Author Contributions

MBYI performed the clinical and study procedures and drafted the manuscript. RLR and SEM contributed to the study concept and design and supervised the clinical and procedural tasks. MBG and EDV contributed to the study design and performed the neuropsychological evaluations and intervention procedures. ERP conducted the statistical analyses and contributed to data interpretation. All authors contributed to editorial changes in the manuscript. All authors reviewed and approved the final manuscript. All authors have participated sufficiently in the work and agreed to be accountable for all aspects of the work.

Ethics Approval and Consent to Participate

The ethics approval committee is at Virgen Macarena University Hospital. The corresponding ethics approval number is EM-Reserve. Clinical trial registration number: NCT05546424. This study adheres to the principles of the Declaration of Helsinki, good clinical practice standards, and current legal regulations. It commenced after obtaining approval from the ethics committee. Participants provided informed consent before admission to the study, having been duly informed by their regular neurologist. The treatment, communication, and transfer of personal data of participating subjects comply with Regulation (EU) 2016/679 of the European Parliament and the Council of April 27, 2016, on Data Protection (GDPR). Under the GDPR, participants could exercise their rights to access, modify, object, and have their data erased. Anonymity of participating subjects was maintained throughout the study.

Acknowledgment

Not applicable.

Funding

The study was sponsored by Bristol‑Myers Squibb and promoted by FISEVI and Servicio Andaluz de Salud, as stated in the original protocol. Funding sources had no involvement in study design, collection, analysis and interpretation of data or writing the report.

Conflict of Interest

We confirm that no conflicts of interest are present. The study was partially supported by Bristol and the Fundación Andaluza de Investigación; however, these entities had no role in the study design, data collection, statistical analysis, interpretation of results, or manuscript preparation. The affiliation of any co-author with a foundation does not constitute a conflict of interest, as no financial, advisory, or commercial relationships exist that could inappropriately influence the work. Accordingly, the authors declare that they have no additional conflicts of interest.