Table 1 Baseline characteristics (safety analysis set)
|  | Placebo (n = 442) | Mirabegron Total (n = 445) |
|---|---|---|
Female sex, n (%) | 324 (73.3) | 317 (71.2) |
Age, mean ± SD | 71.9 ± 6.0 | 71.7 ± 5.5 |
Age ≥75 years, n (%) | 124 (28.1) | 125 (28.1) |
BMI, kg/m2, mean ± SD | 30.2 ± 6.4 | 29.7 ± 6.3 |
 Category, n (%) | ||
  <25 | 91 (20.6) | 108 (24.3) |
  ≥25–<30 | 150 (33.9) | 157 (35.3) |
  ≥30 | 201 (45.5) | 180 (40.4) |
Ethnicity, n (%) | ||
 Not Hispanic or Latino | 395 (89.4) | 401 (90.1) |
 Hispanic or Latino | 43 (9.7) | 41 (9.2) |
 Unknown | 4 (0.9) | 3 (0.7) |
Race, n (%) | ||
 White | 357 (80.8) | 348 (78.2) |
 Asian | 54 (12.2) | 59 (13.3) |
 Black or African American | 25 (5.7) | 33 (7.4) |
 Other | 6 (1.4) | 5 (1.1) |
Country, n (%) | ||
 United States | 389 (88.0) | 385 (86.5) |
 Canada | 53 (12.0) | 60 (13.5) |
Charlson Comorbidity Index score, mean ± SD | 2.3 (1.2) | 2.3 (1.2) |
History of psychiatric disorders | ||
 Depression | 72 (16.3) | 81 (18.2) |
 Insomnia | 82 (18.6) | 57 (12.8) |
 Anxiety | 42 (9.5) | 59 (13.3) |
 Sleep disorder | 5 (1.1) | 6 (1.3) |
 Attention deficit/hyperactivity disorder | 4 (0.9) | 4 (0.9) |
 Libido decreased | 4 (0.9) | 4 (0.9) |
 Bipolar disorder | 3 (0.7) | 4 (0.9) |
 Nicotine dependence | 5 (1.1) | 1 (0.2) |
 Adjustment disorder with depressed mood | 2 (0.5) | 1 (0.2) |
 Initial insomnia | 0 | 2 (0.4) |
 Persistent depressive disorder | 0 | 2 (0.4) |
 Stress | 0 | 2 (0.4) |
 Major depression | 1 (0.2) | 1 (0.2) |
 Adjustment disorder | 0 | 1 (0.2) |
 Alcoholism | 0 | 1 (0.2) |
 Burnout syndrome | 0 | 1 (0.2) |
 Depressed mood | 0 | 1 (0.2) |
 Drug abuse | 0 | 1 (0.2) |
 Drug dependence | 0 | 1 (0.2) |
 Emotional disorder | 0 | 1 (0.2) |
 Mood swings | 0 | 1 (0.2) |
 Nervousness | 0 | 1 (0.2) |
 Post-traumatic stress disorder | 0 | 1 (0.2) |
 Premature ejaculation | 0 | 1 (0.2) |
 Anxiety disorder | 1 (0.2) | 0 |
 Claustrophobia | 1 (0.2) | 0 |
 Obsessive-compulsive disorder | 1 (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) | 0 | 0 |
  Missing | 29 (6.6) | 18 (4.1) |