anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Lisdexamfetamine Dimesylate
Trial phase: Phase 3
SMILES: CC(Cc1ccccc1)NC(=O)C(N)CCCCN.CS(=O)(=O)O.CS(=O)(=O)O
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 77
Group description: Subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of Lisdexamfetamine dimesylate (LDX) 30, 50, or 70mg/day or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period.
Eligibility criteria:
Inclusion Criteria:

Meet DSM-IV-TR criteria for a primary diagnosis of ADHD
Baseline ADHD-RS-IV score >=28
BP w/in 95th percentile for age, gender, and height

Exclusion Criteria:

Subject has controlled or uncontrolled comorbid psychiatric diagnosis
Subject has conduct disorder
Suicidal
Under or overweight
Concurrent chronic or acute illness that might confound results.
Intervention: Telapristone acetate
Trial phase: Phase 3
SMILES: [H][C@@]12CC[C@](OC(C)=O)(C(=O)COC)[C@@]1(C)C[C@H](c1ccc(N(C)C)cc1)C1=C3CCC(=O)C=C3CC[C@]12[H]
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 77
Group description: 25 mg oral daily dose of Proellex

Proellex: One 25 mg capsule of Proellex® and one placebo capsule orally daily for up to four months
Eligibility criteria:
Inclusion Criteria:

Speak, read and understand English or Spanish;
Not have undergone hysterectomy, uterine arterial embolization or endometrial ablation therapy (previous myomectomy is acceptable) for any cause and no surgical interventions for uterine fibroids (e.g. hysterectomy, myomectomy, uterine arterial embolization) are planned or anticipated during the study;
One uterine fibroid must be identifiable and measurable by transvaginal ultrasound;
Menstrual cycle lasting from 24 to 36 days;
History of excessive menstrual bleeding;
Negative urine pregnancy test at screening.

Exclusion Criteria:

Six months or more (immediately prior to Screening Visit) without a menstrual period;
Prior hysterectomy;
Prior bilateral oophorectomy;
Pregnant or lactating females or women who are attempting or expecting to become pregnant at any time during the study;
Documented endometriosis, active pelvic inflammatory disease (PID), platelet dysfunction, or Von Willebrand's Disease;
Any history or diagnosis of gynecological cancer or cervical dysplasia of any grade including atypical squamous cells of undetermined significance (ASCUS) associated with Human Papilloma Virus (HPV);
Subject with diagnosed or suspected carcinoma of the breast, reproductive organs or any other organ system;
Subject with known active infection with HIV, Hepatitis A, B or C, Gonorrhea, or Chlamydia or previous history of auto-immune disease or positive serum antinuclear antibodies.
Intervention: Telapristone acetate
Trial phase: Phase 3
SMILES: [H][C@@]12CC[C@](OC(C)=O)(C(=O)COC)[C@@]1(C)C[C@H](c1ccc(N(C)C)cc1)C1=C3CCC(=O)C=C3CC[C@]12[H]
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 77
Group description: 50 mg oral daily dose of Proellex

Proellex: Two 25 mg mg capsules of Proellex® orally daily for up to four months
Eligibility criteria:
Inclusion Criteria:

Speak, read and understand English or Spanish;
Not have undergone hysterectomy, uterine arterial embolization or endometrial ablation therapy (previous myomectomy is acceptable) for any cause and no surgical interventions for uterine fibroids (e.g. hysterectomy, myomectomy, uterine arterial embolization) are planned or anticipated during the study;
One uterine fibroid must be identifiable and measurable by transvaginal ultrasound;
Menstrual cycle lasting from 24 to 36 days;
History of excessive menstrual bleeding;
Negative urine pregnancy test at screening.

Exclusion Criteria:

Six months or more (immediately prior to Screening Visit) without a menstrual period;
Prior hysterectomy;
Prior bilateral oophorectomy;
Pregnant or lactating females or women who are attempting or expecting to become pregnant at any time during the study;
Documented endometriosis, active pelvic inflammatory disease (PID), platelet dysfunction, or Von Willebrand's Disease;
Any history or diagnosis of gynecological cancer or cervical dysplasia of any grade including atypical squamous cells of undetermined significance (ASCUS) associated with Human Papilloma Virus (HPV);
Subject with diagnosed or suspected carcinoma of the breast, reproductive organs or any other organ system;
Subject with known active infection with HIV, Hepatitis A, B or C, Gonorrhea, or Chlamydia or previous history of auto-immune disease or positive serum antinuclear antibodies.
Intervention: Aprepitant
Trial phase: Not Applicable
ATC code: A04AD12
SMILES: C[C@@H](O[C@H]1OCCN(Cc2n[nH]c(=O)[nH]2)[C@H]1c1ccc(F)cc1)c1cc(C(F)(F)F)cc(C(F)(F)F)c1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 34
Group description: aprepitant

aprepitant : one dose of aprepitant (125 mg PO 4 hours) prior to their ERCP and one dose (80 mg PO) 18 hours after the first dose
Eligibility criteria:
Inclusion Criteria: Patients selected for the study will be those undergoing ERCP who are at high risk for development of post-ERCP pancreatitis

patients expected to undergo a sphincterotomy
patients with suspected sphincter of oddi dysfunction
patients with a known history in the past of post-ERCP pancreatitis
patients less than 60 years of age

Exclusion Criteria:

active pancreatitis
if they are pregnant
known adverse reaction to aprepitant
Intervention: EXENATIDE
Trial phase: Phase 4
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: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 40
Group description: Patients were treated with a 0.05 μg/min bolus of intravenous exenatide for 30 minutes,followed by a fixed dose infusion (0.025 μg/min) for a maximum duration of 48 hours. Blood glucose values were measured hourly following commencement of infusion.
Eligibility criteria:
Inclusion Criteria:

Admission to coronary ICU
Admission blood glucose 140-299 mg/dL
Primary cardiovascular diagnosis by attending physician
Under primary care of cardiology service
Age > 18 years old
Ventilator independent
Able to provide informed consent

Exclusion Criteria:

Admission blood glucose < 140 or > 300 mg/dL
Ventilator dependent
Unconscious sedation
Type 1 diabetes
Known pregnancy
Admitted to coronary ICU for right heart cath to measure hemodynamics prior to transplant
Post transplant procedure
Currently enrolled in another clinical trial
Unable to provide informed consent
Creatinine clearance < 30 mL/min
On insulin treatment except for monotherapy with long-acting basal insulin (e.g., insulin glargine [Lantus®] or detemir [Levemir®])
Gastroparesis
Intervention: Cholecalciferol
Trial phase: Not Applicable
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: 125
Group description: Patients in the vitamin D group will receive cholecalciferol 4000 units daily and calcium carbonate 500 mg twice daily.

Vitamin D3: Cholecalciferol 4000 units orally daily Calcium carbonate 500 mg orally twice daily
Eligibility criteria:
Inclusion Criteria:

Type 2 diabetes
25 (OH) vitamin D levels < 25 ng/ml
Age 25 to 80 years
Not on insulin for diabetes treatment
HbA1c 5.5% -9.5%
Mild/moderately increased blood pressure (systolic 120-160, diastolic 80-100) off BP medications

Exclusion Criteria:

Pregnancy
Patients with systolic >160 or diastolic >100 mmHg
High urine calcium or history of recurrent kidney stones
Cardiovascular disease
Stage 3 or worse chronic kidney disease
Intervention: Dapagliflozin
Trial phase: Phase 3
ATC code: A10BD15 | A10BD21 | A10BD25 | A10BK01
SMILES: CCOc1ccc(Cc2cc([C@@H]3O[C@H](CO)[C@@H](O)[C@H](O)[C@H]3O)ccc2Cl)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 74
Group description: 2.5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
Eligibility criteria:
Inclusion Criteria:

Male and females, ≥18 to ≤77 years old, with type 2 diabetes mellitus
Subjects must have central laboratory pre-randomization A1C ≥7.0 and ≤ 10.0%
C-peptide ≥ 1.0 ng/mL (0.34 nmol/L)
Body Mass Index ≤ 45 kg/m²
Must be able to perform self monitoring of blood glucose

Exclusion Criteria:

aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) >3* upper limit of normal (ULN)
Serum Total bilirubin >2 mg/dL (34.2 µmol/L)
Creatinine kinase >3* ULN
Serum creatinine ≥1.50 mg/dL (133 µmol/L) for male subjects, ≥1.40 mg/dL (124 µmol/L) for female subjects
Currently unstable or serious cardiovascular, renal, hepatic, hematological, oncological, endocrine, psychiatric, or rheumatic diseases
Intervention: Dapagliflozin
Trial phase: Phase 3
ATC code: A10BD15 | A10BD21 | A10BD25 | A10BK01
SMILES: CCOc1ccc(Cc2cc([C@@H]3O[C@H](CO)[C@@H](O)[C@H](O)[C@H]3O)ccc2Cl)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 68
Group description: 5 mg dapagliflozin tablets were taken orally once daily (with morning meal) for 24 weeks during the Double Blind Treatment Period.
Eligibility criteria:
Inclusion Criteria:

Male and females, ≥18 to ≤77 years old, with type 2 diabetes mellitus
Subjects must have central laboratory pre-randomization A1C ≥7.0 and ≤ 10.0%
C-peptide ≥ 1.0 ng/mL (0.34 nmol/L)
Body Mass Index ≤ 45 kg/m²
Must be able to perform self monitoring of blood glucose

Exclusion Criteria:

aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) >3* upper limit of normal (ULN)
Serum Total bilirubin >2 mg/dL (34.2 µmol/L)
Creatinine kinase >3* ULN
Serum creatinine ≥1.50 mg/dL (133 µmol/L) for male subjects, ≥1.40 mg/dL (124 µmol/L) for female subjects
Currently unstable or serious cardiovascular, renal, hepatic, hematological, oncological, endocrine, psychiatric, or rheumatic diseases
Intervention: Modafinil
Trial phase: Phase 4
ATC code: N06BA07 | N06BA13
SMILES: NC(=O)CS(=O)C(c1ccccc1)c1ccccc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 70
Group description: Participants will receive armodafinil for 4 weeks. If responsive, participants will be offered 12 additional weeks of armodafinil.
Eligibility criteria:
Inclusion Criteria:

Ages 18-75
HIV+
Clinically significant fatigue (score of 4.5+ on Fatigue Severity Scale, plus impairment on 1+ categories of Role Function Scale)
Fatigue duration for 3+ months
English-speaking
Able to give informed consent
Fecund women uses barrier method of contraception

Exclusion Criteria:

Primary care doctor does not approve of study participation
Unstable medical condition (e.g. liver failure; cirrhosis, new onset opportunistic infection in past month)
Untreated hypogonadism, except for men for whom testosterone replacement is medically contraindicated (serum testosterone below the reference range)
Untreated hypothyroidism (Thyroid Stimulating Hormone over 5 IUI/mL)
Untreated and uncontrolled hypertension
Clinically significant anemia (hematocrit <30%)
Started testosterone or nandrolone in past 6 weeks
Started or changed an antiretroviral regimen in past 4 weeks if fatigue predated the change; otherwise, started or changed regimen in past 2 months
Untreated or under-treated major depressive disorder
Started antidepressant medication within past 6 weeks
Substance abuse/dependence (past 4 months)
Regular and frequent cannabis use (> twice/week regularly)
Currently clinically significant suicidal ideation or Hamilton Depression Scale (HAM-D) score >24
History or current psychosis or bipolar disorder
Pregnant or breastfeeding
Significant untreated insomnia (score >3 on HAM-D insomnia items)
Currently taking psychostimulant medication or past nonresponse to modafinil
Has no alternative viable antiretroviral regimen after the current one
Left ventricular hypertrophy; mitral valve prolapse
Intervention: Telapristone acetate
Trial phase: Phase 3
SMILES: [H][C@@]12CC[C@](OC(C)=O)(C(=O)COC)[C@@]1(C)C[C@H](c1ccc(N(C)C)cc1)C1=C3CCC(=O)C=C3CC[C@]12[H]
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 175
Group description: Proellex 25 mg once daily

Proellex 25 mg: One capsule Proellex 25 mg administered as daily oral doses for four (4) consecutive months during each treatment cycle
Eligibility criteria:
Inclusion Criteria:

Speak, read and understand English or Spanish;
Not have undergone hysterectomy, uterine arterial embolization or endometrial ablation therapy (previous myomectomy is acceptable) for any cause and no surgical interventions for uterine fibroids (e.g. hysterectomy, myomectomy, uterine arterial embolization) are planned or anticipated during the study;
One uterine fibroid must be identifiable and measurable by transvaginal ultrasound;
Menstrual cycle lasting from 24 to 36 days;
History of excessive menstrual bleeding;
Negative urine pregnancy test at screening.

Additional inclusion criteria may apply.

Exclusion Criteria:

Six months or more (immediately prior to Screening Visit) without a menstrual period;
Prior hysterectomy;
Prior bilateral oophorectomy;
Pregnant or lactating females or women who are attempting or expecting to become pregnant at any time during the study;
Documented endometriosis, active pelvic inflammatory disease (PID), platelet dysfunction, or Von Willebrand's Disease;
Any history or diagnosis of gynecological cancer or cervical dysplasia of any grade including atypical squamous cells of undetermined significance (ASCUS) associated with Human Papilloma Virus (HPV);
Subject with diagnosed or suspected carcinoma of the breast, reproductive organs or any other organ system;
Subject with known active infection with HIV, Hepatitis A, B or C, Gonorrhea, or Chlamydia or previous history of auto-immune disease or positive serum antinuclear antibodies.

Additional exclusion criteria may apply.
Intervention: Telapristone acetate
Trial phase: Phase 3
SMILES: [H][C@@]12CC[C@](OC(C)=O)(C(=O)COC)[C@@]1(C)C[C@H](c1ccc(N(C)C)cc1)C1=C3CCC(=O)C=C3CC[C@]12[H]
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 175
Group description: Proellex 50 mg once daily

Proellex 50 mg: Two capsules Proellex 25 mg administered as daily oral doses for four (4) consecutive months during each treatment cycle
Eligibility criteria:
Inclusion Criteria:

Speak, read and understand English or Spanish;
Not have undergone hysterectomy, uterine arterial embolization or endometrial ablation therapy (previous myomectomy is acceptable) for any cause and no surgical interventions for uterine fibroids (e.g. hysterectomy, myomectomy, uterine arterial embolization) are planned or anticipated during the study;
One uterine fibroid must be identifiable and measurable by transvaginal ultrasound;
Menstrual cycle lasting from 24 to 36 days;
History of excessive menstrual bleeding;
Negative urine pregnancy test at screening.

Additional inclusion criteria may apply.

Exclusion Criteria:

Six months or more (immediately prior to Screening Visit) without a menstrual period;
Prior hysterectomy;
Prior bilateral oophorectomy;
Pregnant or lactating females or women who are attempting or expecting to become pregnant at any time during the study;
Documented endometriosis, active pelvic inflammatory disease (PID), platelet dysfunction, or Von Willebrand's Disease;
Any history or diagnosis of gynecological cancer or cervical dysplasia of any grade including atypical squamous cells of undetermined significance (ASCUS) associated with Human Papilloma Virus (HPV);
Subject with diagnosed or suspected carcinoma of the breast, reproductive organs or any other organ system;
Subject with known active infection with HIV, Hepatitis A, B or C, Gonorrhea, or Chlamydia or previous history of auto-immune disease or positive serum antinuclear antibodies.

Additional exclusion criteria may apply.
Intervention: Cobiprostone
Trial phase: Phase 2
SMILES: CC[C@H](C)CC(F)(F)[C@@]1(O)CC[C@H]2[C@@H](CC(=O)[C@@H]2CCCCCCC(=O)O)O1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 9
Group description: Cobiprostone 36 mcg

Cobiprostone: 12 mcg cobiprostone (capsules) three times daily (TID)
Eligibility criteria:
Inclusion Criteria:

Patient is >= 18 years of age.
Patient has clinical and/or pathological diagnosis of intra-hepatic portal hypertension.
Patient has clinical diagnosis of cirrhosis.
Patient has undergone variceal banding.

Exclusion Criteria:

Patient has a Child-Pugh score >12.
Patient has portal hypertension resulting from hepatic vein obstruction, portal vein occlusion, schistosomiasis, portal vein thrombosis, splenic vein thrombosis, or Budd-Chiari syndrome.
Variceal banding procedure was performed within 1 month of the screening visit.
Patient has active or recurrent variceal bleeding, or has had variceal bleeding within the 12 weeks prior to screening.
Patient is unwilling to discontinue use of vasoactive drugs from the screening visit through the end of the study.
Patient has hepatocellular carcinoma that is being medically treated or is advanced.
Patient has impaired renal function (i.e., serum creatinine concentration >1.8 mg/dl)
Patient has a history of liver transplant, or is expected to receive a liver transplant during the study period.
Patient has undergone a gastrointestinal or abdominal surgical procedure within 90 days prior to the Screening Visit, or has had a bowel resection at any time.
Intervention: Cobiprostone
Trial phase: Phase 2
SMILES: CC[C@H](C)CC(F)(F)[C@@]1(O)CC[C@H]2[C@@H](CC(=O)[C@@H]2CCCCCCC(=O)O)O1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 9
Group description: Cobiprostone 54 mcg

Cobiprostone: 18 mcg cobiprostone (capsules) three times daily (TID)
Eligibility criteria:
Inclusion Criteria:

Patient is >= 18 years of age.
Patient has clinical and/or pathological diagnosis of intra-hepatic portal hypertension.
Patient has clinical diagnosis of cirrhosis.
Patient has undergone variceal banding.

Exclusion Criteria:

Patient has a Child-Pugh score >12.
Patient has portal hypertension resulting from hepatic vein obstruction, portal vein occlusion, schistosomiasis, portal vein thrombosis, splenic vein thrombosis, or Budd-Chiari syndrome.
Variceal banding procedure was performed within 1 month of the screening visit.
Patient has active or recurrent variceal bleeding, or has had variceal bleeding within the 12 weeks prior to screening.
Patient is unwilling to discontinue use of vasoactive drugs from the screening visit through the end of the study.
Patient has hepatocellular carcinoma that is being medically treated or is advanced.
Patient has impaired renal function (i.e., serum creatinine concentration >1.8 mg/dl)
Patient has a history of liver transplant, or is expected to receive a liver transplant during the study period.
Patient has undergone a gastrointestinal or abdominal surgical procedure within 90 days prior to the Screening Visit, or has had a bowel resection at any time.
Intervention: Qsymia
Trial phase: Phase 2
ATC code: A08AA51
SMILES: CC(C)(N)Cc1ccccc1.CC1(C)OC2COC3(COS(N)(=O)=O)OC(C)(C)OC3C2O1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 57
Group description: subjects who were randomized to active during previous study
Eligibility criteria:
Inclusion Criteria:

Have completed the qualifying DM-230 trial
If females of child-bearing potential, subjects must be using adequate contraception
Provide written informed consent
Be willing and able to comply with scheduled study visits, treatment plan, lab tests and other study procedures
Be greater than 80% compliant in study medication use during the last three visits for DM-230

Exclusion Criteria:

Subjects who have developed one or more morbidities during the DM-230 trial that would pose a safety concern
Intervention: Losartan Potassium
Trial phase: Phase 2
SMILES: CCCCc1nc(Cl)c(CO)n1Cc1ccc(-c2ccccc2-c2nnn[n-]2)cc1.[K+]
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 29
Group description: 20,000 units of EPO given on the day before surgery, the day of surgery, and the day after surgery.

Erythropoietin (EPO): Erythropoietin (EPO)-induced Protein 29, Human; 20,000 units subcutaneously given the day before surgery, day of surgery, and the day after surgery.
Eligibility criteria:
Inclusion Criteria:

Patient eligibility consists of men 40 to 65 years of age

Localized prostate cancer

clinical stage T2a or lower
Gleason grade of 3+4 or 3+3
prostate specific antigen (PSA) < 10
Scheduled to undergo curative prostatectomy applying bilateral nerve-sparing procedure, with intact pre-surgical erectile function
International Index of Erectile Function-5 (IIEF-5) score of 22-25.
The patient has a sexual partner, of at least 6 months.
The patient's pre-surgical hematocrit is ≤ 48.
The patient is willing to attempt intercourse at least 5 times per month following recovery from surgery.

Exclusion Criteria:

The patient has known penile deformity or a history of Peyronie's disease.
The patient has planned pre or post operative androgen therapy.
The patient has planned pre or post operative radiation therapy.
The patient is on anticoagulation therapy.
The patient has a history of sickle cell anemia.
The patient has a history of high or low blood pressure that is not controlled.
The patient is taking medications called "nitrates"
The patient has a history of heart problems such as angina, heart failure, irregular heartbeats, or myocardial infarction
The patient has a history of history of drug or alcohol abuse.
The patient currently smokes or has a 20 pack/year history of cigarette smoking.
The patient has a history of acute or chronic depression
The patient has a history liver problems, or kidney problems.
The patient has a history of retinitis pigmentosa or severe vision loss, including a condition called NAION, Nonarteritic Anterior Ischemic Optic Neuropathy.
The patient has a history of spinal trauma or surgery to the brain or spinal cord.
The patient has contraindications to the use of phosphodiesterase type 5 (PDE 5) inhibitors.
Patient is currently participating in another clinical investigation that would serve as a contraindication to administering erythropoietin.