Monitoring
To monitor adherence to the intervention protocol, the research team will gain insight in the GILL modules. There are no further mandatory actions for the intervention. An independent monitor of the Amsterdam UMC Clinical Monitoring Center will control adherence to the research protocol and good clinical practice guidelines. The monitor will report findings to the research team and when necessary to the board of directors of the sponsor. No interim analyses will be performed. Frequency and procedures for auditing trial conduct are performed by the sponsor and follow guidelines of good clinical practice.