anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Gabapentin
Trial phase: Phase 1 | Phase 2
ATC code: N02BF01 | N03AX12
SMILES: NCC1(CC(=O)O)CCCCC1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 3
Group description: Gabapentin 3600mg PO daily

Gabapentin: Subjects will be treated with 400mg pills of gabapentin , titrating up to 3600mg per day, or 9 tablets (3 tabs tid)
Eligibility criteria:
Inclusion Criteria:

COPE patient between age of 18-30
Capacity to give informed consent
Currently using a reliable method of birth control (female) (condom plus spermicide, diaphragm plus spermicide, IUD, birth control pills, norplant, vasectomy in partner)

Exclusion Criteria:

Metal implants in body or a history of metal working, or more than one past MRI scan with gadolinium
Lifetime diagnosis of asthmatic symptoms within the past 3 years or known sensitivity to contrast agents
Lifetime diagnosis of renal failure/disease
Acute neurological, neuroendocrine,or medical disorder including renal insufficiency
Lifetime diagnosis of hypertension or diabetes
Intelligence Quotient (IQ) < 70
Acute risk for suicide and/or violence
Pregnant, lactating
Current abuse of substances (alcohol, cocaine, stimulants, cannabis, opiates, sedative hypnotics)
Current use or anticipated need for antipsychotics or mood stabilizers (all antipsychotics, also Depakote, lithium, lamotrigine, pregabalin or any med with a mechanism of action like gabapentin)
The Clinical Global Impressions Scale (CGI)-improvement score during study equal to or greater than 6
Intervention: Bexagliflozin
Trial phase: Phase 3
ATC code: A10BK08
SMILES: OC[C@H]1O[C@@H](c2ccc(Cl)c(Cc3ccc(OCCOC4CC4)cc3)c2)[C@H](O)[C@@H](O)[C@@H]1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1132
Group description: Each subject will receive bexagliflozin 20 mg once daily for the duration of the study.

Bexagliflozin: 20 mg, tablet
Eligibility criteria:
Inclusion Criteria:

Subjects with a diagnosis of T2DM
Subjects who have had a stable treatment regimen for T2DM for the past 3 months
Subjects who present with at least one of the following 3 histories:

Group 1: A history of atherosclerotic vascular disease Group 2: A history of heart failure Group 3: Age ≥ 55 years with diabetes for ≥ 10 years, uncontrolled hypertension, currently smoking, reduced kidney function, or cholesterol problems

Exclusion Criteria:

Diagnosis of type 1 diabetes mellitus or maturity-onset/diabetes of the young
History of genitourinary tract infections
Evidence of abnormal liver function
History of MI, stroke or hospitalization for heart failure in the past 3 months
Prior kidney transplant or evidence of kidney problems
Prior or planned pace maker implantation
Pregnant or nursing
Intervention: Levodopa
Trial phase: Phase 4
ATC code: N04BA01 | N04BA02 | N04BA03
SMILES: N[C@@H](Cc1ccc(O)c(O)c1)C(=O)O
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 103
Group description: 100mg levodopa administered in pill form once by mouth

Levodopa: EIther 100mg or 200 mg, depending on arm assignment, administered once by mouth.
Eligibility criteria:
Inclusion Criteria:

25-50 years of age
PTSD related to physical or sexual assault
Medically healthy
English speaking

Exclusion Criteria:

Claustrophobia, or the inability to lie still in a confined space
Major medical disorders (e.g., HIV, cancer)
Magnetic metallic implants (such as screws, pins, shrapnel remnants, aneurysm clips, artificial heart valves, inner ear (cochlear) implants, artificial joints, and vascular stents)
Electronic or magnetic implants, such as pacemakers
Permanent makeup or tattoos with metallic dyes
Currently pregnant
A self-reported history of loss of consciousness (greater than 10 minutes)
Physical disabilities that prohibit task performance (such as blindness or deafness)
Psychotic disorders (e.g., schizophrenia)
Any other condition that the investigator believes might put the participant at risk
Intervention: Levodopa
Trial phase: Phase 4
ATC code: N04BA01 | N04BA02 | N04BA03
SMILES: N[C@@H](Cc1ccc(O)c(O)c1)C(=O)O
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 103
Group description: 200mg levodopa administered in pill form once by mouth

Levodopa: EIther 100mg or 200 mg, depending on arm assignment, administered once by mouth.
Eligibility criteria:
Inclusion Criteria:

25-50 years of age
PTSD related to physical or sexual assault
Medically healthy
English speaking

Exclusion Criteria:

Claustrophobia, or the inability to lie still in a confined space
Major medical disorders (e.g., HIV, cancer)
Magnetic metallic implants (such as screws, pins, shrapnel remnants, aneurysm clips, artificial heart valves, inner ear (cochlear) implants, artificial joints, and vascular stents)
Electronic or magnetic implants, such as pacemakers
Permanent makeup or tattoos with metallic dyes
Currently pregnant
A self-reported history of loss of consciousness (greater than 10 minutes)
Physical disabilities that prohibit task performance (such as blindness or deafness)
Psychotic disorders (e.g., schizophrenia)
Any other condition that the investigator believes might put the participant at risk
Intervention: Hexaminolevulinate Hydrochloride
Trial phase: Phase 3
SMILES: CCCCCCOC(=O)CCC(=O)CN.Cl
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 304
Group description: In this single-arm trial, Cystoscopy in white light followed by blue light (BL) is performed in all applicable patients during 2 study visits; Visit 2 (Surveillance) and Visit 3 (Operating room procedure)

All patients receive instillation of 100 mg hexaminolevulinate hydrochloride as intravesical solution (50 mL) in the bladder prior to cystoscopy. Retention time: 1-3 hours.

Surveillance cystoscopy is performed with the investigational device KARL STORZ D-Light C PDD Flexible Videoscope System
Eligibility criteria:
Patients with bladder cancer in follow-up for tumor recurrence (Note: Patients must be included only at the first surveillance cystoscopy after a histologically confirmed tumor. The histologically confirmed tumor could either be from a TURB or from a surveillance cystoscopy where a biopsy was taken and a tumor was confirmed by histology)

History of one or more of the following:

Multiple tumors
Recurrent tumors
High grade tumor(s)

Exclusion Criteria:

Gross haematuria. (Note: Gross haematuria is defined as a heavy bladder bleed resulting in significant amounts of blood in the urine, which may visually limit cystoscopy. Where the haematuria is light, the patient should not be excluded, if in the investigator's opinion, rinsing and/or electro-cautery during cystoscopy will alleviate the haematuria limitations to cystoscopy)
Patients who cannot undergo in-office or operating room cystoscopy (Note: Training patients are eligible even if they cannot undergo operating room cystoscopy)
Patients who have received Bacillus Calmette-Guérin (BCG) immunotherapy or intravesical chemotherapy within the past 6 weeks prior to the procedure
Porphyria
Known allergy to hexaminolevulinate hydrochloride or a similar compound
Pregnancy or breast-feeding (all women of child-bearing potential must document a negative urine pregnancy test before study inclusion and use adequate contraception during the study
Participation in other clinical studies with investigational drugs either concurrently or within the last 30 days
Patient is the investigator or any sub investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol
Patients that the investigator believes are unlikely to comply with the protocol, e.g. mental condition rendering the patient unable to understand the nature, scope, and possible consequences of participating in the clinical study, uncooperative attitude or unlikelihood of completing the study
Intervention: Dorzagliatin
Trial phase: Phase 2
ATC code: A10BX18
SMILES: CC(C)C[C@@H](C(=O)Nc1ccn(C[C@@H](O)CO)n1)N1CC(Oc2ccccc2Cl)=CC1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 53
Group description: HMS5552: 75mgQD
Eligibility criteria:
Inclusion Criteria:

Male & female, 40~75 years old
T2DM patients，anti-hyperglycemic drug-naïve and on diet & exercise for at least 3 months, or with glucose controlled by Metformin or α-glucosidase inhibitor alone
HbA1c 7.5~10.5% at screening and pre-randomization
Fasting plasma glucose (FPG)7.0~11.1 millimole/liter (mmol/L, local lab) at screening, and 7.0~13.3 millimole/liter (mmol/L, central lab) at pre-randomization
BMI: 19~30kg/m^2 & TG<5.5mmol/L

Exclusion Criteria:

T1D，secondary DM, pre-DM
kidney diseases or eGFR MDRD<60ml/min/1.73m^2
unstable CVDs
liver diseases
mental or CNS diseases
Intervention: Dorzagliatin
Trial phase: Phase 2
ATC code: A10BX18
SMILES: CC(C)C[C@@H](C(=O)Nc1ccn(C[C@@H](O)CO)n1)N1CC(Oc2ccccc2Cl)=CC1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 50
Group description: HMS5552: 100mgQD
Eligibility criteria:
Inclusion Criteria:

Male & female, 40~75 years old
T2DM patients，anti-hyperglycemic drug-naïve and on diet & exercise for at least 3 months, or with glucose controlled by Metformin or α-glucosidase inhibitor alone
HbA1c 7.5~10.5% at screening and pre-randomization
Fasting plasma glucose (FPG)7.0~11.1 millimole/liter (mmol/L, local lab) at screening, and 7.0~13.3 millimole/liter (mmol/L, central lab) at pre-randomization
BMI: 19~30kg/m^2 & TG<5.5mmol/L

Exclusion Criteria:

T1D，secondary DM, pre-DM
kidney diseases or eGFR MDRD<60ml/min/1.73m^2
unstable CVDs
liver diseases
mental or CNS diseases
Intervention: Dorzagliatin
Trial phase: Phase 2
ATC code: A10BX18
SMILES: CC(C)C[C@@H](C(=O)Nc1ccn(C[C@@H](O)CO)n1)N1CC(Oc2ccccc2Cl)=CC1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 51
Group description: HMS5552: 50mgBID
Eligibility criteria:
Inclusion Criteria:

Male & female, 40~75 years old
T2DM patients，anti-hyperglycemic drug-naïve and on diet & exercise for at least 3 months, or with glucose controlled by Metformin or α-glucosidase inhibitor alone
HbA1c 7.5~10.5% at screening and pre-randomization
Fasting plasma glucose (FPG)7.0~11.1 millimole/liter (mmol/L, local lab) at screening, and 7.0~13.3 millimole/liter (mmol/L, central lab) at pre-randomization
BMI: 19~30kg/m^2 & TG<5.5mmol/L

Exclusion Criteria:

T1D，secondary DM, pre-DM
kidney diseases or eGFR MDRD<60ml/min/1.73m^2
unstable CVDs
liver diseases
mental or CNS diseases
Intervention: Dorzagliatin
Trial phase: Phase 2
ATC code: A10BX18
SMILES: CC(C)C[C@@H](C(=O)Nc1ccn(C[C@@H](O)CO)n1)N1CC(Oc2ccccc2Cl)=CC1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 51
Group description: HMS5552: 75mgBID
Eligibility criteria:
Inclusion Criteria:

Male & female, 40~75 years old
T2DM patients，anti-hyperglycemic drug-naïve and on diet & exercise for at least 3 months, or with glucose controlled by Metformin or α-glucosidase inhibitor alone
HbA1c 7.5~10.5% at screening and pre-randomization
Fasting plasma glucose (FPG)7.0~11.1 millimole/liter (mmol/L, local lab) at screening, and 7.0~13.3 millimole/liter (mmol/L, central lab) at pre-randomization
BMI: 19~30kg/m^2 & TG<5.5mmol/L

Exclusion Criteria:

T1D，secondary DM, pre-DM
kidney diseases or eGFR MDRD<60ml/min/1.73m^2
unstable CVDs
liver diseases
mental or CNS diseases
Intervention: Delgocitinib
Trial phase: Phase 2
ATC code: D11AH11
SMILES: C[C@H]1CN(C(=O)CC#N)[C@]12CCN(c1ncnc3[nH]ccc13)C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 20
Group description: LEO 124249 ointment 30 mg/g twice daily
Eligibility criteria:
Inclusion Criteria:

Subjects must have signed and dated informed consent after receiving verbal and written information about the clinical trial.
Subjects with unequivocal clinical diagnosis of moderate to severe scalp alopecia areata (patch type, totalis, universalis), as determined by the (sub) investigator, affecting a minimum of 30% scalp area at Visit 1 (Screening) and Visit 2 (Day 1, baseline).
Minimum 6 month duration of hair loss at Visit 1 (Screening). No upper limit time limit.
Subject must accept to not cut hair in the treated scalp areas during the trial.

Exclusion Criteria:

Females who are pregnant or are breast feeding.
Current signs of spontaneous hair regrowth.
Diffuse type alopecia areata.
Co-existing moderate to severe androgenic alopecia (Norwood-Hamilton stage IV-VI and Ludwig stage II and III)
Subjects with changed or expected changes in medication for thyroid disease within 6 month before Visit 1 (screening) or during the trial.
Systemic treatment with immunosuppressive drugs (e.g. methotrexate, cyclosporine, azathioprine), chloroquin derivatives, corticosteroids, or any other systemic therapy that in the opinion of the investigator could affect hair regrowth, within 6 weeks prior to randomization (inhaled or intra-nasal steroids corresponding to up to 1 mg prednisone for asthma or rhinitis may be used).
Intervention: Mexiletine
Trial phase: Phase 2
ATC code: C01BB02
SMILES: Cc1cccc(C)c1OCC(C)N
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 4
Group description: Participants will receive 150 mg of mexiletine by mouth 3 times daily for 5-7 days followed by 7 day washout period and 5-7 days of placebo (240 mg of lactose powder) taken by mouth 3 times daily

Placebo: 240 mg lactose powder in a size 3 capsule taken by mouth 3 times daily for 5-7 days

Mexiletine: 150 mg Mexiletine taken by mouth in capsule form 3 times daily for 5-7 days
Eligibility criteria:
Inclusion Criteria:

The subject has known CMT, previously diagnosed by a neurologist with subspeciality expertise in neuromuscular disorders/peripheral neuropathy. The diagnosis of CMT relies on a combination of clinical history (including family history), neurological examination electrophysiological features, and prior genetic testing results.

The subject is at least 18 years old, and has signed the Informed Consent Form.
The subject is ambulatory (cane, walker, orthoses allowed).
The subject has experienced muscle cramps and has known provokable hamstring or calf muscle cramps on MVC.
The subject has a reliable method of birth control (if a female subject of child bearing potential). Reliable birth control is defined as Hormonal contraception Intrauterine contraception/device Any two barrier methods (combination of male or female condom with diaphragm sponge or cervical cap) together with spermicidal foam/gel/film/cream/suppository True abstinence

Exclusion Criteria:

The subject has a known neuropathy from another source (e.g., diabetes, drug induced, alcohol, etc.).

The subject has an untreated medical disorder known to predispose to muscle cramps
The subject is pregnant or nursing, has a known mexiletine allergy or has taken mexiletine in the past 12 weeks.
The subject is participating in another therapeutic trial.
The subject has second or 3rd degree heart block, atrial flutter/fibrillation, ventricular arrhythmias, or is receiving treatment of a cardiac arrhythmia.
The subject is currently taking another agent for muscle cramps or a muscle relaxant (e.g., benzodiazepine, baclofen, tizanidine, soma, meprobromate).
The subject is on another sodium channel blocker or medication that precludes administration of mexiletine.
The subject has known diabetes mellitus, liver or kidney disease requiring ongoing treatment, untreated thyroid dysfunction, symptomatic cardiomyopathy, or symptomatic coronary artery disease.
The subject, in the opinion of the investigator, is unsuitable for enrollment for any other reason
Intervention: Warfarin
Trial phase: Phase 4
ATC code: B01AA03
SMILES: CC(=O)CC(c1ccccc1)c1c(O)c2ccccc2oc1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 3
Group description: To maintain therapeutic INR level
Eligibility criteria:
Inclusion Criteria:

Subjects with established atrial fibrillation (AF) and bradycardia on long term (>3 weeks) therapeutic oral anticoagulant (OAC) with warfarin or another OAC who are undergoing new pacemaker system implant or existing pacemaker system revision.
Subjects with newly detected bradycardia -tachycardia syndrome and AF who have been recently (less than 3 weeks) started on warfarin, have a therapeutic international normalized ratio (INR) and no thrombus on trans-esophageal echocardiogram (TEE) who are undergoing a new pacemaker system implant or revision.
Subjects with AF and ventricular tachyarrhythmias (VT or VF) or acquired structural heart disease who are candidates for implantable cardioverter-defibrillator (ICD) therapy and are on long term (>3 weeks) therapeutic OAC with warfarin or another OAC who are undergoing new ICD system implant or existing ICD system revision.
Subjects with newly detected AF with VT or VF who have been recently (less than 3 weeks) started on warfarin, have a therapeutic INR and no thrombus on TEE who are undergoing ICD system implant or revision

Exclusion Criteria:

Clinically significant valvular heart disease
Subjects requiring cardiovascular implantable electrical device (CIED) lead extraction e.g. for device site infection, endocarditis, leads under advisory or other conditions warranting lead(s) system extraction.
Recent (<1 month) myocardial infarction
Documented left atrial (LA) thrombus on TEE
Contraindications to anticoagulant therapy or adverse event with prior warfarin or edoxaban therapy
Creatinine clearance <30ml/min or >95 ml/min
Hepatic disease, advanced
Recent stroke (<3 months) or thromboembolic event
Recent (<3months) intracranial or other major bleeding event
Use of concomitant dual antiplatelet therapy or other oral, subcutaneous or parenteral anticoagulant therapy
Subjects on warfarin without therapeutic INR levels before study entry
Subjects with other clinically significant medical condition
Subjects with life expectancy < 1 year
Lead extraction procedures
Intervention: Edoxaban
Trial phase: Phase 4
ATC code: B01AF03
SMILES: CN1CCc2nc(C(=O)N[C@@H]3C[C@@H](C(=O)N(C)C)CC[C@@H]3NC(=O)C(=O)Nc3ccc(Cl)cn3)sc2C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 2
Group description: 60 mg tablet once daily
Eligibility criteria:
Inclusion Criteria:

Subjects with established atrial fibrillation (AF) and bradycardia on long term (>3 weeks) therapeutic oral anticoagulant (OAC) with warfarin or another OAC who are undergoing new pacemaker system implant or existing pacemaker system revision.
Subjects with newly detected bradycardia -tachycardia syndrome and AF who have been recently (less than 3 weeks) started on warfarin, have a therapeutic international normalized ratio (INR) and no thrombus on trans-esophageal echocardiogram (TEE) who are undergoing a new pacemaker system implant or revision.
Subjects with AF and ventricular tachyarrhythmias (VT or VF) or acquired structural heart disease who are candidates for implantable cardioverter-defibrillator (ICD) therapy and are on long term (>3 weeks) therapeutic OAC with warfarin or another OAC who are undergoing new ICD system implant or existing ICD system revision.
Subjects with newly detected AF with VT or VF who have been recently (less than 3 weeks) started on warfarin, have a therapeutic INR and no thrombus on TEE who are undergoing ICD system implant or revision

Exclusion Criteria:

Clinically significant valvular heart disease
Subjects requiring cardiovascular implantable electrical device (CIED) lead extraction e.g. for device site infection, endocarditis, leads under advisory or other conditions warranting lead(s) system extraction.
Recent (<1 month) myocardial infarction
Documented left atrial (LA) thrombus on TEE
Contraindications to anticoagulant therapy or adverse event with prior warfarin or edoxaban therapy
Creatinine clearance <30ml/min or >95 ml/min
Hepatic disease, advanced
Recent stroke (<3 months) or thromboembolic event
Recent (<3months) intracranial or other major bleeding event
Use of concomitant dual antiplatelet therapy or other oral, subcutaneous or parenteral anticoagulant therapy
Subjects on warfarin without therapeutic INR levels before study entry
Subjects with other clinically significant medical condition
Subjects with life expectancy < 1 year
Lead extraction procedures
Intervention: Fevipiprant
Trial phase: Phase 3
SMILES: Cc1c(CC(=O)O)c2cccnc2n1Cc1ccc(S(C)(=O)=O)cc1C(F)(F)F
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 296
Group description: QAW039 150 mg
Eligibility criteria:
Inclusion Criteria:

Written informed consent.
Male and female patients aged ≥12 years.
A diagnosis of severe asthma, uncontrolled on GINA 4/5 asthma medication.
Evidence of airway reversibility or airway hyper- reactivity.
FEV1 ≤80% of the predicted normal value for patients aged ≥18 years; FEV1 of ≤90% for patients aged 12 to <18 years
An ACQ score ≥1.5
A history of 2 or more asthma exacerbations within the 12 months prior to entering the study.

Exclusion Criteria:

Use of other investigational drugs within 5 half-lives of study entry, or within 30 days, whichever is longer.
Subjects who have participated in another trial of QAW039.
A QTcF (Fridericia) ≥450 msec (male) or ≥460 msec (female).
History of malignancy with the exception of local basal cell carcinoma of the skin.
Pregnant or nursing (lactating) women.
Serious co-morbidities.
Patients on >20 mg of simvastatin, > 40 mg of atorvastatin, >40 mg of pravastatin, or >2 mg of pitavastatin.
Intervention: Fevipiprant
Trial phase: Phase 3
SMILES: Cc1c(CC(=O)O)c2cccnc2n1Cc1ccc(S(C)(=O)=O)cc1C(F)(F)F
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 293
Group description: QAW039 450 mg
Eligibility criteria:
Inclusion Criteria:

Written informed consent.
Male and female patients aged ≥12 years.
A diagnosis of severe asthma, uncontrolled on GINA 4/5 asthma medication.
Evidence of airway reversibility or airway hyper- reactivity.
FEV1 ≤80% of the predicted normal value for patients aged ≥18 years; FEV1 of ≤90% for patients aged 12 to <18 years
An ACQ score ≥1.5
A history of 2 or more asthma exacerbations within the 12 months prior to entering the study.

Exclusion Criteria:

Use of other investigational drugs within 5 half-lives of study entry, or within 30 days, whichever is longer.
Subjects who have participated in another trial of QAW039.
A QTcF (Fridericia) ≥450 msec (male) or ≥460 msec (female).
History of malignancy with the exception of local basal cell carcinoma of the skin.
Pregnant or nursing (lactating) women.
Serious co-morbidities.
Patients on >20 mg of simvastatin, > 40 mg of atorvastatin, >40 mg of pravastatin, or >2 mg of pitavastatin.
Intervention: Lovastatin
Trial phase: Phase 2
ATC code: C10AA02 | C10BA01
SMILES: [H][C@@]12C(=C[C@H](C)C[C@@H]1OC(=O)[C@@H](C)CC)C=C[C@H](C)[C@@H]2CC[C@@H]1C[C@@H](O)CC(=O)O1
Sex: Female
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 20
Group description: Treatment with Lovastatin, dose escalating trial according to the following schedule:

10 mg daily for 8 week 20 mg daily for 8 weeks 40 mg daily for 16 weeks.

Lovastatin: dose escallating
Eligibility criteria:
Inclusion Criteria:

Females patients,
Genetically confirmed RTT,
Ambulatory.

Exclusion Criteria:

Presence of co morbid non-Rett related disease,
History of adverse reaction/hypersensitivity to statins,
Levels of aspartate-amino trans-ferase (AST), alanine-amino transferase (ALT) or creatine kinase (CK) triple the normal values,
Active liver disease,
Concomitant use of strong CYP3A4 inhibitors,
Condition predis-posing to renal failure secondary to rhabdomyolysis (scoliosis surgery within 6 months),
Oral contraceptives use.