Table 1.
Summary of protocol versions
| Version | Date | Comment |
|---|---|---|
| 1 | January 11th, 2019 | Initial version submitted to research ethical committee |
| 2 | February 7th, 2019 | Modifications following research ethical committee comments regarding SAE definition. |
| 3 | June 25th, 2019 | Addition of the possibility to include patients unable to write due to physical disability |
| 4 | July 19th, 2019 | Modifications following research ethical committee comments (refusal of next of kin consent by phone) |
| 5 | September 17th, 2021 |
Extension of recruitment period Sponsor contact information update Update on archive duration, according to French law |