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Table 1 Baseline characteristics (safety analysis set)

From: Effect of mirabegron on cognitive function in elderly patients with overactive bladder: MoCA results from a phase 4 randomized, placebo-controlled study (PILLAR)

 Placebo (n = 442)Mirabegron Total (n = 445)
Female sex, n (%)324 (73.3)317 (71.2)
Age, mean ± SD71.9 ± 6.071.7 ± 5.5
Age ≥75 years, n (%)124 (28.1)125 (28.1)
BMI, kg/m2, mean ± SD30.2 ± 6.429.7 ± 6.3
 Category, n (%)
  <2591 (20.6)108 (24.3)
  ≥25–<30150 (33.9)157 (35.3)
  ≥30201 (45.5)180 (40.4)
Ethnicity, n (%)
 Not Hispanic or Latino395 (89.4)401 (90.1)
 Hispanic or Latino43 (9.7)41 (9.2)
 Unknown4 (0.9)3 (0.7)
Race, n (%)
 White357 (80.8)348 (78.2)
 Asian54 (12.2)59 (13.3)
 Black or African American25 (5.7)33 (7.4)
 Other6 (1.4)5 (1.1)
Country, n (%)
 United States389 (88.0)385 (86.5)
 Canada53 (12.0)60 (13.5)
Charlson Comorbidity Index score, mean ± SD2.3 (1.2)2.3 (1.2)
History of psychiatric disorders
 Depression72 (16.3)81 (18.2)
 Insomnia82 (18.6)57 (12.8)
 Anxiety42 (9.5)59 (13.3)
 Sleep disorder5 (1.1)6 (1.3)
 Attention deficit/hyperactivity disorder4 (0.9)4 (0.9)
 Libido decreased4 (0.9)4 (0.9)
 Bipolar disorder3 (0.7)4 (0.9)
 Nicotine dependence5 (1.1)1 (0.2)
 Adjustment disorder with depressed mood2 (0.5)1 (0.2)
 Initial insomnia02 (0.4)
 Persistent depressive disorder02 (0.4)
 Stress02 (0.4)
 Major depression1 (0.2)1 (0.2)
 Adjustment disorder01 (0.2)
 Alcoholism01 (0.2)
 Burnout syndrome01 (0.2)
 Depressed mood01 (0.2)
 Drug abuse01 (0.2)
 Drug dependence01 (0.2)
 Emotional disorder01 (0.2)
 Mood swings01 (0.2)
 Nervousness01 (0.2)
 Post-traumatic stress disorder01 (0.2)
 Premature ejaculation01 (0.2)
 Anxiety disorder1 (0.2)0
 Claustrophobia1 (0.2)0
 Obsessive-compulsive disorder1 (0.2)0
MoCA total scorea, n (%)
 Category, n (%)
  Normal (≥26)305 (69.3)310 (70.0)
  Mild (18–25)103 (23.4)112 (25.3)
  Moderate (10–17)3 (0.7)3 (0.7)
  Severe (<10)00
  Missing29 (6.6)18 (4.1)
  1. Safety analysis set (SAF): all randomized subjects who received ≥1 dose of study medication
  2. MoCA Montreal Cognitive Assessment, SD standard deviation
  3. aN = 440 for placebo and 443 for mirabegron total
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