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Posted On: 12/27/2020 7:25:25 PM
Post# of 145880
Subjects (or their legally authorized representative if sedated on vent) will still need to give informed consent, same as before, and the only change to protocol / consent form will be 100% chance of receiving LL instead of 2/3. CYDY will need to amend the protocol and each site's IRB will need to approve - probably under emergency / ad hoc meeting. I imagine CYDY will continue to provide LL at no cost, and collect more data under the same protocol.
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