Table 4.

Main Outcome Measurement

						Intergroup Comparison
	Case	Eye	Mean ± SD	Median (Range)	Least-Squares Mean ± SE	Difference in Least-Squares Mean (95% CI)	P Value
TK-98	45	88	−52.8 ± 75.0	−40.9 (−480.6, 117.5)	−52.4 ± 10.3	−9.5 (−44.0, 24.9)	0.582
Placebo	25	46	−38.5 ± 63.8	−41.4 (−192.7, 113.4)	−42.9 ± 13.8

Changes in the total point score per year on the Humphrey visual field test (10-2) were analyzed in the FAS population. The coefficients of change per year were obtained using a linear simple regression analysis based on the least squares method, with the evaluation value from the start to 78 weeks (or at the time of discontinuation for the discontinued eye) as the objective variable and the time point as the explanatory variable. The least-squares mean is the mean value for each group estimated using a linear mixed-effects model that considers the correlation between the two eyes. The P values represent the results of a two-tailed test of the null hypothesis “the difference between the least squares means of the two groups is zero” at a significance level of α = 0.05.