TrialPanorama/TrialPanorama-database huggingface dataset:
Primary endpoint: Percentage of Participants With Device Related Anticipated Skin Effects
Endpoint domain: Adverse events/effects
Primary endpoint: Incidence of thrombosis events
Endpoint domain: Mortality/survival
Primary endpoint: Improvement in proportion of quality indicators achieved
Endpoint domain: Life impact
Endpoint subdomain: Global quality of life
Primary endpoint: Time to achieving stable pain control
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Pathological evidence of Alzheimer disease
Endpoint domain: Physiological/clinical
Endpoint subdomain: Nervous system outcomes
Primary endpoint: Percentage of Participants With Wound Closed
Endpoint domain: Physiological/clinical
Endpoint subdomain: Surgical and medical procedures outcomes
Primary endpoint: Rate of error messages per 100 patient years
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Up-regulation of ctDNA
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Mean Change in Unified Parkinson's Disease Rating Scale (UPDRS III)
Endpoint domain: Physiological/clinical
Endpoint subdomain: Nervous system outcomes
Primary endpoint: Participant knowledge and attitudes
Endpoint domain: Life impact
Endpoint subdomain: Perceived health status
Primary endpoint: Changes from baseline in Wolf Motor Function Test
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Changes from baseline in Fugl-Meyer Assessment Upper Extremity
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: change of A1C (∆A1C)
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Time in Hypoglycemic Range
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Breath Carbon Monoxide Level
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: 6 Month Mortality - All Cause
Endpoint domain: Mortality/survival
Primary endpoint: Defocus curve measurement
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Response Rates (50% Decrease in HAM-D-17 Scores)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Size of haematoma
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Size of oedema
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change in Colour
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Area under the concentration-time curve (AUC) from time 0 to infinity
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Apparent terminal elimination half-life
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change in HIV DNA levels
Endpoint domain: Physiological/clinical
Endpoint subdomain: Blood and lymphatic system outcomes
Primary endpoint: Variation in motor evoked potential amplitude
Endpoint domain: Physiological/clinical
Endpoint subdomain: Nervous system outcomes
Primary endpoint: Occurrence of cancer and lymphoma
Endpoint domain: Mortality/survival
Primary endpoint: Number of patients with first line treatment failure
Endpoint domain: Adverse events/effects
Primary endpoint: Platelet Reactivity Unit (PRU) 24 Hours After DAPT
Endpoint domain: Physiological/clinical
Endpoint subdomain: Blood and lymphatic system outcomes
Primary endpoint: Children's Depression Inventory 2: Self Report (CDI2:SR)
Endpoint domain: Life impact
Endpoint subdomain: Emotional functioning/wellbeing
Primary endpoint: Survival after acute cerebrovascular stroke
Endpoint domain: Mortality/survival
Primary endpoint: Neurologic deficit after acute cerebrovascular stroke
Endpoint domain: Physiological/clinical
Endpoint subdomain: Nervous system outcomes
Primary endpoint: Biochemically Confirmed 7-day Point Prevalence Abstinence From Tobacco
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Copeptin value
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Coronary artery disease risk
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Sexual desire and arousal
Endpoint domain: Life impact
Endpoint subdomain: Emotional functioning/wellbeing
Primary endpoint: Number of Participants Who Are Able to Complete THL Without a Dose Delay or Reduction
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Abnormal Involuntary Movements Scale (AIMS)
Endpoint domain: Physiological/clinical
Endpoint subdomain: Neurological outcomes
Primary endpoint: Number of correct responses for fiber and protein ratings of foods
Endpoint domain: Life impact
Endpoint subdomain: Cognitive functioning
Primary endpoint: Primary patency within 12 months post-index procedure
Endpoint domain: Physiological/clinical
Endpoint subdomain: Vascular outcomes
Primary endpoint: Prevention of COVID-19
Endpoint domain: Adverse events/effects
Primary endpoint: Treatment of COVID-19
Endpoint domain: Physiological/clinical
Endpoint subdomain: Infections and infestations outcomes
Primary endpoint: Treatment of Symptoms
Endpoint domain: Life impact
Endpoint subdomain: Physical functioning
Primary endpoint: Cumulative Opioid Requirements for 72 Hours After Surgery
Endpoint domain: Resource use
Endpoint subdomain: Need for further intervention
Primary endpoint: Evaluation of RDI
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: %ID in urine
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: %ID in main organs
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Number of Participants That Experience Grade 3 or Greater Neutropenia
Endpoint domain: Adverse events/effects
Primary endpoint: Number of Participants With Pathological Complete Response (pCR)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Percentage of Patients with Partial Response to Treatment
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Number of Participants With Recurrent Hernias
Endpoint domain: Physiological/clinical
Endpoint subdomain: Surgical and medical procedures outcomes
Primary endpoint: Percent change in measured LDL-C
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Major cardiac and cerebral events
Endpoint domain: Mortality/survival
Primary endpoint: Breastfeeding Self-Efficacy Score
Endpoint domain: Life impact
Endpoint subdomain: Perceived health status
Primary endpoint: Serum C Type Natriuretic Peptide Levels
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Successful transseptal puncture
Endpoint domain: Physiological/clinical
Endpoint subdomain: Surgical and medical procedures outcomes
Primary endpoint: Clinically significant seroma development
Endpoint domain: Adverse events/effects
Primary endpoint: Efficacy of steroid injection
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: maximum walking distance of 6 Minute Walk Test
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Plasmatic and intracellular concentration of raltegravir
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Systemic clearance of acyclovir
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Urgency
Endpoint domain: Physiological/clinical
Endpoint subdomain: Renal and urinary outcomes
Primary endpoint: Mean daily pain intensity
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Clinical Global Impressions- Severity
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: number of hair per square centimeter
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Point prevalence use of a prescription contraceptive
Endpoint domain: Life impact
Endpoint subdomain: Perceived health status
Primary endpoint: Change in preventive headache medication
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change in acute headache medication
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Ability to participate in social roles and activities
Endpoint domain: Life impact
Endpoint subdomain: Social functioning
Primary endpoint: Product Tolerability
Endpoint domain: Life impact
Endpoint subdomain: Perceived health status
Primary endpoint: Change in daily total Sequential Organ Failure Assessment Score (SOFA)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Methylation level of the Differentially Methylated Regions (DMR)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Overall response by IWG 2006 response criteria
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Number of serious adverse events related to vaccination
Endpoint domain: Adverse events/effects
Primary endpoint: Erectile function assessment
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: urine osmolality
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: PPIUS urge-score
Endpoint domain: Life impact
Endpoint subdomain: Emotional functioning/wellbeing
Primary endpoint: Time to catheter removal
Endpoint domain: Physiological/clinical
Endpoint subdomain: Surgical and medical procedures outcomes
Primary endpoint: Proportion of Persons Agreeing to be Screened for Acute HIV Infection
Endpoint domain: Resource use
Endpoint subdomain: Need for further intervention
Primary endpoint: Prevalence of AHI Among Persons Screened
Endpoint domain: Physiological/clinical
Endpoint subdomain: Infections and infestations outcomes
Primary endpoint: Incidence rate
Endpoint domain: Mortality/survival
Primary endpoint: AUC of Rosuvastatin
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change in symptom-limited TED
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Percentage of Participants Who Were Progression Free at 12 and 24 Months
Endpoint domain: Mortality/survival
Primary endpoint: Prevalence of geriatric syndrome
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Normalization of ICT or Stroop Test
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cognitive functioning
Primary endpoint: Dermal pain
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Blood Clearance
Endpoint domain: Physiological/clinical
Endpoint subdomain: Blood and lymphatic system outcomes
Primary endpoint: Excretion
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Percentage of patients who respond to treatment
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change of Peak Enhancement (PE)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change of Wash-in Area Under the Curve (Wi-AUC)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change of Rise Time (RT)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change of mean Transit Time (mTT)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change of Time To Peak (TTP)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change of Wash-in Rate (WiR)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change from baseline in the Post Concussion Symptoms Scale
Endpoint domain: Life impact
Endpoint subdomain: Perceived health status
Primary endpoint: Occurrence and severity of Simulator Sickness
Endpoint domain: Adverse events/effects
Primary endpoint: Initiation of HPV vaccination series
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Tear amount
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Thiol redox status
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Mean Pain Score During Procedure
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Consistency between interface pressure measurements
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: IPF-specific mass spectrometric profile of volatile organic compounds
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Changes in peri-implant horizontal and vertical alveolar bone
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Estimated Weeknight Sleep Duration
Endpoint domain: Life impact
Endpoint subdomain: Sleep
Primary endpoint: Change from Baseline in NTSS6 score
Endpoint domain: Life impact
Endpoint subdomain: Emotional functioning/wellbeing
Primary endpoint: Detection of Borrelia burgdorferi DNA
Endpoint domain: Physiological/clinical
Endpoint subdomain: Blood and lymphatic system outcomes
Primary endpoint: Frequency of MPA AUC below target level
Endpoint domain: Physiological/clinical
Endpoint subdomain: Renal and urinary outcomes
Primary endpoint: Whole-body Glucose Uptake in Part B in PF-05175157 200 mg BID Group
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) or Serious Adverse Events (SAEs), or Discontinuation Due to Adverse Events (AEs) in Part B
Endpoint domain: Adverse events/effects
Primary endpoint: The Number of Participants with Adverse Events
Endpoint domain: Adverse events/effects
Primary endpoint: Mean number of qualifying half-day toothbrushing episodes per week
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Proportion of parents/caregivers attending a dental visit
Endpoint domain: Resource use
Endpoint subdomain: Need for further intervention
Primary endpoint: Mean Sum of Migraine Pain Intensity Differences (SPID)-30
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Objectively Measured Physical Activity
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: score on a depression/anxiety rating scale
Endpoint domain: Life impact
Endpoint subdomain: Emotional functioning/wellbeing
Primary endpoint: score on a quality of life scale
Endpoint domain: Life impact
Endpoint subdomain: Global quality of life
Primary endpoint: gene expression changes of NGF, TRPV1, TrkA and p75
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Plasma concentrations of tazarotenic acid
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: No residual cerebral aneurysm
Endpoint domain: Physiological/clinical
Endpoint subdomain: Neoplasms and related outcomes
Primary endpoint: AUC0-t - Area Under the Concentration-time Curve From Time Zero to Time of the Last Non-zero Concentration
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Time interval to return to fasting grade
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Total Dienogest: area under the plasma concentration-time curve from 0 to 72 hours (AUC0-72)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Total Dienogest: Maximum plasma concentration (Cmax)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Total Dienogest: Time to achieve maximum plasma concentration (tmax)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Positivity rates
Endpoint domain: Physiological/clinical
Endpoint subdomain: Infections and infestations outcomes
Primary endpoint: Change in baseline total score on the International Prostate Symptom Score
Endpoint domain: Life impact
Endpoint subdomain: Perceived health status
Primary endpoint: Adherence to PALS guidelines
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: percent of sex acts protected by female condoms
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Suppression of HIV RNA Levels to <50 Copies/ml
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Total hospital stay (# of days)
Endpoint domain: Resource use
Endpoint subdomain: Hospital
Primary endpoint: Total procedure-related cost
Endpoint domain: Resource use
Endpoint subdomain: Other resource use
Primary endpoint: percentage of time within predefined glucose target range 80-110 mg/dL
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Rate of Reduction of the Incidence of Parastomal Hernia
Endpoint domain: Physiological/clinical
Endpoint subdomain: Surgical and medical procedures outcomes
Primary endpoint: Change in Psoriasis Area Severity Index (PASI-75)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Investigator's Global Assessment (IGA) of Psoriasis
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Prevalence of low bone density
Endpoint domain: Physiological/clinical
Endpoint subdomain: Musculoskeletal and connective tissue outcomes
Primary endpoint: Biological activity of Hespecta
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change in joint kinematics after 30 days
Endpoint domain: Physiological/clinical
Endpoint subdomain: Musculoskeletal and connective tissue outcomes
Primary endpoint: Change in Spatiotemporal parameters after 30 days - Gait velocity
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change in balance after 30 days - center of pressure sway area
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: changes in baseline SUV uptake
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: High intensity signals within the coronary arteries
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Volume Overload
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Inpatient opiate consumption
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change in adolescent treatment engagement
Endpoint domain: Life impact
Endpoint subdomain: Role functioning
Primary endpoint: Percentage of Subjects With Serum Urate Levels <6.0 mg/dL
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Quantity of serum muscle-derived microRNAs
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Impact on functional status
Endpoint domain: Life impact
Endpoint subdomain: Physical functioning
Primary endpoint: FFRct measurement
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Change from baseline on the Modified Oswestry Disability Index (ODI)
Endpoint domain: Life impact
Endpoint subdomain: Physical functioning
Primary endpoint: Change from baseline on the Numeric Pain Rating Scale (NPRS)
Endpoint domain: Life impact
Endpoint subdomain: Pain
Primary endpoint: Fluoride Concentration in Dental Biofilm Fluid
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Fluoride Concentration in Dental Biofilm Solids
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Area Under the Curve of Fluoride Concentration in Dental Biofilm Fluid
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Area Under the Curve of Fluoride Concentration in Dental Biofilm Solids
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Wound surface bioburden
Endpoint domain: Physiological/clinical
Endpoint subdomain: Infections and infestations outcomes
Primary endpoint: Change in Ocular Surface Disease Index (OSDI) Score
Endpoint domain: Life impact
Endpoint subdomain: Perceived health status
Primary endpoint: Profile of Mood State
Endpoint domain: Life impact
Endpoint subdomain: Emotional functioning/wellbeing
Primary endpoint: Usefulness of MRI in colon cancer diagnosis
Endpoint domain: Physiological/clinical
Endpoint subdomain: Neoplasms and related outcomes
Primary endpoint: PACER fitness test
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Number of VEGFR1-Positive Clusters
Endpoint domain: Physiological/clinical
Endpoint subdomain: Vascular outcomes
Primary endpoint: Dry eye disease severity
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Absolute change in percent atheroma volume (PAV)
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Shoulder pain: VAS
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Disability of the shoulder
Endpoint domain: Life impact
Endpoint subdomain: Physical functioning
Primary endpoint: Number of Participants with Active Infection
Endpoint domain: Adverse events/effects
Primary endpoint: Number of Participants with Antibodies Indicating Past Exposure
Endpoint domain: Physiological/clinical
Endpoint subdomain: Immune system outcomes
Primary endpoint: Appetite perceptions
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change in the score of the RESVECH 2.0 scale
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change in disease activity measured by relapse rate
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change in disease activity measured by change in dosage of corticosteroids and immunosuppressive medications
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Composite of Death, MI, Stroke, HF, or Arterial Revasc
Endpoint domain: Mortality/survival
Primary endpoint: Change from Baseline modified Rankin Scale (mRS)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Evaluation of Liver-Related Tests Over Time
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Evaluation of Serum Lipid Values Over Time
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Safety of the Device and/or Procedure as Assessed by the Incidence of SAE and UADE
Endpoint domain: Adverse events/effects
Primary endpoint: Percent Change From Baseline in Bone Mineral Density of the Spine at Week 24
Endpoint domain: Physiological/clinical
Endpoint subdomain: Musculoskeletal and connective tissue outcomes