Cynthia St. Hilaire, Ph here .D., Shira G. Ziegler, B.A., Thomas C. Markello, M.D., Ph.D., Alfredo Brusco, Ph.D., Catherine Groden, M.S., Fred Gill, M.D., Hannah Carlson-Donohoe, B.A., Robert J. Lederman, M.D., Marcus Y. Chen, M.D., Dan Yang, M.D., Ph.D., Michael P. Siegenthaler, M.D., Carlo Arduino, M.D., Cecilia Mancini, M.Sc., Bernard Freudenthal, M.D., Horia C. Stanescu, M.D., Anselm A. Zdebik, M.D., Ph.D., R. Krishna Chaganti, M.D., Robert L. Nussbaum, M.D., Robert Kleta, M.D., Ph.D., William A. Gahl, M.D., Ph.D., and Manfred Boehm, M.D.: NT5E Mutations and Arterial Calcifications.
The principal end point for immunogenicity was seroconversion, defined as an SBA titer that was at least four times as high as that at baseline 28 times after immunization were asked about tenderness and induration at the vaccination site; fever, vomiting, and diarrhea along with lethargy, irritability, and lack of appetite and headache, exhaustion, myalgia, and arthralgia . Solicited reactions within 4 times were presumed to become vaccine-related. Evaluation of causality in the full case of unsolicited adverse occasions was performed by the study investigators in each site. A data and safety monitoring plank was established for studies A and B.