(median) cm diameter PBAC score > inclusive 100 at screening Open-label 90 10 mg 18-48 85.1% myomatous for UPA days daily mean age 40.0 uterus < 16 years; mean weeks, at BMI 25.4; least one 96.0% of myoma 3 ≥ child-bearing cm diameter, potential; nil larger 3 x mean than 10 cm, 90 day (median) eligible for n of course PBAC score at baseline = 319 or (216). 13 5 mg 18-50 88.0% white; PBAC score weeks (n= 96) mean age 41.6 > 100, placebo or 10 years; mean myomatous controlled mg (n= BMI 25.3; uterus 16 ≤ 98) 92.1% of weeks daily child-bearing gestation potential; equivalent, mean at least one (median) myoma 3 ≥ PBAC score at cm diameter, baseline = 452 nil larger (361). than 10 cm, fibroid related anaemia defined as Hb ≤ 10.2g/dL, eligible for surgery. Double 13 5mg (n= 18-50 Mean age 40.4 PBAC score 102) or mean > 100, double 10 mg BMI 25.5; myomatous dummy, (n= 103) 96.3% of uterus 16 ≤ active daily child-bearing weeks potential; gestation mean equivalent, controlled (median) at least one PBAC score at myoma 3 ≥ baseline = 370 cm diameter, (282) nil larger than 10 cm, eligible for surgery. The pictorial bleeding assessment chart (PBAC) is a validated scoring method to objectively measure menstrual blood loss, and was used as a measure of uterine bleeding
(median) PBAC score > 100 at screening cm diameter inclusive Open-label for UPA 90 days 10 mg daily 18-48 85.1% mean age 40.0 years; mean BMI 25.4; 96.0% of child-bearing potential; mean (median) PBAC score at baseline = 319 (216). myomatous uterus < 16 weeks, at least one myoma ≥ 3 cm diameter, nil larger than 10 cm, eligible for or of 3 x 90 day placebo controlled 13 weeks 5 mg (n= 96) or 10 mg (n= 98) daily 18-50 88.0% white; mean age 41.6 years; mean BMI 25.3; 92.1% of child-bearing potential; mean (median) PBAC score at baseline = 452 (361). PBAC score > 100, myomatous uterus ≤ 16 weeks gestation equivalent, at least one myoma ≥ 3 cm diameter, nil larger than 10 cm, fibroid related anaemia defined as Hb ≤ 10.2g/dL, eligible for surgery. Double double dummy, active controlled 13 5mg (n= 102) or 10 mg (n= 103) daily 18-50 Mean age 40.4 mean BMI 25.5; 96.3% of child-bearing potential; mean (median) PBAC score at baseline = 370 (282) PBAC score > 100, myomatous uterus ≤ 16 weeks gestation equivalent, at least one myoma ≥ 3 cm diameter, nil larger than 10 cm, eligible for surgery. The pictorial bleeding assessment chart (PBAC) is a validated scoring method to objectively measure menstrual blood loss, and was used as a measure of uterine bleeding course n
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