Participant safety is paramount to Pfizer. As with all of our trials, we are following all of the rules and regulations in place to ensure participant safety. For example, the trial protocols are reviewed by regulatory authorities and approved by ethics committees or Institutional Review Boards, which are independent committees that review the methods proposed for research. In addition, the trial’s progress is closely monitored by both Pfizer and an outside group of independent experts called a Data Monitoring Committee or DMC. Trial investigators are also responsible for monitoring participants health, and participants in the trial have regular planned follow-up visits as part of the trial.