Precis-mel initiation package

- Registration number of the clinical study in a registry meeting WHO Registry criteria.- Final version of study protocol as approved by the regulators/ethics committee.- Regulatory and ethics approvals required for the enrolment of the first study participant.Study protocol will include information about if and how the incidental (or secondary) findings will be communicated to participants and how the personal data will be processed. Study protocol will also include information about how the retrospective and prospective personal data will be processed and also about the anonymization/pseudoanonymisation techniques that will be implemented.The study protocol will include information about how humans will maintain meaningful control over the decision-making process for the use of the prediction and diagnostic tool to be developed in the project. No further deliverables will be required.