A serious adverse event is defined as one which causes patient death, is life threatening, prolongs hospital stay or results in a persistent or significant disability or incapacity (TGA). An independent physician will be appointed to review all serious adverse events. This review will occur within 24 hours of the adverse event occurring. The monitoring physician may suspend the study if warranted on the basis of the occurrence of adverse events. All serious adverse events will be reported to the Drug Trial Subcommittee of the Human Research Ethics Committee as soon as possible.