anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Cipargamin
Trial phase: Phase 2
SMILES: C[C@H]1Cc2c([nH]c3cc(Cl)c(F)cc23)[C@@]2(N1)C(=O)Nc1ccc(Cl)cc12
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 7
Group description: Single dose of KAE609 30 mg
Eligibility criteria:
Key Inclusion Criteria:

Monoinfection with P. falciparum confirmed by microscopy
Asexual P. falciparum parasitemia count of 5,000 to 50,000/µL
Axillary temperature ≥37.5 ºC or oral/tympanic/rectal temperature ≥38 ºC; or similar documented temperature during the previous 24 hours
Body weight between 40 to 90 kg

Key Exclusion Criteria:

Signs and symptoms of severe malaria according to World Health Organization (WHO) 2010 criteria
Mixed Plasmodium infection, i.e. infection with more than one species of malaria parasites
Use of other investigational drugs within 30 days or within 5 half-lives of enrollment, whichever is longer
History of antimalarial use within 2 months of screening
Use of any antibiotics with antimalarial activity or other prohibited medication within 14 days of screening
Long QT syndrome or QTc using Fridericia's formula >430 msec
History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases
Hemoglobin level <10 g/dL
Liver disease or injury as indicated by elevated liver tests such as SGPT (ALT) or SGOT (AST) >2 times the upper limit of normal
Renal dysfunction as indicated by serum creatinine >2 times the upper limit of normal in the absence of dehydration; in case of dehydration, serum creatinine should be <2 times the upper limit of normal after oral or parental rehydration
Known to be immunocompromised (including HIV infection) or are receiving immunosuppressive therapy at the time or enrollment; HIV testing is not required
Known history of hepatitis B or C; testing is not required
Febrile condition due to diseases other than malaria (e.g. acute lower respiratory tract infection), known underlying chronic or severe disease (e.g. cardiac, hepatic, renal, gastrointestinal, neurologic, or psychiatric disease), or any condition precluding enrollment into this study according to the investigator
Severe vomiting defined as >3 times during the previous 24 hours or inability to tolerate oral medication; severe diarrhea defined as ≥3 watery stools during the previous 24 hours
Severe malnutrition defined by a body mass index (BMI) <18.5 kg/m2 or unintentional loss of weight ≥10% with evidence of suboptimal intake resulting in loss of subcutaneous fat and/or severe muscle wasting
Active tuberculosis or history of taking anti-tuberculosis medications within 24 months prior to screening
Intervention: Cipargamin
Trial phase: Phase 2
SMILES: C[C@H]1Cc2c([nH]c3cc(Cl)c(F)cc23)[C@@]2(N1)C(=O)Nc1ccc(Cl)cc12
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 4
Group description: Single dose of KAE609 20 mg
Eligibility criteria:
Key Inclusion Criteria:

Monoinfection with P. falciparum confirmed by microscopy
Asexual P. falciparum parasitemia count of 5,000 to 50,000/µL
Axillary temperature ≥37.5 ºC or oral/tympanic/rectal temperature ≥38 ºC; or similar documented temperature during the previous 24 hours
Body weight between 40 to 90 kg

Key Exclusion Criteria:

Signs and symptoms of severe malaria according to World Health Organization (WHO) 2010 criteria
Mixed Plasmodium infection, i.e. infection with more than one species of malaria parasites
Use of other investigational drugs within 30 days or within 5 half-lives of enrollment, whichever is longer
History of antimalarial use within 2 months of screening
Use of any antibiotics with antimalarial activity or other prohibited medication within 14 days of screening
Long QT syndrome or QTc using Fridericia's formula >430 msec
History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases
Hemoglobin level <10 g/dL
Liver disease or injury as indicated by elevated liver tests such as SGPT (ALT) or SGOT (AST) >2 times the upper limit of normal
Renal dysfunction as indicated by serum creatinine >2 times the upper limit of normal in the absence of dehydration; in case of dehydration, serum creatinine should be <2 times the upper limit of normal after oral or parental rehydration
Known to be immunocompromised (including HIV infection) or are receiving immunosuppressive therapy at the time or enrollment; HIV testing is not required
Known history of hepatitis B or C; testing is not required
Febrile condition due to diseases other than malaria (e.g. acute lower respiratory tract infection), known underlying chronic or severe disease (e.g. cardiac, hepatic, renal, gastrointestinal, neurologic, or psychiatric disease), or any condition precluding enrollment into this study according to the investigator
Severe vomiting defined as >3 times during the previous 24 hours or inability to tolerate oral medication; severe diarrhea defined as ≥3 watery stools during the previous 24 hours
Severe malnutrition defined by a body mass index (BMI) <18.5 kg/m2 or unintentional loss of weight ≥10% with evidence of suboptimal intake resulting in loss of subcutaneous fat and/or severe muscle wasting
Active tuberculosis or history of taking anti-tuberculosis medications within 24 months prior to screening
Intervention: Cipargamin
Trial phase: Phase 2
SMILES: C[C@H]1Cc2c([nH]c3cc(Cl)c(F)cc23)[C@@]2(N1)C(=O)Nc1ccc(Cl)cc12
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 7
Group description: Single dose of KAE609 10 mg
Eligibility criteria:
Key Inclusion Criteria:

Monoinfection with P. falciparum confirmed by microscopy
Asexual P. falciparum parasitemia count of 5,000 to 50,000/µL
Axillary temperature ≥37.5 ºC or oral/tympanic/rectal temperature ≥38 ºC; or similar documented temperature during the previous 24 hours
Body weight between 40 to 90 kg

Key Exclusion Criteria:

Signs and symptoms of severe malaria according to World Health Organization (WHO) 2010 criteria
Mixed Plasmodium infection, i.e. infection with more than one species of malaria parasites
Use of other investigational drugs within 30 days or within 5 half-lives of enrollment, whichever is longer
History of antimalarial use within 2 months of screening
Use of any antibiotics with antimalarial activity or other prohibited medication within 14 days of screening
Long QT syndrome or QTc using Fridericia's formula >430 msec
History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases
Hemoglobin level <10 g/dL
Liver disease or injury as indicated by elevated liver tests such as SGPT (ALT) or SGOT (AST) >2 times the upper limit of normal
Renal dysfunction as indicated by serum creatinine >2 times the upper limit of normal in the absence of dehydration; in case of dehydration, serum creatinine should be <2 times the upper limit of normal after oral or parental rehydration
Known to be immunocompromised (including HIV infection) or are receiving immunosuppressive therapy at the time or enrollment; HIV testing is not required
Known history of hepatitis B or C; testing is not required
Febrile condition due to diseases other than malaria (e.g. acute lower respiratory tract infection), known underlying chronic or severe disease (e.g. cardiac, hepatic, renal, gastrointestinal, neurologic, or psychiatric disease), or any condition precluding enrollment into this study according to the investigator
Severe vomiting defined as >3 times during the previous 24 hours or inability to tolerate oral medication; severe diarrhea defined as ≥3 watery stools during the previous 24 hours
Severe malnutrition defined by a body mass index (BMI) <18.5 kg/m2 or unintentional loss of weight ≥10% with evidence of suboptimal intake resulting in loss of subcutaneous fat and/or severe muscle wasting
Active tuberculosis or history of taking anti-tuberculosis medications within 24 months prior to screening
Intervention: Cipargamin
Trial phase: Phase 2
SMILES: C[C@H]1Cc2c([nH]c3cc(Cl)c(F)cc23)[C@@]2(N1)C(=O)Nc1ccc(Cl)cc12
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 7
Group description: Single dose of KAE609 15 mg
Eligibility criteria:
Key Inclusion Criteria:

Monoinfection with P. falciparum confirmed by microscopy
Asexual P. falciparum parasitemia count of 5,000 to 50,000/µL
Axillary temperature ≥37.5 ºC or oral/tympanic/rectal temperature ≥38 ºC; or similar documented temperature during the previous 24 hours
Body weight between 40 to 90 kg

Key Exclusion Criteria:

Signs and symptoms of severe malaria according to World Health Organization (WHO) 2010 criteria
Mixed Plasmodium infection, i.e. infection with more than one species of malaria parasites
Use of other investigational drugs within 30 days or within 5 half-lives of enrollment, whichever is longer
History of antimalarial use within 2 months of screening
Use of any antibiotics with antimalarial activity or other prohibited medication within 14 days of screening
Long QT syndrome or QTc using Fridericia's formula >430 msec
History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases
Hemoglobin level <10 g/dL
Liver disease or injury as indicated by elevated liver tests such as SGPT (ALT) or SGOT (AST) >2 times the upper limit of normal
Renal dysfunction as indicated by serum creatinine >2 times the upper limit of normal in the absence of dehydration; in case of dehydration, serum creatinine should be <2 times the upper limit of normal after oral or parental rehydration
Known to be immunocompromised (including HIV infection) or are receiving immunosuppressive therapy at the time or enrollment; HIV testing is not required
Known history of hepatitis B or C; testing is not required
Febrile condition due to diseases other than malaria (e.g. acute lower respiratory tract infection), known underlying chronic or severe disease (e.g. cardiac, hepatic, renal, gastrointestinal, neurologic, or psychiatric disease), or any condition precluding enrollment into this study according to the investigator
Severe vomiting defined as >3 times during the previous 24 hours or inability to tolerate oral medication; severe diarrhea defined as ≥3 watery stools during the previous 24 hours
Severe malnutrition defined by a body mass index (BMI) <18.5 kg/m2 or unintentional loss of weight ≥10% with evidence of suboptimal intake resulting in loss of subcutaneous fat and/or severe muscle wasting
Active tuberculosis or history of taking anti-tuberculosis medications within 24 months prior to screening
Intervention: Nesiritide
Trial phase: Phase 4
ATC code: C01DX19
SMILES: CCC(C)C1NC(=O)C(CCCNC(=N)N)NC(=O)C(CC(=O)O)NC(=O)C(CCSC)NC(=O)C(CCCCN)NC(=O)C(CCCNC(=N)N)NC(=O)CNC(=O)C(Cc2ccccc2)NC(=O)C(NC(=O)CNC(=O)C(CO)NC(=O)CNC(=O)C(CCC(N)=O)NC(=O)C(NC(=O)C(CCSC)NC(=O)C(CCCCN)NC(=O)C2CCCN2C(=O)C(N)CO)C(C)C)CSSCC(C(=O)NC(CCCCN)C(=O)NC(C(=O)NC(CC(C)C)C(=O)NC(CCCNC(=N)N)C(=O)NC(CCCNC(=N)N)C(=O)NC(Cc2c[nH]cn2)C(=O)O)C(C)C)NC(=O)CNC(=O)C(CC(C)C)NC(=O)CNC(=O)C(CO)NC(=O)C(CO)NC(=O)C(CO)NC(=O)C(CO)NC1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 2
Group description: Active arm of the Total Artificial Heart group

randomized to receive nesiritide 0.005 mcg/kg/min without bolus
Eligibility criteria:
Inclusion Criteria:

Implanted with a total artificial heart (CardioWest) or Left ventricular assist device (HeartMate II)
Age > 18 years

Exclusion Criteria:

Previous calcineurin inhibitor (CNI) exposure
Hemodialysis prior to device implant
Intervention: Nesiritide
Trial phase: Phase 4
ATC code: C01DX19
SMILES: CCC(C)C1NC(=O)C(CCCNC(=N)N)NC(=O)C(CC(=O)O)NC(=O)C(CCSC)NC(=O)C(CCCCN)NC(=O)C(CCCNC(=N)N)NC(=O)CNC(=O)C(Cc2ccccc2)NC(=O)C(NC(=O)CNC(=O)C(CO)NC(=O)CNC(=O)C(CCC(N)=O)NC(=O)C(NC(=O)C(CCSC)NC(=O)C(CCCCN)NC(=O)C2CCCN2C(=O)C(N)CO)C(C)C)CSSCC(C(=O)NC(CCCCN)C(=O)NC(C(=O)NC(CC(C)C)C(=O)NC(CCCNC(=N)N)C(=O)NC(CCCNC(=N)N)C(=O)NC(Cc2c[nH]cn2)C(=O)O)C(C)C)NC(=O)CNC(=O)C(CC(C)C)NC(=O)CNC(=O)C(CO)NC(=O)C(CO)NC(=O)C(CO)NC(=O)C(CO)NC1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 2
Group description: Active arm of the LVAD group

randomized to receive nesiritide at 0.005 mcg/kg/min without a bolus
Eligibility criteria:
Inclusion Criteria:

Implanted with a total artificial heart (CardioWest) or Left ventricular assist device (HeartMate II)
Age > 18 years

Exclusion Criteria:

Previous calcineurin inhibitor (CNI) exposure
Hemodialysis prior to device implant
Intervention: Dolutegravir
Trial phase: Phase 2 | Phase 3
ATC code: J05AJ03 | J05AR13 | J05AR21 | J05AR25 | J05AR27
SMILES: [H][C@]12Cn3cc(C(=O)NCc4ccc(F)cc4F)c(=O)c(O)c3C(=O)N1[C@H](C)CCO2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 92
Group description: Patients treated with Dolutegravir
Eligibility criteria:
Inclusion Criteria:

Patients with confirmed HIV-1 infection (positive Western blot or plasma HIV-1 RNA >1,000 copies/ml)
No previous use of any ARV drug (drug-naïve patients)
Presence of clinical symptoms according to Rio de Janeiro / Caracas´ AIDS definition (Asthenia, Cachexia/Wasting, Cough, Dermatitis, persistent, Diarrhea, Fever, Lymphadenopathy, Candidiasis, oral, or hairy leukoplasia, Central nervous system dysfunction, Herpes zoster in individual younger than 60 years of age)), and/or any active AIDS-defining condition
Baseline CD4+ cells count equal or lower than 50 cells/mm3
Age equal or higher than 18 years
HIV-1 plasma viral load ≥ 1,000 copies of HIV-1 RNA/ml

Exclusion Criteria:

Undetectable plasma viral load at screening
CD4 cells count>50 cells/mm3
Asymptomatic individuals
Intervention: Lente
Trial phase: Not Applicable
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=NC=N3)NC(=O)C(CCC(N)=O)NC(=O)C(CC(N)=O)NC(=O)C(NC(=O)C(N)Cc3ccccc3)C(C)C)C(=O)NCC(=O)NC(CO)C(=O)NC(CC3C=NC=N3)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.[Zn]
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 53
Group description: Insulin detemir (IDet)
Eligibility criteria:
Inclusion criteria:

All pregnant women with a viable singleton or multiple gestation at ≤34 weeks with gestational diabetes diagnosed in their current pregnancy requiring medical therapy. "Early diagnosis" GDM patients will also be included; which is defined as a diagnosis made prior to 24 weeks.
Women with known preexisting type 2 diabetes that are in need of medical therapy.

Exclusion criteria:

Patients <18 years of age
a diagnosis of GDM outside of the gestational age stated above
known allergy/prior adverse reaction to insulin NPH or insulin detemir.
type 1 diabetes
Intervention: Rosuvastatin
Trial phase: Phase 2
ATC code: A10BH52 | C10AA07 | C10BA06 | C10BA09 | C10BX05 | C10BX07 | C10BX09 | C10BX10 | C10BX13 | C10BX14 | C10BX16 | C10BX17 | G01AE10
SMILES: CC(C)c1nc(N(C)S(C)(=O)=O)nc(-c2ccc(F)cc2)c1/C=C/[C@@H](O)C[C@@H](O)CC(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 85
Group description: All subjects will receive rosuvastatin 40mg/day 8-12 weeks
Eligibility criteria:
Inclusion Criteria:

Patients >18 years of age and willing to participate.
Fluency in either English or Spanish.
Stable patients who will undergo cardiac catheterization and PCI (intent to stent).
Patient is willing to go on high-dose cholesterol lowering medication for the duration of the study
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.
Proposed non-culprit YELLOW study lesion with max 4mm LCBI ≥ 150.

Exclusion Criteria:

Patients who have acute myocardial infarction (ST-segment elevation presentation, new Q waves or non-ST segment elevation with CK-MB > 5 times above the upper normal (31.5 ng/ml) within 72 hours).
Patients who are in cardiogenic shock.
Patients requiring coronary artery bypass graft surgery.
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 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.
Patients having undergone heart transplantation, or those that may undergo heart transplantation during the study period.
Active autoimmune disease.
Nursing mothers
Intervention: SODIUM CHLORIDE
Trial phase: Phase 2
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 69
Group description: If the patient is randomized to the standard arm, the patient will be given intravenous crystalloid fluid (normal saline) as the initial resuscitation fluid with 2 large bore IVs based on the current ATLS guidelines, the standard of care. Subsequent care will proceed per institutional, ATLS guided resuscitation with acute pRBC administration determined by hemodynamic response and additional blood component administration guided by rTEG and coagulation panel assessment in conjunction with clinical scenario.

Crystalloid fluid (standard of care for resuscitation): Normal saline will be give to subjects in the standard arm as the current standard of care for an initial resuscitation fluid
Eligibility criteria:
Inclusion Criteria:

Age>=18 years
Acutely injured
SBP<70 mmHg or SBP 71-90 mmHg with heart rate (HR)>108 beats per minute.

Exclusion Criteria:

Visibly or verbally reported pregnant women
known prisoners
unsalvageable injuries (defined as asystolic or cardiopulmonary resuscitation prior to randomization)
known objection to blood products
the patient has an opt-out bracelet or, necklace or wallet card
a family member present at the scene objects to the patient's enrollment in research.
Intervention: Betaine
Trial phase: Phase 3
ATC code: A09AB02 | A16AA06
SMILES: C[N+](C)(C)CC(=O)O
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 12
Group description: Betaine will be given orally to all participants and dose will be adjusted to body weight.

Betaine: Betaine will be given orally (mixed with food or dissolved in water, juice, milk, or formula) or through gastrostomy tube as follows:

6 g/day in children < 30 kg, in 3 divided doses (2 g at meal time)
12 g/day in children > 30 kg, in 4 divided doses (3 g at meal time and bed time).
Eligibility criteria:
Inclusion Criteria:

Males or females
Any age

Peroxisome Biogenesis Disorder (PBD) confirmed by biochemical analysis of at least two peroxisomal enzyme parameters:

Elevated plasma VLCFA (C26/22) > 0.02
Elevated plasma branched chain pristanic acid > 0.3 μg/ml
Reduced red blood cell plasmalogen levels (C16:0DMA/C16:0 Fatty acid) < 0.07
PBD clinical syndromes: neonatal adrenoleukodystrophy (NALD) or infantile Refsum disease (IRD)
Genotype PEX1-G843D/G843D, PEX1-G843D/I700fs, or PEX1-G843D and any second PEX1 mutation that is predicted to be null
Expected survival of at least 6 months

Exclusion Criteria:

Genotypes other than PEX1 G843D/G843D, PEX1-G843D//I700fs, or PEX1-G843D and any second PEX1 mutation that is predicted to be null
Patient already treated with betaine
Intervention: Acetylcysteine
Trial phase: Phase 2
ATC code: R05CB01 | S01XA08 | V03AB23
SMILES: CC(=O)N[C@@H](CS)C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 11
Group description: n-acetyl-l-cysteine 1200 mg BID x 4 weeks

N-acetyl-l-cysteine: 1200 mg BID x 4 weeks
Eligibility criteria:
Inclusion Criteria:

18-65 years old
non-cancer neuropathic pain
stable dose of opioids for pain
using breakthrough pain meds
still with persistent pain per VAS

Exclusion Criteria:

pregnant or nursing
serious medical or psychiatric illness (including uncontrolled hypertension)
active stomach ulcer, history or seizures or asthma
breakthrough pain meds other than opioids
using illicit drugs
Intervention: Bepotastine besilate
Trial phase: Phase 3
SMILES: O=C(O)CCCN1CCC(OC(c2ccc(Cl)cc2)c2ccccn2)CC1.O=S(=O)(O)c1ccccc1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 151
Group description: TAU-284 10mg twice daily for 2 weeks
Eligibility criteria:
Inclusion Criteria:

Patients aged between 7 and 15 years
Patients giving assent and whose legal guardian giving informed consent
Outpatients
Patients diagnosed as atopic dermatitis
Patients who require the treatment with topical corticosteroid on areas other than face, head and neck
Patients whose diaries can be properly maintained
Patients who have 2 grades or more pruritus score

Exclusion Criteria:

Patients with bronchial asthma who require concomitant use of the corticosteroid
Patients who have been undergoing specific desensitization therapy or nonspecific immunomodulation therapy or phototherapy
Patients with current or previous history of drug hypersensitivity
Patients who have been treated with Bepotastine besilate in the past
Patients who have; a skin infection, or with zooparasite such as scabies and pediculosis; eczematous otitis externa with perforation in the eardrum; dermal ulcer, or profound heat burn or frostbite of the severity higher than the grade 2; on areas where topical corticosteroid is applied
Patients who have spastic disease such as epilepsy
Patients who concurrently have renal function abnormalities that may cause safety problems
Patients who do not give consent to use birth control
Pregnant patients, at risk of pregnancy or breastfeeding
Patients who had participated in any clinical trial in the last 12 weeks