anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Phenytoin
Trial phase: Phase 4
ATC code: N03AB02 | N03AB52
SMILES: O=C1NC(=O)C(c2ccccc2)(c2ccccc2)N1
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 27
Group description: Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
Eligibility criteria:
Inclusion Criteria:

Healthy, ambulatory, male and female volunteers between 16-45 years of age;
Scheduled to undergo surgical removal of 1 to 3 impacted third molars, one of which must be at least a partial bony mandibular impaction;
Have moderate to severe postoperative pain on the Categorical Pain Rating Scale and a score of >/= 50 mm on the 100-mm visual analog Pain Severity Rating Scale by 2030 h +/- 15 minutes on the day of surgery;
Female subjects of childbearing potential must be using a medically acceptable form of birth control for at least 1 month prior to screening (3 months on oral contraceptives), e.g. oral or patch contraceptives, intrauterine device, Depo-Provera, or double-barrier and have a negative pregnancy test at Screening and prior to surgery. Female subjects of nonchildbearing potential must be amenorrheic for at least 2 years or had a hysterectomy and/or bilateral oophorectomy;
Provide a personally signed and dated informed consent indicating that the subject has been informed of all pertinent aspects of the trial, (subjects <18 years of age must sign a written assent and have parental or guardian consent).

Exclusion Criteria:

History of hypersensitivity to naproxen, diphenhydramine, nonsteroidal antiinflammatory drugs (NSAIDS), tramadol, aspirin or any other antihistamine and similar pharmacological agents or components of the products;
Evidence or history of clinically significant (in the judgment of the investigator) hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic diseases, or malignancies within the last 5 years;
Relevant concomitant disease such as asthma (exercise induced asthma is permitted), chronic sinusitis or nasal structural abnormalities causing greater than 50 percent obstruction (polyposis nasi, marked septal deviation) that can interfere with the conduct of the study in the judgment of the investigator;
Current or past history of bleeding disorder(s);
Acute illness or local infection prior to surgery that can interfere with the conduct of the study in the judgment of the investigator;
Chronic use of antihistamines defined as using 5 or more times a week for 2 or more consecutive weeks during the past 3 months;
Positive alcohol breathalyzer test and negative urine drug test prior to surgery;
Females who are pregnant or lactating;
Chronic or severe sleep problems that do not respond to Over the counter (OTC) medication and requires a prescription hypnotic or sedative;
Intervention: Ticagrelor
Trial phase: Phase 2
ATC code: B01AC24
SMILES: CCCSc1nc(N[C@@H]2C[C@H]2c2ccc(F)c(F)c2)c2nnn([C@@H]3C[C@H](OCCO)[C@@H](O)[C@H]3O)c2n1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 50
Group description: AZD6140 45 mg twice daily
Eligibility criteria:
Inclusion Criteria:

Any Percutaneous Coronary Intervention, more than 3 months prior to randomization
Previous documented acute coronary syndrome (ACS), more than 3 months prior to randomisation
Treatment with ASA

Exclusion Criteria:

ACS, transient ischemic attack (TIA), or Stroke within the 3 months prior to randomisation
Known concurrent disease of stroke or TIA with atrial fibrillation
Persons who are being treated with blood clotting agents that cannot be stopped
Intervention: Ticagrelor
Trial phase: Phase 2
ATC code: B01AC24
SMILES: CCCSc1nc(N[C@@H]2C[C@H]2c2ccc(F)c(F)c2)c2nnn([C@@H]3C[C@H](OCCO)[C@@H](O)[C@H]3O)c2n1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 43
Group description: AZD6140 90 mg twice daily
Eligibility criteria:
Inclusion Criteria:

Any Percutaneous Coronary Intervention, more than 3 months prior to randomization
Previous documented acute coronary syndrome (ACS), more than 3 months prior to randomisation
Treatment with ASA

Exclusion Criteria:

ACS, transient ischemic attack (TIA), or Stroke within the 3 months prior to randomisation
Known concurrent disease of stroke or TIA with atrial fibrillation
Persons who are being treated with blood clotting agents that cannot be stopped
Intervention: Clopidogrel
Trial phase: Phase 2
ATC code: B01AC04
SMILES: [H][C@@](C(=O)OC)(c1ccccc1Cl)N1CCc2sccc2C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 46
Group description: Clopidogrel 75 mg once daily
Eligibility criteria:
Inclusion Criteria:

Any Percutaneous Coronary Intervention, more than 3 months prior to randomization
Previous documented acute coronary syndrome (ACS), more than 3 months prior to randomisation
Treatment with ASA

Exclusion Criteria:

ACS, transient ischemic attack (TIA), or Stroke within the 3 months prior to randomisation
Known concurrent disease of stroke or TIA with atrial fibrillation
Persons who are being treated with blood clotting agents that cannot be stopped
Intervention: Perindopril arginine
Trial phase: Phase 2
SMILES: CCCC(NC(C)C(=O)N1C(C(=O)O)CC2CCCCC21)C(=O)OCC.NC(N)=NCCCC(N)C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 73
Group description: 10mgs orally daily for the duration of the trial
Eligibility criteria:
Inclusion criteria:

Willing and able to give written informed consent

Men or women, aged at least 55 years

With AAA 3 to 5.4 cm in diameter by internal or external measurement according to ultrasound

A systolic BP <150mmHg (unless they require and are already receiving an ACE-inhibitor or amlodipine 10mg daily).

Exclusion criteria:

Patients who are already required to take either an ACE-inhibitor or a calcium channel blocker or Angiotensin II blocker (ARB) who cannot be converted to diuretic therapy and/ora 5mg dose of amlodipine for control (ie SBP < 150mmHg) of their BP.

Those with known renal artery stenosis (>50%), or with a serum creatinine of >180µmol/L

Those unable to give informed consent

Those too frail to travel for 3-monthly surveillance will be excluded

Any clinically significant medical condition which, in the opinion of the investigator, may interfere with the study results and or reduce life expectancy to < 2 years

Participation in another trial of an investigational product or device within the previous 30 days

Known allergy or sensitivity to perindopril or amlodipine

Unable or unwilling to comply with the requirements of the study, in the opinion of the investigator.
Intervention: Amlodipine
Trial phase: Phase 2
ATC code: C07FB07 | C07FB12 | C07FB13 | C08CA01 | C08CA17 | C08CA51 | C08GA02 | C09BB03 | C09BB04 | C09BB07 | C09BB13 | C09BX01 | C09BX03 | C09BX04 | C09DB01 | C09DB02 | C09DB04 | C09DB05 | C09DB06 | C09DB07 | C09DB09 | C09DX01 | C09DX03 | C09DX06 | C09DX07 | C09DX08 | C09XA53 | C09XA54 | C10BX03 | C10BX07 | C10BX09 | C10BX11 | C10BX14 | C10BX18 | C10BX19
SMILES: CCOC(=O)C1=C(COCCN)NC(C)=C(C(=O)OC)C1c1ccccc1Cl
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 72
Group description: 5 mgs taken orally daily for the duration of the trial
Eligibility criteria:
Inclusion criteria:

Willing and able to give written informed consent

Men or women, aged at least 55 years

With AAA 3 to 5.4 cm in diameter by internal or external measurement according to ultrasound

A systolic BP <150mmHg (unless they require and are already receiving an ACE-inhibitor or amlodipine 10mg daily).

Exclusion criteria:

Patients who are already required to take either an ACE-inhibitor or a calcium channel blocker or Angiotensin II blocker (ARB) who cannot be converted to diuretic therapy and/ora 5mg dose of amlodipine for control (ie SBP < 150mmHg) of their BP.

Those with known renal artery stenosis (>50%), or with a serum creatinine of >180µmol/L

Those unable to give informed consent

Those too frail to travel for 3-monthly surveillance will be excluded

Any clinically significant medical condition which, in the opinion of the investigator, may interfere with the study results and or reduce life expectancy to < 2 years

Participation in another trial of an investigational product or device within the previous 30 days

Known allergy or sensitivity to perindopril or amlodipine

Unable or unwilling to comply with the requirements of the study, in the opinion of the investigator.
Intervention: Lefamulin
Trial phase: Phase 2
ATC code: J01XX12
SMILES: C=CC1(C)CC(OC(=O)CSC2CCC(N)CC2O)C2(C)C(C)CCC3(CCC(=O)C32)C(C)C1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 71
Group description: BC-3781: BC-3781 dose 150mg is administered as i.v. infusion every 12 h for 5 to 14 days depending on the clinical response.
Eligibility criteria:
Inclusion Criteria:

Male or female patients > 18
Documented acute bacterial skin and skin structure infection

Exclusion Criteria:

Uncomplicated skin and skin structure infection
Intervention: Vancomycin
Trial phase: Phase 2
ATC code: A07AA09 | J01XA01 | S01AA28
SMILES: CN[C@H](CC(C)C)C(=O)N[C@H]1C(=O)N[C@@H](CC(N)=O)C(=O)N[C@H]2C(=O)N[C@H]3C(=O)N[C@H](C(=O)N[C@H](C(=O)O)c4cc(O)cc(O)c4-c4cc3ccc4O)[C@H](O)c3ccc(c(Cl)c3)Oc3cc2cc(c3O[C@@H]2O[C@H](CO)[C@@H](O)[C@H](O)[C@H]2O[C@H]2C[C@](C)(N)[C@H](O)[C@H](C)O2)Oc2ccc(cc2Cl)[C@H]1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 66
Group description: Vancomycin: Vancomycin is administered as i.v. infusion every 12 h for 5 to 14 days depending on the clinical response.
Eligibility criteria:
Inclusion Criteria:

Male or female patients > 18
Documented acute bacterial skin and skin structure infection

Exclusion Criteria:

Uncomplicated skin and skin structure infection
Intervention: Betamethasone
Trial phase: Phase 4
ATC code: A01AC02 | A07EA04 | C05AA05 | C05AA09 | D07AB19 | D07AC01 | D07BC01 | D07CB04 | D07CC01 | D07XB05 | D07XC01 | D10AA03 | H02AB01 | H02AB02 | R01AD03 | R01AD06 | R01AD53 | R03BA04 | S01BA01 | S01BA06 | S01BB04 | S01CA01 | S01CA05 | S01CB01 | S01CB04 | S02BA06 | S02BA07 | S02CA06 | S03BA01 | S03BA03 | S03CA01 | S03CA06
SMILES: CC1CC2C3CCC4=CC(=O)C=CC4(C)C3(F)C(O)CC2(C)C1(O)C(=O)CO
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 57
Group description: Dexamethasone 0.1% ophthalmic suspension, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days [Visit 4 through Visit 6 morning only]
Eligibility criteria:
Inclusion Criteria:

At least 1 year history of allergic conjunctivitis.
Ability to self administer ophthalmic drops.
Ability to avoid use of disallowed medications during the entire study period and specified period prior to visit 1.
Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

Presence of any ocular infection.
Confirmed diagnosis of dry eye.
Presence of glaucoma or ocular hypertension.
Moderate to severe asthma.
Any severe, unstable, or uncontrolled systemic disease.
Other protocol-defined exclusion criteria may apply.
Intervention: Olopatadine Hydrochloride
Trial phase: Phase 4
SMILES: CN(C)CCC=C1c2ccccc2COc2ccc(CC(=O)O)cc21.Cl
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 55
Group description: Olopatadine hydrochloride 0.1% ophthalmic solution, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days [Visit 4 through Visit 6 morning only]
Eligibility criteria:
Inclusion Criteria:

At least 1 year history of allergic conjunctivitis.
Ability to self administer ophthalmic drops.
Ability to avoid use of disallowed medications during the entire study period and specified period prior to visit 1.
Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

Presence of any ocular infection.
Confirmed diagnosis of dry eye.
Presence of glaucoma or ocular hypertension.
Moderate to severe asthma.
Any severe, unstable, or uncontrolled systemic disease.
Other protocol-defined exclusion criteria may apply.
Intervention: Omeprazole
Trial phase: Phase 4
ATC code: A02BC01 | A02BC05 | A02BD01 | A02BD05 | A02BD06 | A02BD16 | M01AE52
SMILES: COc1ccc2nc(S(=O)Cc3ncc(C)c(OC)c3C)[nH]c2c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 305
Group description: 20 mg q.d. (quaque die) once a day dosing for 8 weeks
Eligibility criteria:
Inclusion Criteria:

Heartburn and/or regurgitation symptoms last for at least 3 months
Endoscopic diagnosed as chronic gastritis (non-atrophic, and mild atrophic gastritis) within 2 weeks prior to randomization GerdQ score =8

Exclusion Criteria:

Endoscopic visible reflux esophagitis, esophageal varices, Barrett's esophagus, malignancy or peptic ulcer Patients with Hp positive result and are eager to take Hp eradication therapy will be excluded
If Hp positive, patients could take Hp eradication therapy after the study completion Previous PPI or H2RA therapy in the last 2 weeks before enrollment
Intervention: Omeprazole
Trial phase: Phase 4
ATC code: A02BC01 | A02BC05 | A02BD01 | A02BD05 | A02BD06 | A02BD16 | M01AE52
SMILES: COc1ccc2nc(S(=O)Cc3ncc(C)c(OC)c3C)[nH]c2c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 305
Group description: 20 mg q.d. (quaque die) once a day dosing for 2 weeks
Eligibility criteria:
Inclusion Criteria:

Heartburn and/or regurgitation symptoms last for at least 3 months
Endoscopic diagnosed as chronic gastritis (non-atrophic, and mild atrophic gastritis) within 2 weeks prior to randomization GerdQ score =8

Exclusion Criteria:

Endoscopic visible reflux esophagitis, esophageal varices, Barrett's esophagus, malignancy or peptic ulcer Patients with Hp positive result and are eager to take Hp eradication therapy will be excluded
If Hp positive, patients could take Hp eradication therapy after the study completion Previous PPI or H2RA therapy in the last 2 weeks before enrollment
Intervention: Glycopyrrolate
Trial phase: Phase 3
ATC code: A03AB02
SMILES: C[N+]1(C)CCC(OC(=O)C(O)(c2ccccc2)C2CCCC2)C1.[Br-]
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 123
Group description: 50µg once daily
Eligibility criteria:
Inclusion Criteria:

Patients with moderate to severe stable COPD (Stage II or Stage III) according to the Gold Guideline 2008.
Current or ex-smokers who have a smoking history of at least 10 pack years.
Patients with a post-bronchodilator FEV1 ≥30% and < 80% of the predicted normal, and postbronchodilator FEV1/FVC < 0.7 at Visit 2 (day -7)

Exclusion Criteria:

Pregnant women or nursing mothers or women of child-bearing potential not using an acceptable method of contraception
Patients requiring long term oxygen therapy
Patients who have had a lower respiratory tract infection within 6 weeks prior to Visit 1
Patients with concomitant pulmonary disease
Patients with a history of asthma
Any patient with lung cancer or a history of lung cancer
Patients with a history of certain cardiovascular comorbid conditions
Patients with a known history and diagnosis of alpha-1 antitrypsin deficiency
Patients in the active phase of a supervised pulmonary rehabilitation program
Patients contraindicated for tiotropium or ipratropium treatment or who have shown an untoward reaction to inhaled anticholinergic agents
Other protocol-defined inclusion/exclusion criteria may apply
Intervention: Tiotropium
Trial phase: Phase 3
ATC code: R03AL06 | R03AL10 | R03BB04 | R03BB54
SMILES: [H][C@]1(OC(=O)C(O)(c2cccs2)c2cccs2)C[C@@]2([H])[C@]3([H])O[C@]3([H])[C@@]([H])(C1)[N+]2(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 40
Group description: 18µg once daily
Eligibility criteria:
Inclusion Criteria:

Patients with moderate to severe stable COPD (Stage II or Stage III) according to the Gold Guideline 2008.
Current or ex-smokers who have a smoking history of at least 10 pack years.
Patients with a post-bronchodilator FEV1 ≥30% and < 80% of the predicted normal, and postbronchodilator FEV1/FVC < 0.7 at Visit 2 (day -7)

Exclusion Criteria:

Pregnant women or nursing mothers or women of child-bearing potential not using an acceptable method of contraception
Patients requiring long term oxygen therapy
Patients who have had a lower respiratory tract infection within 6 weeks prior to Visit 1
Patients with concomitant pulmonary disease
Patients with a history of asthma
Any patient with lung cancer or a history of lung cancer
Patients with a history of certain cardiovascular comorbid conditions
Patients with a known history and diagnosis of alpha-1 antitrypsin deficiency
Patients in the active phase of a supervised pulmonary rehabilitation program
Patients contraindicated for tiotropium or ipratropium treatment or who have shown an untoward reaction to inhaled anticholinergic agents
Other protocol-defined inclusion/exclusion criteria may apply
Intervention: Progesterone
Trial phase: Phase 2 | Phase 3
ATC code: G03DA04 | G03FA04
SMILES: [H][C@@]12CCC3=CC(=O)CC[C@]3(C)[C@@]1([H])CC[C@]1(C)[C@@H](C(C)=O)CC[C@@]21[H]
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 73
Group description: 250 mg of 17P, Makena® intramuscular (IM) weekly.

17-alpha-hydroxy-progesterone caproate, Makena®: Intramuscular (IM) injection of 17P,Makena® (250mg) beginning as early as 23w0d administered weekly until 34w0d, documented fetal lung maturity at 32w0d - 33w6d, or delivery which ever comes first.
Eligibility criteria:
Inclusion Criteria:

Participant is 18 years old or older
Gestational Age (GA) 23w0d and 30w6d @ time of enrollment
Singleton pregnancy
PROM defined as either (a) or (b) or (c) below (a) Documentation of vaginal leakage of indigo carmine dye instilled via amniocentesis (b) Positive Amnisure® test (c) Two or more of (i) through (iv): i. Nitrazine test with pH of 7 or more ii. Positive fern test iii. Gross pooling of clear fluid iv. US exam showing oligohydramnios

Exclusion Criteria:

Any contraindication to expectant management
Any fetal condition likely to cause serious neonatal morbidity independent of gestational age
History of allergy to 17P
Any contraindications to 17P use (e.g. Thrombosis, Breast CA, abnormal vaginal bleeding unrelated to pregnancy, jaundice, liver disease, uncontrolled HTN)
Any medical condition currently treated with systemic steroid medications
Cervical cerclage present at the time of PROM
Informed consent not obtained.
Intervention: Enstilar
Trial phase: Phase 2
SMILES: C=C1C(=CC=C2CCCC3(C)C2CCC3C(C)C=CC(O)C2CC2)CC(O)CC1O.CCC(=O)OCC(=O)C1(OC(=O)CC)C(C)CC2C3CCC4=CC(=O)C=CC4(C)C3(F)C(O)CC21C
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 78
Group description: Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp.
Eligibility criteria:
Inclusion Criteria:

A clinical diagnosis of scalp psoriasis which is of an extent of more than or equal to 10% of the scalp area
A clinical diagnosis of scalp psoriasis which is of at least moderate severity according to the investigator's global assessment
Serum albumin-corrected calcium below the upper reference limit at screening visit 2

Exclusion Criteria:

A history of hypersensitivity to any component of the LEO 80185 gel
Topical treatment on the trunk and/or limbs with very potent (WHO group IV) corticosteroids within 2 weeks prior to Visit 1 or during the study
Topical treatment on the face and/or genital/skin folds with potent or very potent (WHO groups III-IV) corticosteroids within 2 weeks prior to Visit 1 or during the study

Systemic treatment with biological therapies (marketed or not marketed), with a possible effect on scalp psoriasis within the following time period prior to Visit 1 and during the study:

etanercept - within 4 weeks prior to Visit 1
adalimumab, alefacept, infliximab - within 2 months prior to Visit 1
ustekinumab - within 4 months prior to Visit 1
experimental products - within 4 weeks/5 half-lives (whichever is longer) prior to Visit 1
Systemic treatment with therapies other than biologicals, with a possible effect on scalp psoriasis (e.g., corticosteroids, retinoids, immunosuppressants, PUVA) within 4 weeks prior to Visit 1 (Day 0) or during the study
UVB therapy within 2 weeks prior to Visit 1 or during the study
Any topical treatment on the scalp (except for emollients and non-steroid medicated shampoos) within 2 weeks prior to Visit 1 or during the study
Systemic calcium or vitamin D supplements, antacids, diuretics, antiepileptics, diphosphonates or calcitonin within 4 weeks prior to screening visit 2 or during the study
Planned initiation of, or changes to, concomitant medication that could affect scalp psoriasis (e.g., betablockers, chloroquine, lithium, ACE inhibitors) during the study
Current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis
Subjects with any of the following conditions present on the scalp area: viral (e.g., herpes or varicella) lesions of the skin, fungal and bacterial skin infections, parasitic infections, skin manifestations in relation to syphilis or tuberculosis, rosacea, acne vulgaris, acne rosacea, atrophic skin, striae atrophicae, fragility of skin veins, ichthyosis, ulcers and wounds
Planned excessive exposure to sun during the study that may affect scalp psoriasis
Known or suspected disorders of calcium metabolism associated with hypercalcaemia
Intervention: Odanacatib
Trial phase: Phase 3
SMILES: CC(C)(F)C[C@H](N[C@@H](c1ccc(-c2ccc(S(C)(=O)=O)cc2)cc1)C(F)(F)F)C(=O)NC1(C#N)CC1
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 146
Group description: Participants received one Odanacatib 50 mg tablet once weekly. In addition, they received a weekly dose 5600 IU of open-label Vitamin D3 as well as a sufficient supply of open-label calcium carbonate so that their total daily calcium intake from both dietary and supplemental sources was approximately 1200 mg.
Eligibility criteria:
Inclusion Criteria:

Is a male between 40 and 95 years of age
Has osteoporosis
Has anatomy suitable for dual energy x-ray absorptiometry (DXA) scan of the lumbar spine and and hip
Is ambulatory

Exclusion Criteria:

Is currently on oral bisphosphonates or other treatment for osteoporosis
Had previous hip fragility fracture and is a candidate for standard of care therapy
Has had a fragility fracture (vertebral or non-vertebral fractures indicating reduced bone strength) within 12 months
Has had more then one previous vertebral fracture
Has been diagnosed with metabolic bone disorder other than osteoporosis
Is Vitamin D deficient
Has a history of renal stones
Has active parathyroid disease
Has history of thyroid disease not well controlled by medication
Is diagnosed with secondary osteoporosis
Has a daily calcium intake of <1,200 mg and is unwilling to take study prescribed supplements or increase dietary intake, such that his daily calcium intake is at least 1200 mg
Has a history of malignancy ≤5 years prior to signing informed consent
Has been diagnosed with hypogonadism due to causes that affect multiple organ and body systems