Trial Outcomes & Findings for A Study to Evaluate the Antiviral Effect, Safety and Tolerability of GSK3810109A in Viremic Human Immunodeficiency Virus (HIV)-1 Infected Adults (NCT NCT04871113)

NCT ID: NCT04871113

Last Updated: 2024-10-15

Results Overview

Plasma samples were collected for quantitative analysis of plasma HIV-1 RNA. Maximum decline from baseline in plasma HIV-1 RNA were measured in participants. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. End of Monotherapy Phase is defined as the timepoint when a participant had reached the monotherapy endpoint criteria or a maximum of 84 days follow-up, whichever occurred first.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 62 participants
• Primary outcome timeframe: Baseline (Day 1) and up to Day 84 or end of Monotherapy Phase
• Results posted on: 2024-10-15

Participant Flow

62 unique participants were enrolled in the study including one participant that was re-screened. This re-screened participant signed two different informed consent forms, therefore this participant was counted as enrolling twice.

Monotherapy phase had 2 parts (Part 1 and 2) where participants received GSK3810109A. All participants who completed monotherapy phase entered standard of care (SOC) follow-up phase to receive a regimen of dolutegravir + lamivudine.

Participant milestones

Measure	Part 1:GSK3810109A 40milligram(mg)/Kilogram Intravenously (IV) Participants with human immunodeficiency viruses-1 (HIV-1) received GSK3810109A as a single intravenous (IV) infusion of 40 milligrams per kilogram (mg/kg) dose based on individual bodyweight on Day 1 in part 1.	Part 1: GSK3810109A 280 mg IV Participants with HIV-1 received GSK3810109A as a single IV infusion of 280 mg dose on Day 1 in part 1.	Part 2: GSK3810109A 700 mg IV Participants with HIV-1 received GSK3810109A as a single IV infusion of 700 mg dose on Day 1 in part 2. This included dose level determined based on the data of part 1.	Part 2: GSK3810109A 70 mg IV Participants with HIV-1 received GSK3810109A as a single IV infusion of 70 mg dose on Day 1 in part 2. This included dose level determined based on the data of part 1.	Part 2: GSK3810109A 700 mg Subcutaneously (SC) Participants with HIV-1 received GSK3810109A as a subcutaneous (SC) injection of total 700 mg dose administered as three equally divided SC injections of 2.33 mL each (approximately 7 mL) in quick succession at same time on Day 1 in part 2. This included dose level determined based on the data of part 1.	SOC - GSK3810109A 40mg/kg IV Participants who completed the monotherapy phase of treatment of GSK3810109A 40mg/kg IV entered SOC phase to receive dolutegravir + lamivudine regimen as a SOC treatment on SOC Day 1 if deemed appropriate by the investigator and consistent with local guidelines.	SOC - GSK3810109A 280 mg IV Participants who completed the monotherapy phase of treatment of GSK3810109A 280 mg IV entered SOC phase to receive dolutegravir + lamivudine regimen as a SOC treatment on SOC Day 1 if deemed appropriate by the investigator and consistent with local guidelines.	SOC - GSK3810109A 700 mg IV Participants who completed the monotherapy phase of treatment of GSK3810109A 700 mg IV entered SOC phase to receive dolutegravir + lamivudine regimen as a SOC treatment on SOC Day 1 if deemed appropriate by the investigator and consistent with local guidelines.	SOC - GSK3810109A 70 mg IV Participants who completed the monotherapy phase of treatment of GSK3810109A 70 mg IV entered SOC phase to receive dolutegravir + lamivudine regimen as a SOC treatment on SOC Day 1 if deemed appropriate by the investigator and consistent with local guidelines.	SOC - GSK3810109A 700 mg SC Participants who completed the monotherapy phase of treatment of GSK3810109A 700 mg SC entered SOC phase to receive dolutegravir + lamivudine regimen as a SOC treatment on SOC Day 1 if deemed appropriate by the investigator and consistent with local guidelines.
Part1:Monotherapy Phase(up to Day 84) STARTED	8	6	0	0	0	0	0	0	0	0
Part1:Monotherapy Phase(up to Day 84) COMPLETED	8	6	0	0	0	0	0	0	0	0
Part1:Monotherapy Phase(up to Day 84) NOT COMPLETED	0	0	0	0	0	0	0	0	0	0
Part2:Monotherapy Phase(up to Day 84) STARTED	0	0	16	16	16	0	0	0	0	0
Part2:Monotherapy Phase(up to Day 84) COMPLETED	0	0	16	16	16	0	0	0	0	0
Part2:Monotherapy Phase(up to Day 84) NOT COMPLETED	0	0	0	0	0	0	0	0	0	0
SOC Follow-up (SOC Day 1 to 48 Weeks) STARTED	0	0	0	0	0	8	6	16	16	16
SOC Follow-up (SOC Day 1 to 48 Weeks) COMPLETED	0	0	0	0	0	7	5	14	16	16
SOC Follow-up (SOC Day 1 to 48 Weeks) NOT COMPLETED	0	0	0	0	0	1	1	2	0	0

Reasons for withdrawal

Measure	Part 1:GSK3810109A 40milligram(mg)/Kilogram Intravenously (IV) Participants with human immunodeficiency viruses-1 (HIV-1) received GSK3810109A as a single intravenous (IV) infusion of 40 milligrams per kilogram (mg/kg) dose based on individual bodyweight on Day 1 in part 1.	Part 1: GSK3810109A 280 mg IV Participants with HIV-1 received GSK3810109A as a single IV infusion of 280 mg dose on Day 1 in part 1.	Part 2: GSK3810109A 700 mg IV Participants with HIV-1 received GSK3810109A as a single IV infusion of 700 mg dose on Day 1 in part 2. This included dose level determined based on the data of part 1.	Part 2: GSK3810109A 70 mg IV Participants with HIV-1 received GSK3810109A as a single IV infusion of 70 mg dose on Day 1 in part 2. This included dose level determined based on the data of part 1.	Part 2: GSK3810109A 700 mg Subcutaneously (SC) Participants with HIV-1 received GSK3810109A as a subcutaneous (SC) injection of total 700 mg dose administered as three equally divided SC injections of 2.33 mL each (approximately 7 mL) in quick succession at same time on Day 1 in part 2. This included dose level determined based on the data of part 1.	SOC - GSK3810109A 40mg/kg IV Participants who completed the monotherapy phase of treatment of GSK3810109A 40mg/kg IV entered SOC phase to receive dolutegravir + lamivudine regimen as a SOC treatment on SOC Day 1 if deemed appropriate by the investigator and consistent with local guidelines.	SOC - GSK3810109A 280 mg IV Participants who completed the monotherapy phase of treatment of GSK3810109A 280 mg IV entered SOC phase to receive dolutegravir + lamivudine regimen as a SOC treatment on SOC Day 1 if deemed appropriate by the investigator and consistent with local guidelines.	SOC - GSK3810109A 700 mg IV Participants who completed the monotherapy phase of treatment of GSK3810109A 700 mg IV entered SOC phase to receive dolutegravir + lamivudine regimen as a SOC treatment on SOC Day 1 if deemed appropriate by the investigator and consistent with local guidelines.	SOC - GSK3810109A 70 mg IV Participants who completed the monotherapy phase of treatment of GSK3810109A 70 mg IV entered SOC phase to receive dolutegravir + lamivudine regimen as a SOC treatment on SOC Day 1 if deemed appropriate by the investigator and consistent with local guidelines.	SOC - GSK3810109A 700 mg SC Participants who completed the monotherapy phase of treatment of GSK3810109A 700 mg SC entered SOC phase to receive dolutegravir + lamivudine regimen as a SOC treatment on SOC Day 1 if deemed appropriate by the investigator and consistent with local guidelines.
SOC Follow-up (SOC Day 1 to 48 Weeks) Lost to Follow-up	0	0	0	0	0	1	0	0	0	0
SOC Follow-up (SOC Day 1 to 48 Weeks) Withdrawal by Subject	0	0	0	0	0	0	1	2	0	0

Baseline Characteristics

A Study to Evaluate the Antiviral Effect, Safety and Tolerability of GSK3810109A in Viremic Human Immunodeficiency Virus (HIV)-1 Infected Adults

Baseline characteristics by cohort

Measure	Part 1:GSK3810109A 40milligram(mg)/Kilogram Intravenously (IV) n=8 Participants Participants with human immunodeficiency viruses-1 (HIV-1) received GSK3810109A as a single intravenous (IV) infusion of 40 milligrams per kilogram (mg/kg) dose based on individual bodyweight on Day 1 in part 1.	Part 1: GSK3810109A 280 mg IV n=6 Participants Participants with HIV-1 received GSK3810109A as a single IV infusion of 280 mg dose on Day 1 in part 1.	Part 2: GSK3810109A 700 mg IV n=16 Participants Participants with HIV-1 received GSK3810109A as a single IV infusion of 700 mg dose on Day 1 in part 2. This included dose level determined based on the data of part 1.	Part 2: GSK3810109A 70 mg IV n=16 Participants Participants with HIV-1 received GSK3810109A as a single IV infusion of 70 mg dose on Day 1 in part 2. This included dose level determined based on the data of part 1.	Part 2: GSK3810109A 700 mg Subcutaneously (SC) n=16 Participants Participants with HIV-1 received GSK3810109A as a subcutaneous (SC) injection of total 700 mg dose administered as three equally divided SC injections of 2.33 mL each (approximately 7 mL) in quick succession at same time on Day 1 in part 2. This included dose level determined based on the data of part 1.	Total n=62 Participants Total of all reporting groups
Age, Continuous	34.3 YEARS STANDARD_DEVIATION 9.39 • n=5 Participants	34.0 YEARS STANDARD_DEVIATION 14.83 • n=7 Participants	31.2 YEARS STANDARD_DEVIATION 10.46 • n=5 Participants	32.3 YEARS STANDARD_DEVIATION 10.33 • n=4 Participants	31.5 YEARS STANDARD_DEVIATION 11.08 • n=21 Participants	32.2 YEARS STANDARD_DEVIATION 10.62 • n=10 Participants
Sex/Gender, Customized Female	0 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	4 Participants n=10 Participants
Sex/Gender, Customized Male	8 Participants n=5 Participants	5 Participants n=7 Participants	14 Participants n=5 Participants	16 Participants n=4 Participants	15 Participants n=21 Participants	58 Participants n=10 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	1 Participants n=21 Participants	3 Participants n=10 Participants
Race/Ethnicity, Customized Black or African American	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants	3 Participants n=4 Participants	2 Participants n=21 Participants	11 Participants n=10 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=10 Participants
Race/Ethnicity, Customized White - Arabic/ North African Heritage	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	3 Participants n=21 Participants	4 Participants n=10 Participants
Race/Ethnicity, Customized White - White/ Caucasian/ European Heritage	6 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants	8 Participants n=4 Participants	9 Participants n=21 Participants	38 Participants n=10 Participants
Race/Ethnicity, Customized Multiple	0 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	5 Participants n=10 Participants

PRIMARY outcome

Timeframe: Baseline (Day 1) and up to Day 84 or end of Monotherapy Phase

Population: The analysis was performed on the safety population, which included all participants who received at least one dose of study treatment. Only those participants with data available at the specified time points were analyzed.

Plasma samples were collected for quantitative analysis of plasma HIV-1 RNA. Maximum decline from baseline in plasma HIV-1 RNA were measured in participants. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. End of Monotherapy Phase is defined as the timepoint when a participant had reached the monotherapy endpoint criteria or a maximum of 84 days follow-up, whichever occurred first.

Outcome measures

Measure	Part 1:GSK3810109A 40milligram(mg)/Kilogram Intravenously (IV) n=8 Participants Participants with human immunodeficiency viruses-1 (HIV-1) received GSK3810109A as a single intravenous (IV) infusion of 40 milligrams per kilogram (mg/kg) dose based on individual bodyweight on Day 1 in part 1.	Part 1: GSK3810109A 280 mg IV n=6 Participants Participants with HIV-1 received GSK3810109A as a single IV infusion of 280 mg dose on Day 1 in part 1.	Part 2: GSK3810109A 700 mg IV n=16 Participants Participants with HIV-1 received GSK3810109A as a single IV infusion of 700 mg dose on Day 1 in part 2. This included dose level determined based on the data of part 1.	Part 2: GSK3810109A 70 mg IV n=16 Participants Participants with HIV-1 received GSK3810109A as a single IV infusion of 70 mg dose on Day 1 in part 2. This included dose level determined based on the data of part 1.	Part 2: GSK3810109A 700 mg Subcutaneously (SC) n=16 Participants Participants with HIV-1 received GSK3810109A as a subcutaneous (SC) injection of total 700 mg dose administered as three equally divided SC injections of 2.33 mL each (approximately 7 mL) in quick succession at same time on Day 1 in part 2. This included dose level determined based on the data of part 1.
Maximum Decline From Baseline in Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) Levels - Monotherapy Phase Baseline (Day 1)	12258.5 Copies per milliliter (copies/mL) Interval 1351.0 to 173710.0	30833.0 Copies per milliliter (copies/mL) Interval 5938.0 to 104585.0	25466.0 Copies per milliliter (copies/mL) Interval 7180.0 to 110387.0	25689.5 Copies per milliliter (copies/mL) Interval 7225.0 to 683576.0	23146.0 Copies per milliliter (copies/mL) Interval 131.0 to 181078.0
Maximum Decline From Baseline in Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) Levels - Monotherapy Phase Maximum decline from baseline (up to Day 84/end of Monotherapy Phase)	-12014.5 Copies per milliliter (copies/mL) Interval -171577.0 to -1312.0	-26826.5 Copies per milliliter (copies/mL) Interval -103583.0 to -5899.0	-25966.0 Copies per milliliter (copies/mL) Interval -107218.0 to -6944.0	-14720.5 Copies per milliliter (copies/mL) Interval -197793.0 to -4382.0	-12584.0 Copies per milliliter (copies/mL) Interval -178423.0 to -69.0

PRIMARY outcome

Timeframe: Up to Day 84 or end of Monotherapy Phase

Population: The analysis was performed on the safety population, which included all participants who received at least one dose of study treatment. Only those participants with data available at the specified time points were analyzed.

An adverse event (AE) is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. End of Monotherapy Phase is defined as the timepoint when a participant had reached the monotherapy endpoint criteria or a maximum of 84 days follow-up, whichever occurred first.

Outcome measures

Measure	Part 1:GSK3810109A 40milligram(mg)/Kilogram Intravenously (IV) n=8 Participants Participants with human immunodeficiency viruses-1 (HIV-1) received GSK3810109A as a single intravenous (IV) infusion of 40 milligrams per kilogram (mg/kg) dose based on individual bodyweight on Day 1 in part 1.	Part 1: GSK3810109A 280 mg IV n=6 Participants Participants with HIV-1 received GSK3810109A as a single IV infusion of 280 mg dose on Day 1 in part 1.	Part 2: GSK3810109A 700 mg IV n=16 Participants Participants with HIV-1 received GSK3810109A as a single IV infusion of 700 mg dose on Day 1 in part 2. This included dose level determined based on the data of part 1.	Part 2: GSK3810109A 70 mg IV n=16 Participants Participants with HIV-1 received GSK3810109A as a single IV infusion of 70 mg dose on Day 1 in part 2. This included dose level determined based on the data of part 1.	Part 2: GSK3810109A 700 mg Subcutaneously (SC) n=16 Participants Participants with HIV-1 received GSK3810109A as a subcutaneous (SC) injection of total 700 mg dose administered as three equally divided SC injections of 2.33 mL each (approximately 7 mL) in quick succession at same time on Day 1 in part 2. This included dose level determined based on the data of part 1.
Number of Participants With Adverse Events (AEs) - Monotherapy Phase	7 Participants	4 Participants	9 Participants	8 Participants	11 Participants

PRIMARY outcome

Timeframe: Baseline (Day 1) and up to Day 84 or end of Monotherapy Phase

Population: The analysis was performed on the safety population, which included all participants who received at least one dose of study treatment. Only those participants with data available at the specified time points were analyzed.

Blood samples were collected for the analysis of ALT and AST parameters. The parameters ALT and AST were graded using the Division of Acquired Immunodeficiency Syndrome (DAIDS) criteria Version 2.1 where grades were defined based on numeric criteria as follows Grade 0: participants with missing baseline values; Grade 1: Mild; Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences. Higher grade indicates greater severity. Baseline was defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Data of number of participants with 2-4 grade increase at worst-case post-baseline (maximum grade increase post-baseline) is presented. End of Monotherapy Phase is defined as the timepoint when a participant had reached the monotherapy endpoint criteria or a maximum of 84 days follow-up, whichever occurred first.

Outcome measures

Measure	Part 1:GSK3810109A 40milligram(mg)/Kilogram Intravenously (IV) n=8 Participants Participants with human immunodeficiency viruses-1 (HIV-1) received GSK3810109A as a single intravenous (IV) infusion of 40 milligrams per kilogram (mg/kg) dose based on individual bodyweight on Day 1 in part 1.	Part 1: GSK3810109A 280 mg IV n=6 Participants Participants with HIV-1 received GSK3810109A as a single IV infusion of 280 mg dose on Day 1 in part 1.	Part 2: GSK3810109A 700 mg IV n=16 Participants Participants with HIV-1 received GSK3810109A as a single IV infusion of 700 mg dose on Day 1 in part 2. This included dose level determined based on the data of part 1.	Part 2: GSK3810109A 70 mg IV n=16 Participants Participants with HIV-1 received GSK3810109A as a single IV infusion of 70 mg dose on Day 1 in part 2. This included dose level determined based on the data of part 1.	Part 2: GSK3810109A 700 mg Subcutaneously (SC) n=16 Participants Participants with HIV-1 received GSK3810109A as a subcutaneous (SC) injection of total 700 mg dose administered as three equally divided SC injections of 2.33 mL each (approximately 7 mL) in quick succession at same time on Day 1 in part 2. This included dose level determined based on the data of part 1.
Number of Participants With Worst-case Maximum Grade 2-4 Increase in Post-baseline Values of Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) Compared to the Baseline Values - Monotherapy Phase ALT, Baseline, Grade 0	8 Participants	6 Participants	15 Participants	12 Participants	15 Participants
Number of Participants With Worst-case Maximum Grade 2-4 Increase in Post-baseline Values of Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) Compared to the Baseline Values - Monotherapy Phase ALT, Baseline, Grade 1	0 Participants	0 Participants	1 Participants	2 Participants	1 Participants
Number of Participants With Worst-case Maximum Grade 2-4 Increase in Post-baseline Values of Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) Compared to the Baseline Values - Monotherapy Phase ALT, Baseline, Grade 2	0 Participants	0 Participants	0 Participants	2 Participants	0 Participants
Number of Participants With Worst-case Maximum Grade 2-4 Increase in Post-baseline Values of Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) Compared to the Baseline Values - Monotherapy Phase ALT, Baseline, Grade 3	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Worst-case Maximum Grade 2-4 Increase in Post-baseline Values of Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) Compared to the Baseline Values - Monotherapy Phase ALT, Baseline, Grade 4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Worst-case Maximum Grade 2-4 Increase in Post-baseline Values of Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) Compared to the Baseline Values - Monotherapy Phase ALT, Worst Case Post-Baseline, Increase to Grades 2 to 4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Worst-case Maximum Grade 2-4 Increase in Post-baseline Values of Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) Compared to the Baseline Values - Monotherapy Phase ALT, Worst Case Post-Baseline, Increase to Grades 3 to 4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Worst-case Maximum Grade 2-4 Increase in Post-baseline Values of Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) Compared to the Baseline Values - Monotherapy Phase AST, Baseline, Grade 0	8 Participants	6 Participants	15 Participants	14 Participants	16 Participants
Number of Participants With Worst-case Maximum Grade 2-4 Increase in Post-baseline Values of Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) Compared to the Baseline Values - Monotherapy Phase AST, Baseline, Grade 1	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Worst-case Maximum Grade 2-4 Increase in Post-baseline Values of Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) Compared to the Baseline Values - Monotherapy Phase AST, Baseline, Grade 2	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants
Number of Participants With Worst-case Maximum Grade 2-4 Increase in Post-baseline Values of Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) Compared to the Baseline Values - Monotherapy Phase AST, Baseline, Grade 3	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Worst-case Maximum Grade 2-4 Increase in Post-baseline Values of Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) Compared to the Baseline Values - Monotherapy Phase AST, Baseline, Grade 4	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Worst-case Maximum Grade 2-4 Increase in Post-baseline Values of Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) Compared to the Baseline Values - Monotherapy Phase AST, Worst Case Post-Baseline, Increase to Grades 2 to 4	1 Participants	0 Participants	1 Participants	0 Participants	1 Participants
Number of Participants With Worst-case Maximum Grade 2-4 Increase in Post-baseline Values of Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) Compared to the Baseline Values - Monotherapy Phase AST, Worst Case Post-Baseline, Increase to Grades 3 to 4	1 Participants	0 Participants	1 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Up to Day 84 or end of Monotherapy Phase

Population: The analysis was performed on the safety population, which included all participants who received at least one dose of study treatment. Only those participants with data available at the specified time points were analyzed.

A 12-lead ECG were obtained using an ECG machine that automatically calculated the heart rate and measured PR, QRS, QT, and QT interval corrected using Fridericia's formula (QTcF) intervals. ECG findings were categorized as normal, abnormal clinically significant (CS) and abnormal not clinically significant (NCS). Clinically significant abnormal findings are those which are not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. Number of participants with abnormal (CS and NCS) ECG findings are presented. End of Monotherapy Phase is defined as the timepoint when a participant had reached the monotherapy endpoint criteria or a maximum of 84 days follow-up, whichever occurred first.

Outcome measures

Measure	Part 1:GSK3810109A 40milligram(mg)/Kilogram Intravenously (IV) n=8 Participants Participants with human immunodeficiency viruses-1 (HIV-1) received GSK3810109A as a single intravenous (IV) infusion of 40 milligrams per kilogram (mg/kg) dose based on individual bodyweight on Day 1 in part 1.	Part 1: GSK3810109A 280 mg IV n=6 Participants Participants with HIV-1 received GSK3810109A as a single IV infusion of 280 mg dose on Day 1 in part 1.	Part 2: GSK3810109A 700 mg IV n=16 Participants Participants with HIV-1 received GSK3810109A as a single IV infusion of 700 mg dose on Day 1 in part 2. This included dose level determined based on the data of part 1.	Part 2: GSK3810109A 70 mg IV n=16 Participants Participants with HIV-1 received GSK3810109A as a single IV infusion of 70 mg dose on Day 1 in part 2. This included dose level determined based on the data of part 1.	Part 2: GSK3810109A 700 mg Subcutaneously (SC) n=16 Participants Participants with HIV-1 received GSK3810109A as a subcutaneous (SC) injection of total 700 mg dose administered as three equally divided SC injections of 2.33 mL each (approximately 7 mL) in quick succession at same time on Day 1 in part 2. This included dose level determined based on the data of part 1.
Number of Participants With Treatment-emergent Abnormal Electrocardiogram (ECG) Findings - Monotherapy Phase Abnormal - Clinically Significant	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Treatment-emergent Abnormal Electrocardiogram (ECG) Findings - Monotherapy Phase Abnormal - Not Clinically Significant	3 Participants	2 Participants	3 Participants	4 Participants	7 Participants

PRIMARY outcome

Timeframe: Up to Day 84 or end of Monotherapy Phase

Population: The analysis was performed on the safety population, which included all participants who received at least one dose of study treatment. Only those participants with data available at the specified time points were analyzed.

Number of participants with grade 2-4 injection site reactions are presented. The ISR were graded using the Division of Acquired immunodeficiency syndrome (DAIDS) criteria Version 2.1 where grades were defined based on numeric criteria as follows Grade 2: moderate; Grade 3: severe or medically significant; Grade 4: life-threatening consequences. Higher grade indicates more severe condition. End of Monotherapy Phase is defined as the timepoint when a participant had reached the monotherapy endpoint criteria or a maximum of 84 days follow-up, whichever occurred first.

Outcome measures

Measure	Part 1:GSK3810109A 40milligram(mg)/Kilogram Intravenously (IV) n=8 Participants Participants with human immunodeficiency viruses-1 (HIV-1) received GSK3810109A as a single intravenous (IV) infusion of 40 milligrams per kilogram (mg/kg) dose based on individual bodyweight on Day 1 in part 1.	Part 1: GSK3810109A 280 mg IV n=6 Participants Participants with HIV-1 received GSK3810109A as a single IV infusion of 280 mg dose on Day 1 in part 1.	Part 2: GSK3810109A 700 mg IV n=16 Participants Participants with HIV-1 received GSK3810109A as a single IV infusion of 700 mg dose on Day 1 in part 2. This included dose level determined based on the data of part 1.	Part 2: GSK3810109A 70 mg IV n=16 Participants Participants with HIV-1 received GSK3810109A as a single IV infusion of 70 mg dose on Day 1 in part 2. This included dose level determined based on the data of part 1.	Part 2: GSK3810109A 700 mg Subcutaneously (SC) n=16 Participants Participants with HIV-1 received GSK3810109A as a subcutaneous (SC) injection of total 700 mg dose administered as three equally divided SC injections of 2.33 mL each (approximately 7 mL) in quick succession at same time on Day 1 in part 2. This included dose level determined based on the data of part 1.
Number of Participants With Grade 2-4 Injection Site Reactions (ISR) - Monotherapy Phase	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Pre-dose (Day 1), 3 and 24 hours post-dose on day 1, days 3, 6, 9, 11, and 14

Population: Analysis was performed on the Pharmacokinetic (PK) population, which included all participants in the Safety population who had at least 1 non-missing PK assessment (Non-quantifiable \[NQ\] values with the actual dose and PK sampling time will be considered as non-missing values).

Blood samples were collected at indicated time points for pharmacokinetic analysis of GSK3810109A.

Outcome measures

Measure	Part 1:GSK3810109A 40milligram(mg)/Kilogram Intravenously (IV) n=8 Participants Participants with human immunodeficiency viruses-1 (HIV-1) received GSK3810109A as a single intravenous (IV) infusion of 40 milligrams per kilogram (mg/kg) dose based on individual bodyweight on Day 1 in part 1.	Part 1: GSK3810109A 280 mg IV n=6 Participants Participants with HIV-1 received GSK3810109A as a single IV infusion of 280 mg dose on Day 1 in part 1.	Part 2: GSK3810109A 700 mg IV n=14 Participants Participants with HIV-1 received GSK3810109A as a single IV infusion of 700 mg dose on Day 1 in part 2. This included dose level determined based on the data of part 1.	Part 2: GSK3810109A 70 mg IV n=16 Participants Participants with HIV-1 received GSK3810109A as a single IV infusion of 70 mg dose on Day 1 in part 2. This included dose level determined based on the data of part 1.	Part 2: GSK3810109A 700 mg Subcutaneously (SC) n=16 Participants Participants with HIV-1 received GSK3810109A as a subcutaneous (SC) injection of total 700 mg dose administered as three equally divided SC injections of 2.33 mL each (approximately 7 mL) in quick succession at same time on Day 1 in part 2. This included dose level determined based on the data of part 1.
Area Under the Plasma Concentration-time Curve From Time Zero to the Day 14 (AUC [0-14]) of GSK3810109A - Monotherapy Phase	5346.3194 Day *microgram/millilitre (day*ug/mL) Geometric Coefficient of Variation 29.6508	690.8944 Day *microgram/millilitre (day*ug/mL) Geometric Coefficient of Variation 53.2785	1181.1688 Day *microgram/millilitre (day*ug/mL) Geometric Coefficient of Variation 24.4990	212.6213 Day *microgram/millilitre (day*ug/mL) Geometric Coefficient of Variation 79.1478	493.0579 Day *microgram/millilitre (day*ug/mL) Geometric Coefficient of Variation 55.0909

SECONDARY outcome

Timeframe: Pre-dose (Day 1), 3 and 24 hours post-dose on day 1, days 3, 6, 9, 11, and 14

Population: Analysis was performed on the PK population, which included all participants in the Safety population who had at least 1 non-missing PK assessment (NQ values with the actual dose and PK sampling time will be considered as non-missing values).

Cmax is defined as maximum observed concentration of GSK3810109A.

Outcome measures

Measure	Part 1:GSK3810109A 40milligram(mg)/Kilogram Intravenously (IV) n=8 Participants Participants with human immunodeficiency viruses-1 (HIV-1) received GSK3810109A as a single intravenous (IV) infusion of 40 milligrams per kilogram (mg/kg) dose based on individual bodyweight on Day 1 in part 1.	Part 1: GSK3810109A 280 mg IV n=6 Participants Participants with HIV-1 received GSK3810109A as a single IV infusion of 280 mg dose on Day 1 in part 1.	Part 2: GSK3810109A 700 mg IV n=16 Participants Participants with HIV-1 received GSK3810109A as a single IV infusion of 700 mg dose on Day 1 in part 2. This included dose level determined based on the data of part 1.	Part 2: GSK3810109A 70 mg IV n=16 Participants Participants with HIV-1 received GSK3810109A as a single IV infusion of 70 mg dose on Day 1 in part 2. This included dose level determined based on the data of part 1.	Part 2: GSK3810109A 700 mg Subcutaneously (SC) n=16 Participants Participants with HIV-1 received GSK3810109A as a subcutaneous (SC) injection of total 700 mg dose administered as three equally divided SC injections of 2.33 mL each (approximately 7 mL) in quick succession at same time on Day 1 in part 2. This included dose level determined based on the data of part 1.
Maximum Observed Plasma Concentration (Cmax) of GSK3810109A - Monotherapy Phase	1131.5000 Microgram/millilitre (μg/mL) Standard Deviation 329.91168	131.1500 Microgram/millilitre (μg/mL) Standard Deviation 86.65425	243.0625 Microgram/millilitre (μg/mL) Standard Deviation 57.37301	42.7688 Microgram/millilitre (μg/mL) Standard Deviation 54.32691	45.0938 Microgram/millilitre (μg/mL) Standard Deviation 20.48930

SECONDARY outcome

Timeframe: Pre-dose (Day 1), 3 and 24 hours post-dose on day 1, days 3, 6, 9, 11, and 14

Population: Analysis was performed on the PK population, which included all participants in the Safety population who had at least 1 non-missing PK assessment (NQ values with the actual dose and PK sampling time will be considered as non-missing values).

Tmax is defined as time to reach Cmax

Outcome measures

Measure	Part 1:GSK3810109A 40milligram(mg)/Kilogram Intravenously (IV) n=8 Participants Participants with human immunodeficiency viruses-1 (HIV-1) received GSK3810109A as a single intravenous (IV) infusion of 40 milligrams per kilogram (mg/kg) dose based on individual bodyweight on Day 1 in part 1.	Part 1: GSK3810109A 280 mg IV n=6 Participants Participants with HIV-1 received GSK3810109A as a single IV infusion of 280 mg dose on Day 1 in part 1.	Part 2: GSK3810109A 700 mg IV n=16 Participants Participants with HIV-1 received GSK3810109A as a single IV infusion of 700 mg dose on Day 1 in part 2. This included dose level determined based on the data of part 1.	Part 2: GSK3810109A 70 mg IV n=16 Participants Participants with HIV-1 received GSK3810109A as a single IV infusion of 70 mg dose on Day 1 in part 2. This included dose level determined based on the data of part 1.	Part 2: GSK3810109A 700 mg Subcutaneously (SC) n=16 Participants Participants with HIV-1 received GSK3810109A as a subcutaneous (SC) injection of total 700 mg dose administered as three equally divided SC injections of 2.33 mL each (approximately 7 mL) in quick succession at same time on Day 1 in part 2. This included dose level determined based on the data of part 1.
Time to Reach Maximum Observed Plasma Concentration (Tmax) of GSK3810109A - Monotherapy Phase	0.0385 Days Interval 0.024 to 0.125	0.1233 Days Interval 0.026 to 0.149	0.0340 Days Interval 0.021 to 0.128	0.0278 Days Interval 0.003 to 0.994	5.9177 Days Interval 1.884 to 14.966

SECONDARY outcome

Timeframe: At Day 14

Population: Analysis was performed on the PK population, which included all participants in the Safety population who had at least 1 non-missing PK assessment (NQ values with the actual dose and PK sampling time will be considered as non-missing values).

Blood samples were collected at indicated time point for pharmacokinetic analysis of GSK3810109A.

Outcome measures

Measure	Part 1:GSK3810109A 40milligram(mg)/Kilogram Intravenously (IV) n=8 Participants Participants with human immunodeficiency viruses-1 (HIV-1) received GSK3810109A as a single intravenous (IV) infusion of 40 milligrams per kilogram (mg/kg) dose based on individual bodyweight on Day 1 in part 1.	Part 1: GSK3810109A 280 mg IV n=6 Participants Participants with HIV-1 received GSK3810109A as a single IV infusion of 280 mg dose on Day 1 in part 1.	Part 2: GSK3810109A 700 mg IV n=11 Participants Participants with HIV-1 received GSK3810109A as a single IV infusion of 700 mg dose on Day 1 in part 2. This included dose level determined based on the data of part 1.	Part 2: GSK3810109A 70 mg IV n=11 Participants Participants with HIV-1 received GSK3810109A as a single IV infusion of 70 mg dose on Day 1 in part 2. This included dose level determined based on the data of part 1.	Part 2: GSK3810109A 700 mg Subcutaneously (SC) n=15 Participants Participants with HIV-1 received GSK3810109A as a subcutaneous (SC) injection of total 700 mg dose administered as three equally divided SC injections of 2.33 mL each (approximately 7 mL) in quick succession at same time on Day 1 in part 2. This included dose level determined based on the data of part 1.
Plasma Concentration at Day 14 (C14) of GSK3810109A - Monotherapy Phase	221.45 μg/mL Geometric Coefficient of Variation 23.76	27.49 μg/mL Geometric Coefficient of Variation 49.24	55.30 μg/mL Geometric Coefficient of Variation 22.08	7.98 μg/mL Geometric Coefficient of Variation 89.70	29.52 μg/mL Geometric Coefficient of Variation 54.30

SECONDARY outcome

Timeframe: Baseline (Day 1) and up to Day 84 or end of Monotherapy Phase

Population: The analysis was performed on the safety population, which included all participants who received at least one dose of study treatment. Only those participants with data available at the specified time points were analyzed. Only participants in the IV dosing group with data available at the specified time points were analyzed.

Plasma samples were collected for quantitative analysis of HIV-1 RNA. Baseline value was the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from baseline is defined as post-dose visit value minus baseline value. Statistical analysis for relationship between PK parameter (Cmax) and PD measure (change from baseline in logarithm to base 10 (log10) values for plasma HIV-1 RNA) were explored using an Emax non-linear model. The model parameters estimated included: maximum response (Emax), PK parameter value that attains 50 percent (%) of the maximal effect (EC50) and residual variability (s2e). End of Monotherapy Phase is defined as the timepoint when a participant had reached the monotherapy endpoint criteria or a maximum of 84 days follow-up, whichever occurred first.

Outcome measures

Measure	Part 1:GSK3810109A 40milligram(mg)/Kilogram Intravenously (IV) n=8 Participants Participants with human immunodeficiency viruses-1 (HIV-1) received GSK3810109A as a single intravenous (IV) infusion of 40 milligrams per kilogram (mg/kg) dose based on individual bodyweight on Day 1 in part 1.	Part 1: GSK3810109A 280 mg IV n=6 Participants Participants with HIV-1 received GSK3810109A as a single IV infusion of 280 mg dose on Day 1 in part 1.	Part 2: GSK3810109A 700 mg IV n=16 Participants Participants with HIV-1 received GSK3810109A as a single IV infusion of 700 mg dose on Day 1 in part 2. This included dose level determined based on the data of part 1.	Part 2: GSK3810109A 70 mg IV n=16 Participants Participants with HIV-1 received GSK3810109A as a single IV infusion of 70 mg dose on Day 1 in part 2. This included dose level determined based on the data of part 1.	Part 2: GSK3810109A 700 mg Subcutaneously (SC) Participants with HIV-1 received GSK3810109A as a subcutaneous (SC) injection of total 700 mg dose administered as three equally divided SC injections of 2.33 mL each (approximately 7 mL) in quick succession at same time on Day 1 in part 2. This included dose level determined based on the data of part 1.
Change From Baseline in Log10 Plasma HIV-1 RNA Relative to Cmax - Monotherapy Phase Baseline (Day 1)	4.139 Log10 copies per milliliter (copies/mL) Standard Deviation 0.6433	4.493 Log10 copies per milliliter (copies/mL) Standard Deviation 0.4800	4.465 Log10 copies per milliliter (copies/mL) Standard Deviation 0.3594	4.582 Log10 copies per milliliter (copies/mL) Standard Deviation 0.6144	—
Change From Baseline in Log10 Plasma HIV-1 RNA Relative to Cmax - Monotherapy Phase Change from baseline (up to Day 84 or end of Monotherapy Phase)	0.091 Log10 copies per milliliter (copies/mL) Standard Deviation 0.2359	-0.357 Log10 copies per milliliter (copies/mL) Standard Deviation 0.4191	-0.110 Log10 copies per milliliter (copies/mL) Standard Deviation 0.1940	-0.179 Log10 copies per milliliter (copies/mL) Standard Deviation 0.4319	—

SECONDARY outcome

Timeframe: From Day 1 (Baseline) and up to Day 84 or end of Monotherapy Phase

Population: The analysis was performed on the safety population, which included all participants who received at least one dose of study treatment. Only those participants with data available at the specified time points were analyzed.

Blood samples were collected as prespecified. CD4+ and CD8+ T cell counts were assessed using flow cytometry. End of Monotherapy Phase is defined as the timepoint when a participant had reached the monotherapy endpoint criteria or a maximum of 84 days follow-up, whichever occurred first.

Outcome measures

Measure	Part 1:GSK3810109A 40milligram(mg)/Kilogram Intravenously (IV) n=8 Participants Participants with human immunodeficiency viruses-1 (HIV-1) received GSK3810109A as a single intravenous (IV) infusion of 40 milligrams per kilogram (mg/kg) dose based on individual bodyweight on Day 1 in part 1.	Part 1: GSK3810109A 280 mg IV n=6 Participants Participants with HIV-1 received GSK3810109A as a single IV infusion of 280 mg dose on Day 1 in part 1.	Part 2: GSK3810109A 700 mg IV n=16 Participants Participants with HIV-1 received GSK3810109A as a single IV infusion of 700 mg dose on Day 1 in part 2. This included dose level determined based on the data of part 1.	Part 2: GSK3810109A 70 mg IV n=16 Participants Participants with HIV-1 received GSK3810109A as a single IV infusion of 70 mg dose on Day 1 in part 2. This included dose level determined based on the data of part 1.	Part 2: GSK3810109A 700 mg Subcutaneously (SC) n=16 Participants Participants with HIV-1 received GSK3810109A as a subcutaneous (SC) injection of total 700 mg dose administered as three equally divided SC injections of 2.33 mL each (approximately 7 mL) in quick succession at same time on Day 1 in part 2. This included dose level determined based on the data of part 1.
Absolute Values of Cluster of Differentiation 4 Plus (CD4+) and CD8+ T Cell Counts - Monotherapy Phase CD4+, Baseline (Day 1 (Monotherapy Phase)	360.5 Cells per cubic milimeter Standard Deviation 166.54	412.8 Cells per cubic milimeter Standard Deviation 120.85	427.3 Cells per cubic milimeter Standard Deviation 187.22	467.3 Cells per cubic milimeter Standard Deviation 194.45	476.7 Cells per cubic milimeter Standard Deviation 180.28
Absolute Values of Cluster of Differentiation 4 Plus (CD4+) and CD8+ T Cell Counts - Monotherapy Phase CD4+, Day 84/end of Monotherapy Phase	392.3 Cells per cubic milimeter Standard Deviation 196.16	443.0 Cells per cubic milimeter Standard Deviation 155.17	424.0 Cells per cubic milimeter Standard Deviation 171.33	412.9 Cells per cubic milimeter Standard Deviation 98.50	462.4 Cells per cubic milimeter Standard Deviation 276.72
Absolute Values of Cluster of Differentiation 4 Plus (CD4+) and CD8+ T Cell Counts - Monotherapy Phase CD8+, Baseline (Day 1 (Monotherapy Phase)	852.0 Cells per cubic milimeter Standard Deviation 441.83	884.5 Cells per cubic milimeter Standard Deviation 389.42	781.8 Cells per cubic milimeter Standard Deviation 303.75	1161.3 Cells per cubic milimeter Standard Deviation 697.24	898.0 Cells per cubic milimeter Standard Deviation 348.48
Absolute Values of Cluster of Differentiation 4 Plus (CD4+) and CD8+ T Cell Counts - Monotherapy Phase CD8+, Day 84/End of Monotherapy Phase	837.9 Cells per cubic milimeter Standard Deviation 482.68	869.8 Cells per cubic milimeter Standard Deviation 376.86	744.0 Cells per cubic milimeter Standard Deviation 267.73	993.1 Cells per cubic milimeter Standard Deviation 394.84	765.9 Cells per cubic milimeter Standard Deviation 296.18

SECONDARY outcome

Timeframe: Up to Week 48 (SOC Phase)

Population: The analysis was performed on the safety population, which included all participants who received at least one dose of study treatment. Only those participants with data available at the specified time points were analyzed.

Blood samples were collected as prespecified. CD4+ and CD8+ T cell counts were assessed using flow cytometry.

Outcome measures

Measure	Part 1:GSK3810109A 40milligram(mg)/Kilogram Intravenously (IV) n=8 Participants Participants with human immunodeficiency viruses-1 (HIV-1) received GSK3810109A as a single intravenous (IV) infusion of 40 milligrams per kilogram (mg/kg) dose based on individual bodyweight on Day 1 in part 1.	Part 1: GSK3810109A 280 mg IV n=6 Participants Participants with HIV-1 received GSK3810109A as a single IV infusion of 280 mg dose on Day 1 in part 1.	Part 2: GSK3810109A 700 mg IV n=16 Participants Participants with HIV-1 received GSK3810109A as a single IV infusion of 700 mg dose on Day 1 in part 2. This included dose level determined based on the data of part 1.	Part 2: GSK3810109A 70 mg IV n=16 Participants Participants with HIV-1 received GSK3810109A as a single IV infusion of 70 mg dose on Day 1 in part 2. This included dose level determined based on the data of part 1.	Part 2: GSK3810109A 700 mg Subcutaneously (SC) n=16 Participants Participants with HIV-1 received GSK3810109A as a subcutaneous (SC) injection of total 700 mg dose administered as three equally divided SC injections of 2.33 mL each (approximately 7 mL) in quick succession at same time on Day 1 in part 2. This included dose level determined based on the data of part 1.
Absolute Values of CD4+ and CD8+ T Cell Counts - SOC Phase CD8+, Week 48 (SOC Phase)	685.9 Cells per cubic milimeter Standard Deviation 308.89	738.4 Cells per cubic milimeter Standard Deviation 213.22	684.9 Cells per cubic milimeter Standard Deviation 286.60	856.0 Cells per cubic milimeter Standard Deviation 325.04	816.6 Cells per cubic milimeter Standard Deviation 364.40
Absolute Values of CD4+ and CD8+ T Cell Counts - SOC Phase CD4+, Week 48 (SOC Phase)	500.5 Cells per cubic milimeter Standard Deviation 211.17	601.0 Cells per cubic milimeter Standard Deviation 44.74	580.9 Cells per cubic milimeter Standard Deviation 165.29	671.3 Cells per cubic milimeter Standard Deviation 180.25	723.9 Cells per cubic milimeter Standard Deviation 300.24

SECONDARY outcome

Timeframe: Up to Day 84 or end of Monotherapy Phase (compared with baseline [Day 1])

Population: The analysis was performed on the safety population, which included all participants who received at least one dose of study treatment. Only those participants with data available at the specified time points were analyzed.

Blood samples were collected as prespecified. CD4+ and CD8+ T cell counts were assessed using flow cytometry. End of Monotherapy Phase is defined as the timepoint when a participant had reached the monotherapy endpoint criteria or a maximum of 84 days follow-up, whichever occurred first.

Outcome measures

Measure	Part 1:GSK3810109A 40milligram(mg)/Kilogram Intravenously (IV) n=8 Participants Participants with human immunodeficiency viruses-1 (HIV-1) received GSK3810109A as a single intravenous (IV) infusion of 40 milligrams per kilogram (mg/kg) dose based on individual bodyweight on Day 1 in part 1.	Part 1: GSK3810109A 280 mg IV n=6 Participants Participants with HIV-1 received GSK3810109A as a single IV infusion of 280 mg dose on Day 1 in part 1.	Part 2: GSK3810109A 700 mg IV n=16 Participants Participants with HIV-1 received GSK3810109A as a single IV infusion of 700 mg dose on Day 1 in part 2. This included dose level determined based on the data of part 1.	Part 2: GSK3810109A 70 mg IV n=16 Participants Participants with HIV-1 received GSK3810109A as a single IV infusion of 70 mg dose on Day 1 in part 2. This included dose level determined based on the data of part 1.	Part 2: GSK3810109A 700 mg Subcutaneously (SC) n=16 Participants Participants with HIV-1 received GSK3810109A as a subcutaneous (SC) injection of total 700 mg dose administered as three equally divided SC injections of 2.33 mL each (approximately 7 mL) in quick succession at same time on Day 1 in part 2. This included dose level determined based on the data of part 1.
Change From Baseline in CD4+ and CD8+ T Cell Counts - Monotherapy Phase CD4+, Baseline (Day 1 (Monotherapy Phase)	360.5 Cells per cubic milimeter Standard Deviation 166.54	412.8 Cells per cubic milimeter Standard Deviation 120.85	427.3 Cells per cubic milimeter Standard Deviation 187.22	467.3 Cells per cubic milimeter Standard Deviation 194.45	476.7 Cells per cubic milimeter Standard Deviation 180.28
Change From Baseline in CD4+ and CD8+ T Cell Counts - Monotherapy Phase CD4+, Day 84/end of Monotherapy Phase (compared with baseline)	31.8 Cells per cubic milimeter Standard Deviation 48.27	30.2 Cells per cubic milimeter Standard Deviation 79.83	-3.3 Cells per cubic milimeter Standard Deviation 125.78	-54.3 Cells per cubic milimeter Standard Deviation 121.18	-19.6 Cells per cubic milimeter Standard Deviation 166.64
Change From Baseline in CD4+ and CD8+ T Cell Counts - Monotherapy Phase CD8+, Baseline (Day 1 (Monotherapy Phase)	852.0 Cells per cubic milimeter Standard Deviation 441.83	884.5 Cells per cubic milimeter Standard Deviation 389.42	781.8 Cells per cubic milimeter Standard Deviation 303.75	1161.3 Cells per cubic milimeter Standard Deviation 697.24	898.0 Cells per cubic milimeter Standard Deviation 348.48
Change From Baseline in CD4+ and CD8+ T Cell Counts - Monotherapy Phase CD8+, Day 84/end of Monotherapy Phase (compared with baseline)	-14.1 Cells per cubic milimeter Standard Deviation 213.24	-14.7 Cells per cubic milimeter Standard Deviation 281.75	-37.8 Cells per cubic milimeter Standard Deviation 206.05	-168.2 Cells per cubic milimeter Standard Deviation 401.82	-105.7 Cells per cubic milimeter Standard Deviation 246.85

SECONDARY outcome

Timeframe: Up to Week 48 (SOC Phase)

Population: The analysis was performed on the safety population, which included all participants who received at least one dose of study treatment. Only those participants with data available at the specified time points were analyzed.

Blood samples were collected as prespecified. CD4+ and CD8+ T cell counts were assessed using flow cytometry.

Outcome measures

Measure	Part 1:GSK3810109A 40milligram(mg)/Kilogram Intravenously (IV) n=8 Participants Participants with human immunodeficiency viruses-1 (HIV-1) received GSK3810109A as a single intravenous (IV) infusion of 40 milligrams per kilogram (mg/kg) dose based on individual bodyweight on Day 1 in part 1.	Part 1: GSK3810109A 280 mg IV n=6 Participants Participants with HIV-1 received GSK3810109A as a single IV infusion of 280 mg dose on Day 1 in part 1.	Part 2: GSK3810109A 700 mg IV n=16 Participants Participants with HIV-1 received GSK3810109A as a single IV infusion of 700 mg dose on Day 1 in part 2. This included dose level determined based on the data of part 1.	Part 2: GSK3810109A 70 mg IV n=16 Participants Participants with HIV-1 received GSK3810109A as a single IV infusion of 70 mg dose on Day 1 in part 2. This included dose level determined based on the data of part 1.	Part 2: GSK3810109A 700 mg Subcutaneously (SC) n=16 Participants Participants with HIV-1 received GSK3810109A as a subcutaneous (SC) injection of total 700 mg dose administered as three equally divided SC injections of 2.33 mL each (approximately 7 mL) in quick succession at same time on Day 1 in part 2. This included dose level determined based on the data of part 1.
Change From Baseline in CD4+ and CD8+ T Cell Counts - SOC Phase CD4+, Baseline (Day 1 (Monotherapy Phase)	360.5 Cells per cubic milimeter Standard Deviation 166.54	412.8 Cells per cubic milimeter Standard Deviation 120.85	427.3 Cells per cubic milimeter Standard Deviation 187.22	467.3 Cells per cubic milimeter Standard Deviation 194.45	476.7 Cells per cubic milimeter Standard Deviation 180.28
Change From Baseline in CD4+ and CD8+ T Cell Counts - SOC Phase CD4+, Week 48 of SOC Phase (compared with baseline)	140.0 Cells per cubic milimeter Standard Deviation 91.08	180.4 Cells per cubic milimeter Standard Deviation 114.37	134.9 Cells per cubic milimeter Standard Deviation 205.13	233.8 Cells per cubic milimeter Standard Deviation 174.02	247.3 Cells per cubic milimeter Standard Deviation 230.95
Change From Baseline in CD4+ and CD8+ T Cell Counts - SOC Phase CD8+, Baseline (Day 1 (Monotherapy Phase)	852.0 Cells per cubic milimeter Standard Deviation 441.83	884.5 Cells per cubic milimeter Standard Deviation 389.42	781.8 Cells per cubic milimeter Standard Deviation 303.75	1161.3 Cells per cubic milimeter Standard Deviation 697.24	898.0 Cells per cubic milimeter Standard Deviation 348.48
Change From Baseline in CD4+ and CD8+ T Cell Counts - SOC Phase CD8+, Week 48 of SOC Phase (compared with baseline)	-166.1 Cells per cubic milimeter Standard Deviation 274.92	-159.4 Cells per cubic milimeter Standard Deviation 275.37	-119.7 Cells per cubic milimeter Standard Deviation 198.49	-217.5 Cells per cubic milimeter Standard Deviation 490.10	-81.4 Cells per cubic milimeter Standard Deviation 230.95

SECONDARY outcome

Timeframe: At Day 1 and Day 84 or end of Monotherapy Phase

Population: The analysis was performed on the safety population, which included all participants who received at least one dose of study treatment. Only those participants with data available at the specified time points were analyzed.

Serum samples were collected to analyze the presence of ADAs against GSK3810109A using validated immunoassays. End of Monotherapy Phase is defined as the timepoint when a participant had reached the monotherapy endpoint criteria or a maximum of 84 days follow-up, whichever occurred first.

Outcome measures

Measure	Part 1:GSK3810109A 40milligram(mg)/Kilogram Intravenously (IV) n=8 Participants Participants with human immunodeficiency viruses-1 (HIV-1) received GSK3810109A as a single intravenous (IV) infusion of 40 milligrams per kilogram (mg/kg) dose based on individual bodyweight on Day 1 in part 1.	Part 1: GSK3810109A 280 mg IV n=6 Participants Participants with HIV-1 received GSK3810109A as a single IV infusion of 280 mg dose on Day 1 in part 1.	Part 2: GSK3810109A 700 mg IV n=16 Participants Participants with HIV-1 received GSK3810109A as a single IV infusion of 700 mg dose on Day 1 in part 2. This included dose level determined based on the data of part 1.	Part 2: GSK3810109A 70 mg IV n=16 Participants Participants with HIV-1 received GSK3810109A as a single IV infusion of 70 mg dose on Day 1 in part 2. This included dose level determined based on the data of part 1.	Part 2: GSK3810109A 700 mg Subcutaneously (SC) n=16 Participants Participants with HIV-1 received GSK3810109A as a subcutaneous (SC) injection of total 700 mg dose administered as three equally divided SC injections of 2.33 mL each (approximately 7 mL) in quick succession at same time on Day 1 in part 2. This included dose level determined based on the data of part 1.
Number of Participants With Positive Anti-drug Antibodies (ADAs) Against GSK3810109A - Monotherapy Phase Baseline (Day 1)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Positive Anti-drug Antibodies (ADAs) Against GSK3810109A - Monotherapy Phase Day 84/End of Monotherapy Phase	1 Participants	2 Participants	0 Participants	3 Participants	0 Participants

SECONDARY outcome

Timeframe: At Week 48 (SOC Phase)

Population: The analysis was performed on the safety population, which included all participants who received at least one dose of study treatment. Only those participants with data available at the specified time points were analyzed.

Serum samples were collected to analyze the presence of ADAs against GSK3810109A using validated immunoassays.

Outcome measures

Measure	Part 1:GSK3810109A 40milligram(mg)/Kilogram Intravenously (IV) n=8 Participants Participants with human immunodeficiency viruses-1 (HIV-1) received GSK3810109A as a single intravenous (IV) infusion of 40 milligrams per kilogram (mg/kg) dose based on individual bodyweight on Day 1 in part 1.	Part 1: GSK3810109A 280 mg IV n=5 Participants Participants with HIV-1 received GSK3810109A as a single IV infusion of 280 mg dose on Day 1 in part 1.	Part 2: GSK3810109A 700 mg IV n=14 Participants Participants with HIV-1 received GSK3810109A as a single IV infusion of 700 mg dose on Day 1 in part 2. This included dose level determined based on the data of part 1.	Part 2: GSK3810109A 70 mg IV n=16 Participants Participants with HIV-1 received GSK3810109A as a single IV infusion of 70 mg dose on Day 1 in part 2. This included dose level determined based on the data of part 1.	Part 2: GSK3810109A 700 mg Subcutaneously (SC) n=16 Participants Participants with HIV-1 received GSK3810109A as a subcutaneous (SC) injection of total 700 mg dose administered as three equally divided SC injections of 2.33 mL each (approximately 7 mL) in quick succession at same time on Day 1 in part 2. This included dose level determined based on the data of part 1.
Number of Participants With Positive ADAs Against GSK3810109A - SOC Phase	0 Participants	0 Participants	1 Participants	2 Participants	0 Participants

SECONDARY outcome

Timeframe: At Day 84 or end of Monotherapy Phase

Population: The analysis was performed on the safety population, which included all participants who received at least one dose of study treatment. Only those participants with data available at the specified time points were analyzed.

Serum samples were collected to analyze the presence of ADAs against GSK3810109A using validated immunoassays. End of Monotherapy Phase is defined as the timepoint when a participant had reached the monotherapy endpoint criteria or a maximum of 84 days follow-up, whichever occurred first.

Outcome measures

Measure	Part 1:GSK3810109A 40milligram(mg)/Kilogram Intravenously (IV) n=1 Participants Participants with human immunodeficiency viruses-1 (HIV-1) received GSK3810109A as a single intravenous (IV) infusion of 40 milligrams per kilogram (mg/kg) dose based on individual bodyweight on Day 1 in part 1.	Part 1: GSK3810109A 280 mg IV n=2 Participants Participants with HIV-1 received GSK3810109A as a single IV infusion of 280 mg dose on Day 1 in part 1.	Part 2: GSK3810109A 700 mg IV Participants with HIV-1 received GSK3810109A as a single IV infusion of 700 mg dose on Day 1 in part 2. This included dose level determined based on the data of part 1.	Part 2: GSK3810109A 70 mg IV n=3 Participants Participants with HIV-1 received GSK3810109A as a single IV infusion of 70 mg dose on Day 1 in part 2. This included dose level determined based on the data of part 1.	Part 2: GSK3810109A 700 mg Subcutaneously (SC) Participants with HIV-1 received GSK3810109A as a subcutaneous (SC) injection of total 700 mg dose administered as three equally divided SC injections of 2.33 mL each (approximately 7 mL) in quick succession at same time on Day 1 in part 2. This included dose level determined based on the data of part 1.
Titers of Positive ADAs Against GSK3810109A - Monotherapy Phase	40 Titers Interval 40.0 to 40.0	60 Titers Interval 40.0 to 80.0	—	80 Titers Interval 40.0 to 640.0	—

SECONDARY outcome

Timeframe: At Week 48 (SOC Phase)

Population: The analysis was performed on the safety population, which included all participants who received at least one dose of study treatment. Only those participants with data available at the specified time points were analyzed.

Serum samples were collected to analyze the presence of ADAs against GSK3810109A using validated immunoassays.

Outcome measures

Measure	Part 1:GSK3810109A 40milligram(mg)/Kilogram Intravenously (IV) Participants with human immunodeficiency viruses-1 (HIV-1) received GSK3810109A as a single intravenous (IV) infusion of 40 milligrams per kilogram (mg/kg) dose based on individual bodyweight on Day 1 in part 1.	Part 1: GSK3810109A 280 mg IV Participants with HIV-1 received GSK3810109A as a single IV infusion of 280 mg dose on Day 1 in part 1.	Part 2: GSK3810109A 700 mg IV n=1 Participants Participants with HIV-1 received GSK3810109A as a single IV infusion of 700 mg dose on Day 1 in part 2. This included dose level determined based on the data of part 1.	Part 2: GSK3810109A 70 mg IV n=2 Participants Participants with HIV-1 received GSK3810109A as a single IV infusion of 70 mg dose on Day 1 in part 2. This included dose level determined based on the data of part 1.	Part 2: GSK3810109A 700 mg Subcutaneously (SC) Participants with HIV-1 received GSK3810109A as a subcutaneous (SC) injection of total 700 mg dose administered as three equally divided SC injections of 2.33 mL each (approximately 7 mL) in quick succession at same time on Day 1 in part 2. This included dose level determined based on the data of part 1.
Titers of Positive ADAs Against GSK3810109A - SOC Phase	—	—	40 Titers Interval 40.0 to 40.0	160 Titers Interval 160.0 to 160.0	—

Adverse Events

Part 1:GSK3810109A 40milligram(mg)/Kilogram Intravenously (IV)

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Part 1: GSK3810109A 280 mg IV

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Part 2: GSK3810109A 700 mg IV

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Part 2: GSK3810109A 70 mg IV

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Part 2: GSK3810109A 700 mg Subcutaneously (SC)

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

SOC - GSK3810109A 40mg/kg IV

Serious events: 1 serious events

Other events: 8 other events

Deaths: 0 deaths

SOC - GSK3810109A 280 mg IV

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

SOC - GSK3810109A 700 mg IV

Serious events: 3 serious events

Other events: 12 other events

Deaths: 0 deaths

SOC - GSK3810109A 70 mg IV

Serious events: 2 serious events

Other events: 13 other events

Deaths: 0 deaths

SOC - GSK3810109A 700 mg SC

Serious events: 4 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Measure	Part 1:GSK3810109A 40milligram(mg)/Kilogram Intravenously (IV) n=8 participants at risk Participants with human immunodeficiency viruses-1 (HIV-1) received GSK3810109A as a single intravenous (IV) infusion of 40 milligrams per kilogram (mg/kg) dose based on individual bodyweight on Day 1 in part 1.	Part 1: GSK3810109A 280 mg IV n=6 participants at risk Participants with HIV-1 received GSK3810109A as a single IV infusion of 280 mg dose on Day 1 in part 1.	Part 2: GSK3810109A 700 mg IV n=16 participants at risk Participants with HIV-1 received GSK3810109A as a single IV infusion of 700 mg dose on Day 1 in part 2. This included dose level determined based on the data of part 1.	Part 2: GSK3810109A 70 mg IV n=16 participants at risk Participants with HIV-1 received GSK3810109A as a single IV infusion of 70 mg dose on Day 1 in part 2. This included dose level determined based on the data of part 1.	Part 2: GSK3810109A 700 mg Subcutaneously (SC) n=16 participants at risk Participants with HIV-1 received GSK3810109A as a subcutaneous (SC) injection of total 700 mg dose administered as three equally divided SC injections of 2.33 mL each (approximately 7 mL) in quick succession at same time on Day 1 in part 2. This included dose level determined based on the data of part 1.	SOC - GSK3810109A 40mg/kg IV n=8 participants at risk Participants who completed the monotherapy phase of treatment of GSK3810109A 40mg/kg IV entered SOC phase to receive dolutegravir + lamivudine regimen as a SOC treatment on SOC Day 1 if deemed appropriate by the investigator and consistent with local guidelines.	SOC - GSK3810109A 280 mg IV n=6 participants at risk Participants who completed the monotherapy phase of treatment of GSK3810109A 280 mg IV entered SOC phase to receive dolutegravir + lamivudine regimen as a SOC treatment on SOC Day 1 if deemed appropriate by the investigator and consistent with local guidelines.	SOC - GSK3810109A 700 mg IV n=16 participants at risk Participants who completed the monotherapy phase of treatment of GSK3810109A 700 mg IV entered SOC phase to receive dolutegravir + lamivudine regimen as a SOC treatment on SOC Day 1 if deemed appropriate by the investigator and consistent with local guidelines.	SOC - GSK3810109A 70 mg IV n=16 participants at risk Participants who completed the monotherapy phase of treatment of GSK3810109A 70 mg IV entered SOC phase to receive dolutegravir + lamivudine regimen as a SOC treatment on SOC Day 1 if deemed appropriate by the investigator and consistent with local guidelines.	SOC - GSK3810109A 700 mg SC n=16 participants at risk Participants who completed the monotherapy phase of treatment of GSK3810109A 700 mg SC entered SOC phase to receive dolutegravir + lamivudine regimen as a SOC treatment on SOC Day 1 if deemed appropriate by the investigator and consistent with local guidelines.
Psychiatric disorders Suicide attempt	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	12.5% 1/8 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
Infections and infestations Appendicitis	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
Infections and infestations Scrotal abscess	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
Injury, poisoning and procedural complications Craniocerebral injury	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
Injury, poisoning and procedural complications Radius fracture	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
Injury, poisoning and procedural complications Wrist fracture	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
Blood and lymphatic system disorders Anaemia	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 4 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
Gastrointestinal disorders Inguinal hernia	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
Investigations Human rhinovirus test positive	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
Metabolism and nutrition disorders Dehydration	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.

Other adverse events

Measure	Part 1:GSK3810109A 40milligram(mg)/Kilogram Intravenously (IV) n=8 participants at risk Participants with human immunodeficiency viruses-1 (HIV-1) received GSK3810109A as a single intravenous (IV) infusion of 40 milligrams per kilogram (mg/kg) dose based on individual bodyweight on Day 1 in part 1.	Part 1: GSK3810109A 280 mg IV n=6 participants at risk Participants with HIV-1 received GSK3810109A as a single IV infusion of 280 mg dose on Day 1 in part 1.	Part 2: GSK3810109A 700 mg IV n=16 participants at risk Participants with HIV-1 received GSK3810109A as a single IV infusion of 700 mg dose on Day 1 in part 2. This included dose level determined based on the data of part 1.	Part 2: GSK3810109A 70 mg IV n=16 participants at risk Participants with HIV-1 received GSK3810109A as a single IV infusion of 70 mg dose on Day 1 in part 2. This included dose level determined based on the data of part 1.	Part 2: GSK3810109A 700 mg Subcutaneously (SC) n=16 participants at risk Participants with HIV-1 received GSK3810109A as a subcutaneous (SC) injection of total 700 mg dose administered as three equally divided SC injections of 2.33 mL each (approximately 7 mL) in quick succession at same time on Day 1 in part 2. This included dose level determined based on the data of part 1.	SOC - GSK3810109A 40mg/kg IV n=8 participants at risk Participants who completed the monotherapy phase of treatment of GSK3810109A 40mg/kg IV entered SOC phase to receive dolutegravir + lamivudine regimen as a SOC treatment on SOC Day 1 if deemed appropriate by the investigator and consistent with local guidelines.	SOC - GSK3810109A 280 mg IV n=6 participants at risk Participants who completed the monotherapy phase of treatment of GSK3810109A 280 mg IV entered SOC phase to receive dolutegravir + lamivudine regimen as a SOC treatment on SOC Day 1 if deemed appropriate by the investigator and consistent with local guidelines.	SOC - GSK3810109A 700 mg IV n=16 participants at risk Participants who completed the monotherapy phase of treatment of GSK3810109A 700 mg IV entered SOC phase to receive dolutegravir + lamivudine regimen as a SOC treatment on SOC Day 1 if deemed appropriate by the investigator and consistent with local guidelines.	SOC - GSK3810109A 70 mg IV n=16 participants at risk Participants who completed the monotherapy phase of treatment of GSK3810109A 70 mg IV entered SOC phase to receive dolutegravir + lamivudine regimen as a SOC treatment on SOC Day 1 if deemed appropriate by the investigator and consistent with local guidelines.	SOC - GSK3810109A 700 mg SC n=16 participants at risk Participants who completed the monotherapy phase of treatment of GSK3810109A 700 mg SC entered SOC phase to receive dolutegravir + lamivudine regimen as a SOC treatment on SOC Day 1 if deemed appropriate by the investigator and consistent with local guidelines.
Metabolism and nutrition disorders Hypertriglyceridaemia	12.5% 1/8 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
Metabolism and nutrition disorders Vitamin D deficiency	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	12.5% 1/8 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	12.5% 1/8 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
Injury, poisoning and procedural complications Ankle fracture	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	12.5% 1/8 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
Injury, poisoning and procedural complications Foot fracture	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	12.5% 1/8 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
Investigations Lipase increased	12.5% 1/8 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	12.5% 1/8 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
Injury, poisoning and procedural complications Lower limb fracture	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	12.5% 1/8 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
Injury, poisoning and procedural complications Skin laceration	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	12.5% 1/8 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
Investigations Alanine aminotransferase increased	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
Blood and lymphatic system disorders Leukopenia	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
Investigations Aspartate aminotransferase increased	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 3 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
Blood and lymphatic system disorders Neutropenia	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	12.5% 2/16 • Number of events 2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	12.5% 2/16 • Number of events 2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
Gastrointestinal disorders Abdominal distension	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
Gastrointestinal disorders Abdominal pain	12.5% 1/8 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	12.5% 1/8 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
Gastrointestinal disorders Diarrhoea	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
Gastrointestinal disorders Dyspepsia	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
Gastrointestinal disorders Hyperaesthesia teeth	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
Gastrointestinal disorders Gastrointestinal pain	12.5% 1/8 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
Investigations Blood creatine phosphokinase increased	12.5% 1/8 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	12.5% 2/16 • Number of events 2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
Gastrointestinal disorders Inguinal hernia	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
Gastrointestinal disorders Nausea	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
Gastrointestinal disorders Tooth impacted	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	12.5% 1/8 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
Investigations Creatinine renal clearance decreased	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
Gastrointestinal disorders Toothache	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
Gastrointestinal disorders Vomiting	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	12.5% 2/16 • Number of events 2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
General disorders Application site pain	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
General disorders Asthenia	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
General disorders Chills	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	12.5% 1/8 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
General disorders Fatigue	12.5% 1/8 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
General disorders Influenza like illness	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
General disorders Infusion site bruising	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
General disorders Infusion site erythema	12.5% 1/8 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
General disorders Infusion site pain	12.5% 1/8 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
General disorders Injection site bruising	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
General disorders Injection site discolouration	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
General disorders Injection site pain	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
General disorders Injection site pruritus	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
General disorders Vessel puncture site bruise	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
Infections and infestations Anal abscess	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
Infections and infestations Anorectal human papilloma virus infection	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
Infections and infestations Bronchitis	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
Infections and infestations COVID-19	12.5% 1/8 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	12.5% 2/16 • Number of events 2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	25.0% 2/8 • Number of events 2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
Infections and infestations Chlamydial infection	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
Infections and infestations Conjunctivitis	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
Infections and infestations Gastroenteritis	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
Infections and infestations Herpes simplex	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	12.5% 1/8 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
Infections and infestations Hordeolum	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
Infections and infestations Influenza	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	12.5% 2/16 • Number of events 2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
Infections and infestations Monkeypox	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
Infections and infestations Nasopharyngitis	12.5% 1/8 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
Infections and infestations Oropharyngeal gonococcal infection	12.5% 1/8 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
Infections and infestations Pharyngitis	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	12.5% 2/16 • Number of events 2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
Infections and infestations Proctitis gonococcal	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	25.0% 2/8 • Number of events 2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
Infections and infestations Rhinitis	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	12.5% 2/16 • Number of events 2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
Infections and infestations Sinusitis	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
Infections and infestations Syphilis	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	25.0% 2/8 • Number of events 2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
Infections and infestations Tonsillitis	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	12.5% 2/16 • Number of events 2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
Infections and infestations Upper respiratory tract infection	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	12.5% 1/8 • Number of events 2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	18.8% 3/16 • Number of events 3 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	12.5% 2/16 • Number of events 2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	12.5% 2/16 • Number of events 2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
Infections and infestations Viral sinusitis	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders Pain in extremity	12.5% 1/8 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders Plantar fascial fibromatosis	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	12.5% 1/8 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders Plantar fasciitis	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	12.5% 1/8 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin papilloma	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
Nervous system disorders Dizziness	12.5% 1/8 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
Nervous system disorders Headache	12.5% 1/8 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	18.8% 3/16 • Number of events 4 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	12.5% 1/8 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
Nervous system disorders Migraine	12.5% 1/8 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	12.5% 1/8 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
Nervous system disorders Paraesthesia	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
Nervous system disorders Somnolence	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
Psychiatric disorders Attention deficit hyperactivity disorder	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	12.5% 1/8 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
Psychiatric disorders Bipolar disorder	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	12.5% 1/8 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
Psychiatric disorders Depression	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
Psychiatric disorders Hallucination, auditory	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	12.5% 1/8 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
Psychiatric disorders Insomnia	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	12.5% 1/8 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
Psychiatric disorders Nightmare	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
Psychiatric disorders Panic attack	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	12.5% 1/8 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
Psychiatric disorders Sleep disorder	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
Renal and urinary disorders Dysuria	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
Renal and urinary disorders Pollakiuria	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
Renal and urinary disorders Urine abnormality	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
Reproductive system and breast disorders Cervical dysplasia	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	12.5% 1/8 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
Reproductive system and breast disorders Prostatitis	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	12.5% 1/8 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	12.5% 1/8 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Tonsillar hypertrophy	12.5% 1/8 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Upper-airway cough syndrome	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	12.5% 1/8 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
Skin and subcutaneous tissue disorders Dermatitis allergic	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
Skin and subcutaneous tissue disorders Ecchymosis	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
Skin and subcutaneous tissue disorders Eczema	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
Skin and subcutaneous tissue disorders Pruritus	12.5% 1/8 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
Skin and subcutaneous tissue disorders Skin lesion	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
Vascular disorders Hot flush	12.5% 1/8 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
Vascular disorders Hypertension	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	12.5% 1/8 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
Blood and lymphatic system disorders Anaemia	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	12.5% 2/16 • Number of events 2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
Infections and infestations Oral herpes	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
Infections and infestations Cellulitis	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
Infections and infestations Dengue fever	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
Infections and infestations Helminthic infection	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
Infections and infestations Papilloma viral infection	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
Infections and infestations Pneumonia	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
Infections and infestations Scrotal abscess	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
Infections and infestations Secondary syphilis	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
Infections and infestations Sepsis	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
Infections and infestations Urethritis gonococcal	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
Infections and infestations Viral infection	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
Infections and infestations Vulvovaginitis	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
Gastrointestinal disorders Anal haemorrhage	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
Gastrointestinal disorders Food poisoning	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
Gastrointestinal disorders Gastritis	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
Gastrointestinal disorders Haemorrhoids	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 2 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
Gastrointestinal disorders Proctalgia	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
Gastrointestinal disorders Proctitis	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
General disorders Peripheral swelling	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
General disorders Pyrexia	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
Psychiatric disorders Affect lability	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
Psychiatric disorders Anxiety	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
Psychiatric disorders Anxiety disorder	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
Skin and subcutaneous tissue disorders Psoriasis	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders Bone swelling	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
Musculoskeletal and connective tissue disorders Myokymia	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
Injury, poisoning and procedural complications Chemical burn of gastrointestinal tract	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
Injury, poisoning and procedural complications Contusion	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
Injury, poisoning and procedural complications Exposure to communicable disease	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
Injury, poisoning and procedural complications Fall	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
Injury, poisoning and procedural complications Ligament sprain	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
Metabolism and nutrition disorders Dehydration	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
Metabolism and nutrition disorders Hypophagia	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
Renal and urinary disorders Acute kidney injury	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
Renal and urinary disorders Glycosuria	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
Renal and urinary disorders Nephrolithiasis	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Catarrh	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
Vascular disorders Internal haemorrhage	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Anogenital warts	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
Reproductive system and breast disorders Scrotal ulcer	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
Cardiac disorders Tachycardia	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
Ear and labyrinth disorders Vertigo	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
Eye disorders Eye pain	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	6.2% 1/16 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.
Metabolism and nutrition disorders Type 2 diabetes mellitus	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	16.7% 1/6 • Number of events 1 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/8 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/6 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.	0.00% 0/16 • All-cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to 12 weeks for Monotherapy Phase (Part 1 and Part 2 groups) and up to 48 weeks for SOC Phase (SOC groups). Safety population included all participants who received at least one dose of study treatment.

Additional Information

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• Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
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