Any unfavourable or unintended symptom or sign associated with the intervention during the trial.

Any AE considered to be of clinical significance by the local chief investigator as causing harm to the participant will be recorded and rated in severity.

Data to be recorded: onset, resolution outcome, severity.

Causality will be assessed by site investigators and reported as none, unlikely, possible, probable or definite.

Defined as persistent or significant, requiring intervention or hospitalisation. Participants affected by SAEs will undergo risk assessment as to whether it is safe to continue in the trial.

AEs and SAEs that have a reasonable possibility of being attributable to the device.