Clinical Trial Search

Primary: Percentage of Participants With a Spontaneous Bowel Movement (SBM) Response — 47.6; 34.6 percentage of participants — p=0.0020

Primary: Incidence of Any Grade 3 Solicited Adverse Events (AEs) Within 21 Days Follow-up After Dose 1 — 0.0; 0.0; 0.0; 0.0 percentage of subjects

Primary: Regional Change in Air Content (Delta Z, %) — 14.5; 29.0; 43.3; -14.0 percent change

Primary: Number of Participants Successfully Able to Self-administer Their Observed First and Second Doses in Weeks 1 and 2 (Inside Clinic) — 89; 1 Participants

Primary: Change in Smoking Behavior — -6.3; -3.2 Change in Cigarettes Per Day

Primary: Change in Urine cAMP — 3048 fm/uL

Primary: The Number of New or Recurrent Gd-enhancing Lesions That Appear on Brain T1-weighted MRI — 0.12 lesions

Primary: Change From Baseline to Day 92 in Active Forward Flexion — 22.9; 37.5; 42.9; 23.8 degrees

Primary: Change From Baseline to Day 95 in Active Forward Flexion — 41.0; 35.9 degrees

Primary: Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) — 88.9; 100.0 percentage of participants

Primary: Epithelial Disruption Graded by a Pathologist Blinded to Study Intervention. — 1.0; 1.17 units on a scale — p=<0.05

Primary: Change in Frequency of Urination After 6-week Intervention (Last Observation Carried Forward) — 2.7; 1.5; 3.3 voids per day — p=<.0001

Primary: Amplitude Social — -3.72; -3.55; -3.28; -3.30 microvolts — p=.003

Primary: Measurement of Glycemic Control by HbA1c and Prevention of Severe Hypoglycemia — 3 participants

Primary: Co-Primary Efficacy Endpoint - Vaginal Superficial Cells — 17.50; 16.72; 23.20; 5.63 percentage of vaginal superficial cells — p=< 0.0001