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.