anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: FLORBETAPIR
Trial phase: Phase 1
ATC code: V09AX05
SMILES: CNc1ccc(C=Cc2ccc(OCCOCCOCCF)nc2)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 11
Group description: Male or female subjects > 50 years old; probable AD according to NINCDS-ADRDA criteria; MMSE 10-24
Eligibility criteria:
Inclusion Criteria (AD group):

Greater than 50 years of age
Probable AD according to the National Institute of Neurological and Communication Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria
Mild/moderate dementia as evidenced by a Mini-Mental State Examination (MMSE) score ranging from 10 to 24, boundaries included, at screening
History of cognitive decline gradual in onset and progressive over a period of at least 6 months

Inclusion Criteria (healthy volunteer group):

35 to 55 years of age, inclusive
MMSE of 29 or greater

Exclusion Criteria (both groups):

Neurodegenerative disorders other than AD, including, but not limited to Parkinson's disease, Pick's disease, fronto-temporal dementia, Huntington's chorea, Down syndrome, Creutzfeldt-Jacob disease, normal pressure hydrocephalus, and progressive supranuclear palsy
Diagnosis of other dementing / neurodegenerative disease
Diagnosis of mixed dementia
Cognitive impairment resulting from trauma, hypoxic damage, vitamin deficiency, brain infection, brain cancer, endocrine disease, or mental retardation
Clinically significant infarct or possible multi-infarct dementia as defined by the NINCDS criteria
Evidence on screening MRI or other biomarker that suggests alternate etiology for cognitive deficit (for healthy controls, evidence suggesting the presence of AD pathology)
Clinically significant psychiatric disease
History of epilepsy or convulsions
Clinically significant hepatic, renal, pulmonary, metabolic, or endocrine disturbances
Current clinically significant cardiovascular disease
Received investigational medication within the last 30 days
Intervention: Erlotinib
Trial phase: Phase 2
ATC code: L01EB02 | L01XE03
SMILES: C#Cc1cccc(Nc2ncnc3cc(OCCOC)c(OCCOC)cc23)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 61
Group description: Erlotinib at the dose of 150 mg orally once a day continually until progression.

Erlotinib: 150 mg Given orally
Eligibility criteria:
Inclusion Criteria:

Histologically or cytologically confirmed Lung adenocarcinoma
Wld-type EGFR
Stage IIIB/IV
Failure to prior chemotherapy
Life expectancy of more than 3 months
Tissue sample desired for genomic study
Age ≥ 18 years
Performance status (WHO) < 3
Adequate bone marrow function (absolute neutrophil count > 1000/mm^3, platelet count > 100000/mm^3, hemoglobin > 9gr/mm^3)
Adequate liver (bilirubin < 1.5 times upper limit of normal and SGOT/SGPT < 2 times upper limit of normal) and renal function (creatinine < 2mg/dl)
Presence of two-dimensional measurable disease. The measurable disease should not have been irradiated
Informed consent

Exclusion Criteria:

Have previously received pemetrexed or TKIs
Other concurrent uncontrolled illness
Intervention: Pemetrexed
Trial phase: Phase 2
ATC code: L01BA04
SMILES: Nc1nc(=O)c2c(CCc3ccc(C(=O)N[C@@H](CCC(=O)O)C(=O)O)cc3)c[nH]c2[nH]1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 62
Group description: Pemetrexed at the dose of 500mg/m2 IV infusion every 3 weeks until progression.

Pemetrexed: 500mg/m2 Given IV
Eligibility criteria:
Inclusion Criteria:

Histologically or cytologically confirmed Lung adenocarcinoma
Wld-type EGFR
Stage IIIB/IV
Failure to prior chemotherapy
Life expectancy of more than 3 months
Tissue sample desired for genomic study
Age ≥ 18 years
Performance status (WHO) < 3
Adequate bone marrow function (absolute neutrophil count > 1000/mm^3, platelet count > 100000/mm^3, hemoglobin > 9gr/mm^3)
Adequate liver (bilirubin < 1.5 times upper limit of normal and SGOT/SGPT < 2 times upper limit of normal) and renal function (creatinine < 2mg/dl)
Presence of two-dimensional measurable disease. The measurable disease should not have been irradiated
Informed consent

Exclusion Criteria:

Have previously received pemetrexed or TKIs
Other concurrent uncontrolled illness
Intervention: Solifenacin Succinate
Trial phase: Phase 3
SMILES: O=C(O)CCC(=O)O.O=C(OC1CN2CCC1CC2)N1CCc2ccccc2C1c1ccccc1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 76
Group description: Participants aged 5 years to < 18 years, received solifenacin orally once a day, with sequential titrated doses for 12 weeks, to identify optimal dose during the dose-titration period. After completing dose titration period, participants entered the fixed-dose period during which solifenacin was received orally once a day for 40 weeks or until the end of study visit (Week 52).
Eligibility criteria:
Inclusion Criteria:

Documented diagnosis of NDO, confirmed by urodynamics
Practicing clean intermittent catheterization (CIC)
Currently on treatment with an antimuscarinic drug

Exclusion Criteria:

Known genitourinary condition (other than NDO) that may cause incontinence
Bladder augmentation surgery
Current Faecal impaction
Electro-stimulation therapy within 2 weeks prior to screening and at any time during the study
Subjects with the following gastro-intestinal problems: partial or complete obstruction, decreased motility like paralytic ileus, subjects at risk of gastric retention
Reflux grade 3 or 4
Current urinary tract infection (UTI)
Subject has severe renal impairment (glomerular filtration rate < 30 ml/min)
Subject has severe hepatic impairment (Child-Pugh score > 9).
Subject has received intra-vesical botulinum toxin within 9 months prior to screening
Intervention: Insulin
Trial phase: Phase 3
SMILES: CCC(C)C(NC(=O)CN)C(=O)NC(C(=O)NC(CCC(=O)O)C(=O)NC(CCC(N)=O)C(=O)NC1CSSCC2NC(=O)C(C(C)CC)NC(=O)C(CO)NC(=O)C(C(C)O)NC(=O)C(CSSCC(NC(=O)C(CC(C)C)NC(=O)C(Cc3c[nH]cn3)NC(=O)C(CCC(N)=O)NC(=O)C(NC(=O)C(NC(=O)C(N)Cc3ccccc3)C(C)C)C(N)=O)C(=O)NCC(=O)NC(CO)C(=O)NC(Cc3c[nH]cn3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(CCC(=O)O)C(=O)NC(C)C(=O)NC(CC(C)C)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(C(=O)NCC(=O)NC(CCC(=O)O)C(=O)NC(CCCNC(=N)N)C(=O)NCC(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(C(=O)N3CCCC3C(=O)NC(CCCCN)C(=O)NC(C(=O)O)C(C)O)C(C)O)CSSCC(C(=O)NC(CC(N)=O)C(=O)O)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(N)=O)NC(=O)C(CCC(=O)O)NC(=O)C(CC(C)C)NC(=O)C(CCC(N)=O)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(C)C)NC(=O)C(CO)NC2=O)NC1=O)C(C)C
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 349
Group description: Approximately half of the subjects randomized into HALF-PINT will be randomized into TGC-1 which will seek to maintain the subject's blood sugar between 80-110 mg/dL. Intravenous insulin may be administered per insulin algorithm.

Insulin: IV insulin titration to target a blood glucose of 80-110 mg/dL
Eligibility criteria:
Inclusion Criteria:

Cardiovascular failure and/or respiratory failure:

Cardiovascular Failure: Dopamine or dobutamine > 5 mcg/kg/min, or any dose of epinephrine, norepinephrine, phenylephrine, milrinone or vasopressin if used to treat hypotension.
Respiratory Failure: Acute mechanical ventilation via endotracheal tube or tracheostomy.
Age >= 2 weeks and corrected gestational age >= 42 weeks
Age < 18 years (has not yet had 18th birthday)

Exclusion Criteria:

No longer has cardiovascular or respiratory failure (as defined in inclusion criterion 1), or is expected to be extubated in the next 24 hours
Expected to remain in ICU < 24 hours
Previously randomized in HALF-PINT
Enrolled in a competing clinical trial
Family/team decision to limit/redirect from aggressive ICU technological support
Chronic ventilator dependence prior to ICU admission (non-invasive ventilation and ventilation via tracheostomy overnight or during sleep are acceptable)
Type 1 or 2 diabetes
Cardiac surgery within prior 2 months or during/planned for this hospitalization (extra-corporeal life support or non-cardiac surgery is acceptable)
Diffuse skin disease that does not allow securement of a subcutaneous sensor
Therapeutic plan to remain intubated for >28 days
Receiving therapeutic cooling with targeted body temperatures <34 degrees Celsius
Current or planned ketogenic diet
Ward of the state
Pregnancy
Intervention: Insulin
Trial phase: Phase 3
SMILES: CCC(C)C(NC(=O)CN)C(=O)NC(C(=O)NC(CCC(=O)O)C(=O)NC(CCC(N)=O)C(=O)NC1CSSCC2NC(=O)C(C(C)CC)NC(=O)C(CO)NC(=O)C(C(C)O)NC(=O)C(CSSCC(NC(=O)C(CC(C)C)NC(=O)C(Cc3c[nH]cn3)NC(=O)C(CCC(N)=O)NC(=O)C(NC(=O)C(NC(=O)C(N)Cc3ccccc3)C(C)C)C(N)=O)C(=O)NCC(=O)NC(CO)C(=O)NC(Cc3c[nH]cn3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(CCC(=O)O)C(=O)NC(C)C(=O)NC(CC(C)C)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(CC(C)C)C(=O)NC(C(C)C)C(=O)NC(C(=O)NCC(=O)NC(CCC(=O)O)C(=O)NC(CCCNC(=N)N)C(=O)NCC(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccccc3)C(=O)NC(Cc3ccc(O)cc3)C(=O)NC(C(=O)N3CCCC3C(=O)NC(CCCCN)C(=O)NC(C(=O)O)C(C)O)C(C)O)CSSCC(C(=O)NC(CC(N)=O)C(=O)O)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(N)=O)NC(=O)C(CCC(=O)O)NC(=O)C(CC(C)C)NC(=O)C(CCC(N)=O)NC(=O)C(Cc3ccc(O)cc3)NC(=O)C(CC(C)C)NC(=O)C(CO)NC2=O)NC1=O)C(C)C
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 349
Group description: Approximately half of the subjects randomized into HALF-PINT will be randomized into TGC-2 which will seek to maintain the subject's blood sugar between 150-180 mg/dL. Intravenous insulin may be administered per insulin algorithm.

Insulin: IV insulin titration to target a blood glucose of 150-180 mg/dL
Eligibility criteria:
Inclusion Criteria:

Cardiovascular failure and/or respiratory failure:

Cardiovascular Failure: Dopamine or dobutamine > 5 mcg/kg/min, or any dose of epinephrine, norepinephrine, phenylephrine, milrinone or vasopressin if used to treat hypotension.
Respiratory Failure: Acute mechanical ventilation via endotracheal tube or tracheostomy.
Age >= 2 weeks and corrected gestational age >= 42 weeks
Age < 18 years (has not yet had 18th birthday)

Exclusion Criteria:

No longer has cardiovascular or respiratory failure (as defined in inclusion criterion 1), or is expected to be extubated in the next 24 hours
Expected to remain in ICU < 24 hours
Previously randomized in HALF-PINT
Enrolled in a competing clinical trial
Family/team decision to limit/redirect from aggressive ICU technological support
Chronic ventilator dependence prior to ICU admission (non-invasive ventilation and ventilation via tracheostomy overnight or during sleep are acceptable)
Type 1 or 2 diabetes
Cardiac surgery within prior 2 months or during/planned for this hospitalization (extra-corporeal life support or non-cardiac surgery is acceptable)
Diffuse skin disease that does not allow securement of a subcutaneous sensor
Therapeutic plan to remain intubated for >28 days
Receiving therapeutic cooling with targeted body temperatures <34 degrees Celsius
Current or planned ketogenic diet
Ward of the state
Pregnancy
Intervention: Ketamine
Trial phase: Phase 2
ATC code: N01AX03 | N01AX14 | N06AX27
SMILES: CNC1(c2ccccc2Cl)CCCCC1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 30
Group description: Ketamine oral mouthwash 20mg/5ml swish and spit four times daily

Ketamine: 20mg/5ml swish and spit four times daily
Eligibility criteria:
Inclusion Criteria:

Patient has oral mucositis pain that is grade 3 or 4 according to the World Health Organization (WHO) Oral Mucositis Scale
Patient has received at least one prior chemotherapy or radiation treatment
Patient is at least 18 years old
Patient or their legally authorized representative understands and voluntarily signs the written informed consent prior to any study-specific procedures. A copy of the signed informed consent form will be retained by the treating institution.
Intervention: Lorazepam
Trial phase: Not Applicable
ATC code: N05BA06 | N05BA56
SMILES: O=C1Nc2ccc(Cl)cc2C(c2ccccc2Cl)=NC1O
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 1
Group description: Healthy normal men between the ages of 18 and 22 will receive lorazepam prior to completing the Prisoner's Dilemma game task and MRI scan.

Lorazepam: Subjects will take 1.0 mg of lorazepam orally 60 minutes prior to fMRI scan.
Eligibility criteria:
Inclusion Criteria:

18-30 years of age
21-30 for Faces component
Normal or corrected-to-normal vision of 20/40
Unmedicated depressed or anxious men between 18-22 years of age for Anxious and Depressed component

Exclusion Criteria:

Pregnancy, recent birth, or breastfeeding
History of seizures
Neurological Disorder
Current psychiatric disorder
Previous psychiatric disorder (can be included as discretion of PI)
Current use of psychoactive drugs
Previous use of psychoactive drugs (can be included as discretion of PI)
Previous head trauma (can be included at discretion of PI)
Alcoholism or substance abuse
Hypertension
Cardiovascular Disease
Nephritis
Diabetes
Endocrine disease or malignancy
Asthma (can be included as discretion of PI, if episodes are infrequent, nonmedicated, and no active problems at time of study)
Migraines (can be included as discretion of PI, if episodes are infrequent, nonmedicated, and no active problems at time of study)
Claustrophobia (at discretion of PI)

Additional exclusion criteria for Lorazepam arm

Acute narrow-angle glaucoma
Compromised respiratory function (e.g. sleep apnea and chronic obstructive pulmonary disease)
Impaired renal and hepatic function
Intervention: Glycopyrrolate
Trial phase: Phase 3
ATC code: A03AB02
SMILES: C[N+]1(C)CCC(OC(=O)C(O)(c2ccccc2)C2CCCC2)C1.[Br-]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 305
Group description: NVA237 50 µg once daily delivered via a single dose dry powder inhaler
Eligibility criteria:
Inclusion Criteria:

Male or female adults aged ≥40 years, who have signed an Informed Consent Form prior to initiation of any study-related procedure
With moderate to severe stable COPD (Stage II or Stage III).
Current or ex-smokers who have a smoking history of at least 10 pack years (Ten pack- years are defined as 20 cigarettes a day for 10 years, or 10 cigarettes a day for 20 years).
Post-bronchodilator FEV1 ≥30% and < 80% of the predicted normal, and post-bronchodilator FEV1/FVC < 0.7 at Visit 2 (Day -14) (post means: record FEV1 and FVC 45 min after administering ipratropium).
Symptomatic patients, according to daily electronic diary data between Visit 2 (Day -14) and Visit 3 (Day 1), with a total score of 1 or more on at least 4 of the last 7 days prior to Visit 3

Exclusion Criteria:

With a history of malignancy of any organ system (including lung cancer), treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin.
Patients with any history of asthma indicated by (but not limited to) a blood eosinophil count > 600/mm3 (at Visit 2) or onset of symptoms prior to age 40 years. Patients without asthma but who have a blood eosinophil count >600/mm3 at Visit 2 are excluded.
Patients with concomitant pulmonary disease, e.g. pulmonary tuberculosis (unless confirmed by imaging to be no longer active) or clinically significant bronchiectasis, sarcoidosis and interstitial lung disorder.
Patients with lung lobectomy or lung volume reduction or lung transplantation.
Patients with known history and diagnosis of α-1 antitrypsin deficiency.
Patients who have had a COPD exacerbation that required treatment with antibiotics, systemic steroids (oral or intravenous) or hospitalization in the 6 weeks prior to Visit 1 Patients who have had a respiratory tract infection within 6 weeks prior to Visit 1.

Other protocol-defined inclusion/exclusion criteria may apply.
Intervention: Simvastatin
Trial phase: Phase 4
ATC code: A10BH51 | C10AA01 | C10BA02 | C10BA04 | C10BX01 | C10BX04
SMILES: CCC(C)(C)C(=O)OC1CC(C)C=C2C=CC(C)C(CCC3CC(O)CC(=O)O3)C21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 43
Group description: standard-care lipid-lowering therapy: Zocor or Lipitor
Eligibility criteria:
Inclusion Criteria:

Patient > 18 years of age and willing to participate
Stable patients who will undergo cardiac catheterization and PCI (intent to stent)
Patient is willing to go on a cholesterol lowering medication for the duration of the study and willing to change statin therapy to the randomized statin therapy regardless of previous statin therapy and dose (e.g. Atorvastatin 80 mg) Patients that are screened for this study and are receiving another Statin such as Pravachol will be required to be willing to change their therapy to Rosuvastatin as per is randomization. If patients are receiving another statin, such as pravachol, or any other agent, and are at appropriate Lipid levels, they will be permitted to continue this therapy (if randomized to the standard therapy arm). There are a virtually unlimited number of possible scenarios for potential combination of all Lipid lowering agents at the time of enrollment that patients may be taking.
Signed written Informed Consent
Women of childbearing potential must agree to be on an acceptable method of birth control/contraceptive such as barrier method (condoms/diaphragm); hormonal contraceptives (birth control pills, implants (Norplant) or injections (Depo-Provera)); Intrauterine Device; or abstinence (no sexual activity).
Fluency in English and/or Spanish

Exclusion Criteria:

Patients who have acute myocardial infarction (Q wave or non-Q wave with CK-MB > 5 times above the upper normal (31.5 ng/ml) within 72 hours)
Patients who are in cardiogenic shock
Patients with left main disease or restenotic lesions
Patients with elevated CK-MB (> 6.5 ng/ml) or Tnl (> 0.5ng/L) at baseline
Patients with platelet count < 100,000 cell/mm3
Patients who have co-morbidity which reduces life expectancy to one year
Patients who are currently participating in another investigational drug/device study
Patients with known hypersensitivity to HMG CO-A reductase therapy (statins)
Patients with liver disease
Patient with creatinine > 2.0 mg/dL
Pregnant women and women of childbearing potential who intend to have children during the duration of the trial
Intervention: Fluoxetine Hydrochloride
Trial phase: Phase 1
SMILES: CNCCC(Oc1ccc(C(F)(F)F)cc1)c1ccccc1.Cl
Sex: Male
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 8
Group description: Cohort 2: 20-mg LY110140 (fluoxetine hydrochloride) capsule orally administered once, in a fasted state, during the SD period.
Eligibility criteria:
Inclusion Criteria:

Overtly healthy Japanese males (as determined by medical history and physical examination) who agree to use a reliable method of birth control during the study and for 3 months following the last dose of the investigational product.
Have a body mass index (BMI) of 18.5 to 29.9 kilograms per square meter (kg/m^2), inclusive, at the time of screening.
Have given written informed consent approved by Lilly and the ethical review board (ERB) governing the study site.

Exclusion Criteria:

Poor metabolizers of isoenzyme cytochrome P450 2D6 (CYP2D6) (assessed at screening).
Have an abnormality in the 12-lead electrocardiogram (ECG) at screening that, in the opinion of the investigator, increases the risks associated with participating in the study such as, a Bazett's corrected QT (QTcB) interval >450 milliseconds (msec).
Have any lifetime history of a suicide attempt, or have suicidal ideation or, any suicidal behavior within the last month, or who are at significant risk to commit suicide, as judged by the investigator using the Columbia Suicide Severity Rating Scale (C-SSRS).
Are unsuitable (in the opinion of the investigator or sponsor) for inclusion in the study.
Intervention: Fluoxetine Hydrochloride
Trial phase: Phase 1
SMILES: CNCCC(Oc1ccc(C(F)(F)F)cc1)c1ccccc1.Cl
Sex: Male
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 8
Group description: Cohort 3: 40-mg LY110140 (fluoxetine hydrochloride) dose (two 20-mg LY110140 capsules) orally administered once, in a fasted state, during the SD period.
Eligibility criteria:
Inclusion Criteria:

Overtly healthy Japanese males (as determined by medical history and physical examination) who agree to use a reliable method of birth control during the study and for 3 months following the last dose of the investigational product.
Have a body mass index (BMI) of 18.5 to 29.9 kilograms per square meter (kg/m^2), inclusive, at the time of screening.
Have given written informed consent approved by Lilly and the ethical review board (ERB) governing the study site.

Exclusion Criteria:

Poor metabolizers of isoenzyme cytochrome P450 2D6 (CYP2D6) (assessed at screening).
Have an abnormality in the 12-lead electrocardiogram (ECG) at screening that, in the opinion of the investigator, increases the risks associated with participating in the study such as, a Bazett's corrected QT (QTcB) interval >450 milliseconds (msec).
Have any lifetime history of a suicide attempt, or have suicidal ideation or, any suicidal behavior within the last month, or who are at significant risk to commit suicide, as judged by the investigator using the Columbia Suicide Severity Rating Scale (C-SSRS).
Are unsuitable (in the opinion of the investigator or sponsor) for inclusion in the study.
Intervention: Fluoxetine Hydrochloride
Trial phase: Phase 1
SMILES: CNCCC(Oc1ccc(C(F)(F)F)cc1)c1ccccc1.Cl
Sex: Male
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 12
Group description: Participants, in Cohort 4, who received 20-mg LY110140 (fluoxetine hydrochloride) capsule, orally administered once daily for 28 days, during the MD period. On Days 1 and 28 participants were required to fast at least 8 hours prior to dosing and 4 hours postdose.
Eligibility criteria:
Inclusion Criteria:

Overtly healthy Japanese males (as determined by medical history and physical examination) who agree to use a reliable method of birth control during the study and for 3 months following the last dose of the investigational product.
Have a body mass index (BMI) of 18.5 to 29.9 kilograms per square meter (kg/m^2), inclusive, at the time of screening.
Have given written informed consent approved by Lilly and the ethical review board (ERB) governing the study site.

Exclusion Criteria:

Poor metabolizers of isoenzyme cytochrome P450 2D6 (CYP2D6) (assessed at screening).
Have an abnormality in the 12-lead electrocardiogram (ECG) at screening that, in the opinion of the investigator, increases the risks associated with participating in the study such as, a Bazett's corrected QT (QTcB) interval >450 milliseconds (msec).
Have any lifetime history of a suicide attempt, or have suicidal ideation or, any suicidal behavior within the last month, or who are at significant risk to commit suicide, as judged by the investigator using the Columbia Suicide Severity Rating Scale (C-SSRS).
Are unsuitable (in the opinion of the investigator or sponsor) for inclusion in the study.