Table 1.

Baseline Participant Characteristics (According to Full analysis Set/Per-protocol Set Analysis)

Variable	FAS					PPS
	Total	BID group	QD group	P-value		Total	BID group	QD group	P-value
	(n = 101)	(n = 50)	(n = 51)			(n = 76)	(n = 37)	(n = 38)
Age (yr)	54.4 ± 12.2	55.2 ± 11.8	53.6 ± 12.7	0.505		54.4 ± 12.2	54.3 ± 12.8	54.4 ± 11.7	0.973
Sex
Male	54 (53.5)	30 (60.0)	24 (47.1)	0.192		39 (52.0)	23 (62.2)	16 (42.1)	0.082
Female	47 (46.5)	20 (40.0)	27 (52.9)			36 (48.0)	14 (37.8)	22 (57.9)
Body weight	65.5 ± 11.4	65.3 ± 11.8	65.8 ± 11.1	0.812		65.4 ± 11.6	66.1 ± 12.7	64.8 ± 10.6	0.531
Height	163.6 ± 8.9	163.1 ± 9.0	164.0 ± 8.8	0.604		163.7 ± 9.1	163.7 ± 9.5	163.7 ± 8.8	0.991
BMI (kg/m2)	24.4 ± 3.2	24.5 ± 3.7	24.3 ± 2.7	0.818		24.4 ± 3.4	24.6 ± 4.1	24.1 ± 2.6	0.491
Alcohol
Non drinker	37 (37.0)	20 (40.0)	17 (34.0)	0.626		27 (36.0)	14 (37.8)	13 (34.2)	0.302
Former drinker	24 (24.0)	10 (20.0)	14 (28.0)			20 (26.7)	7 (18.9)	13 (34.2)
Current drinker	39 (39.0)	20 (40.0)	19 (38.0)			28 (37.3)	16 (43.2)	12 (31.6)
Smoking
Never smoker	63 (63.0)	33 (66.0)	30 (60.0)	0.664		49 (65.3)	25 (67.6)	24 (63.2)	0.694
Ex-smoker	30 (30.0)	13 (26.0)	17 (34.0)			23 (30.7)	10 (27.0)	13 (34.2)
Current smoker	7 (7.0)	4 (8.0)	3 (6.0)			3 (4.0)	2 (5.4)	1 (2.6)
Baseline RSI	17.5 ± 9.2	14.2 ± 8.4	20.8 ± 8.8	< 0.001		17.7 ± 9.0	14.6 ± 9.0	20.7 ± 8.0	0.003
Baseline RFS	10.5 ± 2.5	11.2 ± 2.4	9.8 ± 2.3	0.003		9.9 ± 3.4	11.2 ± 2.5	9.7 ± 2.4	0.009

FAS, full analysis set; PPS, per-protocol set; BID, twice daily; QD, once daily; RSI, Reflux Symptom Index; RFS, Reflux Finding Score.

P < 0.05 was considered statistically significant.

Data are presented as mean ± SD or n (%).