Transitional changes of FI scores
(A) Mean FI scores in the investigational phase (n = 24 in the TK-98 group, 23 in the placebo group). The improvement rate of the average score of all motions through the first 12 weeks was greater in the TK-98 group (*P < 0.05). The increase of FI scores of right and left shoulder flexions from baseline to week 12 was greater in the TK-98 group (**P < 0.05). (B) Mean FI scores of those who participated in the extension study (n = 13 in the TK-98 group, 12 in the placebo group). The improvements of shoulder flexions from baseline at each time point marked with a dagger (†) were greater in the TK-98 group (†P < 0.05). Solid circles with a line represent the TK-98 group and open squares with a broken line represent the placebo group. Error bars represent s.e.m. FI: functional index.