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.