Table 2.

Response Rate (Reflux Symptom Index) at 8-week and 16-week Follow-up

FAS	BID group (n = 50)	QD group (n = 51)	COR (95% CI)	P-valuea
Primary outcome
16 weeks RSI responder	16 (32.0)	19 (37.3)	1.05 (0.00-2.15)	0.541
Secondary outcome
8 weeks RSI responder	13 (26.0)	15 (29.4)	0.92 (0.00-2.01)	0.433

PPS	BID group (n = 37)	QD group (n = 38)	COR (95% CI)	P-valuea
Primary outcome
16 weeks RSI responder	13 (35.1)	14 (36.8)	0.83 (0.00-1.93)	0.460
Secondary outcome
8 weeks RSI responder	10 (27.0)	11 (28.9)	0.82 (0.00-2.02)	0.465

^aLeft tail test for one-sided alpha 0.05.

FAS, full analysis set; BID, twice daily; QD, once daily; COR, common odds ratio; RSI, Reflux Symptom Index; PPS, per-protocol set.