anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Lacosamide
Trial phase: Phase 4
ATC code: N03AX18
SMILES: COC[C@@H](NC(C)=O)C(=O)NCc1ccccc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 100
Group description: Flexible dosing between 200mg/day and 400mg/day

Lacosamide: 50 mg tablets bid. Titration phase: (12 weeks) 100 mg/day: duration 1 to 3 weeks. Then uptitration to optimal therapeutic dose of 200 mg/day to 400 mg/day, in steps of 100 mg/day and a time period per step of 1 to 3 weeks.

Maintenance phase (12 weeks): Optimal therapeutic dose 200 mg/day to 400 mg/day.

Taper phase if needed: 3 to 4 weeks
Eligibility criteria:
Inclusion Criteria:

Patient has a diagnosis of partial-onset epilepsy with or without secondary generalization
Currently taking 1 to 3 concomitant marketed antiepileptic drugs
18 years and older at study entry

Exclusion Criteria:

Previous use of lacosamide
Hypersensitivity to any component of lacosamide
Patients with partial onset seizures not clearly identifiable
History of generalized epilepsy
History of status epilepticus within last 12 months
Uncountable seizures due to clustering within last 12 weeks
Non epileptic events, including pseudoseizures, conversion disorder that could be confused with seizures
History of drug or alcohol abuse
History of suicide attempt
Progressive cerebral disease
Concomitant treatment of felbamate
Prior or concomitant vigabatrin use
Under legal protection
Intervention: Azithromycin
Trial phase: Not Applicable
ATC code: J01FA10 | J01RA07 | J01RA16 | S01AA26
SMILES: CCC1OC(=O)C(C)C(OC2CC(C)(OC)C(O)C(C)O2)C(C)C(OC2OC(C)CC(N(C)C)C2O)C(C)(O)CC(C)CN(C)C(C)C(O)C1(C)O
Sex: Female
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1018
Group description: Azithromycin: 500 mg in 250 cc normal saline and Standard of care (cefazolin or clindamycin)
Eligibility criteria:
Inclusion Criteria:

-

Pregnant Women aged 14 years and over at ≥ 24 weeks' viable gestation who will undergo unscheduled/non-elective cesareans with either:

Labor (spontaneous or induced): active labor (ongoing contractions and at least 4cm dilated or contractions for at least 4 hours with documented cervical change of ≥1cm dilatation or ≥50% effacement), or
Membrane rupture (standardized to duration of at least 4 hours prior to randomization).

Exclusion Criteria:

Patient unwilling or unable to provide consent
Multiple pregnancy
Known azithromycin (or other macrolide) allergy
Vaginal delivery
Elective or scheduled cesarean prior to labor or membrane rupture.
Azithromycin, erythromycin or other macrolide antibiotic use within 7 days of enrollment.
Clinical chorioamnionitis or any other active bacterial infection (e.g. pyelonephritis, pneumonia, abscess) at time of randomization.
Patient is unable or unlikely to follow-up after delivery (e.g. no prenatal care or a non-resident patient)
Fetal demise or major congenital anomaly
Significant liver disease defined as known cirrhosis or elevated transaminases of at least 3-fold upper limit of normal
Significant renal disease defined as serum creatinine known to be >2.0 mg/dl or on dialysis.
Active congestive heart failure (EF<45%) or pulmonary edema
Active diarrhea at time of delivery
Any patient with significant electrolyte abnormalities such as hypokalemia or hypocalcemia
Any patient with structural heart disease or arrhythmias, or taking any medications known to prolong the QT interval
Patient currently being treated with efavirenz, nelfinavir or fluconazole
Intervention: Aliskiren
Trial phase: Phase 4
ATC code: C09DX02 | C09XA02 | C09XA52 | C09XA53 | C09XA54
SMILES: COCCCOc1cc(C[C@@H](C[C@H](N)[C@@H](O)C[C@H](C(=O)NCC(C)(C)C(N)=O)C(C)C)C(C)C)ccc1OC
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1
Group description: Aliskiren 75 mg once daily x 2 weeks, then aliskiren 150 mg once daily x 2 weeks, if blood pressure allows

Aliskiren: Aliskiren 75 mg once daily x 2 weeks, then aliskiren 150 mg once daily x 2 weeks, if blood pressure allows
Eligibility criteria:
Inclusion Criteria:

6 months or more since cardiac transplant
Clinically stable from a transplant perspective
Maintained on a stable immunosuppressant regimen containing cyclosporine + an antiproliferative agent (e.g., azathioprine, mycophenolate), +/- an oral steroid
Hypertension, as defined by a seated average systolic blood pressure of ≥ 140 mm Hg and a seated average diastolic blood pressure of ≥ 90 mm Hg, based on 3 separate measurements, spaced 2 minutes apart.

Exclusion Criteria:

Clinical instability from a cardiac transplant perspective
Contraindications to aliskiren therapy
Conditions that may increase the risk of aliskiren adverse effects
Severe hypertension
Concomitant medications known to increase or decrease aliskiren plasma exposure.
Intervention: Atorvastatin
Trial phase: Phase 3
ATC code: C10AA05 | C10BA05 | C10BX03 | C10BX06 | C10BX08 | C10BX11 | C10BX12 | C10BX15 | C10BX18 | C10BX19
SMILES: CC(C)c1c(C(=O)Nc2ccccc2)c(-c2ccccc2)c(-c2ccc(F)cc2)n1CC[C@@H](O)C[C@@H](O)CC(=O)O
Sex: All
Age groups: Child | Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 21
Group description: Atorvastatin: 10 or 20 mg daily
Eligibility criteria:
Inclusion Criteria:Project 1

T1DM diagnosed clinically for > 1 year
any HbA1C
on stable insulin therapy
Ages: 10 - 20 years
both genders
BMI < 85th percentile
Fasting LDL-C>100mg/dl
Normal thyroid function

Inclusion Criteria:Projects 2 and 3

T1DM diagnosed clinically for > 3 year
HbA1C > 8%
on stable insulin therapy
Ages: 12- 20 years
both genders
BMI < 85th percentile
Fasting LDL-C>100mg/dl
Normal thyroid function

Exclusion Criteria:Projects 1,2 and 3

Severe dyslipidemia (LDL-C >160, TG > 400 mg/dl)
Smoking
Pregnancy
Current use of anti-inflammatory or immunomodulatory drugs, lipid lowering, antidiabetic drugs
Patients with hypertension and/or microalbuminuria will be allowed using balanced randomization and standardized treatment
Intervention: Lubiprostone
Trial phase: Phase 4
ATC code: A06AX03
SMILES: [H][C@@]12CC(=O)[C@H](CCCCCCC(=O)O)[C@@]1([H])CC[C@](O)(C(F)(F)CCCC)O2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 11
Group description: Lubiprostone : 24 mcg twice daily for 21 days.
Eligibility criteria:
Inclusion Criteria:

Multiple Sclerosis
Chronic Constipation defined as < 3 spontaneous bowel movements per week by history and confirmed by diary during the 14 day washout period.
Women of child-bearing potential must agree to use adequate birth control.

Exclusion Criteria:

history of other clinically significant medical or psychiatric disorders or suicidal ideation.
Subjects who have a suspicion of a mechanical bowel obstruction by clinical evaluation prior to dosing that include nausea, vomiting, abdominal pain or distention.
Subjects with a positive urine pregnancy test prior to dosing.
Medication changes within one month prior to visit one.
Corticosteroid use within 2 months prior to visit one.
Age<18.
Known intolerance to lubiprostone.
Inability to perform any required study procedures.
Intervention: Ovral
Trial phase: Phase 3
SMILES: C#CC1(O)CCC2C3CCC4=CC(=O)CCC4C3CCC21CC.C#CC1(O)CCC2C3CCc4cc(O)ccc4C3CCC21C
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 177
Group description: Thin transdermal contraceptive delivery system (TCDS) that gives systemic exposure of levonorgestrel (LNG) and ethinyl estradiol (EE)

AG200-15: Contraception; AG200-15 is applied and replaced every 7 days for 3 weeks, followed by a 1-week "patch free" period.
Eligibility criteria:
Inclusion Criteria:

sexually active women requesting contraception
Regular menses every 24 - 35 days
In good general health, confirmed by medical history, physical (including gynecologic examination adn screening laboratory values

Exclusion Criteria:

Known or suspected pregnancy
Lactating women
Significant skin reaction to transdermal preparations or sensitivity to surgical / medical tape
Any disease that may worsen under hormonal treatment (cardiovascular, liver, metabolic)
Use of other contraceptive methods than study medication
Intervention: Ovral
Trial phase: Phase 3
SMILES: C#CC1(O)CCC2C3CCC4=CC(=O)CCC4C3CCC21CC.C#CC1(O)CCC2C3CCc4cc(O)ccc4C3CCC21C
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 188
Group description: oral contraceptive containing 150mcg of LNG and 30mcg of EE

Levora: One tablet of Levora will be taken each day for a 28 day cycle.
Eligibility criteria:
Inclusion Criteria:

sexually active women requesting contraception
Regular menses every 24 - 35 days
In good general health, confirmed by medical history, physical (including gynecologic examination adn screening laboratory values

Exclusion Criteria:

Known or suspected pregnancy
Lactating women
Significant skin reaction to transdermal preparations or sensitivity to surgical / medical tape
Any disease that may worsen under hormonal treatment (cardiovascular, liver, metabolic)
Use of other contraceptive methods than study medication
Intervention: EXENATIDE
Trial phase: Phase 2
ATC code: A10BJ01
SMILES: CC[C@H](C)[C@H](NC(=O)[C@H](Cc1ccccc1)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CCCNC(=N)N)NC(=O)[C@@H](NC(=O)[C@H](C)NC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](CCC(=O)O)NC(=O)[C@H](CCSC)NC(=O)[C@H](CCC(N)=O)NC(=O)[C@H](CCCCN)NC(=O)[C@H](CO)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CC(=O)O)NC(=O)[C@H](CO)NC(=O)[C@@H](NC(=O)[C@H](Cc1ccccc1)NC(=O)[C@@H](NC(=O)CNC(=O)[C@H](CCC(=O)O)NC(=O)CNC(=O)[C@@H](N)Cc1cnc[nH]1)[C@@H](C)O)[C@@H](C)O)C(C)C)C(=O)N[C@@H](CCC(=O)O)C(=O)N[C@@H](Cc1c[nH]c2ccccc12)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CC(N)=O)C(=O)NCC(=O)NCC(=O)N1CCC[C@H]1C(=O)N[C@@H](CO)C(=O)N[C@@H](CO)C(=O)NCC(=O)N[C@@H](C)C(=O)N1CCC[C@H]1C(=O)N1CCC[C@H]1C(=O)N1CCC[C@H]1C(=O)N[C@@H](CO)C(N)=O
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 13
Group description: Exenatide 5 micrograms (mcg): administered with injection twice per day for one month; up-titrated to 10 mcg twice per day for remainder of study (5 months)

Open Label Exenatide : Exenatide 5 micrograms (mcg) twice per day for one month; up-titrated to 10 mcg twice per day for remainder of study.
Eligibility criteria:
Inclusion Criteria:

Body mass index > or = 1.2 times the 95th percentile (based on gender and age) or Body mass index > or = 35 kg/m2
12-19 years old

Exclusion Criteria:

Type 1 or 2 diabetes mellitus
Previous (within 3-months) or current use of weight loss medication (patients may undergo washout)
Previous bariatric surgery
Recent initiation (within 1-month) of anti-hypertensive or lipid medication
Previous (within 1-month) or current use of medication to treat insulin resistance or hyperglycemia (patients may undergo washout)
Major psychiatric disorder
Pregnant or planning to become pregnant
Tobacco use
Liver/renal dysfunction
History of pancreatitis
Obesity associated with genetic disorder
Hyperthyroidism or uncontrolled hypothyroidism
Uncontrolled hypertriglyceridemia (=300 mg/dL)
Current eating disorder
Previous (within 3-months) or current use of drugs associated with weight gain (e.g. steroids/anti-psychotics)
Intervention: Adapalene
Trial phase: Not Applicable
ATC code: D10AD03 | D10AD53
SMILES: COc1ccc(-c2ccc3cc(C(=O)O)ccc3c2)cc1C12CC3CC(CC(C3)C1)C2
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 66
Group description: Evaluate and compare tolerance and efficacy of two anti-acne creams, Effaclar and Benzaclin over a twelve week period.

Effaclar: Topical, (Benzoyl peroxide 5.5%) Bid, 12 weeks
Eligibility criteria:
Inclusion Criteria:males and females ages 18-50, mild to moderate acne vulgaris with > or equal to 15 inflammatory lesions, > or equal to 20 non-inflammatory lesions, avoid excessive sun exposure or tanning beds throughout the study

Exclusion Criteria:Participants who have another skin condition that will interfere with lesion counting or assessments
Intervention: Cleocin
Trial phase: Not Applicable
SMILES: CCCC1CC(C(=O)NC(C(C)Cl)C2OC(SC)C(O)C(O)C2O)N(C)C1.Cl
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 66
Group description: Evaluate and compare tolerance and efficacy of two anti-acne creams, Effaclar and Benzaclin over a twelve week period.

BenzaClin: Topical, 1% Clindamycin/5% Benzoyl Peroxide, BID, 12 weeks
Eligibility criteria:
Inclusion Criteria:males and females ages 18-50, mild to moderate acne vulgaris with > or equal to 15 inflammatory lesions, > or equal to 20 non-inflammatory lesions, avoid excessive sun exposure or tanning beds throughout the study

Exclusion Criteria:Participants who have another skin condition that will interfere with lesion counting or assessments
Intervention: Ibuprofen
Trial phase: Phase 2
ATC code: C01EB16 | G02CC01 | M01AE01 | M01AE14 | M01AE51 | M02AA13 | N02AJ08 | N02AJ19 | R02AX02
SMILES: CC(C)Cc1ccc(C(C)C(=O)O)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 24
Group description: 200mg ibuprofen (taken twice a day at least 8 hours apart) for a period of 6 weeks.

Ibuprofen: 200 mg BID and 8 hours apart
Eligibility criteria:
Inclusion Criteria:

Must report cognitive difficulties of 3 or higher on a 0-10 scale
Must provide informed consent
Be able to read English
Have a primary diagnosis of cancer
Be able to swallow medication
Women of child-bearing potential must not be pregnant or become pregnant during the 6 week study
Agree not to take NSAIDs during the 6 week intervention period
Be scheduled to receive at least 2 additional cycles of oral or IV chemotherapy over the 42-day study period.
Must have the approval of their treating physician to begin the exercise program and receive the ibuprofen
Must be over 18 years of age

Exclusion Criteria:

Currently taking a consistent dosage of a NSAID at least 3 days a week for the last 3 months that is over 400mg daily
Have an allergy to ibuprofen
Be identified as in active or maintenance stage of exercise behavior as assessed by the single-item exercise stages of change short form
have physical limitations that contraindicate participation in sub-maximal physiological fitness testing or a low to moderate home-based walking and progressive resistance program
have a history of peptic ulcer disease within the last 12 months
Diagnosed with a neurodegenerative disease
Had a myocardial infraction within the past 6 months
Patients with a neutropenic episode during the first cycle of chemotherapy or at high risk for a neutropenic episode during future chemotherapy cycles at the treating physicians discretion
Have confirmed metastatic disease to the central nervous system
Have been hospitalized for a major psychiatric illness within the last 5 years
Intervention: Propranolol
Trial phase: Phase 1 | Phase 2
ATC code: C07AA05 | C07BA05 | C07FX01
SMILES: CC(C)NCC(O)COc1cccc2ccccc12
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 10
Group description: Oral propranolol for premature infants allocated to this arm by randomization

propranolol: 2 mg per kg per day divided in 3 doses for 2-4 weeks
Eligibility criteria:
Inclusion Criteria:

Evidence for ROP that might progress and that includes any one of the following:

Stage 1 (zone I)
Stage 2 or higher (zones I, II or III), or Plus disease. The classification of ROP is according to International Classification of Retinopathy of Prematurity (ICROP) 2005 (40) (Appendix I, with scheme of retina showing zones and clock hours).Zone III ROP is not included since it will always regress spontaneously.

Exclusion Criteria:

The presence of one or more of the following conditions at enrollment in the study:
More than 10 episodes of bradycardia of prematurity/day (HR< 90 bpm) [
Atrio-ventricular (A-V) block [2nd or 3rd degree]
Significant congenital heart anomaly [not including patent ductus arteriosus, patent foramen ovale or small ventricular septal defect]
Heart failure
Hypotension (mean blood pressure <45 mmHg)
Hypoglycemia (<50mg/dL)
Platelet count <100000/mm3
Intervention: CID 11593706
Trial phase: Not Applicable
SMILES: C=CCN.ClCC1CO1.O=C(O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 12
Group description: Sevelamer Carbonate (Renvela). Information including those from the scans and blood test will be compared before and after treatment with Renvela.

Sevelamer Carbonate (Renvela): Patients' will be given doses of Renvela equivalent to their prior dose of calcium based phosphate binders and the dose will be titrated as necessary to achieve phosphate levels recommended by KDOQI guidelines.
Eligibility criteria:
Inclusion Criteria:

A signed consent form;
Male or Female, 50 years or older;
Diagnosed with end stage renal disease (ESRD), on maintenance hemodialysis for at least three (3) months;
On calcium-based phosphate binders;
Subject must be able to understand and provide informed consent;
No known contraindications to therapy with sevelamer carbonate.

Exclusion Criteria:

Any patient with a medical condition or taking any medications that would be contraindicated with the use of sevelamer carbonate, such as history of bowel obstruction;
History of severe allergic reactions to the study medication;
History of active infection (other than a simple respiratory tract infection) or acute gouty attack within 2 weeks prior to enrollment;
Known serological positivity for Human Immunodeficiency Virus (HIV), Hepatitis B surface Antigen (HBsAg), or Hepatitis C Virus Antibody (HCV Ab) except dose with normal liver function tests (AST, ALT, Bilirubin, and Alkaline Phophatase) and no history of cirrhosis;
Elevation of liver function tests at time of entry (Aspartate Aminotransferase (AST) and/or Alanine Aminotransferase (ALT) > 2 times the upper limit of normal);
History of drug, alcohol, or chemical abuse within 6 months prior to enrollment;
History of malignancy except those adequately treated, has completed treatment and clinically in remission for more than 6 month; adequately treated in-situ cervical carcinoma, or adequately treated basal or squamous cell carcinoma of the skin;
History of an inflammatory disease such as systemic lupus erythematosus (SLE), rheumatoid arthritis or ulcerative colitis except those in remission for more than 6 months;
Patients currently on sevelamer carbonate or sevelamer chloride or history of taking them for more than a week in the past three months;
Patients receiving chronic anti-inflammatory therapy;
Patients in whom FDG-PET/CT dual scans are contraindicated.
Intervention: Methylphenidate
Trial phase: Phase 4
ATC code: N06BA04 | N06BA11 | N06BA15
SMILES: COC(=O)C(c1ccccc1)C1CCCCN1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 96
Group description: Low dose: 18 mg methylphenidate
Eligibility criteria:
Inclusion Criteria. Participants for the study must meet all of the following criteria:

Consent: The family must provide signature of informed consent by parents or legal guardians.
Age at time of Screening: 7 years to 11 years, inclusive
Gender: includes male and female children.
ADHD Diagnostic Status: ADHD patients must meet DSM-IV criteria for ADHD, Inattentive or Combined subtype. Normal controls must not meet DSM-IV criteria for ADHD, any subtype. Section D.4 below describes in detail the diagnostic process for arriving at diagnosis.
Cognitive Functioning: IQ of greater than 80 as estimated by Vocabulary and Block Design subtests of the Wechsler Intelligence Scale for Children, Fourth Edition (WISC-IV).
Learning Disability: All children will be administered the abbreviated WIAT including the Spelling, Reading, and Math subtests. Children must score above 80 on all three WIAT subtests.
School: Children must be enrolled in a school setting from which teacher ratings can be obtained.

Exclusion Criteria. Potential participants will be excluded if they meet any of the following criteria:

Understanding Level. The patient and parent cannot understand or follow instructions given in the study.
History of Psychiatric Medications: Children who have a history of taking any medication for psychological or psychiatric problems will be excluded from participation.
Exclusionary Psychiatric Conditions: Children whose primary diagnosis is something other than ADHD will be excluded from participation.
Developmental Disabilities. As a result of scores on the IQ screening, additional assessments, or the judgment of the study clinicians, patients will be excluded if they are deemed to be significantly developmentally delayed. This includes clinically significant delays in cognitive function or the presence of other Pervasive Developmental Disorders (PDD).
Organic Brain Injury: Children must not have a history of head trauma, neurological disorder, or any other organic disorder that could possibly affect brain function.
Intervention: SODIUM CHLORIDE
Trial phase: Not Applicable
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 82
Group description: Hypertonic saline (sodium chloride 0.3%) + albuterol
Eligibility criteria:
Inclusion criteria:

Infants aged 1 to 24 months, hospitalized for first episode of bronchiolitis, with severity score ≥ 5 points and oxygen saturation ≥ 97%.

Exclusion Criteria:

Chronic respiratory or cardiovascular disease, respiratory failure.
Intervention: SODIUM CHLORIDE
Trial phase: Not Applicable
ATC code: A12CA01 | B05CB01 | B05XA03 | S01XA03
SMILES: [Cl-].[Na+]
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 82
Group description: Normal saline (sodium chloride 0.9%) + albuterol
Eligibility criteria:
Inclusion criteria:

Infants aged 1 to 24 months, hospitalized for first episode of bronchiolitis, with severity score ≥ 5 points and oxygen saturation ≥ 97%.

Exclusion Criteria:

Chronic respiratory or cardiovascular disease, respiratory failure.
Intervention: Everolimus
Trial phase: Phase 4
ATC code: L01EG02 | L04AA18
SMILES: COC1CC2CCC(C)C(O)(O2)C(=O)C(=O)N2CCCCC2C(=O)OC(C(C)CC2CCC(OCCO)C(OC)C2)CC(=O)C(C)C=C(C)C(O)C(OC)C(=O)C(C)CC(C)C=CC=CC=C1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 15
Group description: Kidney transplant patients taking tacrolimus, mycophenolate sodium and prednisone, and whom switched tacrolimus to everolimus 90 days after renal transplantation. Therefore the patients were taking everolimus, mycophenolate sodium and prednisone since 90 days after the transplant, and kept this way during the whole study
Eligibility criteria:
Inclusion Criteria:

Patients over 18 years old and under 65 years old
Recipients of first kidney transplant
Donor younger than 65 years old
PRA (panel reactive antigen) ≤ 30% in class I or class II
No acute rejection episodes
Proteinuria <1000 mg / day

Exclusion Criteria:

multiple organ transplant recipient
Chronic liver failure
Asymptomatic bacteriuria or urinary infection at randomization time
Creatinine ≥ 2 mg / dL at randomization time (90 days after transplant)
Presence of uncontrolled hypercholesterolemia (≥ 350 mg / dL, ≥ 9.1 mmol / L) or hypertriglyceridemia (≥ 500 mg / dL, ≥ 5.6 mmol / L) at randomization time (90 days after transplant)