Safety reporting: the investigator needs to report all Serious Adverse Events (SAEs) within 24 hours (or within the timelines stipulated in the protocol) via e-mail to the Ethical Committee (EC) via HIRUZ CTU using the SAE form. HIRUZ CTU will contact the investigator to determine the type of SAE. In case of a Suspected Unexpected Serious Adverse Reactions (SUSAR) HIRUZ CTU will report the SUSAR to both the EC and the Competent Authorities (CA), i.e. FAMHP in Belgium. HIRUZ CTU will safeguard the legal requirements of the reporting as far as the necessary information is provided by the investigator. SAE forms need to be submitted to