The Sponsor will report all Suspected Unexpected Serious Adverse Reactions (SUSARs) to the MHRA and the Research Ethics Committee (REC) concerned. Fatal or life-threatening SUSARs must be reported within 7 days and all other SUSARs within 15 days. The Chief Investigator will inform all investigators concerned of relevant information about SUSARs that could adversely affect the safety of participants. The Sponsor will use the Summary of Product Characteristics (SMPC) as the Reference Safety Information (RSI) when determining the expectedness of any untoward medical occurrences and thus SAE/SUSAR reporting.