anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Intralipid
Trial phase: Phase 4
SMILES: CCCCCC=CCC=CCCCCCCCC(=O)O.CCCCCCCCC=CCCCCCCCC(=O)OC(COC(=O)CCCCCCCCCCCCCCC)COP(=O)(O)OCC[N+](C)(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 13
Group description: Obese, normotensive African-Americans without diabetes received Intralipid 20% at 40ml/hr intravenously for 48 hours
Eligibility criteria:
Inclusion Criteria:

Males or females between the ages of 18 and 70 years.
Subjects must have a BMI of ≥ 30 kg/m2.
Subjects must have a BP < 130/80 mm Hg and no prior history of hypertension.
A known history of type 2 diabetes mellitus < 3 years (now 5 years).
Subjects must have an HbA1c of < 9%.
Diabetic subjects must have been receiving as their only current anti-diabetic therapy stable doses of sulfonylureas for the last 2 months.
Subjects must be able to understand and willing to adhere to the study protocol.

Exclusion Criteria:

Subjects with history of hypertension (BP > 140/90 mm HG) or who have received antihypertensive drug therapy prior to the study.
Obese nondiabetic controls with impaired glucose tolerance (2-hour glucose between 140 - 199 mg/dl) during a 75-g OGTT.
Diabetic subjects who require insulin therapy or have received an insulin sensitizer agent (metformin, rosiglitazone, pioglitazone) within 3 months of entering the study (at SV1, week-2).
Subjects with fasting triglyceride levels > 250 mg/dL prior to the study (at SV1, week-2).
Clinically relevant hepatic disease (ALT 2.5x > upper limit of normal), or other significant medical or surgical illness.
Renal failure, as shown by a serum creatinine ≥1.5 mg/dL for males, or ≥ 1.4 mg/dL for females.
Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
Female subjects are pregnant or breast feeding at time of enrollment into the study.
Intervention: Promega
Trial phase: Not Applicable
SMILES: CCC=CCC=CCC=CCC=CCC=CCC=CCCC(=O)O.CCCC=CCC=CCC=CCC=CCC=CCCCC(=O)O
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 286
Group description: Once eligible, Soybean Oil Emulsion was discontinued and Fish Oil Emulsion was commenced at 1 g/kg/d. Fish Oil Emulsion was provided as an infusion over 18-24 hours a day. Fish Oil Emulsion was provided in a dedicated peripheral or central venous access.

Any cause mortality prior to the End of Study
Eligibility criteria:
Inclusion Criteria:

Be greater than 14 days old and less than 5 years old
Conjugated bilirubin greater than 2 mg/dL.
Be expected to require intravenous nutrition for at least an additional 28 days

Exclusion Criteria:

Have a congenitally lethal condition (e.g. Trisomy 13).
Have clinically severe bleeding not able to be managed with routine measures.
Have evidence of a viral hepatitis or primary liver disease as the primary etiology of their cholestasis.
Have other health problems such that survival is extremely unlikely even if the infant's cholestasis improves.

Home Use of Omegaven®:

In order for a subject to receive the Omegaven® at home through a home health care agency, subjects will first be required to be admitted to Texas Children's Hospital for 72 hours in initiate the administration of the Omegaven®. This will allow time for observation of any unexpected side effects and for parents to be provided education on home TPN and Omegaven®.

If a subject has already received Omegaven® either at TCH or at another hospital, they will not be required to be admitted for the 72 hour inpatient admission prior to starting Omegaven® at home. Parent training will occur during the previous hospital admission and will continue through the TCH Pediatric Intestinal Rehabilitation Clinic.

Outpatient Monitoring:

After the initial evaluation by the TCH Pediatric Intestinal Rehabilitation Clinic physicians, subjects will return to the clinic for routine follow-up. Subjects will be asked to return to the clinic every 2 weeks for the first 2 months of treatment. Thereafter, subjects will return to the clinic on a monthly basis, or as directed by the clinic team.
Intervention: Vardenafil
Trial phase: Phase 4
ATC code: G04BE09
SMILES: CCCc1nc(C)c2c(=O)nc(-c3cc(S(=O)(=O)N4CCN(CC)CC4)ccc3OCC)[nH]n12
Sex: Male
Age groups: Adult
Healthy volunteers: No
Participants at risk: 75
Group description: Vardenafil 10 mg tablets PRN (pro re nata) for 4 weeks, Vardenafil 5 mg/10 mg/20 mg tablets PRN for consecutive 4 weeks
Eligibility criteria:
Inclusion Criteria:

Stable heterosexual relationship
History of erectile dysfunction for at least 6 months
IIEF- EF Domain entry score (at Visit 2): >21 points
Documented metabolic syndrome according to the IDF (International Diabetes Foundation)
Subjects motivated for erectile dysfunction treatment
Documented, dated, written informed consent

Exclusion Criteria:

Any underlying cardiovascular condition
History of myocardial infarction
Uncontrolled atrial fibrillation
Resting hypotension
Postural hypotension within 6 months of Visit 1
History of congenital QT prolongation
Bleeding disorder
History of prostatectomy because of prostate cancer
Hereditary degenerative retinal disorders
History of loss of vision because of NAION (non-arteritic anterior ischemic optic neuropathy)
29 Additional Exclusion Criteria
Intervention: Valsartan
Trial phase: Phase 3
ATC code: C09CA03 | C09DA03 | C09DB01 | C09DB08 | C09DX01 | C09DX02 | C09DX04 | C09DX05 | C10BX10
SMILES: CCCCC(=O)N(Cc1ccc(-c2ccccc2-c2nn[nH]n2)cc1)[C@H](C(=O)O)C(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 12
Group description: Participants who were administered Valsartan 80 mg by mouth daily for one year. (Group D)
Eligibility criteria:
Inclusion Criteria:

Females Or Males Over 18 Years Old
Patients With Systemic Arterial Hypertension Grade I And II According With The European Society Of Cardiology
Left Ventricular hypertrophy Demonstrated By Echocardiography
Mild To Moderated hypercholesterolemia
Willing To Participate And Sign The Informed Consent Form (ICF)

Exclusion Criteria:

Type 1 Or 2 Diabetes Mellitus
Familiar hypercholesterolemia
Low Density Lipoprotein-Cholesterol (LDL-C) > 190 mg/dl
History Of Myocardial Infarction Or Stable Chronic Angina
Triglycerides >250 mg/dl
Intervention: Simvastatin
Trial phase: Phase 4
ATC code: A10BH51 | C10AA01 | C10BA02 | C10BA04 | C10BX01 | C10BX04
SMILES: CCC(C)(C)C(=O)OC1CC(C)C=C2C=CC(C)C(CCC3CC(O)CC(=O)O3)C21
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 4
Group description: simvastatin 20 mg daily at nights for 12 weeks
Eligibility criteria:
Inclusion Criteria:

Female Patients Over 18 Years Old
Confirmed Systemic Lupus Erythematosus (SLE) diagnosis according to American College of Rheumatology (ACR)
Signed Informed Consent Form (ICF)

Exclusion Criteria:

Patients With LDL-C Below 90 mg/dL
Pregnant Or Breast Feeding
Diabetes Mellitus
Or Any Clinically Relevant Organ Disfunction
Intervention: Chloraprep
Trial phase: Phase 4
SMILES: CC(C)O.NC(=NCCCCCCN=C(N)N=C(N)Nc1ccc(Cl)cc1)N=C(N)Nc1ccc(Cl)cc1.O=C(O)C(O)C(O)C(O)C(O)CO.O=C(O)CC(O)C(O)C(O)CO
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 20
Group description: Skin preparation for hip replacement with a Chlorhexidine based skin preparation solution, Chloraprep® (CHG 2% w/v and IPA 70% v/v; Enturia Inc., Leawood, KS, USA)
Eligibility criteria:
Inclusion Criteria:

English speaking
Patients undergoing primary total hip surgery in a supine position.
Patients must be of light skin color
Patients must not be allergic to chlorhexidine or iodine

Exclusion Criteria:

Non English speaking
Patients not undergoing primary total hip surgery in a supine position.
Patients not of light skin color
Patients allergic to chlorhexidine or iodine
Intervention: ISOPROPYL ALCOHOL
Trial phase: Phase 4
ATC code: D08AX05
SMILES: CC(C)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 20
Group description: Skin preparation for hip replacement with an Iodine based skin preparation solution, Duraprep® (Iodophor 0.7% and IPA 74% w/w; 3M Healthcare, St. Paul, MN, USA.
Eligibility criteria:
Inclusion Criteria:

English speaking
Patients undergoing primary total hip surgery in a supine position.
Patients must be of light skin color
Patients must not be allergic to chlorhexidine or iodine

Exclusion Criteria:

Non English speaking
Patients not undergoing primary total hip surgery in a supine position.
Patients not of light skin color
Patients allergic to chlorhexidine or iodine
Intervention: Losartan Potassium (DuP 753)
Trial phase: Phase 3
SMILES: CCCCc1nc(Cl)c(CO)n1Cc1ccc(-c2ccccc2-c2nn[nH]n2)cc1.[K]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 531
Group description: Losartan-based regimen (50 mg or 100 mg once daily for 40 weeks) with sequential titration including HCTZ 12.5 mg or 25 mg and CCB as needed to achieve target blood pressure.
Eligibility criteria:
Inclusion Criteria:

Non Diabetic, Newly Diagnosed And Untreated For Mild To Moderate Hypertension (blood pressure > 161; < 221; 140/90 mm Hg But < 180/110 mm Hg)
Non diabetic, newly diagnosed and untreated for severe hypertension (blood pressure > 180/110 mm Hg but < 200/120 mm Hg); Patients who are asymptomatic with no evidence of significant end organ damage including direct pressure effects can be included. Patients in an urgency/emergency state are to be excluded
Or Diabetic, Newly Diagnosed With Hypertension And Untreated With Mild To Moderate Hypertension (blood pressure > 161;< 221; 130/80 mm Hg But < 160/100 mm Hg); Or Patient Receiving One Antihypertensive Agent (Monotherapy Only) Used To Treat Hypertension For At Least 4 Weeks And Whose Blood Pressure Is Not Controlled: blood pressure > 161;< 221; 140/90 mm Hg But < 160/100 mm Hg Or For Diabetic And/Or Coronary Artery Disease Patients: blood pressure > 161;< 221; 130/80 mm Hg But > 161;< 221; 150/90 mm Hg
The Antihypertensive Agent Will Need To Be Discontinued Prior To Starting Study Drug

Exclusion Criteria:

Known Secondary Hypertension Of Any Aetiology (E.G., Uncorrected Renal Artery Stenosis, Malignant Hypertension, Hypertensive Encephalopathy. Patient With Symptomatic Heart Failure (Classes 3 And 4). Patient With A Prior Myocardial Infarction Or Stroke Within The Last 6 Months
Patient Has Undergone Percutaneous Coronary Angioplasty, Has Had Coronary Artery Bypass Within The Last 6 Months Or Has Unstable Angina
Patient With Anuria Or Confirmed Clinically Significant Renal Or Hepatic Dysfunction (Taken From Current/Past Medical Records) And/Or Electrolyte Imbalance Laboratory Test Within The Last 3 Months Prior To Visit 1: Serum Creatinine > 130 Ìmol/L Or Creatinine Clearance < 45 Ml/Min, Ast > 3 Times Above The Normal Range, Alt > 3 Times Above The Normal Range, Serum Potassium < 3.5 Or > 5.5 Meq/L
Significant Liver Or Respiratory Disease, Cancer Or Other concomitant Disease That Is Likely To Affect Life Expectancy Of The Patient
Intervention: Linagliptin
Trial phase: Phase 3
ATC code: A10BD11 | A10BD19 | A10BD27 | A10BH05
SMILES: CC#CCn1c(N2CCC[C@@H](N)C2)nc2c1c(=O)n(Cc1nc(C)c3ccccc3n1)c(=O)n2C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 151
Group description: Patients treated with Linagliptin 5mg once daily (up to 52 weeks)
Eligibility criteria:
Inclusion criteria Patients between 18 and 80 years old with type 2 diabetes and insufficient glycemic control (HbA1c 7% to 10%) for whom metformin therapy is inappropriate (intolerability or contraindication)

Exclusion criteria Myocardial infarction, stroke or Transient ischaemic attack in last 6 months Treatment with rosiglitazone or pioglitazone, GLP-1 analogues, insulin or anti-obesity drugs in past 3 months Impaired hepatic function Severe renal impairment current treatment with systemic steroids change in dosage of thyroid hormones hereditary galactose intolerance
Intervention: Iopamidol
Trial phase: Phase 4
ATC code: V08AB04
SMILES: C[C@H](O)C(=O)Nc1c(I)c(C(=O)NC(CO)CO)c(I)c(C(=O)NC(CO)CO)c1I
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 17
Group description: Participants were injected at least once in 1 of the following 3 locations: aortic bifurcation (injection rate 8-10 mL/s, total volume 15-20 mL), iliac arteries (injection rate 5-6 mL/s, total volume 10-12 mL), or superficial femoral artery (injection rate 3-5 mL/s, depending on diameter and condition of artery, total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
Eligibility criteria:
Inclusion Criteria:

Enroll a patient in this study if the patient meets the following inclusion criteria:

Provides written Informed Consent and is willing to comply with protocol requirements;
Is at least 18 years of age;
Is scheduled to undergo peripheral DSA for the diagnosis and/or treatment (PTA) of PAOD.

Exclusion Criteria:

Exclude a patient from this study if the patient does not fulfill the inclusion criteria, or if any of the following conditions are observed:

Is a pregnant or lactating female. Exclude the possibility of pregnancy:
by testing on site at the institution (serum or urine βHCG) within 24 hours prior to the start of investigational product administration,
by surgical history (e.g., tubal ligation or hysterectomy),
post menopausal with a minimum 1 year without menses;
Has any known allergy to one or more of the ingredients of the investigational products;
Has a history of severe congestive heart failure [class IV in accordance with the classification of the New York Heart Association (NYHA)]
Was previously entered into this study or received an investigational compound within 30 days before admission into this study;
Has a history of hypersensitivity to iodinated contrast agents;
Has renal impairment (eGFR <60 mL/min/1.73 m2, calculated using the Modification of Diet in Renal Disease [MDRD] study equation , );
Has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study and/or postdose follow-up examinations.
Intervention: Iodixanol
Trial phase: Phase 4
ATC code: V08AB09
SMILES: CC(=O)N(CC(O)CN(C(C)=O)c1c(I)c(C(=O)NCC(O)CO)c(I)c(C(=O)NCC(O)CO)c1I)c1c(I)c(C(=O)NCC(O)CO)c(I)c(C(=O)NCC(O)CO)c1I
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 16
Group description: Participants were injected at least once in 1 of the following 3 locations: aortic bifurcation (injection rate 8-10 mL/s, total volume 15-20 mL), iliac arteries (injection rate 5-6 mL/s, total volume 10-12 mL), or superficial femoral artery (injection rate 3-5 mL/s, depending on diameter and condition of artery, total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
Eligibility criteria:
Inclusion Criteria:

Enroll a patient in this study if the patient meets the following inclusion criteria:

Provides written Informed Consent and is willing to comply with protocol requirements;
Is at least 18 years of age;
Is scheduled to undergo peripheral DSA for the diagnosis and/or treatment (PTA) of PAOD.

Exclusion Criteria:

Exclude a patient from this study if the patient does not fulfill the inclusion criteria, or if any of the following conditions are observed:

Is a pregnant or lactating female. Exclude the possibility of pregnancy:
by testing on site at the institution (serum or urine βHCG) within 24 hours prior to the start of investigational product administration,
by surgical history (e.g., tubal ligation or hysterectomy),
post menopausal with a minimum 1 year without menses;
Has any known allergy to one or more of the ingredients of the investigational products;
Has a history of severe congestive heart failure [class IV in accordance with the classification of the New York Heart Association (NYHA)]
Was previously entered into this study or received an investigational compound within 30 days before admission into this study;
Has a history of hypersensitivity to iodinated contrast agents;
Has renal impairment (eGFR <60 mL/min/1.73 m2, calculated using the Modification of Diet in Renal Disease [MDRD] study equation , );
Has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study and/or postdose follow-up examinations.
Intervention: Silodosin
Trial phase: Phase 2
ATC code: G04CA04
SMILES: C[C@H](Cc1cc2c(c(C(N)=O)c1)N(CCCO)CC2)NCCOc1ccccc1OCC(F)(F)F
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 52
Group description: Silodosin 4 mg daily
Eligibility criteria:
Inclusion Criteria:

Male, at least 18 years of age
Has a total NIH-CPSI total score of 15
Has a NIH-CPSI pain score of 8
Has had pain in the pelvic region for at least 3 months prior to screening

Exclusion Criteria:

Has previously participated in a Watson study with silodosin
Has previously received α-blocked therapy for chronic prostatitis/chronic pelvic pain syndrome or is currently receiving α-blocked therapy for any condition
Has experience ≥2 urinary tract infections within the previous 12 months
Has any medical condition that in the opinion of the investigator precludes safe participation in the study
Has any medical condition that could confound the efficacy evaluation
Is receiving ketoconazole, or other known potent inhibitors of cytochrome P450 3A4 or any medication in the opinion of the investigator that precludes safe participation in the study
Is receiving any medication that in the opinion of the investigator that could confound the efficacy evaluation
Has participated in a study involving the administration of an investigational agent within the past 30 days
Intervention: Silodosin
Trial phase: Phase 2
ATC code: G04CA04
SMILES: C[C@H](Cc1cc2c(c(C(N)=O)c1)N(CCCO)CC2)NCCOc1ccccc1OCC(F)(F)F
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 45
Group description: Silodosin 8 mg daily
Eligibility criteria:
Inclusion Criteria:

Male, at least 18 years of age
Has a total NIH-CPSI total score of 15
Has a NIH-CPSI pain score of 8
Has had pain in the pelvic region for at least 3 months prior to screening

Exclusion Criteria:

Has previously participated in a Watson study with silodosin
Has previously received α-blocked therapy for chronic prostatitis/chronic pelvic pain syndrome or is currently receiving α-blocked therapy for any condition
Has experience ≥2 urinary tract infections within the previous 12 months
Has any medical condition that in the opinion of the investigator precludes safe participation in the study
Has any medical condition that could confound the efficacy evaluation
Is receiving ketoconazole, or other known potent inhibitors of cytochrome P450 3A4 or any medication in the opinion of the investigator that precludes safe participation in the study
Is receiving any medication that in the opinion of the investigator that could confound the efficacy evaluation
Has participated in a study involving the administration of an investigational agent within the past 30 days
Intervention: ULIPRISTAL ACETATE
Trial phase: Phase 3
SMILES: CC(=O)O[C@]1(C(C)=O)CC[C@H]2[C@@H]3CCC4=CC(=O)CCC4=C3[C@@H](c3ccc(N(C)C)cc3)C[C@@]21C
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 97
Group description: Drug: PGL4001 5mg (oral tablets) and leuproreline matching placebo (intramuscular injection)
Eligibility criteria:
Inclusion Criteria:

Be a pre-menopausal woman between 18 and 50 years inclusive.
Have excessive uterine bleeding due to myoma
Have a myomatous uterus with at least one myoma of ≥ 3 cm diameter in size
Be eligible for one surgical procedure: e.g. hysterectomy, myomectomy or others.
If of childbearing potential the subject must be practicing a non-hormonal method of contraception.
Have a Body Mass Index (BMI) ≥ 18 and ≤ 40.

Exclusion Criteria:

Has a history of or current uterine, cervical, ovarian or breast cancer.
Has a history of or current endometrium atypical hyperplasia or adenocarcinoma.
Has a known severe coagulation disorder.
Has a history of or current treatment for myoma with a Selective Progesterone Receptor Modulator (SPRM) or a GnRH-agonist.
Has a history of or known current osteoporosis.
Has abnormal hepatic function at study entry.
Has a positive pregnancy test at baseline or is nursing or planning a pregnancy during the course of the study.
Has a current (within twelve months) problem with alcohol or drug abuse.
Is currently enrolled in an investigational drug or device study or has participated in such a study within the last 30 days.
Intervention: ULIPRISTAL ACETATE
Trial phase: Phase 3
SMILES: CC(=O)O[C@]1(C(C)=O)CC[C@H]2[C@@H]3CCC4=CC(=O)CCC4=C3[C@@H](c3ccc(N(C)C)cc3)C[C@@]21C
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 103
Group description: Drug: PGL4001 10 mg (oral tablets) and leuproreline matching placebo (intramuscular injection)
Eligibility criteria:
Inclusion Criteria:

Be a pre-menopausal woman between 18 and 50 years inclusive.
Have excessive uterine bleeding due to myoma
Have a myomatous uterus with at least one myoma of ≥ 3 cm diameter in size
Be eligible for one surgical procedure: e.g. hysterectomy, myomectomy or others.
If of childbearing potential the subject must be practicing a non-hormonal method of contraception.
Have a Body Mass Index (BMI) ≥ 18 and ≤ 40.

Exclusion Criteria:

Has a history of or current uterine, cervical, ovarian or breast cancer.
Has a history of or current endometrium atypical hyperplasia or adenocarcinoma.
Has a known severe coagulation disorder.
Has a history of or current treatment for myoma with a Selective Progesterone Receptor Modulator (SPRM) or a GnRH-agonist.
Has a history of or known current osteoporosis.
Has abnormal hepatic function at study entry.
Has a positive pregnancy test at baseline or is nursing or planning a pregnancy during the course of the study.
Has a current (within twelve months) problem with alcohol or drug abuse.
Is currently enrolled in an investigational drug or device study or has participated in such a study within the last 30 days.
Intervention: Leuprolide
Trial phase: Phase 3
ATC code: L02AE02 | L02AE51
SMILES: CCNC(=O)[C@@H]1CCCN1C(=O)[C@H](CCCNC(=N)N)NC(=O)[C@H](CC(C)C)NC(=O)[C@@H](CC(C)C)NC(=O)[C@H](Cc1ccc(O)cc1)NC(=O)[C@H](CO)NC(=O)[C@H](Cc1c[nH]c2ccccc12)NC(=O)[C@H](Cc1c[nH]cn1)NC(=O)[C@@H]1CCC(=O)N1
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 101
Group description: PGL4001 matching placebo (oral tablets) and leuprorelin 3.75 mg (intramuscular injection)
Eligibility criteria:
Inclusion Criteria:

Be a pre-menopausal woman between 18 and 50 years inclusive.
Have excessive uterine bleeding due to myoma
Have a myomatous uterus with at least one myoma of ≥ 3 cm diameter in size
Be eligible for one surgical procedure: e.g. hysterectomy, myomectomy or others.
If of childbearing potential the subject must be practicing a non-hormonal method of contraception.
Have a Body Mass Index (BMI) ≥ 18 and ≤ 40.

Exclusion Criteria:

Has a history of or current uterine, cervical, ovarian or breast cancer.
Has a history of or current endometrium atypical hyperplasia or adenocarcinoma.
Has a known severe coagulation disorder.
Has a history of or current treatment for myoma with a Selective Progesterone Receptor Modulator (SPRM) or a GnRH-agonist.
Has a history of or known current osteoporosis.
Has abnormal hepatic function at study entry.
Has a positive pregnancy test at baseline or is nursing or planning a pregnancy during the course of the study.
Has a current (within twelve months) problem with alcohol or drug abuse.
Is currently enrolled in an investigational drug or device study or has participated in such a study within the last 30 days.