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Table 2 Evaluation of pitting edema score (ITT analysis, N = 172)

From: Leg edema with (S)-amlodipine vs conventional amlodipine given in triple therapy for hypertension: a randomized double blind controlled clinical trial

Variable Test group Reference group p*
N Pitting edema score (mean ± sd) N Pitting edema score (mean ± sd)  
Baseline (day 0), V1 86 00.00 ± 00.00 86 0.05 ± 00.34 na
After 30 days of therapy, V2 86 01.09 ± 02.47 86 00.97 ± 01.88 ns
After 60 days of therapy, V3 86 00.44 ± 01.36 86 00.88 ± 01.88 ns
After 90 days of therapy, V4 86 00.38 ± 01.21 86 00.73 ± 01.66 ns
After 120 days of therapy, V5 86 0.33 ± 01.00 86 00.83 ± 01.52 0.0380
p**   na   <0.0001  
  1. ITT intention to treat, N number of patients, V1-V5 Visits 1–5, na not applicable, ns not significant
  2. Mann-Whitney test was applied; *p value, when compared between the groups; **p value, when V5 value compared with baseline value in same group; p <0.05 = statistically significant