Table 6.

Percentage of change in laboratory test results for the protocol population on visits 2 (V₂) and 3 (V₃) compared with values obtained on the initial visit (V₀)

Parameter	Visits	P1 (Naprosyn®)	P2 (Toragesic®)	P1–P2	95% CI (LCL)	95% CI (UCL)	Levene’s testa (P-value)	t-testb (P-value)
Creatinine	(V0 × V2)	0.086	0.081	0.005	−0.127	0.137	0.889	0.944
	n	35	37
AST	(V0 × V2)	0.029	0.027	0.002	−0.077	0.080	0.938	0.969
	n	35	37
ALT	(V0 × V2)	0.000	0.027	−0.027	−0.082	0.028	0.049	0.334
	n	35	37
Urinalysis
Urine density	(V0 × V2)	0.229	0.405	−0.177	−0.394	0.041	0.002	0.109
	n	35	37
Urine pH	(V0 × V2)	0.171	0.189	−0.018	−0.201	0.165	0.700	0.847
	n	35	37
Urine WBC	(V0 × V2)	0.057	0.027	0.030	−0.065	0.125	0.206	0.529
	n	35	37
Urine RBC	(V0 × V2)	0.143	0.108	0.035	−0.123	0.192	0.380	0.661
	n	35	37
Urine density	(V0 × V3)	0.314	0.270	0.044	−0.173	0.261	0.422	0.686
	n	35	37
Urine pH	(V0 × V3)	0.143	0.189	−0.046	−0.224	0.131	0.298	0.604
	n	35	37
Urine WBC	(V0 × V3)	0.086	0.027	0.059	−0.052	0.169	0.029	0.284
	n	35	37
Urine RBC	(V0 × V3)	0.057	0.054	0.003	−0.106	0.112	0.911	0.955
	n	35	37

Notes:

^aTest for variance equality.

^bTest for equality of means. t-test for two independent samples to compare means between two groups.

Abbreviations: ALT, alanine transaminase; AST, aspartate transaminase; CI, confidence interval; RBC, red blood cells; WBC, white blood cells; P₁, percentage Naprosyn^®; P₂, percentage Toragesic^®; LCL, lower confidence limit; UCL, upper confidence limit.