Randomization, allocation, and blinding
Eligible participants were randomly allocated in a 1:1 ratio to receive γ-Toc followed by placebo (group A) or the same supplementation in reverse order (group B), in the order where they were assessed for eligibility by the trial site physician. A computer-generated list of random numbers was used for block randomization (block size = 4). Allocation was performed by the sponsor’s allocator, who was not involved in this study before the enrollment of the first participant. The allocator sealed the allocation list envelope and concealed it in a locked cabinet that only the allocator could open. All participants, personnel, and outcome assessors were blinded until all study data except for plasma γ-Toc and γ-CEHC levels were collected.