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Table 2 Baseline characteristicsa of patients in the intent-to-treat (ITT; n = 578) and per-protocol (PP; n = 154) populations

From: Supplementation of standard antibiotic therapy with oral probiotics for bacterial vaginosis and aerobic vaginitis: a randomised, double-blind, placebo-controlled trial

Characteristic Placebo Probiotic p
Hormonal treatment ITT 15 20 0.3388
Hormonal treatment PP 3 5 0.3798
Contraception ITT 89 91 0.6866
Contraception PP 26 20 0.5244
Contraceptive tablets ITT 66 71 0.4999
Contraceptive tablets PP 16 13 0.8095
Transdermal contraception ITT 10 6 0.3380
Transdermal contraception PP 2 0 0.2047
Contraception condom ITT 10 8 0.6750
Contraception condom PP 5 4 0.9480
Contraception other ITT 4 6 0.4951
Contraception other PP 3 3 0.9420
Sexually active ITT 270 266 0.5838
Sexually active PP 76 70 0.5646
More than one sexual partner ITT 1 1 0.9844
More than one sexual partner PP 0 0  
Smoking ITT 46 32 0.1120
Smoking PP 14 12 0.8888
Vaginal douching ITT 2 3 0.6310
Vaginal douching PP 1 1 0.9411
Complaints at first visit (PP)
Vaginal itching 7 6 0.9249
Vaginal burning 14 14 0.7301
Vaginal pain 1 1 0.9410
Vaginal discharge 79 70 0.5663
Pelvic pain 2 1 0.6221
Conditions reported by investigators at first visit (PP)
Vaginal erythema 0 3 0.0354
Palpation tenderness 1 1 0.9624
Homogenous vaginal discharge 78 71 0.9260
Clue cell presence 79 71 0.9160
Positive amine test 78 72 0.3632
BV (Amsel’s criteria [13]) 80 72 0.2559
Vulvovaginal candidiasis 0 1 0.2206
Microbial species cultured from vaginal swabs collected at first visit b(PP)
Gardnerella vaginalis 46 52 0.0628
Streptococcus agalactiae 17 15 0.9465
Escherichia coli 5 3 0.5646
Enterococcus spp. 0 1 0.2206
Candida albicans 2 0 0.1076
Lactobacillus spp. 48 44 0.8980
  1. aAnalyses were not carried for age, sex, or race, as only Caucasian women aged 18–50 years were included
  2. bOnly populations exceeding 105 organisms per swab were counted