Randomization and blinding
The subjects were randomly assigned 1:1 to either the UO or M3 group. The principal investigator, co-investigators, study personnel, and study participants were blinded to the treatment through the completion of the study. Blinding was maintained by labeling both products in a similar manner, differentiated only by their computer-generated randomization code, and with no other distinguishing information between the two products. In addition, the M3 capsules were similar in size and shape to the UO capsules. Allocation concealment was implemented by means of a restricted access drug dispensary unit within the CRO. An allocation schedule facilitated the release of subject supplements to trial personnel as scheduled.