Composition of the data monitoring committee, its role and reporting structure {21a}
RECRUITMENT
An independent data monitoring committee was not set up for this study. The main reason for this is the study is minimal risk to human health. The Trial statistician has analysed information on recruitment, baseline characteristics, and total counts of all VVRs recorded approximately two times per year, and presented summary data to the Trial Steering Committee, which then makes the decision on whether the study should continue.