Table 2. The Primary and Key Secondary End Points in the Chinese Population (FAS)^a.

Measures	Day	Change from baseline, LS mean (95% CI)		Between group difference, LS mean (95% CI)	P valueb
		Cyclosporine (n = 103)	Vehicle (n = 103)
Primary
tCFS	29	−4.8	−3.0	−1.8 (−2.7 to −1.0)	<.001
Dryness score	29	−19.2	−15.4	−3.8 (−9.2 to 1.6)	.17
Key secondary
tCFS	15	−4.0	−2.8	−1.2 (−2.0 to −0.3)	.01
Central CFS	29	−1.0	−0.6	−0.4 (−0.6 to −0.1)	.01
Total LGCS	29	−1.4	−0.8	−0.6 (−1.1 to −0.2)	.003
Blurred vision	29	−9.2	−2.8	−6.4 (−11.1 to −1.7)	.01
Central CFS response rate, %c	29	61.5	52.1	9.5 (−4.2 to 23.1)	.17
tCFS Response rate, %b	29	78.6	47.2	31.4 (18.5 to 44.3)	<.001

Abbreviations: FAS, full analysis set; LGCS, lissamine green conjunctival staining; LS, least squares; tCFS, total corneal fluorescein staining.

^a According to the protocol, if the overall dropout rate for this study was less than 5%, missing values were not imputed. At day 15, 98 participants in the cyclosporine group and 101 participants in the vehicle group were evaluable. At day 29, 99 and 102 participants were evaluable in the 2 groups, respectively.

^b P values for key secondary end points were nominal.

^c Data presented are predictive marginal proportion.