Assessment of success

Since this is the first trial ever conducted in Denmark to use the setup and design described in this report, the study team found it impossible to devise specific criteria for success with meaningful numerical cutoffs. Significant uncertainties pertaining primarily to the obtainment of approvals for this novel trial design from the Danish authorities and obtaining real-time access to registry data for a drug trial existed, leaving the study team wondering whether it would even be possible to initiate the trial. Due to this, the assessment of success will rely on an overall evaluation of the conduct of the trial including the obtainment of approvals, recruitment rate and success, randomization agreement, and reliability with regards to the registry-based obtainment of baseline characteristics, safety events, and clinical endpoints. This overall evaluation will be used by the study team as part of the decision on whether to progress to a fully powered trial. Any specific issues encountered during this feasibility trial will be addressed in the design of a fully powered trial, in case the study team should decide to progress.