Clinical Trial Search

Primary: Number of Participants Experiencing Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) — 519; 212; 207; 69 Participants

Primary: Percentage of Participants With an Antibody Response (≥10 IU/Liter) to Hepatitis B Surface Antigens One Month After the Third Vaccination — 120; 115; 109 Participants

Primary: Overall Survival — 5.9; 5.7 Months — p=<0.0249

Primary: Change in Hemoglobin g/dL — 2.22; 1.92 g/dL — p=0.3108

Primary: Percent of Patients Successfully Transitioned Off Buprenorphine — 2; 3 Participants

Primary: Change From Baseline in North Star Ambulatory Assessment (NSAA) — -1.5; -1.8 score on a scale

Primary: Endogenous Glucose Production (EGP) — 4.99; 5.02; 6.82; 5.52 umol/kg/min

Primary: The Primary Outcome Measure Was Any Response at 6 Months — 178; 173 Participants — p=<0.05

Primary: Part 2: Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs) — 91.5; 95.4; 24.8; 38.0 Percentage of Participants

Primary: Aberrant Behavior Checklist-Community Fragile X Factor Structure (ABC-C FXS) Social Avoidance Subscale - Full Analysis Set — -2.68; -2.29 change in score — p=0.321

Primary: Change From Baseline in The Mean Frequency of Moderate to Severe VMS at Week 4 — -3.72; -5.53; -6.26 VMS per day — p=<0.001

Primary: US Specific: Percentage of Participants With Crohn's Disease Activity Index (CDAI) Clinical Remission — 19.8; 42.0; 40.3 percentage of participants — p=<0.001

Primary: Blood Loss — 2046; 1596 mL

Primary: Incidence of Treatment-Emergent Adverse Events (AEs), by System Organ Class and Preferred Term (Safety Population) — 401; 408; 71; 87 Participants

Primary: Number of Participants Who Experienced the Occurrence of a Third Episode of Post-RSV Wheezing (Recurrent Wheeze) — 45; 33 Participants — p=0.08