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Two pivotal Phase III trials by Lichtman et al., registered as NCT01361607 and NCT01424566, used double-blind, randomized, placebo-controlled designs but differed in methodology

All animal experiments were approved by the Institutional Animal Care and Use Committee of the Yunnan Agricultural University (Approval Number: YNAU2019LLWYH003), and were performed in accordance with the National Institutes of Healths Guide for the Care and Use of Laboratory Animals (NIH publication No.80-23, revised in 1978)

Effects of colon-targeted vitamins on the composition and metabolic activity of the human gut microbiome- a pilot study

Bounous G, Kongshavn PAL, Gold P