serious breaches of GCP must be reported immediately to the Sponsor without any delay.
: Not applicable.
: The authors declare that they have no competing interests.