Randomization
After signedconsent, the study team confirmed inclusion and exclusion criteria, and then enrolled the patient in the study. The study team would then notify unblinded study staff at Cell Therapy & Regenerative Medicine [CellReGen] (Salt Lake City, UT, USA) that the patient was enrolled. CellReGen study staff would confirm enrollment and immediately randomized the patient using the randomization module of REDCap (Nashville, TN, USA), which utilized a 1:1 allocation and permuted block randomization with blocks of size 2 and 4. Concealment was assured using this secure, centralized, web-based system. The study drug (hAF or saline placebo) was then prepared by CellReGen according to the randomization allocation, packaged as blinded study drug, and hand delivered to a study clinical research coordinator at the University of Utah Hospital. Drug preparation was done in accordance with US FDA IND regulation and has already been described [