A Multinational Study Comparing the Long-term Efficacy and Safety of Two Medicines, Solifenacin Succinate and Mirabegron Taken Together, or Separately, in Subjects With Symptoms of Overactive Bladder

Inclusion Criteria:

Main Inclusion at Screening (Visit 1):

• Subject had completed study 178-CL-101 or study 905-EC-012 (This inclusion criterionwould no longer apply once the recruitment for study 178-CL-101 and study 905-EC-012had been completed. In that case the subject had to have symptoms of "wet" OAB (urinary frequency and urgency with incontinence) for at least 3 months);

• Subject was willing and able to complete the micturition diary and questionnairescorrectly and able to measure his/her vital signs at home at stipulated time points,using the device provided by the study personnel, and to adequately record thereadings;

Main Inclusion at Randomization (Visit 2):

• Subject had a micturition frequency of on average ≥ 8 times per 24-hour periodduring the last 7 days of the micturition diary period (incontinence episode shouldnot be counted as a micturition).

• Subject had experienced at least 3 incontinence episodes during the last 7 days ofthe micturition diary period.

• Subject had experienced on average at least 1 urgency episode (grade 3 or 4 onPatient Perception of Intensity of Urgency Scale [PPIUS]) per 24-hour period duringthe 7-day micturition diary period.

Exclusion Criteria:

Main Exclusion at Screening (Visit 1):

• Subject had clinically significant bladder outflow obstruction at risk of urinaryretention;

• Subject had significant PVR volume (> 150 mL);

• Subject had significant stress incontinence or mixed stress/urgency incontinencewhere stress is the predominant factor;

• Subject has an indwelling catheter or practices intermittent self-catheterization;

• Subject had evidence of a UTI (urine culture containing > 100,000 cfu/mL), chronicinflammation such as interstitial cystitis, bladder stones, previous pelvicradiation therapy or previous or current malignant disease of the pelvic organs;

• Subject had intravesical treatment in the past 12 months with e.g., botulinum toxin,resiniferatoxin, capsaicin;

Main Exclusion at Randomization (Visit 2):

• Subject had evidence of a urinary tract infection (UTI) (urine culture containing > 100,000 cfu/mL) as assessed in the Screening visit (V1) samples. The subject couldbe rescreened after successful treatment of the UTI (confirmed by a dipsticknegative for nitrite).

• Subject had an average total daily urine volume > 3000 mL as recorded in themicturition diary period.