The document submissions to the Competent Authorities, and obtaining organizational approvals from clinical trial units, can be done in parallel processes to achieve a timely start for the study. The notification will be submitted to Finnish Medicine Agency, FIMEA. The pre-notification for ruling on jurisdiction will be submitted to the National Committee on Medical Research Ethics, TUKIJA. The ethical admissibility of the proposal will be reviewed by TUKIJA or by one of the Regional Ethics Committees. Trial agreements and study contracts including subcontracts and employment contracts are taken care by University hospitals' Clinical Trial Units.