Author contributions
SECONDARY, RECRUITMENT
J.M., A.Co., R.D.A., M.P. had the idea for the study, did the literature searches and designed the study. E.Z., I.M., N.F., G.G., C.L., F.G., C.T., L.M., F.D.M., A.S., G.S., A.F., G.L., E.D.B., C.C., G.M., A.Ch., and A.Ca. were co-investigators, were responsible for patients recruitment, treatment, biological samples collection, data input in eCRF. Clinical oversight of the study was undertaken by J.M. and supported by R.D.A. The RAP-ALS Investigators provided feedback on the protocol and oversaw site recruitment and data collection for their respective sites. J.M., R.D.A., A.Co., E.Z., I.M., R.V., F.B. were responsible for development of protocols, site training, and validation and creation of the eCRF and database. The study conduct was overseen by J.M. and R.V., supported by R.D.A. and a local management team comprising I.M., E.Z., N.F. A.Co., S.D.B., M.P. developed standard operating procedures for immunological analyses. S.D.B., C.S., D.L.T., M.P., under the supervision of A.Co., performed immunological analysis of biological samples. Acquisition of the financial support for the project leading to this publication was performed by J.M., A.Co. and R.D.A. with participation of A.C., C.C., C.L., G.S., E.D.B., L.M. Project administration was performed by J.M., R.D.A. and A.Co. The final analysis of all the primary and secondary outcomes was undertaken by F.B. under the supervision of R.D.A., and both veri fied the raw data. The manuscript was drafted by J.M., E.Z., F.B., S.D.B. All authors had access to all the study data and read, contributed to, reviewed and approved the submission of the manuscript for final publication.