anthonyyazdaniml/CT-ADE-SOC huggingface dataset:
Intervention: Betamethasone
Trial phase: Phase 3
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: Child
Healthy volunteers: No
Participants at risk: 1
Group description: DFD01 spray, twice daily, 29 days

DFD01 Spray: DFD-01 (betamethasone dipropionate) Spray, 0.05%
Eligibility criteria:
Inclusion Criteria:

Subjects must weigh at least 55 pounds
Subjects must present with a clinical diagnosis of stable (at least 3 months) plaque psoriasis.
Subjects with psoriasis involving ≥ 10% BSA, not including the face, scalp, groin, axillae and other intertriginous areas..
Subjects must have moderate to severe plaque psoriasis at the Baseline Visit.
Subjects whose results from the screening ACTH stimulation test are considered normal (cortisol level >18 ug/dL at 30 minutes post stimulation) and show no other signs of abnormal HPA axis function or adrenal response.

Exclusion Criteria:

Current diagnosis of unstable forms of psoriasis including guttate, erythrodermic, exfoliative or pustular psoriasis.
History of organ transplant requiring immunosuppression, HIV, or other immunocompromised state.
Have received treatment for any type of cancer within 5 years of the Baseline Visit.
Use within 60 days prior to the Baseline Visit of: 1) immunosuppressive drugs (e.g., tacrolimus, pimecrolimus), 2) systemic antipsoriatic treatment (e.g., methotrexate, cyclosporine, hydroxyurea), or 3) biologic treatment for psoriasis (e.g., infliximab, adalimumab, etanercept, ustekinumab, secukinumab, or alefacept).
Use within 30 days prior to the Baseline Visit of: 1) topical antipsoriatic drugs (salicylic acid, anthralin, coal tar, calcipotriene), 2) PUVA therapy, 3) systemic anti-inflammatory agents (e.g., mycophenolate mofetil, sulfasalazine, 6-thioguanine), or 4) UVB therapy.
Use within 30 days prior to the Screening Visit of any product containing corticosteroids. Inhaled, intraocular, intranasal, etc. steroids are not allowed.
Subjects who have an abnormal sleep schedule or work overnight.
Subjects with a known history of acute adrenal crisis, Addison's disease or decreased adrenal output, low pituitary function or pituitary tumors.
Subjects who have a history of an adverse reaction to cosyntropin injection or similar test reagents.
Intervention: Malathion
Trial phase: Not Applicable
ATC code: P03AX03
SMILES: CCOC(=O)CC(SP(=S)(OC)OC)C(=O)OCC
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 2
Group description: Albumin administered per standard care on day 1 (1.5g/kg). Second dose administered on day 2 only to those individuals with renal insufficiency and risk for renal failure (Cr > 1.0 or BUN or Cr > baseline). If albumin not administered at 48 hours, BUN and Cr will be monitored daily for 72 hours and will be administered if Cr > 1.0 or BUN or Cr are above baseline.

Experimental: 25% salt poor albumin administered per standard care on day 1 (1.5g/kg). Second dose administered on day 2 or later only to those individuals with renal insufficiency and risk for renal failure (Cr > 1.0 or BUN or Cr > baseline)
Eligibility criteria:
Inclusion Criteria:

Age 18 to 75
Evidence of end stage liver disease / cirrhosis
Documented SBP (ANC > 250 or positive ascites culture
Ability to provide informed consent
Serum Creatinine > 1.0 mg/dL and/or Total Bilirubin > 4.0 mg/dL

Exclusion Criteria:

Nonportal hypertensive ascites (i.e. malignancy)
Intervention: CID 12303048
Trial phase: Phase 1 | Phase 2
ATC code: S03AA04
SMILES: NC(=NCCCCCCN=C(N)N=C(N)Nc1ccc(Cl)cc1)N=C(N)Nc1ccc(Cl)cc1.O=C(O)C(O)C(O)C(O)C(O)CO.O=C(O)C(O)C(O)C(O)C(O)CO
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 33
Group description: 1 min application time, 2 min application time or comparator application. Up to 2 products applied to the same participant.
Eligibility criteria:
Inclusion Criteria:

Healthy
No dermatological conditions

Exclusion Criteria:

Sensitivity to CHG
Sensitivity to natural latex rubber or adhesive skin products
Intervention: CID 12303048
Trial phase: Phase 1 | Phase 2
ATC code: S03AA04
SMILES: NC(=NCCCCCCN=C(N)N=C(N)Nc1ccc(Cl)cc1)N=C(N)Nc1ccc(Cl)cc1.O=C(O)C(O)C(O)C(O)C(O)CO.O=C(O)C(O)C(O)C(O)C(O)CO
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 14
Group description: 3 min application time for CHG and the comparator CHG was applied according to instructions.
Eligibility criteria:
Inclusion Criteria:

Healthy
No dermatological conditions

Exclusion Criteria:

Sensitivity to CHG
Sensitivity to natural latex rubber or adhesive skin products
Intervention: Sapropterin
Trial phase: Phase 1 | 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: 12
Group description: 12 SSc participants were studied 5 hours after oral BH4 administration (10 mg/kg body mass)
Eligibility criteria:
Inclusion Criteria:

Diagnosis of systemic sclerosis (SSc, scleroderma) by ACR/EULAR 2013 criteria.

Exclusion Criteria:

Age < 18
Pregnant or breast feeding
Unwillingness to consent
Intervention: Sotagliflozin
Trial phase: Phase 3
ATC code: A10BK06
SMILES: CCOc1ccc(Cc2cc([C@@H]3O[C@H](SC)[C@@H](O)[C@H](O)[C@H]3O)ccc2Cl)cc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 699
Group description: Sotagliflozin 400 mg (two 200 mg tablets) once daily, orally, before the first meal of the day for 24 weeks.
Eligibility criteria:
Inclusion Criteria:

Participants had given written informed consent to participate in the study in accordance with local regulations
Adult participants 18 years and older with a diagnosis of T1DM made at least 1 year prior to informed consent
Participants were being treated with insulin or insulin analog
Willing and able to perform self-monitoring of blood glucose (SMBG) and complete the study diary as required per protocol
At the Screening Visit, A1C was between 7.0% to 11.0%
Females of childbearing potential used an adequate method of contraception and had a negative pregnancy test

Exclusion Criteria:

Use of antidiabetic agent other than insulin or insulin analog at the time of screening
Use of sodium-glucose cotransporter (SGLT) inhibitors within 8 weeks prior to screening
Chronic systemic corticosteroid use
Type 2 diabetes mellitus (T2DM), or severely uncontrolled T1D as determined by the Investigator
Intervention: Ovral
Trial phase: Phase 4
SMILES: C#CC1(O)CCC2C3CCC4=CC(=O)CCC4C3CCC21CC.C#CC1(O)CCC2C3CCc4cc(O)ccc4C3CCC21C
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 17
Group description: Participants taking antiretroviral regimens including ritonavir-boosted protease inhibitors will take a combined oral contraceptive containing 150mcg levonorgestrel and 30mcg ethinyl estradiol for 21 days.

Levonorgestrel and Ethinyl Estradiol: All participants will take a combined oral contraceptive containing 150mcg levonorgestrel and 30mcg ethinyl estradiol for 21 days. Pharmacokinetics and pharmacodynamics will be compared between participants using antiretroviral regimens including ritonavir-boosted protease inhibitors and those using regimens that do not interact with oral contraceptives.
Eligibility criteria:
Inclusion Criteria:

HIV positive
Female
Age 18-45
Using any of the following medication regimens: no ARV medication, entry inhibitors, nucleoside reverse transcriptase inhibitors (NRTIs), integrase inhibitors, and CCR5 agonists. Acceptable NRTI combinations include zidovudine (ZDV), lamivudine (3TC), emtricitabine (FTC), didanosine (ddl), stavudine (d4T), abacavir (ABC), and tenofovir disoproxil fumarate (TDF)
Ovulatory (mid-luteal progesterone >3ng/dL)
Not planning to conceive during the study period
Willing to abstain from grapefruit products
If taking ritonavir, willing to use alternate non-hormonal contraception
BMI < or = 40
Able to consent in English or Spanish
No change in medication regimen for at least 21 days prior to study entry and no planned change during the study period
CD4 > or =200, and/or not considered profoundly immuncompromised by primary HIV provider

Exclusion Criteria:

Using on the combination of ZDV at d4T
Platelets <50,000
AST or ALT > twice upper limit of normal
Bilirubin > twice upper limit of normal
Use of other CYP3A4 inducing or inhibiting medications
Pregnant or breastfeeding in last 30 days
Use of DepoProvera in last 180 days
Use of any other hormonal contraception in last 30 days

Undiagnosed vaginal bleeding or invasive cancer of the reproductive tract

->50% change in tobacco use in the last month

Initiation or titration of methadone therapy in the last month
Uncontrolled thyroid disease
Contraindication to estrogen use
Inability to comply with study protocol
Intervention: Ovral
Trial phase: Phase 4
SMILES: C#CC1(O)CCC2C3CCC4=CC(=O)CCC4C3CCC21CC.C#CC1(O)CCC2C3CCc4cc(O)ccc4C3CCC21C
Sex: Female
Age groups: Adult
Healthy volunteers: No
Participants at risk: 17
Group description: Participants taking antiretroviral regimens known not to interact with oral contraceptives will take a combined oral contraceptive containing 150mcg levonorgestrel and 30mcg ethinyl estradiol for 21 days.

Levonorgestrel and Ethinyl Estradiol: All participants will take a combined oral contraceptive containing 150mcg levonorgestrel and 30mcg ethinyl estradiol for 21 days. Pharmacokinetics and pharmacodynamics will be compared between participants using antiretroviral regimens including ritonavir-boosted protease inhibitors and those using regimens that do not interact with oral contraceptives.
Eligibility criteria:
Inclusion Criteria:

HIV positive
Female
Age 18-45
Using any of the following medication regimens: no ARV medication, entry inhibitors, nucleoside reverse transcriptase inhibitors (NRTIs), integrase inhibitors, and CCR5 agonists. Acceptable NRTI combinations include zidovudine (ZDV), lamivudine (3TC), emtricitabine (FTC), didanosine (ddl), stavudine (d4T), abacavir (ABC), and tenofovir disoproxil fumarate (TDF)
Ovulatory (mid-luteal progesterone >3ng/dL)
Not planning to conceive during the study period
Willing to abstain from grapefruit products
If taking ritonavir, willing to use alternate non-hormonal contraception
BMI < or = 40
Able to consent in English or Spanish
No change in medication regimen for at least 21 days prior to study entry and no planned change during the study period
CD4 > or =200, and/or not considered profoundly immuncompromised by primary HIV provider

Exclusion Criteria:

Using on the combination of ZDV at d4T
Platelets <50,000
AST or ALT > twice upper limit of normal
Bilirubin > twice upper limit of normal
Use of other CYP3A4 inducing or inhibiting medications
Pregnant or breastfeeding in last 30 days
Use of DepoProvera in last 180 days
Use of any other hormonal contraception in last 30 days

Undiagnosed vaginal bleeding or invasive cancer of the reproductive tract

->50% change in tobacco use in the last month

Initiation or titration of methadone therapy in the last month
Uncontrolled thyroid disease
Contraindication to estrogen use
Inability to comply with study protocol
Intervention: Omadacycline
Trial phase: Phase 3
ATC code: J01AA15 | J01AA20
SMILES: [H][C@@]12Cc3c(N(C)C)cc(CNCC(C)(C)C)c(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 | Older Adult
Healthy volunteers: No
Participants at risk: 382
Group description: Participants received omadacycline 100 milligrams (mg) intravenously (IV) every 12 hours (q12h) (first 2 doses), followed by 100 mg IV every 24 hours (q24h) (starting 24 hours after the first dose), with the option to switch to a 300 mg (two 150 mg omadacycline tablets and 1 over-encapsulated placebo tablet matching moxifloxacin) oral administration q24h after at least 3 days (4 doses) of IV treatment. The total duration of test article therapy (IV plus oral administration) for all participants was at least 7 days and no more than 14 days.
Eligibility criteria:
Inclusion Criteria:

Patients, ages 18 years or older who have signed the informed consent
Has qualifying bacterial pneumonia
Female patients must not be pregnant at the time of enrollment
Must agree to a reliable method of birth control during the study and for 30 days following the last dose of study drug

Exclusion Criteria:

Known or suspected hospital-acquired pneumonia
Evidence of significant immunological disease
Has a history of hypersensitivity or allergic reaction to any tetracycline or to any fluoroquinolone antibiotic
Has received an investigational drug within past 30 days
Women who are pregnant or nursing
Intervention: Moxifloxacin
Trial phase: Phase 3
ATC code: J01MA14 | S01AE07
SMILES: [H][C@@]12CCCN[C@]1([H])CN(c1c(F)cc3c(=O)c(C(=O)O)cn(C4CC4)c3c1OC)C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 388
Group description: Participants received moxifloxacin 400 mg IV q24h (with a single placebo infusion to match the omadacycline dosing regimen 12 hours after the first dose on Day 1) with the option to switch to a 400 mg (one 400 mg moxifloxacin over-encapsulated tablet and 2 placebo tablets matching omadacycline tablets) oral administration q24h after at least 3 days (4 doses) of IV treatment. The total duration of test article therapy (IV plus oral administration) for all participants was at least 7 days and no more than 14 days.
Eligibility criteria:
Inclusion Criteria:

Patients, ages 18 years or older who have signed the informed consent
Has qualifying bacterial pneumonia
Female patients must not be pregnant at the time of enrollment
Must agree to a reliable method of birth control during the study and for 30 days following the last dose of study drug

Exclusion Criteria:

Known or suspected hospital-acquired pneumonia
Evidence of significant immunological disease
Has a history of hypersensitivity or allergic reaction to any tetracycline or to any fluoroquinolone antibiotic
Has received an investigational drug within past 30 days
Women who are pregnant or nursing
Intervention: Dextromethorphan
Trial phase: Phase 2
ATC code: N07XX59 | R05DA09
SMILES: COc1ccc2c(c1)C13CCCCC1C(C2)N(C)CC3
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 1
Group description: Participants received AVP-786 (up to a target dose of d6-DM 28 milligrams [mg]/Q 4.9 mg [AVP-786-28/4.9] twice a day [BID]) for 6 weeks.
Eligibility criteria:
Inclusion Criteria:

Documented diagnosis of a Neurodegenerative Disorder including frontotemporal dementia, Alzheimer's disease (AD), progressive supranuclear palsy (PSP), corticobasal degeneration (CBD), dementia with Lewy bodies (DBL), vascular cognitive disorders, or Huntington's disease, at least 3 months prior to Baseline
The participant has behavior from 2 of the 3 categories of disinhibited behavior from the definition of the behavioral variant of frontotemporal dementia
The behavioral changes are not due to a pre-existing major psychiatric disorder (e.g., schizophrenia, bipolar disease, etc.) and are not due to the direct effect of systemic illness, drug action, or substance use
Disinhibition scale score of ≥4 on the 3 core disinhibition items of the Frontal Behavioral Inventory (FBI) at Screening and Baseline

Exclusion Criteria:

Participants with symptoms of disinhibition that is not secondary to Neurodegenerative Disorders
Participants with myasthenia gravis
Participants with co-existent clinically significant or unstable systemic diseases that could confound the interpretation of the safety results of the study (e.g., malignancy [except skin basal-cell carcinoma or untreated prostate cancer], poorly controlled diabetes, poorly controlled hypertension, unstable pulmonary, renal or hepatic disease, unstable ischemic cardiac disease, dilated cardiomyopathy, or unstable valvular heart disease)
Intervention: Duloxetine
Trial phase: Phase 4
ATC code: N06AX21
SMILES: CNCC[C@H](Oc1cccc2ccccc12)c1cccs1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 28
Group description: subjects who will receive one capsule of duloxetine 60 mg before the surgery and being repeated the next day

Duloxetine: duloxetine 60 mg
Eligibility criteria:
Inclusion Criteria:

Patients were included, of both genders, aged between 18 and 70 years and American Society of Anesthesiologists (ASA) physical status 1-3 and were eligible for the study

Exclusion Criteria:

Patients allergics to duloxetine, ketoralac or fentanyl, pre-existing history of use of illegal substances or alcohol in an abusive manner and abnormal kidney or liver function tests.
Intervention: Memantine
Trial phase: Phase 3
ATC code: N06DA52 | N06DA53 | N06DX01
SMILES: CC12CC3CC(C)(C1)CC(N)(C3)C2
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 47
Group description: Patients with ischemic stroke in middle cerebral artery (MCA) territory who will receive 20 mg/d(2 tab 5mg BID) memantine for 7 days and then 10mg/d(1 tab 5mg BID) memantine for 21 days.

Memantine: Beside the usual treatment for ischemic stroke this group will be treated by memantine.
Eligibility criteria:
Inclusion Criteria:

Presentation at first 24hrs of disease onset
Confirmation of ischemic stroke in MCA territory by imaging.
Accepted consent form

Exclusion Criteria:

Allergy history to memantine
Stage 4 -5 renal failure base on Acute Kidney Injury Network criteria
Moderate to severe hepatic failure (Child-Pugh criteria, grade B and C)
History of epilepsy
History of dementia
History of memantine use in recent 6 months
Pregnancy or breastfeeding
Severe drug adverse effects
Intervention: Tranexamic acid
Trial phase: Phase 2
ATC code: B02AA02
SMILES: NC[C@H]1CC[C@H](C(=O)O)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 49
Group description: One time dose IV TXA 2 Grams given over 10 minutes within 2 hours of initial injury

Tranexamic Acid: Tranexamic acid is a man-made form of an amino acid (protein) called lysine. Tranexamic acid prevents enzymes in the body from breaking down blood clots.
Eligibility criteria:
Inclusion Criteria:

Patients with traumatic injury that are ordered to receive at least 1 blood product and/or
Patients admitted to the Emergency Department with a traumatic injury and require immediate transfer to the operating room to control the bleeding
Able to receive the study drug within 2 hours from estimated time of injury **Please note that in circumstances where the patient initially met inclusion/exclusion criteria (i.e. received blood products in the ED before a full evaluation of their injuries is complete) but is later found to only have a soft tissue involved injury or does not have a traumatic bleeding source), the Investigator may determine that the patient should not be randomized into the trial and the patient should be considered a screen failure

Exclusion Criteria:

Patients known to be < 18 years of age
Suspected Acute MI or stroke(thromboembolic and/or hemorrhagic) on admission
Known inherited coagulation disorders

Known history of thromboembolic events (DVT, PE, MI, Stroke)

• Please note that past medical history of hemorrhagic stroke is permitted, but not current admission with hemorrhagic stroke

Known history of seizures and/or seizure after injury/on admission related to this hospitalization
Suspected or known pregnancy
Known to be lactating
Suspected or known prisoners
Futile care
Known current state of immunosuppression (i.e. on high dose steroids, chemotherapeutics, etc.)
Unknown estimated time of injury 12). Patients wearing an "Opt Out" TAMPITI Study bracelet 13). Known presence of subarachnoid hemorrhage.

14.) Isolated injuries to hands and/or feet (distal) 15.) Administration of antifibrinolytics pre-hospital and/or during this ED admission prior to enrollment
Intervention: Tranexamic acid
Trial phase: Phase 2
ATC code: B02AA02
SMILES: NC[C@H]1CC[C@H](C(=O)O)CC1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 50
Group description: One time dose IV TXA 4 Grams given over 10 minutes within 2 hours of initial injury

Tranexamic Acid: Tranexamic acid is a man-made form of an amino acid (protein) called lysine. Tranexamic acid prevents enzymes in the body from breaking down blood clots.
Eligibility criteria:
Inclusion Criteria:

Patients with traumatic injury that are ordered to receive at least 1 blood product and/or
Patients admitted to the Emergency Department with a traumatic injury and require immediate transfer to the operating room to control the bleeding
Able to receive the study drug within 2 hours from estimated time of injury **Please note that in circumstances where the patient initially met inclusion/exclusion criteria (i.e. received blood products in the ED before a full evaluation of their injuries is complete) but is later found to only have a soft tissue involved injury or does not have a traumatic bleeding source), the Investigator may determine that the patient should not be randomized into the trial and the patient should be considered a screen failure

Exclusion Criteria:

Patients known to be < 18 years of age
Suspected Acute MI or stroke(thromboembolic and/or hemorrhagic) on admission
Known inherited coagulation disorders

Known history of thromboembolic events (DVT, PE, MI, Stroke)

• Please note that past medical history of hemorrhagic stroke is permitted, but not current admission with hemorrhagic stroke

Known history of seizures and/or seizure after injury/on admission related to this hospitalization
Suspected or known pregnancy
Known to be lactating
Suspected or known prisoners
Futile care
Known current state of immunosuppression (i.e. on high dose steroids, chemotherapeutics, etc.)
Unknown estimated time of injury 12). Patients wearing an "Opt Out" TAMPITI Study bracelet 13). Known presence of subarachnoid hemorrhage.

14.) Isolated injuries to hands and/or feet (distal) 15.) Administration of antifibrinolytics pre-hospital and/or during this ED admission prior to enrollment
Intervention: SILVER DIAMMINE FLUORIDE
Trial phase: Phase 3
SMILES: N.N.[Ag+].[F-]
Sex: All
Age groups: Child
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 66
Group description: Topical application of 38% diammine silver fluoride to active cavity

38% diammine silver fluoride: treatment of cavity with study agent
Eligibility criteria:
Inclusion Criteria:

Nyvad criteria 3
Active carious lesion

Exclusion Criteria:

Allergy to silver
Stomatitis or oral ulcerative condition
Weight less than 15 kg
Intervention: Velpatasvir
Trial phase: Phase 2
ATC code: J05AP55 | J05AP56
SMILES: COC[C@H]1C[C@@H](c2nc(-c3ccc4c(c3)COc3cc5c(ccc6nc([C@@H]7CC[C@H](C)N7C(=O)[C@@H](NC(=O)OC)C(C)C)[nH]c65)cc3-4)c[nH]2)N(C(=O)[C@H](NC(=O)OC)c2ccccc2)C1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 24
Group description: SOF/VEL/VOX (400/100/100 mg) tablet orally once daily for 12 weeks
Eligibility criteria:
Key Inclusion Criteria:

Individuals with chronic HCV genotype 1 infection
Documented as treatment experienced with a direct acting antiviral-containing regimen without achieving sustained viral response
Absence of cirrhosis or presence of compensated cirrhosis
Screening laboratory values within defined thresholds
Must use specific contraceptive methods if female of childbearing potential or sexually active male

Key Exclusion Criteria:

Co-infection with HIV or hepatitis B virus (HBV)
Current or prior history of clinical hepatic decompensation
Chronic use of systemic immunosuppressive agents
History of clinically significant illness or any other medical disorder that may interfere with individual's treatment, assessment or compliance with the protocol
Pregnant or a nursing female

Note: Other protocol defined Inclusion/Exclusion criteria may apply.