Authors’ contributions
The whole study team was involved in the design and conduct of this trial. The first version of the protocol was written by Mihai Netea, revised by Andrew DiNardo, and edited by Jeffrey Cirillo, Moshe Arditi, Ashish Kamat, and Pablo Avalos prior to submission to respective IRB. Corrections were made to the protocol by all study team members. All study team members reviewed and made corrections to the protocol manuscript.