Data monitoring committee
ADVERSE EFFECTS
There is no data monitoring committee and no independent auditing process. The quality of the data is assured by the blinded clinical raters and there are no known serious adverse effects. If serious adverse effects occur, they will be reported to the principal investigator, who will then interview the patient in question and refer them to a psychiatry if needed. Adherence to therapeutic measures is ensured by regular supervision by the principal investigators. Completeness of data will be regularly verified by the study coordinators.