Author contributions
JP, JRA
JRA
The trial protocol was designed by MT, ICO, JAR, DC, JRA, AD, VT, LdG, and LA with contribution from other members of the writing committee and Eli Lilly. YY, JAR, MT, ICO, ET, JP and DC obtained funding for the study. LA, LB, AB, and SR were responsible for the data management, and AD, VT, and LdG for the pharmacovigilance. MB, MAT, FL-J, BH, and TBD were responsible for the virological and serological analysis, and biobanking. The SAP was written by LA and approved by MT, DC, JRA, and ICO. AB and LA performed the statistical analysis. This manuscript was drafted by MT, JRA, LA, ARH, JP, VT, ICO, and DC. ICO, LA, AB and DC had full access to the data. All members of the writing committee edited the manuscript for important intellectual content. All authors gave final approval of the version to be published and had final responsibility for the decision to submit for publication.