Subjects (or their legally authorized representati

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.