Unmasking of the Study Treatment. Masked information on the identity of the assigned medical device should not be disclosed during the study. If the treatment code needs to be broken in the interest of subject safety, the Investigator is encouraged to contact an appropriate Study Sponsor representative prior to unmasking the information if there is sufficient time. Dependent upon the individual circumstances (ie, medical emergency), the code may be broken prior to contact with the Study Sponsor. The Study Sponsor must be informed of all cases in which the code was broken and of the circumstances involved. Additionally, the Study Sponsor may be required to unmask the information in order to fulfill expedited regulatory requirements.
Unmasking of the Study Treatment. Masked information on the identity of the assigned medical device should not be disclosed during the study.
Unmasking of the Study Treatment. Not applicable; this study is open-label.
Unmasking of the Study Treatment. Masked information on the identity of the assigned medical device should not be disclosed during the study. If unmasking is required in the interest of subject safety, the investigator is encouraged to contact an appropriate study sponsor to obtain unmasking information. Additionally, the study sponsor may be required to unmask the information in order to fulfill expedited regulatory reporting
