A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneously Administered Guselkumab for the Treatment of Chronic Plaque Psoriasis in Pediatric Participants

The IGA assesses participant's plaque psoriasis. Lesions were graded for induration, erythema and scaling, each using a 5 point scale. Induration: 0 = no evidence of plaque elevation, 1 = minimal plaque elevation, = 0.25 mm; 2 = mild plaque elevation, = 0.5 mm; 3 = moderate plaque elevation, = 0.75 mm; 4 = severe plaque elevation, \>1 mm; Erythema: 0 = no evidence of erythema, hyperpigmentation may be present, 1 = faint erythema, 2 = light red coloration, 3 = moderate red coloration, 4 = bright red coloration; Scaling: 0 = no evidence of scaling, 1 = minimal; occasional fine scale over less than 5% of the lesion, 2 = mild; fine scale dominates, 3 = moderate; coarse scale predominates, 4 = severe; thick, scale predominates. Final IGA score of psoriasis was based upon the average of induration, erythema and scaling scores assessed on a 5 point scale: cleared (0), minimal (1), mild (2), moderate (3), or severe (4). A higher score indicated more severe disease.

Time frame: At Week 16

Population: The efficacy analysis for Part 1 of the study was based upon the full analysis set (FAS) which included all randomized participants in Part 1. In the efficacy analyses, participants were analyzed according to their assigned treatment group regardless of their actual treatment received.

The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent \[%\] to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produced a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicated more severe disease. A PASI 75 response represented participants who achieved at least a 75 % improvement from baseline in the PASI score.

Time frame: At Week 16

Population: The efficacy analysis for Part 1 of the study was based upon the FAS which included all randomized participants in Part 1. In the efficacy analyses, participants were analyzed according to their assigned treatment group regardless of their actual treatment received.

Time frame: Week 60 and Week 84

Time frame: From Week 52 to EOS (Dec 2026)

Time frame: Week 60 and Week 84

Time frame: From Week 52 to EOS (December 2026)

Time frame: Week 60 and Week 84

Time frame: From Week 52 to End of the study (EOS) (December 2026)

Time frame: From Week 52 to EOS (December 2026)

Time frame: Week 60 and Week 84

Change from baseline in percent body surface area with psoriasis skin involvement was reported. BSA as physical measure to define disease severity is to determine how much of the BSA is affected by psoriasis. Involved BSA is calculated by using the palm of the participant's hand as equivalent to 1% of the BSA (rule of palm). Psoriasis affected BSA under 5% suggests mild psoriasis, a BSA of 5% to 10% is considered moderate, and an involved BSA of over 10% indicates severe psoriasis.

Time frame: Baseline and Week 16

Population: The efficacy analysis for Part 1 of the study was based upon the FAS which included all randomized participants in Part 1. In the efficacy analyses, participants were analyzed according to their assigned treatment group regardless of their actual treatment received.

CDLQI is a 10-item questionnaire that measures the impact of skin disease on children's quality of life. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. CDLQI total score was the sum of individual scores of questions 1-10 and ranged from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of children. Change from baseline is defined as post baseline score minus baseline score.

Time frame: Baseline and Week 16

Population: The efficacy analysis for Part 1 of the study was based upon the FAS which included all randomized participants in Part 1. In the efficacy analyses, participants were analyzed according to their assigned treatment group regardless of their actual treatment received.

The FDLQI was a 10-item questionnaire that examined the impact of participant's skin disease on different aspects of their QoL (example, emotional, physical well-being, relationships, social life, leisure activities, burden of care, job/study, housework and expenditure) over the last 1 month, as assessed by a family member/partner. Each item had a four-point response option, where Not at all/Not relevant = 0; A little = 1; Quite a lot = 2; and Very much = 3. The scores of individual items (0-3) are added to give a total scale score that ranged from 0 to 30; a higher score indicates greater impairment of QoL.

Time frame: Baseline and Week 16

Population: The efficacy analysis for Part 1 of the study was based upon the FAS which included all randomized participants in Part 1. In the efficacy analyses, participants were analyzed according to their assigned treatment group regardless of their actual treatment received. Here, N (Overall Number of Participants Analyzed) signifies participants evaluable for this outcome measure.

Cumulative maintenance rate was defined as percentage of participants who maintained their PASI 90 response through Week 52 among guselkumab PASI 90 responders at Week 16. The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In PASI system, body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90% to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produced a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicated more severe disease. A PASI 90 response represented participants who achieved at least a 90% improvement from baseline in PASI score.

Time frame: Week 20, 24, 28, 32, 36, 40, 44, 48, and 52

Population: Analysis population included Guselkumab PASI 90 responders at Week 16. This outcome measure was planned to be analyzed for Group 2 (Part 1): Guselkumab (Week 16-52) arm only.

Cumulative rate of loss of at least 50% of PASI improvement was defined as percentage of participants with a loss of \>=50% of Week 16 PASI improvement after treatment is withdrawn. The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In PASI system, body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 % to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produced a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicated more severe disease.

Time frame: Weeks 20, 24, 28, 32, 36, 40, 44, 48, and 52

Population: Analysis population included Guselkumab PASI 90 responders at Week 16. This outcome measure was planned to be analyzed for Group 2 (Part 1): Guselkumab (Week 16-52) arm only.

The IGA assesses participant's plaque psoriasis. Lesions were graded for induration, erythema and scaling, each using a 5 point scale. Induration: 0 = no evidence of plaque elevation, 1 = minimal plaque elevation, = 0.25 mm; 2 = mild plaque elevation, = 0.5 mm; 3 = moderate plaque elevation, = 0.75 mm; 4 = severe plaque elevation, \>1 mm; Erythema: 0 = no evidence of erythema, hyperpigmentation may be present, 1 = faint erythema, 2 = light red coloration, 3 = moderate red coloration, 4 = bright red coloration; Scaling: 0 = no evidence of scaling, 1 = minimal; occasional fine scale over less than 5% of the lesion, 2 = mild; fine scale dominates, 3 = moderate; coarse scale predominates, 4 = severe; thick, scale predominates. Final IGA score of psoriasis was based upon the average of induration, erythema and scaling scores assessed on a 5 point scale: cleared (0), minimal (1), mild (2), moderate (3), or severe (4). A higher score indicated more severe disease.

Time frame: At Week 16

Population: The efficacy analysis for Part 1 of the study was based upon the FAS which included all randomized participants in Part 1. In the efficacy analyses, participants were analyzed according to their assigned treatment group regardless of their actual treatment received.

The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In PASI system, body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 % to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produced a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicated more severe disease. A PASI 50 response represented at least a 50% improvement from baseline in the PASI score.

Time frame: At Week 16

Population: The efficacy analysis for Part 1 of the study was based upon the FAS which included all randomized participants in Part 1. In the efficacy analyses, participants were analyzed according to their assigned treatment group regardless of their actual treatment received.

The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 percent \[%\] to 100% involvement), and for erythema, induration, and scaling, which were each rated on a scale of 0 (none) to 4 (severe). The PASI produced a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicated more severe disease. A PASI 100 response represented participants who achieved a 100 % improvement from baseline in the PASI score.

Time frame: At Week 16

Population: The efficacy analysis for Part 1 of the study was based upon the FAS which included all randomized participants in Part 1. In the efficacy analyses, participants were analyzed according to their assigned treatment group regardless of their actual treatment received.

The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90 % to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). The PASI produced a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicated more severe disease. A PASI 90 response represented participants who achieved at least a 90 % improvement from baseline in the PASI score.

Time frame: At Week 16

Population: The efficacy analysis for Part 1 of the study was based upon the FAS which included all randomized participants in Part 1. In the efficacy analyses, participants were analyzed according to their assigned treatment group regardless of their actual treatment received.

CDLQI is a 10-item questionnaire that measures the impact of skin disease on children's quality of life. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. CDLQI total score was the sum of individual scores of question 1-10 and ranges from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of children.

Time frame: At Week 16

Population: The efficacy analysis for Part 1 of the study was based upon the FAS which included all randomized participants in Part 1. In the efficacy analyses, participants were analyzed according to their assigned treatment group regardless of their actual treatment received. Here, N (Overall Number of Participants Analyzed) signifies participants evaluable for this outcome measure.

The FDLQI was a 10-item questionnaire that examined the impact of participant's skin disease on different aspects of their QoL (example: emotional, physical well-being, relationships, social life, leisure activities, burden of care, job/study, housework and expenditure) over the last 1 month, as assessed by a family member/partner. Each item had a four-point response option, where Not at all/Not relevant = 0; A little = 1; Quite a lot = 2; and Very much = 3. The scores of individual items (0-3) were added to give a total scale score that ranged from 0 to 30; a higher score indicated greater impairment of QoL.

Time frame: At Week 16

Population: The efficacy analysis for Part 1 of the study was based upon the FAS which included all randomized participants in Part 1. In the efficacy analyses, participants were analyzed according to their assigned treatment group regardless of their actual treatment received. Here, N (Overall Number of Participants Analyzed) signifies participants evaluable for this outcome measure.

The IGA assesses participant's plaque psoriasis. Lesions were graded for induration, erythema and scaling, each using a 5 points scale. Induration: 0 = no evidence of plaque elevation, 1 = minimal plaque elevation, = 0.25 mm; 2 = mild plaque elevation, = 0.5 mm; 3 = moderate plaque elevation, = 0.75 mm; 4 = severe plaque elevation, \>1 mm; Erythema: 0 = no evidence of erythema, hyperpigmentation may be present, 1 = faint erythema, 2 = light red coloration, 3 = moderate red coloration, 4 = bright red coloration; Scaling: 0 = no evidence of scaling, 1 = minimal; occasional fine scale over less than 5% of the lesion, 2 = mild; fine scale dominates, 3 = moderate; coarse scale predominates, 4 = severe; thick, scale predominates. Final IGA score of psoriasis was based upon the average of induration, erythema and scaling scores assessed on a 5 points scale: cleared (0), minimal (1), mild (2), moderate (3), or severe (4). A higher score indicated more severe disease.

Time frame: Weeks 4, 8, 12, and 16

Population: The efficacy analysis for Part 1 of the study was based upon the FAS which included all randomized participants in Part 1. In the efficacy analyses, participants were analyzed according to their assigned treatment group regardless of their actual treatment received.

The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90% to 100% involvement), and for erythema, induration, and scaling, which were each rated on a scale of 0 to 4. The PASI produced a numeric score that can range from 0 (no psoriasis) to 72. A higher score indicated more severe disease. PASI 50, 75, 90, and 100 responses represented at least 50%, 75%, 90%, and 100% improvement from baseline respectively, in the PASI score.

Time frame: Weeks 4, 8, 12, and 16

Population: The efficacy analysis for Part 1 of the study was based upon the FAS which included all randomized participants in Part 1. In the efficacy analyses, participants were analyzed according to their assigned treatment group regardless of their actual treatment received.

PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In PASI system, body was divided into 4 regions: head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for percentage of area involved, which translates to score that ranges from 0 (indicates no involvement) to 6 (90 % to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 (none) to 4 (severe). PASI produced a numeric score that can range from 0 (no visible skin involvement) to 72 (maximal skin involvement of the whole body). A higher score indicated more severe disease. A PASI 90 response represented participants who achieved at least a 90 % improvement from baseline in PASI score.

Time frame: At 4 and 8 weeks post retreatment (retreatment period ranged from Week 16 to Week 52)

Population: Analysis population included Guselkumab PASI 90 responders at Week 16 who were retreated with guselkumab prior to Week 52. This outcome measure was planned to be analyzed for Group 2 (Part 1): Guselkumab (Week 16-52) arm only. Here, n (Number Analyzed) signifies number of participants evaluable at specified time points.

The IGA assesses participant's plaque psoriasis. Lesions were graded for induration, erythema and scaling, each using a 5 points scale. Induration: 0 = no evidence of plaque elevation, 1 = minimal plaque elevation, = 0.25 mm; 2 = mild plaque elevation, = 0.5 mm; 3 = moderate plaque elevation, = 0.75 mm; 4 = severe plaque elevation, \>1 mm; Erythema: 0 = no evidence of erythema, hyperpigmentation may be present, 1 = faint erythema, 2 = light red coloration, 3 = moderate red coloration, 4 = bright red coloration; Scaling: 0 = no evidence of scaling, 1 = minimal; occasional fine scale over less than 5% of the lesion, 2 = mild; fine scale dominates, 3 = moderate; coarse scale predominates, 4 = severe; thick, scale predominates. Final IGA score of psoriasis was based upon the average of induration, erythema and scaling scores assessed on a 5 points scale: cleared (0), minimal (1), mild (2), moderate (3), or severe (4). A higher score indicated more severe disease.

Time frame: At 4 and 8 weeks post retreatment (retreatment period ranged from Week 16 to Week 52)

Population: Analysis population included Guselkumab PASI 90 responders at Week 16 who were retreated with guselkumab prior to Week 52. Here, n (Number Analyzed) signifies number of participants evaluable at specified time points. This outcome measure was planned to be analyzed for Group 2 (Part 1): Guselkumab (Week 16-52) arm only.

The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90%-100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produced a numeric score that can range from 0 (no psoriasis) to 72. A higher score indicated more severe disease. PASI 50, 75, 90 and 100 response represented at least 50, 75, 90 and 100% improvement from baseline respectively, in the PASI score.

Time frame: At 4 and 8 weeks post retreatment (retreatment period ranged from Week 16 to Week 52)

Population: Analysis population included guselkumab PASI 90 responders at Week 16 who were retreated with guselkumab prior to Week 52. Here, n (Number Analyzed) signifies number of participants evaluable at specified time points. This outcome measure was planned to be analyzed for Group 2 (Part 1): Guselkumab (Week 16-52) arm only.

The PASI is a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90% to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produced a numeric score that can range from 0 (no psoriasis) to 72. A higher score indicated more severe disease.

Time frame: Weeks 4, 8, 12, and 16

Population: The efficacy analysis for Part 1 of the study was based upon the FAS which included all randomized participants in Part 1. In the efficacy analyses, participants were analyzed according to their assigned treatment group regardless of their actual treatment received. Here, n (number analyzed): number of participants evaluable for each arm at specified time points.

Change from baseline in CDLQI score through Week 52 were reported. CDLQI is a 10-item questionnaire that measures the impact of skin disease on children's quality of life. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. CDLQI total score was the sum of individual scores of questions 1-10 and ranged from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of children.

Time frame: Baseline, Weeks 8, 16, 28, 36, and 52

Population: FAS for Part 2 included all participants enrolled in Part 2. Here, n (number analyzed) signifies number of participants evaluable at specified time points.

The FDLQI was a 10-item questionnaire that examine the impact of participant's skin disease on different aspects of their QoL (example, emotional, physical well-being, relationships, social life, leisure activities, burden of care, job/study, housework and expenditure) over the last 1 month, as assessed by a family member/partner. Each item had a four-point response option, where Not at all/Not relevant = 0; A little = 1; Quite a lot = 2; and Very much = 3. The scores of individual items (0-3) are added to give a total scale score that ranged from 0 to 30; a higher score indicated greater impairment of QoL.

Time frame: Baseline, Weeks 8, 16, 28, 36, and 52

Population: FAS for Part 2 included all participants enrolled in Part 2. Here, N (Overall Number of Participants Analyzed) signifies participants evaluable for this outcome measure and n (number analyzed) signifies number of participants evaluable at specified time points.

CDLQI is a 10-item questionnaire that measures the impact of skin disease on children's quality of life. Each question was evaluated on a 4-point scale ranging from 0 (not at all) to 3 (very much); where higher scores indicate more impact on quality of life. CDLQI total score was the sum of individual scores of question 1-10 and ranges from 0 (not at all) to 30 (very much). Higher scores indicated more impact on quality of life of children.

Time frame: Weeks 8, 16, 28, 36, and 52

Population: FAS for Part 2 included all participants enrolled in Part 2. Here, N (Overall Number of Participants Analyzed) signifies participants evaluable for this outcome measure.

The FDLQI was a 10-item questionnaire that examine the impact of participant's skin disease on different aspects of their QoL (example, emotional, physical well-being, relationships, social life, leisure activities, burden of care, job/study, housework and expenditure) over the last 1 month, as assessed by a family member/partner. Each item had a four-point response option, where Not at all/Not relevant = 0; A little = 1; Quite a lot = 2; and Very much = 3. The scores of individual items (0-3) were added to give a total scale score that ranged from 0 to 30; a higher score indicates greater impairment of QoL.

Time frame: Weeks 8, 16, 28, 36, and 52

Population: FAS for Part 2 included all participants enrolled in Part 2. Here, N (Overall Number of Participants Analyzed) signifies participants evaluable for this outcome measure.

The IGA assesses participant's plaque psoriasis. Lesions were graded for induration, erythema and scaling, each using a 5 points scale. Induration: 0 = no evidence of plaque elevation, 1 = minimal plaque elevation, = 0.25 mm; 2 = mild plaque elevation, = 0.5 mm; 3 = moderate plaque elevation, = 0.75 mm; 4 = severe plaque elevation, \>1 mm; Erythema: 0 = no evidence of erythema, hyperpigmentation may be present, 1 = faint erythema, 2 = light red coloration, 3 = moderate red coloration, 4 = bright red coloration; Scaling: 0 = no evidence of scaling, 1 = minimal; occasional fine scale over less than 5% of the lesion, 2 = mild; fine scale dominates, 3 = moderate; coarse scale predominates, 4 = severe; thick, scale predominates. Final IGA score of psoriasis was based upon the average of induration, erythema and scaling scores assessed on a 5 points scale: cleared (0), minimal (1), mild (2), moderate (3), or severe (4). A higher score indicated more severe disease.

Time frame: Weeks 4, 8, 12, 16, 20, 28, 36, 44, and 52

Population: FAS for Part 2 included all participants enrolled in Part 2.

The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90% to 100% involvement), and for erythema, induration, and scaling, which are each rated on a scale of 0 to 4. The PASI produced a numeric score that can range from 0 (no psoriasis) to 72. A higher score indicated more severe disease. PASI 50, 75, 90, and 100 responses represented at least 50%, 75%, 90%, and 100% improvement from baseline respectively, in the PASI score.

Time frame: Weeks 4, 8, 12, 16, 20, 28, 36, 44, and 52

Population: FAS for Part 2 included all participants enrolled in Part 2.

The PASI was a system used for assessing and grading the severity of psoriatic lesions and their response to therapy. In the PASI system, the body was divided into 4 regions: the head, trunk, upper extremities, and lower extremities. Each of these areas was assessed separately for the percentage of the area involved, which translates to a numeric score that ranges from 0 (indicates no involvement) to 6 (90% to 100% involvement), and for erythema, induration, and scaling, which were each rated on a scale of 0 to 4. The PASI produced a numeric score that can range from 0 (no psoriasis) to 72. A higher score indicated more severe disease.

Time frame: Weeks 4, 8, 12, 16, 20, 28, 36, 44, and 52

Population: FAS for Part 2 included all participants enrolled in Part 2. Here, n (number analyzed) signifies number of participants evaluable at specified time points.

Change from baseline in percent body surface area with psoriasis skin involvement was reported. BSA as physical measure to define disease severity is to determine how much of the BSA is affected by psoriasis. Involved BSA is calculated by using the palm of the participant's hand as equivalent to 1% of the BSA (rule of palm). Psoriasis affected BSA under 5% suggests mild psoriasis, a BSA of 5% to 10% is considered moderate, and an involved BSA of over 10% indicates severe psoriasis.

Time frame: Baseline, Weeks 4, 8, 12, 16, 20, 28, 36, 44, and 52

Population: FAS for Part 2 included all participants enrolled in Part 2. Here, n (number analyzed) signifies number of participants evaluable at specified time points.