**2. Methods**

#### *2.1. Ethics, Consent and Permission*

The final protocol was approved by the Sagunto Hospital Clinical Research Ethics Committee, in accordance with applicable national and local laws and requirements. The study was classified by the Spanish Agency for Medicine and Health Products as a prospective follow-up post-authorization study.

The study adheres to the European guidelines for the protection of human research subjects, the Declaration of Helsinki and the recommendations of the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance. Approval was obtained from all local ethics committees at all participating centers. Prior to inclusion, each patient will receive a detailed report on the nature, scope and possible consequences of the study from a physician and then will provide written informed consent. No action specifically required for the study will be taken without the valid consent of the patient.
