Please select the eligibility criteria that correspond to the clinical trial below.
Title: An International Phase 3, Randomized, Double-Blind, Active (Tolterodine)-Controlled Multicenter Extension Study to Evaluate the Long-Term Safety and Efficacy of Vibegron in Patients With Symptoms of Overactive Bladder
Brief Summary: This study is designed to evaluate the safety, tolerability, and efficacy of vibegron administered once daily in participants with OAB for up to 52 weeks.


Options:
A: Inclusion Criteria:

* Patient is willing and able to complete the micturition diary correctly.
* Symptoms of overactive bladder (including urinary frequency, urgency with/without urge incontinence) for \>= 3 months
* At least 3 episodes of urgency with or without incontinence in last 3 days
* At least three episodes of urgency with or without incontinence (PPIUS grade 3 or 4) during the 3-day micturition diary period
* Patient must experience frequency of micturition on average \>= 8 times per 24-hour period during the 3-day micturition diary period

Exclusion Criteria:

* Pregnant women or women who intend to become pregnant during the study or women of childbearing potential who are sexually active and practising an unreliable method of birth control or will be lactating during the study. Reliable contraceptive methods are intra-uterine devices, contraceptive pills of combination type, hormonal implants and injectable or patch contraceptives
* Clinically significant outflow obstruction (at the discretion of the investigator)
* Significant post void residual volume (PVR\>200ml)
* Significant stress incontinence or mixed stress/urge incontinence where stress is the predominant factor as determined by the investigator
* Patient with indwelling catheters or practising intermittent self-catheterisation
* Evidence of a symptomatic urinary tract infection, chronic inflammation such as interstitial cystitis, bladder stones, previous pelvic radiation therapy or previous or current malignant disease of the pelvic organs
* Hypersensitivity to solifenacin or to any of the excipients, uncontrolled narrow angle glaucoma, myasthenia gravis, urinary or gastric retention, severe renal impairment (GFR ≥30 ml/min), moderate or severe hepatic impairment, chronic intestinal disease, megacolon, requirement for dialysis, concomitant use of a strong CYP3A4 inhibitor, e.g. ketoconazole
* Non drug OAB treatment such as bladder-training, biofeedback and pelvic floor exercises are permissible if established at least 4 weeks prior to study start and intended to be continued throughout the study; electrostimulation therapy is not permissible at any time
* Use of drugs intended to treat urinary incontinence
* Diabetic neuropathy
* Any clinically significant condition, which in the opinion of the investigator makes the patient unsuitable for the trial
* Participation in any clinical trial within 30 days prior to randomisation
* Employees of the Yamanouchi Group, third parties associated with the study, or the study site
* Patient who did not complete the micturition diary according to the instructions
B: Inclusion Criteria:

* Females and males, 18 years of older with overactive bladder symptoms

Exclusion Criteria:

* Treatable conditions that may cause urinary incontinence
* Medical conditions in which it would be unsafe to use an anti-cholinergic agent.
* The use of concomitant drugs that would confound the efficacy evaluation.
* The use of concomitant drugs that would be unsafe with an anti-cholinergic agent.
C: Inclusion Criteria:

1. Has completed participation in study RVT-901-3003.
2. Has demonstrated ≥ 80% compliance with self-administration of Study Treatment in study RVT-901-3003.

Exclusion Criteria:

1. Has a change in history or current evidence of any clinically significant condition, therapy, lab abnormality, or other circumstance that might, in the opinion of the Investigator, confound the results of the study, interfere with the participant's ability to comply with study procedures, or make participation in the study not in the participant's best interest.
2. Has coronary or neurovascular interventions planned during the duration of the study.
3. Has uncontrolled hyperglycemia (defined as fasting blood glucose \>150 mg/dL or 8.33 mmol/L and/or non-fasting blood glucose \>200 mg/dL or 11.1 mmol/L) based on most recent available lab results in study RVT-901-3003 or, if in the opinion of the Investigator, is uncontrolled.
4. Has uncontrolled hypertension (systolic blood pressure of ≥ 180 mm Hg and/or diastolic blood pressure of ≥ 100 mm Hg) or has a resting heart rate (by pulse) \> 100 beats per minute.
5. Has clinically significant ECG abnormality which, in the opinion of the Investigator, exposes the participant to risk by participating in the study
6. Has alanine aminotransferase or aspartate aminotransferase \> 2.0 times the upper limit of normal (ULN), or bilirubin (total bilirubin) \> 1.5 x ULN (or \> 2.0 x ULN if secondary to Gilbert syndrome or pattern consistent with Gilbert syndrome) based on most recent available lab results in study RVT-901-3003.
7. Has an estimated glomerular filtration rate (eGFR) \< 30mL/min/1.73 m2 based on most recent available lab results in study RVT-901-3003.
8. Use of any prohibited medications as detailed in Section 7.7.3.
9. Plans to initiate or change the dosing of any medications listed in Section 7.7.5 during the study that in the opinion of the investigator is assessed to be clinical significant.
10. Has an allergy, intolerance, or a history of a significant clinical or laboratory adverse experience associated with any of the active or inactive components of the vibegron formulation or tolterodine formulation.
11. Is currently participating or has participated in a study with an investigational compound or device within 28 days of signing informed consent, not including participation in study RVT-901-3003.
12. Has a history of significant drug or alcohol abuse/dependence within a year of informed consent, as assessed by the investigator.
13. Has a varying sleep schedule anticipated during times when the voiding diaries are to be completed.
D: Inclusion Criteria:

* Overactive bladder symptoms for greater than or equal to 3 months.
* Mean urinary frequency of greater than or equal to 8 micturitions per 24 hours in bladder diary.
* Mean number of Urgency episodes greater than or equal to 3 per 24 hours in bladder diary.

Exclusion Criteria:

* Contraindication to fesoterodine (antimuscarinics).
* Known etiology of OAB (e.g., neurogenic, local urinary tract pathology).
* Previous history of acute urinary retention requiring catheterization or severe voiding difficulties in the judgment of the investigator, prior to baseline.
* Unable to follow the study procedures, including completion of self-administered bladder diary and patient reported outcome questionnaires.

Answer: C