Randomization and blinding
blindness
BLINDNESS
The study was conducted in a double-blind randomized manner. The subjects were enrolled by the investigator at each site and randomized (1:1) at the screening visit to the ColdZyme or placebo group. Several whole blocks of 8 were allocated to each of the ten study centers. The investigational products, containing ColdZyme or placebo, were identical in appearance, as well as packaging and labelling, to ensure blindness to treatment assignment for subjects and all involved site personnel.