araag2/HINT huggingface dataset:
Clinical trial NCT02600494 (phase 3, status: completed)
Conditions: bipolar depression
ICD codes: F32.A, F53.0, P91.4, Z13.31, Z13.32
Drugs: iti-007 (lumateperone), placebo
SMILES: [H][C@]12CCN(CCCC(=O)C3=CC=C(F)C=C3)C[C@@]1([H])C1=CC=CC3=C1N2CCN3C, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility criteria:

        Major Inclusion Criteria:

          -  male or female subjects of any race, ages 18-75 inclusive, with a clinical diagnosis
             of Bipolar I or Bipolar II disorder

          -  experiencing a current major depressive episode

        Major Exclusion Criteria:

          -  any subject unable to provide informed consent

          -  any female subject who is pregnant or breast-feeding

          -  any subject judged to be medically inappropriate for study participation
Clinical trial NCT02600819 (phase 3, status: completed)
Conditions: hiv-1 infection
ICD codes: B20, Z71.7, O98.72, Z21, O98.73, R75, Z11.4
Drugs: e/c/f/taf, b/f/taf
SMILES: [H][C@@](CO)(C(C)C)N1C=C(C(O)=O)C(=O)C2=C1C=C(OC)C(CC1=C(F)C(Cl)=CC=C1)=C2, CC(C)[C@@H]1CC[C@@H](C)C[C@H]1O
Eligibility criteria:

        Key Inclusion Criteria:

          -  Currently on a stable antiretroviral regimen for ≥ 6 consecutive months

          -  Plasma HIV-1 ribonucleic acid (RNA) concentrations < 50 copies/mL for ≥ 6 months
             preceding the screening visit and have HIV-1 RNA < 50 copies/mL at screening

          -  No documented history of HIV-1 resistance to elvitegravir (EVG), emtricitabine (FTC),
             lamivudine (3TC) or tenofovir (TFV) and no history of switching off EVG, FTC, 3TC or
             TFV due to concern for resistance

          -  Cluster determinant 4 (CD4+) T cell count ≥ 200 cells/μL

          -  ESRD with estimated glomerular filtration rate (eGFR) < 15 mL/min by Cockcroft-Gault
             formula for creatinine clearance

          -  On chronic HD for ≥ 6 months prior to screening

          -  Adequate hematologic function (absolute neutrophil count ≥ 1,000/mm^3; platelets ≥
             50,000/mm^3; hemoglobin ≥ 8.5 g/dL)

        Key Exclusion Criteria:

          -  Hepatitis B co-infection

          -  Any clinical history, condition, or test result that, in the opinion of the
             Investigator, would make the individual unsuitable for the study or unable to comply
             with dosing requirements

          -  Administration of other investigational agents (unless approved by Gilead Sciences).
             Participation in any other clinical trial, including observational trials, without
             prior approval from the sponsor is prohibited while participating in this trial.

          -  History or presence of allergy or intolerance to the study drugs or their components

          -  A new acquired immunodeficiency syndrome (AIDS)-defining condition (excluding CD4+ T
             cell count and percentage criteria) diagnosed within the 30 days prior to screening,
             with the exception of oropharyngeal candidiasis

          -  Received solid organ or bone marrow transplant

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Clinical trial NCT02603120 (phase 3, status: completed)
Conditions: hiv-1 infection
ICD codes: B20, Z71.7, O98.72, Z21, O98.73, R75, Z11.4
Drugs: abc/dtg/3tc, b/f/taf, abc/dtg/3tc placebo, b/f/taf placebo
SMILES: NC1=NC(=O)N(C=C1)[C@@H]1CS[C@H](CO)O1, CC(C)[C@@H]1CC[C@@H](C)C[C@H]1O, NC1=NC(=O)N(C=C1)[C@@H]1CS[C@H](CO)O1, CC(C)[C@@H]1CC[C@@H](C)C[C@H]1O
Eligibility criteria:

        Key Inclusion Criteria:

          -  Estimated glomerular filtration rate ≥ 50 mL/min (≥ 0.83 mL/sec).

          -  Currently receiving an antiretroviral regimen of DTG + ABC/3TC, or ABC/DTG/3TC FDC for
             ≥ 3 months prior to the screening visit.

          -  HIV ribonucleic acid (RNA) < 50 copies/mL at the screening visit.

          -  Currently on a stable regimen for ≥ 3 months preceding the screening visit with
             documented plasma HIV-1 RNA < 50 copies/mL for ≥ 3 months preceding the screening
             visit (or undetectable HIV-1 RNA level according to the local assay being used if the
             limit of detection is ≥ 50 copies/mL).

          -  Have no documented or suspected resistance to emtricitabine (FTC), tenofovir (TFV),
             DTG, ABC or 3TC.

        Key Exclusion Criteria:

          -  Current alcohol or substance use judged by the Investigator to potentially interfere
             with subject study compliance.

          -  Active tuberculosis infection.

          -  Individuals experiencing decompensated cirrhosis (eg, ascites, encephalopathy, or
             variceal bleeding).

          -  Females who are pregnant.

          -  Females who are breastfeeding.

          -  Acute hepatitis in the 30 days prior to study entry.

          -  Chronic Hepatitis B Virus (HBV) infection.

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Clinical trial NCT02604017 (phase 3, status: completed)
Conditions: chronic hepatitis c, hepatitis c virus, hcv
ICD codes: B18.2, B18.0, B18.1, B18.8, B18.9, K71.3, K71.4, B00.81, B25.1, B26.81, B58.1, K75.4, A51.45, B17.2
Drugs: abt-493/abt-530
SMILES: [H][C@](C)(OC)[C@]([H])(N=C(O)OC)C(=O)N1CCC[C@@]1([H])C1=NC2=C(N1)C=C(F)C(=C2)[C@@]1([H])CC[C@@]([H])(N1C1=CC(F)=C(N2CCC(CC2)C2=CC=C(F)C=C2)C(F)=C1)C1=CC2=C(NC(=N2)[C@]2([H])CCCN2C(=O)[C@@]([H])(N=C(O)OC)[C@@]([H])(C)OC)C=C1F
Eligibility criteria:

        Inclusion Criteria:

          -  Male or female, at least 18 years of age at time of screening.

          -  Screening laboratory result indicating hepatitis C virus (HCV) genotype 1 (GT1)
             infection.

          -  Chronic HCV infection.

          -  Subject must be HCV treatment-naïve (i.e., patient has never received a single dose of
             any approved or investigational regimen) or treatment-experienced (has failed prior
             interferon [IFN] or pegylated IFN (pegIFN) with or without ribivarin (RBV), or
             sofosbuvir (SOF) plus RBV with or without pegIFN therapy).

          -  Subjects must be non-cirrhotic.

        Additional Inclusion Criteria for HCV GT1/human immununovirus type 1 (HIV-1) co-infected
        patients:

          -  HIV-1 antiretroviral treatment (ART) naïve with CD4 ≥ 500 cells/mm3 (or CD4+ % ≥ 29%)
             at Screening and plasma HIV-1 RNA <1,000 copies/mL at Screening and at least once
             during the 12 months prior to Screening.

        OR

          -  On a stable, qualifying HIV-1 ART regimen for at least 8 weeks prior to screening,
             with CD4 ≥ 200 cells/mm3 (or CD4+ % ≥14%) at Screening and plasma HIV-1 RNA < LLOQ at
             Screening and at least once during the 12 months prior to Screening.

        Exclusion Criteria:

          -  History of severe, life-threatening or other significant sensitivity to any excipients
             of the study drugs.

          -  Female who is pregnant, planning to become pregnant during the study or breastfeeding;
             or male whose partner is pregnant or planning to become pregnant during the study.

          -  Recent (within 6 months prior to study drug administration) history of drug or alcohol
             abuse that could preclude adherence to the protocol in the opinion of the
             investigator.

          -  Positive test result at Screening for hepatitis B surface antigen (HBsAg).

          -  HCV genotype performed during screening indicating co-infection with more than one HCV
             genotype.

          -  Chronic HIV type 2 (HIV-2) infection.
Clinical trial NCT02604342 (phase 3, status: completed)
Conditions: non-small cell lung cancer
ICD codes: C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2
Drugs: alectinib, docetaxel, pemetrexed
SMILES: CCC1=CC2=C(C=C1N1CCC(CC1)N1CCOCC1)C(C)(C)C1=C(C3=C(N1)C=C(C=C3)C#N)C2=O, [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1, [H][N]([H])([H])[Pt](Cl)(Cl)[N]([H])([H])[H]
Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed diagnosis of advanced or recurrent (Stage
             IIIB not amenable for multimodality treatment) or metastatic (Stage IV) NSCLC that is
             ALK-positive. ALK positivity must have been determined by a validated fluorescence in
             situ hybridization (FISH) test (recommended probe, Vysis ALK Break-Apart Probe) or a
             validated immunohistochemistry (IHC) test (recommended antibody, clone D5F3)

          -  Participant had received two prior systemic lines of therapy, which must have included
             one line of platinum-based chemotherapy and one line of crizotinib

          -  Prior CNS or leptomeningeal metastases allowed if asymptomatic

          -  Participants with symptomatic CNS metastases for whom radiotherapy is not an option
             will be allowed to participate in this study

          -  Measurable disease by RECIST Version 1.1 prior to the administration of study
             treatment

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0-2

          -  For all females of childbearing potential, a negative pregnancy test must be obtained
             within 3 days before starting study treatment

        Exclusion Criteria:

          -  Participants with a previous malignancy within the past 3 years are excluded (other
             than curatively treated basal cell carcinoma of the skin, early gastrointestinal [GI]
             cancer by endoscopic resection or in situ carcinoma of the cervix)

          -  Participants who have received any previous ALK inhibitor other than crizotinib

          -  Any GI disorder that may affect absorption of oral medications
Clinical trial NCT02607306 (phase 3, status: completed)
Conditions: diabetes, diabetes mellitus, type 2
ICD codes: E23.2, N25.1, P70.2, O24.92, Z83.3, Z86.32, E10.65, E11.65, E11.9, E11.21, E11.36, E11.41, E11.42, E11.44
Drugs: insulin degludec/liraglutide, insulin degludec, liraglutide
SMILES: CN(C)C(=N)NC(N)=N, [Na+].[Na+].[O-]P([O-])(F)=O, CN(C)C(=N)NC(N)=N
Eligibility criteria:

        Inclusion Criteria:

          -  Male or female Japanese subjects, age at least 20 years at the time of signing
             informed consent

          -  Type 2 diabetes subjects (diagnosed clinically) at least 6 months prior to screening

          -  HbA1c (glycosylated haemoglobin) 7.0-11.0 % (both inclusive) by central laboratory
             analysis, with the aim of a median of 8.3%. When approximately 50% of the randomised
             subjects have a HbA1c above 8.3%, the remaining subjects randomised must have a HbA1c
             below or equal to 8.3%; or when approximately 50% of the randomised subjects have a
             HbA1c below or equal to 8.3%, the remaining subjects randomised must have a HbA1c
             above 8.3%

          -  Body-mass index (BMI) above or equal to 20 kg/m^2

          -  Subjects on stable therapy with one OAD (defined as unchanged medication and unchanged
             dose) for at least 60 days (metformin, a-GI, TZD, SU, SGLT2i or glinide) prior to
             screening according to approved Japanese labelling

        Exclusion Criteria:

          -  Previous treatment with insulin (except for short-term treatment in connection with
             intercurrent illness including gestational diabetes)

          -  Treatment with any medication for the indication of diabetes or obesity other than
             stated in the inclusion criteria in a period of 60 days before screening

          -  Anticipated initiation or change in concomitant medications in excess of 14 days known
             to affect weight or glucose metabolism

          -  Impaired liver function, defined as alanine aminotransferase (ALT) or aspartate
             aminotransferase (AST) equal to or above 2.5 times upper limit of normal

          -  Renal impairment estimated Glomerular Filtration Rate (eGFR) below 60mL/min/1.73m^2 as
             per Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI)

          -  Screening calcitonin equal to or above 50 ng/L

          -  History of pancreatitis (acute or chronic)

          -  Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine
             neoplasia type 2 (MEN 2)

          -  Subjects presently classified as being in New York Heart Association (NYHA) Class IV
Clinical trial NCT02607735 (phase 3, status: completed)
Conditions: hepatitis c
ICD codes: B18.2, B17.10, B17.11, B19.20, B19.21, B15.0, B15.9
Drugs: sof/vel/vox, placebo
SMILES: [H][C@](N=C(O)OC)(C(C)C)C(=O)N1[C@@]([H])(C)CC[C@@]1([H])C1=NC2=C(N1)C1=CC3=C(C=C1C=C2)C1=C(CO3)C=C(C=C1)C1=CN=C(N1)[C@]1([H])C[C@]([H])(COC)CN1C(=O)[C@]([H])(N=C(O)OC)C1=CC=CC=C1, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility criteria:

        Key Inclusion Criteria:

          -  Willing and able to provide written informed consent

          -  HCV RNA ≥ 10^4 IU/mL at screening

          -  Chronic HCV infection (≥ 6 months)

          -  Treatment experienced with a direct acting antiviral medication for HCV

          -  Use of protocol specified methods of contraception

        Key Exclusion Criteria:

          -  Current or prior history of clinically significant illness that may interfere with
             participation in the study

          -  Screening ECG with clinically significant abnormalities

          -  Laboratory results outside of acceptable ranges at screening

          -  Pregnant or nursing female

          -  Chronic liver disease not caused by HCV

          -  Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Clinical trial NCT02607800 (phase 3, status: completed)
Conditions: hepatitis c
ICD codes: B18.2, B17.10, B17.11, B19.20, B19.21, B15.0, B15.9
Drugs: sof/vel/vox, sof/vel
SMILES: [H][C@](N=C(O)OC)(C(C)C)C(=O)N1[C@@]([H])(C)CC[C@@]1([H])C1=NC2=C(N1)C1=CC3=C(C=C1C=C2)C1=C(CO3)C=C(C=C1)C1=CN=C(N1)[C@]1([H])C[C@]([H])(COC)CN1C(=O)[C@]([H])(N=C(O)OC)C1=CC=CC=C1, [H][C@](N=C(O)OC)(C(C)C)C(=O)N1[C@@]([H])(C)CC[C@@]1([H])C1=NC2=C(N1)C1=CC3=C(C=C1C=C2)C1=C(CO3)C=C(C=C1)C1=CN=C(N1)[C@]1([H])C[C@]([H])(COC)CN1C(=O)[C@]([H])(N=C(O)OC)C1=CC=CC=C1
Eligibility criteria:

        Key Inclusion Criteria:

          -  Willing and able to provide written informed consent

          -  HCV RNA ≥ 10^4 IU/mL at screening

          -  Chronic HCV infection (≥ 6 months)

          -  HCV treatment naive or treatment experienced with an interferon (IFN)-based regimen

          -  Use of protocol specified methods of contraception

        Key Exclusion Criteria:

          -  Current or prior history of clinically significant illness that may interfere with
             participation in the study

          -  Screening ECG with clinically significant abnormalities

          -  Laboratory parameters outside the acceptable range at screening

          -  Pregnant or nursing female

          -  Chronic liver disease not caused by HCV

          -  Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Clinical trial NCT02607930 (phase 3, status: active, not recruiting)
Conditions: hiv-1 infection
ICD codes: B20, Z71.7, O98.72, Z21, O98.73, R75, Z11.4
Drugs: abc/dtg/3tc, b/f/taf, abc/dtg/3tc placebo, b/f/taf placebo
SMILES: NC1=NC(=O)N(C=C1)[C@@H]1CS[C@H](CO)O1, CC(C)[C@@H]1CC[C@@H](C)C[C@H]1O, NC1=NC(=O)N(C=C1)[C@@H]1CS[C@H](CO)O1, CC(C)[C@@H]1CC[C@@H](C)C[C@H]1O
Eligibility criteria:

        Key Inclusion Criteria:

          -  Antiretroviral treatment naïve (≤ 10 days of prior therapy with any antiretroviral
             agent following a diagnosis of HIV-1 infection) except the use for pre-exposure
             prophylaxis (PrEP) or post-exposure prophylaxis (PEP), up to one month prior to
             screening

          -  Plasma HIV-1 RNA levels ≥ 500 copies/mL at screening

          -  Adequate renal function: Estimated glomerular filtration rate ≥ 50 mL/min (≥ 0.83
             mL/sec) according to the Cockcroft-Gault formula

          -  Negative screening test for human leukocyte antigen (HLA) -B x 5701 allele provided by
             Gilead Sciences

        Key Exclusion Criteria:

          -  An opportunistic illness indicative of stage 3 HIV diagnosed within the 30 days prior
             to screening (refer to study protocol)

          -  Decompensated cirrhosis (e.g, ascites, encephalopathy, or variceal bleeding)

          -  Current alcohol or substance use judged by the Investigator to potentially interfere
             with subject study compliance

          -  Females who are pregnant (as confirmed by positive serum pregnancy test)

          -  Females who are breastfeeding

          -  Chronic Hepatitis B Virus (HBV) infection

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Clinical trial NCT02607956 (phase 3, status: active, not recruiting)
Conditions: hiv-1 infection
ICD codes: B20, Z71.7, O98.72, Z21, O98.73, R75, Z11.4
Drugs: dtg, f/taf, b/f/taf, dtg placebo, f/taf placebo, b/f/taf placebo
SMILES: [H][C@]12CN3C=C(C(=O)NCC4=CC=C(F)C=C4F)C(=O)C(O)=C3C(=O)N1[C@H](C)CCO2, CC(C)OC(=O)[C@H](C)N[P@](=O)(CO[C@H](C)CN1C=NC2=C(N)N=CN=C12)OC1=CC=CC=C1, CC(C)[C@@H]1CC[C@@H](C)C[C@H]1O, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O, CC(C)[C@@H]1CC[C@@H](C)C[C@H]1O
Eligibility criteria:

        Key Inclusion Criteria:

          -  Antiretroviral treatment naive (≤ 10 days of prior therapy with any antiretroviral
             agent following a diagnosis of HIV-1 infection) except the use for pre-exposure
             prophylaxis (PrEP) or post-exposure prophylaxis (PEP), up to one month prior to
             screening

          -  Plasma HIV-1 RNA levels ≥ 500 copies/mL at screening

          -  Adequate renal function: Estimated glomerular filtration rate ≥ 30 mL/min (≥ 0.50
             mL/sec) according to the Cockcroft-Gault formula

        Key Exclusion Criteria:

          -  An opportunistic illness indicative of stage 3 HIV diagnosed within the 30 days prior
             to screening

          -  Decompensated cirrhosis (eg, ascites, encephalopathy, or variceal bleeding)

          -  Current alcohol or substance use judged by the Investigator to potentially interfere
             with subject study compliance

          -  Females who are pregnant (as confirmed by positive serum pregnancy test)

          -  Females who are breastfeeding

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Clinical trial NCT02611830 (phase 3, status: completed)
Conditions: colitis, ulcerative
ICD codes: K51.80, K51.813, K51.814, K51.90, K51.913, K51.914, K51.811
Drugs: vedolizumab 300 mg iv, placebo iv, vedolizumab 108 mg sc, placebo sc
SMILES: [Na+].[Cl-], CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility criteria:

        Inclusion Criteria:

          1. Diagnosis of ulcerative colitis (UC) established at least 6 months prior to screening,
             by clinical and endoscopic evidence and corroborated by a histopathology report.

          2. Moderately to severely active UC as determined by a complete Mayo score of 6-12 (with
             an endoscopic subscore ≥2)

          3. Evidence of UC extending proximal to the rectum (≥15 cm of involved colon).

          4. Inadequate response with, loss of response to, or intolerance to corticosteroids,
             immunomodulators, or Tumor Necrosis Factor-alpha (TNF-α) antagonists

        Exclusion Criteria:

          1. Evidence of abdominal abscess or toxic megacolon at the initial Screening Visit.

          2. Extensive colonic resection, subtotal or total colectomy.

          3. Ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine.

          4. Prior exposure to investigational or approved non-biologic therapies (eg,
             cyclosporine, tacrolimus, thalidomide, methotrexate or tofacitinib) for the treatment
             of underlying disease within 30 days or 5 half-lives of screening (whichever is
             longer).

          5. Prior exposure to any investigational or approved biologic or biosimilar agent within
             60 days or 5 half-lives of screening (whichever is longer).

          6. Prior exposure to vedolizumab

          7. Surgical intervention for UC required at any time during the study.

          8. History or evidence of adenomatous colonic polyps that have not been removed or has a
             history or evidence of colonic mucosal dysplasia.

          9. Suspected or confirmed diagnosis of Crohn's entercolitis, indeterminate colitis,
             ischaemic colitis, radiation colitis, diverticular disease associated with colitis, or
             microscopic colitis.

         10. Active infections

         11. Chronic hepatitis B virus (HBV) infection or chronic hepatitis C virus (HCV)
             infection, HIV or tuberculosis (active or latent), identified congenital or acquired
             immunodeficiency. HBV immune participants (ie, being hepatitis B surface antigen
             [HBsAg] negative and hepatitis B antibody positive) may, however, be included.

         12. History of any major neurological disorders, including stroke, multiple sclerosis,
             brain tumor, demyelinating or neurodegenerative disease.
Clinical trial NCT02613507 (phase 3, status: active, not recruiting)
Conditions: non-small cell lung cancer
ICD codes: C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2
Drugs: nivolumab, docetaxel
SMILES: [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1, [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1
Eligibility criteria:

        For more information regarding BMS clinical trial participation, please visit
        www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Disease progression experienced during or after one prior platinum containing doublet
             chemotherapy

          -  Stage IIIb/IV or recurrent disease

          -  Male and Female ≥ 18 years of age

          -  Measurable disease per RECIST 1.1

          -  Performance Status ≤ 1

        Exclusion Criteria:

          -  History of Carcinomatous meningitis

          -  Active Central nervous system (CNS) metastases

          -  History of auto immune diseases

          -  Prior treatment with Docetaxel

          -  Prior treatment with ipilimumab or any drug targeting T-Cell costimulation or
             checkpoint pathways
Clinical trial NCT02613871 (phase 3, status: completed)
Conditions: hepatitis c virus infection
ICD codes: B00.81, B25.1, B26.81, B58.1, K75.4, A51.45, B17.2
Drugs: ldv/sof
SMILES: CC(C)OC(=O)[C@H](C)N[P@](=O)(OC[C@H]1O[C@@H](N2C=CC(=O)NC2=O)[C@](C)(F)[C@@H]1O)OC1=CC=CC=C1
Eligibility criteria:

        Key Inclusion Criteria:

          -  Individuals ≥ 40 kg in weight with chronic genotype 1 or 2 HCV and HBV coinfection

          -  Individuals must not be taking or requiring treatment with HBV antiviral therapy at
             screening. For participants that are HBV treatment experienced, the most recent
             treatment must have been completed at least 6 months prior to Day 1.

          -  Cirrhosis determination by Fibroscan

          -  Screening laboratory values within defined thresholds

          -  Use of two effective contraception methods if female or male is of childbearing
             potential

        Key Exclusion Criteria:

          -  Current or prior history of clinically-significant illness or any other major medical
             disorder that may interfere with individual's treatment, assessment or compliance with
             the protocol

          -  Pregnant or nursing female

          -  Infection with human immunodeficiency virus (HIV) or hepatitis delta virus (HDV)

          -  Hepatocellular carcinoma (HCC) or other malignancy

          -  Current or prior history of clinical hepatic decompensation

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