anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Edoxaban
Trial phase: Phase 3
ATC code: B01AF03
SMILES: CN1CCc2nc(C(=O)N[C@@H]3C[C@@H](C(=O)N(C)C)CC[C@@H]3NC(=O)C(=O)Nc3ccc(Cl)cn3)sc2C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 405
Group description: Edoxaban-based regimen for 21 days pre- and 90 days post-ablation period.

Edoxaban: Edoxaban 60 mg once-daily or 30 mg once-daily in selected subjects.
Eligibility criteria:
Inclusion Criteria:

Male or female at least 18 years of age with documented history of paroxysmal (lasting ≤7 days), persistent (lasting >7 days but ≤12 months) or long-standing [long-lasting] persistent (>12 months) non-valvular AF. Duration of AF can be confirmed by any electrical tracing or a recording in the subject's medical records (e.g., medical chart, hospital discharge summary).
Subject is eligible and is scheduled for either radio frequency (RF) or cryoballoon catheter ablation (both first and repeated procedure included).
Signed informed consent form (ICF).

Exclusion Criteria:

AF considered to be of a transient or reversible nature (such as in myocarditis, post-surgery, ionic disturbances, thyrotoxicosis, pneumonia, severe anemia etc.).
Subject post stroke, or with a systemic thromboembolic event within the past 6 months prior to randomization.
Subject has a thrombus in the left atrial appendage (LAA), left atrium (LA), left ventricle (LV), or aorta, or an intracardial mass.
Subject had a myocardial infarction (MI) within the 2 months prior to randomization or coronary artery bypass graft (CABG) surgery within 3 months prior to the randomization.
Subject has signs of bleeding, history of clinically-relevant bleeding according to International Society on Thrombosis and Hemostasis (ISTH), or conditions associated with high risk of bleeding
Subjects with any contraindication for anticoagulant agents.
Intervention: Warfarin
Trial phase: Phase 3
ATC code: B01AA03
SMILES: CC(=O)CC(c1ccccc1)c1c(O)c2ccccc2oc1=O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 197
Group description: VKA-based regimen for 21 days pre- and 90 days post-ablation period (control regimen)

VKA-Based Regimen: Dosed at International Normalised Ratio (INR) levels, which is a test of how long it takes for blood to clot. Standard of Care treatment in Canada, Italy, Poland, Hungary, Czech Republic, UK, Taiwan and Korea.

VKA-Based Regimen: Dosed at INR levels. Standard of Care treatment in Germany, Belgium, and the Netherlands.

VKA-Based Regimen: Dosed at INR levels. Standard of Care treatment in France.

VKA-Based Regimen: Dosed at INR levels. Standard of Care treatment in Spain.
Eligibility criteria:
Inclusion Criteria:

Male or female at least 18 years of age with documented history of paroxysmal (lasting ≤7 days), persistent (lasting >7 days but ≤12 months) or long-standing [long-lasting] persistent (>12 months) non-valvular AF. Duration of AF can be confirmed by any electrical tracing or a recording in the subject's medical records (e.g., medical chart, hospital discharge summary).
Subject is eligible and is scheduled for either radio frequency (RF) or cryoballoon catheter ablation (both first and repeated procedure included).
Signed informed consent form (ICF).

Exclusion Criteria:

AF considered to be of a transient or reversible nature (such as in myocarditis, post-surgery, ionic disturbances, thyrotoxicosis, pneumonia, severe anemia etc.).
Subject post stroke, or with a systemic thromboembolic event within the past 6 months prior to randomization.
Subject has a thrombus in the left atrial appendage (LAA), left atrium (LA), left ventricle (LV), or aorta, or an intracardial mass.
Subject had a myocardial infarction (MI) within the 2 months prior to randomization or coronary artery bypass graft (CABG) surgery within 3 months prior to the randomization.
Subject has signs of bleeding, history of clinically-relevant bleeding according to International Society on Thrombosis and Hemostasis (ISTH), or conditions associated with high risk of bleeding
Subjects with any contraindication for anticoagulant agents.
Intervention: Rapastinel
Trial phase: Phase 3
SMILES: CC(O)C(N)C(=O)N1CCCC1C(=O)N1CCCC1C(=O)NC(C(N)=O)C(C)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 211
Group description: Rapastinel 225 milligram (mg) weekly intravenous (IV) injections. Each participant will continue to take the same dose of antidepressant therapy the participant was receiving prior to entering this study throughout treatment.
Eligibility criteria:
Inclusion Criteria:

Meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for MDD
Current major depressive episode of at least 8 weeks and not exceeding 18 months in duration at Visit 1
Have no more than partial response (< 50% improvement) to ongoing treatment with a protocol-allowed antidepressant
If female of childbearing potential, have a negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test.

Exclusion Criteria:

DSM-5-based diagnosis of any disorder other than MDD that was the primary focus of treatment within 6 months before Visit 1

Lifetime history of meeting DSM-5 criteria for:

Schizophrenia spectrum or other psychotic disorder
Bipolar or related disorder
Major neurocognitive disorder
Neurodevelopmental disorder of greater than mild severity or of a severity that impacts the participant's ability to consent, follow study directions, or otherwise safely participate in the study
Dissociative disorder
Posttraumatic stress disorder
MDD with psychotic features
Significant suicide risk, as judged by the Investigator.
Intervention: Rapastinel
Trial phase: Phase 3
SMILES: CC(O)C(N)C(=O)N1CCCC1C(=O)N1CCCC1C(=O)NC(C(N)=O)C(C)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 210
Group description: Rapastinel 450 mg weekly IV injections. Each participant will continue to take the same dose of antidepressant therapy the participant was receiving prior to entering this study throughout treatment.
Eligibility criteria:
Inclusion Criteria:

Meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for MDD
Current major depressive episode of at least 8 weeks and not exceeding 18 months in duration at Visit 1
Have no more than partial response (< 50% improvement) to ongoing treatment with a protocol-allowed antidepressant
If female of childbearing potential, have a negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test.

Exclusion Criteria:

DSM-5-based diagnosis of any disorder other than MDD that was the primary focus of treatment within 6 months before Visit 1

Lifetime history of meeting DSM-5 criteria for:

Schizophrenia spectrum or other psychotic disorder
Bipolar or related disorder
Major neurocognitive disorder
Neurodevelopmental disorder of greater than mild severity or of a severity that impacts the participant's ability to consent, follow study directions, or otherwise safely participate in the study
Dissociative disorder
Posttraumatic stress disorder
MDD with psychotic features
Significant suicide risk, as judged by the Investigator.
Intervention: Rapastinel
Trial phase: Phase 3
SMILES: CC(O)C(N)C(=O)N1CCCC1C(=O)N1CCCC1C(=O)NC(C(N)=O)C(C)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 156
Group description: Rapastinel 450 mg weekly intravenous (IV) injections. Each participant will continue to take the same dose of antidepressant therapy the participant was receiving prior to entering this study throughout treatment.
Eligibility criteria:
Inclusion Criteria:

Meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for MDD
Current major depressive episode of at least 8 weeks and not exceeding 18 months in duration at Visit 1
Have no more than partial response (< 50% improvement) to ongoing treatment with a protocol-allowed antidepressant
If female of childbearing potential, have a negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test.

Exclusion Criteria:

DSM-5-based diagnosis of any disorder other than MDD that was the primary focus of treatment within 6 months before Visit 1

Lifetime history of meeting DSM-5 criteria for:

Schizophrenia spectrum or other psychotic disorder
Bipolar or related disorder
Major neurocognitive disorder
Neurodevelopmental disorder of greater than mild severity or of a severity that impacts the participant's ability to consent, follow study directions, or otherwise safely participate in the study
Dissociative disorder
Posttraumatic stress disorder
MDD with psychotic features
Significant suicide risk, as judged by the Investigator.
Intervention: Atorvastatin
Trial phase: Phase 2
ATC code: C10AA05 | C10BA05 | C10BX03 | C10BX06 | C10BX08 | C10BX11 | C10BX12 | C10BX15 | C10BX18 | C10BX19
SMILES: CC(C)c1c(C(=O)Nc2ccccc2)c(-c2ccccc2)c(-c2ccc(F)cc2)n1CC[C@@H](O)C[C@@H](O)CC(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 150
Group description: Atorvastatin will be administered at a pre determined dose The drug is taken by mouth, once a day (evening)

Atorvastatin: A pill taken once a day
Eligibility criteria:
Inclusion Criteria:

> 18 years of age
All patients with newly diagnosed NHL and HL
Scheduled to receive anthracycline-based therapy

Exclusion Criteria:

Statin use or Statin use is indicated based on guidelines
Pregnancy or breastfeeding
Unable to provide informed consent
Unexplained persistent elevation of transaminases (>3 times upper limits of normal)
Concomitant use of cyclosporine
Renal failure: estimated glomerular filtration <45 mL/min/1.73 m2
Contraindication to a CMR (metallic object, severe claustrophobia, pacemaker, vascular clip
LVEF of <50% at baseline
Intervention: Dapsone
Trial phase: Phase 4
ATC code: D10AX05 | J04BA02 | J04BA50 | J04BA51
SMILES: Nc1ccc(S(=O)(=O)c2ccc(N)cc2)cc1
Sex: All
Age groups: Child | Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 20
Group description: Dapsone gel 7.5% to be applied to truncal acne once daily for 16 weeks.

Dapsone 7.5 % gel: Dapsone gel 7.5% applied once daily to truncal acne
Eligibility criteria:
Inclusion Criteria:

Male and female subjects of any race and at least 12 years of age.
Female subjects of childbearing potential must have a negative urine pregnancy test at Baseline and practice a reliable method of contraception throughout the study.
Truncal acne IGA score of 3.
Able to understand the requirements of study and sign Informed Consent/HIPAA forms.

Exclusion Criteria:

Female subjects who are pregnant , breast feeding or are of childbearing potential who are not willing to use a reliable method birth control.
Subjects who have an allergy or sensitivity to any component of the test medication.
Subjects who have not complied with the proper wash out periods for prohibited medications.
Evidence of recent drug or alcohol abuse.
Skin disease /disorder that might interfere with the diagnosis or evaluation of truncal acne.
Exposure to an investigational drug within 30 days of the Baseline visit.
Medical condition that contraindicates the subject's participation in the study.
History of poor cooperation, non-compliance with medical treatment or unreliability.
Intervention: Gabapentin
Trial phase: Phase 4
ATC code: N02BF01 | N03AX12
SMILES: NCC1(CC(=O)O)CCCCC1
Sex: Female
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 54
Group description: Participants receiving local anesthesia per clinic protocol plus two 300mg capsules of gabapentin 1-2 hours prior to the procedure.
Eligibility criteria:
Inclusion Criteria:

Women >=18 years-old
Presenting for a surgical abortion
Fluency in English and able to provide informed consent
Has a driver to take them home following the procedure

Exclusion Criteria:

Allergy, sensitivity or contraindication to gabapentin
Severe renal disease
Currently using gabapentin or pregabalin
Contraindication to outpatient abortion under local anesthesia
Intervention: Zepatier
Trial phase: Phase 4
ATC code: J05AP54
SMILES: C=CC1CC1(NC(=O)C1CC2CN1C(=O)C(C(C)(C)C)NC(=O)OC1CC1CCCCCc1nc3ccc(OC)cc3nc1O2)C(=O)NS(=O)(=O)C1CC1.COC(=O)NC(C(=O)N1CCCC1c1ncc(-c2ccc3c(c2)cc2n3C(c3ccccc3)Oc3cc(C4=NC(C5CCCN5C(=O)C(NC(=O)OC)C(C)C)N=C4)ccc3-2)[nH]1)C(C)C
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 8
Group description: Elbasvir (50mg) / grazoprevir (100mg) (fixed dose combination) treatment for Hepatitis C virus (HCV)-naive recipients who receive a kidney transplant from a deceased, HCV-infected donor

Subjects receive first dose on-call to operating room, and continue daily for 12 weeks. Treatment length is extended to 16 weeks and ribavirin (daily dose 1000 mg for those <75 kg and 1200 mg for those ≥75 kg) if subject receives a kidney from a donor who is infected with HCV containing resistance-associated variants (RAV).
Eligibility criteria:
Inclusion Criteria:

Must meet Massachusetts General Hospital (MGH) transplant center criteria and already be listed for isolated kidney transplant
No available living kidney donor
Has ≤ 730 days (two years) of accrued transplant waiting time if blood type A and ≤ 1095 days of accrued transplant waiting time if blood type B or O.
On chronic hemodialysis or peritoneal dialysis or has a glomerular filtration rate <15mL/min/1.73m2 at the time of screening
Weight ≥ 50kg
Serum alanine transaminase (ALT) within normal limits

Exclusion Criteria:

AB blood type
Body mass index (BMI > 35
History of liver disease
Pregnant or nursing (lactating) women
Cardiomyopathy (LV ejection fraction < 50%)
Positive crossmatch or positive donor specific antibodies
Human immunodeficiency virus (HIV) positive
Hepatitis C virus (HCV) RNA positive
Hepatitis B virus (HBV) surface antigen positive
Any contraindication to kidney transplant per MGH center protocol
Intervention: Difamilast
Trial phase: Phase 2
SMILES: CCOc1ccccc1C(=O)NCc1coc(-c2ccc(OC(F)F)c(OC(C)C)c2)n1
Sex: All
Age groups: Child
Healthy volunteers: No
Participants at risk: 31
Group description: MM36 topical ointment, 1%, applied twice daily for 15 days
Eligibility criteria:
Inclusion Criteria:

Subjects 2 to <18 years of age
Diagnosis of atopic dermatitis (AD)
AD affecting ≥ 35% body surface area (BSA) if 2 to < 12 years of age or ≥ 25% if subject is ≥ 12 years of age (excluding scalp and venous access areas)

Exclusion Criteria:

Active or acute viral skin infection
History of recurrent bacterial infection
Malignancy
Clinically significant history or physical findings that may pose a health risk to subject or may have an impact on study assessments
Intervention: Naloxegol
Trial phase: Phase 4
ATC code: A06AH03
SMILES: C=CCN1CC[C@]23c4c5ccc(O)c4O[C@H]2[C@@H](OCCOCCOCCOCCOCCOCCOCCOC)CC[C@@]3(O)[C@H]1C5
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 28
Group description: Subjects in the treatment group will be administered MOVANTIK™ (naloxegol) 25 mg tablet or placebo once daily beginning 2 hours after the completion of their surgery until their discharge from the hospital (variable timing). Subjects with renal impairments (creatine clearance rate of less than 60 mL/min) will receive a 12.5 mg dose tablet of naloxegol in place of the 25 mg dose as advised by FDA guidelines. For patients who are unable to swallow the tablet whole, the tablet can be crushed and given orally or administered via nasogastric tube.

MOVANTIK™ (naloxegol)
Eligibility criteria:
Inclusion Criteria:

Male or female patients between the ages of 18 and 75 years undergoing non-urgent, elective spinal fusion at Massachusetts General Hospital who are admitted to the neurosurgery floor from the operating room

Exclusion Criteria:

Patients who are taken to the operating room from another inpatient floor or service (already hospitalized prior to surgery)
Patients with evidence of bowel obstruction
Patients unable to take oral medications by mouth or by enteric feeding tube (gastrostomy or jejunostomy)
Patients with a documented or potential allergy or adverse reaction to Movantik (naloxegol) from outpatient use
Patients currently taking Movantik (naloxegol) in the outpatient setting
Patients with a preoperative diagnosis of irritable bowel syndrome (IBS) obtained via Rome III questionnaire on screening
Patients with disruptions to the blood-brain barrier (eg, multiple sclerosis, recent brain injury, Alzheimer's disease, and uncontrolled epilepsy)
Patients with a history of cancer.
Patients concomitantly using strong CYP3A4 inhibitors (eg, clarithromycin, ketoconazole), strong CYP3A4 inducers and other opioid antagonists.
Patients with severe hepatic impairment.
Patients with a previous history of or risk of bowel perforation.
Patients with a post-op regional anesthetic technique employed like a continuous epidural or spinal.
Patients for which local anesthetics will be placed in the wound.
Intervention: Minocycline
Trial phase: Phase 2
ATC code: A01AB23 | D10AF07 | J01AA08 | J01AA20
SMILES: [H][C@@]12Cc3c(N(C)C)ccc(O)c3C(=O)C1=C(O)[C@]1(O)C(=O)C(C(N)=O)=C(O)[C@@H](N(C)C)[C@]1([H])C2
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 8
Group description: BPX-01 1% minocycline topical gel

Minocycline: BPX-01 1 or 2% topical gel will be applied to face once daily at bedtime
Eligibility criteria:
Inclusion Criteria:

- moderate to severe inflammatory non-nodular acne vulgaris

Exclusion Criteria:

female subject who is breastfeeding, pregnant or planning a pregnancy during the study
have other skin condition or disease that would interfere with the study
have had any prior treatment with minocycline
have a known or suspected allergy to tetracycline class products
have used OTC medications for the treatment of facial acne within the last 14 days
have used any prescription topical or oral medications for the treatment of facial acne in the last 28 days
have had a facial procedure (chemical peel, dermabrasion, laser, etc) within the last 8 weeks
Intervention: Minocycline
Trial phase: Phase 2
ATC code: A01AB23 | D10AF07 | J01AA08 | J01AA20
SMILES: [H][C@@]12Cc3c(N(C)C)ccc(O)c3C(=O)C1=C(O)[C@]1(O)C(=O)C(C(N)=O)=C(O)[C@@H](N(C)C)[C@]1([H])C2
Sex: All
Age groups: Adult
Healthy volunteers: No
Participants at risk: 10
Group description: BPX-01 2% minocycline topical gel

Minocycline: BPX-01 1 or 2% topical gel will be applied to face once daily at bedtime
Eligibility criteria:
Inclusion Criteria:

- moderate to severe inflammatory non-nodular acne vulgaris

Exclusion Criteria:

female subject who is breastfeeding, pregnant or planning a pregnancy during the study
have other skin condition or disease that would interfere with the study
have had any prior treatment with minocycline
have a known or suspected allergy to tetracycline class products
have used OTC medications for the treatment of facial acne within the last 14 days
have used any prescription topical or oral medications for the treatment of facial acne in the last 28 days
have had a facial procedure (chemical peel, dermabrasion, laser, etc) within the last 8 weeks
Intervention: Levothyroxine
Trial phase: Phase 4
ATC code: C10AX01 | H03AA01 | H03AA51
SMILES: N[C@@H](Cc1cc(I)c(Oc2cc(I)c(O)c(I)c2)c(I)c1)C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 6
Group description: Patients in this arm will receive levothyroxine tablets (encapsulated for blinding purposes)

Levothyroxine: Patients post-thyroidectomy will receive either levothyroxine in tablet form or in gelcaps
Eligibility criteria:
Inclusion Criteria:

Age > 18 years
Presumed AJCC (American Joint Committee on Cancer) tumor Stage I or II
Planned total or near-total thyroidectomy
Planned goal TSH suppression 0.1-0.5 mU/L for at least 18 weeks postoperatively
Normal serum TSH within 12 months preceding surgery

Exclusion Criteria:

AJCC Stage III or greater
Undifferentiated, Anaplastic or Medullary Thyroid Cancer
Planned postoperative TSH goal other than 0.1-0.5 mU/L
History of gastrointestinal malabsorption or gastric bypass surgery
Pregnancy
Use of medications that alter the absorption or metabolism of levothyroxine
Prior use of levothyroxine
Intervention: Levothyroxine
Trial phase: Phase 4
ATC code: C10AX01 | H03AA01 | H03AA51
SMILES: N[C@@H](Cc1cc(I)c(Oc2cc(I)c(O)c(I)c2)c(I)c1)C(=O)O
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 8
Group description: Patients in this arm will receive levothyroxine gelcaps (encapsulated for blinding purposes)

Levothyroxine: Patients post-thyroidectomy will receive either levothyroxine in tablet form or in gelcaps
Eligibility criteria:
Inclusion Criteria:

Age > 18 years
Presumed AJCC (American Joint Committee on Cancer) tumor Stage I or II
Planned total or near-total thyroidectomy
Planned goal TSH suppression 0.1-0.5 mU/L for at least 18 weeks postoperatively
Normal serum TSH within 12 months preceding surgery

Exclusion Criteria:

AJCC Stage III or greater
Undifferentiated, Anaplastic or Medullary Thyroid Cancer
Planned postoperative TSH goal other than 0.1-0.5 mU/L
History of gastrointestinal malabsorption or gastric bypass surgery
Pregnancy
Use of medications that alter the absorption or metabolism of levothyroxine
Prior use of levothyroxine
Intervention: Atenolol
Trial phase: Phase 1 | Phase 2
ATC code: C07AB03 | C07BB03 | C07CB03 | C07CB53 | C07DB01 | C07FB03
SMILES: CC(C)NCC(O)COc1ccc(CC(N)=O)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 29
Group description: Subjects will be given Prolastin-C intravenously at 60mg/kg weekly for 4 weeks.

Prolastin-C: Patients will receive Prolastin-C at 60mg/kg on day 0, 7, 14, and 21 days of transplantation
Eligibility criteria:
Inclusion Criteria:

Patients scheduled for total pancreatectomy and islet auto-transplantation
Age > 18 years
Diabetes free before surgery

Exclusion Criteria:

Patients who are under immunosuppression
Patients who have had Puestow or Frey pancreatic surgery
Patients who have Immunoglobulin A (IgA) deficiency, known antibodies against IgA, or individuals with a history of severe immediate hypersensitivity reactions, including anaphylaxis to Alpha1-proteinase inhibitor products (allergic to AAT)
Intervention: Kenalog
Trial phase: Phase 1 | Phase 2
SMILES: CC1(C)OC2CC3C4CCC5=CC(=O)C=CC5(C)C4(F)C(O)CC3(C)C2(C(=O)CO)O1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 10
Group description: Treatment in the Previous TX arm of the study will consist of one unilateral injection of SC CLS-TA.

SC CLS-TA: [4 mg (100 µL)]
Eligibility criteria:
Inclusion Criteria:

Men or women ≥ 18 years of age with type 1 or type 2 diabetes mellitus
DME with central involvement (>320 microns in the central subfield on SD-OCT) in the study eye
ETDRS BCVA letter score of 83 to 14, inclusive (Snellen equivalent of 20/25 to 20/500) in the study eye

Exclusion Criteria:

Evidence of DME due to any other cause other than diabetes mellitus in the study eye
PRP or focal laser photocoagulation in the study eye within 90 days of screening
Intraocular pressure ≥ 22 mmHg or uncontrolled glaucoma (open angle or angle closure) in the study eye
History of any previous ophthalmic surgeries in the study eye within 90 days of screening
High risk PDR in the study eye, for whom enrollment into the study, in the principal investigator's opinion would put the eye at undue risk for vision loss
Any previous treatment in the study eye with ILUVIEN implant
Previous treatment for DME in the study eye (TX naive arm only); treatment in the study eye for DME greater than 1 year prior to screening can be considered as treatment naive, at the investigator's discretion
Subjects previously treated for DME cannot have been treated in the study eye with an intravitreal injection of anti-VEGF or periocular corticosteroids within 90 days prior to screening (Previous TX arm only)
Subjects previously treated for DME cannot have been treated in the study eye with intraocular corticosteroids within 6 months prior to screening (Previous TX arm only)