Aura Biosciences
AU-011-403 is a multicenter long-term follow-up safety and efficacy study of subjects with early CM who previously participated in the AU-011-301 Phase 3 trial. There are no required interventions or use of AU-011 (bel-sar) in this long-term follow-up study
Informed consent will be obtained for each subject, preferably during their participation in the AU-011-301 trial and no more than approximately 6 months after their AU-011-301 End of Trial (EoT)/Early Termination (ET) visit. All subjects will be followed for an additional \~5 years (not including AU-011-301 participation). The AU-011-301 assigned subject numbering will continue to be used in this study. The AU-011-301 randomization (treatment received) will continue to be masked during this study until the completion of the AU-011-301 trial and database lock. The purpose of this long-term fol…
Inclusion Criteria: * Have received bel-sar or sham treatment in the Aura-sponsored clinical trial AU-011-301. * Be willing and able to consent to the AU-011-403 study. Exclusion Criteria: * None
The intention is to collect data for an additional \~5 years (Post AU-011-301 participation)