Criteria for discontinuing or modifying allocated interventions {11b}
CRF
ADVERSE EVENTS, CRF
All adverse events must be transmitted to the sponsor-investigator (AL). He will manage or supervise reporting of adverse events and ensure that the follow-up of concerned patients is performed. He will be advised of all patients who withdraw or discontinue. He will plan additional monitoring visits, rehabilitation, or data collection if he judges it necessary. Trial data of the patient will be stored in a coded manner. The names of the patients will not be disclosed on CRF. A sequential unique patient number (UPN) will be attributed to each patient randomized into the trial. Identification of patients will be stored on a randomization list. Patients must be informed of and agree to data and material handling in accordance with Swiss data protection law.