Procedure for unblinding if needed {17b}
ADVERSE EVENTS, PREMATURE
A randomized log is kept at the study center by the study personnel conducting the intervention treatment at the study center. This list contains patient name, patient study ID and the assigned treatment condition. The study personnel has to ensure that the log is kept at a safe place, that is accessible in case of emergency unblinding. The operator and study physicians will have access to the un-blinding list, if necessary for medical reasons. The actual allocation must not be disclosed to the patient and/or other study personnel including other site personnel, monitors, corporate sponsors or project office staff. Investigators are encouraged to discuss with the principal investigators if they believe that unblinding is necessary. Premature unblinding of study participant has to be considered in case of severe adverse events or medical emergency. The reason for unblinding, date and time, and names of the study team members will be documented on the un-blinding log. The monitor and the biostatistical center will be informed.