Table 3. Changes in the mean TOI score over the study period in the intention-to-treat population.

Mean TOI	Baseline*	Months							p-value
		3	6	12	18	24	30	36
Total
N	888	853	822	762	697	652	576	554	< 0.0001†
Mean	2.58	2.62	2.63	2.7	2.71	2.72	2.77	2.78	< 0.0001‡
SD	0.53	0.52	0.53	0.53	0.56	0.54	0.53	0.54
p-value§	-	0.0023	0.0004	< 0.0001	< 0.0001	< 0.0001	< 0.0001	< 0.0001
Chemotherapy
N	676	652	633	592	538	501	450	436	0.2039II
Mean	2.55	2.6	2.62	2.7	2.7	2.71	2.76	2.77	0.0311¶
SD	0.53	0.52	0.53	0.53	0.57	0.55	0.55	0.56	< 0.0001‡
p-value§	-	0.0008	< 0.0001	< 0.0001	< 0.0001	< 0.0001	< 0.0001	< 0.0001
Non-chemotherapy
N	210	199	188	168	157	149	124	115	0.0122‡
Mean	2.68	2.69	2.69	2.71	2.74	2.77	2.82	2.84
SD	0.51	0.52	0.52	0.53	0.53	0.53	0.49	0.48
p-value§	-	0.8009	0.6947	0.6722	0.3305	0.0549	0.0531	0.0184

TOI=trial outcome index; SD=standard deviation.

^*p=0.0025 using Student t-test for equality of mean baseline TOI scores between the chemotherapy and non-chemotherapy groups; ^†For equality of mean TOI scores across visits using the generalized estimating equation (GEE); ^‡For a linear trend test of mean TOI scores across visits using GEE analysis; ^§For comparisons of mean TOI score changes between baseline and each follow-up visit using contrasts within the GEE; ^∥For an interaction effect between the chemotherapy/non-chemotherapy group and visits using the GEE; ^¶Overall equality of mean TOI scores between the chemotherapy and non-chemotherapy groups using the GEE.