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Lykiri

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Lykiri

Re: flipper44 post# 302923

Sunday, 08/30/2020 11:22:20 AM

Sunday, August 30, 2020 11:22:20 AM

Post# of 704471
Sorry, I posted the draft, here's the final version:

Brussels, 10.10.2019 C(2019) 7140 final

https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-10/atmp_guidelines_en.pdf

same quote:

Placebo: The use of placebo should be scientifically and ethically justified. When invasive procedures are required to administer the ATMP or for the collection/extraction of the cells/tissues, control groups receiving placebo only should not be subjected to a procedure if it presents more than minimal risk and minimal burden. The risk posed by the procedure should be duly explained in the Protocol
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