Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Phase 3, Parallel Group, Randomized, Double-Blind, Double-Dummy, Placebo and Active-Controlled Multicenter Trial to Investigate the Efficacy, Tolerability and Safety of Fesoterodine Sustained Release in Subjects With Overactive Bladder Syndrome
Brief Summary: The trial consisted of a 2 week Run-In period, 12 week double-blind Treatment period and 2 week Safety Follow-Up period. Subjects were randomized to one of 4 treatment arms receiving either fesoterodine (SPM 907) 4mg, fesoterodine 8mg, active control (tolterodine SR 4mg) or placebo during the Double-Blind Treatment Period.

Two primary efficacy variables will be assessed for submission in the United States: change in the average number of micturitions (frequency) per 24 hours and the change in the average number of urge incontinence episodes per 24 hours. For the submissions in the European Union, the first primary variable will be the change in the average number of micturitions (frequency) per 24 hours and the co-primary variable is the treatment response, based on a treatment benefit scale. All continuous variables will be measured as changes from baseline to value after 12 weeks of treatment.

The most important safety variables included the assessment of adverse events, laboratory parameters, changes in ECG, physical exams and measurement of residual urine.


Options:
A: Inclusion Criteria:

* Diagnosis of overactive bladder and incontinence for at least 6 months
* Using birth control or menopausal
* Willing to discontinue current medication for overactive bladder

Exclusion Criteria:

* Pregnant or given birth in the last 6 months
* Three or more urinary tract infections a year
* Uncontrolled glaucoma, hypertension, diabetes or myasthenia gravis
* History of bladder cancer, ulcerative colitis or severe constipation
* Any contraindication to vaginal delivery systems
B: Inclusion Criteria:

* Adult subjects with overactive bladder symptoms (subject-reported) for greater than or equal to 3 months prior to Screening/Enrollment visit.
* Reported at least an average of 1 UUI episode per 24 hours in the 3-day bladder diary prior to the Randomization/Baseline visit
* Mean urinary frequency of greater than or equal to 8 micturitions per 24 hours as verified by the 3-day bladder diary prior to randomization/Baseline visit.

Exclusion Criteria:

* Subjects with any condition that would contraindicate their usage of fesoterodine including: hypersensitivity to the active substance (fesoterodine fumarate) or to peanut or soya or any of the excipients, urinary retention, gastric retention, uncontrolled narrow angle glaucoma, myasthenia gravis, severe hepatic impairment (Child Pugh C), severe ulcerative colitis, and toxic megacolon.
* Subjects with clinically significant hepatic or renal disease or other significant unstable diseases.
* OAB symptoms caused by neurological conditions, known pathologies of urinary tract, etc.
* Subjects with previous history of acute urinary retention requiring catheterization, or severe voiding difficulties in the judgment of the investigator, prior to baseline.
C: Inclusion Criteria:

* Overactive Bladder Syndrome

Exclusion Criteria:

* less than 8 micturitions in 24 hours
D: Inclusion Criteria:

1. Patients who are 20 years old or over with overactive bladder
2. Total number of urinary incontinence episodes per week is 5 or over
3. Mean number of micturition per day is 8 or over
4. Mean number of urinary urgency episodes per day is 1 or over
5. Other inclusion criteria as specified in the study protocol

Exclusion Criteria:

1. Patients with genuine stress incontinence
2. Patients suffering from complications such as bladder tumor, bladder stone and urinary tract infection
3. Patients who have undergone surgical operation of urinary and/or genital organs within 6 months prior to the study
4. Patients suffering from complications for which anticholinergics are contraindicated
5. Other exlcusion criteria as specified in the study protocol

Answer: C