Plans for assessment and collection of outcomes {18a}
We will create a research database hosted by OPEN in Odense, Denmark to enter and store the data, as this solution applies to the General Data Protection Regulation and Danish legislation to securely handle patient data. The research database is based on the system by Redcap and the database is available by any internet browser, allowing the sites to enter data directly into the database.We will store the data for up to 5 years after the end of the project, and hereafter the data will be either transferred to the Danish National Archives and made anonymous, or destroyed.Patients that are included in the study will have to have a blood sample (approximately 11.3 ml per patient) and a small fecal sample (approximately 2 × 3 ml per patient). The sample material and any excess material will be deposited in a research biobank after analyses during the project. The material in the research biobank will after the end of the project be stored for up to 5 years in a future biobank enabling any future research in relation to this project, and both biobanks follow the valid general data protection regulation. Patients also need to have external measures, such as waist circumference, blood pressure, and answer questionnaires regarding quality of life.