Table 3.

Change from Baseline in efficacy scores at Week 8 and between-group comparison.

	Total possible range of scores	Mean change from baseline to Week 8		p Value for comparison
Assessment		Placebo Mean (n = 37)	Varithena 1% Mean (n = 39)
Symptoms
HASTI (primary endpoint)	0–100a	16.7 (3.2)b	30.7 (3.0)b	0.0009
m-VEINES-Sym	0–100a	14.2 (2.8)b	27.1 (2.7)b	0.0006
m-VEINES-QOL	0–100a	13.7 (2.6)b	26.6 (2.5)b	0.0002
CIVIQ-2	0–100c	−11.3 (2.3)b	−18.9 (2.2)b	0.0110
PGIC-Symptoms	−3 to +3a	0.3 (0.9)d	1.7 (1.2)d	<0.0001e
PGIC-Day-To-Day Problems	−3 to +3a	0.3 (0.9)d	1.6 (1.3)d	<0.0001e
Appearance of veins
PGIC-Appearance	−3 to +3a	0.1 (1.0)d	1.9 (1.1)d	<0.0001e
Independent Photography Reviewf	−3 to +3a	0.1 (0.3)d	1.8 (1.1)d,g	<0.0001e

HASTI: heaviness, achiness, swelling, throbbing, itching; m-VEINES-QOL/Sym: modified Venous Epidemiological and Economic Study-Quality-of-Life/Symptoms; CIVIQ-2: Chronic Venous Insufficiency Questionnaire 2; PGIC: Patient Global Impression of Change.

^a Higher scores indicate better outcome. Raw scores were transformed to final summary scores (Lamping et al.²⁴).

^b Least square mean and standard error (SE) from ANCOVA model with treatment group and site as class variables and corresponding Baseline score from the questionnaire as a continuous variable.

^c Lower scores indicate better outcome. Raw scores transformed to final summary scores (CIVIQ User's GUIDE²⁶).

^d Mean (SD).

^e p Values from the Cochran-Mantel-Haenszel Chi square statistic with rank scores stratified by site.

^f Clinician-assessed instrument.

^g n = 38.