Percentage of patients reaching PASI 75 in treatment groups (150 and 300 mg bid) compared to placebo. The PASI (psoriasis area severity index) is the most commonly used and validated assessment for grading the severity of psoriasis in clinical studies and combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease) wherein any value higher than 10 is considered as moderate to severe psoriasis. The number of responders corresponds to the number of patients with an improvement of at least 75% in the PASI score at End-of-Treatment (EoT) compared to baseline.

The full-analysis-set (FAS) included all randomized patients who received at least one dose of IMP and had at least one post-baseline assessment. The FAS was considered primary analysis set for the efficacy analysis.

PGA improvement rate in treatment groups (150 and 300 mg bid) compared to placebo. The PGA (Physician's global assessment) provides an overall evaluation of the severity of the disease ranging from 0 (clear skin - no diseases) to 6 (severe disease). The number of responders corresponds to the number of patients with an improvement of 1 or more points on the 7-points PGA scale at End-of-Treatment (EoT) compared to baseline.

The full-analysis-set (FAS) included all randomized patients who received at least one dose of IMP and had at least one post-baseline assessment. The FAS was considered primary analysis set for the efficacy analysis.

Percentage of patients reaching PASI 75 in treatment groups (150 and 300 mg bid) compared to placebo in the valid cases set (VCS). The PASI (psoriasis area severity index) is the most commonly used and validated assessment for grading the severity of psoriasis in clinical studies and combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease) wherein any value higher than 10 is considered as moderate to severe psoriasis. The number of responders corresponds to the number of patients with an improvement of at least 75% in the PASI score at End-of-Treatment (EoT) compared to baseline.

The valid-cases-set (VCS) included all patients from the full-analysis-set (FAS), who completed the assessment of the co-primary endpoints without any protocol violation interfering with the precise evaluation of treatment efficacy and with sufficient exposure to IMP.

PGA improvement rate in treatment groups (150 and 300 mg bid) compared to placebo in the valid-cases-set (VCS). The PGA (Physician's global assessment) provides an overall evaluation of the severity of the disease ranging from 0 (clear skin - no diseases) to 6 (severe disease). The number of responders corresponds to the number of patients with an improvement of 1 or more points on the 7-points PGA scale at End-of-Treatment (EoT) compared to baseline.

The valid-cases-set (VCS) included all patients from the full-analysis-set (FAS), who completed the assessment of the co-primary endpoints without any protocol violation interfering with the precise evaluation of treatment efficacy and with sufficient exposure to IMP.

Percentage of patients reaching PASI 50 in treatment groups (150 and 300 mg bid) compared to placebo. The PASI (psoriasis area severity index) is the most commonly used and validated assessment for grading the severity of psoriasis in clinical studies and combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease) wherein any value higher than 10 is considered as moderate to severe psoriasis. The number of responders corresponds to the number of patients with an improvement of at least 50% in the PASI score at End-of-Treatment (EoT) compared to baseline.

The full-analysis-set (FAS) included all randomized patients who received at least one dose of IMP and had at least one post-baseline assessment. The FAS was considered primary analysis set for the efficacy analysis.

Mean PASI score and change to baseline in treatment groups (150 and 300mg) compared to placebo. The PASI (psoriasis area severity index) is the most commonly used and validated assessment for grading the severity of psoriasis in clinical studies and combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease) wherein any value higher than 10 is considered as moderate to severe psoriasis. Displayed are changes in the PASI score (LS mean estimates) at end of treatment (EoT) compared to baseline in the different arms in patients of the FAS subject analysis set wherein negative values indicate a better outcome.

The full-analysis-set (FAS) included all randomized patients who received at least one dose of IMP and had at least one post-baseline assessment. The FAS was considered primary analysis set for the efficacy analysis.

Mean PASI score and change to baseline in treatment groups (150 and 300mg) compared to placebo. The PASI (psoriasis area severity index) is the most commonly used and validated assessment for grading the severity of psoriasis in clinical studies and combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease) wherein any value higher than 10 is considered as moderate to severe psoriasis. For the change of baseline negative values indicate improvement and positive values indicate worsening.

The full-analysis-set (FAS) included all randomized patients who received at least one dose of IMP and had at least one post-baseline assessment. The FAS was considered primary analysis set for the efficacy analysis.

Time to the achievement of PASI 75, if applicable. The PASI (psoriasis area severity index) is the most commonly used and validated assessment for grading the severity of psoriasis in clinical studies and combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease) wherein any value higher than 10 is considered as moderate to severe psoriasis. Displayed is the number of responders that reached an improvement of at least 75% in the PASI score in the respective week.

The full-analysis-set (FAS) included all randomized patients who received at least one dose of IMP and had at least one post-baseline assessment. The FAS was considered primary analysis set for the efficacy analysis.

Time to the achievement of PASI 50, if applicable. The PASI (psoriasis area severity index) is the most commonly used and validated assessment for grading the severity of psoriasis in clinical studies. It is a physician's assessment of psoriasis that is a therapeutic standard in clinical studies for this disease. Displayed is the number of responders that reached an improvement of at least 50% in the PASI score in the respective week.

The full-analysis-set (FAS) included all randomized patients who received at least one dose of IMP and had at least one post-baseline assessment. The FAS was considered primary analysis set for the efficacy analysis.

Mean PGA score and change to baseline in treatment groups (150 and 300mg) compared to placebo at end of treatment. The PGA (Physician's global assessment) provides an overall evaluation of the severity of the disease ranging from 0 (clear skin - no diseases) to 6 (severe disease). For change from baseline negative values indicate improvement.

The full-analysis-set (FAS) included all randomized patients who received at least one dose of IMP and had at least one post-baseline assessment. The FAS was considered primary analysis set for the efficacy analysis.

The PGA (Physician's global assessment) provides an overall evaluation of the severity of the disease ranging from 0 (clear skin - no diseases) to 6 (severe disease). The 7-point's assessment of psoriasis is a therapeutic standard in clinical studies for this disease. Frequency of the scores from 0 to 6 at end of treatment in the different treatment groups is displayed.

The full-analysis-set (FAS) included all randomized patients who received at least one dose of IMP and had at least one post-baseline assessment. The FAS was considered primary analysis set for the efficacy analysis.

Mean BSA score and change to baseline in treatment groups (150 and 300mg) compared to placebo at end of treatment. The BSA (Body Surface Area) provides information on the total surface area of the body affected with psoriasis plaques in percent (%).

The full-analysis-set (FAS) included all randomized patients who received at least one dose of IMP and had at least one post-baseline assessment. The FAS was considered primary analysis set for the efficacy analysis.

Percentage of patients reaching PASI 75 in treatment groups (150 and 300 mg bid) compared to placebo. The PASI (psoriasis area severity index) is the most commonly used and validated assessment for grading the severity of psoriasis in clinical studies and combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease) wherein any value higher than 10 is considered as moderate to severe psoriasis. The number of responders corresponds to the number of patients with an improvement of at least 75% in the PASI score at the respective visit (week 4) compared to baseline.

The full-analysis-set (FAS) included all randomized patients who received at least one dose of IMP and had at least one post-baseline assessment. The FAS was considered primary analysis set for the efficacy analysis.

Percentage of patients reaching PASI 75 in treatment groups (150 and 300 mg bid) compared to placebo. The PASI (psoriasis area severity index) is the most commonly used and validated assessment for grading the severity of psoriasis in clinical studies and combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease) wherein any value higher than 10 is considered as moderate to severe psoriasis. The number of responders corresponds to the number of patients with an improvement of at least 75% in the PASI score at the respective visit (week 8) compared to baseline.

The full-analysis-set (FAS) included all randomized patients who received at least one dose of IMP and had at least one post-baseline assessment. The FAS was considered primary analysis set for the efficacy analysis.

Percentage of patients reaching PASI 75 in treatment groups (150 and 300 mg bid) compared to placebo. The PASI (psoriasis area severity index) is the most commonly used and validated assessment for grading the severity of psoriasis in clinical studies and combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease) wherein any value higher than 10 is considered as moderate to severe psoriasis. The number of responders corresponds to the number of patients with an improvement of at least 75% in the PASI score at the respective visit (Follow Up) compared to baseline.

The full-analysis-set (FAS) included all randomized patients who received at least one dose of IMP and had at least one post-baseline assessment. The FAS was considered primary analysis set for the efficacy analysis.

Percentage of patients reaching PASI 50 in treatment groups (150 and 300 mg bid) compared to placebo. The PASI (psoriasis area severity index) is the most commonly used and validated assessment for grading the severity of psoriasis in clinical studies and combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease) wherein any value higher than 10 is considered as moderate to severe psoriasis. The number of responders corresponds to the number of patients with an improvement of at least 50% in the PASI score at the respective visit (week 4) compared to baseline.

The full-analysis-set (FAS) included all randomized patients who received at least one dose of IMP and had at least one post-baseline assessment. The FAS was considered primary analysis set for the efficacy analysis.

Percentage of patients reaching PASI 50 in treatment groups (150 and 300 mg bid) compared to placebo. The PASI (psoriasis area severity index) is the most commonly used and validated assessment for grading the severity of psoriasis in clinical studies and combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease) wherein any value higher than 10 is considered as moderate to severe psoriasis. The number of responders corresponds to the number of patients with an improvement of at least 50% in the PASI score at the respective visit (week 8) compared to baseline.

The full-analysis-set (FAS) included all randomized patients who received at least one dose of IMP and had at least one post-baseline assessment. The FAS was considered primary analysis set for the efficacy analysis.

Percentage of patients reaching PASI 50 in treatment groups (150 and 300 mg bid) compared to placebo. The PASI (psoriasis area severity index) is the most commonly used and validated assessment for grading the severity of psoriasis in clinical studies and combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease) wherein any value higher than 10 is considered as moderate to severe psoriasis. The number of responders corresponds to the number of patients with an improvement of at least 50% in the PASI score at the respective visit (Follow Up) compared to baseline.

The full-analysis-set (FAS) included all randomized patients who received at least one dose of IMP and had at least one post-baseline assessment. The FAS was considered primary analysis set for the efficacy analysis.

Mean PASI score and change to baseline in treatment groups (150 and 300mg) compared to placebo. The PASI (psoriasis area severity index) is the most commonly used and validated assessment for grading the severity of psoriasis in clinical studies and combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease) wherein any value higher than 10 is considered as moderate to severe psoriasis. Displayed are changes in the PASI score (LS mean estimates) at the respective visit (week 4) compared to baseline in the different arms in patients of the FAS subject analysis set wherein negative values indicate a better outcome.

The full-analysis-set (FAS) included all randomized patients who received at least one dose of IMP and had at least one post-baseline assessment. The FAS was considered primary analysis set for the efficacy analysis.

Mean PASI score and change to baseline in treatment groups (150 and 300mg) compared to placebo. The PASI (psoriasis area severity index) is the most commonly used and validated assessment for grading the severity of psoriasis in clinical studies with a maximum value of 72 points, any value higher than 10 is considered as moderate to severe psoriasis. It is a physician's assessment of psoriasis that is a therapeutic standard in clinical studies for this disease. Displayed are changes in the PASI score (LS mean estimates) at the respective visit (week 8) compared to baseline in the different arms in patients of the FAS subject analysis set wherein negative values indicate a better outcome.

The full-analysis-set (FAS) included all randomized patients who received at least one dose of IMP and had at least one post-baseline assessment. The FAS was considered primary analysis set for the efficacy analysis.

Mean PASI score and change to baseline in treatment groups (150 and 300mg) compared to placebo. The PASI (psoriasis area severity index) is the most commonly used and validated assessment for grading the severity of psoriasis in clinical studies and combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease) wherein any value higher than 10 is considered as moderate to severe psoriasis. Displayed are changes in the PASI score (LS mean estimates) at the respective visit (week 16, FU) compared to baseline in the different arms in patients of the FAS subject analysis set wherein negative values indicate a better outcome.

The full-analysis-set (FAS) included all randomized patients who received at least one dose of IMP and had at least one post-baseline assessment. The FAS was considered primary analysis set for the efficacy analysis.

Mean PASI score and change to baseline in treatment groups (150 and 300mg) compared to placebo. The PASI (psoriasis area severity index) is the most commonly used and validated assessment for grading the severity of psoriasis in clinical studies and combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease) wherein any value higher than 10 is considered as moderate to severe psoriasis. For the change of baseline negative values indicate improvement and positive values indicate worsening.

The full-analysis-set (FAS) included all randomized patients who received at least one dose of IMP and had at least one post-baseline assessment. The FAS was considered primary analysis set for the efficacy analysis.

Mean PASI score and change to baseline in treatment groups (150 and 300mg) compared to placebo. The PASI (psoriasis area severity index) is the most commonly used and validated assessment for grading the severity of psoriasis in clinical studies and combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease) wherein any value higher than 10 is considered as moderate to severe psoriasis. For the change of baseline negative values indicate improvement and positive values indicate worsening.

The full-analysis-set (FAS) included all randomized patients who received at least one dose of IMP and had at least one post-baseline assessment. The FAS was considered primary analysis set for the efficacy analysis.

Mean PASI score and change to baseline in treatment groups (150 and 300mg) compared to placebo. The PASI (psoriasis area severity index) is the most commonly used and validated assessment for grading the severity of psoriasis in clinical studies and combines the assessment of the severity of lesions and the area affected into a single score in the range 0 (no disease) to 72 (maximal disease) wherein any value higher than 10 is considered as moderate to severe psoriasis. For the change of baseline negative values indicate improvement and positive values indicate worsening.

The full-analysis-set (FAS) included all randomized patients who received at least one dose of IMP and had at least one post-baseline assessment. The FAS was considered primary analysis set for the efficacy analysis.

PGA improvement rate in treatment groups (150 and 300 mg bid) compared to placebo. The PGA (Physician's global assessment) provides an overall evaluation of the severity of the disease ranging from 0 (clear skin - no diseases) to 6 (severe disease). The number of responders corresponds to the number of patients with an improvement of 1 or more points on the 7-points PGA scale at the respective visit (week 4) compared to baseline.

The full-analysis-set (FAS) included all randomized patients who received at least one dose of IMP and had at least one post-baseline assessment. The FAS was considered primary analysis set for the efficacy analysis.

PGA improvement rate in treatment groups (150 and 300 mg bid) compared to placebo. The PGA (Physician's global assessment) provides an overall evaluation of the severity of the disease ranging from 0 (clear skin - no diseases) to 6 (severe disease). The number of responders corresponds to the number of patients with an improvement of 1 or more points on the 7-points PGA scale at the respective visit (week 8) compared to baseline.

The full-analysis-set (FAS) included all randomized patients who received at least one dose of IMP and had at least one post-baseline assessment. The FAS was considered primary analysis set for the efficacy analysis.

PGA improvement rate in treatment groups (150 and 300 mg bid) compared to placebo. The PGA (Physician's global assessment) provides an overall evaluation of the severity of the disease ranging from 0 (clear skin - no diseases) to 6 (severe disease). The number of responders corresponds to the number of patients with an improvement of 1 or more points on the 7-points PGA scale at the respective visit (Follow Up) compared to baseline.

The full-analysis-set (FAS) included all randomized patients who received at least one dose of IMP and had at least one post-baseline assessment. The FAS was considered primary analysis set for the efficacy analysis.

Mean PGA score and change to baseline in treatment groups (150 and 300mg) compared to placebo at the respective visit (week 4). The PGA (Physician's global assessment) provides an overall evaluation of the severity of the disease ranging from 0 (clear skin - no diseases) to 6 (severe disease).

The full-analysis-set (FAS) included all randomized patients who received at least one dose of IMP and had at least one post-baseline assessment. The FAS was considered primary analysis set for the efficacy analysis.

Mean PGA score and change to baseline in treatment groups (150 and 300mg) compared to placebo at the respective visit (week 8). The PGA (Physician's global assessment) provides an overall evaluation of the severity of the disease ranging from 0 (clear skin - no diseases) to 6 (severe disease).

The full-analysis-set (FAS) included all randomized patients who received at least one dose of IMP and had at least one post-baseline assessment. The FAS was considered primary analysis set for the efficacy analysis.

Mean PGA score and change to baseline in treatment groups (150 and 300mg) compared to placebo at Follow Up visit. The PGA (Physician's global assessment) provides an overall evaluation of the severity of the disease ranging from 0 (clear skin - no diseases) to 6 (severe disease).

The full-analysis-set (FAS) included all randomized patients who received at least one dose of IMP and had at least one post-baseline assessment. The FAS was considered primary analysis set for the efficacy analysis.

The PGA (Physician's global assessment) provides an overall evaluation of the severity of the disease ranging from 0 (clear skin - no diseases) to 6 (severe disease). Frequency of different scores at the respective visit (baseline) is displayed.

The full-analysis-set (FAS) included all randomized patients who received at least one dose of IMP and had at least one post-baseline assessment. The FAS was considered primary analysis set for the efficacy analysis.

The PGA (Physician's global assessment) provides an overall evaluation of the severity of the disease ranging from 0 (clear skin - no diseases) to 6 (severe disease). Frequency of different scores at the respective visit (week 4) is displayed.

The full-analysis-set (FAS) included all randomized patients who received at least one dose of IMP and had at least one post-baseline assessment. The FAS was considered primary analysis set for the efficacy analysis.

The PGA (Physician's global assessment) provides an overall evaluation of the severity of the disease ranging from 0 (clear skin - no diseases) to 6 (severe disease). Frequency of different scores at the respective visit (week 8) is displayed.

The full-analysis-set (FAS) included all randomized patients who received at least one dose of IMP and had at least one post-baseline assessment. The FAS was considered primary analysis set for the efficacy analysis.

The PGA (Physician's global assessment) provides an overall evaluation of the severity of the disease ranging from 0 (clear skin - no diseases) to 6 (severe disease). Frequency of different scores at follow up visit is displayed.

The full-analysis-set (FAS) included all randomized patients who received at least one dose of IMP and had at least one post-baseline assessment. The FAS was considered primary analysis set for the efficacy analysis.

Mean BSA score and change to baseline in treatment groups (150 and 300mg) compared to placebo at the respective visit (week 4). The BSA (Body Surface Area) provides information on the total surface area of the body affected with psoriasis plaques in percent (%).

The full-analysis-set (FAS) included all randomized patients who received at least one dose of IMP and had at least one post-baseline assessment. The FAS was considered primary analysis set for the efficacy analysis.

Mean BSA score and change to baseline in treatment groups (150 and 300mg) compared to placebo at the respective visit (week 8). The BSA (Body Surface Area) provides information on the total surface area of the body affected with psoriasis plaques in percent (%).

The full-analysis-set (FAS) included all randomized patients who received at least one dose of IMP and had at least one post-baseline assessment. The FAS was considered primary analysis set for the efficacy analysis.

Mean BSA score and change to baseline in treatment groups (150 and 300mg) compared to placebo at follow up visit. The BSA (Body Surface Area) provides information on the total surface area of the body affected with psoriasis plaques in percent (%).

The full-analysis-set (FAS) included all randomized patients who received at least one dose of IMP and had at least one post-baseline assessment. The FAS was considered primary analysis set for the efficacy analysis.

The non-compartment parameter Cmax is the maximum MP1032 concentration observed based on the evaluation of systemic MP1032 concentrations in plasma samples wherein the respective blood samples were taken predose and 15, 30, 60 and 120 minutes after dosing.

The pharmacokinetics evaluation set (PKS) includes all patients without any protocol deviations that could have interfered with the administration of the treatment or the evaluation of systemic concentrations of MP1032, who received at least one dose of IMP and who had any completed determination of MP1032 levels.

The non-compartment parameter tmax is the time point (effective) at which the maximum concentration (Cmax) was observed based on the evaluation of systemic MP1032 concentrations in plasma samples wherein the respective blood samples were taken predose and 15, 30, 60 and 120 minutes after dosing.

The pharmacokinetics evaluation set (PKS) includes all patients without any protocol deviations that could have interfered with the administration of the treatment or the evaluation of systemic concentrations of MP1032, who received at least one dose of IMP and who had any completed determination of MP1032 levels.

The non-compartment parameter AUC(0,t) is the area under the concentration-time curve up to the last quantifiable sample drawn based on the evaluation of systemic MP1032 concentrations in plasma samples wherein the respective blood samples were taken predose and 15, 30, 60 and 120 minutes after dosing.

The pharmacokinetics evaluation set (PKS) includes all patients without any protocol deviations that could have interfered with the administration of the treatment or the evaluation of systemic concentrations of MP1032, who received at least one dose of IMP and who had any completed determination of MP1032 levels.

Number of patients with treatment emergent adverse events (TEAEs) in treatment groups compared to placebo

The safety-evaluation-set (SES) included all patients who received any trial medication at least once.

Number of patients with serious treatment emergent adverse events (TEAEs) in treatment groups compared to placebo

The safety-evaluation-set (SES) included all patients who received any trial medication at least once.

Number of patients with treatment emergent adverse events (TEAEs) leading to study discontinuation in treatment groups compared to placebo

The safety-evaluation-set (SES) included all patients who received any trial medication at least once.

Number of patients with treatment emergent adverse events (TEAEs) in treatment groups compared to placebo displayed by MedDRA System Organ Classes (SOCs). Only PTs (MedDRA Preferred Terms) occuring in at least 5% of the patients were considered for this overview.

The safety-evaluation-set (SES) included all patients who received any trial medication at least once.

Number of patients with treatment emergent adverse events (TEAEs) in treatment groups compared to placebo displayed by severity

The safety-evaluation-set (SES) included all patients who received any trial medication at least once.

Number of patients with treatment emergent adverse events (TEAEs) in treatment groups compared to placebo displayed according to investigators causality assessment.

The safety-evaluation-set (SES) included all patients who received any trial medication at least once.

Number of patients with treatment emergent adverse events (TEAEs) in treatment groups compared to placebo displayed according to investigators causality assessment wherein "certainly", "probably" and "possibly related" were summarized as "related" whereas "unlikely" and "not related" were summarized as "not related".

The safety-evaluation-set (SES) included all patients who received any trial medication at least once.

Total (cumulative) number of dosed capsules = 6 * # planned applications - # missed capsules + # overdose capsules.

Planned were 2 applications (a 6 capsules) twice a day over a treatment period of 12 weeks. The number of missed and/or overdosed capsules is determined based on the restitution of used study drug packages.

The safety-evaluation-set (SES) included all patients who received any trial medication at least once.

Average number of capsules per application = # dosed capsules / # applications.

Planned were 2 applications (a 6 capsules) twice a day over a treatment period of 12 weeks. The number of missed and/or overdosed capsules is determined based on the restitution of used study drug packages.

The safety-evaluation-set (SES) included all patients who received any trial medication at least once.

Average number of capsules per day = # dosed capsules / days of treatment.

Planned were 2 applications (a 6 capsules) twice a day over a treatment period of 12 weeks. The number of missed and/or overdosed capsules is determined based on the restitution of used study drug packages.

The safety-evaluation-set (SES) included all patients who received any trial medication at least once.

Exposure was regarded as sufficient if the patient took at least 80% of planned applications (respectively capsules) wherein % exposure was calculated as 100 * # dosed capsules / # planned capsules.

Planned were 2 applications (a 6 capsules) twice a day over a treatment period of 12 weeks (i.e. 1008 capsules). The number of missed and/or overdosed capsules is determined based on the restitution of used study drug packages.

The safety-evaluation-set (SES) included all patients who received any trial medication at least once.

Treatment duration = date of last dose - date of first dose + 1. 84 treatment days (12 weeks) were planned.

The safety-evaluation-set (SES) included all patients who received any trial medication at least once.