RESULTS	The mean + / - SEM LFI score decreased from 9.7 + / - 0.3 to 6.8 + / - 0.4 in the ASU group and from 9.4 + / - 0.3 to 8.9 + / - 0.4 in the placebo group ( P < 0.001 for intergroup difference at month 6 ) .\