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North Manchester General Hospital, Manchester (A.U.), Biometrics (A.T., S.S.) and Clinical Development (R.B., G.C.K.W.K.), Vaccines and Immune Therapies, Biopharmaceuticals Research and Development (M.N.P.), AstraZeneca, Cambridge, and Mounts Bay Medical, Penzance (A.E.) \u2014 all in the United Kingdom; the Division of Infectious Diseases, Saint-Pierre University Hospital, Universit\u00e9 Libre de Bruxelles, Brussels (S.D.W.); Universit\u00e9 de Paris, INSERM French Clinical Research Infrastructure Network, Innovative Clinical Research Network in Vaccinology, Assistance Publique\u2013H\u00f4pitaux de Paris, Paris (O.L.); Chicago Clinical Research Institute, Chicago (D.J.L.); Clinical Development, Late-Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals Research and Development, AstraZeneca, Gothenburg, Sweden (P.A.); Clinical Pharmacology and Quantitative Pharmacology (R.H.A.), Clinical Development (K.D., P.G., K.A.N., K.P.), Biometrics (..."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrew","family":"Ustianowski","sequence":"additional","affiliation":[{"name":"From the University of Colorado School of Medicine, Aurora (M.J.L.); North Manchester General Hospital, Manchester (A.U.), Biometrics (A.T., S.S.) and Clinical Development (R.B., G.C.K.W.K.), Vaccines and Immune Therapies, Biopharmaceuticals Research and Development (M.N.P.), AstraZeneca, Cambridge, and Mounts Bay Medical, Penzance (A.E.) \u2014 all in the United Kingdom; the Division of Infectious Diseases, Saint-Pierre University Hospital, Universit\u00e9 Libre de Bruxelles, Brussels (S.D.W.); Universit\u00e9 de Paris, INSERM French Clinical Research Infrastructure Network, Innovative Clinical Research Network in Vaccinology, Assistance Publique\u2013H\u00f4pitaux de Paris, Paris (O.L.); Chicago Clinical Research Institute, Chicago (D.J.L.); Clinical Development, Late-Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals Research and Development, AstraZeneca, Gothenburg, Sweden (P.A.); Clinical Pharmacology and Quantitative Pharmacology (R.H.A.), Clinical Development (K.D., P.G., K.A.N., K.P.), Biometrics (..."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"St\u00e9phane","family":"De Wit","sequence":"additional","affiliation":[{"name":"From the University of Colorado School of Medicine, Aurora (M.J.L.); 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North Manchester General Hospital, Manchester (A.U.), Biometrics (A.T., S.S.) and Clinical Development (R.B., G.C.K.W.K.), Vaccines and Immune Therapies, Biopharmaceuticals Research and Development (M.N.P.), AstraZeneca, Cambridge, and Mounts Bay Medical, Penzance (A.E.) \u2014 all in the United Kingdom; the Division of Infectious Diseases, Saint-Pierre University Hospital, Universit\u00e9 Libre de Bruxelles, Brussels (S.D.W.); Universit\u00e9 de Paris, INSERM French Clinical Research Infrastructure Network, Innovative Clinical Research Network in Vaccinology, Assistance Publique\u2013H\u00f4pitaux de Paris, Paris (O.L.); Chicago Clinical Research Institute, Chicago (D.J.L.); Clinical Development, Late-Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals Research and Development, AstraZeneca, Gothenburg, Sweden (P.A.); Clinical Pharmacology and Quantitative Pharmacology (R.H.A.), Clinical Development (K.D., P.G., K.A.N., K.P.), Biometrics (..."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Miles","family":"Avila","sequence":"additional","affiliation":[{"name":"From the University of Colorado School of Medicine, Aurora (M.J.L.); North Manchester General Hospital, Manchester (A.U.), Biometrics (A.T., S.S.) and Clinical Development (R.B., G.C.K.W.K.), Vaccines and Immune Therapies, Biopharmaceuticals Research and Development (M.N.P.), AstraZeneca, Cambridge, and Mounts Bay Medical, Penzance (A.E.) \u2014 all in the United Kingdom; the Division of Infectious Diseases, Saint-Pierre University Hospital, Universit\u00e9 Libre de Bruxelles, Brussels (S.D.W.); Universit\u00e9 de Paris, INSERM French Clinical Research Infrastructure Network, Innovative Clinical Research Network in Vaccinology, Assistance Publique\u2013H\u00f4pitaux de Paris, Paris (O.L.); Chicago Clinical Research Institute, Chicago (D.J.L.); Clinical Development, Late-Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals Research and Development, AstraZeneca, Gothenburg, Sweden (P.A.); Clinical Pharmacology and Quantitative Pharmacology (R.H.A.), Clinical Development (K.D., P.G., K.A.N., K.P.), Biometrics (..."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alison","family":"Templeton","sequence":"additional","affiliation":[{"name":"From the University of Colorado School of Medicine, Aurora (M.J.L.); North Manchester General Hospital, Manchester (A.U.), Biometrics (A.T., S.S.) and Clinical Development (R.B., G.C.K.W.K.), Vaccines and Immune Therapies, Biopharmaceuticals Research and Development (M.N.P.), AstraZeneca, Cambridge, and Mounts Bay Medical, Penzance (A.E.) \u2014 all in the United Kingdom; the Division of Infectious Diseases, Saint-Pierre University Hospital, Universit\u00e9 Libre de Bruxelles, Brussels (S.D.W.); Universit\u00e9 de Paris, INSERM French Clinical Research Infrastructure Network, Innovative Clinical Research Network in Vaccinology, Assistance Publique\u2013H\u00f4pitaux de Paris, Paris (O.L.); Chicago Clinical Research Institute, Chicago (D.J.L.); Clinical Development, Late-Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals Research and Development, AstraZeneca, Gothenburg, Sweden (P.A.); Clinical Pharmacology and Quantitative Pharmacology (R.H.A.), Clinical Development (K.D., P.G., K.A.N., K.P.), Biometrics (..."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yuan","family":"Yuan","sequence":"additional","affiliation":[{"name":"From the University of Colorado School of Medicine, Aurora (M.J.L.); 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North Manchester General Hospital, Manchester (A.U.), Biometrics (A.T., S.S.) and Clinical Development (R.B., G.C.K.W.K.), Vaccines and Immune Therapies, Biopharmaceuticals Research and Development (M.N.P.), AstraZeneca, Cambridge, and Mounts Bay Medical, Penzance (A.E.) \u2014 all in the United Kingdom; the Division of Infectious Diseases, Saint-Pierre University Hospital, Universit\u00e9 Libre de Bruxelles, Brussels (S.D.W.); Universit\u00e9 de Paris, INSERM French Clinical Research Infrastructure Network, Innovative Clinical Research Network in Vaccinology, Assistance Publique\u2013H\u00f4pitaux de Paris, Paris (O.L.); Chicago Clinical Research Institute, Chicago (D.J.L.); Clinical Development, Late-Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals Research and Development, AstraZeneca, Gothenburg, Sweden (P.A.); Clinical Pharmacology and Quantitative Pharmacology (R.H.A.), Clinical Development (K.D., P.G., K.A.N., K.P.), Biometrics (..."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dennis J.","family":"Levinson","sequence":"additional","affiliation":[{"name":"From the University of Colorado School of Medicine, Aurora (M.J.L.); North Manchester General Hospital, Manchester (A.U.), Biometrics (A.T., S.S.) and Clinical Development (R.B., G.C.K.W.K.), Vaccines and Immune Therapies, Biopharmaceuticals Research and Development (M.N.P.), AstraZeneca, Cambridge, and Mounts Bay Medical, Penzance (A.E.) \u2014 all in the United Kingdom; the Division of Infectious Diseases, Saint-Pierre University Hospital, Universit\u00e9 Libre de Bruxelles, Brussels (S.D.W.); Universit\u00e9 de Paris, INSERM French Clinical Research Infrastructure Network, Innovative Clinical Research Network in Vaccinology, Assistance Publique\u2013H\u00f4pitaux de Paris, Paris (O.L.); Chicago Clinical Research Institute, Chicago (D.J.L.); Clinical Development, Late-Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals Research and Development, AstraZeneca, Gothenburg, Sweden (P.A.); Clinical Pharmacology and Quantitative Pharmacology (R.H.A.), Clinical Development (K.D., P.G., K.A.N., K.P.), Biometrics (..."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Philip","family":"Ambery","sequence":"additional","affiliation":[{"name":"From the University of Colorado School of Medicine, Aurora (M.J.L.); 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North Manchester General Hospital, Manchester (A.U.), Biometrics (A.T., S.S.) and Clinical Development (R.B., G.C.K.W.K.), Vaccines and Immune Therapies, Biopharmaceuticals Research and Development (M.N.P.), AstraZeneca, Cambridge, and Mounts Bay Medical, Penzance (A.E.) \u2014 all in the United Kingdom; the Division of Infectious Diseases, Saint-Pierre University Hospital, Universit\u00e9 Libre de Bruxelles, Brussels (S.D.W.); Universit\u00e9 de Paris, INSERM French Clinical Research Infrastructure Network, Innovative Clinical Research Network in Vaccinology, Assistance Publique\u2013H\u00f4pitaux de Paris, Paris (O.L.); Chicago Clinical Research Institute, Chicago (D.J.L.); Clinical Development, Late-Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals Research and Development, AstraZeneca, Gothenburg, Sweden (P.A.); Clinical Pharmacology and Quantitative Pharmacology (R.H.A.), Clinical Development (K.D., P.G., K.A.N., K.P.), Biometrics (..."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rohini","family":"Beavon","sequence":"additional","affiliation":[{"name":"From the University of Colorado School of Medicine, Aurora (M.J.L.); North Manchester General Hospital, Manchester (A.U.), Biometrics (A.T., S.S.) and Clinical Development (R.B., G.C.K.W.K.), Vaccines and Immune Therapies, Biopharmaceuticals Research and Development (M.N.P.), AstraZeneca, Cambridge, and Mounts Bay Medical, Penzance (A.E.) \u2014 all in the United Kingdom; the Division of Infectious Diseases, Saint-Pierre University Hospital, Universit\u00e9 Libre de Bruxelles, Brussels (S.D.W.); Universit\u00e9 de Paris, INSERM French Clinical Research Infrastructure Network, Innovative Clinical Research Network in Vaccinology, Assistance Publique\u2013H\u00f4pitaux de Paris, Paris (O.L.); Chicago Clinical Research Institute, Chicago (D.J.L.); Clinical Development, Late-Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals Research and Development, AstraZeneca, Gothenburg, Sweden (P.A.); Clinical Pharmacology and Quantitative Pharmacology (R.H.A.), Clinical Development (K.D., P.G., K.A.N., K.P.), Biometrics (..."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kanika","family":"Dey","sequence":"additional","affiliation":[{"name":"From the University of Colorado School of Medicine, Aurora (M.J.L.); North Manchester General Hospital, Manchester (A.U.), Biometrics (A.T., S.S.) and Clinical Development (R.B., G.C.K.W.K.), Vaccines and Immune Therapies, Biopharmaceuticals Research and Development (M.N.P.), AstraZeneca, Cambridge, and Mounts Bay Medical, Penzance (A.E.) \u2014 all in the United Kingdom; the Division of Infectious Diseases, Saint-Pierre University Hospital, Universit\u00e9 Libre de Bruxelles, Brussels (S.D.W.); Universit\u00e9 de Paris, INSERM French Clinical Research Infrastructure Network, Innovative Clinical Research Network in Vaccinology, Assistance Publique\u2013H\u00f4pitaux de Paris, Paris (O.L.); Chicago Clinical Research Institute, Chicago (D.J.L.); Clinical Development, Late-Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals Research and Development, AstraZeneca, Gothenburg, Sweden (P.A.); Clinical Pharmacology and Quantitative Pharmacology (R.H.A.), Clinical Development (K.D., P.G., K.A.N., K.P.), Biometrics (..."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pedro","family":"Garbes","sequence":"additional","affiliation":[{"name":"From the University of Colorado School of Medicine, Aurora (M.J.L.); North Manchester General Hospital, Manchester (A.U.), Biometrics (A.T., S.S.) and Clinical Development (R.B., G.C.K.W.K.), Vaccines and Immune Therapies, Biopharmaceuticals Research and Development (M.N.P.), AstraZeneca, Cambridge, and Mounts Bay Medical, Penzance (A.E.) \u2014 all in the United Kingdom; the Division of Infectious Diseases, Saint-Pierre University Hospital, Universit\u00e9 Libre de Bruxelles, Brussels (S.D.W.); Universit\u00e9 de Paris, INSERM French Clinical Research Infrastructure Network, Innovative Clinical Research Network in Vaccinology, Assistance Publique\u2013H\u00f4pitaux de Paris, Paris (O.L.); Chicago Clinical Research Institute, Chicago (D.J.L.); Clinical Development, Late-Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals Research and Development, AstraZeneca, Gothenburg, Sweden (P.A.); Clinical Pharmacology and Quantitative Pharmacology (R.H.A.), Clinical Development (K.D., P.G., K.A.N., K.P.), Biometrics (..."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elizabeth J.","family":"Kelly","sequence":"additional","affiliation":[{"name":"From the University of Colorado School of Medicine, Aurora (M.J.L.); North Manchester General Hospital, Manchester (A.U.), Biometrics (A.T., S.S.) and Clinical Development (R.B., G.C.K.W.K.), Vaccines and Immune Therapies, Biopharmaceuticals Research and Development (M.N.P.), AstraZeneca, Cambridge, and Mounts Bay Medical, Penzance (A.E.) \u2014 all in the United Kingdom; the Division of Infectious Diseases, Saint-Pierre University Hospital, Universit\u00e9 Libre de Bruxelles, Brussels (S.D.W.); Universit\u00e9 de Paris, INSERM French Clinical Research Infrastructure Network, Innovative Clinical Research Network in Vaccinology, Assistance Publique\u2013H\u00f4pitaux de Paris, Paris (O.L.); Chicago Clinical Research Institute, Chicago (D.J.L.); Clinical Development, Late-Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals Research and Development, AstraZeneca, Gothenburg, Sweden (P.A.); Clinical Pharmacology and Quantitative Pharmacology (R.H.A.), Clinical Development (K.D., P.G., K.A.N., K.P.), Biometrics (..."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gavin C.K.W.","family":"Koh","sequence":"additional","affiliation":[{"name":"From the University of Colorado School of Medicine, Aurora (M.J.L.); North Manchester General Hospital, Manchester (A.U.), Biometrics (A.T., S.S.) and Clinical Development (R.B., G.C.K.W.K.), Vaccines and Immune Therapies, Biopharmaceuticals Research and Development (M.N.P.), AstraZeneca, Cambridge, and Mounts Bay Medical, Penzance (A.E.) \u2014 all in the United Kingdom; the Division of Infectious Diseases, Saint-Pierre University Hospital, Universit\u00e9 Libre de Bruxelles, Brussels (S.D.W.); Universit\u00e9 de Paris, INSERM French Clinical Research Infrastructure Network, Innovative Clinical Research Network in Vaccinology, Assistance Publique\u2013H\u00f4pitaux de Paris, Paris (O.L.); Chicago Clinical Research Institute, Chicago (D.J.L.); Clinical Development, Late-Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals Research and Development, AstraZeneca, Gothenburg, Sweden (P.A.); Clinical Pharmacology and Quantitative Pharmacology (R.H.A.), Clinical Development (K.D., P.G., K.A.N., K.P.), Biometrics (..."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Karen A.","family":"Near","sequence":"additional","affiliation":[{"name":"From the University of Colorado School of Medicine, Aurora (M.J.L.); North Manchester General Hospital, Manchester (A.U.), Biometrics (A.T., S.S.) and Clinical Development (R.B., G.C.K.W.K.), Vaccines and Immune Therapies, Biopharmaceuticals Research and Development (M.N.P.), AstraZeneca, Cambridge, and Mounts Bay Medical, Penzance (A.E.) \u2014 all in the United Kingdom; the Division of Infectious Diseases, Saint-Pierre University Hospital, Universit\u00e9 Libre de Bruxelles, Brussels (S.D.W.); Universit\u00e9 de Paris, INSERM French Clinical Research Infrastructure Network, Innovative Clinical Research Network in Vaccinology, Assistance Publique\u2013H\u00f4pitaux de Paris, Paris (O.L.); Chicago Clinical Research Institute, Chicago (D.J.L.); Clinical Development, Late-Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals Research and Development, AstraZeneca, Gothenburg, Sweden (P.A.); Clinical Pharmacology and Quantitative Pharmacology (R.H.A.), Clinical Development (K.D., P.G., K.A.N., K.P.), Biometrics (..."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kelly W.","family":"Padilla","sequence":"additional","affiliation":[{"name":"From the University of Colorado School of Medicine, Aurora (M.J.L.); North Manchester General Hospital, Manchester (A.U.), Biometrics (A.T., S.S.) and Clinical Development (R.B., G.C.K.W.K.), Vaccines and Immune Therapies, Biopharmaceuticals Research and Development (M.N.P.), AstraZeneca, Cambridge, and Mounts Bay Medical, Penzance (A.E.) \u2014 all in the United Kingdom; the Division of Infectious Diseases, Saint-Pierre University Hospital, Universit\u00e9 Libre de Bruxelles, Brussels (S.D.W.); Universit\u00e9 de Paris, INSERM French Clinical Research Infrastructure Network, Innovative Clinical Research Network in Vaccinology, Assistance Publique\u2013H\u00f4pitaux de Paris, Paris (O.L.); Chicago Clinical Research Institute, Chicago (D.J.L.); Clinical Development, Late-Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals Research and Development, AstraZeneca, Gothenburg, Sweden (P.A.); Clinical Pharmacology and Quantitative Pharmacology (R.H.A.), Clinical Development (K.D., P.G., K.A.N., K.P.), Biometrics (..."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Konstantina","family":"Psachoulia","sequence":"additional","affiliation":[{"name":"From the University of Colorado School of Medicine, Aurora (M.J.L.); North Manchester General Hospital, Manchester (A.U.), Biometrics (A.T., S.S.) and Clinical Development (R.B., G.C.K.W.K.), Vaccines and Immune Therapies, Biopharmaceuticals Research and Development (M.N.P.), AstraZeneca, Cambridge, and Mounts Bay Medical, Penzance (A.E.) \u2014 all in the United Kingdom; the Division of Infectious Diseases, Saint-Pierre University Hospital, Universit\u00e9 Libre de Bruxelles, Brussels (S.D.W.); Universit\u00e9 de Paris, INSERM French Clinical Research Infrastructure Network, Innovative Clinical Research Network in Vaccinology, Assistance Publique\u2013H\u00f4pitaux de Paris, Paris (O.L.); Chicago Clinical Research Institute, Chicago (D.J.L.); Clinical Development, Late-Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals Research and Development, AstraZeneca, Gothenburg, Sweden (P.A.); Clinical Pharmacology and Quantitative Pharmacology (R.H.A.), Clinical Development (K.D., P.G., K.A.N., K.P.), Biometrics (..."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Audrey","family":"Sharbaugh","sequence":"additional","affiliation":[{"name":"From the University of Colorado School of Medicine, Aurora (M.J.L.); 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