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The primary analysis was realised in February 2022 on 1000 enrolled procedures. The sponsor and the scientific committee decided to stop the trial on March 2022 as the results demonstrated a significative diminution of CDE in AS group versus non-AS group (p<0.0001).
Copyright and License information: ©2023-11-16 Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.
This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.
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