Trial Outcomes & Findings for Study to Evaluate Efficacy, Safety, and Tolerability of MT-7117 in Subjects With Erythropoietic Protoporphyria or X-Linked Protoporphyria (NCT NCT04402489)

NCT ID: NCT04402489

Last Updated: 2025-12-30

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

184 participants

Primary outcome timeframe

From 1 hour post-sunrise to 1 hour pre-sunset at Week 26 (Visit 7)

Results posted on

2025-12-30

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo Subjects who were randomized to receive matching oral tablet of placebo once a day in Double-Blind treatment	MT-7117 Low Dose Subjects who were randomized to receive oral tablet of MT-7117 Low Dose once a day in Double-Blind Treatment and Double-Blind Extension	MT-7117 High Dose Subjects who were randomized to receive oral tablet of MT-7117 High Dose once a day in Double-Blind Treatment and Double-Blind Extension	Placebo -> MT-7117 Low Dose Subjects who received placebo in Double-Blind Treatment, and after that received MT-7117 low dose in Double-Blind Extension	Placebo -> MT-7117 High Dose Subjects who received placebo in Double-Blind Treatment, and after that received MT-7117 high dose in Double-Blind Extension
26 Weeks Double-Blind Treatment (DBT) STARTED	61	63	60	0	0
26 Weeks Double-Blind Treatment (DBT) COMPLETED	57	60	58	0	0
26 Weeks Double-Blind Treatment (DBT) NOT COMPLETED	4	3	2	0	0
26 Weeks Double-Blind Extension (DBE) STARTED	0	56	55	28	28
26 Weeks Double-Blind Extension (DBE) COMPLETED	0	55	52	27	28
26 Weeks Double-Blind Extension (DBE) NOT COMPLETED	0	1	3	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Subjects who were randomized to receive matching oral tablet of placebo once a day in Double-Blind treatment	MT-7117 Low Dose Subjects who were randomized to receive oral tablet of MT-7117 Low Dose once a day in Double-Blind Treatment and Double-Blind Extension	MT-7117 High Dose Subjects who were randomized to receive oral tablet of MT-7117 High Dose once a day in Double-Blind Treatment and Double-Blind Extension	Placebo -> MT-7117 Low Dose Subjects who received placebo in Double-Blind Treatment, and after that received MT-7117 low dose in Double-Blind Extension
26 Weeks Double-Blind Treatment (DBT) Adverse Event	0	1	0	0
26 Weeks Double-Blind Treatment (DBT) Physician Decision	1	0	0	0
26 Weeks Double-Blind Treatment (DBT) Withdrawal by Subject	3	2	2	0
26 Weeks Double-Blind Extension (DBE) Adverse Event	0	0	1	0
26 Weeks Double-Blind Extension (DBE) Lost to Follow-up	0	0	0	1
26 Weeks Double-Blind Extension (DBE) Withdrawal by Subject	0	1	2	0

Baseline Characteristics

Study to Evaluate Efficacy, Safety, and Tolerability of MT-7117 in Subjects With Erythropoietic Protoporphyria or X-Linked Protoporphyria

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=61 Participants Subjects who were randomized to receive matching oral tablet of placebo once a day in Double-Blind treatment	MT-7117 Low Dose n=63 Participants Subjects who were randomized to receive oral tablet of MT-7117 Low Dose once a day in Double-Blind Treatment and Double-Blind Extension	MT-7117 High Dose n=60 Participants Subjects who were randomized to receive oral tablet of MT-7117 High Dose once a day in Double-Blind Treatment and Double-Blind Extension	Total n=184 Participants Total of all reporting groups
Age, Categorical <=18 years	12 Participants n=174 Participants	13 Participants n=166 Participants	12 Participants n=167 Participants	37 Participants n=164 Participants
Age, Categorical Between 18 and 65 years	47 Participants n=174 Participants	45 Participants n=166 Participants	46 Participants n=167 Participants	138 Participants n=164 Participants
Age, Categorical >=65 years	2 Participants n=174 Participants	5 Participants n=166 Participants	2 Participants n=167 Participants	9 Participants n=164 Participants
Sex: Female, Male Female	30 Participants n=174 Participants	30 Participants n=166 Participants	33 Participants n=167 Participants	93 Participants n=164 Participants
Sex: Female, Male Male	31 Participants n=174 Participants	33 Participants n=166 Participants	27 Participants n=167 Participants	91 Participants n=164 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants n=174 Participants	7 Participants n=166 Participants	2 Participants n=167 Participants	16 Participants n=164 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	53 Participants n=174 Participants	52 Participants n=166 Participants	58 Participants n=167 Participants	163 Participants n=164 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=174 Participants	4 Participants n=166 Participants	0 Participants n=167 Participants	5 Participants n=164 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=174 Participants	0 Participants n=166 Participants	0 Participants n=167 Participants	0 Participants n=164 Participants
Race (NIH/OMB) Asian	9 Participants n=174 Participants	1 Participants n=166 Participants	2 Participants n=167 Participants	12 Participants n=164 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=174 Participants	0 Participants n=166 Participants	1 Participants n=167 Participants	1 Participants n=164 Participants
Race (NIH/OMB) Black or African American	0 Participants n=174 Participants	0 Participants n=166 Participants	0 Participants n=167 Participants	0 Participants n=164 Participants
Race (NIH/OMB) White	52 Participants n=174 Participants	60 Participants n=166 Participants	55 Participants n=167 Participants	167 Participants n=164 Participants
Race (NIH/OMB) More than one race	0 Participants n=174 Participants	0 Participants n=166 Participants	0 Participants n=167 Participants	0 Participants n=164 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=174 Participants	2 Participants n=166 Participants	2 Participants n=167 Participants	4 Participants n=164 Participants

PRIMARY outcome

Timeframe: From 1 hour post-sunrise to 1 hour pre-sunset at Week 26 (Visit 7)

Population: Included all randomized subjects who received at least 1 dose of study medication with Baseline and post randomization- sunlight exposure diary assessments during the double-blind treatment period.

Outcome measures

Outcome measures
Measure	DBT ITT1 Placebo n=60 Participants Oral tablet of placebo once a day in DBT	DBT ITT1 MT- 7117 Low Dose n=63 Participants Oral tablet of MT-7117 Low Dose once a day in DBT	DBT ITT1 MT- 7117 High Dose n=60 Participants Oral tablet of MT-7117 High Dose once a day in DBT
Change From Baseline in Average Daily Sunlight Exposure Time (Minutes) to First Prodromal Symptom (Burning, Tingling, Itching, or Stinging) Associated With Sunlight Exposure Between 1 Hour Post Sunrise and 1 Hour Pre-sunset at Week 26 (Visit 7)	20.59 minute Standard Error 10.29	30.39 minute Standard Error 10.04	43.29 minute Standard Error 10.13

SECONDARY outcome

Timeframe: Week 26

PGIC: Scale from 1 to 7, where 7 is worse.

Outcome measures

Outcome measures
Measure	DBT ITT1 Placebo n=56 Participants Oral tablet of placebo once a day in DBT	DBT ITT1 MT- 7117 Low Dose n=59 Participants Oral tablet of MT-7117 Low Dose once a day in DBT	DBT ITT1 MT- 7117 High Dose n=56 Participants Oral tablet of MT-7117 High Dose once a day in DBT
Patient Global Impression of Change (PGIC) at Week 26	3.25 point Standard Error 1.14	2.41 point Standard Error 0.14	1.82 point Standard Error 0.14

SECONDARY outcome

Timeframe: During the 26-week double-blind treatment period

The Likert scale used ranges from 0 to 10, where 0 indicates the lowest pain rating and 10 indicates the highest pain rating. Likewise, 0 indicates to best outcome and 10 indicates the worst outcome. The sum of the number of pain events with pain rating of 1 to 10 for the day is used as the number of sunlight-induced pain events in the day. The sum of the number of the pain events with pain rating of 1 to 10 in each day during the 26-week Double-blind Treatment Period is calculated as this endpoint.

Outcome measures

Outcome measures
Measure	DBT ITT1 Placebo n=60 Participants Oral tablet of placebo once a day in DBT	DBT ITT1 MT- 7117 Low Dose n=63 Participants Oral tablet of MT-7117 Low Dose once a day in DBT	DBT ITT1 MT- 7117 High Dose n=60 Participants Oral tablet of MT-7117 High Dose once a day in DBT
Total Number of Sunlight-induced Pain Events Defined as Prodrome Symptoms (Burning, Tingling, Itching, or Stinging) With Pain Rating of 1-10 on the Likert Scale During the 26-week Double-blind Treatment Period.	23.9 events Standard Deviation 30.93	15.87 events Standard Deviation 22.05	13.78 events Standard Deviation 18.7

SECONDARY outcome

Timeframe: Baseline (Week 0) and Week 26

Pain intensity: 0 to 10, where 10 is worst pain imaginable.

Outcome measures

Outcome measures
Measure	DBT ITT1 Placebo n=49 Participants Oral tablet of placebo once a day in DBT	DBT ITT1 MT- 7117 Low Dose n=59 Participants Oral tablet of MT-7117 Low Dose once a day in DBT	DBT ITT1 MT- 7117 High Dose n=56 Participants Oral tablet of MT-7117 High Dose once a day in DBT
Change From Baseline for Total Score in the Domain of Pain Intensity in the PROMIS-57 at Week 26	-1.42 total score Standard Error 0.18	-1.56 total score Standard Error 0.16	-1.65 total score Standard Error 0.17

SECONDARY outcome

Timeframe: Week 26

The percentage of subjects who are responders based on average daily sunlight exposure time to first prodromal symptom associated with sunlight exposure between 1 hour post-sunrise and 1 hour presunset defined by within-subject meaningful change of 66 minutes increase from baseline to Week 26

Outcome measures

Outcome measures
Measure	DBT ITT1 Placebo n=60 Participants Oral tablet of placebo once a day in DBT	DBT ITT1 MT- 7117 Low Dose n=63 Participants Oral tablet of MT-7117 Low Dose once a day in DBT	DBT ITT1 MT- 7117 High Dose n=60 Participants Oral tablet of MT-7117 High Dose once a day in DBT
The Percentage of Subjects Who Are Responders	12 percentage of participants	11 percentage of participants	16 percentage of participants

SECONDARY outcome

Timeframe: Baseline (Week 0) and Week 26

Physical function: 1-5, where 5 is without any difficulty.

Outcome measures

Outcome measures
Measure	DBT ITT1 Placebo n=49 Participants Oral tablet of placebo once a day in DBT	DBT ITT1 MT- 7117 Low Dose n=59 Participants Oral tablet of MT-7117 Low Dose once a day in DBT	DBT ITT1 MT- 7117 High Dose n=56 Participants Oral tablet of MT-7117 High Dose once a day in DBT
Change From Baseline for Total Score in the Domain of Physical Function in the PROMIS-57 at Week 26	0.67 total score Standard Error 0.36	1.54 total score Standard Error 0.32	1.22 total score Standard Error 0.33

Adverse Events

DBT: Placebo

Serious events: 0 serious events

Other events: 30 other events

Deaths: 0 deaths

DBT: MT-7117 Low Dose

Serious events: 2 serious events

Other events: 35 other events

Deaths: 0 deaths

DBT: MT-7117 High Dose

Serious events: 2 serious events

Other events: 40 other events

Deaths: 1 deaths

DBE: MT-7117 Low Dose Switched From Placebo

Serious events: 2 serious events

Other events: 19 other events

Deaths: 0 deaths

DBE: MT-7117 High Dose Switched From Placebo

Serious events: 1 serious events

Other events: 18 other events

Deaths: 0 deaths

DBE: MT-7117 Low Dose

Serious events: 1 serious events

Other events: 24 other events

Deaths: 0 deaths

DBE: MT-7117 High Dose

Serious events: 2 serious events

Other events: 21 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	DBT: Placebo n=61 participants at risk Subjects who were randomized to receive matching oral tablet of placebo once a day in Double-Blind Treatment	DBT: MT-7117 Low Dose n=63 participants at risk Subjects who were randomized to receive oral tablet of MT-7117 Low Dose once a day in Double-Blind Treatment	DBT: MT-7117 High Dose n=60 participants at risk Subjects who were randomized to receive oral tablet of MT-7117 High Dose once a day in Double-Blind Treatment	DBE: MT-7117 Low Dose Switched From Placebo n=28 participants at risk Subjects who received MT-7117 low dose in Double-Blind Extension The subjects were switched from Placebo for Double-Blind Extension.	DBE: MT-7117 High Dose Switched From Placebo n=28 participants at risk Subjects who received MT-7117 high dose in Double-Blind Extension. The subjects were switched from Placebo for Double-Blind Extension.	DBE: MT-7117 Low Dose n=56 participants at risk Subjects who received oral tablet of MT-7117 Low Dose once a day in Double-Blind Extension	DBE: MT-7117 High Dose n=54 participants at risk Subjects who were received oral tablet of MT-7117 High Dose once a day in Double-Blind Extension
Cardiac disorders Myocarditis	0.00% 0/61 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	1.6% 1/63 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	0.00% 0/60 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	0.00% 0/28 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	0.00% 0/28 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	0.00% 0/56 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	0.00% 0/54 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".
Cardiac disorders Pericarditis	0.00% 0/61 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	0.00% 0/63 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	0.00% 0/60 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	0.00% 0/28 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	0.00% 0/28 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	1.8% 1/56 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	0.00% 0/54 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".
Congenital, familial and genetic disorders Porphyria non-acute	0.00% 0/61 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	0.00% 0/63 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	0.00% 0/60 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	0.00% 0/28 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	3.6% 1/28 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	0.00% 0/56 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	0.00% 0/54 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".
Gastrointestinal disorders Oesophagitis	0.00% 0/61 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	0.00% 0/63 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	0.00% 0/60 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	0.00% 0/28 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	0.00% 0/28 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	0.00% 0/56 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	1.9% 1/54 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".
Hepatobiliary disorders Cholestasis	0.00% 0/61 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	0.00% 0/63 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	1.7% 1/60 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	0.00% 0/28 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	0.00% 0/28 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	0.00% 0/56 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	0.00% 0/54 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".
Infections and infestations Meningitis viral	0.00% 0/61 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	1.6% 1/63 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	0.00% 0/60 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	0.00% 0/28 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	0.00% 0/28 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	0.00% 0/56 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	0.00% 0/54 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".
Injury, poisoning and procedural complications Fibula fracture	0.00% 0/61 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	0.00% 0/63 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	0.00% 0/60 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	0.00% 0/28 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	0.00% 0/28 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	0.00% 0/56 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	1.9% 1/54 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".
Investigations Hepatic enzyme increased	0.00% 0/61 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	0.00% 0/63 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	0.00% 0/60 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	7.1% 2/28 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	0.00% 0/28 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	0.00% 0/56 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	0.00% 0/54 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/61 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	0.00% 0/63 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	1.7% 1/60 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	0.00% 0/28 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	0.00% 0/28 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	0.00% 0/56 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	0.00% 0/54 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".

Other adverse events

Other adverse events
Measure	DBT: Placebo n=61 participants at risk Subjects who were randomized to receive matching oral tablet of placebo once a day in Double-Blind Treatment	DBT: MT-7117 Low Dose n=63 participants at risk Subjects who were randomized to receive oral tablet of MT-7117 Low Dose once a day in Double-Blind Treatment	DBT: MT-7117 High Dose n=60 participants at risk Subjects who were randomized to receive oral tablet of MT-7117 High Dose once a day in Double-Blind Treatment	DBE: MT-7117 Low Dose Switched From Placebo n=28 participants at risk Subjects who received MT-7117 low dose in Double-Blind Extension The subjects were switched from Placebo for Double-Blind Extension.	DBE: MT-7117 High Dose Switched From Placebo n=28 participants at risk Subjects who received MT-7117 high dose in Double-Blind Extension. The subjects were switched from Placebo for Double-Blind Extension.	DBE: MT-7117 Low Dose n=56 participants at risk Subjects who received oral tablet of MT-7117 Low Dose once a day in Double-Blind Extension	DBE: MT-7117 High Dose n=54 participants at risk Subjects who were received oral tablet of MT-7117 High Dose once a day in Double-Blind Extension
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/61 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	0.00% 0/63 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	0.00% 0/60 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	0.00% 0/28 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	7.1% 2/28 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	0.00% 0/56 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	0.00% 0/54 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".
Congenital, familial and genetic disorders Porphyria non-acute	8.2% 5/61 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	1.6% 1/63 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	1.7% 1/60 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	7.1% 2/28 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	3.6% 1/28 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	1.8% 1/56 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	1.9% 1/54 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".
Gastrointestinal disorders Abdominal pain	1.6% 1/61 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	1.6% 1/63 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	6.7% 4/60 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	0.00% 0/28 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	0.00% 0/28 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	0.00% 0/56 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	0.00% 0/54 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".
Gastrointestinal disorders Diarrhoea	1.6% 1/61 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	7.9% 5/63 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	13.3% 8/60 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	0.00% 0/28 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	3.6% 1/28 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	0.00% 0/56 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	1.9% 1/54 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".
Gastrointestinal disorders Nausea	6.6% 4/61 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	6.3% 4/63 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	28.3% 17/60 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	3.6% 1/28 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	17.9% 5/28 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	1.8% 1/56 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	3.7% 2/54 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".
General disorders Cyst	0.00% 0/61 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	0.00% 0/63 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	0.00% 0/60 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	0.00% 0/28 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	7.1% 2/28 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	0.00% 0/56 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	0.00% 0/54 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".
General disorders Fatigue	6.6% 4/61 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	4.8% 3/63 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	5.0% 3/60 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	0.00% 0/28 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	3.6% 1/28 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	3.6% 2/56 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	1.9% 1/54 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".
Infections and infestations COVID-19	3.3% 2/61 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	7.9% 5/63 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	1.7% 1/60 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	25.0% 7/28 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	28.6% 8/28 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	19.6% 11/56 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	18.5% 10/54 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".
Infections and infestations Nasopharyngitis	1.6% 1/61 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	1.6% 1/63 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	1.7% 1/60 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	7.1% 2/28 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	0.00% 0/28 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	7.1% 4/56 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	5.6% 3/54 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".
Infections and infestations Upper respiratory tract infection	8.2% 5/61 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	1.6% 1/63 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	3.3% 2/60 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	3.6% 1/28 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	3.6% 1/28 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	0.00% 0/56 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	0.00% 0/54 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".
Infections and infestations Urinary tract infection	0.00% 0/61 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	1.6% 1/63 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	1.7% 1/60 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	7.1% 2/28 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	0.00% 0/28 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	0.00% 0/56 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	1.9% 1/54 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".
Investigations Alanine aminotransferase increased	1.6% 1/61 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	4.8% 3/63 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	0.00% 0/60 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	7.1% 2/28 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	0.00% 0/28 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	1.8% 1/56 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	3.7% 2/54 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".
Investigations Aspartate aminotransferase increased	1.6% 1/61 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	6.3% 4/63 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	0.00% 0/60 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	10.7% 3/28 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	3.6% 1/28 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	1.8% 1/56 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	1.9% 1/54 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".
Investigations Blood creatine phosphokinase increased	0.00% 0/61 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	1.6% 1/63 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	1.7% 1/60 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	10.7% 3/28 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	0.00% 0/28 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	1.8% 1/56 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	0.00% 0/54 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".
Investigations Gamma-glutamyltransferase increased	8.2% 5/61 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	4.8% 3/63 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	1.7% 1/60 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	7.1% 2/28 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	3.6% 1/28 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	1.8% 1/56 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	0.00% 0/54 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".
Investigations SARS-CoV-2 test positive	0.00% 0/61 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	0.00% 0/63 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	0.00% 0/60 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	0.00% 0/28 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	0.00% 0/28 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	5.4% 3/56 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	1.9% 1/54 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".
Investigations Vitamin D decreased	1.6% 1/61 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	0.00% 0/63 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	0.00% 0/60 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	7.1% 2/28 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	0.00% 0/28 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	1.8% 1/56 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	0.00% 0/54 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".
Metabolism and nutrition disorders Iron deficiency	0.00% 0/61 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	1.6% 1/63 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	0.00% 0/60 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	0.00% 0/28 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	0.00% 0/28 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	7.1% 4/56 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	3.7% 2/54 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".
Metabolism and nutrition disorders Vitamin B12 deficiency	0.00% 0/61 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	0.00% 0/63 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	0.00% 0/60 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	7.1% 2/28 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	0.00% 0/28 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	0.00% 0/56 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	1.9% 1/54 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".
Metabolism and nutrition disorders Vitamin D deficiency	0.00% 0/61 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	1.6% 1/63 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	0.00% 0/60 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	10.7% 3/28 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	3.6% 1/28 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	5.4% 3/56 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	3.7% 2/54 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/61 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	1.6% 1/63 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	1.7% 1/60 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	7.1% 2/28 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	0.00% 0/28 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	0.00% 0/56 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	0.00% 0/54 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Melanocytic naevus	1.6% 1/61 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	9.5% 6/63 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	13.3% 8/60 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	14.3% 4/28 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	10.7% 3/28 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	5.4% 3/56 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	3.7% 2/54 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".
Nervous system disorders Headache	4.9% 3/61 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	12.7% 8/63 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	15.0% 9/60 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	7.1% 2/28 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	10.7% 3/28 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	3.6% 2/56 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	3.7% 2/54 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".
Nervous system disorders Paraesthesia	0.00% 0/61 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	1.6% 1/63 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	0.00% 0/60 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	10.7% 3/28 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	3.6% 1/28 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	0.00% 0/56 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	0.00% 0/54 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".
Psychiatric disorders Anxiety	0.00% 0/61 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	0.00% 0/63 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	0.00% 0/60 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	0.00% 0/28 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	7.1% 2/28 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	1.8% 1/56 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	0.00% 0/54 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".
Skin and subcutaneous tissue disorders Ephelides	1.6% 1/61 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	4.8% 3/63 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	6.7% 4/60 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	0.00% 0/28 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	0.00% 0/28 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	0.00% 0/56 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	0.00% 0/54 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".
Skin and subcutaneous tissue disorders Nail pigmentation	0.00% 0/61 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	0.00% 0/63 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	3.3% 2/60 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	7.1% 2/28 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	0.00% 0/28 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	0.00% 0/56 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	1.9% 1/54 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".
Skin and subcutaneous tissue disorders Photosensitivity reaction	9.8% 6/61 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	1.6% 1/63 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	3.3% 2/60 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	3.6% 1/28 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	7.1% 2/28 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	0.00% 0/56 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	3.7% 2/54 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".
Skin and subcutaneous tissue disorders Skin discolouration	0.00% 0/61 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	7.9% 5/63 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	10.0% 6/60 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	0.00% 0/28 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	3.6% 1/28 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	0.00% 0/56 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	0.00% 0/54 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".
Skin and subcutaneous tissue disorders Skin hyperpigmentation	1.6% 1/61 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	4.8% 3/63 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	13.3% 8/60 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	7.1% 2/28 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	10.7% 3/28 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	0.00% 0/56 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	0.00% 0/54 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".
Skin and subcutaneous tissue disorders Skin lesion	0.00% 0/61 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	1.6% 1/63 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	1.7% 1/60 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	7.1% 2/28 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	0.00% 0/28 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	0.00% 0/56 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".	0.00% 0/54 • through study completion, an average of 58 weeks Total Number At Risk of Adverse event is the number of patients who enrolled in DBT or DBE period and who received at least 1 dose of study medication during the period. For "DBE: MT-7117 high dose", 55 patients were enrolled in DBE period and 54 patients received at least 1 dose of study medication during DBE period. Therefore, 54 patients are the Total Number At Risk for "DBE: MT-7117 high dose".

Additional Information

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Tanabe Pharma America, Inc.

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