Vandenhaute, Jessica
Tsakeu, Elyonore
Chevalier, Pierre
Pawaskar, Manjiri
BenĨina, Goran
Vertriest, Jan
Article History
Received: 5 March 2021
Accepted: 1 November 2021
First Online: 11 November 2021
Declarations
:
: This was a database study. The database has been fully audited for GDPR compliance; it is pseudonymized by a Third Party before being used by IQVIA and all precautions have been taken by design to avoid any risk of patient identification. Based on the recommendations of the Belgian Ethics Committees, available on the Federal agency for medicines and health products (FAMHP), on non-interventional studies, informed consent was not necessary [CitationRef removed]. Strict attention to confidentiality is present at every stage of data collection, storage and analysis in accordance with these recommendations. The protocol of this study has been reviewed and approved by Merk Center of Observational and Real-world Evidence.
: Not applicable.
: ET, PC and RC are employees of IQVIA, the CRO hired to manage the study and provide statistics and writing services. Dr. JV, Dr. MP, Dr. GB and JV are employees of MSD (Merck & Co., Inc. in USA and Canada). Dr MP and Dr GB are stock holder of MSD.