TrialPanorama/TrialPanorama-database huggingface dataset:
Primary endpoint: Presence of cell free tumor DNA and/or circulating tumor cells
Endpoint domain: Physiological/clinical
Endpoint subdomain: Blood and lymphatic system outcomes
Primary endpoint: Natural Killer cell activity levels
Endpoint domain: Physiological/clinical
Endpoint subdomain: Immune system outcomes
Primary endpoint: Allergen response
Endpoint domain: Physiological/clinical
Endpoint subdomain: Immune system outcomes
Primary endpoint: Accuracy of ultra-low-dose-CT of the chest
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Accuracy of plain film of the chest
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Hemoglobin level measurement
Endpoint domain: Physiological/clinical
Endpoint subdomain: Blood and lymphatic system outcomes
Primary endpoint: Numeric risk recall
Endpoint domain: Life impact
Endpoint subdomain: Cognitive functioning
Primary endpoint: Numeric risk recognition
Endpoint domain: Life impact
Endpoint subdomain: Cognitive functioning
Primary endpoint: acute transplant rejection
Endpoint domain: Physiological/clinical
Endpoint subdomain: Immune system outcomes
Primary endpoint: mean percentage change of the number and size of polyps
Endpoint domain: Physiological/clinical
Endpoint subdomain: Gastrointestinal outcomes
Primary endpoint: Median Absolute Change From Baseline in EMG Peak Amplitude
Endpoint domain: Physiological/clinical
Endpoint subdomain: Musculoskeletal and connective tissue outcomes
Primary endpoint: Number of operative deliveries
Endpoint domain: Physiological/clinical
Endpoint subdomain: Surgical and medical procedures outcomes
Primary endpoint: Early postoperative morbidities
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Total small vessel density
Endpoint domain: Physiological/clinical
Endpoint subdomain: Vascular outcomes
Primary endpoint: Perfused small vessel density
Endpoint domain: Physiological/clinical
Endpoint subdomain: Vascular outcomes
Primary endpoint: serum magnesium
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: thiamine
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: erythrocyte transketolase activity
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Number of Participants With >20 on the 26 Children Eating Attitudes Test
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change in UPDRS part III (Motor Score)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: amygdala activity
Endpoint domain: Physiological/clinical
Endpoint subdomain: Nervous system outcomes
Primary endpoint: amygdala connectivity
Endpoint domain: Physiological/clinical
Endpoint subdomain: Nervous system outcomes
Primary endpoint: Glucose control quality
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Working Memory Capacity Composite Score
Endpoint domain: Life impact
Endpoint subdomain: Cognitive functioning
Primary endpoint: Goal Maintenance Composite Score
Endpoint domain: Life impact
Endpoint subdomain: Cognitive functioning
Primary endpoint: Interference Control Composite Score
Endpoint domain: Life impact
Endpoint subdomain: Cognitive functioning
Primary endpoint: The University of California San Diego Performance-Based Skills Assessment Total Score
Endpoint domain: Life impact
Endpoint subdomain: Cognitive functioning
Primary endpoint: Qualitative detection of ribosomal RNA from Dengue Virus
Endpoint domain: Physiological/clinical
Endpoint subdomain: Infections and infestations outcomes
Primary endpoint: Reduction of hair, vascular lesions and wrinkles
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Plasma Concentration of Dalcetrapib Active Form
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Plasma Concentration of Atorvastatin
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Objective sleep assessment
Endpoint domain: Life impact
Endpoint subdomain: Sleep
Primary endpoint: Level of handicap
Endpoint domain: Life impact
Endpoint subdomain: Physical functioning
Primary endpoint: Change in Average Daily Pain Score
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Clinical improvement based on repetitive behavior scale
Endpoint domain: Life impact
Endpoint subdomain: Emotional functioning/wellbeing
Primary endpoint: incidence of protocol-defined DLT
Endpoint domain: Adverse events/effects
Primary endpoint: proportion of patients with a decline in PSA blood concentrations of ≥50% and ≥90%
Endpoint domain: Physiological/clinical
Endpoint subdomain: Blood and lymphatic system outcomes
Primary endpoint: significant delayed medical events
Endpoint domain: Adverse events/effects
Primary endpoint: Thumb opposition
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Thumb retropulsion
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Maximal palmar abduction
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Maximal radial abduction
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Tip-to-tip force
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: 30% decline of eGFR
Endpoint domain: Physiological/clinical
Endpoint subdomain: Renal and urinary outcomes
Primary endpoint: AUC 0-inf for midazolam
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: AUC 0-inf for metoprolol
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: AUC 0-inf for bupropion
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Cmax for midazolam
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Cmax for metoprolol
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Cmax for bupropion
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Improvement in clinical symptoms following antibiotic treatment
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Regional 5-HT1A receptor binding
Endpoint domain: Physiological/clinical
Endpoint subdomain: Nervous system outcomes
Primary endpoint: Change in Intra-dialytic Decline in Systolic Blood Pressure
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Number of Participants With Serious Adverse Drug Reactions (SADRs)
Endpoint domain: Adverse events/effects
Primary endpoint: Number of Participants With Unexpected AEs
Endpoint domain: Adverse events/effects
Primary endpoint: Number of Participants With Unexpected ADRs
Endpoint domain: Adverse events/effects
Primary endpoint: Proportion of patients who can undergo 10 fractions of SBRT followed by surgery
Endpoint domain: Physiological/clinical
Endpoint subdomain: Surgical and medical procedures outcomes
Primary endpoint: Overall level of functioning
Endpoint domain: Life impact
Endpoint subdomain: Global quality of life
Primary endpoint: Change in Gross Motor Function Measure-66
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Summated pain intensity
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Fold Change in Serum Gamma-glutamyl Transferase (GGT)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change in gait speed at 12 weeks
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change in level of physical activity at 12 weeks
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Snai2 gene and protein expression
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Number of patients with a BMI above or equal to 30 kg/m^2
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Mean weight loss in patients not treated according to stopping rule
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Number of patients with at least 5% weight loss and continuing treatment
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Corneal aberration
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change From Baseline in Pulmonary Capillary Wedge Pressure
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: survival in relation to time
Endpoint domain: Mortality/survival
Primary endpoint: Biopsy/Referral Sensitivity
Endpoint domain: Physiological/clinical
Endpoint subdomain: Skin and subcutaneous tissue outcomes
Primary endpoint: Proportion of scheduled eye care visits attended
Endpoint domain: Resource use
Endpoint subdomain: Need for further intervention
Primary endpoint: Decrease in serum creatinine level
Endpoint domain: Physiological/clinical
Endpoint subdomain: Renal and urinary outcomes
Primary endpoint: time to onset of action
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Depression severity measured by HAM-D21
Endpoint domain: Life impact
Endpoint subdomain: Emotional functioning/wellbeing
Primary endpoint: Change on the Montgomery Asberg Depression Rating Scale (MADRS)
Endpoint domain: Life impact
Endpoint subdomain: Emotional functioning/wellbeing
Primary endpoint: glucose and lipid uptake
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: testicular volume
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Pharmacokinetic
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: ECG Evaluation
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Number of Participants With a Clinically Meaningful Abnormal Clinical Laboratory Parameter
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Number of Participants With a Clinically Meaningful Abnormal Electrocardiogram (ECG) Test Results
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Number of Participants With a Dose-Limiting Toxicity as Measured by Hepatic and Renal Toxicity
Endpoint domain: Adverse events/effects
Primary endpoint: Correlation of coagulation tests
Endpoint domain: Physiological/clinical
Endpoint subdomain: Blood and lymphatic system outcomes
Primary endpoint: Ashworth scale at the rectus femoris
Endpoint domain: Physiological/clinical
Endpoint subdomain: Musculoskeletal and connective tissue outcomes
Primary endpoint: Change of Scintigraphic Split Renal Function (%)
Endpoint domain: Physiological/clinical
Endpoint subdomain: Renal and urinary outcomes
Primary endpoint: Normalization of International Normalised Ratio (INR)
Endpoint domain: Physiological/clinical
Endpoint subdomain: Blood and lymphatic system outcomes
Primary endpoint: Change in Beck Scale for Suicide Ideation (BSS) score
Endpoint domain: Life impact
Endpoint subdomain: Emotional functioning/wellbeing
Primary endpoint: MMR rate at 12 months
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change in Height Standard Deviation Score (SDS) After 1 Year
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change in Growth Velocity Standard Deviation Score (SDS) After 1 Year
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Rate of Late Radiation Morbidity (≥ Grade 2 Lymphedema, Subcutaneous Fibrosis, or Joint Stiffness)
Endpoint domain: Physiological/clinical
Endpoint subdomain: Skin and subcutaneous tissue outcomes
Primary endpoint: Change in 6-minute walk test
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Amount of Salivation
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Number of Participants Experiencing Acute Respiratory Decompensation
Endpoint domain: Physiological/clinical
Endpoint subdomain: Respiratory outcomes
Primary endpoint: Number of Participants With Hypersensitivity Reactions
Endpoint domain: Adverse events/effects
Primary endpoint: Number of Treatment-emergent Adverse Events (TEAEs) Related to Investigational Product or Administration and Serious Adverse Events (SAEs)
Endpoint domain: Adverse events/effects
Primary endpoint: Number of Participants With Immune Sensitization Syndrome
Endpoint domain: Adverse events/effects
Primary endpoint: Flow mediated dilation (FMD)
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Pharmacokinetics of ceftobiprole and its open-ring metabolite
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Pharmacokinetics parameters (AUC, Cmax, tmax, λz, t1/2, systemic clearance, apparent volume of distribution)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Proportion of children with radiologically-defined bronchiectasis
Endpoint domain: Physiological/clinical
Endpoint subdomain: Respiratory outcomes
Primary endpoint: The proportion of lung tissue affected by disease
Endpoint domain: Physiological/clinical
Endpoint subdomain: Respiratory outcomes
Primary endpoint: SARS-COV2 seroconversion
Endpoint domain: Physiological/clinical
Endpoint subdomain: Immune system outcomes
Primary endpoint: Change in participant's Hamilton Rating Scale for Depression (HAM-D) score
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change in participants's Quality of life scale (QOLs) scores [WHOQOL-BREF]
Endpoint domain: Life impact
Endpoint subdomain: Global quality of life
Primary endpoint: Change in participant's Cognitive performance
Endpoint domain: Life impact
Endpoint subdomain: Cognitive functioning
Primary endpoint: Good Functional Independence
Endpoint domain: Life impact
Endpoint subdomain: Physical functioning
Primary endpoint: Hemorrhage transformation
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Microbiome Reproducibility
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Proportion of Participants Who Remain Well Controlled
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Number of participants with a treatment-related adverse event
Endpoint domain: Adverse events/effects
Primary endpoint: Self Reported Pain Rating
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: All cause mortality at 30 days
Endpoint domain: Mortality/survival
Primary endpoint: New ST elevation acute myocardial infarction at 30 days
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Coronary revascularization as a result of recurrent ischemia at 30 days
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Major vascular complications at 30 days
Endpoint domain: Physiological/clinical
Endpoint subdomain: Vascular outcomes
Primary endpoint: Arterial carbon dioxide reduction
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Increase in PaO2/FiO2 ratio
Endpoint domain: Physiological/clinical
Endpoint subdomain: Respiratory outcomes
Primary endpoint: Number of Subjects Biochemically Confirmed to be Abstinent From Smoking at End of Treatment
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Number of Subjects Biochemically Confirmed to be Abstinent From Smoking at End of Study
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Surgical blood loss
Endpoint domain: Physiological/clinical
Endpoint subdomain: Blood and lymphatic system outcomes
Primary endpoint: Changes in Postural Sway Thresholds
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Changes in Gait dynamics
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Changes in reported quality of life
Endpoint domain: Life impact
Endpoint subdomain: Global quality of life
Primary endpoint: Time to the First On-Study Skeletal-Related Event
Endpoint domain: Physiological/clinical
Endpoint subdomain: Neoplasms and related outcomes
Primary endpoint: Treatment-related mortality within the first 6 months post-transplant
Endpoint domain: Mortality/survival
Primary endpoint: Discharge clinical scores
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Curative effect of angina pectoris symptoms
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Incident Malaria Cases Per Person Year at Risk in HIV-unexposed Participants
Endpoint domain: Physiological/clinical
Endpoint subdomain: Infections and infestations outcomes
Primary endpoint: Incident Malaria Cases Per Person Year at Risk in HIV-exposed Participants
Endpoint domain: Physiological/clinical
Endpoint subdomain: Infections and infestations outcomes
Primary endpoint: Stent thrombosis rates
Endpoint domain: Mortality/survival
Primary endpoint: Composite endpoint of cardiac death and myocardial infarction (MI)
Endpoint domain: Mortality/survival
Primary endpoint: Overactive Bladder questionnaire (OAB-q)
Endpoint domain: Life impact
Endpoint subdomain: Global quality of life
Primary endpoint: 3 days voiding diary
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change of Body Mass Index (BMI) Z-score for Toddlers
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Change in Body Mass Index (BMI) Score Among Mothers
Endpoint domain: Physiological/clinical
Endpoint subdomain: Metabolic and nutritional outcomes
Primary endpoint: Composite of adverse maternal outcome
Endpoint domain: Adverse events/effects
Primary endpoint: Composite of adverse fetal outcome
Endpoint domain: Adverse events/effects
Primary endpoint: Percentage of Participants Achieving a ≥ 75% Improvement in F-VASI75 Score
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Self-reported Partner Notification
Endpoint domain: Life impact
Endpoint subdomain: Perceived health status
Primary endpoint: Apnoea-Hypopnoea-Index
Endpoint domain: Physiological/clinical
Endpoint subdomain: Respiratory outcomes
Primary endpoint: Change in pain extent
Endpoint domain: Life impact
Endpoint subdomain: Physical functioning
Primary endpoint: hospital acquired infections incidence
Endpoint domain: Adverse events/effects
Primary endpoint: Worst Pain Score at Day 14
Endpoint domain: Life impact
Endpoint subdomain: Fatigue
Primary endpoint: Worst Pain Score at Day 28
Endpoint domain: Life impact
Endpoint subdomain: Fatigue
Primary endpoint: Count of pregnant women with concordant test results between the SHC-POC test and the TT/NTT test
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Count of pregnant women with concordant test results between the SHC-POC test and maternal syphilis diagnosis requiring treatment
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Incidence of Congenital Syphilis
Endpoint domain: Physiological/clinical
Endpoint subdomain: Infections and infestations outcomes
Primary endpoint: Risk cardiovascular score
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Activation of brain opioid neurotransmission
Endpoint domain: Physiological/clinical
Endpoint subdomain: Nervous system outcomes
Primary endpoint: RA graft failure at Week 1
Endpoint domain: Physiological/clinical
Endpoint subdomain: Surgical and medical procedures outcomes
Primary endpoint: RA graft failure at Week 24
Endpoint domain: Physiological/clinical
Endpoint subdomain: Surgical and medical procedures outcomes
Primary endpoint: Cardiac and all cause mortality
Endpoint domain: Mortality/survival
Primary endpoint: Non-fatal vascular events
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: molecular testing patterns
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: treatment patterns and associated clinical outcomes
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change in obesity as indicated by body mass index (BMI)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Time to next need treatment
Endpoint domain: Resource use
Endpoint subdomain: Need for further intervention
Primary endpoint: Levels of Hippo signaling and autophagy markers
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Rate of dose limiting toxicity (DLT)
Endpoint domain: Adverse events/effects
Primary endpoint: Safety of Inactivated Poliomyelitis Vaccine
Endpoint domain: Adverse events/effects
Primary endpoint: Ongoing pregnancy rate per patient
Endpoint domain: Physiological/clinical
Endpoint subdomain: Pregnancy and childbirth outcomes
Primary endpoint: Echocardiographic parameter
Endpoint domain: Physiological/clinical
Endpoint subdomain: Cardiovascular outcomes
Primary endpoint: Patient fears before and after transportation to the OR
Endpoint domain: Life impact
Endpoint subdomain: Emotional functioning/wellbeing
Primary endpoint: Pain Intensity (Trial Stage)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Pain Intensity (Implant Stage)
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Device-Related Adverse Events
Endpoint domain: Adverse events/effects
Primary endpoint: Adjusted Percent Change in Femoral Neck Bone Mineral Density
Endpoint domain: Physiological/clinical
Endpoint subdomain: General outcomes
Primary endpoint: Change in level of insulin
Endpoint domain: Physiological/clinical
Endpoint subdomain: Endocrine outcomes
Primary endpoint: Change in level of glucagon
Endpoint domain: Physiological/clinical
Endpoint subdomain: Endocrine outcomes
Primary endpoint: Hamilton Depression Rating Scale (HAMD-17)
Endpoint domain: Life impact
Endpoint subdomain: Emotional functioning/wellbeing
Primary endpoint: Number of participants with any treatment-emergent adverse events (AEs)
Endpoint domain: Adverse events/effects
Primary endpoint: Number of participants with any serious AEs (SAEs)
Endpoint domain: Adverse events/effects
Primary endpoint: Number of participants with any treatment-emergent clinical laboratory abnormalities
Endpoint domain: Adverse events/effects
Primary endpoint: cognitive assessment scores
Endpoint domain: Life impact
Endpoint subdomain: Cognitive functioning
Primary endpoint: Change in neural responses to infant cry stimuli
Endpoint domain: Physiological/clinical
Endpoint subdomain: Nervous system outcomes
Primary endpoint: Safety of calcium intake
Endpoint domain: Adverse events/effects