Trial Outcomes & Findings for A Dose-finding Study of OPC-6535 in Patients With Active Crohn's Disease (NCT NCT00317369)

NCT ID: NCT00317369

Last Updated: 2021-02-15

Results Overview

Definition of clinical improvement: Total Crohn's Disease Activity Index (CDAI) score improved by at least 70 points from the baseline score or to below 150 (CDAI \< 150: Remission, CDAI \> 450: severe disease)

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 29 participants
• Primary outcome timeframe: Week 8
• Results posted on: 2021-02-15

Participant Flow

Participant milestones

Measure	OPC-6535 25 mg 25 mg OPC-6535 orally administered once daily in the morning for 8 weeks.	OPC-6535 50 mg 25 mg OPC-6535 orally administered once daily in the morning for the first week, and the dose was increased to 50 mg for the remaining 7 weeks.	Placebo 0 mg OPC-6535 orally administered once daily in the morning for 8 weeks.
Overall Study STARTED	10	9	10
Overall Study COMPLETED	8	7	8
Overall Study NOT COMPLETED	2	2	2

Reasons for withdrawal

Measure	OPC-6535 25 mg 25 mg OPC-6535 orally administered once daily in the morning for 8 weeks.	OPC-6535 50 mg 25 mg OPC-6535 orally administered once daily in the morning for the first week, and the dose was increased to 50 mg for the remaining 7 weeks.	Placebo 0 mg OPC-6535 orally administered once daily in the morning for 8 weeks.
Overall Study Adverse Event	2	1	0
Overall Study Lack of Efficacy	0	1	1
Overall Study Withdrawal by Subject	0	0	1

Baseline Characteristics

A Dose-finding Study of OPC-6535 in Patients With Active Crohn's Disease

Baseline characteristics by cohort

Measure	OPC-6535 25 mg n=10 Participants 25 mg OPC-6535 orally administered once daily in the morning for 8 weeks.	OPC-6535 50 mg n=9 Participants 25 mg OPC-6535 orally administered once daily in the morning for the first week, and the dose was increased to 50 mg for the remaining 7 weeks.	Placebo n=10 Participants 0 mg OPC-6535 orally administered once daily in the morning for 8 weeks.	Total n=29 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants	9 Participants n=7 Participants	10 Participants n=5 Participants	29 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Continuous	35.5 years STANDARD_DEVIATION 9.9 • n=5 Participants	36.7 years STANDARD_DEVIATION 15.0 • n=7 Participants	33.4 years STANDARD_DEVIATION 6.3 • n=5 Participants	35.1 years STANDARD_DEVIATION 10.5 • n=4 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	5 Participants n=4 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	8 Participants n=7 Participants	10 Participants n=5 Participants	24 Participants n=4 Participants
Race/Ethnicity, Customized Japanese	10 Participants n=5 Participants	9 Participants n=7 Participants	10 Participants n=5 Participants	29 Participants n=4 Participants
Region of Enrollment Japan	10 Participants n=5 Participants	9 Participants n=7 Participants	10 Participants n=5 Participants	29 Participants n=4 Participants

PRIMARY outcome

Timeframe: Week 8

Population: Efficacy was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the efficacy endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.

Definition of clinical improvement: Total Crohn's Disease Activity Index (CDAI) score improved by at least 70 points from the baseline score or to below 150 (CDAI < 150: Remission, CDAI > 450: severe disease)

Outcome measures

Measure	OPC-6535 25 mg n=10 Participants 25 mg OPC-6535 orally administered once daily in the morning for 8 weeks.	OPC-6535 50 mg n=9 Participants 25 mg OPC-6535 orally administered once daily in the morning for the first week, and the dose was increased to 50 mg for the remaining 7 weeks.	Placebo n=10 Participants 0 mg OPC-6535 orally administered once daily in the morning for 8 weeks.
Clinical Improvement Rate (Number of Subjects Showing Clinical Improvement/Number of Subjects Evaluated x 100) After 8 Weeks of Study Drug Administration	20.0 percentage of participants Interval 2.5 to 55.6	33.3 percentage of participants Interval 7.5 to 70.1	10.0 percentage of participants Interval 0.3 to 44.5

SECONDARY outcome

Timeframe: Week 2, Week 4

Population: Efficacy was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the efficacy endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.

Definition of clinical improvement: Total CDAI score improved by at least 70 points from the baseline score or to below 150 (CDAI < 150: Remission, CDAI > 450: severe disease)

Outcome measures

Measure	OPC-6535 25 mg n=10 Participants 25 mg OPC-6535 orally administered once daily in the morning for 8 weeks.	OPC-6535 50 mg n=9 Participants 25 mg OPC-6535 orally administered once daily in the morning for the first week, and the dose was increased to 50 mg for the remaining 7 weeks.	Placebo n=10 Participants 0 mg OPC-6535 orally administered once daily in the morning for 8 weeks.
Clinical Improvement Rate After 2 and 4 Weeks of Study Drug Administration Week 2	20.0 percentage of participants Interval 2.5 to 55.6	22.2 percentage of participants Interval 2.8 to 60.0	0.0 percentage of participants Interval 0.0 to 30.8
Clinical Improvement Rate After 2 and 4 Weeks of Study Drug Administration Week 4	20.0 percentage of participants Interval 2.5 to 55.6	22.2 percentage of participants Interval 2.8 to 60.0	10.0 percentage of participants Interval 0.3 to 44.5

SECONDARY outcome

Timeframe: Week 2, Week 4，Week 8

Population: Efficacy was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the efficacy endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.

Definition of remission: Total CDAI score improved to below 150

Outcome measures

Measure	OPC-6535 25 mg n=10 Participants 25 mg OPC-6535 orally administered once daily in the morning for 8 weeks.	OPC-6535 50 mg n=9 Participants 25 mg OPC-6535 orally administered once daily in the morning for the first week, and the dose was increased to 50 mg for the remaining 7 weeks.	Placebo n=10 Participants 0 mg OPC-6535 orally administered once daily in the morning for 8 weeks.
Remission Rate (Number of Patients Showing Remission/Number of Patients Evaluated x 100) After 2, 4, and 8 Weeks of Study Drug Administration Week 2	10.0 percentage of participants Interval 0.3 to 44.5	11.1 percentage of participants Interval 0.3 to 48.2	0.0 percentage of participants Interval 0.0 to 30.8
Remission Rate (Number of Patients Showing Remission/Number of Patients Evaluated x 100) After 2, 4, and 8 Weeks of Study Drug Administration Week 4	20.0 percentage of participants Interval 2.5 to 55.6	11.1 percentage of participants Interval 0.3 to 48.2	0.0 percentage of participants Interval 0.0 to 30.8
Remission Rate (Number of Patients Showing Remission/Number of Patients Evaluated x 100) After 2, 4, and 8 Weeks of Study Drug Administration Week 8	20.0 percentage of participants Interval 2.5 to 55.6	11.1 percentage of participants Interval 0.3 to 48.2	0.0 percentage of participants Interval 0.0 to 30.8

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, and 8

Population: Efficacy was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the efficacy endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.

Definition of clinical improvement (50) : Total CDAI score improved by at least 50 points from the baseline score or to below 150 (CDAI < 150: Remission, CDAI > 450: severe disease)

Outcome measures

Measure	OPC-6535 25 mg n=10 Participants 25 mg OPC-6535 orally administered once daily in the morning for 8 weeks.	OPC-6535 50 mg n=9 Participants 25 mg OPC-6535 orally administered once daily in the morning for the first week, and the dose was increased to 50 mg for the remaining 7 weeks.	Placebo n=10 Participants 0 mg OPC-6535 orally administered once daily in the morning for 8 weeks.
Clinical Improvement Rate (50) by Change in Total CDAI Score (Number of Subjects for Each Change/Number of Subjects Evaluated x 100) After 2, 4, and 8 Weeks of Study Drug Administration Week 2	30.0 percentage of participants Interval 6.7 to 65.2	22.2 percentage of participants Interval 2.8 to 60.0	10.0 percentage of participants Interval 0.3 to 44.5
Clinical Improvement Rate (50) by Change in Total CDAI Score (Number of Subjects for Each Change/Number of Subjects Evaluated x 100) After 2, 4, and 8 Weeks of Study Drug Administration Week 4	30.0 percentage of participants Interval 6.7 to 65.2	22.2 percentage of participants Interval 2.8 to 60.0	30.0 percentage of participants Interval 6.7 to 65.2
Clinical Improvement Rate (50) by Change in Total CDAI Score (Number of Subjects for Each Change/Number of Subjects Evaluated x 100) After 2, 4, and 8 Weeks of Study Drug Administration Week 8	30.0 percentage of participants Interval 6.7 to 65.2	33.3 percentage of participants Interval 7.5 to 70.1	20.0 percentage of participants Interval 2.5 to 55.6

SECONDARY outcome

Timeframe: Baseline, Weeks 2, 4, and 8

Population: Efficacy was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the efficacy endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.

CDAI scores range approximately from 0 to 600, higher scores indicating greater disease activity (CDAI < 150: Remission, CDAI > 450: Very severe). A negative change in mean score indicates improvement.

Outcome measures

Measure	OPC-6535 25 mg n=10 Participants 25 mg OPC-6535 orally administered once daily in the morning for 8 weeks.	OPC-6535 50 mg n=9 Participants 25 mg OPC-6535 orally administered once daily in the morning for the first week, and the dose was increased to 50 mg for the remaining 7 weeks.	Placebo n=10 Participants 0 mg OPC-6535 orally administered once daily in the morning for 8 weeks.
Mean Change From Baseline in Total CDAI Score After 2, 4, and 8 Weeks of Study Drug Administration Week 2	-19.4 score on a scale Standard Deviation 46.5	-4.1 score on a scale Standard Deviation 57.9	-8.8 score on a scale Standard Deviation 25.9
Mean Change From Baseline in Total CDAI Score After 2, 4, and 8 Weeks of Study Drug Administration Week 4	-17.1 score on a scale Standard Deviation 77.6	-22.1 score on a scale Standard Deviation 78.2	-23.5 score on a scale Standard Deviation 32.0
Mean Change From Baseline in Total CDAI Score After 2, 4, and 8 Weeks of Study Drug Administration Week 8	-30.3 score on a scale Standard Deviation 60.3	-32.3 score on a scale Standard Deviation 80.4	-31.2 score on a scale Standard Deviation 51.4

SECONDARY outcome

Timeframe: Baseline, Week 8

Population: Efficacy was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the efficacy endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.

The IBDQ has been frequently adopted in Japanese and overseas clinical assessments as a scale for evaluating the quality of life (QOL) of patients with inflammatory bowel disease. The IBDQ score was calculated as the sum of the responses (each ranging from 1 to 7) to all 32 questions that address symptoms as a result of Crohn's disease: bowel symptoms, systemic symptoms, emotional function, and social function. Total IBDQ score ranges from 32 to 224 with a higher score indicating a better QOL.

Outcome measures

Measure	OPC-6535 25 mg n=10 Participants 25 mg OPC-6535 orally administered once daily in the morning for 8 weeks.	OPC-6535 50 mg n=9 Participants 25 mg OPC-6535 orally administered once daily in the morning for the first week, and the dose was increased to 50 mg for the remaining 7 weeks.	Placebo n=10 Participants 0 mg OPC-6535 orally administered once daily in the morning for 8 weeks.
Mean Change From the Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Score After 8 Weeks of Study Drug Administration	11.6 score on a scale Standard Deviation 19.7	1.4 score on a scale Standard Deviation 14.6	5.0 score on a scale Standard Deviation 17.0

SECONDARY outcome

Timeframe: Baseline, Week 8

Population: Efficacy was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the efficacy endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.

Large bowel endoscopic findings were assessed based on the CDEIS. The CDEIS considers deep ulcer, superficial ulcer, lesion ratio of , and ulcer ratio of the 5 pre-defined segments of the colon (small intestine, right colon, transverse colon, left colon, and rectum). The score ranges from 0 to 44 where higher scores indicate more severe disease.

Outcome measures

Measure	OPC-6535 25 mg 25 mg OPC-6535 orally administered once daily in the morning for 8 weeks.	OPC-6535 50 mg 25 mg OPC-6535 orally administered once daily in the morning for the first week, and the dose was increased to 50 mg for the remaining 7 weeks.	Placebo n=1 Participants 0 mg OPC-6535 orally administered once daily in the morning for 8 weeks.
Mean Change From the Baseline in Crohn's Disease Endoscopic Index of Severity (CDEIS) Score After 8 Weeks of Study Drug Administration	—	—	-4.0 score on a scale

SECONDARY outcome

Timeframe: Baseline, Weeks 4 and 8

Population: Efficacy was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the efficacy endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.

Outcome measures

Measure	OPC-6535 25 mg n=10 Participants 25 mg OPC-6535 orally administered once daily in the morning for 8 weeks.	OPC-6535 50 mg n=9 Participants 25 mg OPC-6535 orally administered once daily in the morning for the first week, and the dose was increased to 50 mg for the remaining 7 weeks.	Placebo n=10 Participants 0 mg OPC-6535 orally administered once daily in the morning for 8 weeks.
Mean Change in C-reactive Protein (CRP) Level From the Baseline After 4 and 8 Weeks of Study Drug Administration Week 4	-0.65 mg/dL Standard Deviation 0.72	-1.49 mg/dL Standard Deviation 2.06	0.52 mg/dL Standard Deviation 1.19
Mean Change in C-reactive Protein (CRP) Level From the Baseline After 4 and 8 Weeks of Study Drug Administration Week 8	-0.63 mg/dL Standard Deviation 0.99	-1.21 mg/dL Standard Deviation 1.90	1.26 mg/dL Standard Deviation 2.05

Adverse Events

OPC-6535 25 mg

Serious events: 1 serious events

Other events: 9 other events

Deaths: 0 deaths

OPC-6535 50 mg

Serious events: 2 serious events

Other events: 9 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Measure	OPC-6535 25 mg n=10 participants at risk 25 mg OPC-6535 orally administered once daily in the morning for 8 weeks.	OPC-6535 50 mg n=9 participants at risk 25 mg OPC-6535 orally administered once daily in the morning for the first week, and the dose was increased to 50 mg for the remaining 7 weeks.	Placebo n=10 participants at risk 0 mg OPC-6535 orally administered once daily in the morning for 8 weeks.
Gastrointestinal disorders Anal fistula	0.00% 0/10 • Adverse Events (AEs) occurred during the period from treatment initiation to the completion of examinations at Week 8 of the study drug administration, and serious AEs (SAEs) observed prior to the post-trial investigation (from 14 to 21 days after the completion date of the trial period), regardless of the causal relationship with the study drug, were to be reported and analyzed in the trial. Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.	11.1% 1/9 • Adverse Events (AEs) occurred during the period from treatment initiation to the completion of examinations at Week 8 of the study drug administration, and serious AEs (SAEs) observed prior to the post-trial investigation (from 14 to 21 days after the completion date of the trial period), regardless of the causal relationship with the study drug, were to be reported and analyzed in the trial. Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.	0.00% 0/10 • Adverse Events (AEs) occurred during the period from treatment initiation to the completion of examinations at Week 8 of the study drug administration, and serious AEs (SAEs) observed prior to the post-trial investigation (from 14 to 21 days after the completion date of the trial period), regardless of the causal relationship with the study drug, were to be reported and analyzed in the trial. Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.
Gastrointestinal disorders Subileus	10.0% 1/10 • Adverse Events (AEs) occurred during the period from treatment initiation to the completion of examinations at Week 8 of the study drug administration, and serious AEs (SAEs) observed prior to the post-trial investigation (from 14 to 21 days after the completion date of the trial period), regardless of the causal relationship with the study drug, were to be reported and analyzed in the trial. Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.	0.00% 0/9 • Adverse Events (AEs) occurred during the period from treatment initiation to the completion of examinations at Week 8 of the study drug administration, and serious AEs (SAEs) observed prior to the post-trial investigation (from 14 to 21 days after the completion date of the trial period), regardless of the causal relationship with the study drug, were to be reported and analyzed in the trial. Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.	0.00% 0/10 • Adverse Events (AEs) occurred during the period from treatment initiation to the completion of examinations at Week 8 of the study drug administration, and serious AEs (SAEs) observed prior to the post-trial investigation (from 14 to 21 days after the completion date of the trial period), regardless of the causal relationship with the study drug, were to be reported and analyzed in the trial. Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.
Renal and urinary disorders Haematuria	0.00% 0/10 • Adverse Events (AEs) occurred during the period from treatment initiation to the completion of examinations at Week 8 of the study drug administration, and serious AEs (SAEs) observed prior to the post-trial investigation (from 14 to 21 days after the completion date of the trial period), regardless of the causal relationship with the study drug, were to be reported and analyzed in the trial. Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.	11.1% 1/9 • Adverse Events (AEs) occurred during the period from treatment initiation to the completion of examinations at Week 8 of the study drug administration, and serious AEs (SAEs) observed prior to the post-trial investigation (from 14 to 21 days after the completion date of the trial period), regardless of the causal relationship with the study drug, were to be reported and analyzed in the trial. Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.	0.00% 0/10 • Adverse Events (AEs) occurred during the period from treatment initiation to the completion of examinations at Week 8 of the study drug administration, and serious AEs (SAEs) observed prior to the post-trial investigation (from 14 to 21 days after the completion date of the trial period), regardless of the causal relationship with the study drug, were to be reported and analyzed in the trial. Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.

Other adverse events

Measure	OPC-6535 25 mg n=10 participants at risk 25 mg OPC-6535 orally administered once daily in the morning for 8 weeks.	OPC-6535 50 mg n=9 participants at risk 25 mg OPC-6535 orally administered once daily in the morning for the first week, and the dose was increased to 50 mg for the remaining 7 weeks.	Placebo n=10 participants at risk 0 mg OPC-6535 orally administered once daily in the morning for 8 weeks.
Cardiac disorders Supraventricular extrasystoles	0.00% 0/10 • Adverse Events (AEs) occurred during the period from treatment initiation to the completion of examinations at Week 8 of the study drug administration, and serious AEs (SAEs) observed prior to the post-trial investigation (from 14 to 21 days after the completion date of the trial period), regardless of the causal relationship with the study drug, were to be reported and analyzed in the trial. Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.	11.1% 1/9 • Adverse Events (AEs) occurred during the period from treatment initiation to the completion of examinations at Week 8 of the study drug administration, and serious AEs (SAEs) observed prior to the post-trial investigation (from 14 to 21 days after the completion date of the trial period), regardless of the causal relationship with the study drug, were to be reported and analyzed in the trial. Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.	0.00% 0/10 • Adverse Events (AEs) occurred during the period from treatment initiation to the completion of examinations at Week 8 of the study drug administration, and serious AEs (SAEs) observed prior to the post-trial investigation (from 14 to 21 days after the completion date of the trial period), regardless of the causal relationship with the study drug, were to be reported and analyzed in the trial. Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.
Eye disorders Conjunctivitis	0.00% 0/10 • Adverse Events (AEs) occurred during the period from treatment initiation to the completion of examinations at Week 8 of the study drug administration, and serious AEs (SAEs) observed prior to the post-trial investigation (from 14 to 21 days after the completion date of the trial period), regardless of the causal relationship with the study drug, were to be reported and analyzed in the trial. Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.	0.00% 0/9 • Adverse Events (AEs) occurred during the period from treatment initiation to the completion of examinations at Week 8 of the study drug administration, and serious AEs (SAEs) observed prior to the post-trial investigation (from 14 to 21 days after the completion date of the trial period), regardless of the causal relationship with the study drug, were to be reported and analyzed in the trial. Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.	10.0% 1/10 • Adverse Events (AEs) occurred during the period from treatment initiation to the completion of examinations at Week 8 of the study drug administration, and serious AEs (SAEs) observed prior to the post-trial investigation (from 14 to 21 days after the completion date of the trial period), regardless of the causal relationship with the study drug, were to be reported and analyzed in the trial. Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.
Gastrointestinal disorders Abdominal distension	0.00% 0/10 • Adverse Events (AEs) occurred during the period from treatment initiation to the completion of examinations at Week 8 of the study drug administration, and serious AEs (SAEs) observed prior to the post-trial investigation (from 14 to 21 days after the completion date of the trial period), regardless of the causal relationship with the study drug, were to be reported and analyzed in the trial. Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.	11.1% 1/9 • Adverse Events (AEs) occurred during the period from treatment initiation to the completion of examinations at Week 8 of the study drug administration, and serious AEs (SAEs) observed prior to the post-trial investigation (from 14 to 21 days after the completion date of the trial period), regardless of the causal relationship with the study drug, were to be reported and analyzed in the trial. Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.	0.00% 0/10 • Adverse Events (AEs) occurred during the period from treatment initiation to the completion of examinations at Week 8 of the study drug administration, and serious AEs (SAEs) observed prior to the post-trial investigation (from 14 to 21 days after the completion date of the trial period), regardless of the causal relationship with the study drug, were to be reported and analyzed in the trial. Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.
Gastrointestinal disorders Abdominal pain	10.0% 1/10 • Adverse Events (AEs) occurred during the period from treatment initiation to the completion of examinations at Week 8 of the study drug administration, and serious AEs (SAEs) observed prior to the post-trial investigation (from 14 to 21 days after the completion date of the trial period), regardless of the causal relationship with the study drug, were to be reported and analyzed in the trial. Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.	0.00% 0/9 • Adverse Events (AEs) occurred during the period from treatment initiation to the completion of examinations at Week 8 of the study drug administration, and serious AEs (SAEs) observed prior to the post-trial investigation (from 14 to 21 days after the completion date of the trial period), regardless of the causal relationship with the study drug, were to be reported and analyzed in the trial. Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.	0.00% 0/10 • Adverse Events (AEs) occurred during the period from treatment initiation to the completion of examinations at Week 8 of the study drug administration, and serious AEs (SAEs) observed prior to the post-trial investigation (from 14 to 21 days after the completion date of the trial period), regardless of the causal relationship with the study drug, were to be reported and analyzed in the trial. Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.
Gastrointestinal disorders Abdominal pain lower	0.00% 0/10 • Adverse Events (AEs) occurred during the period from treatment initiation to the completion of examinations at Week 8 of the study drug administration, and serious AEs (SAEs) observed prior to the post-trial investigation (from 14 to 21 days after the completion date of the trial period), regardless of the causal relationship with the study drug, were to be reported and analyzed in the trial. Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.	11.1% 1/9 • Adverse Events (AEs) occurred during the period from treatment initiation to the completion of examinations at Week 8 of the study drug administration, and serious AEs (SAEs) observed prior to the post-trial investigation (from 14 to 21 days after the completion date of the trial period), regardless of the causal relationship with the study drug, were to be reported and analyzed in the trial. Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.	0.00% 0/10 • Adverse Events (AEs) occurred during the period from treatment initiation to the completion of examinations at Week 8 of the study drug administration, and serious AEs (SAEs) observed prior to the post-trial investigation (from 14 to 21 days after the completion date of the trial period), regardless of the causal relationship with the study drug, were to be reported and analyzed in the trial. Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/10 • Adverse Events (AEs) occurred during the period from treatment initiation to the completion of examinations at Week 8 of the study drug administration, and serious AEs (SAEs) observed prior to the post-trial investigation (from 14 to 21 days after the completion date of the trial period), regardless of the causal relationship with the study drug, were to be reported and analyzed in the trial. Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.	11.1% 1/9 • Adverse Events (AEs) occurred during the period from treatment initiation to the completion of examinations at Week 8 of the study drug administration, and serious AEs (SAEs) observed prior to the post-trial investigation (from 14 to 21 days after the completion date of the trial period), regardless of the causal relationship with the study drug, were to be reported and analyzed in the trial. Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.	0.00% 0/10 • Adverse Events (AEs) occurred during the period from treatment initiation to the completion of examinations at Week 8 of the study drug administration, and serious AEs (SAEs) observed prior to the post-trial investigation (from 14 to 21 days after the completion date of the trial period), regardless of the causal relationship with the study drug, were to be reported and analyzed in the trial. Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.
Gastrointestinal disorders Anal fissure	0.00% 0/10 • Adverse Events (AEs) occurred during the period from treatment initiation to the completion of examinations at Week 8 of the study drug administration, and serious AEs (SAEs) observed prior to the post-trial investigation (from 14 to 21 days after the completion date of the trial period), regardless of the causal relationship with the study drug, were to be reported and analyzed in the trial. Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.	11.1% 1/9 • Adverse Events (AEs) occurred during the period from treatment initiation to the completion of examinations at Week 8 of the study drug administration, and serious AEs (SAEs) observed prior to the post-trial investigation (from 14 to 21 days after the completion date of the trial period), regardless of the causal relationship with the study drug, were to be reported and analyzed in the trial. Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.	0.00% 0/10 • Adverse Events (AEs) occurred during the period from treatment initiation to the completion of examinations at Week 8 of the study drug administration, and serious AEs (SAEs) observed prior to the post-trial investigation (from 14 to 21 days after the completion date of the trial period), regardless of the causal relationship with the study drug, were to be reported and analyzed in the trial. Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.
Gastrointestinal disorders Anorectal disorder	0.00% 0/10 • Adverse Events (AEs) occurred during the period from treatment initiation to the completion of examinations at Week 8 of the study drug administration, and serious AEs (SAEs) observed prior to the post-trial investigation (from 14 to 21 days after the completion date of the trial period), regardless of the causal relationship with the study drug, were to be reported and analyzed in the trial. Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.	0.00% 0/9 • Adverse Events (AEs) occurred during the period from treatment initiation to the completion of examinations at Week 8 of the study drug administration, and serious AEs (SAEs) observed prior to the post-trial investigation (from 14 to 21 days after the completion date of the trial period), regardless of the causal relationship with the study drug, were to be reported and analyzed in the trial. Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.	10.0% 1/10 • Adverse Events (AEs) occurred during the period from treatment initiation to the completion of examinations at Week 8 of the study drug administration, and serious AEs (SAEs) observed prior to the post-trial investigation (from 14 to 21 days after the completion date of the trial period), regardless of the causal relationship with the study drug, were to be reported and analyzed in the trial. Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.
Gastrointestinal disorders Crohn's disease	10.0% 1/10 • Adverse Events (AEs) occurred during the period from treatment initiation to the completion of examinations at Week 8 of the study drug administration, and serious AEs (SAEs) observed prior to the post-trial investigation (from 14 to 21 days after the completion date of the trial period), regardless of the causal relationship with the study drug, were to be reported and analyzed in the trial. Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.	22.2% 2/9 • Adverse Events (AEs) occurred during the period from treatment initiation to the completion of examinations at Week 8 of the study drug administration, and serious AEs (SAEs) observed prior to the post-trial investigation (from 14 to 21 days after the completion date of the trial period), regardless of the causal relationship with the study drug, were to be reported and analyzed in the trial. Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.	10.0% 1/10 • Adverse Events (AEs) occurred during the period from treatment initiation to the completion of examinations at Week 8 of the study drug administration, and serious AEs (SAEs) observed prior to the post-trial investigation (from 14 to 21 days after the completion date of the trial period), regardless of the causal relationship with the study drug, were to be reported and analyzed in the trial. Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.
Gastrointestinal disorders Diarrhoea	10.0% 1/10 • Adverse Events (AEs) occurred during the period from treatment initiation to the completion of examinations at Week 8 of the study drug administration, and serious AEs (SAEs) observed prior to the post-trial investigation (from 14 to 21 days after the completion date of the trial period), regardless of the causal relationship with the study drug, were to be reported and analyzed in the trial. Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.	0.00% 0/9 • Adverse Events (AEs) occurred during the period from treatment initiation to the completion of examinations at Week 8 of the study drug administration, and serious AEs (SAEs) observed prior to the post-trial investigation (from 14 to 21 days after the completion date of the trial period), regardless of the causal relationship with the study drug, were to be reported and analyzed in the trial. Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.	0.00% 0/10 • Adverse Events (AEs) occurred during the period from treatment initiation to the completion of examinations at Week 8 of the study drug administration, and serious AEs (SAEs) observed prior to the post-trial investigation (from 14 to 21 days after the completion date of the trial period), regardless of the causal relationship with the study drug, were to be reported and analyzed in the trial. Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.
Gastrointestinal disorders Dyspepsia	0.00% 0/10 • Adverse Events (AEs) occurred during the period from treatment initiation to the completion of examinations at Week 8 of the study drug administration, and serious AEs (SAEs) observed prior to the post-trial investigation (from 14 to 21 days after the completion date of the trial period), regardless of the causal relationship with the study drug, were to be reported and analyzed in the trial. Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.	0.00% 0/9 • Adverse Events (AEs) occurred during the period from treatment initiation to the completion of examinations at Week 8 of the study drug administration, and serious AEs (SAEs) observed prior to the post-trial investigation (from 14 to 21 days after the completion date of the trial period), regardless of the causal relationship with the study drug, were to be reported and analyzed in the trial. Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.	10.0% 1/10 • Adverse Events (AEs) occurred during the period from treatment initiation to the completion of examinations at Week 8 of the study drug administration, and serious AEs (SAEs) observed prior to the post-trial investigation (from 14 to 21 days after the completion date of the trial period), regardless of the causal relationship with the study drug, were to be reported and analyzed in the trial. Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.
Gastrointestinal disorders Eructation	0.00% 0/10 • Adverse Events (AEs) occurred during the period from treatment initiation to the completion of examinations at Week 8 of the study drug administration, and serious AEs (SAEs) observed prior to the post-trial investigation (from 14 to 21 days after the completion date of the trial period), regardless of the causal relationship with the study drug, were to be reported and analyzed in the trial. Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.	0.00% 0/9 • Adverse Events (AEs) occurred during the period from treatment initiation to the completion of examinations at Week 8 of the study drug administration, and serious AEs (SAEs) observed prior to the post-trial investigation (from 14 to 21 days after the completion date of the trial period), regardless of the causal relationship with the study drug, were to be reported and analyzed in the trial. Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.	10.0% 1/10 • Adverse Events (AEs) occurred during the period from treatment initiation to the completion of examinations at Week 8 of the study drug administration, and serious AEs (SAEs) observed prior to the post-trial investigation (from 14 to 21 days after the completion date of the trial period), regardless of the causal relationship with the study drug, were to be reported and analyzed in the trial. Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.
Gastrointestinal disorders Nausea	20.0% 2/10 • Adverse Events (AEs) occurred during the period from treatment initiation to the completion of examinations at Week 8 of the study drug administration, and serious AEs (SAEs) observed prior to the post-trial investigation (from 14 to 21 days after the completion date of the trial period), regardless of the causal relationship with the study drug, were to be reported and analyzed in the trial. Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.	44.4% 4/9 • Adverse Events (AEs) occurred during the period from treatment initiation to the completion of examinations at Week 8 of the study drug administration, and serious AEs (SAEs) observed prior to the post-trial investigation (from 14 to 21 days after the completion date of the trial period), regardless of the causal relationship with the study drug, were to be reported and analyzed in the trial. Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.	10.0% 1/10 • Adverse Events (AEs) occurred during the period from treatment initiation to the completion of examinations at Week 8 of the study drug administration, and serious AEs (SAEs) observed prior to the post-trial investigation (from 14 to 21 days after the completion date of the trial period), regardless of the causal relationship with the study drug, were to be reported and analyzed in the trial. Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.
General disorders Malaise	20.0% 2/10 • Adverse Events (AEs) occurred during the period from treatment initiation to the completion of examinations at Week 8 of the study drug administration, and serious AEs (SAEs) observed prior to the post-trial investigation (from 14 to 21 days after the completion date of the trial period), regardless of the causal relationship with the study drug, were to be reported and analyzed in the trial. Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.	44.4% 4/9 • Adverse Events (AEs) occurred during the period from treatment initiation to the completion of examinations at Week 8 of the study drug administration, and serious AEs (SAEs) observed prior to the post-trial investigation (from 14 to 21 days after the completion date of the trial period), regardless of the causal relationship with the study drug, were to be reported and analyzed in the trial. Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.	10.0% 1/10 • Adverse Events (AEs) occurred during the period from treatment initiation to the completion of examinations at Week 8 of the study drug administration, and serious AEs (SAEs) observed prior to the post-trial investigation (from 14 to 21 days after the completion date of the trial period), regardless of the causal relationship with the study drug, were to be reported and analyzed in the trial. Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.
General disorders Pyrexia	0.00% 0/10 • Adverse Events (AEs) occurred during the period from treatment initiation to the completion of examinations at Week 8 of the study drug administration, and serious AEs (SAEs) observed prior to the post-trial investigation (from 14 to 21 days after the completion date of the trial period), regardless of the causal relationship with the study drug, were to be reported and analyzed in the trial. Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.	22.2% 2/9 • Adverse Events (AEs) occurred during the period from treatment initiation to the completion of examinations at Week 8 of the study drug administration, and serious AEs (SAEs) observed prior to the post-trial investigation (from 14 to 21 days after the completion date of the trial period), regardless of the causal relationship with the study drug, were to be reported and analyzed in the trial. Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.	10.0% 1/10 • Adverse Events (AEs) occurred during the period from treatment initiation to the completion of examinations at Week 8 of the study drug administration, and serious AEs (SAEs) observed prior to the post-trial investigation (from 14 to 21 days after the completion date of the trial period), regardless of the causal relationship with the study drug, were to be reported and analyzed in the trial. Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.
Immune system disorders Seasonal allergy	10.0% 1/10 • Adverse Events (AEs) occurred during the period from treatment initiation to the completion of examinations at Week 8 of the study drug administration, and serious AEs (SAEs) observed prior to the post-trial investigation (from 14 to 21 days after the completion date of the trial period), regardless of the causal relationship with the study drug, were to be reported and analyzed in the trial. Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.	0.00% 0/9 • Adverse Events (AEs) occurred during the period from treatment initiation to the completion of examinations at Week 8 of the study drug administration, and serious AEs (SAEs) observed prior to the post-trial investigation (from 14 to 21 days after the completion date of the trial period), regardless of the causal relationship with the study drug, were to be reported and analyzed in the trial. Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.	0.00% 0/10 • Adverse Events (AEs) occurred during the period from treatment initiation to the completion of examinations at Week 8 of the study drug administration, and serious AEs (SAEs) observed prior to the post-trial investigation (from 14 to 21 days after the completion date of the trial period), regardless of the causal relationship with the study drug, were to be reported and analyzed in the trial. Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.
Infections and infestations Bronchitis	0.00% 0/10 • Adverse Events (AEs) occurred during the period from treatment initiation to the completion of examinations at Week 8 of the study drug administration, and serious AEs (SAEs) observed prior to the post-trial investigation (from 14 to 21 days after the completion date of the trial period), regardless of the causal relationship with the study drug, were to be reported and analyzed in the trial. Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.	0.00% 0/9 • Adverse Events (AEs) occurred during the period from treatment initiation to the completion of examinations at Week 8 of the study drug administration, and serious AEs (SAEs) observed prior to the post-trial investigation (from 14 to 21 days after the completion date of the trial period), regardless of the causal relationship with the study drug, were to be reported and analyzed in the trial. Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.	10.0% 1/10 • Adverse Events (AEs) occurred during the period from treatment initiation to the completion of examinations at Week 8 of the study drug administration, and serious AEs (SAEs) observed prior to the post-trial investigation (from 14 to 21 days after the completion date of the trial period), regardless of the causal relationship with the study drug, were to be reported and analyzed in the trial. Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.
Infections and infestations Nasopharyngitis	10.0% 1/10 • Adverse Events (AEs) occurred during the period from treatment initiation to the completion of examinations at Week 8 of the study drug administration, and serious AEs (SAEs) observed prior to the post-trial investigation (from 14 to 21 days after the completion date of the trial period), regardless of the causal relationship with the study drug, were to be reported and analyzed in the trial. Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.	22.2% 2/9 • Adverse Events (AEs) occurred during the period from treatment initiation to the completion of examinations at Week 8 of the study drug administration, and serious AEs (SAEs) observed prior to the post-trial investigation (from 14 to 21 days after the completion date of the trial period), regardless of the causal relationship with the study drug, were to be reported and analyzed in the trial. Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.	10.0% 1/10 • Adverse Events (AEs) occurred during the period from treatment initiation to the completion of examinations at Week 8 of the study drug administration, and serious AEs (SAEs) observed prior to the post-trial investigation (from 14 to 21 days after the completion date of the trial period), regardless of the causal relationship with the study drug, were to be reported and analyzed in the trial. Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.
Infections and infestations Skin infection	10.0% 1/10 • Adverse Events (AEs) occurred during the period from treatment initiation to the completion of examinations at Week 8 of the study drug administration, and serious AEs (SAEs) observed prior to the post-trial investigation (from 14 to 21 days after the completion date of the trial period), regardless of the causal relationship with the study drug, were to be reported and analyzed in the trial. Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.	0.00% 0/9 • Adverse Events (AEs) occurred during the period from treatment initiation to the completion of examinations at Week 8 of the study drug administration, and serious AEs (SAEs) observed prior to the post-trial investigation (from 14 to 21 days after the completion date of the trial period), regardless of the causal relationship with the study drug, were to be reported and analyzed in the trial. Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.	0.00% 0/10 • Adverse Events (AEs) occurred during the period from treatment initiation to the completion of examinations at Week 8 of the study drug administration, and serious AEs (SAEs) observed prior to the post-trial investigation (from 14 to 21 days after the completion date of the trial period), regardless of the causal relationship with the study drug, were to be reported and analyzed in the trial. Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.
Infections and infestations Enteritis infectious	10.0% 1/10 • Adverse Events (AEs) occurred during the period from treatment initiation to the completion of examinations at Week 8 of the study drug administration, and serious AEs (SAEs) observed prior to the post-trial investigation (from 14 to 21 days after the completion date of the trial period), regardless of the causal relationship with the study drug, were to be reported and analyzed in the trial. Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.	11.1% 1/9 • Adverse Events (AEs) occurred during the period from treatment initiation to the completion of examinations at Week 8 of the study drug administration, and serious AEs (SAEs) observed prior to the post-trial investigation (from 14 to 21 days after the completion date of the trial period), regardless of the causal relationship with the study drug, were to be reported and analyzed in the trial. Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.	0.00% 0/10 • Adverse Events (AEs) occurred during the period from treatment initiation to the completion of examinations at Week 8 of the study drug administration, and serious AEs (SAEs) observed prior to the post-trial investigation (from 14 to 21 days after the completion date of the trial period), regardless of the causal relationship with the study drug, were to be reported and analyzed in the trial. Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.
Injury, poisoning and procedural complications Contusion	0.00% 0/10 • Adverse Events (AEs) occurred during the period from treatment initiation to the completion of examinations at Week 8 of the study drug administration, and serious AEs (SAEs) observed prior to the post-trial investigation (from 14 to 21 days after the completion date of the trial period), regardless of the causal relationship with the study drug, were to be reported and analyzed in the trial. Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.	0.00% 0/9 • Adverse Events (AEs) occurred during the period from treatment initiation to the completion of examinations at Week 8 of the study drug administration, and serious AEs (SAEs) observed prior to the post-trial investigation (from 14 to 21 days after the completion date of the trial period), regardless of the causal relationship with the study drug, were to be reported and analyzed in the trial. Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.	10.0% 1/10 • Adverse Events (AEs) occurred during the period from treatment initiation to the completion of examinations at Week 8 of the study drug administration, and serious AEs (SAEs) observed prior to the post-trial investigation (from 14 to 21 days after the completion date of the trial period), regardless of the causal relationship with the study drug, were to be reported and analyzed in the trial. Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.
Investigations Alanine aminotransferase increased	10.0% 1/10 • Adverse Events (AEs) occurred during the period from treatment initiation to the completion of examinations at Week 8 of the study drug administration, and serious AEs (SAEs) observed prior to the post-trial investigation (from 14 to 21 days after the completion date of the trial period), regardless of the causal relationship with the study drug, were to be reported and analyzed in the trial. Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.	0.00% 0/9 • Adverse Events (AEs) occurred during the period from treatment initiation to the completion of examinations at Week 8 of the study drug administration, and serious AEs (SAEs) observed prior to the post-trial investigation (from 14 to 21 days after the completion date of the trial period), regardless of the causal relationship with the study drug, were to be reported and analyzed in the trial. Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.	0.00% 0/10 • Adverse Events (AEs) occurred during the period from treatment initiation to the completion of examinations at Week 8 of the study drug administration, and serious AEs (SAEs) observed prior to the post-trial investigation (from 14 to 21 days after the completion date of the trial period), regardless of the causal relationship with the study drug, were to be reported and analyzed in the trial. Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.
Investigations Aspartate aminotransferase increased	10.0% 1/10 • Adverse Events (AEs) occurred during the period from treatment initiation to the completion of examinations at Week 8 of the study drug administration, and serious AEs (SAEs) observed prior to the post-trial investigation (from 14 to 21 days after the completion date of the trial period), regardless of the causal relationship with the study drug, were to be reported and analyzed in the trial. Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.	0.00% 0/9 • Adverse Events (AEs) occurred during the period from treatment initiation to the completion of examinations at Week 8 of the study drug administration, and serious AEs (SAEs) observed prior to the post-trial investigation (from 14 to 21 days after the completion date of the trial period), regardless of the causal relationship with the study drug, were to be reported and analyzed in the trial. Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.	0.00% 0/10 • Adverse Events (AEs) occurred during the period from treatment initiation to the completion of examinations at Week 8 of the study drug administration, and serious AEs (SAEs) observed prior to the post-trial investigation (from 14 to 21 days after the completion date of the trial period), regardless of the causal relationship with the study drug, were to be reported and analyzed in the trial. Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.
Investigations Blood creatine phosphokinase increased	0.00% 0/10 • Adverse Events (AEs) occurred during the period from treatment initiation to the completion of examinations at Week 8 of the study drug administration, and serious AEs (SAEs) observed prior to the post-trial investigation (from 14 to 21 days after the completion date of the trial period), regardless of the causal relationship with the study drug, were to be reported and analyzed in the trial. Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.	0.00% 0/9 • Adverse Events (AEs) occurred during the period from treatment initiation to the completion of examinations at Week 8 of the study drug administration, and serious AEs (SAEs) observed prior to the post-trial investigation (from 14 to 21 days after the completion date of the trial period), regardless of the causal relationship with the study drug, were to be reported and analyzed in the trial. Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.	20.0% 2/10 • Adverse Events (AEs) occurred during the period from treatment initiation to the completion of examinations at Week 8 of the study drug administration, and serious AEs (SAEs) observed prior to the post-trial investigation (from 14 to 21 days after the completion date of the trial period), regardless of the causal relationship with the study drug, were to be reported and analyzed in the trial. Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.
Investigations Blood glucose increased	0.00% 0/10 • Adverse Events (AEs) occurred during the period from treatment initiation to the completion of examinations at Week 8 of the study drug administration, and serious AEs (SAEs) observed prior to the post-trial investigation (from 14 to 21 days after the completion date of the trial period), regardless of the causal relationship with the study drug, were to be reported and analyzed in the trial. Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.	22.2% 2/9 • Adverse Events (AEs) occurred during the period from treatment initiation to the completion of examinations at Week 8 of the study drug administration, and serious AEs (SAEs) observed prior to the post-trial investigation (from 14 to 21 days after the completion date of the trial period), regardless of the causal relationship with the study drug, were to be reported and analyzed in the trial. Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.	0.00% 0/10 • Adverse Events (AEs) occurred during the period from treatment initiation to the completion of examinations at Week 8 of the study drug administration, and serious AEs (SAEs) observed prior to the post-trial investigation (from 14 to 21 days after the completion date of the trial period), regardless of the causal relationship with the study drug, were to be reported and analyzed in the trial. Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.
Investigations Blood potassium increased	0.00% 0/10 • Adverse Events (AEs) occurred during the period from treatment initiation to the completion of examinations at Week 8 of the study drug administration, and serious AEs (SAEs) observed prior to the post-trial investigation (from 14 to 21 days after the completion date of the trial period), regardless of the causal relationship with the study drug, were to be reported and analyzed in the trial. Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.	11.1% 1/9 • Adverse Events (AEs) occurred during the period from treatment initiation to the completion of examinations at Week 8 of the study drug administration, and serious AEs (SAEs) observed prior to the post-trial investigation (from 14 to 21 days after the completion date of the trial period), regardless of the causal relationship with the study drug, were to be reported and analyzed in the trial. Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.	0.00% 0/10 • Adverse Events (AEs) occurred during the period from treatment initiation to the completion of examinations at Week 8 of the study drug administration, and serious AEs (SAEs) observed prior to the post-trial investigation (from 14 to 21 days after the completion date of the trial period), regardless of the causal relationship with the study drug, were to be reported and analyzed in the trial. Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.
Investigations Glucose urine present	0.00% 0/10 • Adverse Events (AEs) occurred during the period from treatment initiation to the completion of examinations at Week 8 of the study drug administration, and serious AEs (SAEs) observed prior to the post-trial investigation (from 14 to 21 days after the completion date of the trial period), regardless of the causal relationship with the study drug, were to be reported and analyzed in the trial. Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.	11.1% 1/9 • Adverse Events (AEs) occurred during the period from treatment initiation to the completion of examinations at Week 8 of the study drug administration, and serious AEs (SAEs) observed prior to the post-trial investigation (from 14 to 21 days after the completion date of the trial period), regardless of the causal relationship with the study drug, were to be reported and analyzed in the trial. Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.	0.00% 0/10 • Adverse Events (AEs) occurred during the period from treatment initiation to the completion of examinations at Week 8 of the study drug administration, and serious AEs (SAEs) observed prior to the post-trial investigation (from 14 to 21 days after the completion date of the trial period), regardless of the causal relationship with the study drug, were to be reported and analyzed in the trial. Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.
Investigations Blood urine present	0.00% 0/10 • Adverse Events (AEs) occurred during the period from treatment initiation to the completion of examinations at Week 8 of the study drug administration, and serious AEs (SAEs) observed prior to the post-trial investigation (from 14 to 21 days after the completion date of the trial period), regardless of the causal relationship with the study drug, were to be reported and analyzed in the trial. Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.	22.2% 2/9 • Adverse Events (AEs) occurred during the period from treatment initiation to the completion of examinations at Week 8 of the study drug administration, and serious AEs (SAEs) observed prior to the post-trial investigation (from 14 to 21 days after the completion date of the trial period), regardless of the causal relationship with the study drug, were to be reported and analyzed in the trial. Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.	0.00% 0/10 • Adverse Events (AEs) occurred during the period from treatment initiation to the completion of examinations at Week 8 of the study drug administration, and serious AEs (SAEs) observed prior to the post-trial investigation (from 14 to 21 days after the completion date of the trial period), regardless of the causal relationship with the study drug, were to be reported and analyzed in the trial. Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.
Investigations White blood cell count increased	0.00% 0/10 • Adverse Events (AEs) occurred during the period from treatment initiation to the completion of examinations at Week 8 of the study drug administration, and serious AEs (SAEs) observed prior to the post-trial investigation (from 14 to 21 days after the completion date of the trial period), regardless of the causal relationship with the study drug, were to be reported and analyzed in the trial. Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.	0.00% 0/9 • Adverse Events (AEs) occurred during the period from treatment initiation to the completion of examinations at Week 8 of the study drug administration, and serious AEs (SAEs) observed prior to the post-trial investigation (from 14 to 21 days after the completion date of the trial period), regardless of the causal relationship with the study drug, were to be reported and analyzed in the trial. Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.	10.0% 1/10 • Adverse Events (AEs) occurred during the period from treatment initiation to the completion of examinations at Week 8 of the study drug administration, and serious AEs (SAEs) observed prior to the post-trial investigation (from 14 to 21 days after the completion date of the trial period), regardless of the causal relationship with the study drug, were to be reported and analyzed in the trial. Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.
Investigations Platelet count increased	0.00% 0/10 • Adverse Events (AEs) occurred during the period from treatment initiation to the completion of examinations at Week 8 of the study drug administration, and serious AEs (SAEs) observed prior to the post-trial investigation (from 14 to 21 days after the completion date of the trial period), regardless of the causal relationship with the study drug, were to be reported and analyzed in the trial. Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.	11.1% 1/9 • Adverse Events (AEs) occurred during the period from treatment initiation to the completion of examinations at Week 8 of the study drug administration, and serious AEs (SAEs) observed prior to the post-trial investigation (from 14 to 21 days after the completion date of the trial period), regardless of the causal relationship with the study drug, were to be reported and analyzed in the trial. Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.	0.00% 0/10 • Adverse Events (AEs) occurred during the period from treatment initiation to the completion of examinations at Week 8 of the study drug administration, and serious AEs (SAEs) observed prior to the post-trial investigation (from 14 to 21 days after the completion date of the trial period), regardless of the causal relationship with the study drug, were to be reported and analyzed in the trial. Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.
Investigations Blood alkaline phosphatase increased	0.00% 0/10 • Adverse Events (AEs) occurred during the period from treatment initiation to the completion of examinations at Week 8 of the study drug administration, and serious AEs (SAEs) observed prior to the post-trial investigation (from 14 to 21 days after the completion date of the trial period), regardless of the causal relationship with the study drug, were to be reported and analyzed in the trial. Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.	11.1% 1/9 • Adverse Events (AEs) occurred during the period from treatment initiation to the completion of examinations at Week 8 of the study drug administration, and serious AEs (SAEs) observed prior to the post-trial investigation (from 14 to 21 days after the completion date of the trial period), regardless of the causal relationship with the study drug, were to be reported and analyzed in the trial. Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.	0.00% 0/10 • Adverse Events (AEs) occurred during the period from treatment initiation to the completion of examinations at Week 8 of the study drug administration, and serious AEs (SAEs) observed prior to the post-trial investigation (from 14 to 21 days after the completion date of the trial period), regardless of the causal relationship with the study drug, were to be reported and analyzed in the trial. Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/10 • Adverse Events (AEs) occurred during the period from treatment initiation to the completion of examinations at Week 8 of the study drug administration, and serious AEs (SAEs) observed prior to the post-trial investigation (from 14 to 21 days after the completion date of the trial period), regardless of the causal relationship with the study drug, were to be reported and analyzed in the trial. Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.	11.1% 1/9 • Adverse Events (AEs) occurred during the period from treatment initiation to the completion of examinations at Week 8 of the study drug administration, and serious AEs (SAEs) observed prior to the post-trial investigation (from 14 to 21 days after the completion date of the trial period), regardless of the causal relationship with the study drug, were to be reported and analyzed in the trial. Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.	0.00% 0/10 • Adverse Events (AEs) occurred during the period from treatment initiation to the completion of examinations at Week 8 of the study drug administration, and serious AEs (SAEs) observed prior to the post-trial investigation (from 14 to 21 days after the completion date of the trial period), regardless of the causal relationship with the study drug, were to be reported and analyzed in the trial. Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/10 • Adverse Events (AEs) occurred during the period from treatment initiation to the completion of examinations at Week 8 of the study drug administration, and serious AEs (SAEs) observed prior to the post-trial investigation (from 14 to 21 days after the completion date of the trial period), regardless of the causal relationship with the study drug, were to be reported and analyzed in the trial. Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.	11.1% 1/9 • Adverse Events (AEs) occurred during the period from treatment initiation to the completion of examinations at Week 8 of the study drug administration, and serious AEs (SAEs) observed prior to the post-trial investigation (from 14 to 21 days after the completion date of the trial period), regardless of the causal relationship with the study drug, were to be reported and analyzed in the trial. Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.	10.0% 1/10 • Adverse Events (AEs) occurred during the period from treatment initiation to the completion of examinations at Week 8 of the study drug administration, and serious AEs (SAEs) observed prior to the post-trial investigation (from 14 to 21 days after the completion date of the trial period), regardless of the causal relationship with the study drug, were to be reported and analyzed in the trial. Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.
Nervous system disorders Dizziness	0.00% 0/10 • Adverse Events (AEs) occurred during the period from treatment initiation to the completion of examinations at Week 8 of the study drug administration, and serious AEs (SAEs) observed prior to the post-trial investigation (from 14 to 21 days after the completion date of the trial period), regardless of the causal relationship with the study drug, were to be reported and analyzed in the trial. Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.	11.1% 1/9 • Adverse Events (AEs) occurred during the period from treatment initiation to the completion of examinations at Week 8 of the study drug administration, and serious AEs (SAEs) observed prior to the post-trial investigation (from 14 to 21 days after the completion date of the trial period), regardless of the causal relationship with the study drug, were to be reported and analyzed in the trial. Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.	10.0% 1/10 • Adverse Events (AEs) occurred during the period from treatment initiation to the completion of examinations at Week 8 of the study drug administration, and serious AEs (SAEs) observed prior to the post-trial investigation (from 14 to 21 days after the completion date of the trial period), regardless of the causal relationship with the study drug, were to be reported and analyzed in the trial. Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.
Nervous system disorders Postural dizziness	10.0% 1/10 • Adverse Events (AEs) occurred during the period from treatment initiation to the completion of examinations at Week 8 of the study drug administration, and serious AEs (SAEs) observed prior to the post-trial investigation (from 14 to 21 days after the completion date of the trial period), regardless of the causal relationship with the study drug, were to be reported and analyzed in the trial. Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.	0.00% 0/9 • Adverse Events (AEs) occurred during the period from treatment initiation to the completion of examinations at Week 8 of the study drug administration, and serious AEs (SAEs) observed prior to the post-trial investigation (from 14 to 21 days after the completion date of the trial period), regardless of the causal relationship with the study drug, were to be reported and analyzed in the trial. Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.	0.00% 0/10 • Adverse Events (AEs) occurred during the period from treatment initiation to the completion of examinations at Week 8 of the study drug administration, and serious AEs (SAEs) observed prior to the post-trial investigation (from 14 to 21 days after the completion date of the trial period), regardless of the causal relationship with the study drug, were to be reported and analyzed in the trial. Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.
Nervous system disorders Headache	30.0% 3/10 • Adverse Events (AEs) occurred during the period from treatment initiation to the completion of examinations at Week 8 of the study drug administration, and serious AEs (SAEs) observed prior to the post-trial investigation (from 14 to 21 days after the completion date of the trial period), regardless of the causal relationship with the study drug, were to be reported and analyzed in the trial. Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.	44.4% 4/9 • Adverse Events (AEs) occurred during the period from treatment initiation to the completion of examinations at Week 8 of the study drug administration, and serious AEs (SAEs) observed prior to the post-trial investigation (from 14 to 21 days after the completion date of the trial period), regardless of the causal relationship with the study drug, were to be reported and analyzed in the trial. Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.	20.0% 2/10 • Adverse Events (AEs) occurred during the period from treatment initiation to the completion of examinations at Week 8 of the study drug administration, and serious AEs (SAEs) observed prior to the post-trial investigation (from 14 to 21 days after the completion date of the trial period), regardless of the causal relationship with the study drug, were to be reported and analyzed in the trial. Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.
Nervous system disorders Somnolence	0.00% 0/10 • Adverse Events (AEs) occurred during the period from treatment initiation to the completion of examinations at Week 8 of the study drug administration, and serious AEs (SAEs) observed prior to the post-trial investigation (from 14 to 21 days after the completion date of the trial period), regardless of the causal relationship with the study drug, were to be reported and analyzed in the trial. Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.	11.1% 1/9 • Adverse Events (AEs) occurred during the period from treatment initiation to the completion of examinations at Week 8 of the study drug administration, and serious AEs (SAEs) observed prior to the post-trial investigation (from 14 to 21 days after the completion date of the trial period), regardless of the causal relationship with the study drug, were to be reported and analyzed in the trial. Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.	0.00% 0/10 • Adverse Events (AEs) occurred during the period from treatment initiation to the completion of examinations at Week 8 of the study drug administration, and serious AEs (SAEs) observed prior to the post-trial investigation (from 14 to 21 days after the completion date of the trial period), regardless of the causal relationship with the study drug, were to be reported and analyzed in the trial. Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.
Psychiatric disorders Insomnia	10.0% 1/10 • Adverse Events (AEs) occurred during the period from treatment initiation to the completion of examinations at Week 8 of the study drug administration, and serious AEs (SAEs) observed prior to the post-trial investigation (from 14 to 21 days after the completion date of the trial period), regardless of the causal relationship with the study drug, were to be reported and analyzed in the trial. Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.	0.00% 0/9 • Adverse Events (AEs) occurred during the period from treatment initiation to the completion of examinations at Week 8 of the study drug administration, and serious AEs (SAEs) observed prior to the post-trial investigation (from 14 to 21 days after the completion date of the trial period), regardless of the causal relationship with the study drug, were to be reported and analyzed in the trial. Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.	0.00% 0/10 • Adverse Events (AEs) occurred during the period from treatment initiation to the completion of examinations at Week 8 of the study drug administration, and serious AEs (SAEs) observed prior to the post-trial investigation (from 14 to 21 days after the completion date of the trial period), regardless of the causal relationship with the study drug, were to be reported and analyzed in the trial. Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.
Psychiatric disorders Depressive symptom	0.00% 0/10 • Adverse Events (AEs) occurred during the period from treatment initiation to the completion of examinations at Week 8 of the study drug administration, and serious AEs (SAEs) observed prior to the post-trial investigation (from 14 to 21 days after the completion date of the trial period), regardless of the causal relationship with the study drug, were to be reported and analyzed in the trial. Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.	11.1% 1/9 • Adverse Events (AEs) occurred during the period from treatment initiation to the completion of examinations at Week 8 of the study drug administration, and serious AEs (SAEs) observed prior to the post-trial investigation (from 14 to 21 days after the completion date of the trial period), regardless of the causal relationship with the study drug, were to be reported and analyzed in the trial. Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.	0.00% 0/10 • Adverse Events (AEs) occurred during the period from treatment initiation to the completion of examinations at Week 8 of the study drug administration, and serious AEs (SAEs) observed prior to the post-trial investigation (from 14 to 21 days after the completion date of the trial period), regardless of the causal relationship with the study drug, were to be reported and analyzed in the trial. Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.
Psychiatric disorders Affect lability	0.00% 0/10 • Adverse Events (AEs) occurred during the period from treatment initiation to the completion of examinations at Week 8 of the study drug administration, and serious AEs (SAEs) observed prior to the post-trial investigation (from 14 to 21 days after the completion date of the trial period), regardless of the causal relationship with the study drug, were to be reported and analyzed in the trial. Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.	11.1% 1/9 • Adverse Events (AEs) occurred during the period from treatment initiation to the completion of examinations at Week 8 of the study drug administration, and serious AEs (SAEs) observed prior to the post-trial investigation (from 14 to 21 days after the completion date of the trial period), regardless of the causal relationship with the study drug, were to be reported and analyzed in the trial. Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.	0.00% 0/10 • Adverse Events (AEs) occurred during the period from treatment initiation to the completion of examinations at Week 8 of the study drug administration, and serious AEs (SAEs) observed prior to the post-trial investigation (from 14 to 21 days after the completion date of the trial period), regardless of the causal relationship with the study drug, were to be reported and analyzed in the trial. Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.
Renal and urinary disorders Residual urine	0.00% 0/10 • Adverse Events (AEs) occurred during the period from treatment initiation to the completion of examinations at Week 8 of the study drug administration, and serious AEs (SAEs) observed prior to the post-trial investigation (from 14 to 21 days after the completion date of the trial period), regardless of the causal relationship with the study drug, were to be reported and analyzed in the trial. Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.	0.00% 0/9 • Adverse Events (AEs) occurred during the period from treatment initiation to the completion of examinations at Week 8 of the study drug administration, and serious AEs (SAEs) observed prior to the post-trial investigation (from 14 to 21 days after the completion date of the trial period), regardless of the causal relationship with the study drug, were to be reported and analyzed in the trial. Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.	10.0% 1/10 • Adverse Events (AEs) occurred during the period from treatment initiation to the completion of examinations at Week 8 of the study drug administration, and serious AEs (SAEs) observed prior to the post-trial investigation (from 14 to 21 days after the completion date of the trial period), regardless of the causal relationship with the study drug, were to be reported and analyzed in the trial. Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/10 • Adverse Events (AEs) occurred during the period from treatment initiation to the completion of examinations at Week 8 of the study drug administration, and serious AEs (SAEs) observed prior to the post-trial investigation (from 14 to 21 days after the completion date of the trial period), regardless of the causal relationship with the study drug, were to be reported and analyzed in the trial. Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.	0.00% 0/9 • Adverse Events (AEs) occurred during the period from treatment initiation to the completion of examinations at Week 8 of the study drug administration, and serious AEs (SAEs) observed prior to the post-trial investigation (from 14 to 21 days after the completion date of the trial period), regardless of the causal relationship with the study drug, were to be reported and analyzed in the trial. Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.	10.0% 1/10 • Adverse Events (AEs) occurred during the period from treatment initiation to the completion of examinations at Week 8 of the study drug administration, and serious AEs (SAEs) observed prior to the post-trial investigation (from 14 to 21 days after the completion date of the trial period), regardless of the causal relationship with the study drug, were to be reported and analyzed in the trial. Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.
Respiratory, thoracic and mediastinal disorders Upper respiratory tract inflammation	10.0% 1/10 • Adverse Events (AEs) occurred during the period from treatment initiation to the completion of examinations at Week 8 of the study drug administration, and serious AEs (SAEs) observed prior to the post-trial investigation (from 14 to 21 days after the completion date of the trial period), regardless of the causal relationship with the study drug, were to be reported and analyzed in the trial. Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.	11.1% 1/9 • Adverse Events (AEs) occurred during the period from treatment initiation to the completion of examinations at Week 8 of the study drug administration, and serious AEs (SAEs) observed prior to the post-trial investigation (from 14 to 21 days after the completion date of the trial period), regardless of the causal relationship with the study drug, were to be reported and analyzed in the trial. Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.	0.00% 0/10 • Adverse Events (AEs) occurred during the period from treatment initiation to the completion of examinations at Week 8 of the study drug administration, and serious AEs (SAEs) observed prior to the post-trial investigation (from 14 to 21 days after the completion date of the trial period), regardless of the causal relationship with the study drug, were to be reported and analyzed in the trial. Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.
Skin and subcutaneous tissue disorders Eczema	10.0% 1/10 • Adverse Events (AEs) occurred during the period from treatment initiation to the completion of examinations at Week 8 of the study drug administration, and serious AEs (SAEs) observed prior to the post-trial investigation (from 14 to 21 days after the completion date of the trial period), regardless of the causal relationship with the study drug, were to be reported and analyzed in the trial. Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.	0.00% 0/9 • Adverse Events (AEs) occurred during the period from treatment initiation to the completion of examinations at Week 8 of the study drug administration, and serious AEs (SAEs) observed prior to the post-trial investigation (from 14 to 21 days after the completion date of the trial period), regardless of the causal relationship with the study drug, were to be reported and analyzed in the trial. Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.	0.00% 0/10 • Adverse Events (AEs) occurred during the period from treatment initiation to the completion of examinations at Week 8 of the study drug administration, and serious AEs (SAEs) observed prior to the post-trial investigation (from 14 to 21 days after the completion date of the trial period), regardless of the causal relationship with the study drug, were to be reported and analyzed in the trial. Safety was evaluated in the subjects who took at least one dose of the study drug and provided postdosing data concerning the safety endpoints. Subjects with GCP violations (noncompliance of obtaining informed consent, start of the trial before obtaining informed consent, trial conducted outside the contract period) were to be excluded from the analysis.

Additional Information

Director of Clinical Trials

Otsuka Pharmaceutical Co., LTD.

Phone: +81-3-6361-7366

Email: CL_OPCJ_RDA_Team@otsuka.jp

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place