follow-up (1.6% versus 2.5%; P = 0.68); protocol violation (4.9% versus 3.3%; P = 0.75); lack of efficacy (3.3% versus 6.6%; P = 0.25); miscellaneous reasons, for example, disliked the taste of the herbs (2.4% versus 2.5%; P = 1). Subjects' laboratory values and vital signs were similar in the two groups. Changes in these values were minor, infrequent, and not considered clinically meaningful.