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. 2022 Dec 12;23:993. doi: 10.1186/s13063-022-06896-4

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