Blinding and randomization
Study subjects were masked to treatment allocation and were randomized
to either treatment or placebo group when admitted to the Hospital at
day 0. We established a system of opaque closed envelopes containing the
arm designation. The pharmacist of the study randomly selected the
envelope for each study subject in the presence of the principal
investigator. For safety reasons, the researchers responsible for the
clinical trial were aware of treatment allocation. INM004 was provided
to the nursing staff in anonymized bags with the preparation already
reconstituted and labeled with participant and treatment identification
number without the specific content (INM004 or placebo) so that the
subject could not infer the assigned treatment. The physician
responsible for safety monitoring during the infusion of INM004 or
placebo was blinded to treatment allocation.