Plans for communicating important protocol amendments to relevant parties (e.g., trial participants, ethical committees) {25}
All notifications defined as relevant or non-relevant amendments will be made to the Spanish Agency for Medicines and Health Products and to the Ethics Committee of reference in accordance with Spanish legislation on clinical trials RD 1090/2015 of December 4. These decrees regulate clinical trials with medicinal products: the Ethics Committees for Research with medicines and the Spanish Registry of Clinical Trials.