Fig.1.

Study design and subject disposition. The randomized, double-blind, controlled study design and subject flow are shown. After stratification and randomization, the three groups received 24 weeks of treatment. At Week 24, 9 placebo subjects crossed over to 6 g/day to form a 24 subject combined 6 g/day group and 5 placebo subjects crossed over to the 3 g/day group to form a 23 subject combined 3 g/day group. The combined groups received an additional 24 weeks of treatment for a total of 48 weeks of exposure.