anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Methotrexate
Trial phase: Phase 4
ATC code: L01BA01 | L04AX03
SMILES: CN(Cc1cnc2nc(N)nc(N)c2n1)c1ccc(C(=O)N[C@@H](CCC(=O)O)C(=O)O)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 10
Group description: Escalating dose (Start with 15 mg MTX/week, escalating dose until 25 mg/week, administered orally)
Eligibility criteria:
Inclusion Criteria:

MTX-naive
Age > 18 years
DAS-28 > 3.2
American College of Rheumatology-criteria for RA
Chest-X-ray
Informed consent
Prednisolon < 10 mg a day

Exclusion Criteria:

Pregnancy
Lactation
Renal and hepatic impairment
Malignant diseases (last 5 years)
Contraindications
Human Immunodeficiency Virus (HIV), Hepatitis B and C
Intervention: Methotrexate
Trial phase: Phase 4
ATC code: L01BA01 | L04AX03
SMILES: CN(Cc1cnc2nc(N)nc(N)c2n1)c1ccc(C(=O)N[C@@H](CCC(=O)O)C(=O)O)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 9
Group description: Start with 25 mg MTX per week, administered orally
Eligibility criteria:
Inclusion Criteria:

MTX-naive
Age > 18 years
DAS-28 > 3.2
American College of Rheumatology-criteria for RA
Chest-X-ray
Informed consent
Prednisolon < 10 mg a day

Exclusion Criteria:

Pregnancy
Lactation
Renal and hepatic impairment
Malignant diseases (last 5 years)
Contraindications
Human Immunodeficiency Virus (HIV), Hepatitis B and C
Intervention: Tobramycin
Trial phase: Phase 1
ATC code: J01GB01 | S01AA12
SMILES: NC[C@H]1O[C@H](O[C@H]2[C@H](O)[C@@H](O[C@H]3O[C@H](CO)[C@@H](O)[C@H](N)[C@H]3O)[C@H](N)C[C@@H]2N)[C@H](N)C[C@@H]1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 21
Group description: TOBREX® Ophthalmic Solution
Eligibility criteria:
Inclusion:

Visual Acuity (VA) of 0.6 logMAR or better
Tear meniscus height of ≥ 0.3mm at Visit 1.
No concomitant topical ocular medications, including artificial tears, during the study period

Exclusion

ocular hypertension, iritis or uveitis, glaucoma
ocular surgery, intraocular surgery or ocular laser procedures in either eye within the past six months
epithelial herpes simplex (dendritic keratitis); Vaccinia, active or recent varicella viral disease of the cornea and/or conjunctiva; ocular Rosacea; Mycobacterial infection of the eye; and / or fungal disease of the eye
lacrimal duct obstruction, dry eye, ocular allergies.
contact lens within 7 days of Visit 1.
ocular medications within 14 days of Visit 1.
Intervention: Tobramycin
Trial phase: Phase 1
ATC code: J01GB01 | S01AA12
SMILES: NC[C@H]1O[C@H](O[C@H]2[C@H](O)[C@@H](O[C@H]3O[C@H](CO)[C@@H](O)[C@H](N)[C@H]3O)[C@H](N)C[C@@H]2N)[C@H](N)C[C@@H]1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 21
Group description: TOBRADEX® Ophthalmic Suspension
Eligibility criteria:
Inclusion:

Visual Acuity (VA) of 0.6 logMAR or better
Tear meniscus height of ≥ 0.3mm at Visit 1.
No concomitant topical ocular medications, including artificial tears, during the study period

Exclusion

ocular hypertension, iritis or uveitis, glaucoma
ocular surgery, intraocular surgery or ocular laser procedures in either eye within the past six months
epithelial herpes simplex (dendritic keratitis); Vaccinia, active or recent varicella viral disease of the cornea and/or conjunctiva; ocular Rosacea; Mycobacterial infection of the eye; and / or fungal disease of the eye
lacrimal duct obstruction, dry eye, ocular allergies.
contact lens within 7 days of Visit 1.
ocular medications within 14 days of Visit 1.
Intervention: Alfuzosin
Trial phase: Phase 4
ATC code: G04CA01 | G04CA51
SMILES: COc1cc2nc(N(C)CCCNC(=O)C3CCCO3)nc(N)c2cc1OC
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 41
Group description: BOOI<20, BCI≥ 100)

alfuzosin : 10mg, once daily, 12months
Eligibility criteria:
Inclusion Criteria:

Ambulatory males (≥50 years) suffering from LUTS suggestive of BPH
Patients satisfying all of the following:
Moderate to severe LUTS :
international prostate symptom score (IPSS)≥ 8
An enlarged prostate (≥25 mL)
Decreased peak flow rate : Qmax ≤15 mL/s (volume voided ≥ 120 mL)

Exclusion Criteria:

Post voided residual urine ≥ 200 mL
Patients performing catheterization
Urinary tract infection patients
Patients taking 5 alpha reductase inhibitor
Known hypersensitivity to alfuzosin
History of postural hypotension or syncope
Hypertension patients treated with other alpha1-blockers
Patients newly taking anticholinergic medication within 1 month
Hepatic insufficiency (Aspartate transaminase /alanine aminotransferase ≥ 2 times of normal range)
Renal insufficiency (s-Cr ≥ 2mg/dL)
Unstable angina pectoris
Uninvestigated hematuria
Serum Prostate specific antigen ≥ 4 ng/mL (biopsy proven no cancer patients can be included)
Interstitial cystitis patients
Severe concomitant condition threatening life.
Patient who is unable to make voiding diary
Bladder or prostate cancer patients
Patients receiving prostate or bladder surgery
Intervention: Alfuzosin
Trial phase: Phase 4
ATC code: G04CA01 | G04CA51
SMILES: COc1cc2nc(N(C)CCCNC(=O)C3CCCO3)nc(N)c2cc1OC
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 54
Group description: BOOI<20, BCI<100

alfuzosin : 10mg, once daily, 12 months
Eligibility criteria:
Inclusion Criteria:

Ambulatory males (≥50 years) suffering from LUTS suggestive of BPH
Patients satisfying all of the following:
Moderate to severe LUTS :
international prostate symptom score (IPSS)≥ 8
An enlarged prostate (≥25 mL)
Decreased peak flow rate : Qmax ≤15 mL/s (volume voided ≥ 120 mL)

Exclusion Criteria:

Post voided residual urine ≥ 200 mL
Patients performing catheterization
Urinary tract infection patients
Patients taking 5 alpha reductase inhibitor
Known hypersensitivity to alfuzosin
History of postural hypotension or syncope
Hypertension patients treated with other alpha1-blockers
Patients newly taking anticholinergic medication within 1 month
Hepatic insufficiency (Aspartate transaminase /alanine aminotransferase ≥ 2 times of normal range)
Renal insufficiency (s-Cr ≥ 2mg/dL)
Unstable angina pectoris
Uninvestigated hematuria
Serum Prostate specific antigen ≥ 4 ng/mL (biopsy proven no cancer patients can be included)
Interstitial cystitis patients
Severe concomitant condition threatening life.
Patient who is unable to make voiding diary
Bladder or prostate cancer patients
Patients receiving prostate or bladder surgery
Intervention: Alfuzosin
Trial phase: Phase 4
ATC code: G04CA01 | G04CA51
SMILES: COc1cc2nc(N(C)CCCNC(=O)C3CCCO3)nc(N)c2cc1OC
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 61
Group description: BOOI≥ 20, BCI≥ 100

alfuzosin : 10mg, once daily, 12months
Eligibility criteria:
Inclusion Criteria:

Ambulatory males (≥50 years) suffering from LUTS suggestive of BPH
Patients satisfying all of the following:
Moderate to severe LUTS :
international prostate symptom score (IPSS)≥ 8
An enlarged prostate (≥25 mL)
Decreased peak flow rate : Qmax ≤15 mL/s (volume voided ≥ 120 mL)

Exclusion Criteria:

Post voided residual urine ≥ 200 mL
Patients performing catheterization
Urinary tract infection patients
Patients taking 5 alpha reductase inhibitor
Known hypersensitivity to alfuzosin
History of postural hypotension or syncope
Hypertension patients treated with other alpha1-blockers
Patients newly taking anticholinergic medication within 1 month
Hepatic insufficiency (Aspartate transaminase /alanine aminotransferase ≥ 2 times of normal range)
Renal insufficiency (s-Cr ≥ 2mg/dL)
Unstable angina pectoris
Uninvestigated hematuria
Serum Prostate specific antigen ≥ 4 ng/mL (biopsy proven no cancer patients can be included)
Interstitial cystitis patients
Severe concomitant condition threatening life.
Patient who is unable to make voiding diary
Bladder or prostate cancer patients
Patients receiving prostate or bladder surgery
Intervention: Alfuzosin
Trial phase: Phase 4
ATC code: G04CA01 | G04CA51
SMILES: COc1cc2nc(N(C)CCCNC(=O)C3CCCO3)nc(N)c2cc1OC
Sex: Male
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 76
Group description: BOOI≥ 20, BCI<100

alfuzosin : 10mg, once daily, 12months
Eligibility criteria:
Inclusion Criteria:

Ambulatory males (≥50 years) suffering from LUTS suggestive of BPH
Patients satisfying all of the following:
Moderate to severe LUTS :
international prostate symptom score (IPSS)≥ 8
An enlarged prostate (≥25 mL)
Decreased peak flow rate : Qmax ≤15 mL/s (volume voided ≥ 120 mL)

Exclusion Criteria:

Post voided residual urine ≥ 200 mL
Patients performing catheterization
Urinary tract infection patients
Patients taking 5 alpha reductase inhibitor
Known hypersensitivity to alfuzosin
History of postural hypotension or syncope
Hypertension patients treated with other alpha1-blockers
Patients newly taking anticholinergic medication within 1 month
Hepatic insufficiency (Aspartate transaminase /alanine aminotransferase ≥ 2 times of normal range)
Renal insufficiency (s-Cr ≥ 2mg/dL)
Unstable angina pectoris
Uninvestigated hematuria
Serum Prostate specific antigen ≥ 4 ng/mL (biopsy proven no cancer patients can be included)
Interstitial cystitis patients
Severe concomitant condition threatening life.
Patient who is unable to make voiding diary
Bladder or prostate cancer patients
Patients receiving prostate or bladder surgery
Intervention: Idebenone
Trial phase: Phase 3
ATC code: N06BX13
SMILES: COC1=C(OC)C(=O)C(CCCCCCCCCCO)=C(C)C1=O
Sex: All
Age groups: Child | Adult
Healthy volunteers: No
Participants at risk: 68
Group description: Patients ≤ 45 kg/99 lbs: idebenone 1350 mg/day (3 x 150 mg tablets, t.i.d.)

Patients > 45 kg/99 lbs: idebenone 2250 mg/day (5 x 150 mg tablets, t.i.d.)
Eligibility criteria:
Inclusion criteria:

Friedreich's ataxia patients completing core study SNT-III-002 (NCT00537680) and presenting at Week 24 (Visit 5) of that study
Body weight ≥ 25kg/55 lbs
Negative urine pregnancy test
Patients who in the opinion of the investigator are able to comply with the requirements of this study

Exclusion criteria:

Adverse events during the course of SNT-III-002(NCT00537680)which in the opinion of the investigator are attributable to idebenone and preclude further treatment with idebenone
Clinically significant abnormalities of clinical hematology or biochemistry including, but not limited to, elevations greater than 2 times the upper limit of normal of AST, ALT or creatinine
Treatment with coenzyme Q10, vitamin E (if taken at a dose 5 times above the daily requirement) or other sources of idebenone within the past month
Parallel participation in another clinical drug trial
Past or present history of abuse of drugs or alcohol
Pregnancy or breast-feeding
Intervention: Treprostinil
Trial phase: Phase 2
ATC code: B01AC21
SMILES: [H][C@@]12Cc3c(cccc3OCC(=O)O)C[C@]1([H])[C@@H](CC[C@@H](O)CCCCC)[C@H](O)C2
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 15
Group description: Patients with pulmonary fibrosis with an advanced pulmonary hypertension phenotype will be treated with parenteral treprostinil in an open-label fashion

Treprostinil: For both SQ and IV routes, treprostinil will be started in the hospital at 1ng/kg/min and titrated up by 1ng/kg/min every 1-3 days as tolerated
Eligibility criteria:
Inclusion Criteria:

Eligible subjects must have IPF and severe pulmonary arterial hypertension (PAH) documented on standard of care right-heart catheterization (RHC) and planned to receive therapy with treprostinil as recommended by the treating physician.

All subjects must have high resolution CT scan (HRCT) diagnostic of IPF (performed as part of standard of care evaluation) or if available, biopsy proven histological usual interstitial pneumonia (UIP).
Severe pulmonary arterial hypertension defined as a resting mean pulmonary artery pressure (mPAP) > 35 mm Hg; AND pulmonary vascular resistance (PVR) > 3 woods-units; AND pulmonary capillary wedge pressure (PCWP) < 18 mm Hg by right-heart catheterization (RHC) performed as part of standard of care evaluation.
All subjects must be planned to receive treprostinil therapy as recommended by their treating physician.

Exclusion Criteria:

Acute or chronic impairment other than dyspnea (e.g. angina pectoris, intermittent claudication) limiting the ability to perform standard of care six-minute walk tests (6MWT).
Six-minute walk distance (6MWD) < 50 meters at screening or baseline standard of care evaluations
Standard of care pulmonary function test (PFT) showing forced expiratory volume in one second (FEV1)/ forced vital capacity (FVC) ratio < 0.65
Standard of care pulmonary function test (PFT) showing a residual volume >120% predicted
Standard of care high-resolution chest computed tomography (HRCT) showing emphysema extent > 30%
Any investigational therapy as part of a clinical trial for any indication with 30 days before screening
Change in dose of treatment for IPF - investigational agent (gamma interferon-1b, pirfenidone, etanercept, and any other investigational agent intended to treat IPF), corticosteroids, or cytotoxic agents, within 30 days before screening. That is, subjects can be on any of these agents provided the dose is stable for at least 30 days prior to enrollment.
Current treatment for pulmonary hypertension with other prostaglandins (epoprostenol or iloprost)
Change in dose of treatment for PAH - (bosentan, sitaxsentan, ambrisentan, tadalafil, sildenafil, vardenafil, calcium channel blockers, nitrates, digitalis), within 30 days before screening. That is, subjects can be on any of these agents provided the dose is stable for at least 30 days prior to enrollment
Pulmonary rehabilitation initiated within 30 days of baseline.
Intervention: Loteprednol etabonate/tobramycin
Trial phase: Phase 4
SMILES: CCOC(=O)OC1(C(=O)OCCl)CCC2C3CCC4=CC(=O)C=CC4(C)C3C(O)CC21C.NCC1OC(OC2C(N)CC(N)C(OC3OC(CO)C(O)C(N)C3O)C2O)C(N)CC1O
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 34
Group description: Drug: Zylet (loteprednol etabonate 0.5% and tobramycin 0.3%)one or two drops in the study eye four times a day (QID).
Eligibility criteria:
Inclusion Criteria:

children 0-6 years of age.
clinical diagnosis of blepharoconjunctivitis
Parent/guardian must understand, be willing and able to comply with all treatment and follow-up procedures.
Parent/guardian must understand, be willing and able to provide informed consent and Health Insurance Portability Accountability Act (HIPAA) authorization.

Exclusion Criteria:

Known hypersensitivity to corticosteroids, aminoglycosides, or any component of the study medication.
Subjects who have a history of ocular surgery, including laser procedures, within the past 6 months.
Subjects who are monocular.
Subjects who have a history of any severe/serious ocular pathology or medical condition that could result in the subject's inability to complete the study.
Subjects who have participated in an ophthalmic drug or device research study within 30 days prior to entry in this study.
Intervention: Tobramycin
Trial phase: Phase 4
ATC code: J01GB01 | S01AA12
SMILES: NC[C@H]1O[C@H](O[C@H]2[C@H](O)[C@@H](O[C@H]3O[C@H](CO)[C@@H](O)[C@H](N)[C@H]3O)[C@H](N)C[C@@H]2N)[C@H](N)C[C@@H]1O
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 34
Group description: Drug: Tobramycin 0.3%. One or two drops in study eye four times a day (QID).
Eligibility criteria:
Inclusion Criteria:

children 0-6 years of age.
clinical diagnosis of blepharoconjunctivitis
Parent/guardian must understand, be willing and able to comply with all treatment and follow-up procedures.
Parent/guardian must understand, be willing and able to provide informed consent and Health Insurance Portability Accountability Act (HIPAA) authorization.

Exclusion Criteria:

Known hypersensitivity to corticosteroids, aminoglycosides, or any component of the study medication.
Subjects who have a history of ocular surgery, including laser procedures, within the past 6 months.
Subjects who are monocular.
Subjects who have a history of any severe/serious ocular pathology or medical condition that could result in the subject's inability to complete the study.
Subjects who have participated in an ophthalmic drug or device research study within 30 days prior to entry in this study.
Intervention: Latanoprost
Trial phase: Phase 4
ATC code: S01EE01 | S01EE51
SMILES: CC(C)OC(=O)CCC/C=C\C[C@@H]1[C@@H](CC[C@@H](O)CCc2ccccc2)[C@H](O)C[C@@H]1O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 29
Group description: Participants were assigned to use Xalatan/latanoprost 0.005% ophthalmic sol. one drop qhs for one year in affected eye(s)
Eligibility criteria:
Inclusion Criteria:

patients recently diagnosed with primary open angle glaucoma or ocular hypertension
Caucasian and African American ethnicities
Male and Female
Age 30 and above

Exclusion Criteria:

A history of ocular medication use within the last 12 months
Inflammatory/ allergic skin diseases or dermatitis
presence of periocular hyperpigmented skin lesions
Systemic pigmentation disorders
Use of systemic drugs that can affect skin pigmentation
Visitation of tanning salons, or use of self tanning products
Pregnancy or patients planning to become pregnant in the near future
Intervention: Methotrexate
Trial phase: Phase 4
ATC code: L01BA01 | L04AX03
SMILES: CN(Cc1cnc2nc(N)nc(N)c2n1)c1ccc(C(=O)N[C@@H](CCC(=O)O)C(=O)O)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 63
Group description: Utilized Disease-Modifying Antirheumatic Drugs (DMARDs) from a list of the 6 most commonly prescribed in the participating countries (Methotrexate, sulfasalazine, hydroxychloroquine, leflunomide, cyclosporine A and gold).
Eligibility criteria:
Inclusion Criteria:

Meet the 1987 ACR Revised Criteria for Rheumatoid Arthritis.
Documented evidence, confirmed by a blinded 3rd party assessor, of at least one erosion observed by X-ray at randomization based on X-ray taken at the screening visit.
Have received MTX as stable dose for 28 days prior to the screening visit.

Exclusion Criteria:

Previous treatment with ETN, infliximab, adalimumab, other Tumor necrosis factor (TNF) -a inhibitors, anakinra or other biological agents.
Receipt of any DMARD, other than MTX, within 28 days before screening.
Intervention: Cisplatin
Trial phase: Phase 2
ATC code: L01XA01
SMILES: Cl[Pt]Cl.N.N
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 6
Group description: Radiation therapy given at 50 Gy, 20 fractions, for 4 weeks (2.5 Gy/day). Cisplatin given at 100mg/m2 i.v. every 3 weeks for a total of 2 doses (days 1 and 22) during radiation.
Eligibility criteria:
Inclusion criteria:

Signed study-specific consent form prior to registration.
Pathologically confirmed malignant melanoma.
Measurable melanoma lesion deemed to require radiation by treating physicians for purposes of local control or palliation. The lesion may be the primary melanoma, a nodal metastasis, or a distant metastasis. Recurrent lesions are allowed.
Lesion has to be measurable clinically or radiographically in 2 dimensions.
Karnofsky Performance Scale (KPS) > 70.

Laboratory values

White blood cells (WBC) > 3000/mm3
Absolute granulocyte count > 1,500
Platelets > 100,000/mm3
Total bilirubin < 2.0 x institutional upper limit of normal
AST or ALT (aminotransferase/alanine aminotransferase) < 2.5 x institutional upper limit of normal
Serum calcium < 1.3 x institutional upper limit of normal
Serum creatinine < 1.5 mg/dL or Creatinine clearance > 50 cc/min,calculated as follows: CCr = 0.85 x (140-age) x (weight in kg) 72 x serum creatinine in mg/dL

Exclusion criteria:

Systemic therapy for malignant melanoma within one month preceding trial enrollment.
Prior irradiation to the planned field.
Concomitant chemotherapy (in addition to cisplatin) or biologic therapy is allowed.
Significant infection or other co-existent medical condition which would prevent the use of full dose chemotherapy.
Pre-existing sensory neuropathy (CTC 3.0 ≥ Grade II)
Pregnancy or lactation.
Intervention: Imiquimod
Trial phase: Not Applicable
ATC code: D06BB10
SMILES: CC(C)Cn1cnc2c(N)nc3ccccc3c21
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 46
Group description: Topical imiquimod group:

treat the LM site two centimeters beyond the perimeter margin with topical imiquimod 5% cream Monday thru Friday of each week for a total of twelve weeks. After three months of topical treatment, a one-month wash out period will be observed to allow for resolution of inflammation that can obscure the pathologist's ability to evaluate the excised tumor/treatment site.
Eligibility criteria:
Inclusion Criteria:

The study population will consist of eighty subjects who are 18 years or older and have a biopsy-proven lentigo maligna.
The subjects must have a LM that is in a location amenable to treatment with imiquimod, express a willingness and ability to comply with study requirements, and tolerate an outpatient surgical procedure.
All participants will sign consent documents prior to enrollment.
The typical age of patient that develops a LM is beyond the child-bearing range.

Exclusion Criteria:

In the event that a patient with a LM is pregnant, they will be excluded from the study.
inability to tolerate the surgical procedure
invasive melanoma
previous surgery on the site of interest
Intervention: Vortioxetine
Trial phase: Phase 3
ATC code: N06AX26
SMILES: Cc1ccc(Sc2ccccc2N2CCNCC2)c(C)c1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 834
Group description: Vortioxetine 2.5 mg, 5 mg or 10 mg, encapsulated tablets, orally, once daily for up to 52 weeks. For the first week of treatment all participants received 5 mg/day vortioxetine, thereafter, the dose could be increased to 10 mg/day or decreased to 2.5 mg/day, based on participant's response and tolerability as judged by the investigator.
Eligibility criteria:
Inclusion Criteria:

Has completed the double blind treatment period of either study Lu AA21004_304 (NCT00672620) or LuAA21004_305 (NCT00735709) immediately prior to enrollment in the extension study (ie, the baseline visit is the same visit as the completion visit of the double blind treatment of the preceding protocol).
Suffers from a major depressive episode as the primary diagnosis according to Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) criteria (classification code 296.xx) at entry into the prior Lu AA21004_304 or Lu AA21004_305 study.

Exclusion Criteria:

In addition to meeting the exclusion criteria for studies Lu AA21004_304 or Lu AA21004_305 at the time of enrollment into those studies respectively, with the exception of the criteria prohibiting previous exposure to Lu AA21004 and investigational drugs, and the criteria prohibiting patients with increased intraocular pressure, or risk of acute narrow-angle glaucoma, the following exclusion criteria apply:

Has Major Depressive Disorder for whom other psychiatric disorders (mania, bipolar disorder, schizophrenia, or any psychotic disorder) have been diagnosed during the prior study.
The participant, in the investigator's opinion, has a significant risk of suicide and/or a score of ≥5 points on item 10 (suicidal thoughts) of the Montgomery Åsberg Depression Rating Scale.
The participant, in the opinion of the investigator, is unlikely to comply with the clinical study protocol or is unsuitable for any reason.
Has a clinically significant moderate or severe ongoing adverse event related to study medication from the prior study.
Has used/uses disallowed concomitant medication.