anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Cholecalciferol
Trial phase: Phase 2
ATC code: A11CC05 | A11CC55 | M05BB03 | M05BB04 | M05BB05 | M05BB07 | M05BB08 | M05BB09 | M05BX53
SMILES: [H][C@@]12CC[C@]([H])([C@H](C)CCCC(C)C)[C@@]1(C)CCC/C2=C\C=C1\C[C@@H](O)CCC1=C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 6
Group description: 5,000 IU vitamin D (cholecalciferol) given orally daily

Cholecalciferol: 5,000 International units versus 400 international units as an active comparator
Eligibility criteria:
Inclusion Criteria:

Diagnosis of SLE per 1997 American College of Rheumatology Criteria(at least 4 criteria present)
Documented Vitamin D deficiency
Able to give informed consent

Exclusion Criteria:

Using tobacco products
Pregnant/Planning pregnancy
Known Hypercalcemia (Serum Ca >10.4)
Known Hypercalcuria (Calcium/Creatinine >0.8)
Chronic active lupus nephritis or end stage renal disease or kidney stones
Known Hyperparathyroidism
Known chronic viral/mycobacterial infections
Uncontrolled medical disease - Pl judgment
Current drug or alcohol abuse
Anticipated poor compliance/known neuropsychiatric disorders
Hx of cardiovascular events (i.e. Ml, PVD, CVE)
Subjects taking medications known to affect FMD in lupus subjects such as but not limited to fish oil, statins, will remain on stable doses throughout the study.
Intervention: Cholecalciferol
Trial phase: Phase 2
ATC code: A11CC05 | A11CC55 | M05BB03 | M05BB04 | M05BB05 | M05BB07 | M05BB08 | M05BB09 | M05BX53
SMILES: [H][C@@]12CC[C@]([H])([C@H](C)CCCC(C)C)[C@@]1(C)CCC/C2=C\C=C1\C[C@@H](O)CCC1=C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 3
Group description: cholecalciferol 400 IU daily by mouth

Cholecalciferol: 5,000 International units versus 400 international units as an active comparator
Eligibility criteria:
Inclusion Criteria:

Diagnosis of SLE per 1997 American College of Rheumatology Criteria(at least 4 criteria present)
Documented Vitamin D deficiency
Able to give informed consent

Exclusion Criteria:

Using tobacco products
Pregnant/Planning pregnancy
Known Hypercalcemia (Serum Ca >10.4)
Known Hypercalcuria (Calcium/Creatinine >0.8)
Chronic active lupus nephritis or end stage renal disease or kidney stones
Known Hyperparathyroidism
Known chronic viral/mycobacterial infections
Uncontrolled medical disease - Pl judgment
Current drug or alcohol abuse
Anticipated poor compliance/known neuropsychiatric disorders
Hx of cardiovascular events (i.e. Ml, PVD, CVE)
Subjects taking medications known to affect FMD in lupus subjects such as but not limited to fish oil, statins, will remain on stable doses throughout the study.
Intervention: NITROUS OXIDE
Trial phase: Not Applicable
ATC code: N01AX13 | N01AX63
SMILES: [N-]=[N+]=O
Sex: All
Age groups: Child
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 43
Group description: Patients randomized to this arm will receive nitrous oxide plus standard management for their minor procedure.

Nitrous Oxide: Patients randomized to the intervention arm will receive nitrous oxide plus standard management for their minor procedure.
Eligibility criteria:
Inclusion Criteria:

Minor Procedure
Age 3 - 12 years

Exclusion Criteria:

Behavioral Disorders
Anxiety Score <10
Intervention: Methylphenidate
Trial phase: Not Applicable
ATC code: N06BA04 | N06BA11 | N06BA15
SMILES: COC(=O)C(c1ccccc1)C1CCCCN1
Sex: All
Age groups: Child | Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 83
Group description: Participants were treated with methylphenidate (raning from 10mg to 63mg) for 8 weeks. Doses of MPH were titrated depending on symptoms and adverse eff ects at the 2nd and 4 th weeks of treatment.
Eligibility criteria:
Inclusion Criteria:

Clinical diagnosis of Attention-deficit Hyperactivity Disorder
6-18 years old

Exclusion Criteria:

History of neurological diseases, including convulsive disorders or brain damage
IQ below 70
Pervasive developmental disorder (autism)
Language difficulties or learning disorders (reading disorders, mathematics disorders and disorders of written expression).
Tourette's syndrome
Bipolar disorder
Psychosis
Intervention: Boceprevir
Trial phase: Phase 2
ATC code: J05AP03
SMILES: [H][C@@]12[C@@H](C(=O)NC(CC3CCC3)C(=O)C(N)=O)N(C(=O)[C@@H](NC(=O)NC(C)(C)C)C(C)(C)C)C[C@]1([H])C2(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 57
Group description: 12 week Boceprevir, Peginterferon and Ribavirin in RVR4 group
Eligibility criteria:
Inclusion Criteria:

Documented recent HCV genotype 1 infection (≤26 weeks old at the time of the baseline visit) according to definition mentioned below.
Plan to start a Standard Of Care therapy for acute HCV consisting of 24 weeks of Peginterferon + Ribavirin. HCV RNA plasma viral load at screening >1000 IU/ml.
A previously performed HCV RNA plasma measurement can be used for screening if <4 weeks old.
On HAART at the time of screening.
Minimum age 18 years.

Exclusion Criteria:

Disallowed co-medication that cannot be stopped or replaced: Several potentially life-threatening drug-drug interactions (DDI) are possible when boceprevir is combined with other drugs. Therefore ALL co-medication, including over-the-counter drugs should be checked for potential DDI with DDI table in the Dutch summary of product characteristics (SPC, appendix A). If the co-medication is not mentioned in the SPC DDI table, www.HCV-druginteractions.org should be used.
Contraindications for the use of full dose of peginterferon alpha-2b or ribavirin: neutrophils <0,75×109/l or thrombocytes < 100.000×109/l or a Hb <6.2mmol/L, creatinine clearance <50ml/min).
History of liver cirrhosis or >F1 fibrosis on fibroscan. Inclusion of patients with a chronic well-controlled HBV (HBV-DNA below the limit of detection) with tenofovir, lamivudine or emtricitabine therapy is allowed if fibroscan excludes >F1 fibrosis. Fibroscan reports <2 years old can be used for screening. Fibroscan is not required for other patients at screening.
HAART was started <4 weeks before baseline visit.
Inability to switch to a HAART regimen consisting of 2 nucleoside/tide reverse transcriptase inhibitors + Raltegravir (Isentress®) 400mg BID or rilpivirine 25mg QD or atazanavir (Reyataz®) 300mg QD + ritonavir (Norvir®) 100mg QD.
Patient that virologically failed HAART in the past
Intervention: Fondaparinux
Trial phase: Phase 3
ATC code: B01AX05
SMILES: CO[C@H]1O[C@H](COS(=O)(=O)O)[C@@H](O[C@@H]2O[C@@H](C(=O)O)[C@@H](O[C@H]3O[C@H](COS(=O)(=O)O)[C@@H](O[C@@H]4O[C@H](C(=O)O)[C@@H](O[C@H]5O[C@H](COS(=O)(=O)O)[C@@H](O)[C@H](O)[C@H]5NS(=O)(=O)O)[C@H](O)[C@H]4O)[C@H](OS(=O)(=O)O)[C@H]3NS(=O)(=O)O)[C@H](O)[C@H]2OS(=O)(=O)O)[C@H](O)[C@H]1NS(=O)(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 321
Group description: UFH was administered as an IV bolus for the duration of the procedure (mean duration of 48.6 minutes). UFH was administered via weight-based IV bolus at a dose of 50 units (U)/kg to 70 U/kg. Additional bolus doses were administered per standard-of-care use.
Eligibility criteria:
Inclusion Criteria:

Participants ≥ 18 years of age

Must be undergoing one of the following PEI procedures:

Carotid artery stenting
Lower Extremity Interventions (LEI) for Critical Limb Ischemia
LEI for claudication
Provide written informed consent prior to any study-specific procedure being performed

Exclusion Criteria:

Any known contra-indication to the use of bivalirudin or UFH
Acute limb ischemia
Planned amputation regardless of the outcome of the PEI
Dialysis dependent
Weight less than 38 kg or more than 202 kg
History of any bleeding diathesis or severe hematological disease
History of intra-cranial: mass, aneurysm, arteriovenous malformation or hemorrhage
Gastrointestinal or genitourinary bleeding within the 30 days prior to randomization
Any surgery (excluding punch or shave skin biopsy) within the 30 days prior to randomization
Concomitant percutaneous coronary intervention
Any percutaneous coronary, endovascular, or structural heart disease procedure within 30 days prior to randomization
International normalized ratio >1.7 within 24 h prior to the index procedure
Administration of therapeutic doses of UFH within 30 min prior to the index procedure (a low dose [≤2000 U] of heparin is permitted during the diagnostic angiogram prior to the intervention)
Administration of enoxaparin within 8 h; other low molecular weight heparins or fondaparinux within 24 h; any oral anti-Xa or antithrombin agent within 48 h; or thrombolytics, glycoprotein inhibitors, or warfarin within 72 h prior to the index procedure
Severe contrast allergy that cannot be pre-medicated
Procedures performed by radial access when they are intended as the primary access site for the index procedure
Known or suspected pregnant women or nursing mothers
Previous enrollment in this study (MDCO-BIV-12-03)
Participation in other investigational drug or device trials within 30 days prior to randomization
Participants who, for any reason, are deemed by the investigator to be inappropriate for this study
Intervention: Metoprolol
Trial phase: Phase 4
ATC code: C07AB02 | C07BB02 | C07BB52 | C07CB02 | C07FB02 | C07FB13 | C07FX03 | C07FX05
SMILES: COCCc1ccc(OCC(O)CNC(C)C)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 54
Group description: Patients Receiving metoprolol administered at a dose of 0.15 mg/kg (to a maximum dose of 10 mg)
Eligibility criteria:
Inclusion Criteria:

Eligible patients had to have a 12-lead electrocardiogram (ECG) showing atrial fibrillation or atrial flutter with a ventricular rate of greater than or equal to 120 beats per minute and a systolic blood pressure of greater than or equal to 90 mmHg.

Exclusion Criteria:

Patients were excluded if they had any of the following:

a systolic blood pressure <90 mmHg, ventricular rate greater than or equal to 220 beats per minute,
QRS >0.100 seconds, 2nd or 3rd degree atrioventricular (AV) block,
temperature >38.0 ˚C,
acute ST elevation myocardial infarction,
known history of New York Heart Association Class IV heart failure or
active wheezing with a history of bronchial asthma or COPD.

In addition, patients were excluded if there was:

prehospital administration of diltiazem or any other AV nodal blockading agent,
a history of cocaine or methamphetamine use in the previous 24 hours prior to arrival,
a history of allergic reaction to diltiazem or metoprolol,
a history of sick sinus or pre-excitation syndromes,
a history of anemia with hemoglobin <11.0 g/dl,
pregnancy or breastfeeding.
Intervention: Diltiazem
Trial phase: Phase 4
ATC code: C05AE03 | C08DB01
SMILES: COc1ccc([C@@H]2Sc3ccccc3N(CCN(C)C)C(=O)[C@@H]2OC(C)=O)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 54
Group description: Patients receiving diltiazem administered parenterally at a dose of 0.25 mg/kg (to a maximum dose of 30 mg)
Eligibility criteria:
Inclusion Criteria:

Eligible patients had to have a 12-lead electrocardiogram (ECG) showing atrial fibrillation or atrial flutter with a ventricular rate of greater than or equal to 120 beats per minute and a systolic blood pressure of greater than or equal to 90 mmHg.

Exclusion Criteria:

Patients were excluded if they had any of the following:

a systolic blood pressure <90 mmHg, ventricular rate greater than or equal to 220 beats per minute,
QRS >0.100 seconds, 2nd or 3rd degree atrioventricular (AV) block,
temperature >38.0 ˚C,
acute ST elevation myocardial infarction,
known history of New York Heart Association Class IV heart failure or
active wheezing with a history of bronchial asthma or COPD.

In addition, patients were excluded if there was:

prehospital administration of diltiazem or any other AV nodal blockading agent,
a history of cocaine or methamphetamine use in the previous 24 hours prior to arrival,
a history of allergic reaction to diltiazem or metoprolol,
a history of sick sinus or pre-excitation syndromes,
a history of anemia with hemoglobin <11.0 g/dl,
pregnancy or breastfeeding.
Intervention: Remifentanil
Trial phase: Not Applicable
ATC code: N01AH06
SMILES: CCC(=O)N(c1ccccc1)C1(C(=O)OC)CCN(CCC(=O)OC)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 30
Group description: remifentanil Ce of 1.5 ng/ml

Remifentanil: All patients received a predetermined Ce of remifentanil by TCI according to their group assignments 10 minutes before the end of surgery (R0, remifentanil Ce of 0 ng/ml; R0.5, remifentanil Ce of 0.5 ng/ml; R1.0, remifentanil Ce of 1.0 ng/ml; R1.5, remifentanil Ce of 1.5 ng/ml).
Eligibility criteria:
Inclusion Criteria:

American Society of Anesthesiologists physical status 1 or 2
undergoing lower extremity surgery under general anesthesia

Exclusion Criteria:

suspected difficult airways
respiratory disease (chronic obstructive pulmonary disease, upper respiratory infection)
body mass index > 30 kg/m2
allergies to the study drugs
a history of gastric reflux
Intervention: Remifentanil
Trial phase: Not Applicable
ATC code: N01AH06
SMILES: CCC(=O)N(c1ccccc1)C1(C(=O)OC)CCN(CCC(=O)OC)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 29
Group description: remifentanil Ce of 0.5 ng/ml

Remifentanil: All patients received a predetermined Ce of remifentanil by TCI according to their group assignments 10 minutes before the end of surgery (R0, remifentanil Ce of 0 ng/ml; R0.5, remifentanil Ce of 0.5 ng/ml; R1.0, remifentanil Ce of 1.0 ng/ml; R1.5, remifentanil Ce of 1.5 ng/ml).
Eligibility criteria:
Inclusion Criteria:

American Society of Anesthesiologists physical status 1 or 2
undergoing lower extremity surgery under general anesthesia

Exclusion Criteria:

suspected difficult airways
respiratory disease (chronic obstructive pulmonary disease, upper respiratory infection)
body mass index > 30 kg/m2
allergies to the study drugs
a history of gastric reflux
Intervention: Remifentanil
Trial phase: Not Applicable
ATC code: N01AH06
SMILES: CCC(=O)N(c1ccccc1)C1(C(=O)OC)CCN(CCC(=O)OC)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 31
Group description: remifentanil Ce of 1.0 ng/ml

Remifentanil: All patients received a predetermined Ce of remifentanil by TCI according to their group assignments 10 minutes before the end of surgery (R0, remifentanil Ce of 0 ng/ml; R0.5, remifentanil Ce of 0.5 ng/ml; R1.0, remifentanil Ce of 1.0 ng/ml; R1.5, remifentanil Ce of 1.5 ng/ml).
Eligibility criteria:
Inclusion Criteria:

American Society of Anesthesiologists physical status 1 or 2
undergoing lower extremity surgery under general anesthesia

Exclusion Criteria:

suspected difficult airways
respiratory disease (chronic obstructive pulmonary disease, upper respiratory infection)
body mass index > 30 kg/m2
allergies to the study drugs
a history of gastric reflux
Intervention: Prazosin
Trial phase: Not Applicable
ATC code: C02CA01 | C02LE01
SMILES: COc1cc2nc(N3CCN(C(=O)c4ccco4)CC3)nc(N)c2cc1OC
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 18
Group description: Prazosin titrated to 16 mg daily x 6 weeks

Prazosin
Eligibility criteria:
Inclusion Criteria:

Males and females age 18-65 meeting DSM-IV criteria for alcohol dependence in the past year;
seeking but not currently receiving treatment;
able to provide voluntary informed consent;
have at least 4 drinking days in the past 30 days
english-speaking
have a primary care physician or psychiatrist willing to continue prazosin if the patient tolerates it well and is finding it beneficial.

Exclusion Criteria:

severe neurological (e.g., head injury/stroke) conditions, Meniere's disease, narcolepsy, benign positional vertigo, heart disease or unstable angina, history of dysrhythmia/syncope, SBP<110, SBP>160, DBP>110, HR<55, HR>110, irregular heart rhythm, chronic renal or hepatic failure, pancreatitis or insulin-dependent diabetes, or other medical problems requiring immediate attention;
schizophrenia, schizoaffective disorder, PTSD, Bipolar I disorder, suicidal thoughts within the last month;
current dependence on another drug of abuse (except nicotine);
contraindications to MRI (e.g., pacemaker);
active legal problems with the potential to result in incarceration;
pregnancy or lactation, or child bearing age and not on birth control;
currently receiving treatment for alcohol dependence;
current use of psychoactive medications including SSRI's and other antidepressants, anti-craving medications, anxiolytics including benzodiazepines, antipsychotics, mood stabilizers or anticonvulsants;
history of seizures or DT's during alcohol withdrawal.
Intervention: Desloratadine
Trial phase: Phase 3
ATC code: R06AX27
SMILES: Clc1ccc2c(c1)CCc1cccnc1C2=C1CCNCC1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 79
Group description: Participants receive desloratadine 10 mg, as two 5-mg tablets, orally, once daily in the evening for 2 weeks
Eligibility criteria:
Inclusion Criteria:

Chronic urticaria [rash (erythema, wheal) for more than 1 month without any known cause]
Out-patient

Exclusion Criteria:

Stimulation-induced urticaria [physical urticaria (e.g. cold, solar, and heat urticaria), cholinergic urticaria, contact urticaria)]
Hypersensitivity to antihistamines or ingredients of a study drug
Intervention: Desloratadine
Trial phase: Phase 3
ATC code: R06AX27
SMILES: Clc1ccc2c(c1)CCc1cccnc1C2=C1CCNCC1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 65
Group description: Participants with eczema/dermatitis receive desloratadine 5 mg, taken as one 5-mg tablet, orally once daily in the evening for up to 12 weeks. After Week 4, the dose of desloratadine can be increased from 5 mg/day to 10 mg/day (two 5-mg tablets, orally once daily in the evening for up to 8 weeks), if criteria for dose up-titration are met, there is insufficient anti-pruritic efficacy and there is no safety concern.
Eligibility criteria:
Inclusion Criteria:

Eczema/dermatitis (acute eczema, chronic eczema, contact dermatitis, atopic dermatitis, nummular eczema, seborrheic dermatitis, asteatotic eczema, neurodermatitis, etc. among eczema/dermatitis for which the observation of pruritus is appropriate)
Dermal pruritus (generalized dermal pruritus, localized dermal pruritus)

Exclusion Criteria:

Hypersensitivity to antihistamines or ingredients of a study drug
Intervention: Desloratadine
Trial phase: Phase 3
ATC code: R06AX27
SMILES: Clc1ccc2c(c1)CCc1cccnc1C2=C1CCNCC1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 29
Group description: Participants with dermal pruritus receive desloratadine 5 mg, taken as one 5-mg tablet, orally once daily in the evening for up to 12 weeks. After Week 4, the dose of desloratadine can be increased from 5 mg/day to 10 mg/day (two 5-mg tablets, orally once daily in the evening for up to 8 weeks), if criteria for dose up-titration are met, there is insufficient anti-pruritic efficacy and there is no safety concern.
Eligibility criteria:
Inclusion Criteria:

Eczema/dermatitis (acute eczema, chronic eczema, contact dermatitis, atopic dermatitis, nummular eczema, seborrheic dermatitis, asteatotic eczema, neurodermatitis, etc. among eczema/dermatitis for which the observation of pruritus is appropriate)
Dermal pruritus (generalized dermal pruritus, localized dermal pruritus)

Exclusion Criteria:

Hypersensitivity to antihistamines or ingredients of a study drug
Intervention: Desloratadine
Trial phase: Phase 3
ATC code: R06AX27
SMILES: Clc1ccc2c(c1)CCc1cccnc1C2=C1CCNCC1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 203
Group description: Participants receive two desloratadine 5 mg tablets orally once daily for up to 2 weeks
Eligibility criteria:
Inclusion Criteria:

Diagnosed with perennial allergic rhinitis
Outpatient.

Exclusion Criteria:

Lower respiratory tract infection or nasopharyngolaryngeal infection (acute upper respiratory tract infection, acute pharyngolaryngitis, or acute tonsillitis, etc.)
Coexisting infections or systemic mycosis for which there are no effective antibiotics
Asthma complication under treatment
Nasal septum ulcers, nasal surgery, or nasal trauma, which has not healed
Vasomotor rhinitis or eosinophilic rhinitis
Nasal conditions (infectious sinusitis, hypertrophic rhinitis, acute or chronic rhinitis, nasal polyps, septal deviation, etc.) which may interfere with the evaluation of the efficacy of the study drug
History of hypersensitivity to antihistamines or study drug
Currently receiving treatment with another investigational drug or has received an investigational drug in the past 3 months
Has started specific desensitization therapy or nonspecific allassotherapy (Histaglobin, vaccine therapy, etc.) or who had discontinued such therapies within 90 days (3 months) before the day of obtaining informed consent
Severe hepatic, renal, cardiac, hematological disease, or other serious coexisting diseases and whose general condition is poor
History of malignancy or clinically important hematological disorder
History of severe drug allergy (e.g., anaphylactoid reaction).
Intervention: Bupivacaine
Trial phase: Phase 4
ATC code: N01BB01 | N01BB10 | N01BB51 | N01BB59
SMILES: CCCCN1CCCCC1C(=O)Nc1c(C)cccc1C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 33
Group description: EXPAREL (266 mg/20 mL) with 40 mL of 0.9% normal saline for a total volume of 60 mL, 30 mL to be administered to the right TAP and 30 mL to be administered to the left TAP

EXPAREL
Eligibility criteria:
Inclusion Criteria:

Males and females >18 years of age
American Society of Anesthesiologists (ASA) physical status 1-3
Undergoing either lower abdominal surgery defined as Laparoscopic Hysterectomy (female), Laparoscopic Myomectomy (female), Laparoscopic Colectomy (male/female)
Physically and mentally able to give full informed consent to participate in this study and complete all study assessments within the timeframes required (including electronic diaries should patient be discharged prior to day 4)
Capable of returning the diary after POD 4 by mail (preferably) or upon follow up visit.

Exclusion Criteria:

History of hypersensitivity or idiosyncratic reactions to amide-type local anesthetics.
Any patient whose anatomy, or surgical procedure, in the opinion of the Investigator, might preclude the potential successful local administration of EXPAREL.
Patients who have received any investigational drug within 30 days prior to EXPAREL administration, or planned administration of another investigational product or procedure during their participation in this study.
Any chronic condition requiring use of opioids for treatment of a medical condition for 2 weeks or more prior to surgery.
Confirmed pregnancy at time of enrollment or breast feeding (females of child-bearing potential).
Patients that would constitute a contraindication to participation in the study, or cause inability to comply with the study requirements.
Any patient with diagnosed or potential metastatic disease.
Any condition that in the investigator's opinion might be harmed or be a poor candidate for participation in the study (such as patients requiring long acting opioids as part of the induction medications).
Initiation of treatment with any of the following medications within 1 month of study drug administration or if the medication(s) are being given to control pain: selective serotonin reuptake inhibitors (SSRIs), selective norepinephrine reuptake inhibitors (SNRIs), gabapentin, pregabalin (Lyrica®), or duloxetine (Cymbalta®)
History of suspected or known addiction to, or abuse of, illicit drug(s), prescription medicine(s), or alcohol within the past 2 years.