Data management
ADVERSE EVENT
Evaluation and testing procedures were standardized via written guidelines, videos, and team meetings to ensure inter-site consistency. The oversight committee comprised the co-PIs (MFL, DGL) and an uninvolved individual. The data monitoring and management committee (SFT, JS, MCB), led by MCB ensured the uploading of coded data to a secured repository. Adverse events were reported to local ethics committees, and mitigating procedures were followed.