Custodio, A. http://orcid.org/0000-0002-7287-4060
Jimenez-Fonseca, P.
Carmona-Bayonas, A.
Gomez, M. J.
Del Olmo-García, M. I.
Lorenzo, I.
Díaz, J. Á.
Canal, N.
De la Cruz, G.
Villabona, C.
Article History
Received: 22 February 2021
Accepted: 22 March 2021
First Online: 9 June 2021
Declarations
:
: PJF: travel grants from Ipsen and consulting/advisory role for Bristol, Mylan, Rovi, LeoPharma, ADACAP, all outside of the scope of this work; ACB: travel grants and honoraria from Ipsen, Roche and Novartis and consulting/advisory role for Roche, Rovi, LeoPharma, Pfizer, Esteve, Elsevier, Bristol, all outside of the scope of this work; MIDO: honoraria and/or research grants and/or advisory board and/or consultancy fees from ADACAP, Ipsen, Novartis, Pfizer; IL: honoraria and/or congress support from Bristol Myers, Novartis, Pfizer, Pierre Fabre, Roche; JÁD: Ipsen advisory board; NC: employee of IQVIA; MP, GDLC: employees of Ipsen; ACB: honoraria and/or advisory board from BMS, Ipsen, MSD, Novartis, Pfizer; CV, MJG: nothing to disclose.
: Where patient data can be anonymised, Ipsen will share all individual participant data that underlie the results reported in this article with qualified researchers who provide a valid research question. Study documents, such as the study protocol and clinical study report, are not always available. Proposals should be submitted to DataSharing@Ipsen.com and will be assessed by a scientific review board. Data are available beginning 6 months and ending 5 years after publication; after this time, only raw data may be available.
: This non-interventional study was approved by the Ethics Committee of <i>Hospital Universitari de Bellvitge,</i> Barcelona (27 April 2017), and classified as a post-approval study by the Spanish Agency for Medicines and Medical Devices (AEMPS; 16 February 2017). The study followed the International Society for Pharmacoepidemiology Guidelines on Good Pharmacoepidemiological Practice [CitationRef removed]. Prior to any data collection, living participants received a full explanation and provided written informed consent. In the case of deceased participants, following ethics committee review, consent from living relatives was not required.
: Subjects signed the informed consent.