| Primary | Percentage of Participants With HIV-1 RNA ≥50 Copies/mL at Week 48 | HIV-1 RNA levels in plasma were measured by polymerase chain reaction (PCR) assay with a reliable lower limit of quantification of <50 copies/mL. The percentage of participants with HIV-1 RNA ≥50 copies/mL at Week 48 is presented using the FDA Snapshot missing data approach. | All randomized participants who received at least one dose of study intervention and had data for analysis. | Posted | | Number | | Percentage of Participants | | Week 48 | | | | ID | Title | Description |
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| OG000 | Doravirine/Islatravir (DOR/ISL) | Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months who were previously treated with continuous baseline antiretroviral therapy (ART) received doravine/islatravir (DOR/ISL), a fixed dose combination (FDC) of 100 mg DOR/0.25 mg ISL orally once daily (qd) for 144 weeks. At Week 144, participants who consent to enter the optional study extension will continue to receive DOR/ISL qd (100 mg/0.25 mg) for an additional 96 weeks or until it is commercially accessible (whichever comes first). | | OG001 | Baseline ART + DOR/ISL | Participants with HIV-1 that has been virologically suppressed for ≥3 consecutive months who were previously treated with continuous baseline ART received standard of care (SOC) ART for 48 weeks, followed by treatment with DOR/ISL as a FDC of 100 mg DOR/0.25 mg ISL orally qd until Week 144. At Week 144, participants who consent to enter the optional study extension will continue to receive DOR/ISL qd (100 mg/0.25 mg) for an additional 96 weeks or until it is commercially accessible (whichever comes first). |
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| | Miettinen and Nurminen | The Miettinen and Nurminen method was stratified by corrected baseline ART regimen with Cochran-Mantel-Haenszel (CMH) weights. | <0.001 | | Estimated difference | -3.58 | | | 2-Sided | 95 | -7.81 | -0.77 | | | | | Non-Inferiority | Doravirine/Islatravir (DOR/ISL) - Baseline Antiretroviral Therapy (ART). Non-inferiority was concluded if the upper bound of the 2-sided multiplicity-adjusted 95% CI was less than 4 percentage points. | |
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| Primary | Percentage of Participants With One or More Adverse Events (AEs) at Week 48 | An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who experienced at least one AE from Day 1 up to Week 48 are reported. | All randomized participants who received at least one dose of study intervention. | Posted | | Number | | Percentage of Participants | | Up to Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Doravirine/Islatravir (DOR/ISL) | Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months who were previously treated with continuous baseline antiretroviral therapy (ART) received doravine/islatravir (DOR/ISL), a fixed dose combination (FDC) of 100 mg DOR/0.25 mg ISL orally once daily (qd) for 144 weeks. At Week 144, participants who consent to enter the optional study extension will continue to receive DOR/ISL qd (100 mg/0.25 mg) for an additional 96 weeks or until it is commercially accessible (whichever comes first). | | OG001 | Baseline ART + DOR/ISL | Participants with HIV-1 that has been virologically suppressed for ≥3 consecutive months who were previously treated with continuous baseline ART received standard of care (SOC) ART for 48 weeks, followed by treatment with DOR/ISL as a FDC of 100 mg DOR/0.25 mg ISL orally qd until Week 144. At Week 144, participants who consent to enter the optional study extension will continue to receive DOR/ISL qd (100 mg/0.25 mg) for an additional 96 weeks or until it is commercially accessible (whichever comes first). |
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| Primary | Percentage of Participants With an AE Leading to Discontinuation of Study Intervention at Week 48 | An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who experienced at least one AE leading to discontinuation of study intervention from Day 1 up to Week 48 are reported. | All randomized participants who received at least one dose of study intervention. | Posted | | Number | | Percentage of Participants | | Up to Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Doravirine/Islatravir (DOR/ISL) | Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months who were previously treated with continuous baseline antiretroviral therapy (ART) received doravine/islatravir (DOR/ISL), a fixed dose combination (FDC) of 100 mg DOR/0.25 mg ISL orally once daily (qd) for 144 weeks. At Week 144, participants who consent to enter the optional study extension will continue to receive DOR/ISL qd (100 mg/0.25 mg) for an additional 96 weeks or until it is commercially accessible (whichever comes first). | | OG001 | Baseline ART + DOR/ISL | Participants with HIV-1 that has been virologically suppressed for ≥3 consecutive months who were previously treated with continuous baseline ART received standard of care (SOC) ART for 48 weeks, followed by treatment with DOR/ISL as a FDC of 100 mg DOR/0.25 mg ISL orally qd until Week 144. At Week 144, participants who consent to enter the optional study extension will continue to receive DOR/ISL qd (100 mg/0.25 mg) for an additional 96 weeks or until it is commercially accessible (whichever comes first). |
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| Secondary | Percentage of Participants With HIV-1 RNA <200 Copies/mL at Week 48 | HIV-1 RNA levels in plasma were measured by a polymerase chain reaction (PCR) assay with a reliable lower limit of quantification of <50 copies/mL. The percentage of participants with HIV-1 RNA <200 copies/mL at Week 48 is presented using the FDA Snapshot missing data approach. | All randomized participants who received at least one dose of study intervention and had data for analysis excluding participants who had at least one major deviation that may substantially affect the results of the outcome measure. | Posted | | Number | | Percentage of Participants | | Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Doravirine/Islatravir (DOR/ISL) | Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months who were previously treated with continuous baseline antiretroviral therapy (ART) received doravine/islatravir (DOR/ISL), a fixed dose combination (FDC) of 100 mg DOR/0.25 mg ISL orally once daily (qd) for 144 weeks. At Week 144, participants who consent to enter the optional study extension will continue to receive DOR/ISL qd (100 mg/0.25 mg) for an additional 96 weeks or until it is commercially accessible (whichever comes first). | | OG001 | Baseline ART + DOR/ISL | Participants with HIV-1 that has been virologically suppressed for ≥3 consecutive months who were previously treated with continuous baseline ART received standard of care (SOC) ART for 48 weeks, followed by treatment with DOR/ISL as a FDC of 100 mg DOR/0.25 mg ISL orally qd until Week 144. At Week 144, participants who consent to enter the optional study extension will continue to receive DOR/ISL qd (100 mg/0.25 mg) for an additional 96 weeks or until it is commercially accessible (whichever comes first). |
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| Secondary | Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 48 | HIV-1 RNA levels in plasma were measured by a polymerase chain reaction (PCR) assay with a reliable lower limit of quantification of <50 copies/mL. The percentage of participants with HIV-1 RNA <50 copies/mL at Week 48 is presented using the FDA Snapshot missing data approach. | All randomized participants who received at least one dose of study intervention and had data for analysis excluding participants who had at least one major deviation that may substantially affect the results of the outcome measure. | Posted | | Number | | Percentage of Participants | | Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Doravirine/Islatravir (DOR/ISL) | Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months who were previously treated with continuous baseline antiretroviral therapy (ART) received doravine/islatravir (DOR/ISL), a fixed dose combination (FDC) of 100 mg DOR/0.25 mg ISL orally once daily (qd) for 144 weeks. At Week 144, participants who consent to enter the optional study extension will continue to receive DOR/ISL qd (100 mg/0.25 mg) for an additional 96 weeks or until it is commercially accessible (whichever comes first). | | OG001 | Baseline ART + DOR/ISL | Participants with HIV-1 that has been virologically suppressed for ≥3 consecutive months who were previously treated with continuous baseline ART received standard of care (SOC) ART for 48 weeks, followed by treatment with DOR/ISL as a FDC of 100 mg DOR/0.25 mg ISL orally qd until Week 144. At Week 144, participants who consent to enter the optional study extension will continue to receive DOR/ISL qd (100 mg/0.25 mg) for an additional 96 weeks or until it is commercially accessible (whichever comes first). |
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| Secondary | Percentage of Participants With HIV-1 RNA <200 Copies/mL at Week 96 | HIV-1 RNA levels in plasma were measured by a polymerase chain reaction (PCR) assay with a reliable lower limit of quantification of <50 copies/mL. The percentage of participants with HIV-1 RNA <200 copies/mL at Week 96 is presented using the FDA Snapshot missing data approach. | | Not Posted | Jul 2029 | | | | | Week 96 | | Participants | | | | |
| Secondary | Participants With HIV-1 RNA <200 Copies/mL at Week 144 | HIV-1 RNA levels in plasma were measured by a polymerase chain reaction (PCR) assay with a reliable lower limit of quantification of <50 copies/mL. The percentage of participants with HIV-1 RNA <200 copies/mL at Week 144 is presented using the FDA Snapshot missing data approach. | | Not Posted | Jul 2029 | | | | | Week 144 | | Participants | | | | |
| Secondary | Percentage of Participants With HIV-1 RNA ≥50 Copies/mL at Week 96 | HIV-1 RNA levels in plasma were measured by a polymerase chain reaction (PCR) assay with a reliable lower limit of quantification of <50 copies/mL. The percentage of participants with HIV-1 RNA ≥50 copies/mL at Week 96 is presented using the FDA Snapshot missing data approach. | | Not Posted | Jul 2029 | | | | | Week 96 | | Participants | | | | |
| Secondary | Percentage of Participants With HIV-1 RNA ≥50 Copies/mL at Week 144 | HIV-1 RNA levels in plasma were measured by a polymerase chain reaction (PCR) assay with a reliable lower limit of quantification of <50 copies/mL. The percentage of participants with HIV-1 RNA ≥50 copies/mL at Week 144 is presented using the FDA Snapshot missing data approach. | | Not Posted | Jul 2029 | | | | | Week 144 | | Participants | | | | |
| Secondary | Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 96 | HIV-1 RNA levels in plasma were measured by a polymerase chain reaction (PCR) assay with a reliable lower limit of quantification of <50 copies/mL. The percentage of participants with HIV-1 RNA <50 copies/mL at Week 96 is presented using the FDA Snapshot missing data approach. | | Not Posted | Jul 2029 | | | | | Week 96 | | Participants | | | | |
| Secondary | Percentage of Participants With HIV-1 RNA <50 Copies/mL at Week 144 | HIV-1 RNA levels in plasma were measured by a polymerase chain reaction (PCR) assay with a reliable lower limit of quantification of <50 copies/mL. The percentage of participants with HIV-1 RNA <50 copies/mL at Week 144 is presented using the FDA Snapshot missing data approach. | | Not Posted | Jul 2029 | | | | | Week 144 | | Participants | | | | |
| Secondary | Mean Change of Plasma Cluster of Differentiation 4 (CD4+) T-Cell Count From Baseline Day 1 to Week 48 | Plasma CD4+ T-Cell Count was measured in cells/mm^3 for baseline and 48 weeks. Baseline measurements were defined as the Day 1 value of each participant. The mean change of plasma CD4+ T-Cell count from baseline to Week 48 is presented. | All randomized participants who received at least one dose of study intervention and who have baseline data. | Posted | | Mean | 95% Confidence Interval | cells/mm^3 | | Baseline at Day 1 and Week 48 | | | | ID | Title | Description |
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| OG000 | Doravirine/Islatravir (DOR/ISL) | Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months who were previously treated with continuous baseline antiretroviral therapy (ART) received doravine/islatravir (DOR/ISL), a fixed dose combination (FDC) of 100 mg DOR/0.25 mg ISL orally once daily (qd) for 144 weeks. At Week 144, participants who consent to enter the optional study extension will continue to receive DOR/ISL qd (100 mg/0.25 mg) for an additional 96 weeks or until it is commercially accessible (whichever comes first). | | OG001 | Baseline ART + DOR/ISL | Participants with HIV-1 that has been virologically suppressed for ≥3 consecutive months who were previously treated with continuous baseline ART received standard of care (SOC) ART for 48 weeks, followed by treatment with DOR/ISL as a FDC of 100 mg DOR/0.25 mg ISL orally qd until Week 144. At Week 144, participants who consent to enter the optional study extension will continue to receive DOR/ISL qd (100 mg/0.25 mg) for an additional 96 weeks or until it is commercially accessible (whichever comes first). |
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| Secondary | Mean Change of Plasma CD4+ T-Cell Count From Baseline Week 48 to Week 96 | Mean change from baseline at Week 48 in CD4+ T-cell count at Week 96. This outcome measure is applicable to participants who were randomized to switch to DOR/ISL at Week 48. | | Not Posted | Jul 2029 | | | | | Baseline at Week 48 and Week 96 | | Participants | | | | |
| Secondary | Mean Change of Plasma CD4+ T-Cell Count From Baseline Day 48 to Week 144 | Mean change from baseline at Week 48 in CD4+ T-cell count at Week 144. This outcome measure is applicable to participants who were randomized to switch to DOR/ISL at Week 48. | | Not Posted | Jul 2029 | | | | | Baseline at Week 48 and Week 144 | | Participants | | | | |
| Secondary | Mean Change of Plasma CD4+ T-Cell Count From Baseline Day 1 to Week 96 | Mean change from baseline at Day 1 in CD4+ T-cell count at Week 96. This outcome measure is applicable to those randomized to start DOR/ISL on Day 1. | | Not Posted | Jul 2029 | | | | | Baseline at Day 1 and Week 96 | | Participants | | | | |
| Secondary | Mean Change of Plasma CD4+ T-Cell Count From Baseline Day 1 to Week 144 | Mean change from baseline at Day 1 in CD4+ T-cell count at Week 144. This outcome measure is applicable to those randomized to start DOR/ISL on Day 1. | | Not Posted | Jul 2029 | | | | | Baseline at Day 1 and Week 144 | | Participants | | | | |
| Secondary | Percentage of Participants With Treatment-Emergent, Resistance-associated Substitutions at Week 48 | Participants with clinically significant confirmed viremia [2 consecutive occurences 4 weeks (+-1 week) apart of HIV-1 RNA >=200 copies/mL at any time during the study] or who discontinue study intervention for another reason with HIV-1 RNA >=200 copies/mL at the time of discontinuation met the criteria for post-baseline resistance testing. Participants with HIV-1 RNA >=400 copies/mL or any participant for whom available genotypic or phenotypic data show evidence of resistance, irrespective of viral load were included in the resistance analysis subset. Plasma samples were collected for genotypic and phenotypic HIV-1 viral drug resistance testing and used to assess resistance-associated substitutions and virus susceptibility to study intervention. The percentage of participants in the resistance analysis subset with treatment-emergent resistance-associated substitutions to the study intervention is presented. | Participants with HIV-1 RNA >=400 copies/mL or any participant for whom available genotypic or phenotypic data show evidence of resistance, irrespective of viral load were included in the resistance analysis subset. | Posted | | Number | | Percentage of participants | | Up to Week 48 | | | | ID | Title | Description |
|---|
| OG000 | Doravirine/Islatravir (DOR/ISL) | Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months who were previously treated with continuous baseline antiretroviral therapy (ART) received doravine/islatravir (DOR/ISL), a fixed dose combination (FDC) of 100 mg DOR/0.25 mg ISL orally once daily (qd) for 144 weeks. At Week 144, participants who consent to enter the optional study extension will continue to receive DOR/ISL qd (100 mg/0.25 mg) for an additional 96 weeks or until it is commercially accessible (whichever comes first). |
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| Secondary | Mean Change From Baseline in Fasting Low Density Lipoprotein Cholesterol (LDL-C) at Week 48 | Blood serum samples were taken at baseline and Week 48. The mean change from baseline in fasting Low density lipoprotein cholesterol (LDL-C) at Week 48 is presented for PI-containing regimens (including PI- + InSTI-containing regimens), non-PI- and non-InSTI-containing regimens, and InSTI-containing regimens (non-PI-containing regimens) are presented. | All randomized participants who received at least one dose of study intervention and had baseline data and at least one post-baseline test result in the specified analysis window. | Posted | | Mean | 95% Confidence Interval | mg/dL | | Baseline and Week 48 | | | | ID | Title | Description |
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| OG000 | Doravirine/Islatravir (DOR/ISL) | Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months who were previously treated with continuous baseline antiretroviral therapy (ART) received doravine/islatravir (DOR/ISL), a fixed dose combination (FDC) of 100 mg DOR/0.25 mg ISL orally once daily (qd) for 144 weeks. At Week 144, participants who consent to enter the optional study extension will continue to receive DOR/ISL qd (100 mg/0.25 mg) for an additional 96 weeks or until it is commercially accessible (whichever comes first). | | OG001 | Baseline ART + DOR/ISL | Participants with HIV-1 that has been virologically suppressed for ≥3 consecutive months who were previously treated with continuous baseline ART received standard of care (SOC) ART for 48 weeks, followed by treatment with DOR/ISL as a FDC of 100 mg DOR/0.25 mg ISL orally qd until Week 144. At Week 144, participants who consent to enter the optional study extension will continue to receive DOR/ISL qd (100 mg/0.25 mg) for an additional 96 weeks or until it is commercially accessible (whichever comes first). |
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| Secondary | Mean Change From Baseline in Fasting Non-High Density Lipoprotein Cholesterol (Non-HDL-C) at Week 48 | Blood serum samples were taken at baseline and Week 48. The mean change from baseline in fasting Non-HDL-C at Week 48 is presented for PI-containing regimens (including PI- + InSTI-containing regimens), non-PI- and non-InSTI-containing regimens, and InSTI-containing regimens (non-PI-containing regimens) are presented. | All randomized participants who received at least one dose of study intervention and had baseline data and at least one post-baseline test result in the specified analysis window. | Posted | | Mean | 95% Confidence Interval | mg/dL | | Baseline and Week 48 | | | | ID | Title | Description |
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| OG000 | Doravirine/Islatravir (DOR/ISL) | Participants with Human Immunodeficiency Virus-1 (HIV-1) that have been virologically suppressed for ≥3 consecutive months who were previously treated with continuous baseline antiretroviral therapy (ART) received doravine/islatravir (DOR/ISL), a fixed dose combination (FDC) of 100 mg DOR/0.25 mg ISL orally once daily (qd) for 144 weeks. At Week 144, participants who consent to enter the optional study extension will continue to receive DOR/ISL qd (100 mg/0.25 mg) for an additional 96 weeks or until it is commercially accessible (whichever comes first). | | OG001 | Baseline ART + DOR/ISL | Participants with HIV-1 that has been virologically suppressed for ≥3 consecutive months who were previously treated with continuous baseline ART received standard of care (SOC) ART for 48 weeks, followed by treatment with DOR/ISL as a FDC of 100 mg DOR/0.25 mg ISL orally qd until Week 144. At Week 144, participants who consent to enter the optional study extension will continue to receive DOR/ISL qd (100 mg/0.25 mg) for an additional 96 weeks or until it is commercially accessible (whichever comes first). |
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| Secondary | Participants With One or More AEs at Week 96 | An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who experienced at least one AE from Day 1 up to Week 96 is reported. | | Not Posted | Jul 2029 | | | | | Up to Week 96 | | Participants | | | | |
| Secondary | Participants With One or More AEs at Week 144 | An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who experienced at least one AE from Day 1 up to Week 144 is reported. | | Not Posted | Jul 2029 | | | | | Up to Week 144 | | Participants | | | | |
| Secondary | Percentage of Participants With AEs Leading to Discontinuation of Study Intervention at Week 96 | An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who experienced at least one AE leading to discontinuation of study intervention from Day 1 up to Week 96 are reported. | | Not Posted | Jul 2029 | | | | | Up to Week 96 | | Participants | | | | |
| Secondary | Percentage of Participants With AEs Leading to Discontinuation of Study Intervention at Week 144 | An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who experienced at least one AE leading to discontinuation of study intervention from Day 1 up to Week 144 are reported. | | Not Posted | Jul 2029 | | | | | Up to Week 144 | | Participants | | | | |
| Secondary | Percentage of Participants With One or More AEs From Week 48 up to Week 96 | An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who experienced at least one AE from Week 48 up to Week 96 is reported. | | Not Posted | Jul 2029 | | | | | Week 48 up to Week 96 | | Participants | | | | |
| Secondary | Percentage of Participants With One or More AEs From Week 48 up to Week 144 | An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who experienced at least one AE from Week 48 up to Week 144 is presented. | | Not Posted | Jul 2029 | | | | | Week 48 up to Week 144 | | Participants | | | | |
| Secondary | Percentage of Participants With AEs Leading to Discontinuation of Study Intervention From Week 48 up to Week 96 | An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who experienced at least one AE leading to discontinuation of study intervention from Week 48 up to Week 96 are reported. | | Not Posted | Jul 2029 | | | | | Week 48 up to Week 96 | | Participants | | | | |
| Secondary | Percentage of Participants With AEs Leading to Discontinuation of Study Intervention From Week 48 up to Week 144 | An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who experienced at least one AE leading to discontinuation of study intervention from Week 48 up to Week 144 are reported. | | Not Posted | Jul 2029 | | | | | Week 48 up to Week 144 | | Participants | | | | |