Received: 12 May 2021
Accepted: 29 October 2021
First Online: 6 November 2021
: The study was designed, conducted and reported in accordance with the Guidelines for Good Pharmacoepidemiology Practices of the International Society for Pharmacoepidemiology, with the ethical principles of the Declaration of Helsinki, and with the current Spanish legislation related to observational studies (Ministerial Order SAS/3470/2009).The study was reviewed and approved by the Clinical Research Ethics Committee of the Basque Country in Txagorritxu Hospital (Vitoria, Spain). This Committee was the reference Ethics Committee for the study coordinator hospital (Hospital de Basurto).According to the Guidelines for Good Pharmacoepidemiology Practices and the Spanish regulation for non-interventional observational studies using secondary data sources in which a procedure for de-identification of data is implemented, there is no need for subject informed consent collection. In the present study, only already existing data from databases and clinical records was collected, there was no interview with subjects, and all data was securely and adequately dissociated. The Ethics Committee of the Basque Country in Txagorritxu Hospital (Vitoria, Spain) approved this informed consent waiver.
: Not applicable.
: MC and MSM are employees of MSD Spain. All other authors do not have any competing interest.