Department of Biostatistics and Programming, Mail Stop 55C-305A, 55 Corporate Drive, Sanofi, Bridgewater, NJ 08807, USA. li.liu@sanofi.com|Department of Biostatistics and Programming, Mail Stop 55C-305A, 55 Corporate Drive, Sanofi, Bridgewater, NJ 08807, USA. li.liu@sanofi.com|Department of Biostatistics and Programming, Mail Stop 55C-305A, 55 Corporate Drive, Sanofi, Bridgewater, NJ 08807, USA. li.liu@sanofi.com|Department of Biostatistics and Programming, Mail Stop 55C-305A, 55 Corporate Drive, Sanofi, Bridgewater, NJ 08807, USA. li.liu@sanofi.com