Updates are available Correction dated 2022-06-24

Article History

Received: 2 October 2020

Accepted: 21 May 2021

First Online: 23 August 2021

Change Date: 24 June 2022

Change Type: Correction

Change Details: A Correction to this paper has been published:

Change Details: https://doi.org/10.1007/s12028-022-01553-9

Source of Support

: The United States Food and Drug Administration provided grant funding for this trial (FDA FD-R-5387; DTL, MM). Aegis-CN provided the study drug, CN-105, and funding for this trial.

: DTL is an officer and has equity in Aegis-CN. Duke University has equity and an intellectual property stake in CN-105 and might benefit if proven effective and successful commercially. MLJ serves as Principal Investigator for the CATCH trial, receiving grant funding for the trial from Aegis-CN. JT received consulting fees from Aegis-CN during the conduct of this trial. MM is an officer in Aegis-CN. All other authors have no conflicts to report.

: CATCH was approved by central institutional review board, Copernicus Group Independent Review Board, and by each participating site’s institutional review board. The study was performed in accordance with ethical standards laid down in the 1964 Declaration of Helsinki and its later amendments. Informed consent was obtained from all individual participants or their legal authorized representatives prior to engagement in study procedures. Because of potential conflicts of interest with Duke University, which holds a portion of intellectual property, CATCH was required to have all primary data provenance and statistical analyses performed by a third party not financially related to Duke University (Pharpoint). Further, oversight of the study was performed using Data Safety and Monitoring Board Plus format, for which all participants were external to Duke and whose express duties included examining any potential conflicts of interest.