Lopez-Ruz, Sergio
Barca-Hernando, Maria
Marin-Romero, Samira
Elias-Hernandez, Teresa
Otero- Candelera, Remedios
Jara-Palomares, Luis http://orcid.org/0000-0002-4125-3376
Funding for this research was provided by:
LEO Pharma Research Foundation
Article History
Received: 2 July 2022
Revised: 28 September 2022
Accepted: 29 September 2022
First Online: 14 October 2022
Competing interests
: LJ-P reports personal fees from Bayer Hispania, Actelion, Rovi, Pfizer, Menarini, and Leo Pharma, outside the submitted work. ROC reports grant support from Leo Pharma and Bayer Healthcare, and fees for serving on advisory boards and giving lectures from Leo Pharma, Rovi, Bayer Healthcare, MSD and Actelion. There are no other competing interests.
: This post hoc analysis was evaluated and approved by the Ethical Committee of the centre according to Spanish Regulatory Authorities (0511-N-22). This study was conducted in accordance with the principles of the Declaration of Helsinki and the International Council for Harmonisation (ICH) Guidelines for Good Clinical Practice and in full conformity with relevant regulations. Documents constituting the master file of the study included all the documents established in good clinical practice (CPMP/ICH/135/95). In this project, the collection, process and analysis of all data were anonymously carried out, and only for the purposes of the project. All data were protected in accordance with the European Union directive 2016/679 of the European Parliament and the European Council, of April 27, 2016, regarding the protection of persons and their personal data.
: No publication consent is required for this specific study. This post hoc analysis was evaluated and approved by the Ethical Committee of the centre according to Spanish Regulatory Authorities (0511-N-22). Original prospective studies required informed consent.