Trial Outcomes & Findings for Study to Evaluate the Safety and Efficacy of Switching to Tenofovir Alafenamide (TAF) From Tenofovir Disoproxil Fumarate (TDF) and/or Other Oral Antiviral Treatment (OAV) (NCT NCT03180619)

NCT ID: NCT03180619

Last Updated: 2021-09-27

Results Overview

The percentage of participants with HBV DNA \< 20 IU/mL at Week 24 was determined by the Missing = Failure (M = F) approach.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 124 participants
• Primary outcome timeframe: Week 24
• Results posted on: 2021-09-27

Participant Flow

Participants were enrolled at study sites in Asia Pacific, North America, New Zealand and Europe. The first participant was screened on 29 June 2017. The last study visit occurred on 04 September 2020.

147 participants were screened.

Participant milestones

Measure	Part A (Renal Impairment): Moderate or Severe Renal Impairment Participants with chronic hepatitis B (CHB) and moderate or severe renal impairment who were virologically suppressed and took tenofovir disoproxil fumarate (TDF), a TDF-containing anti-hepatitis B virus (HBV) regimen, or other oral antivirals (OAVs), switched to tenofovir alafenamide (TAF) and received TAF 25 mg tablet once daily orally for 96 weeks.	Part A (Renal Impairment): End Stage Renal Disease Participants with CHB and end stage renal disease who were virologically suppressed and took TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.	Part B: Hepatic Impairment Participants with CHB and moderate or severe hepatic impairment who were virologically suppressed and took TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.
Overall Study STARTED	78	15	31
Overall Study COMPLETED	67	14	25
Overall Study NOT COMPLETED	11	1	6

Reasons for withdrawal

Measure	Part A (Renal Impairment): Moderate or Severe Renal Impairment Participants with chronic hepatitis B (CHB) and moderate or severe renal impairment who were virologically suppressed and took tenofovir disoproxil fumarate (TDF), a TDF-containing anti-hepatitis B virus (HBV) regimen, or other oral antivirals (OAVs), switched to tenofovir alafenamide (TAF) and received TAF 25 mg tablet once daily orally for 96 weeks.	Part A (Renal Impairment): End Stage Renal Disease Participants with CHB and end stage renal disease who were virologically suppressed and took TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.	Part B: Hepatic Impairment Participants with CHB and moderate or severe hepatic impairment who were virologically suppressed and took TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.
Overall Study Withdrew Consent	5	0	2
Overall Study Death	2	1	2
Overall Study Adverse Event	2	0	1
Overall Study Investigator's discretion	2	0	1

Baseline Characteristics

Measure Analysis Population Description: Hip Dual-Energy X-Ray Absorptiometry (DXA) Analysis Set included all participants who were enrolled and received at least 1 dose of study drug and had non-missing baseline hip BMD values.

Baseline characteristics by cohort

Measure	Part A (Renal Impairment): Moderate or Severe Renal Impairment n=78 Participants Participants with CHB and moderate or severe renal impairment who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or other OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.	Part A (Renal Impairment): End Stage Renal Disease n=15 Participants Participants with CHB and end stage renal disease who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.	Part B: Hepatic Impairment n=31 Participants Participants with CHB and moderate or severe hepatic impairment who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.	Total n=124 Participants Total of all reporting groups
Age, Continuous	66 years STANDARD_DEVIATION 10.1 • n=78 Participants	54 years STANDARD_DEVIATION 12.8 • n=15 Participants	55 years STANDARD_DEVIATION 10.8 • n=31 Participants	61 years STANDARD_DEVIATION 11.8 • n=124 Participants
Sex: Female, Male Female	21 Participants n=78 Participants	3 Participants n=15 Participants	10 Participants n=31 Participants	34 Participants n=124 Participants
Sex: Female, Male Male	57 Participants n=78 Participants	12 Participants n=15 Participants	21 Participants n=31 Participants	90 Participants n=124 Participants
Race/Ethnicity, Customized Ethnicity · Hispanic or Latino	0 Participants n=78 Participants	0 Participants n=15 Participants	1 Participants n=31 Participants	1 Participants n=124 Participants
Race/Ethnicity, Customized Ethnicity · Not Hispanic or Latino	78 Participants n=78 Participants	15 Participants n=15 Participants	30 Participants n=31 Participants	123 Participants n=124 Participants
Race/Ethnicity, Customized Race · Asian	59 Participants n=78 Participants	13 Participants n=15 Participants	25 Participants n=31 Participants	97 Participants n=124 Participants
Race/Ethnicity, Customized Race · Black or African American	3 Participants n=78 Participants	0 Participants n=15 Participants	1 Participants n=31 Participants	4 Participants n=124 Participants
Race/Ethnicity, Customized Race · Native Hawaiian or Pacific Islander	0 Participants n=78 Participants	2 Participants n=15 Participants	0 Participants n=31 Participants	2 Participants n=124 Participants
Race/Ethnicity, Customized Race · White	15 Participants n=78 Participants	0 Participants n=15 Participants	4 Participants n=31 Participants	19 Participants n=124 Participants
Race/Ethnicity, Customized Race · Other	1 Participants n=78 Participants	0 Participants n=15 Participants	1 Participants n=31 Participants	2 Participants n=124 Participants
Region of Enrollment New Zealand	0 Participants n=78 Participants	2 Participants n=15 Participants	0 Participants n=31 Participants	2 Participants n=124 Participants
Region of Enrollment Canada	22 Participants n=78 Participants	0 Participants n=15 Participants	3 Participants n=31 Participants	25 Participants n=124 Participants
Region of Enrollment South Korea	12 Participants n=78 Participants	3 Participants n=15 Participants	5 Participants n=31 Participants	20 Participants n=124 Participants
Region of Enrollment Hong Kong	14 Participants n=78 Participants	1 Participants n=15 Participants	2 Participants n=31 Participants	17 Participants n=124 Participants
Region of Enrollment United States	3 Participants n=78 Participants	0 Participants n=15 Participants	7 Participants n=31 Participants	10 Participants n=124 Participants
Region of Enrollment Taiwan	13 Participants n=78 Participants	9 Participants n=15 Participants	11 Participants n=31 Participants	33 Participants n=124 Participants
Region of Enrollment Italy	13 Participants n=78 Participants	0 Participants n=15 Participants	2 Participants n=31 Participants	15 Participants n=124 Participants
Region of Enrollment United Kingdom	1 Participants n=78 Participants	0 Participants n=15 Participants	1 Participants n=31 Participants	2 Participants n=124 Participants
Alanine Aminotransferase (ALT)	20 Units/Liter (U/L) STANDARD_DEVIATION 9.6 • n=78 Participants	14 Units/Liter (U/L) STANDARD_DEVIATION 5.2 • n=15 Participants	28 Units/Liter (U/L) STANDARD_DEVIATION 12.4 • n=31 Participants	21 Units/Liter (U/L) STANDARD_DEVIATION 10.8 • n=124 Participants
ALT Level Based on Central Lab Normal Range ≤ ULN	75 Participants n=78 Participants	15 Participants n=15 Participants	27 Participants n=31 Participants	117 Participants n=124 Participants
ALT Level Based on Central Lab Normal Range > ULN - 5xULN	3 Participants n=78 Participants	0 Participants n=15 Participants	4 Participants n=31 Participants	7 Participants n=124 Participants
ALT Level Based on Central Lab Normal Range > 5xULN	0 Participants n=78 Participants	0 Participants n=15 Participants	0 Participants n=31 Participants	0 Participants n=124 Participants
ALT Level Based on 2018 American Association for the Study of Liver Diseases (AASLD) Normal Range ≤ ULN	73 Participants n=78 Participants	15 Participants n=15 Participants	21 Participants n=31 Participants	109 Participants n=124 Participants
ALT Level Based on 2018 American Association for the Study of Liver Diseases (AASLD) Normal Range > ULN - 5xULN	5 Participants n=78 Participants	0 Participants n=15 Participants	10 Participants n=31 Participants	15 Participants n=124 Participants
ALT Level Based on 2018 American Association for the Study of Liver Diseases (AASLD) Normal Range > 5xULN	0 Participants n=78 Participants	0 Participants n=15 Participants	0 Participants n=31 Participants	0 Participants n=124 Participants
Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Categories < 20 IU/mL	77 Participants n=78 Participants	14 Participants n=15 Participants	31 Participants n=31 Participants	122 Participants n=124 Participants
Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Categories ≥ 20 IU/mL - < 69 IU/mL	0 Participants n=78 Participants	1 Participants n=15 Participants	0 Participants n=31 Participants	1 Participants n=124 Participants
Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Categories ≥ 69 IU/mL	1 Participants n=78 Participants	0 Participants n=15 Participants	0 Participants n=31 Participants	1 Participants n=124 Participants
Estimated Glomerular Filtration Rate by the Cockcroft-Gault Formula (eGFRcg)	45.5 milliliter/minute (mL/min) STANDARD_DEVIATION 10.89 • n=78 Participants	7.8 milliliter/minute (mL/min) STANDARD_DEVIATION 2.63 • n=15 Participants	98.8 milliliter/minute (mL/min) STANDARD_DEVIATION 33.94 • n=31 Participants	54.3 milliliter/minute (mL/min) STANDARD_DEVIATION 34.16 • n=124 Participants
Hip Bone Mineral Density (BMD) Status Normal (T-score ≥ -1.0)	34 Participants n=77 Participants • Measure Analysis Population Description: Hip Dual-Energy X-Ray Absorptiometry (DXA) Analysis Set included all participants who were enrolled and received at least 1 dose of study drug and had non-missing baseline hip BMD values.	3 Participants n=15 Participants • Measure Analysis Population Description: Hip Dual-Energy X-Ray Absorptiometry (DXA) Analysis Set included all participants who were enrolled and received at least 1 dose of study drug and had non-missing baseline hip BMD values.	18 Participants n=31 Participants • Measure Analysis Population Description: Hip Dual-Energy X-Ray Absorptiometry (DXA) Analysis Set included all participants who were enrolled and received at least 1 dose of study drug and had non-missing baseline hip BMD values.	55 Participants n=123 Participants • Measure Analysis Population Description: Hip Dual-Energy X-Ray Absorptiometry (DXA) Analysis Set included all participants who were enrolled and received at least 1 dose of study drug and had non-missing baseline hip BMD values.
Hip Bone Mineral Density (BMD) Status Osteopenia (-2.5 ≤ T-score < -1.0)	36 Participants n=77 Participants • Measure Analysis Population Description: Hip Dual-Energy X-Ray Absorptiometry (DXA) Analysis Set included all participants who were enrolled and received at least 1 dose of study drug and had non-missing baseline hip BMD values.	5 Participants n=15 Participants • Measure Analysis Population Description: Hip Dual-Energy X-Ray Absorptiometry (DXA) Analysis Set included all participants who were enrolled and received at least 1 dose of study drug and had non-missing baseline hip BMD values.	12 Participants n=31 Participants • Measure Analysis Population Description: Hip Dual-Energy X-Ray Absorptiometry (DXA) Analysis Set included all participants who were enrolled and received at least 1 dose of study drug and had non-missing baseline hip BMD values.	53 Participants n=123 Participants • Measure Analysis Population Description: Hip Dual-Energy X-Ray Absorptiometry (DXA) Analysis Set included all participants who were enrolled and received at least 1 dose of study drug and had non-missing baseline hip BMD values.
Hip Bone Mineral Density (BMD) Status Osteoporosis (T-score < -2.5)	7 Participants n=77 Participants • Measure Analysis Population Description: Hip Dual-Energy X-Ray Absorptiometry (DXA) Analysis Set included all participants who were enrolled and received at least 1 dose of study drug and had non-missing baseline hip BMD values.	7 Participants n=15 Participants • Measure Analysis Population Description: Hip Dual-Energy X-Ray Absorptiometry (DXA) Analysis Set included all participants who were enrolled and received at least 1 dose of study drug and had non-missing baseline hip BMD values.	1 Participants n=31 Participants • Measure Analysis Population Description: Hip Dual-Energy X-Ray Absorptiometry (DXA) Analysis Set included all participants who were enrolled and received at least 1 dose of study drug and had non-missing baseline hip BMD values.	15 Participants n=123 Participants • Measure Analysis Population Description: Hip Dual-Energy X-Ray Absorptiometry (DXA) Analysis Set included all participants who were enrolled and received at least 1 dose of study drug and had non-missing baseline hip BMD values.
Spine BMD Status Normal (T-score ≥ -1.0)	37 Participants n=78 Participants	5 Participants n=15 Participants	16 Participants n=31 Participants	58 Participants n=124 Participants
Spine BMD Status Osteopenia (-2.5 ≤ T-score < -1.0)	22 Participants n=78 Participants	7 Participants n=15 Participants	9 Participants n=31 Participants	38 Participants n=124 Participants
Spine BMD Status Osteoporosis (T-score < -2.5)	19 Participants n=78 Participants	3 Participants n=15 Participants	6 Participants n=31 Participants	28 Participants n=124 Participants
Hepatitis s-Antigen (HBsAg) (log10 IU/mL)	2.51 log10 IU/mL STANDARD_DEVIATION 0.782 • n=78 Participants	2.72 log10 IU/mL STANDARD_DEVIATION 1.405 • n=15 Participants	1.90 log10 IU/mL STANDARD_DEVIATION 1.169 • n=31 Participants	2.38 log10 IU/mL STANDARD_DEVIATION 1.012 • n=124 Participants
Hepatitis B e Antigen/Antibody (HBeAg/HBeAb) Status Positive/Negative	13 Participants n=78 Participants	3 Participants n=15 Participants	3 Participants n=31 Participants	19 Participants n=124 Participants
Hepatitis B e Antigen/Antibody (HBeAg/HBeAb) Status Positive/Positive	0 Participants n=78 Participants	0 Participants n=15 Participants	0 Participants n=31 Participants	0 Participants n=124 Participants
Hepatitis B e Antigen/Antibody (HBeAg/HBeAb) Status Negative/Negative	15 Participants n=78 Participants	1 Participants n=15 Participants	10 Participants n=31 Participants	26 Participants n=124 Participants
Hepatitis B e Antigen/Antibody (HBeAg/HBeAb) Status Negative/Positive	50 Participants n=78 Participants	11 Participants n=15 Participants	18 Participants n=31 Participants	79 Participants n=124 Participants
FibroTest® Score	0.53 units on a scale STANDARD_DEVIATION 0.199 • n=77 Participants • Participants in Safety Analysis Set with available data were analyzed.	0.37 units on a scale STANDARD_DEVIATION 0.199 • n=15 Participants • Participants in Safety Analysis Set with available data were analyzed.	0.75 units on a scale STANDARD_DEVIATION 0.206 • n=31 Participants • Participants in Safety Analysis Set with available data were analyzed.	0.57 units on a scale STANDARD_DEVIATION 0.231 • n=123 Participants • Participants in Safety Analysis Set with available data were analyzed.
Child-Pugh-Turcotte (CPT) Score	—	—	6 units on a scale STANDARD_DEVIATION 1.7 • n=31 Participants • Participants in the Full Analysis Set only from Part B (Hepatic Impairment) were analyzed.	6 units on a scale STANDARD_DEVIATION 1.7 • n=31 Participants • Participants in the Full Analysis Set only from Part B (Hepatic Impairment) were analyzed.
Model for End-Stage Liver Disease (MELD) Score	—	—	10.7 units on a scale STANDARD_DEVIATION 3.40 • n=31 Participants • Participants in Full Analysis Set only from Part B (Hepatic Impairment) were analyzed.	10.7 units on a scale STANDARD_DEVIATION 3.40 • n=31 Participants • Participants in Full Analysis Set only from Part B (Hepatic Impairment) were analyzed.

PRIMARY outcome

Timeframe: Week 24

Population: The Full Analysis Set included all participants who were enrolled and received at least 1 dose of study drug.

The percentage of participants with HBV DNA < 20 IU/mL at Week 24 was determined by the Missing = Failure (M = F) approach.

Outcome measures

Measure	Part A (Renal Impairment): End Stage Renal Disease n=15 Participants Participants with CHB and end stage renal disease who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.	Part B: Hepatic Impairment n=31 Participants Participants with CHB and moderate or severe hepatic impairment who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.	Part A (Renal Impairment): Moderate or Severe Renal Impairment n=78 Participants Participants with chronic hepatitis B (CHB) and moderate or severe renal impairment who were virologically suppressed and took tenofovir disoproxil fumarate (TDF), a TDF-containing anti-hepatitis B virus (HBV) regimen, or other oral antivirals (OAVs), switched to tenofovir alafenamide (TAF) and received TAF 25 mg tablet once daily orally for 96 weeks.
Percentage of Participants Achieving Virologic Response (Plasma Hepatitis B Virus [HBV] Deoxyribonucleic Acid [DNA] < 20 IU/mL) at Week 24	100.0 percentage of participants	100.0 percentage of participants	97.4 percentage of participants

PRIMARY outcome

Timeframe: Week 24

Population: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug.

Treatment-emergent AEs were defined as:

• Any AEs with an onset date on or after the study drug start date and no later than the study drug stop date + 3 days after permanent discontinuation of study drug;
• Any AEs with onset date on or after the study drug start date for those who have not permanently discontinued study drug;
• Any AEs leading to premature discontinuation of study drug.

The most severe graded AE from all tests was counted for each participant.

Outcome measures

Measure	Part A (Renal Impairment): End Stage Renal Disease n=15 Participants Participants with CHB and end stage renal disease who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.	Part B: Hepatic Impairment n=31 Participants Participants with CHB and moderate or severe hepatic impairment who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.	Part A (Renal Impairment): Moderate or Severe Renal Impairment n=78 Participants Participants with chronic hepatitis B (CHB) and moderate or severe renal impairment who were virologically suppressed and took tenofovir disoproxil fumarate (TDF), a TDF-containing anti-hepatitis B virus (HBV) regimen, or other oral antivirals (OAVs), switched to tenofovir alafenamide (TAF) and received TAF 25 mg tablet once daily orally for 96 weeks.
Percentage of Participants Who Experienced Graded Treatment-Emergent Adverse Events (AEs) at Week 24 Any Treatment-emergent AEs	73.3 percentage of participants	54.8 percentage of participants	53.8 percentage of participants
Percentage of Participants Who Experienced Graded Treatment-Emergent Adverse Events (AEs) at Week 24 Grade 3 and Above Treatment-emergent AEs	13.3 percentage of participants	6.5 percentage of participants	6.4 percentage of participants

PRIMARY outcome

Timeframe: Week 24

Population: Participants in the Safety Analysis Set were analyzed.

Graded treatment-emergent laboratory abnormalities were defined as values that increased at least 1 toxicity grade from baseline at any postbaseline visit, up to and including the date of last dose of study drug + 3 days for participants who permanently discontinued study drug or the last available date in the database snapshot for participants who were on treatment at the time of the analysis.

The most severe graded abnormality from all tests was counted for each participant.

Outcome measures

Measure	Part A (Renal Impairment): End Stage Renal Disease n=15 Participants Participants with CHB and end stage renal disease who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.	Part B: Hepatic Impairment n=31 Participants Participants with CHB and moderate or severe hepatic impairment who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.	Part A (Renal Impairment): Moderate or Severe Renal Impairment n=78 Participants Participants with chronic hepatitis B (CHB) and moderate or severe renal impairment who were virologically suppressed and took tenofovir disoproxil fumarate (TDF), a TDF-containing anti-hepatitis B virus (HBV) regimen, or other oral antivirals (OAVs), switched to tenofovir alafenamide (TAF) and received TAF 25 mg tablet once daily orally for 96 weeks.
Percentage of Participants Who Experienced Graded Treatment-Emergent Laboratory Abnormalities at Week 24 Any Graded Laboratory Abnormality	100.0 percentage of participants	90.3 percentage of participants	96.2 percentage of participants
Percentage of Participants Who Experienced Graded Treatment-Emergent Laboratory Abnormalities at Week 24 Grade 3 and Above Laboratory Abnormality	46.7 percentage of participants	48.4 percentage of participants	11.5 percentage of participants

SECONDARY outcome

Timeframe: Week 48

Population: Participants in the Safety Analysis Set were analyzed.

Treatment-emergent AEs were defined as: Any AEs with an onset date on or after the study drug start date and no later than the study drug stop date + 3 days after permanent discontinuation of study drug; Any AEs with onset date on or after the study drug start date for those who have not permanently discontinued study drug; Any AEs leading to premature discontinuation of study drug. The most severe graded AE from all tests was counted for each participant.

Outcome measures

Measure	Part A (Renal Impairment): End Stage Renal Disease n=15 Participants Participants with CHB and end stage renal disease who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.	Part B: Hepatic Impairment n=31 Participants Participants with CHB and moderate or severe hepatic impairment who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.	Part A (Renal Impairment): Moderate or Severe Renal Impairment n=78 Participants Participants with chronic hepatitis B (CHB) and moderate or severe renal impairment who were virologically suppressed and took tenofovir disoproxil fumarate (TDF), a TDF-containing anti-hepatitis B virus (HBV) regimen, or other oral antivirals (OAVs), switched to tenofovir alafenamide (TAF) and received TAF 25 mg tablet once daily orally for 96 weeks.
Percentage of Participants Who Experienced Graded Treatment-Emergent AEs at Week 48 Any Treatment-emergent AE	86.7 percentage of participants	71.0 percentage of participants	71.8 percentage of participants
Percentage of Participants Who Experienced Graded Treatment-Emergent AEs at Week 48 Grade 3 and Above Treatment-emergent AEs	20.0 percentage of participants	12.9 percentage of participants	15.4 percentage of participants

SECONDARY outcome

Timeframe: Week 96

Population: Participants in the Safety Analysis Set were analyzed.

Treatment-emergent AEs were defined as: Any AEs with an onset date on or after the study drug start date and no later than the study drug stop date + 3 days after permanent discontinuation of study drug; Any AEs with onset date on or after the study drug start date for those who have not permanently discontinued study drug; Any AEs leading to premature discontinuation of study drug. The most severe graded AE from all tests was counted for each participant.

Outcome measures

Measure	Part A (Renal Impairment): End Stage Renal Disease n=15 Participants Participants with CHB and end stage renal disease who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.	Part B: Hepatic Impairment n=31 Participants Participants with CHB and moderate or severe hepatic impairment who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.	Part A (Renal Impairment): Moderate or Severe Renal Impairment n=78 Participants Participants with chronic hepatitis B (CHB) and moderate or severe renal impairment who were virologically suppressed and took tenofovir disoproxil fumarate (TDF), a TDF-containing anti-hepatitis B virus (HBV) regimen, or other oral antivirals (OAVs), switched to tenofovir alafenamide (TAF) and received TAF 25 mg tablet once daily orally for 96 weeks.
Percentage of Participants Who Experienced Graded Treatment-Emergent AEs at Week 96 Any Treatment-emergent AEs	100.0 percentage of participants	77.4 percentage of participants	74.4 percentage of participants
Percentage of Participants Who Experienced Graded Treatment-Emergent AEs at Week 96 Grade 3 and Above treatment-emergent AEs	26.7 percentage of participants	25.8 percentage of participants	17.9 percentage of participants

SECONDARY outcome

Timeframe: Week 48

Population: Participants in the Safety Analysis Set were analyzed.

Graded treatment-emergent laboratory abnormalities were defined as values that increased at least 1 toxicity grade from baseline at any postbaseline visit, up to and including the date of last dose of study drug + 3 days for participants who permanently discontinued study drug or the last available date in the database snapshot for participants who were on treatment at the time of the analysis.

The most severe graded abnormality from all tests was counted for each participant.

Outcome measures

Measure	Part A (Renal Impairment): End Stage Renal Disease n=15 Participants Participants with CHB and end stage renal disease who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.	Part B: Hepatic Impairment n=31 Participants Participants with CHB and moderate or severe hepatic impairment who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.	Part A (Renal Impairment): Moderate or Severe Renal Impairment n=78 Participants Participants with chronic hepatitis B (CHB) and moderate or severe renal impairment who were virologically suppressed and took tenofovir disoproxil fumarate (TDF), a TDF-containing anti-hepatitis B virus (HBV) regimen, or other oral antivirals (OAVs), switched to tenofovir alafenamide (TAF) and received TAF 25 mg tablet once daily orally for 96 weeks.
Percentage of Participants Who Experienced Graded Treatment-Emergent Laboratory Abnormalities at Week 48 Any Graded Laboratory Abnormality	100.0 percentage of participants	90.3 percentage of participants	96.2 percentage of participants
Percentage of Participants Who Experienced Graded Treatment-Emergent Laboratory Abnormalities at Week 48 Grade 3	40.0 percentage of participants	41.9 percentage of participants	12.8 percentage of participants
Percentage of Participants Who Experienced Graded Treatment-Emergent Laboratory Abnormalities at Week 48 Grade 4	26.7 percentage of participants	9.7 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: Week 96

Population: Participants in the Safety Analysis Set were analyzed.

Graded treatment-emergent laboratory abnormalities were defined as values that increased at least 1 toxicity grade from baseline at any post-baseline visit, up to and including the date of last dose of study drug + 3 days for participants who permanently discontinued study drug or the last available date in the database snapshot for participants who were on treatment at the time of the analysis. The most severe graded abnormality from all tests was counted for each participant.

Outcome measures

Measure	Part A (Renal Impairment): End Stage Renal Disease n=15 Participants Participants with CHB and end stage renal disease who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.	Part B: Hepatic Impairment n=31 Participants Participants with CHB and moderate or severe hepatic impairment who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.	Part A (Renal Impairment): Moderate or Severe Renal Impairment n=78 Participants Participants with chronic hepatitis B (CHB) and moderate or severe renal impairment who were virologically suppressed and took tenofovir disoproxil fumarate (TDF), a TDF-containing anti-hepatitis B virus (HBV) regimen, or other oral antivirals (OAVs), switched to tenofovir alafenamide (TAF) and received TAF 25 mg tablet once daily orally for 96 weeks.
Percentage of Participants Who Experienced Graded Treatment-Emergent Laboratory Abnormalities at Week 96 Any Graded Laboratory Abnormality	100.0 percentage of particpants	100.0 percentage of particpants	96.2 percentage of particpants
Percentage of Participants Who Experienced Graded Treatment-Emergent Laboratory Abnormalities at Week 96 Grade 3	46.7 percentage of particpants	41.9 percentage of particpants	15.4 percentage of particpants
Percentage of Participants Who Experienced Graded Treatment-Emergent Laboratory Abnormalities at Week 96 Grade 4	26.7 percentage of particpants	12.9 percentage of particpants	1.3 percentage of particpants

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: Participants in the Safety Analysis Set with available data were analyzed.

GFR is a measure of the rate at which blood is filtered by the kidney. Cockcroft-Gault is an equation (calculation) used to estimate GFR based on serum creatinine, weight, and gender. eGFRcg = (140 - age in years) x (body weight in kg) x (0.85 if female) divided by 72 x serum creatinine in mg/dL.

Moderate renal impairment= 30 mL/min ≤ eGFRCG ≤ 59 mL/min Severe renal impairment= 15 mL/min ≤ eGFRCG < 30 mL/min Change from baseline was calculated as the value at Week 24 minus the value at Baseline.

Outcome measures

Measure	Part A (Renal Impairment): End Stage Renal Disease n=31 Participants Participants with CHB and end stage renal disease who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.	Part B: Hepatic Impairment Participants with CHB and moderate or severe hepatic impairment who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.	Part A (Renal Impairment): Moderate or Severe Renal Impairment n=77 Participants Participants with chronic hepatitis B (CHB) and moderate or severe renal impairment who were virologically suppressed and took tenofovir disoproxil fumarate (TDF), a TDF-containing anti-hepatitis B virus (HBV) regimen, or other oral antivirals (OAVs), switched to tenofovir alafenamide (TAF) and received TAF 25 mg tablet once daily orally for 96 weeks.
Change From Baseline in Estimated Glomerular Filtration Rate by the Cockcroft-Gault Formula (eGFRcg) in Participants With Moderate or Severe Renal Impairment and Hepatically Impaired Participants at Week 24	1.9 mL/min Interval -5.6 to 12.2	—	-0.4 mL/min Interval -3.9 to 4.5

SECONDARY outcome

Timeframe: Baseline, Week 48

Population: Participants in the Safety Analysis Set with available data were analyzed.

GFR is a measure of the rate at which blood is filtered by the kidney. Cockcroft-Gault is an equation (calculation) used to estimate GFR based on serum creatinine, weight, and gender. eGFRcg = (140 - age in years) x (body weight in kg) x (0.85 if female) divided by 72 x serum creatinine in mg/dL.

Moderate renal impairment= 30 mL/min ≤ eGFRCG ≤ 59 mL/min Severe renal impairment= 15 mL/min ≤ eGFRCG < 30 mL/min Change from baseline was calculated as the value at Week 48 minus the value at Baseline.

Outcome measures

Measure	Part A (Renal Impairment): End Stage Renal Disease n=31 Participants Participants with CHB and end stage renal disease who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.	Part B: Hepatic Impairment Participants with CHB and moderate or severe hepatic impairment who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.	Part A (Renal Impairment): Moderate or Severe Renal Impairment n=73 Participants Participants with chronic hepatitis B (CHB) and moderate or severe renal impairment who were virologically suppressed and took tenofovir disoproxil fumarate (TDF), a TDF-containing anti-hepatitis B virus (HBV) regimen, or other oral antivirals (OAVs), switched to tenofovir alafenamide (TAF) and received TAF 25 mg tablet once daily orally for 96 weeks.
Change From Baseline in eGFRcg in Participants With Moderate or Severe Renal Impairment and Hepatically Impaired Participants at Week 48	1.2 mL/min Interval -13.5 to 6.5	—	-0.5 mL/min Interval -4.1 to 3.0

SECONDARY outcome

Timeframe: Baseline, Week 96

Population: Participants in the Safety Analysis Set with available data were analyzed.

GFR is a measure of the rate at which blood is filtered by the kidney. Cockcroft-Gault is an equation (calculation) used to estimate GFR based on serum creatinine, weight, and gender. eGFRcg = (140 - age in years) x (body weight in kg) x (0.85 if female) divided by 72 x serum creatinine in mg/dL.

Moderate renal impairment= 30 mL/min ≤ eGFRCG ≤ 59 mL/min Severe renal impairment= 15 mL/min ≤ eGFRCG < 30 mL/min Change from baseline was calculated as the value at Week 96 minus the value at Baseline.

Outcome measures

Measure	Part A (Renal Impairment): End Stage Renal Disease n=25 Participants Participants with CHB and end stage renal disease who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.	Part B: Hepatic Impairment Participants with CHB and moderate or severe hepatic impairment who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.	Part A (Renal Impairment): Moderate or Severe Renal Impairment n=66 Participants Participants with chronic hepatitis B (CHB) and moderate or severe renal impairment who were virologically suppressed and took tenofovir disoproxil fumarate (TDF), a TDF-containing anti-hepatitis B virus (HBV) regimen, or other oral antivirals (OAVs), switched to tenofovir alafenamide (TAF) and received TAF 25 mg tablet once daily orally for 96 weeks.
Change From Baseline in eGFRcg in Participants With Moderate or Severe Renal Impairment and Hepatically Impaired Participants at Week 96	-2.4 mL/min Interval -11.4 to 10.7	—	1.0 mL/min Interval -2.8 to 4.5

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: Participants in the Hip Dual-Energy X-Ray Absorptiometry (DXA) Analysis Set (all participants who were enrolled and received at least 1 dose of study drug and had non-missing baseline hip BMD values) with available data were analyzed.

Percent change = Change from baseline at a postbaseline visit/baseline * 100%.

Outcome measures

Measure	Part A (Renal Impairment): End Stage Renal Disease n=15 Participants Participants with CHB and end stage renal disease who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.	Part B: Hepatic Impairment n=31 Participants Participants with CHB and moderate or severe hepatic impairment who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.	Part A (Renal Impairment): Moderate or Severe Renal Impairment n=74 Participants Participants with chronic hepatitis B (CHB) and moderate or severe renal impairment who were virologically suppressed and took tenofovir disoproxil fumarate (TDF), a TDF-containing anti-hepatitis B virus (HBV) regimen, or other oral antivirals (OAVs), switched to tenofovir alafenamide (TAF) and received TAF 25 mg tablet once daily orally for 96 weeks.
Percent Change From Baseline in Hip Bone Mineral Density (BMD) at Week 24	0.322 percent change Standard Deviation 2.1835	0.322 percent change Standard Deviation 2.5105	0.135 percent change Standard Deviation 1.8348

SECONDARY outcome

Timeframe: Baseline, Week 48

Population: Participants in Hip DXA Analysis Set with available data were analyzed.

Percent change = Change from baseline at a postbaseline visit/baseline * 100%.

Outcome measures

Measure	Part A (Renal Impairment): End Stage Renal Disease n=14 Participants Participants with CHB and end stage renal disease who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.	Part B: Hepatic Impairment n=31 Participants Participants with CHB and moderate or severe hepatic impairment who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.	Part A (Renal Impairment): Moderate or Severe Renal Impairment n=72 Participants Participants with chronic hepatitis B (CHB) and moderate or severe renal impairment who were virologically suppressed and took tenofovir disoproxil fumarate (TDF), a TDF-containing anti-hepatitis B virus (HBV) regimen, or other oral antivirals (OAVs), switched to tenofovir alafenamide (TAF) and received TAF 25 mg tablet once daily orally for 96 weeks.
Percent Change From Baseline in Hip BMD at Week 48	-1.075 percent change Standard Deviation 3.6355	-0.221 percent change Standard Deviation 3.0158	0.565 percent change Standard Deviation 2.6160

SECONDARY outcome

Timeframe: Baseline, Week 96

Population: Participants in Hip DXA Analysis Set with available data were analyzed.

Percent change = Change from baseline at a postbaseline visit/baseline * 100%.

Outcome measures

Measure	Part A (Renal Impairment): End Stage Renal Disease n=13 Participants Participants with CHB and end stage renal disease who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.	Part B: Hepatic Impairment n=24 Participants Participants with CHB and moderate or severe hepatic impairment who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.	Part A (Renal Impairment): Moderate or Severe Renal Impairment n=59 Participants Participants with chronic hepatitis B (CHB) and moderate or severe renal impairment who were virologically suppressed and took tenofovir disoproxil fumarate (TDF), a TDF-containing anti-hepatitis B virus (HBV) regimen, or other oral antivirals (OAVs), switched to tenofovir alafenamide (TAF) and received TAF 25 mg tablet once daily orally for 96 weeks.
Percent Change From Baseline in Hip BMD at Week 96	-0.834 percent change Standard Deviation 4.7171	0.277 percent change Standard Deviation 3.2549	0.425 percent change Standard Deviation 2.8381

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: Participants in the Spine DXA Analysis Set (all participants who were enrolled and received at least 1 dose of study drug and had non-missing baseline spine BMD values) with available data were analyzed.

Percent change = Change from baseline at a postbaseline visit/baseline * 100%.

Outcome measures

Measure	Part A (Renal Impairment): End Stage Renal Disease n=15 Participants Participants with CHB and end stage renal disease who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.	Part B: Hepatic Impairment n=31 Participants Participants with CHB and moderate or severe hepatic impairment who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.	Part A (Renal Impairment): Moderate or Severe Renal Impairment n=76 Participants Participants with chronic hepatitis B (CHB) and moderate or severe renal impairment who were virologically suppressed and took tenofovir disoproxil fumarate (TDF), a TDF-containing anti-hepatitis B virus (HBV) regimen, or other oral antivirals (OAVs), switched to tenofovir alafenamide (TAF) and received TAF 25 mg tablet once daily orally for 96 weeks.
Percent Change From Baseline in Spine BMD at Week 24	0.683 percent change Standard Deviation 3.1370	1.258 percent change Standard Deviation 2.3416	1.229 percent change Standard Deviation 3.4252

SECONDARY outcome

Timeframe: Baseline, Week 48

Population: Participants in the Spine DXA Analysis Set with available data were analyzed.

Percent change = Change from baseline at a postbaseline visit/baseline * 100%.

Outcome measures

Measure	Part A (Renal Impairment): End Stage Renal Disease n=14 Participants Participants with CHB and end stage renal disease who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.	Part B: Hepatic Impairment n=31 Participants Participants with CHB and moderate or severe hepatic impairment who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.	Part A (Renal Impairment): Moderate or Severe Renal Impairment n=73 Participants Participants with chronic hepatitis B (CHB) and moderate or severe renal impairment who were virologically suppressed and took tenofovir disoproxil fumarate (TDF), a TDF-containing anti-hepatitis B virus (HBV) regimen, or other oral antivirals (OAVs), switched to tenofovir alafenamide (TAF) and received TAF 25 mg tablet once daily orally for 96 weeks.
Percent Change From Baseline in Spine BMD at Week 48	0.016 percent change Standard Deviation 4.1636	0.535 percent change Standard Deviation 3.4386	1.516 percent change Standard Deviation 3.7486

SECONDARY outcome

Timeframe: Baseline, Week 96

Population: Participants in the Spine DXA Analysis Set with available data were analyzed.

Percent change = Change from baseline at a postbaseline visit/baseline * 100%.

Outcome measures

Measure	Part A (Renal Impairment): End Stage Renal Disease n=13 Participants Participants with CHB and end stage renal disease who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.	Part B: Hepatic Impairment n=23 Participants Participants with CHB and moderate or severe hepatic impairment who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.	Part A (Renal Impairment): Moderate or Severe Renal Impairment n=61 Participants Participants with chronic hepatitis B (CHB) and moderate or severe renal impairment who were virologically suppressed and took tenofovir disoproxil fumarate (TDF), a TDF-containing anti-hepatitis B virus (HBV) regimen, or other oral antivirals (OAVs), switched to tenofovir alafenamide (TAF) and received TAF 25 mg tablet once daily orally for 96 weeks.
Percent Change From Baseline in Spine BMD at Week 96	-0.283 percent change Standard Deviation 4.5327	-0.249 percent change Standard Deviation 3.9127	1.293 percent change Standard Deviation 4.4136

SECONDARY outcome

Timeframe: Weeks 48

Population: Participants in the Full Analysis Set were analyzed.

The percentage of participants with HBV DNA < 20 IU/mL at Week 48 was determined by the Missing = Failure (M = F) approach.

Outcome measures

Measure	Part A (Renal Impairment): End Stage Renal Disease n=15 Participants Participants with CHB and end stage renal disease who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.	Part B: Hepatic Impairment n=31 Participants Participants with CHB and moderate or severe hepatic impairment who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.	Part A (Renal Impairment): Moderate or Severe Renal Impairment n=78 Participants Participants with chronic hepatitis B (CHB) and moderate or severe renal impairment who were virologically suppressed and took tenofovir disoproxil fumarate (TDF), a TDF-containing anti-hepatitis B virus (HBV) regimen, or other oral antivirals (OAVs), switched to tenofovir alafenamide (TAF) and received TAF 25 mg tablet once daily orally for 96 weeks.
Percentage of Participants Achieving Virologic Response (Plasma HBV DNA < 20 IU/mL) at Week 48	93.3 percentage of participants	100.0 percentage of participants	92.3 percentage of participants

SECONDARY outcome

Timeframe: Weeks 96

Population: Participants in the Full Analysis Set were analyzed.

The percentage of participants with HBV DNA < 20 IU/mL at Week 48 was determined by the Missing = Failure (M = F) approach.

Outcome measures

Measure	Part A (Renal Impairment): End Stage Renal Disease n=15 Participants Participants with CHB and end stage renal disease who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.	Part B: Hepatic Impairment n=31 Participants Participants with CHB and moderate or severe hepatic impairment who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.	Part A (Renal Impairment): Moderate or Severe Renal Impairment n=78 Participants Participants with chronic hepatitis B (CHB) and moderate or severe renal impairment who were virologically suppressed and took tenofovir disoproxil fumarate (TDF), a TDF-containing anti-hepatitis B virus (HBV) regimen, or other oral antivirals (OAVs), switched to tenofovir alafenamide (TAF) and received TAF 25 mg tablet once daily orally for 96 weeks.
Percentage of Participants Achieving Virologic Response (Plasma HBV DNA < 20 IU/mL) at Week 96	86.7 percentage of participants	77.4 percentage of participants	83.3 percentage of participants

SECONDARY outcome

Timeframe: Week 24

Population: Participants in the Full Analysis Set were analyzed.

The percentage of participants with HBV DNA < 20 IU/mL and target detected (≥ LLOD; i.e. 10 IU/mL) at Week 24 was determined by the M = F approach.

Outcome measures

Measure	Part A (Renal Impairment): End Stage Renal Disease n=15 Participants Participants with CHB and end stage renal disease who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.	Part B: Hepatic Impairment n=31 Participants Participants with CHB and moderate or severe hepatic impairment who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.	Part A (Renal Impairment): Moderate or Severe Renal Impairment n=78 Participants Participants with chronic hepatitis B (CHB) and moderate or severe renal impairment who were virologically suppressed and took tenofovir disoproxil fumarate (TDF), a TDF-containing anti-hepatitis B virus (HBV) regimen, or other oral antivirals (OAVs), switched to tenofovir alafenamide (TAF) and received TAF 25 mg tablet once daily orally for 96 weeks.
Percentage of Participants With Plasma HBV DNA < 20 IU/mL and Target Detected (≥ Lower Limit of Detection [LLOD]) at Week 24	40.0 percentage of participants	22.6 percentage of participants	21.8 percentage of participants

SECONDARY outcome

Timeframe: Week 48

Population: Participants in the Full Analysis Set were analyzed.

The percentage of participants with HBV DNA < 20 IU/mL and target detected (≥ LLOD; i.e. 10 IU/mL) at Week 48 was determined by the M = F approach.

Outcome measures

Measure	Part A (Renal Impairment): End Stage Renal Disease n=15 Participants Participants with CHB and end stage renal disease who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.	Part B: Hepatic Impairment n=31 Participants Participants with CHB and moderate or severe hepatic impairment who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.	Part A (Renal Impairment): Moderate or Severe Renal Impairment n=78 Participants Participants with chronic hepatitis B (CHB) and moderate or severe renal impairment who were virologically suppressed and took tenofovir disoproxil fumarate (TDF), a TDF-containing anti-hepatitis B virus (HBV) regimen, or other oral antivirals (OAVs), switched to tenofovir alafenamide (TAF) and received TAF 25 mg tablet once daily orally for 96 weeks.
Percentage of Participants With Plasma HBV DNA < 20 IU/mL and Target Detected (≥ LLOD) at Week 48	26.7 percentage of participants	25.8 percentage of participants	26.9 percentage of participants

SECONDARY outcome

Timeframe: Week 96

Population: Participants in the Full Analysis Set were analyzed.

The percentage of participants with HBV DNA < 20 IU/mL and target detected (≥ LLOD; i.e. 10 IU/mL) at Week 96 was determined by the M = F approach.

Outcome measures

Measure	Part A (Renal Impairment): End Stage Renal Disease n=15 Participants Participants with CHB and end stage renal disease who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.	Part B: Hepatic Impairment n=31 Participants Participants with CHB and moderate or severe hepatic impairment who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.	Part A (Renal Impairment): Moderate or Severe Renal Impairment n=78 Participants Participants with chronic hepatitis B (CHB) and moderate or severe renal impairment who were virologically suppressed and took tenofovir disoproxil fumarate (TDF), a TDF-containing anti-hepatitis B virus (HBV) regimen, or other oral antivirals (OAVs), switched to tenofovir alafenamide (TAF) and received TAF 25 mg tablet once daily orally for 96 weeks.
Percentage of Participants With Plasma HBV DNA < 20 IU/mL and Target Detected (≥ LLOD) at Week 96	20.0 percentage of participants	0 percentage of participants	14.1 percentage of participants

SECONDARY outcome

Timeframe: Week 24

Population: Participants in the Full Analysis Set were analyzed.

The percentage of participants with HBV DNA < 20 IU/mL and target not detected (< LLOD; i.e. 10 IU/mL) at Week 24 was determined by the M = F approach.

Outcome measures

Measure	Part A (Renal Impairment): End Stage Renal Disease n=15 Participants Participants with CHB and end stage renal disease who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.	Part B: Hepatic Impairment n=31 Participants Participants with CHB and moderate or severe hepatic impairment who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.	Part A (Renal Impairment): Moderate or Severe Renal Impairment n=78 Participants Participants with chronic hepatitis B (CHB) and moderate or severe renal impairment who were virologically suppressed and took tenofovir disoproxil fumarate (TDF), a TDF-containing anti-hepatitis B virus (HBV) regimen, or other oral antivirals (OAVs), switched to tenofovir alafenamide (TAF) and received TAF 25 mg tablet once daily orally for 96 weeks.
Percentage of Participants With Plasma HBV DNA < 20 IU/mL and Target Not Detected (< LLOD) at Week 24	60.0 percentage of participants	77.4 percentage of participants	75.6 percentage of participants

SECONDARY outcome

Timeframe: Weeks 48

Population: Participants in the Full Analysis Set were analyzed.

The percentage of participants with HBV DNA < 20 IU/mL and target not detected (< LLOD; i.e. 10 IU/mL) at Week 48 was determined by the M = F approach.

Outcome measures

Measure	Part A (Renal Impairment): End Stage Renal Disease n=15 Participants Participants with CHB and end stage renal disease who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.	Part B: Hepatic Impairment n=31 Participants Participants with CHB and moderate or severe hepatic impairment who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.	Part A (Renal Impairment): Moderate or Severe Renal Impairment n=78 Participants Participants with chronic hepatitis B (CHB) and moderate or severe renal impairment who were virologically suppressed and took tenofovir disoproxil fumarate (TDF), a TDF-containing anti-hepatitis B virus (HBV) regimen, or other oral antivirals (OAVs), switched to tenofovir alafenamide (TAF) and received TAF 25 mg tablet once daily orally for 96 weeks.
Percentage of Participants With Plasma HBV DNA < 20 IU/mL and Target Not Detected (< LLOD) at Week 48	66.7 percentage of participants	74.2 percentage of participants	65.4 percentage of participants

SECONDARY outcome

Timeframe: Weeks 96

Population: Participants in the Full Analysis Set were analyzed.

The percentage of participants with HBV DNA < 20 IU/mL and target not detected (< LLOD; i.e. 10 IU/mL) at Week 96 was determined by the M = F approach.

Outcome measures

Measure	Part A (Renal Impairment): End Stage Renal Disease n=15 Participants Participants with CHB and end stage renal disease who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.	Part B: Hepatic Impairment n=31 Participants Participants with CHB and moderate or severe hepatic impairment who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.	Part A (Renal Impairment): Moderate or Severe Renal Impairment n=78 Participants Participants with chronic hepatitis B (CHB) and moderate or severe renal impairment who were virologically suppressed and took tenofovir disoproxil fumarate (TDF), a TDF-containing anti-hepatitis B virus (HBV) regimen, or other oral antivirals (OAVs), switched to tenofovir alafenamide (TAF) and received TAF 25 mg tablet once daily orally for 96 weeks.
Percentage of Participants With Plasma HBV DNA < 20 IU/mL and Target Not Detected (< LLOD) at Week 96	66.7 percentage of participants	77.4 percentage of participants	69.2 percentage of participants

SECONDARY outcome

Timeframe: Week 24

Population: The Serologically Evaluable Full Analysis Set for HBsAg Loss/Seroconversion (all participants who were enrolled and received at least 1 dose of study drug, and with HBsAg positive and HBsAb negative or missing at baseline) with available data were analyzed..

HBsAg loss was defined as HBsAg changing from positive at baseline to negative at a postbaseline. The M = F approach was used for this analysis.

Outcome measures

Measure	Part A (Renal Impairment): End Stage Renal Disease n=15 Participants Participants with CHB and end stage renal disease who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.	Part B: Hepatic Impairment n=30 Participants Participants with CHB and moderate or severe hepatic impairment who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.	Part A (Renal Impairment): Moderate or Severe Renal Impairment n=78 Participants Participants with chronic hepatitis B (CHB) and moderate or severe renal impairment who were virologically suppressed and took tenofovir disoproxil fumarate (TDF), a TDF-containing anti-hepatitis B virus (HBV) regimen, or other oral antivirals (OAVs), switched to tenofovir alafenamide (TAF) and received TAF 25 mg tablet once daily orally for 96 weeks.
Percentage of Participants With Serological Response: Loss of Hepatitis B s-Antigen (HBsAg) at Week 24	0 percentage of participants	0 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: Week 48

Population: Participants in the Serologically Evaluable Full Analysis Set for HBsAg Loss/Seroconversion with available data were analyzed.

HBsAg loss was defined as HBsAg changing from positive at baseline to negative at a postbaseline. The M = F approach was used for this analysis.

Outcome measures

Measure	Part A (Renal Impairment): End Stage Renal Disease n=15 Participants Participants with CHB and end stage renal disease who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.	Part B: Hepatic Impairment n=30 Participants Participants with CHB and moderate or severe hepatic impairment who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.	Part A (Renal Impairment): Moderate or Severe Renal Impairment n=78 Participants Participants with chronic hepatitis B (CHB) and moderate or severe renal impairment who were virologically suppressed and took tenofovir disoproxil fumarate (TDF), a TDF-containing anti-hepatitis B virus (HBV) regimen, or other oral antivirals (OAVs), switched to tenofovir alafenamide (TAF) and received TAF 25 mg tablet once daily orally for 96 weeks.
Percentage of Participants With Serological Response: Loss of HBsAg at Week 48	6.7 percentage of participants	3.3 percentage of participants	0.0 percentage of participants

SECONDARY outcome

Timeframe: Week 96

Population: Participants in the Serologically Evaluable Full Analysis Set for HBsAg Loss/Seroconversion with available data were analyzed.

HBsAg loss was defined as HBsAg changing from positive at baseline to negative at a postbaseline. The M = F approach was used for this analysis.

Outcome measures

Measure	Part A (Renal Impairment): End Stage Renal Disease n=15 Participants Participants with CHB and end stage renal disease who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.	Part B: Hepatic Impairment n=30 Participants Participants with CHB and moderate or severe hepatic impairment who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.	Part A (Renal Impairment): Moderate or Severe Renal Impairment n=78 Participants Participants with chronic hepatitis B (CHB) and moderate or severe renal impairment who were virologically suppressed and took tenofovir disoproxil fumarate (TDF), a TDF-containing anti-hepatitis B virus (HBV) regimen, or other oral antivirals (OAVs), switched to tenofovir alafenamide (TAF) and received TAF 25 mg tablet once daily orally for 96 weeks.
Percentage of Participants With Serological Response: Loss of HBsAg at Week 96	0 percentage of participants	6.7 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: Week 24

Population: The Serologically Evaluable Full Analysis Set for HBsAg Loss/Seroconversion were analyzed.

HBsAg seroconversion was defined as HBsAg loss and HBsAb test changing from negative/missing at baseline to positive at a postbaseline visit. The M = F approach was used for this analysis.

Outcome measures

Measure	Part A (Renal Impairment): End Stage Renal Disease n=15 Participants Participants with CHB and end stage renal disease who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.	Part B: Hepatic Impairment n=30 Participants Participants with CHB and moderate or severe hepatic impairment who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.	Part A (Renal Impairment): Moderate or Severe Renal Impairment n=78 Participants Participants with chronic hepatitis B (CHB) and moderate or severe renal impairment who were virologically suppressed and took tenofovir disoproxil fumarate (TDF), a TDF-containing anti-hepatitis B virus (HBV) regimen, or other oral antivirals (OAVs), switched to tenofovir alafenamide (TAF) and received TAF 25 mg tablet once daily orally for 96 weeks.
Percentage of Participants With Serological Response: Seroconversion to Anti-HBs at Week 24	0 percentage of participants	0 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: Week 48

Population: Participants in the Serologically Evaluable Full Analysis Set for HBsAg Loss/Seroconversion were analyzed.

HBsAg seroconversion was defined as HBsAg loss and HBsAb test changing from negative/missing at baseline to positive at a postbaseline visit. The M = F approach was used for this analysis.

Outcome measures

Measure	Part A (Renal Impairment): End Stage Renal Disease n=15 Participants Participants with CHB and end stage renal disease who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.	Part B: Hepatic Impairment n=30 Participants Participants with CHB and moderate or severe hepatic impairment who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.	Part A (Renal Impairment): Moderate or Severe Renal Impairment n=78 Participants Participants with chronic hepatitis B (CHB) and moderate or severe renal impairment who were virologically suppressed and took tenofovir disoproxil fumarate (TDF), a TDF-containing anti-hepatitis B virus (HBV) regimen, or other oral antivirals (OAVs), switched to tenofovir alafenamide (TAF) and received TAF 25 mg tablet once daily orally for 96 weeks.
Percentage of Participants With Serological Response: Seroconversion to Anti-HBs at Week 48	0 percentage of participants	0 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: Week 96

Population: The Serologically Evaluable Full Analysis Set for HBsAg Loss/Seroconversion were analyzed.

HBsAg seroconversion was defined as HBsAg loss and HBsAb test changing from negative/missing at baseline to positive at a postbaseline visit. The M = F approach was used for this analysis.

Outcome measures

Measure	Part A (Renal Impairment): End Stage Renal Disease n=15 Participants Participants with CHB and end stage renal disease who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.	Part B: Hepatic Impairment n=30 Participants Participants with CHB and moderate or severe hepatic impairment who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.	Part A (Renal Impairment): Moderate or Severe Renal Impairment n=78 Participants Participants with chronic hepatitis B (CHB) and moderate or severe renal impairment who were virologically suppressed and took tenofovir disoproxil fumarate (TDF), a TDF-containing anti-hepatitis B virus (HBV) regimen, or other oral antivirals (OAVs), switched to tenofovir alafenamide (TAF) and received TAF 25 mg tablet once daily orally for 96 weeks.
Percentage of Participants With Serological Response: Seroconversion to Anti-HBs at Week 96	0 percentage of participants	0 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: Week 24

Population: The Serologically Evaluable Full Analysis Set for HBeAg Loss/Seroconversion included all participants who were enrolled and received at least 1 dose of study drug, and with HBeAg positive and HBeAb negative or missing at baseline.

HBeAg loss was defined as HBeAg changing from positive at baseline to negative at a postbaseline. The M = F approach was used for this analysis.

Outcome measures

Measure	Part A (Renal Impairment): End Stage Renal Disease n=3 Participants Participants with CHB and end stage renal disease who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.	Part B: Hepatic Impairment n=3 Participants Participants with CHB and moderate or severe hepatic impairment who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.	Part A (Renal Impairment): Moderate or Severe Renal Impairment n=13 Participants Participants with chronic hepatitis B (CHB) and moderate or severe renal impairment who were virologically suppressed and took tenofovir disoproxil fumarate (TDF), a TDF-containing anti-hepatitis B virus (HBV) regimen, or other oral antivirals (OAVs), switched to tenofovir alafenamide (TAF) and received TAF 25 mg tablet once daily orally for 96 weeks.
Percentage of Participants With Serological Response: Loss of HBeAg in HBeAg-Positive Participants at Week 24	0 percentage of participants	0 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: Week 48

Population: Participants in the Serologically Evaluable Full Analysis Set were analyzed.

HBeAg loss was defined as HBeAg changing from positive at baseline to negative at a postbaseline. The M = F approach was used for this analysis.

Outcome measures

Measure	Part A (Renal Impairment): End Stage Renal Disease n=3 Participants Participants with CHB and end stage renal disease who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.	Part B: Hepatic Impairment n=3 Participants Participants with CHB and moderate or severe hepatic impairment who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.	Part A (Renal Impairment): Moderate or Severe Renal Impairment n=13 Participants Participants with chronic hepatitis B (CHB) and moderate or severe renal impairment who were virologically suppressed and took tenofovir disoproxil fumarate (TDF), a TDF-containing anti-hepatitis B virus (HBV) regimen, or other oral antivirals (OAVs), switched to tenofovir alafenamide (TAF) and received TAF 25 mg tablet once daily orally for 96 weeks.
Percentage of Participants With Serological Response: Loss of HBeAg in HBeAg-Positive Participants at Week 48	0 percentage of participants	0 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: Week 96

Population: The Serologically Evaluable Full Analysis Set for HBeAg Loss/Seroconversion included all participants who were enrolled and received at least 1 dose of study drug, and with HBeAg positive and HBeAb negative or missing at baseline.

HBeAg loss was defined as HBeAg changing from positive at baseline to negative at a postbaseline. The M = F approach was used for this analysis.

Outcome measures

Measure	Part A (Renal Impairment): End Stage Renal Disease n=3 Participants Participants with CHB and end stage renal disease who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.	Part B: Hepatic Impairment n=3 Participants Participants with CHB and moderate or severe hepatic impairment who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.	Part A (Renal Impairment): Moderate or Severe Renal Impairment n=13 Participants Participants with chronic hepatitis B (CHB) and moderate or severe renal impairment who were virologically suppressed and took tenofovir disoproxil fumarate (TDF), a TDF-containing anti-hepatitis B virus (HBV) regimen, or other oral antivirals (OAVs), switched to tenofovir alafenamide (TAF) and received TAF 25 mg tablet once daily orally for 96 weeks.
Percentage of Participants With Serological Response: Loss of HBeAg in HBeAg-Positive Participants at Week 96	33.3 percentage of participants	0 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: Week 24

Population: The Serologically Evaluable Full Analysis Set for HBeAg Loss/Seroconversion were analyzed.

HBeAg seroconversion was defined as HBeAg loss and HBeAb test changing from negative/missing at baseline to positive at a postbaseline visit. The M = F approach was used for this analysis.

Outcome measures

Measure	Part A (Renal Impairment): End Stage Renal Disease n=3 Participants Participants with CHB and end stage renal disease who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.	Part B: Hepatic Impairment n=3 Participants Participants with CHB and moderate or severe hepatic impairment who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.	Part A (Renal Impairment): Moderate or Severe Renal Impairment n=13 Participants Participants with chronic hepatitis B (CHB) and moderate or severe renal impairment who were virologically suppressed and took tenofovir disoproxil fumarate (TDF), a TDF-containing anti-hepatitis B virus (HBV) regimen, or other oral antivirals (OAVs), switched to tenofovir alafenamide (TAF) and received TAF 25 mg tablet once daily orally for 96 weeks.
Percentage of Participants With Serological Response: Seroconversion to Anti-HBe in HBeAg-Positive Participants at Week 24	0 percentage of participants	0 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: Week 48

Population: The Serologically Evaluable Full Analysis Set for HBeAg Loss/Seroconversion were analyzed.

HBeAg seroconversion was defined as HBeAg loss and HBeAb test changing from negative/missing at baseline to positive at a postbaseline visit. The M = F approach was used for this analysis.

Outcome measures

Measure	Part A (Renal Impairment): End Stage Renal Disease n=3 Participants Participants with CHB and end stage renal disease who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.	Part B: Hepatic Impairment n=3 Participants Participants with CHB and moderate or severe hepatic impairment who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.	Part A (Renal Impairment): Moderate or Severe Renal Impairment n=13 Participants Participants with chronic hepatitis B (CHB) and moderate or severe renal impairment who were virologically suppressed and took tenofovir disoproxil fumarate (TDF), a TDF-containing anti-hepatitis B virus (HBV) regimen, or other oral antivirals (OAVs), switched to tenofovir alafenamide (TAF) and received TAF 25 mg tablet once daily orally for 96 weeks.
Percentage of Participants With Serological Response: Seroconversion to Anti-HBe in HBeAg-Positive Participants at Week 48	0 percentage of participants	0 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: Week 96

Population: The Serologically Evaluable Full Analysis Set for HBeAg Loss/Seroconversion were analyzed.

HBeAg seroconversion was defined as HBeAg loss and HBeAb test changing from negative/missing at baseline to positive at a postbaseline visit. The M = F approach was used for this analysis.

Outcome measures

Measure	Part A (Renal Impairment): End Stage Renal Disease n=3 Participants Participants with CHB and end stage renal disease who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.	Part B: Hepatic Impairment n=3 Participants Participants with CHB and moderate or severe hepatic impairment who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.	Part A (Renal Impairment): Moderate or Severe Renal Impairment n=13 Participants Participants with chronic hepatitis B (CHB) and moderate or severe renal impairment who were virologically suppressed and took tenofovir disoproxil fumarate (TDF), a TDF-containing anti-hepatitis B virus (HBV) regimen, or other oral antivirals (OAVs), switched to tenofovir alafenamide (TAF) and received TAF 25 mg tablet once daily orally for 96 weeks.
Percentage of Participants With Serological Response: Seroconversion to Anti-HBe in HBeAg-Positive Participants at Week 96	33.3 percentage of participants	0 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: Week 24

Population: Participants in the Full Analysis Set were analyzed.

Central laboratory ULN for ALT were as follows: ≤ 43 U/L for males aged 18 to < 69 years and ≤ 35 U/L for males aged ≥ 69 years; ≤ 34 U/L for females aged 18 to < 69 years and ≤ 32 U/L for females aged ≥ 69 years. The ULN for ALT using the 2018 AASLD normal range was 25 U/L for females and 35 U/L for males. The M = F approach was used for this analysis.

Outcome measures

Measure	Part A (Renal Impairment): End Stage Renal Disease n=15 Participants Participants with CHB and end stage renal disease who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.	Part B: Hepatic Impairment n=31 Participants Participants with CHB and moderate or severe hepatic impairment who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.	Part A (Renal Impairment): Moderate or Severe Renal Impairment n=78 Participants Participants with chronic hepatitis B (CHB) and moderate or severe renal impairment who were virologically suppressed and took tenofovir disoproxil fumarate (TDF), a TDF-containing anti-hepatitis B virus (HBV) regimen, or other oral antivirals (OAVs), switched to tenofovir alafenamide (TAF) and received TAF 25 mg tablet once daily orally for 96 weeks.
Percentage of Participants With Normal Alanine Aminotransferase (ALT) at Week 24 by Central Laboratory and the American Association for the Study of Liver Diseases (AASLD) Criteria ALT by central laboratory	93.3 percentage of participants	83.9 percentage of participants	92.3 percentage of participants
Percentage of Participants With Normal Alanine Aminotransferase (ALT) at Week 24 by Central Laboratory and the American Association for the Study of Liver Diseases (AASLD) Criteria ALT by AASLD criteria	93.3 percentage of participants	80.6 percentage of participants	87.2 percentage of participants

SECONDARY outcome

Timeframe: Week 48

Population: Participants in the Full Analysis Set were analyzed.

Central laboratory ULN for ALT were as follows: ≤ 43 U/L for males aged 18 to < 69 years and ≤ 35 U/L for males aged ≥ 69 years; ≤ 34 U/L for females aged 18 to < 69 years and ≤ 32 U/L for females aged ≥ 69 years. The ULN for ALT using the 2018 AASLD normal range was 25 U/L for females and 35 U/L for males. The M = F approach was used for this analysis.

Outcome measures

Measure	Part A (Renal Impairment): End Stage Renal Disease n=15 Participants Participants with CHB and end stage renal disease who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.	Part B: Hepatic Impairment n=31 Participants Participants with CHB and moderate or severe hepatic impairment who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.	Part A (Renal Impairment): Moderate or Severe Renal Impairment n=78 Participants Participants with chronic hepatitis B (CHB) and moderate or severe renal impairment who were virologically suppressed and took tenofovir disoproxil fumarate (TDF), a TDF-containing anti-hepatitis B virus (HBV) regimen, or other oral antivirals (OAVs), switched to tenofovir alafenamide (TAF) and received TAF 25 mg tablet once daily orally for 96 weeks.
Percentage of Participants With Normal ALT at Week 48 by Central Laboratory and the AASLD Criteria ALT by central laboratory	86.7 percentage of participants	90.3 percentage of participants	89.7 percentage of participants
Percentage of Participants With Normal ALT at Week 48 by Central Laboratory and the AASLD Criteria ALT by AASLD criteria	80.0 percentage of participants	80.6 percentage of participants	87.2 percentage of participants

SECONDARY outcome

Timeframe: Week 96

Population: Participants in the Full Analysis Set were analyzed.

Central laboratory ULN for ALT were as follows: ≤ 43 U/L for males aged 18 to < 69 years and ≤ 35 U/L for males aged ≥ 69 years; ≤ 34 U/L for females aged 18 to < 69 years and ≤ 32 U/L for females aged ≥ 69 years. The ULN for ALT using the 2018 AASLD normal range was 25 U/L for females and 35 U/L for males. The M = F approach was used for this analysis.

Outcome measures

Measure	Part A (Renal Impairment): End Stage Renal Disease n=15 Participants Participants with CHB and end stage renal disease who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.	Part B: Hepatic Impairment n=31 Participants Participants with CHB and moderate or severe hepatic impairment who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.	Part A (Renal Impairment): Moderate or Severe Renal Impairment n=78 Participants Participants with chronic hepatitis B (CHB) and moderate or severe renal impairment who were virologically suppressed and took tenofovir disoproxil fumarate (TDF), a TDF-containing anti-hepatitis B virus (HBV) regimen, or other oral antivirals (OAVs), switched to tenofovir alafenamide (TAF) and received TAF 25 mg tablet once daily orally for 96 weeks.
Percentage of Participants With Normal ALT at Week 96 by Central Laboratory and the AASLD Criteria ALT by central laboratory	86.7 percentage of participants	71.0 percentage of participants	82.1 percentage of participants
Percentage of Participants With Normal ALT at Week 96 by Central Laboratory and the AASLD Criteria ALT by AASLD criteria	86.7 percentage of participants	58.1 percentage of participants	74.4 percentage of participants

SECONDARY outcome

Timeframe: Week 24

Population: Participants in the Full Analysis Set with Baseline ALT \> ULN were analyzed.

ALT normalization was defined as an ALT value that changed from above the normal range at baseline to within the normal range at the given postbaseline visit. Central laboratory ULN for ALT were as follows: ≤ 43 U/L for males aged 18 to < 69 years and ≤ 35 U/L for males aged ≥ 69 years; ≤ 34 U/L for females aged 18 to < 69 years and ≤ 32 U/L for females aged ≥ 69 years. The ULN for ALT using the 2018 AASLD normal range was 25 U/L for females and 35 U/L for males. The M = F approach was used for this analysis.

Outcome measures

Measure	Part A (Renal Impairment): End Stage Renal Disease Participants with CHB and end stage renal disease who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.	Part B: Hepatic Impairment n=10 Participants Participants with CHB and moderate or severe hepatic impairment who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.	Part A (Renal Impairment): Moderate or Severe Renal Impairment n=5 Participants Participants with chronic hepatitis B (CHB) and moderate or severe renal impairment who were virologically suppressed and took tenofovir disoproxil fumarate (TDF), a TDF-containing anti-hepatitis B virus (HBV) regimen, or other oral antivirals (OAVs), switched to tenofovir alafenamide (TAF) and received TAF 25 mg tablet once daily orally for 96 weeks.
Percentage of Participants With Normalized ALT at Week 24 by Central Laboratory and the AASLD Criteria Normalized ALT by Central Laboratory	—	50.0 percentage of participants	66.7 percentage of participants
Percentage of Participants With Normalized ALT at Week 24 by Central Laboratory and the AASLD Criteria Normalized ALT by AASLD Criteria	—	60.0 percentage of participants	40.0 percentage of participants

SECONDARY outcome

Timeframe: Week 48

Population: Participants in the Full Analysis Set with Baseline ALT \> ULN were analyzed.

ALT normalization was defined as an ALT value that changed from above the normal range at baseline to within the normal range at the given postbaseline visit. Central laboratory ULN for ALT were as follows: ≤ 43 U/L for males aged 18 to < 69 years and ≤ 35 U/L for males aged ≥ 69 years; ≤ 34 U/L for females aged 18 to < 69 years and ≤ 32 U/L for females aged ≥ 69 years. The ULN for ALT using the 2018 AASLD normal range was 25 U/L for females and 35 U/L for males. The M = F approach was used for this analysis.

Outcome measures

Measure	Part A (Renal Impairment): End Stage Renal Disease Participants with CHB and end stage renal disease who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.	Part B: Hepatic Impairment n=10 Participants Participants with CHB and moderate or severe hepatic impairment who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.	Part A (Renal Impairment): Moderate or Severe Renal Impairment n=5 Participants Participants with chronic hepatitis B (CHB) and moderate or severe renal impairment who were virologically suppressed and took tenofovir disoproxil fumarate (TDF), a TDF-containing anti-hepatitis B virus (HBV) regimen, or other oral antivirals (OAVs), switched to tenofovir alafenamide (TAF) and received TAF 25 mg tablet once daily orally for 96 weeks.
Percentage of Participants With Normalized ALT at Week 48 by Central Laboratory and the AASLD Criteria Normalized ALT by Central Laboratory	—	75.0 percentage of participants	33.3 percentage of participants
Percentage of Participants With Normalized ALT at Week 48 by Central Laboratory and the AASLD Criteria Normalized ALT by AASLD Criteria	—	60.0 percentage of participants	60.0 percentage of participants

SECONDARY outcome

Timeframe: Week 96

Population: Participants in the Full Analysis Set with Baseline ALT \> ULN were analyzed.

ALT normalization was defined as an ALT value that changed from above the normal range at baseline to within the normal range at the given postbaseline visit. Central laboratory ULN for ALT were as follows: ≤ 43 U/L for males aged 18 to < 69 years and ≤ 35 U/L for males aged ≥ 69 years; ≤ 34 U/L for females aged 18 to < 69 years and ≤ 32 U/L for females aged ≥ 69 years. The ULN for ALT using the 2018 AASLD normal range was 25 U/L for females and 35 U/L for males. The M = F approach was used for this analysis.

Outcome measures

Measure	Part A (Renal Impairment): End Stage Renal Disease Participants with CHB and end stage renal disease who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.	Part B: Hepatic Impairment n=10 Participants Participants with CHB and moderate or severe hepatic impairment who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.	Part A (Renal Impairment): Moderate or Severe Renal Impairment n=5 Participants Participants with chronic hepatitis B (CHB) and moderate or severe renal impairment who were virologically suppressed and took tenofovir disoproxil fumarate (TDF), a TDF-containing anti-hepatitis B virus (HBV) regimen, or other oral antivirals (OAVs), switched to tenofovir alafenamide (TAF) and received TAF 25 mg tablet once daily orally for 96 weeks.
Percentage of Participants With Normalized ALT at Week 96 by Central Laboratory and the AASLD Criteria Normalized ALT by Central Laboratory	—	50.0 percentage of participants	33.3 percentage of participants
Percentage of Participants With Normalized ALT at Week 96 by Central Laboratory and the AASLD Criteria Normalized ALT by AASLD Criteria	—	50.0 percentage of participants	20.0 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: Participants in the Full Analysis Set with available data were analyzed.

The FibroTest® score is used to assess liver fibrosis. Scores range from 0.00 to 1.00, with higher scores indicating a greater degree of fibrosis. Change from baseline was calculated as the value at Week 24 minus the value at Baseline.

Outcome measures

Measure	Part A (Renal Impairment): End Stage Renal Disease n=15 Participants Participants with CHB and end stage renal disease who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.	Part B: Hepatic Impairment n=31 Participants Participants with CHB and moderate or severe hepatic impairment who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.	Part A (Renal Impairment): Moderate or Severe Renal Impairment n=74 Participants Participants with chronic hepatitis B (CHB) and moderate or severe renal impairment who were virologically suppressed and took tenofovir disoproxil fumarate (TDF), a TDF-containing anti-hepatitis B virus (HBV) regimen, or other oral antivirals (OAVs), switched to tenofovir alafenamide (TAF) and received TAF 25 mg tablet once daily orally for 96 weeks.
Change From Baseline in FibroTest® Score at Week 24	-0.01 units on a scale Standard Deviation 0.064	-0.05 units on a scale Standard Deviation 0.106	-0.01 units on a scale Standard Deviation 0.099

SECONDARY outcome

Timeframe: Baseline, Week 48

Population: Participants in the Full Analysis Set with available data were analyzed.

The FibroTest® score is used to assess liver fibrosis. Scores range from 0.00 to 1.00, with higher scores indicating a greater degree of fibrosis. Change from baseline was calculated as the value at Week 48 minus the value at Baseline.

Outcome measures

Measure	Part A (Renal Impairment): End Stage Renal Disease n=14 Participants Participants with CHB and end stage renal disease who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.	Part B: Hepatic Impairment n=31 Participants Participants with CHB and moderate or severe hepatic impairment who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.	Part A (Renal Impairment): Moderate or Severe Renal Impairment n=73 Participants Participants with chronic hepatitis B (CHB) and moderate or severe renal impairment who were virologically suppressed and took tenofovir disoproxil fumarate (TDF), a TDF-containing anti-hepatitis B virus (HBV) regimen, or other oral antivirals (OAVs), switched to tenofovir alafenamide (TAF) and received TAF 25 mg tablet once daily orally for 96 weeks.
Change From Baseline in FibroTest® Score at Week 48	-0.01 units on a scale Standard Deviation 0.071	-0.03 units on a scale Standard Deviation 0.102	-0.03 units on a scale Standard Deviation 0.102

SECONDARY outcome

Timeframe: Week 96

Population: Participants in the Full Analysis Set with available data were analyzed.

The FibroTest® score is used to assess liver fibrosis. Scores range from 0.00 to 1.00, with higher scores indicating a greater degree of fibrosis. Change from baseline was calculated as the value at Week 96 minus the value at Baseline.

Outcome measures

Measure	Part A (Renal Impairment): End Stage Renal Disease n=13 Participants Participants with CHB and end stage renal disease who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.	Part B: Hepatic Impairment n=26 Participants Participants with CHB and moderate or severe hepatic impairment who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.	Part A (Renal Impairment): Moderate or Severe Renal Impairment n=65 Participants Participants with chronic hepatitis B (CHB) and moderate or severe renal impairment who were virologically suppressed and took tenofovir disoproxil fumarate (TDF), a TDF-containing anti-hepatitis B virus (HBV) regimen, or other oral antivirals (OAVs), switched to tenofovir alafenamide (TAF) and received TAF 25 mg tablet once daily orally for 96 weeks.
Change From Baseline in FibroTest® Score at Week 96	0.03 units on a scale Standard Deviation 0.107	-0.02 units on a scale Standard Deviation 0.118	-0.01 units on a scale Standard Deviation 0.114

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: Participants in the Full Analysis Set only from Part B (Hepatic Impairment) were analyzed.

CPT scores grade the severity of cirrhosis and are used to determine the need for liver transplantation. Scores can range from 5 to 15, with higher scores indicating a greater severity of disease.

Outcome measures

Measure	Part A (Renal Impairment): End Stage Renal Disease Participants with CHB and end stage renal disease who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.	Part B: Hepatic Impairment Participants with CHB and moderate or severe hepatic impairment who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.	Part A (Renal Impairment): Moderate or Severe Renal Impairment n=31 Participants Participants with chronic hepatitis B (CHB) and moderate or severe renal impairment who were virologically suppressed and took tenofovir disoproxil fumarate (TDF), a TDF-containing anti-hepatitis B virus (HBV) regimen, or other oral antivirals (OAVs), switched to tenofovir alafenamide (TAF) and received TAF 25 mg tablet once daily orally for 96 weeks.
Change From Baseline in Child-Pugh-Turcotte (CPT) Score in Hepatically Impaired Participants at Week 24	—	—	0 units on a scale Standard Deviation 1.1

SECONDARY outcome

Timeframe: Baseline, Week 48

Population: Participants in the Full Analysis Set only from Part B (Hepatic Impairment) were analyzed.

CPT scores grade the severity of cirrhosis and are used to determine the need for liver transplantation. Scores can range from 5 to 15, with higher scores indicating a greater severity of disease.

Outcome measures

Measure	Part A (Renal Impairment): End Stage Renal Disease Participants with CHB and end stage renal disease who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.	Part B: Hepatic Impairment Participants with CHB and moderate or severe hepatic impairment who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.	Part A (Renal Impairment): Moderate or Severe Renal Impairment n=31 Participants Participants with chronic hepatitis B (CHB) and moderate or severe renal impairment who were virologically suppressed and took tenofovir disoproxil fumarate (TDF), a TDF-containing anti-hepatitis B virus (HBV) regimen, or other oral antivirals (OAVs), switched to tenofovir alafenamide (TAF) and received TAF 25 mg tablet once daily orally for 96 weeks.
Change From Baseline in CPT Score in Hepatically Impaired Participants at Week 48	—	—	0 units on a scale Standard Deviation 1.1

SECONDARY outcome

Timeframe: Baseline, Week 96

Population: Participants in the Full Analysis Set only from Part B (Hepatic Impairment) with available data were analyzed.

CPT scores grade the severity of cirrhosis and are used to determine the need for liver transplantation. Scores can range from 5 to 15, with higher scores indicating a greater severity of disease.

Outcome measures

Measure	Part A (Renal Impairment): End Stage Renal Disease Participants with CHB and end stage renal disease who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.	Part B: Hepatic Impairment Participants with CHB and moderate or severe hepatic impairment who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.	Part A (Renal Impairment): Moderate or Severe Renal Impairment n=25 Participants Participants with chronic hepatitis B (CHB) and moderate or severe renal impairment who were virologically suppressed and took tenofovir disoproxil fumarate (TDF), a TDF-containing anti-hepatitis B virus (HBV) regimen, or other oral antivirals (OAVs), switched to tenofovir alafenamide (TAF) and received TAF 25 mg tablet once daily orally for 96 weeks.
Change From Baseline in CPT Score in Hepatically Impaired Participants at Week 96	—	—	0 units on a scale Standard Deviation 1.2

SECONDARY outcome

Timeframe: Baseline, Week 24

Population: Participants in the Full Analysis Set only from Part B (Hepatic Impairment) were analyzed.

MELD scores are used to assess prognosis and suitability for liver transplantation. Scores can range from 6 to 40, with higher scores indicating greater disease severity.

Outcome measures

Measure	Part A (Renal Impairment): End Stage Renal Disease Participants with CHB and end stage renal disease who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.	Part B: Hepatic Impairment Participants with CHB and moderate or severe hepatic impairment who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.	Part A (Renal Impairment): Moderate or Severe Renal Impairment n=31 Participants Participants with chronic hepatitis B (CHB) and moderate or severe renal impairment who were virologically suppressed and took tenofovir disoproxil fumarate (TDF), a TDF-containing anti-hepatitis B virus (HBV) regimen, or other oral antivirals (OAVs), switched to tenofovir alafenamide (TAF) and received TAF 25 mg tablet once daily orally for 96 weeks.
Change From Baseline in Model for End-Stage Liver Disease (MELD) Score in Hepatically Impaired Participants at Week 24	—	—	-0.6 units on a scale Standard Deviation 1.94

SECONDARY outcome

Timeframe: Baseline, Week 48

Population: Participants in the Full Analysis Set only from Part B (Hepatic Impairment) with available data were analyzed.

MELD scores are used to assess prognosis and suitability for liver transplantation. Scores can range from 6 to 40, with higher scores indicating greater disease severity.

Outcome measures

Measure	Part A (Renal Impairment): End Stage Renal Disease Participants with CHB and end stage renal disease who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.	Part B: Hepatic Impairment Participants with CHB and moderate or severe hepatic impairment who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.	Part A (Renal Impairment): Moderate or Severe Renal Impairment n=30 Participants Participants with chronic hepatitis B (CHB) and moderate or severe renal impairment who were virologically suppressed and took tenofovir disoproxil fumarate (TDF), a TDF-containing anti-hepatitis B virus (HBV) regimen, or other oral antivirals (OAVs), switched to tenofovir alafenamide (TAF) and received TAF 25 mg tablet once daily orally for 96 weeks.
Change From Baseline in MELD Score in Hepatically Impaired Participants at Week 48	—	—	0.1 units on a scale Standard Deviation 2.35

SECONDARY outcome

Timeframe: Baseline, Week 96

Population: Participants in the Full Analysis Set only from Part B (Hepatic Impairment) with available data were analyzed.

MELD scores are used to assess prognosis and suitability for liver transplantation. Scores can range from 6 to 40, with higher scores indicating greater disease severity.

Outcome measures

Measure	Part A (Renal Impairment): End Stage Renal Disease Participants with CHB and end stage renal disease who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.	Part B: Hepatic Impairment Participants with CHB and moderate or severe hepatic impairment who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.	Part A (Renal Impairment): Moderate or Severe Renal Impairment n=25 Participants Participants with chronic hepatitis B (CHB) and moderate or severe renal impairment who were virologically suppressed and took tenofovir disoproxil fumarate (TDF), a TDF-containing anti-hepatitis B virus (HBV) regimen, or other oral antivirals (OAVs), switched to tenofovir alafenamide (TAF) and received TAF 25 mg tablet once daily orally for 96 weeks.
Change From Baseline in MELD Score in Hepatically Impaired Participants at Week 96	—	—	-1.0 units on a scale Standard Deviation 1.61

Adverse Events

Part A (Renal Impairment): Moderate or Severe Renal Impairment

Serious events: 12 serious events

Other events: 34 other events

Deaths: 2 deaths

Part A (Renal Impairment): End Stage Renal Disease (Cohort 2)

Serious events: 8 serious events

Other events: 15 other events

Deaths: 1 deaths

Part B (Hepatic Impairment): Moderate or Severe Hepatic Impair

Serious events: 10 serious events

Other events: 23 other events

Deaths: 2 deaths

Serious adverse events

Measure	Part A (Renal Impairment): Moderate or Severe Renal Impairment n=78 participants at risk Participants with CHB and moderate or severe renal impairment who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or other OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.	Part A (Renal Impairment): End Stage Renal Disease (Cohort 2) n=15 participants at risk Participants with CHB and end stage renal disease who were virologically suppressed and taking TDF), a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.	Part B (Hepatic Impairment): Moderate or Severe Hepatic Impair n=31 participants at risk Participants with CHB and moderate or severe hepatic impairment who were virologically suppressed and taking TDF), a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.
Blood and lymphatic system disorders Anaemia	0.00% 0/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	6.7% 1/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	6.7% 1/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
Cardiac disorders Atrial flutter	0.00% 0/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	3.2% 1/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
Cardiac disorders Atrioventricular block complete	1.3% 1/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
Ear and labyrinth disorders Deafness neurosensory	0.00% 0/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	6.7% 1/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
Endocrine disorders Adrenal mass	0.00% 0/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	3.2% 1/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
Eye disorders Cataract	2.6% 2/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
Gastrointestinal disorders Abdominal pain	0.00% 0/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	6.7% 1/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
Gastrointestinal disorders Ascites	0.00% 0/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	3.2% 1/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
Gastrointestinal disorders Colitis	0.00% 0/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	6.7% 1/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
Gastrointestinal disorders Duodenal ulcer haemorrhage	0.00% 0/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	3.2% 1/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
Gastrointestinal disorders Gingival bleeding	0.00% 0/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	3.2% 1/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
Gastrointestinal disorders Intestinal obstruction	0.00% 0/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	6.7% 1/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.00% 0/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	3.2% 1/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
General disorders Catheter site discharge	0.00% 0/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	6.7% 1/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
Hepatobiliary disorders Bile duct stone	0.00% 0/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	3.2% 1/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
Hepatobiliary disorders Hepatic failure	0.00% 0/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	3.2% 1/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
Hepatobiliary disorders Hepatorenal syndrome	0.00% 0/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	3.2% 1/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
Infections and infestations Bacteraemia	0.00% 0/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	6.7% 1/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
Infections and infestations Fungal cystitis	0.00% 0/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	3.2% 1/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
Infections and infestations Lower respiratory tract infection	0.00% 0/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	6.7% 1/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
Infections and infestations Lower respiratory tract infection viral	0.00% 0/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	6.7% 1/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
Infections and infestations Peritonitis bacterial	0.00% 0/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	3.2% 1/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
Infections and infestations Pneumonia	2.6% 2/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	6.7% 1/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
Infections and infestations Sepsis	0.00% 0/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	6.7% 1/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	3.2% 1/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
Infections and infestations Urinary tract infection	0.00% 0/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	3.2% 1/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
Injury, poisoning and procedural complications Arteriovenous fistula site complication	0.00% 0/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	6.7% 1/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
Injury, poisoning and procedural complications Arteriovenous fistula thrombosis	0.00% 0/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	6.7% 1/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
Injury, poisoning and procedural complications Drain site complication	0.00% 0/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	3.2% 1/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
Injury, poisoning and procedural complications Head injury	1.3% 1/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
Injury, poisoning and procedural complications Shunt occlusion	0.00% 0/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	6.7% 1/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
Injury, poisoning and procedural complications Subdural haematoma	0.00% 0/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	3.2% 1/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
Investigations Carcinoembryonic antigen increased	1.3% 1/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
Investigations Model for end stage liver disease score increased	0.00% 0/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	3.2% 1/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
Metabolism and nutrition disorders Hyperkalaemia	1.3% 1/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Back pain	1.3% 1/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Focal myositis	0.00% 0/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	6.7% 1/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	1.3% 1/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatocellular carcinoma	0.00% 0/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	6.7% 1/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	3.2% 1/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	1.3% 1/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian cancer	0.00% 0/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	6.7% 1/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal cancer	1.3% 1/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
Nervous system disorders Encephalopathy	0.00% 0/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	3.2% 1/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
Nervous system disorders Hepatic encephalopathy	0.00% 0/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	6.5% 2/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
Nervous system disorders Ischaemic stroke	2.6% 2/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	3.2% 1/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
Nervous system disorders Subarachnoid haemorrhage	1.3% 1/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	3.2% 1/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.00% 0/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	6.7% 1/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	6.7% 1/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Haemothorax	0.00% 0/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	6.7% 1/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	13.3% 2/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Pneumonia aspiration	1.3% 1/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	3.2% 1/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Respiratory failure	1.3% 1/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.

Other adverse events

Measure	Part A (Renal Impairment): Moderate or Severe Renal Impairment n=78 participants at risk Participants with CHB and moderate or severe renal impairment who were virologically suppressed and taking TDF, a TDF-containing anti-HBV regimen, or other OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.	Part A (Renal Impairment): End Stage Renal Disease (Cohort 2) n=15 participants at risk Participants with CHB and end stage renal disease who were virologically suppressed and taking TDF), a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.	Part B (Hepatic Impairment): Moderate or Severe Hepatic Impair n=31 participants at risk Participants with CHB and moderate or severe hepatic impairment who were virologically suppressed and taking TDF), a TDF-containing anti-HBV regimen, or OAVs, switched to TAF and received TAF 25 mg tablet once daily orally for 96 weeks.
Blood and lymphatic system disorders Anaemia	2.6% 2/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	20.0% 3/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	3.2% 1/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
Blood and lymphatic system disorders Blood loss anaemia	0.00% 0/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	6.7% 1/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
Blood and lymphatic system disorders Coagulopathy	0.00% 0/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	6.7% 1/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	6.7% 1/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	3.2% 1/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
Blood and lymphatic system disorders Thrombotic thrombocytopenic purpura	0.00% 0/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	6.7% 1/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
Ear and labyrinth disorders Deafness neurosensory	0.00% 0/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	6.7% 1/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
Ear and labyrinth disorders Ear haemorrhage	0.00% 0/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	6.7% 1/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
Ear and labyrinth disorders Ear pain	0.00% 0/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	6.7% 1/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
Ear and labyrinth disorders Vertigo	1.3% 1/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	6.7% 1/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
Eye disorders Cataract	1.3% 1/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	6.7% 1/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	3.2% 1/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
Eye disorders Cataract nuclear	0.00% 0/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	6.7% 1/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
Eye disorders Conjunctival haemorrhage	0.00% 0/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	6.7% 1/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	3.2% 1/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
Eye disorders Iridocyclitis	0.00% 0/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	6.7% 1/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
Gastrointestinal disorders Abdominal pain	2.6% 2/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	6.7% 1/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	6.5% 2/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
Gastrointestinal disorders Abdominal pain lower	1.3% 1/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	6.7% 1/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
Gastrointestinal disorders Ascites	0.00% 0/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	13.3% 2/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	12.9% 4/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
Gastrointestinal disorders Constipation	2.6% 2/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	26.7% 4/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	9.7% 3/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
Gastrointestinal disorders Dental caries	0.00% 0/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	6.7% 1/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	6.5% 2/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
Gastrointestinal disorders Diarrhoea	3.8% 3/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	20.0% 3/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	19.4% 6/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
Gastrointestinal disorders Flatulence	0.00% 0/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	6.5% 2/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
Gastrointestinal disorders Haemorrhoids	2.6% 2/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	6.7% 1/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
Gastrointestinal disorders Mouth ulceration	0.00% 0/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	6.7% 1/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
Gastrointestinal disorders Nausea	1.3% 1/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	6.7% 1/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	3.2% 1/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
Gastrointestinal disorders Peptic ulcer	0.00% 0/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	6.7% 1/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
Gastrointestinal disorders Portal hypertensive gastropathy	0.00% 0/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	6.5% 2/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
Gastrointestinal disorders Stomatitis	0.00% 0/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	6.7% 1/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
Gastrointestinal disorders Toothache	3.8% 3/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	6.7% 1/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
Gastrointestinal disorders Vomiting	0.00% 0/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	6.7% 1/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	6.5% 2/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
General disorders Chest discomfort	0.00% 0/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	6.7% 1/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
General disorders Fatigue	0.00% 0/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	6.5% 2/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
General disorders Oedema peripheral	1.3% 1/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	6.7% 1/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	6.5% 2/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
General disorders Pain	0.00% 0/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	6.7% 1/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
General disorders Pyrexia	0.00% 0/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	20.0% 3/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	16.1% 5/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
Hepatobiliary disorders Jaundice	0.00% 0/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	6.7% 1/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
Infections and infestations Cellulitis	0.00% 0/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	6.7% 1/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
Infections and infestations Conjunctivitis	0.00% 0/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	6.7% 1/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	6.5% 2/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
Infections and infestations Endophthalmitis	0.00% 0/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	6.7% 1/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
Infections and infestations Hordeolum	0.00% 0/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	6.7% 1/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
Infections and infestations Nasopharyngitis	7.7% 6/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
Infections and infestations Pneumonia	2.6% 2/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	6.7% 1/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	3.2% 1/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
Infections and infestations Skin infection	0.00% 0/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	6.7% 1/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
Infections and infestations Upper respiratory tract infection	14.1% 11/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	20.0% 3/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	19.4% 6/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
Infections and infestations Urinary tract infection	3.8% 3/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	6.7% 1/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
Injury, poisoning and procedural complications Arteriovenous fistula site complication	0.00% 0/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	6.7% 1/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
Injury, poisoning and procedural complications Incision site pain	0.00% 0/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	6.7% 1/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
Injury, poisoning and procedural complications Ligament sprain	1.3% 1/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	6.7% 1/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
Injury, poisoning and procedural complications Limb injury	0.00% 0/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	6.7% 1/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
Injury, poisoning and procedural complications Procedural pain	0.00% 0/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	6.7% 1/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
Injury, poisoning and procedural complications Shunt occlusion	0.00% 0/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	6.7% 1/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
Injury, poisoning and procedural complications Vascular pseudoaneurysm	0.00% 0/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	6.7% 1/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
Investigations Blood bilirubin increased	0.00% 0/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	6.5% 2/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
Investigations Blood creatinine increased	1.3% 1/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	6.5% 2/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
Investigations Bone density decreased	1.3% 1/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	16.1% 5/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
Metabolism and nutrition disorders Hyperkalaemia	1.3% 1/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	13.3% 2/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
Metabolism and nutrition disorders Hyperlipidaemia	1.3% 1/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	6.5% 2/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	6.7% 1/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	3.2% 1/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
Metabolism and nutrition disorders Metabolic acidosis	0.00% 0/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	6.7% 1/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
Metabolism and nutrition disorders Vitamin B12 deficiency	0.00% 0/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	6.7% 1/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	13.3% 2/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	9.7% 3/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Back pain	2.6% 2/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	6.7% 1/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Bone loss	0.00% 0/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	6.7% 1/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Groin pain	0.00% 0/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	6.7% 1/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	1.3% 1/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	20.0% 3/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	3.2% 1/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatocellular carcinoma	1.3% 1/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	6.7% 1/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian cancer stage I	0.00% 0/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	6.7% 1/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
Nervous system disorders Amnesia	0.00% 0/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	6.7% 1/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
Nervous system disorders Carotid arteriosclerosis	0.00% 0/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	6.7% 1/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
Nervous system disorders Cerebral atrophy	0.00% 0/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	6.7% 1/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
Nervous system disorders Cerebrovascular accident	0.00% 0/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	6.7% 1/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
Nervous system disorders Cognitive disorder	1.3% 1/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	6.7% 1/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
Nervous system disorders Dementia	0.00% 0/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	6.7% 1/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
Nervous system disorders Dizziness	3.8% 3/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	6.7% 1/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
Nervous system disorders Dyskinesia	0.00% 0/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	6.7% 1/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
Nervous system disorders Headache	2.6% 2/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	6.5% 2/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
Nervous system disorders Hydrocephalus	0.00% 0/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	6.7% 1/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
Nervous system disorders Vascular encephalopathy	0.00% 0/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	6.7% 1/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
Psychiatric disorders Insomnia	5.1% 4/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	6.7% 1/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	6.5% 2/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
Renal and urinary disorders Chronic kidney disease	0.00% 0/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	6.5% 2/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
Renal and urinary disorders Haematuria	3.8% 3/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	6.7% 1/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	3.2% 1/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
Renal and urinary disorders Renal mass	0.00% 0/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	6.7% 1/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Cough	5.1% 4/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	19.4% 6/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Dyspnoea	1.3% 1/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	13.3% 2/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	6.7% 1/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	3.2% 1/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	6.7% 1/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Nasal obstruction	0.00% 0/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	6.7% 1/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	1.3% 1/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	9.7% 3/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	20.0% 3/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	6.5% 2/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	13.3% 2/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	3.2% 1/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.00% 0/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	6.7% 1/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	1.3% 1/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	13.3% 2/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
Skin and subcutaneous tissue disorders Dermatitis	1.3% 1/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	6.7% 1/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
Skin and subcutaneous tissue disorders Pruritus	3.8% 3/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	13.3% 2/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	3.2% 1/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
Skin and subcutaneous tissue disorders Skin lesion	0.00% 0/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	6.7% 1/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
Vascular disorders Hypertension	2.6% 2/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	26.7% 4/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	3.2% 1/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
Vascular disorders Hypotension	0.00% 0/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	13.3% 2/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
Vascular disorders Thrombosis	0.00% 0/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	6.7% 1/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.
Vascular disorders Venous occlusion	0.00% 0/78 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	6.7% 1/15 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.	0.00% 0/31 • Adverse Events: From the first dose date up to last dose date (maximum: 108.1 weeks) plus 3 days; All-Cause Mortality: Enrollment up to last dose date (maximum: 166.2 weeks) plus 3 days Adverse Events: The Safety Analysis Set included all participants who were enrolled and received at least 1 dose of study drug. All-Cause Mortality: The Full Analysis Set included all participants who were enrolled and received at least one dose of study drug.

Additional Information

Gilead Clinical Study Information Center

Gilead Sciences

Phone: 1-833-445-3230 (GILEAD-0)

Email: GileadClinicalTrials@gilead.com

Results disclosure agreements

• Principal investigator is a sponsor employee After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: * The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or * The study has been completed at all study sites for at least 2 years
• Publication restrictions are in place

Restriction type: OTHER