Funding for this research was provided by:
University of Jaen
Received: 4 March 2020
Accepted: 23 May 2020
First Online: 8 June 2020
Ethics approval and consent to participate
: This study was approved by the Ethics Committee of Jaén with the number 0645-N-19. It was approved by the Spanish Agency for Medicines and Medical Devices. The trial’s protocol was registered at ExternalRef removed on 2 May 2019 (NCT03934671). Study participants will provide written consent prior to participation; all participants will sign informed consent before enrolment in the study. These materials are available from the corresponding author on request. Any changes to the protocol or severe adverse events will be reported to the steering committee. Confidentiality of the data and the results of monitoring will be protected.
: Not applicable.
: BC is an employee of Histocell (the collaborating company). The other authors declare that they have no competing interests.