anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Estradiol
Trial phase: Phase 3
ATC code: G02BB01 | G03AA14 | G03AA17 | G03AB08 | G03CA03 | G03CA53 | G03EA01 | G03EA02 | G03EA03 | G03FA01 | G03FA02 | G03FA03 | G03FA04 | G03FA05 | G03FA06 | G03FA07 | G03FA08 | G03FA09 | G03FA10 | G03FA11 | G03FA12 | G03FA13 | G03FA14 | G03FA15 | G03FA16 | G03FA17 | G03FB01 | G03FB02 | G03FB03 | G03FB04 | G03FB05 | G03FB06 | G03FB07 | G03FB08 | G03FB09 | G03FB10 | G03FB11 | G03FB12 | G03HB01 | H01CC53 | H01CC54
SMILES: [H][C@@]12CCc3cc(O)ccc3[C@@]1([H])CC[C@]1(C)[C@@H](O)CC[C@@]21[H]
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 695
Group description: estradiol cream

estrace cream (Perrigo)
Eligibility criteria:
Inclusion Criteria:

postmenopausal female and otherwise healthy, 30 - 75 years of age.
≤ 5% superficial cells on vaginal smear cytology at Visit 1/Screening.
vaginal pH > 5.0 at Visit 1/Screening
Have at least one self-assessed moderate to severe symptom of Vulvar and Vaginal Atrophy identified by the subject as being the most bothersome
For women with an intact uterus, vaginal ultrasonography confirmation at Visit 1/Screening of an inactive endometrial lining with an endometrial thickness less than 4 mm.
Systolic blood pressure no greater than 150 mm Hg and diastolic blood pressure no greater than 90 mm Hg at Visit 1/Screening and at Visit 2/Randomization

Exclusion Criteria:

Undiagnosed vaginal bleeding or a history of significant risk factors for endometrial cancer.
Known, suspected, or history of cancer of the breast or mammogram indicating any abnormalities or subject has a history of cervical cancer.
Vaginal ultrasonography for all women with an intact uterus confirming endometrial thickness of 4mm or more
History of hypersensitivity or allergy to estradiol or any of the other study medication ingredients.
Known or suspected estrogen-dependent neoplasia.

Has deep vein thrombosis, pulmonary embolism or history of these conditions.

• Subject has active arterial thromboembolic disease (e. g. stroke, myocardial infarction) or history of these conditions.

Known acute or chronic hepatic disease or dysfunction
Intervention: Estradiol
Trial phase: Phase 3
ATC code: G02BB01 | G03AA14 | G03AA17 | G03AB08 | G03CA03 | G03CA53 | G03EA01 | G03EA02 | G03EA03 | G03FA01 | G03FA02 | G03FA03 | G03FA04 | G03FA05 | G03FA06 | G03FA07 | G03FA08 | G03FA09 | G03FA10 | G03FA11 | G03FA12 | G03FA13 | G03FA14 | G03FA15 | G03FA16 | G03FA17 | G03FB01 | G03FB02 | G03FB03 | G03FB04 | G03FB05 | G03FB06 | G03FB07 | G03FB08 | G03FB09 | G03FB10 | G03FB11 | G03FB12 | G03HB01 | H01CC53 | H01CC54
SMILES: [H][C@@]12CCc3cc(O)ccc3[C@@]1([H])CC[C@]1(C)[C@@H](O)CC[C@@]21[H]
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 695
Group description: estradiol cream

estrace cream (Reference)
Eligibility criteria:
Inclusion Criteria:

postmenopausal female and otherwise healthy, 30 - 75 years of age.
≤ 5% superficial cells on vaginal smear cytology at Visit 1/Screening.
vaginal pH > 5.0 at Visit 1/Screening
Have at least one self-assessed moderate to severe symptom of Vulvar and Vaginal Atrophy identified by the subject as being the most bothersome
For women with an intact uterus, vaginal ultrasonography confirmation at Visit 1/Screening of an inactive endometrial lining with an endometrial thickness less than 4 mm.
Systolic blood pressure no greater than 150 mm Hg and diastolic blood pressure no greater than 90 mm Hg at Visit 1/Screening and at Visit 2/Randomization

Exclusion Criteria:

Undiagnosed vaginal bleeding or a history of significant risk factors for endometrial cancer.
Known, suspected, or history of cancer of the breast or mammogram indicating any abnormalities or subject has a history of cervical cancer.
Vaginal ultrasonography for all women with an intact uterus confirming endometrial thickness of 4mm or more
History of hypersensitivity or allergy to estradiol or any of the other study medication ingredients.
Known or suspected estrogen-dependent neoplasia.

Has deep vein thrombosis, pulmonary embolism or history of these conditions.

• Subject has active arterial thromboembolic disease (e. g. stroke, myocardial infarction) or history of these conditions.

Known acute or chronic hepatic disease or dysfunction
Intervention: Sapropterin
Trial phase: Phase 2
ATC code: A16AX07
SMILES: CC(O)C(O)C1CNc2nc(N)[nH]c(=O)c2N1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 15
Group description: Blood samples, flow-mediated dilation, arterial stiffness, lung function, and microvascular function will be performed at baseline and 12 weeks following 5mg/kg of Kuvan® or sapropterin dihydrochloride which is a synthetic preparation of the dihydrochloride salt of naturally occurring tetrahydrobiopterin (BH4), taken once a day.

Tetrahydrobiopterin (BH4): 12 week intervention
Eligibility criteria:
Inclusion Criteria:

patients with medically diagnosed COPD
apparently healthy controls

Exclusion Criteria:

FEV1/FVC >0.7 (normal lung function in patients only)
Clinical diagnosis of heart disease or diabetes
Vasoactive medications (i.e. nitrates, beta-blockers, Viagra etc.)
uncontrolled high blood pressure
high blood pressure in your lungs
thyroid problems
Fluid in the lungs
Sleep apnea
Anemia
Raynaud's Phenomenon
GI bleeding
Gangrene of the digits
History of low platelets or coagulopathies
Phenylketonuria (PKU)
Any allergy to Kuvan
Intervention: Lovenox
Trial phase: Phase 3
SMILES: CC(=O)NC1C(O)OC(COS(=O)(=O)O)C(OC2OC(C(=O)O)C(OC3OC(CO)C(OC4OC(C(=O)O)C(O)C(O)C4OS(=O)(=O)O)C(OS(=O)(=O)O)C3NS(=O)(=O)O)C(O)C2OS(=O)(=O)O)C1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 329
Group description: The group receiving VTE prophylaxis with enoxaparin 30mg subcutaneous BID.

VTE prophylaxis with Enoxaparin 30mg BID: Patients will receive Enoxaparin 30mg BID for DVT prophylaxis and will be followed to determine the efficacy, safety and cost when used for VTE prophylaxis in high-risk orthopedic traumas administered for the length of time indicated by standard of care based on the injury.
Eligibility criteria:
Inclusion Criteria:

All patients treated at a level-1 trauma center with any one or more of the following injuries: Pelvis fracture (operative or non-operative), Acetabulum fracture (operative or non-operative), or any operative extremity fracture (proximal to metatarsals/carpals)
Age greater than or equal to 18 years old

Exclusion Criteria:

Patients receiving pre-existing confounding prophylaxis or therapeutic anticoagulation (not to include anti-platelet agents) prior to admission or those receiving greater than one dose of LMWH since injury
Patients with pre-existing coagulopathy
Patients with a previous history of VTE within the last 6 months
Patients who are pregnant
Patients with CNS or spinal cord injury with potential need for further neurosurgical intervention precluding anticoagulation with aspirin
Patients with active bleeding precluding the use of anticoagulation
Impaired creatinine clearance <30ml/min at the time of randomization
History of Heparin Induced Thrombocytopenia or ASA or NSAID allergy
Prisoners
Non-english speaking patients
Patients who have an indication for therapeutic anticoagulation
Patients deemed inappropriate for inclusion in the study by their treating physician. Reason must be documented
Patients who would not normally receive VTE prophylaxis for their injury
Intervention: ASPIRIN
Trial phase: Phase 3
ATC code: A01AD05 | B01AC06 | B01AC56 | C07FX02 | C07FX03 | C07FX04 | C10BX01 | C10BX02 | C10BX04 | C10BX05 | C10BX06 | C10BX08 | C10BX12 | M01BA03 | N02AJ02 | N02AJ07 | N02AJ18 | N02BA01 | N02BA51 | N02BA71
SMILES: CC(=O)Oc1ccccc1C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 329
Group description: The group receiving VTE prophylaxis with ASA 81mg PO BID

VTE prophylaxis with Aspirin 81mg BID: Patients will receive Aspirin 81mg BID for DVT prophylaxis and will be followed to determine the efficacy, safety and cost when used for VTE prophylaxis in high-risk orthopedic traumas administered for the length of time indicated by standard of care based on the injury.
Eligibility criteria:
Inclusion Criteria:

All patients treated at a level-1 trauma center with any one or more of the following injuries: Pelvis fracture (operative or non-operative), Acetabulum fracture (operative or non-operative), or any operative extremity fracture (proximal to metatarsals/carpals)
Age greater than or equal to 18 years old

Exclusion Criteria:

Patients receiving pre-existing confounding prophylaxis or therapeutic anticoagulation (not to include anti-platelet agents) prior to admission or those receiving greater than one dose of LMWH since injury
Patients with pre-existing coagulopathy
Patients with a previous history of VTE within the last 6 months
Patients who are pregnant
Patients with CNS or spinal cord injury with potential need for further neurosurgical intervention precluding anticoagulation with aspirin
Patients with active bleeding precluding the use of anticoagulation
Impaired creatinine clearance <30ml/min at the time of randomization
History of Heparin Induced Thrombocytopenia or ASA or NSAID allergy
Prisoners
Non-english speaking patients
Patients who have an indication for therapeutic anticoagulation
Patients deemed inappropriate for inclusion in the study by their treating physician. Reason must be documented
Patients who would not normally receive VTE prophylaxis for their injury
Intervention: Erlotinib
Trial phase: Phase 2
ATC code: L01EB02 | L01XE03
SMILES: C#Cc1cccc(Nc2ncnc3cc(OCCOC)c(OCCOC)cc23)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 261
Group description: Erlotinib was administered at 150 milligrams (mg) orally daily until disease progression, unacceptable toxicity or death.
Eligibility criteria:
Inclusion Criteria:

Advanced NSCLC
Tumor accessible for biopsy by bronchoscopy
Disease progression following course of standard chemotherapy, or participants unwilling/unable to undergo chemotherapy

Exclusion Criteria:

Unstable systemic disease
Any other malignancies in the last 5 years
Brain metastases
Previous treatment with therapy acting on the epidermal growth factor receptor (EGFR) axis
Intervention: Pioglitazone
Trial phase: Phase 1 | Phase 2
ATC code: A10BD05 | A10BD06 | A10BD09 | A10BD12 | A10BG03
SMILES: CCc1ccc(CCOc2ccc(CC3SC(=O)NC3=O)cc2)nc1
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 30
Group description: Pioglitazone: Subjects randomized to pioglitazone begin with a starting dose of 15 mg daily administered. The dose will be titrated up to 30mg on the second week and 45 mg on the third week of the study. Subjects will remain on 45 mg of pioglitazone until the end of week 12. At the end of week 12 the study medication will be discontinued.

Therapy: Cognitive-behavioral therapy 1 hour per week

Contingency Management: Prize-based contingency management for attendance
Eligibility criteria:
Inclusion Criteria:

DSM-IV criteria for cocaine dependence
At least one cocaine positive urine during screening
Female subjects: a negative pregnancy test
Be in acceptable health on the basis of interview, medical history and physical exam
Be able to understand the consent form and provide written informed consent
Be able to provide the names of at least 2 persons who can generally locate their whereabouts.

Exclusion Criteria:

Current Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV diagnosis of any psychoactive substance dependence other than cocaine marijuana, alcohol, or nicotine
Any serious medical or psychiatric illness and/or clinically significant abnormal laboratory value, which in the judgment of the Principal Investigator or his/her designee would make study participation unsafe, or would make treatment compliance difficult or put the study staff at undue risk
Significant current suicidal or homicidal ideation
Medical conditions contraindicating pioglitazone pharmacotherapy (e.g., congestive heart failure as determined by Framingham criteria, clinically significant edema, clinically significant liver disease, hypoglycemia, diabetes, history of bladder cancer)
Taking medications known to have significant drug interactions with the study medication (CYP2C8 inhibitors or inducers, antihyperglycemic medications)
Currently being treated for substance misuse with medication
Conditions of probation or parole requiring reports of drug use to officers of the court
Impending incarceration
Pregnant or planning to become pregnant during the course of the trial or nursing for female patients
Inability to read, write, or speak English (many of the research instruments in this study only exist in English)
Having plans to leave the immediate geographical area within 3 months
Unwillingness to sign a written informed consent form
Unwillingness to use a barrier method of birth control during the study for female patients
History of pacemaker or metal implants or welding or metal work without protective eyewear (for risk of MRI scans).
Intervention: Victoza
Trial phase: Not Applicable
ATC code: A10BJ02
SMILES: CCCCCCCCCCCCCCCC(=O)NC(CCC(=O)NCCCCC(NC(=O)C(C)NC(=O)C(C)NC(=O)C(CCC(N)=O)NC(=O)CNC(=O)C(CCC(=O)O)NC(=O)C(CC(C)C)NC(=O)C(Cc1ccc(O)cc1)NC(=O)C(CO)NC(=O)C(CO)NC(=O)C(NC(=O)C(CC(=O)O)NC(=O)C(CO)NC(=O)C(NC(=O)C(Cc1ccccc1)NC(=O)C(NC(=O)CNC(=O)C(CCC(=O)O)NC(=O)C(C)NC(=O)C(N)Cc1cnc[nH]1)C(C)O)C(C)O)C(C)C)C(=O)NC(CCC(=O)O)C(=O)NC(Cc1ccccc1)C(=O)NC(C(=O)NC(C)C(=O)NC(Cc1c[nH]c2ccccc12)C(=O)NC(CC(C)C)C(=O)NC(C(=O)NC(CCCNC(=N)N)C(=O)NCC(=O)NC(CCCNC(=N)N)C(=O)NCC(=O)O)C(C)C)C(C)CC)C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 43
Group description: single dose of Victoza ( liraglutide) 1.8 mg

Victoza: Single dose of Liraglutide
Eligibility criteria:
Inclusion Criteria:

Type 1 Diabetes on continuous subcutaneous insulin infusion (CSII, also known as insulin pump).
Undetectable c peptide (c-peptide < 0.1 ng/ml).
HbA1c of less than or equal to 8.5%.
Age 18-75 inclusive

Exclusion Criteria:

Type 1 diabetes for less than 12 months
Coronary event/ procedure (MI, Unstable angina, CABG, PCI) in the last four weeks
Hepatic disease (Transaminase > 3 times normal) or Cirrhosis
Renal impairment (serum eGFR <30ml/min/1.73m2)
HIV or Hepatitis B or C positive status
History of pancreatitis, i.e., history of gallstones, alcohol abuse and hypertriglyceridemia
Pregnancy
Inability to give informed consent
History of Gastroparesis
Personal or Family History of medullary thyroid carcinoma or MEN 2 syndrome
Alcoholism
Hypertriglyceridemia (>500 mg/dl).
Those with history of bladder cancer , diabetic ketoacidosis
Intervention: Dapagliflozin
Trial phase: Not Applicable
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: 43
Group description: Single dose of dapagliflozin 10 mg
Eligibility criteria:
Inclusion Criteria:

Type 1 Diabetes on continuous subcutaneous insulin infusion (CSII, also known as insulin pump).
Undetectable c peptide (c-peptide < 0.1 ng/ml).
HbA1c of less than or equal to 8.5%.
Age 18-75 inclusive

Exclusion Criteria:

Type 1 diabetes for less than 12 months
Coronary event/ procedure (MI, Unstable angina, CABG, PCI) in the last four weeks
Hepatic disease (Transaminase > 3 times normal) or Cirrhosis
Renal impairment (serum eGFR <30ml/min/1.73m2)
HIV or Hepatitis B or C positive status
History of pancreatitis, i.e., history of gallstones, alcohol abuse and hypertriglyceridemia
Pregnancy
Inability to give informed consent
History of Gastroparesis
Personal or Family History of medullary thyroid carcinoma or MEN 2 syndrome
Alcoholism
Hypertriglyceridemia (>500 mg/dl).
Those with history of bladder cancer , diabetic ketoacidosis
Intervention: Sertraline
Trial phase: Phase 4
ATC code: N06AB06
SMILES: CN[C@H]1CC[C@@H](c2ccc(Cl)c(Cl)c2)c2ccccc21
Sex: Female
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 84
Group description: To determine the impact of short term luteal phase treatment with Sertraline 50mg tablets (PMDD group only) on arousal regulation across the menstrual cycle.

Sertraline: Sertraline will be provided at a dose of 50 mg daily for up to 3 weeks, depending on the length of a woman's luteal phase. Medication will be taken only during the luteal phase. Women will initiate sertraline treatment upon determining that they have ovulated (using a urine LH Kit) and remain on sertraline until onset of their next menstrual period at which time they will stop taking the medication.
Eligibility criteria:
Inclusion Criteria:

Participants must be:

Aged 18 - 50 years, per self-report
Able to give written informed consent, per self-report
Fluent in written and spoken English
Have normal or corrected to normal hearing and vision, per self-report
Female participants must be experiencing regular menstrual cycles (24-39 days), per self-report
Have a negative urine drug screen.

Exclusion Criteria:

Participants cannot have:

Use of an psychotropic medication anytime in the past 2 months, per self-report
Drug or alcohol abuse history within previous 2 years
Lifetime history of psychotic disorder including, schizophrenia, schizoaffective disorder, major depression with psychotic features and bipolar disorder, per self-report
Currently homeless, per self-report
History of any Axis I disorder other then specific phobia within the past 12 months, per Structured Clinical Interview for Diagnostic and Statistical Manual (SCID) interview
Active suicidal ideation (suicide plan or suicide attempt) within the previous 6 months, per self-report
Steroid hormone or hormonal contraceptive use in the past 6 months, per self-report, except emergency contraceptive use
Pregnancy in the past year, per self-report. Pregnancy during the study is also exclusionary. Participants must use a reliable, nonhormonal form of birth control during the study. If a participant becomes pregnant, she must inform study staff.
Sensitive hearing, per self-report.
Intervention: Bupivacaine
Trial phase: Phase 4
ATC code: N01BB01 | N01BB10 | N01BB51 | N01BB59
SMILES: CCCCN1CCCCC1C(=O)Nc1c(C)cccc1C
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 155
Group description: 15 cc's of 0.5% bupivacaine preoperatively administered by the regional pain anesthesia team in the pre-operative block area, just prior to surgery.

Adductor Canal Block (ACB)

Bupivacaine: 15 cc's of 0.5% bupivacaine or 50 cc's of 0.25% short-acting bupivacaine (SB), intramuscular injection
Eligibility criteria:
Inclusion Criteria:

- Patients undergoing an unilateral primary total knee arthroplasty under the care of the two senior arthroplasty surgeons.

Exclusion Criteria:

- Allergy to bupivicaine or liposomal bupivicaine.
Intervention: Bupivacaine
Trial phase: Phase 4
ATC code: N01BB01 | N01BB10 | N01BB51 | N01BB59
SMILES: CCCCN1CCCCC1C(=O)Nc1c(C)cccc1C
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 155
Group description: 50 cc's of 0.25% bupivacaine will be injected intraoperatively, just prior to wound closure, by the performing surgeon.

Bupivacaine: 15 cc's of 0.5% bupivacaine or 50 cc's of 0.25% short-acting bupivacaine (SB), intramuscular injection
Eligibility criteria:
Inclusion Criteria:

- Patients undergoing an unilateral primary total knee arthroplasty under the care of the two senior arthroplasty surgeons.

Exclusion Criteria:

- Allergy to bupivicaine or liposomal bupivicaine.
Intervention: Bupivacaine
Trial phase: Phase 4
ATC code: N01BB01 | N01BB10 | N01BB51 | N01BB59
SMILES: CCCCN1CCCCC1C(=O)Nc1c(C)cccc1C
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 155
Group description: 15 cc's of 0.5% bupivacaine preoperatively administered by the regional pain anesthesia team in the pre-operative block area, just prior to surgery.

50 cc's of 0.25% bupivacaine will be injected intraoperatively, just prior to wound closure, by the performing surgeon.

Bupivacaine: 15 cc's of 0.5% bupivacaine or 50 cc's of 0.25% short-acting bupivacaine (SB), intramuscular injection
Eligibility criteria:
Inclusion Criteria:

- Patients undergoing an unilateral primary total knee arthroplasty under the care of the two senior arthroplasty surgeons.

Exclusion Criteria:

- Allergy to bupivicaine or liposomal bupivicaine.
Intervention: Fasoracetam
Trial phase: Phase 2 | Phase 3
SMILES: O=C1CC[C@H](C(=O)N2CCCCC2)N1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 47
Group description: Doses of NFC-1 will be administered as 100, 200, or 400 mg twice daily as capsules (size 2 hard gelatin capsules).
Eligibility criteria:
Inclusion Criteria:

Subject has ADHD as defined by the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) and Version 5 of the Attention Deficit Hyperactivity Disorder Rating Scale (ADHD-RS-5) ≥ 28 at Baseline with or without conventional ADHD therapy.
Subject has an intelligence quotient (IQ) > 79, based on the Wechsler Abbreviated Scale of Intelligence, second edition (WASI-II).
Subject has been genotyped previously and determined to have disruptive mutations in genes within the glutamate receptor metabotropic (GRM)-network as determined by the presence of copy number variations (CNVs) (GRM biomarker-positive subjects). The confirmation of a subject's positive status will be provided by the sponsor.
Subject is judged to be in general good health, other than having ADHD, based on medical history, physical examination, vital signs measurements, laboratory safety tests, and the Columbia Suicide Severity Rating Scale (C-SSRS) performed at the Screening Visit and/or prior to administration of investigational product (IP).
Subject has no clinically significant abnormality on electrocardiogram (ECG) performed at the Screening Visit and/or prior to administration of IP such as serious arrhythmia, bradycardia, tachycardia, cardiac conduction problems, or other abnormalities deemed to be a potential safety issue.
Parent/legal guardian and subject understand the study procedures and agree to the subject's participation in the study as indicated by parental/legal guardian signature on the subject informed consent form and subject signature on the assent form.

Exclusion Criteria:

Subjects with prior diagnosis of comorbid major psychiatric disorders (ie, aside from ADHD), including major depression, bipolar disease, schizophrenia, pervasive development disorder, and intellectual disability.
Subject is currently taking a prohibited medication and/or is unwilling to wean off current ADHD medication to participate in the study
Subject has a history of any illness that in the opinion of the study investigator might confound the results of the study or poses an additional risk to the subject by his or her participation in the study.
Subject has a known history or presence of syncope, cardiac conduction problems (eg, clinically significant heart block), exercise-related cardiac events including syncope and pre-syncope, or clinically significant bradycardia.
Subject has a history of stroke, chronic seizures, or major neurological disorder which, in the opinion of the investigator, would interfere with the subject's ability to participate and/or be evaluated in the study.