Funding for this research was provided by:
Instituto de Salud Carlos III (PI17/01372)
Received: 5 February 2020
Accepted: 10 April 2020
First Online: 18 May 2020
Ethics approval and consent to participate
: The study protocol was approved by the Clinical Research Ethics Committee at Bellvitge Hospital (Ref. Number AC007/19), the Spanish Regulatory Agency (AEMPS, Agencia Española del Medicamento y Productos Sanitarios) and the Institutional Review Boards at each participating site. A formal contract agreement was signed with each of the institutions and with the study sponsor.The study will be conducted in accordance with the protocol and with the principles established in the latest version of the Declaration of Helsinki, with the standards of Good Clinical Practice as described in CPMP/ICH/135/95 and with the Royal Decree of Clinical Trials 1090/2015, which regulates clinical trials with medicines in Spain and includes the full text of European Directive 2001/20/EC, relating to the provisions of member states on the implementation of Good Clinical Practice in the conduct of clinical trials on medicinal products for human use.The researchers agreed, when signing the protocol, to adhere to the instructions and procedures described therein and thus to follow the principles of Good Clinical Practice that they imply.The data will be treated anonymously at all times, identifying each patient with a protocol number. The privacy and confidentiality of all data will be protected. All patients’ personal data will be processed, disclosed and transferred in accordance with Organic Law 3/2018 of 5 December 2018 and Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016.All participants will sign the informed consent. Before signing, all patients will be informed of the study objectives, possible AEs, procedures that they will undergo and the process used to assign the intervention. Furthermore, they will be informed that their data will be treated with strict confidentiality. On the consent form, participants will be asked by the research team if they agree to collect biological specimens. Biological specimens will be blood samples to determine plasma BLA concentrations. All biological specimens will be destroyed at the end of the study.
: Not applicable
: CG has received honoraria for lectures from Pfizer, Gilead Sciences and MSD. JC has received honoraria for lectures from Gilead Sciences and MSD. CGV has received honoraria for lectures form Gilead Sciences, Pfizer, Janssen, Novartis and Lilly and has received grants and personal fees from Gilead Sciences and MSD. JLdP has received honoraria for lectures form Pfizer, Novartis, MSD and Angelini and has received grants from Novartis. All other authors report no potential conflicts of interest.