Data collection and data management
Data will be collected by research personnel, all of which have been trained in the principles of good clinical practice. Experimental data is pseudo-anonymised then recorded and managed on a secure encrypted local database. Filled-out data collection files will be transferred to the secure database by one researcher. Digitalised data are stored for 5 years after study end. For each participant, a physical Case Report Form, containing all physical source material, will be kept in a secure and locked location for 5 years. Serum samples will be stored at the research laboratory for a maximum of 5 years. Samples will be anonymised and labelled with subject randomisation ID and date of sample collection.