Maintenance of Randomisation and Blinding Sample Clauses

Maintenance of Randomisation and Blinding. The dose(s) administered as allocated by the randomisation sequence should remain blinded throughout the study. However, in the event of an SAE or unexpected AE, which requires the identification of the study treatment group, the investigator should first contact the pharmacovigilance representative as outlined in the protocol. The investigator should then review the case status and all pertinent information with the representative from Global Patient Safety who will consult with the therapeutic area drug safety physician prior to any code break. In case of a medical emergency requiring an urgent unblinding, the investigator and/or Global Patient Safety may break the blind by asking the IRT to obtain the subject's treatment identification. In addition, hard copy sealed code-break envelopes will be prepared by the spousor's raudomisation manager, and held by Global Patient Safety at Ipsen in case of IRT failure. The final decision to unblind rests with the investigators as they are ultimately responsible for subject safety. If a code break is performed using the IRT, the investigator must store the email notification revealing unblinded treatment in a sealed envelope. The investigator will then sign, date, and provide reason for the code break on the Emergency Code break form, and on the sealed envelope. The date and reason for identifying the treatment group will be recorded in the electronic case report form (eCRF).