Institutional Review Board Statement
RECRUITMENT
The study was conducted in accordance with the Declaration of Helsinki, and the clinical trial protocol was reviewed and approved by the Research Ethics Committee of the Province of Malaga, on 28 March 2019 (File number: AP-0157-2018). The study is registered at ClinicalTrials.gov, NCT04052074. Registered 9 August 2019. Recruitment between July 2020 and September 2021.