A SAE is any adverse event or unexpected adverse reaction that results in death is life-threatening requires hospitalisation or prolongation of existing hospitalisation results in persistent or significant disability or incapacity consists of a congenital anomaly or birth defect. In addition, the Investigators will also define an event as serious if it is an important and significant medical event that may not be immediately life threatening or resulting in death or hospitalisation but, based upon appropriate medical judgement may jeopardise the patient or may require intervention to prevent one or more outcomes listed above. Adverse events which do not fall into these categories are defined as non-serious.