Document is current

Article History

Received: 17 December 2020

Accepted: 20 April 2021

First Online: 6 May 2021

Declarations

:

: The study was conducted in compliance with the institutional review board (IRB-approved) protocol, Good Clinical Practice, and applicable regulatory requirements. Eligible participants received all relevant study information and provided written informed consent in accordance with the International Conference on Harmonization GCP guideline E6. Ethics approval was received from Salus IRB () on 5th October 2017 (Salus IRB 2017) []. The research was determined to involve no more than minimal risk and qualified for expedited review in accordance with 21 CFR 56.110 and 45 CFR 46.110. All communication used the protocol number: AL001. Informed consent was collected from all study participants using the IRB-approved informed consent form.

: This study specifically maintained the anonymity of all participants for confidentiality. The authors removed any identifying information from all data used in this publication.

: AN: Company Director at Chilli Consultancy, Chilli Consultancy were paid by Alacrita to conduct this research, Alacrita were paid by NovImmune SA, the study sponsor. KM: Consultant for Chilli Consultancy, Chilli Consultancy were paid by Alacrita to conduct this research, Alacrita were paid by NovImmune SA, the study sponsor. DW: Consultant for Chilli Consultancy, Chilli Consultancy were paid by Alacrita to conduct this research, Alacrita were paid by NovImmune SA, the study sponsor. ER: Consultant for Chilli Consultancy, Chilli Consultancy were paid by Alacrita to conduct this research, Alacrita were paid by NovImmune SA, the study sponsor.