Navarra, Pierluigi
Milleri, Stefano
Perez III, Marcos
Uboldi, Maria Chiara
Pellegrino, Paolo
Bois De Fer, Beatrice
Morelli, Lorenzo
Funding for this research was provided by:
Sanofi
Article History
Received: 5 November 2020
Accepted: 12 February 2021
First Online: 8 March 2021
Declarations
:
: Sanofi provided financial support for the conduct of the research and preparation of the article. Sanofi, in collaboration with all authors, was involved in the study design; in the collection, analysis and interpretation of data; in the writing of the report; and in the decision to submit the article.
: MP, MCU, PP, BBDF are employees of Sanofi Aventis. PN has undertaken consultancy for Sanofi and attended board meetings supported by Sanofi.
: Approval was obtained from the local ethics committee prior to the conduct of any study-related procedures. The protocol complied with recommendations of the 18th World Health Congress (Helsinki, 1964) and all applicable amendments. The protocol also complied with the laws and regulations, as well as any applicable guidelines, of the country where the study was conducted.
: Not applicable as this section relates to case reports/case series.
: All authors agreed to submit this manuscript to European Journal of Drug Metabolism and Pharmacokinetics.
: Qualified researchers may request access to subject level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized, and study documents will be redacted to protect the privacy of our trial participants. Further details on Sanofi’s data sharing criteria, eligible studies, and process for requesting access can be found at: ExternalRef removed.
: Not applicable.