Trial Outcomes & Findings for PROSEEK: A Phase 2 Study In Early Parkinson's Disease Patients Evaluating The Safety And Efficacy Of Abl Tyrosine Kinase Inhibition Using K0706 (NCT NCT03655236)

NCT ID: NCT03655236

Last Updated: 2025-07-25

Results Overview

Part III: Motor examination: 18 items. Score range: 0-132, 32 and below is mild, 59 and above is severe.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 513 participants
• Primary outcome timeframe: Week 40
• Results posted on: 2025-07-25

Participant Flow

Participant milestones

Measure	K0706, Low Dose K0706: low dose, orally, once-daily. This study consists of two parts. Subjects received K0706, Low dose in Part 1 and Part 2 of the study. All subjects will continue treatment for up to 36 weeks	K0706, High Dose K0706: high dose, orally, once-daily This study consists of two parts. Subjects received K0706, high dose in Part 1 and Part 2 of the study. All subjects will continue treatment for up to 36 weeks.	Placebo placebo: placebo, orally, once-daily This study consists of two parts. Subjects who had been randomized to placebo in Part 1 will be rolled over to a high dose K0706 (384 mg powder for suspension or equivalent formulation) at Week 40. All subjects will continue treatment for up to 36 weeks.
Subject Disposition in Part 1 Period STARTED	171	174	168
Subject Disposition in Part 1 Period COMPLETED	114	66	120
Subject Disposition in Part 1 Period NOT COMPLETED	57	108	48
Subject Disposition in Part 2 Period STARTED	72	40	77
Subject Disposition in Part 2 Period COMPLETED	36	21	27
Subject Disposition in Part 2 Period NOT COMPLETED	36	19	50

Reasons for withdrawal

Measure	K0706, Low Dose K0706: low dose, orally, once-daily. This study consists of two parts. Subjects received K0706, Low dose in Part 1 and Part 2 of the study. All subjects will continue treatment for up to 36 weeks	K0706, High Dose K0706: high dose, orally, once-daily This study consists of two parts. Subjects received K0706, high dose in Part 1 and Part 2 of the study. All subjects will continue treatment for up to 36 weeks.	Placebo placebo: placebo, orally, once-daily This study consists of two parts. Subjects who had been randomized to placebo in Part 1 will be rolled over to a high dose K0706 (384 mg powder for suspension or equivalent formulation) at Week 40. All subjects will continue treatment for up to 36 weeks.
Subject Disposition in Part 1 Period Adverse Event	25	55	12
Subject Disposition in Part 1 Period Death	1	0	0
Subject Disposition in Part 1 Period Physician Decision	0	3	2
Subject Disposition in Part 1 Period Lost to Follow-up	1	3	2
Subject Disposition in Part 1 Period Parkinson's disease progression	2	8	5
Subject Disposition in Part 1 Period Poor compliance	0	2	0
Subject Disposition in Part 1 Period Protocol Violation	1	1	0
Subject Disposition in Part 1 Period Requires prohibited medication	4	5	3
Subject Disposition in Part 1 Period Study terminated by Sponsor	12	8	13
Subject Disposition in Part 1 Period Withdrawal by Subject	0	5	3
Subject Disposition in Part 1 Period Withdrawal of consent	11	16	6
Subject Disposition in Part 1 Period Other	0	2	2
Subject Disposition in Part 2 Period Adverse Event	2	5	12
Subject Disposition in Part 2 Period Lost to Follow-up	1	0	0
Subject Disposition in Part 2 Period Parkinson's disease progression	4	0	2
Subject Disposition in Part 2 Period Protocol Violation	1	0	4
Subject Disposition in Part 2 Period Requires prohibited medication	3	1	5
Subject Disposition in Part 2 Period Study terminated by Sponsor	18	11	13
Subject Disposition in Part 2 Period Withdrawal by Subject	1	1	2
Subject Disposition in Part 2 Period Withdrawal of consent	5	1	12
Subject Disposition in Part 2 Period Other	1	0	0

Baseline Characteristics

Prior placebo transitioned to K0706 high-dose

Baseline characteristics by cohort

Measure	K0706, Low Dose n=171 Participants K0706: low dose, orally, once-daily This study consists of two parts. Subjects who had been randomized to placebo in Part 1 will be rolled over to a high dose K0706 (384 mg powder for suspension or equivalent formulation) at Week 40. Subjects that had been randomized to either dose of K0706 in part 1 of the study will continue on the same dosing regimen in Part 2 of the study. All subjects will continue treatment for up to 36 weeks.	K0706, High Dose n=174 Participants K0706: high dose, orally, once-daily This study consists of two parts. Subjects who had been randomized to placebo in Part 1 will be rolled over to a high dose K0706 (384 mg powder for suspension or equivalent formulation) at Week 40. Subjects that had been randomized to either dose of K0706 in part 1 of the study will continue on the same dosing regimen in Part 2 of the study. All subjects will continue treatment for up to 36 weeks.	Placebo n=168 Participants placebo: placebo, orally, once-daily (Prior placebo transitioned to K0706 high-dose) This study consists of two parts. Subjects who had been randomized to placebo in Part 1 will be rolled over to a high dose K0706 (384 mg powder for suspension or equivalent formulation) at Week 40. Subjects that had been randomized to either dose of K0706 in part 1 of the study will continue on the same dosing regimen in Part 2 of the study. All subjects will continue treatment for up to 36 weeks.	Total n=513 Participants Total of all reporting groups
Race (NIH/OMB) Part 1 · Unknown or Not Reported	0 Participants n=171 Participants • Prior placebo transitioned to K0706 high-dose	0 Participants n=174 Participants • Prior placebo transitioned to K0706 high-dose	0 Participants n=168 Participants • Prior placebo transitioned to K0706 high-dose	0 Participants n=513 Participants • Prior placebo transitioned to K0706 high-dose
Age, Continuous Part 1	64.3 years STANDARD_DEVIATION 8.44 • n=171 Participants • Prior placebo transitioned to K0706 high-dose	65.3 years STANDARD_DEVIATION 7.67 • n=174 Participants • Prior placebo transitioned to K0706 high-dose	65.4 years STANDARD_DEVIATION 8.03 • n=168 Participants • Prior placebo transitioned to K0706 high-dose	65.0 years STANDARD_DEVIATION 8.05 • n=513 Participants • Prior placebo transitioned to K0706 high-dose
Age, Continuous Part 2	62.6 years STANDARD_DEVIATION 7.75 • n=72 Participants • Prior placebo transitioned to K0706 high-dose	65.3 years STANDARD_DEVIATION 6.66 • n=40 Participants • Prior placebo transitioned to K0706 high-dose	66.0 years STANDARD_DEVIATION 7.84 • n=77 Participants • Prior placebo transitioned to K0706 high-dose	64.5 years STANDARD_DEVIATION 7.70 • n=189 Participants • Prior placebo transitioned to K0706 high-dose
Sex: Female, Male Part 1 · Female	61 Participants n=171 Participants • Prior placebo transitioned to K0706 high-dose	71 Participants n=174 Participants • Prior placebo transitioned to K0706 high-dose	47 Participants n=168 Participants • Prior placebo transitioned to K0706 high-dose	179 Participants n=513 Participants • Prior placebo transitioned to K0706 high-dose
Sex: Female, Male Part 1 · Male	110 Participants n=171 Participants • Prior placebo transitioned to K0706 high-dose	103 Participants n=174 Participants • Prior placebo transitioned to K0706 high-dose	121 Participants n=168 Participants • Prior placebo transitioned to K0706 high-dose	334 Participants n=513 Participants • Prior placebo transitioned to K0706 high-dose
Sex: Female, Male Part 2 · Female	23 Participants n=72 Participants • Prior placebo transitioned to K0706 high-dose	11 Participants n=40 Participants • Prior placebo transitioned to K0706 high-dose	20 Participants n=77 Participants • Prior placebo transitioned to K0706 high-dose	54 Participants n=189 Participants • Prior placebo transitioned to K0706 high-dose
Sex: Female, Male Part 2 · Male	49 Participants n=72 Participants • Prior placebo transitioned to K0706 high-dose	29 Participants n=40 Participants • Prior placebo transitioned to K0706 high-dose	57 Participants n=77 Participants • Prior placebo transitioned to K0706 high-dose	135 Participants n=189 Participants • Prior placebo transitioned to K0706 high-dose
Ethnicity (NIH/OMB) Part 1 · Hispanic or Latino	16 Participants n=171 Participants • Prior placebo transitioned to K0706 high-dose	17 Participants n=174 Participants • Prior placebo transitioned to K0706 high-dose	15 Participants n=168 Participants • Prior placebo transitioned to K0706 high-dose	48 Participants n=513 Participants • Prior placebo transitioned to K0706 high-dose
Ethnicity (NIH/OMB) Part 1 · Not Hispanic or Latino	154 Participants n=171 Participants • Prior placebo transitioned to K0706 high-dose	156 Participants n=174 Participants • Prior placebo transitioned to K0706 high-dose	153 Participants n=168 Participants • Prior placebo transitioned to K0706 high-dose	463 Participants n=513 Participants • Prior placebo transitioned to K0706 high-dose
Ethnicity (NIH/OMB) Part 1 · Unknown or Not Reported	1 Participants n=171 Participants • Prior placebo transitioned to K0706 high-dose	1 Participants n=174 Participants • Prior placebo transitioned to K0706 high-dose	0 Participants n=168 Participants • Prior placebo transitioned to K0706 high-dose	2 Participants n=513 Participants • Prior placebo transitioned to K0706 high-dose
Ethnicity (NIH/OMB) Part 2 · Hispanic or Latino	8 Participants n=72 Participants • Prior placebo transitioned to K0706 high-dose	2 Participants n=40 Participants • Prior placebo transitioned to K0706 high-dose	4 Participants n=77 Participants • Prior placebo transitioned to K0706 high-dose	14 Participants n=189 Participants • Prior placebo transitioned to K0706 high-dose
Ethnicity (NIH/OMB) Part 2 · Not Hispanic or Latino	64 Participants n=72 Participants • Prior placebo transitioned to K0706 high-dose	38 Participants n=40 Participants • Prior placebo transitioned to K0706 high-dose	73 Participants n=77 Participants • Prior placebo transitioned to K0706 high-dose	175 Participants n=189 Participants • Prior placebo transitioned to K0706 high-dose
Ethnicity (NIH/OMB) Part 2 · Unknown or Not Reported	0 Participants n=72 Participants • Prior placebo transitioned to K0706 high-dose	0 Participants n=40 Participants • Prior placebo transitioned to K0706 high-dose	0 Participants n=77 Participants • Prior placebo transitioned to K0706 high-dose	0 Participants n=189 Participants • Prior placebo transitioned to K0706 high-dose
Race (NIH/OMB) Part 1 · American Indian or Alaska Native	0 Participants n=171 Participants • Prior placebo transitioned to K0706 high-dose	0 Participants n=174 Participants • Prior placebo transitioned to K0706 high-dose	1 Participants n=168 Participants • Prior placebo transitioned to K0706 high-dose	1 Participants n=513 Participants • Prior placebo transitioned to K0706 high-dose
Race (NIH/OMB) Part 1 · Asian	33 Participants n=171 Participants • Prior placebo transitioned to K0706 high-dose	29 Participants n=174 Participants • Prior placebo transitioned to K0706 high-dose	28 Participants n=168 Participants • Prior placebo transitioned to K0706 high-dose	90 Participants n=513 Participants • Prior placebo transitioned to K0706 high-dose
Race (NIH/OMB) Part 1 · Native Hawaiian or Other Pacific Islander	0 Participants n=171 Participants • Prior placebo transitioned to K0706 high-dose	0 Participants n=174 Participants • Prior placebo transitioned to K0706 high-dose	0 Participants n=168 Participants • Prior placebo transitioned to K0706 high-dose	0 Participants n=513 Participants • Prior placebo transitioned to K0706 high-dose
Race (NIH/OMB) Part 1 · Black or African American	6 Participants n=171 Participants • Prior placebo transitioned to K0706 high-dose	1 Participants n=174 Participants • Prior placebo transitioned to K0706 high-dose	3 Participants n=168 Participants • Prior placebo transitioned to K0706 high-dose	10 Participants n=513 Participants • Prior placebo transitioned to K0706 high-dose
Race (NIH/OMB) Part 1 · White	132 Participants n=171 Participants • Prior placebo transitioned to K0706 high-dose	144 Participants n=174 Participants • Prior placebo transitioned to K0706 high-dose	136 Participants n=168 Participants • Prior placebo transitioned to K0706 high-dose	412 Participants n=513 Participants • Prior placebo transitioned to K0706 high-dose
Race (NIH/OMB) Part 1 · More than one race	0 Participants n=171 Participants • Prior placebo transitioned to K0706 high-dose	0 Participants n=174 Participants • Prior placebo transitioned to K0706 high-dose	0 Participants n=168 Participants • Prior placebo transitioned to K0706 high-dose	0 Participants n=513 Participants • Prior placebo transitioned to K0706 high-dose
Race (NIH/OMB) Part 2 · Unknown or Not Reported	0 Participants n=72 Participants • Prior placebo transitioned to K0706 high-dose	0 Participants n=40 Participants • Prior placebo transitioned to K0706 high-dose	0 Participants n=77 Participants • Prior placebo transitioned to K0706 high-dose	0 Participants n=189 Participants • Prior placebo transitioned to K0706 high-dose
Race (NIH/OMB) Part 2 · American Indian or Alaska Native	0 Participants n=72 Participants • Prior placebo transitioned to K0706 high-dose	0 Participants n=40 Participants • Prior placebo transitioned to K0706 high-dose	1 Participants n=77 Participants • Prior placebo transitioned to K0706 high-dose	1 Participants n=189 Participants • Prior placebo transitioned to K0706 high-dose
Race (NIH/OMB) Part 2 · Asian	19 Participants n=72 Participants • Prior placebo transitioned to K0706 high-dose	6 Participants n=40 Participants • Prior placebo transitioned to K0706 high-dose	13 Participants n=77 Participants • Prior placebo transitioned to K0706 high-dose	38 Participants n=189 Participants • Prior placebo transitioned to K0706 high-dose
Race (NIH/OMB) Part 2 · Native Hawaiian or Other Pacific Islander	0 Participants n=72 Participants • Prior placebo transitioned to K0706 high-dose	0 Participants n=40 Participants • Prior placebo transitioned to K0706 high-dose	0 Participants n=77 Participants • Prior placebo transitioned to K0706 high-dose	0 Participants n=189 Participants • Prior placebo transitioned to K0706 high-dose
Race (NIH/OMB) Part 2 · Black or African American	1 Participants n=72 Participants • Prior placebo transitioned to K0706 high-dose	1 Participants n=40 Participants • Prior placebo transitioned to K0706 high-dose	0 Participants n=77 Participants • Prior placebo transitioned to K0706 high-dose	2 Participants n=189 Participants • Prior placebo transitioned to K0706 high-dose
Race (NIH/OMB) Part 2 · White	52 Participants n=72 Participants • Prior placebo transitioned to K0706 high-dose	33 Participants n=40 Participants • Prior placebo transitioned to K0706 high-dose	63 Participants n=77 Participants • Prior placebo transitioned to K0706 high-dose	148 Participants n=189 Participants • Prior placebo transitioned to K0706 high-dose
Race (NIH/OMB) Part 2 · More than one race	0 Participants n=72 Participants • Prior placebo transitioned to K0706 high-dose	0 Participants n=40 Participants • Prior placebo transitioned to K0706 high-dose	0 Participants n=77 Participants • Prior placebo transitioned to K0706 high-dose	0 Participants n=189 Participants • Prior placebo transitioned to K0706 high-dose

PRIMARY outcome

Timeframe: Week 40

Population: Efficacy analysis set

Part III: Motor examination: 18 items. Score range: 0-132, 32 and below is mild, 59 and above is severe.

Outcome measures

Measure	K0706, Low Dose n=164 Participants K0706: low dose, orally, once-daily	K0706, High Dose n=162 Participants K0706: high dose, orally, once-daily	Placebo n=161 Participants placebo: placebo, orally, once-daily
Change From Baseline to Week 40 in the Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III Total Score.	1.5 score on a scale Standard Deviation 8.77	1 score on a scale Standard Deviation 7.58	-1 score on a scale Standard Deviation 8.13

PRIMARY outcome

Timeframe: Part 2 (Week 40 to 80)

Population: Safety analysis set

Outcome measures

Measure	K0706, Low Dose n=72 Participants K0706: low dose, orally, once-daily	K0706, High Dose n=40 Participants K0706: high dose, orally, once-daily	Placebo n=77 Participants placebo: placebo, orally, once-daily
Number of Participants With Treatment-emergent Adverse Events	37 Participants	24 Participants	61 Participants

SECONDARY outcome

Timeframe: Part 1: Week 40 and Part 2: Week 76

Population: Efficacy analysis set

The Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II assesses the motor aspects of experiences of daily living based on patient self-report. It comprises 13 items, each rated on a 5-point scale ranging from 0 (normal) to 4 (severe impairment). The total score for Part II ranges from 0 to 52, calculated as the sum of the individual item scores.

The MDS-UPDRS Part III assesses the motor symptoms of Parkinson's disease. This part consists of 18 items, which are assessed across various body regions, resulting in 33 individual scores. Each item is rated on a 5-point scale from 0 (normal) to 4 (severe impairment), with higher scores indicating greater motor dysfunction. The total score for Part III ranges from 0 to 132, which is the sum of the individual item scores.

The sum of the MDS-UPDRS Part II and Part III total scores ranges from 0 to 184, with high scores indicating greater clinical impairment.

Outcome measures

Measure	K0706, Low Dose n=164 Participants K0706: low dose, orally, once-daily	K0706, High Dose n=162 Participants K0706: high dose, orally, once-daily	Placebo n=161 Participants placebo: placebo, orally, once-daily
Part 1: Change From Baseline to Week 40 in the Sum of the MDS-UPDRS Part II and Part III Total Scores and Part 2: Change From Week 40 to Week 76 in the MDS-UPDRS Part III Total Score. Part 1 Period: MDS-UPDRS (Sum of Parts II and III Total Scores)	2.6 score on a scale Standard Deviation 10.83	2.7 score on a scale Standard Deviation 9.72	-0.6 score on a scale Standard Deviation 9.53
Part 1: Change From Baseline to Week 40 in the Sum of the MDS-UPDRS Part II and Part III Total Scores and Part 2: Change From Week 40 to Week 76 in the MDS-UPDRS Part III Total Score. Part 2 Period: MDS-UPDRS Part III Tremors Subscore	0.4 score on a scale Standard Deviation 1.87	-0.9 score on a scale Standard Deviation 2.54	-0.4 score on a scale Standard Deviation 2.68
Part 1: Change From Baseline to Week 40 in the Sum of the MDS-UPDRS Part II and Part III Total Scores and Part 2: Change From Week 40 to Week 76 in the MDS-UPDRS Part III Total Score. Part 2 Period: MDS-UPDRS Part III Bradykinesia Subscore	-0.7 score on a scale Standard Deviation 2.25	-0.1 score on a scale Standard Deviation 0.83	0.0 score on a scale Standard Deviation 2.20
Part 1: Change From Baseline to Week 40 in the Sum of the MDS-UPDRS Part II and Part III Total Scores and Part 2: Change From Week 40 to Week 76 in the MDS-UPDRS Part III Total Score. Part 2 Period: MDS-UPDRS Part III Rigidity Subscore	1.7 score on a scale Standard Deviation 4.46	0.2 score on a scale Standard Deviation 3.81	0.8 score on a scale Standard Deviation 4.12
Part 1: Change From Baseline to Week 40 in the Sum of the MDS-UPDRS Part II and Part III Total Scores and Part 2: Change From Week 40 to Week 76 in the MDS-UPDRS Part III Total Score. Part 2 Period: MDS-UPDRS Part III Axial Symptoms Subscore	0.5 score on a scale Standard Deviation 1.22	0.4 score on a scale Standard Deviation 1.15	0.0 score on a scale Standard Deviation 1.37

SECONDARY outcome

Timeframe: Part 1: Week 40 and Part 2: Week 80 (Part 2 is applicable to the subjects who complete the EoT visit of part 1 (V11/Week 40) and who confirm their willingness to participate in part 2 of the study.

Population: Efficacy analysis set

Outcome measures

Measure	K0706, Low Dose n=164 Participants K0706: low dose, orally, once-daily	K0706, High Dose n=162 Participants K0706: high dose, orally, once-daily	Placebo n=161 Participants placebo: placebo, orally, once-daily
To Determine if K0706 Delays the Initiation of Symptomatic Medications in Participants	149 Participants	129 Participants	144 Participants

SECONDARY outcome

Timeframe: Week 40

Population: Efficacy analysis set

Health-Related quality of life (HRQoL) will be measured using the European Quality of Life Questionnaire 5 level version (EQ-5D-5L). This scale is numbered from 0 to 100. 100 means the best health you can imagine. 0 means the worst health you can imagine.

Outcome measures

Measure	K0706, Low Dose n=164 Participants K0706: low dose, orally, once-daily	K0706, High Dose n=162 Participants K0706: high dose, orally, once-daily	Placebo n=161 Participants placebo: placebo, orally, once-daily
Change in Health Related Quality of Life as Measured by the European Quality of Life Questionnaire 5 Level Version	-0.0419 score on a scale Standard Deviation 0.11060	-0.0531 score on a scale Standard Deviation 0.16289	-0.0140 score on a scale Standard Deviation 0.10787

SECONDARY outcome

Timeframe: Week 40

Population: Efficacy analysis set

The Clinician Global Impression Severity (CGIS) is a tool used to measure overall disease severity, assessed as follows:

1. Normal

2. Borderline

3. Mild

4. Moderate

5. Marked

6. Severe

7. Among the Most Extremely Ill Patient

Outcome measures

Measure	K0706, Low Dose n=164 Participants K0706: low dose, orally, once-daily	K0706, High Dose n=162 Participants K0706: high dose, orally, once-daily	Placebo n=161 Participants placebo: placebo, orally, once-daily
Change in Clinician Global Impression Severity	0.2 score on a scale Standard Deviation 0.68	0.0 score on a scale Standard Deviation 0.74	0.2 score on a scale Standard Deviation 0.91

SECONDARY outcome

Timeframe: Week 40

Population: Efficacy analysis set

The Scales for Outcome in Parkinson's disease - Autonomic (SCOPA-AUT) sum score is a sum of rating scores over 23 items. The SCOPA-AUT sum score ranges from 0 to 69. A higher score means a more severe autonomic dysfunction (i.e., a worse outcome). For each of the 23 items, the score ranges from 0 to 3. The rating scale is the follows:

0= Never experiencing the symptom;

1. Sometimes experiencing the symptom;

2. Regularly experiencing the symptom;

3. Often experiencing the symptom

Outcome measures

Measure	K0706, Low Dose n=164 Participants K0706: low dose, orally, once-daily	K0706, High Dose n=162 Participants K0706: high dose, orally, once-daily	Placebo n=161 Participants placebo: placebo, orally, once-daily
Change in the Scales for Outcomes in Parkinson's Disease - Autonomic Questionnaire	1.6 score on a scale Standard Deviation 7.70	3.8 score on a scale Standard Deviation 10.11	0.3 score on a scale Standard Deviation 7.76

SECONDARY outcome

Timeframe: Week 28

Population: PK Analysis Set (Part 1): The PK Analysis Set (Part 1) included all subjects who received at least one dose of study drug in Part 1 (i.e., the 40-week double-blind part) of the study and also had at least one blood sample taken to measure the K0706 concentration level.

Plasma pharmacokinetic (PK) samples were collected Week 28, per the Schedule of Assessment of the study protocol. There was no PK samples collected after Week 28 per the study protocol.

Outcome measures

Measure	K0706, Low Dose n=151 Participants K0706: low dose, orally, once-daily	K0706, High Dose n=150 Participants K0706: high dose, orally, once-daily	Placebo placebo: placebo, orally, once-daily
Serum Concentration Level of K0706	1127.8 ng/mL Standard Deviation 1379.69	1451.9 ng/mL Standard Deviation 1371.79	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 40

Not available: The results of the exploratory analyses, including examination of CSF using the α-synuclein aggregation assay and measurement of neurofilament light, were not intended for interpretation of efficacy.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 40

Not available: The results of the exploratory analyses, including examination of CSF using the α-synuclein aggregation assay and measurement of neurofilament light, were not intended for interpretation of efficacy.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 40

Not available: The results of the exploratory analyses, including examination of CSF using the α-synuclein aggregation assay and measurement of neurofilament light, were not intended for interpretation of efficacy.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 40

Not available: The results of the exploratory analyses, including examination of CSF using the α-synuclein aggregation assay and measurement of neurofilament light, were not intended for interpretation of efficacy.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Week 40

Not available: The results of the exploratory analyses, including examination of CSF using the α-synuclein aggregation assay and measurement of neurofilament light, were not intended for interpretation of efficacy.

Outcome measures

Outcome data not reported

Adverse Events

K0706, Low Dose (Part 2)

Serious events: 3 serious events

Other events: 21 other events

Deaths: 0 deaths

K0706, High Dose (Part 2)

Serious events: 11 serious events

Other events: 85 other events

Deaths: 0 deaths

Placebo (Part 2)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

K0706, Low Dose (Part 1)

Serious events: 14 serious events

Other events: 131 other events

Deaths: 1 deaths

K0706, High Dose (Part 1)

Serious events: 7 serious events

Other events: 150 other events

Deaths: 0 deaths

Placebo (Part 1)

Serious events: 5 serious events

Other events: 124 other events

Deaths: 0 deaths

Serious adverse events

Measure	K0706, Low Dose (Part 2) n=72 participants at risk K0706: low dose, orally, once-daily	K0706, High Dose (Part 2) n=117 participants at risk K0706: high dose, orally, once-daily	Placebo (Part 2) Prior placebo transitioned to K0706 high dose	K0706, Low Dose (Part 1) n=171 participants at risk K0706: low dose, orally, once-daily	K0706, High Dose (Part 1) n=173 participants at risk K0706: high dose, orally, once-daily	Placebo (Part 1) n=167 participants at risk placebo: placebo, orally, once-daily
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/72 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.85% 1/117 • Number of events 1 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	— 0/0 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.00% 0/171 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.00% 0/173 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.60% 1/167 • Number of events 1 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.
Psychiatric disorders Delirium	0.00% 0/72 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.85% 1/117 • Number of events 1 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	— 0/0 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.00% 0/171 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.00% 0/173 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.00% 0/167 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.
Infections and infestations Bacterial sepsis	0.00% 0/72 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.85% 1/117 • Number of events 1 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	— 0/0 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.00% 0/171 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.00% 0/173 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.00% 0/167 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.
Infections and infestations Pneumonia	1.4% 1/72 • Number of events 1 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.85% 1/117 • Number of events 1 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	— 0/0 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.58% 1/171 • Number of events 1 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.00% 0/173 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.00% 0/167 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.
Infections and infestations Lower respiratory tract infection	0.00% 0/72 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.85% 1/117 • Number of events 1 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	— 0/0 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.00% 0/171 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.00% 0/173 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.00% 0/167 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.
Infections and infestations Sepsis	0.00% 0/72 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.85% 1/117 • Number of events 1 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	— 0/0 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.00% 0/171 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.00% 0/173 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.00% 0/167 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-Hodgkin's Lymphoma	0.00% 0/72 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.85% 1/117 • Number of events 1 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	— 0/0 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.00% 0/171 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.00% 0/173 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.00% 0/167 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/72 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.85% 1/117 • Number of events 1 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	— 0/0 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.00% 0/171 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.58% 1/173 • Number of events 1 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	1.8% 3/167 • Number of events 3 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.
Psychiatric disorders Psychotic disorder	0.00% 0/72 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.85% 1/117 • Number of events 1 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	— 0/0 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.00% 0/171 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.00% 0/173 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.00% 0/167 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.
Nervous system disorders Brain stem syndrome	0.00% 0/72 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.85% 1/117 • Number of events 1 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	— 0/0 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.00% 0/171 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.00% 0/173 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.00% 0/167 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.
Nervous system disorders Encephalopathy	0.00% 0/72 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.85% 1/117 • Number of events 1 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	— 0/0 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.00% 0/171 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.00% 0/173 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.00% 0/167 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.
Nervous system disorders Idiopathic intracranial hypertension	0.00% 0/72 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.85% 1/117 • Number of events 1 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	— 0/0 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.00% 0/171 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.00% 0/173 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.00% 0/167 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.
Nervous system disorders Parkinson's disease	0.00% 0/72 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.85% 1/117 • Number of events 1 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	— 0/0 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.58% 1/171 • Number of events 3 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.58% 1/173 • Number of events 1 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	1.2% 2/167 • Number of events 2 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.
Cardiac disorders Coronary Heart Disease	1.4% 1/72 • Number of events 1 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.00% 0/117 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	— 0/0 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.00% 0/171 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.00% 0/173 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.00% 0/167 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/72 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.85% 1/117 • Number of events 1 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	— 0/0 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.58% 1/171 • Number of events 1 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.00% 0/173 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.60% 1/167 • Number of events 1 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.
Respiratory, thoracic and mediastinal disorders Pneumonitis	1.4% 1/72 • Number of events 1 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.00% 0/117 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	— 0/0 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.00% 0/171 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.00% 0/173 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.00% 0/167 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.
Gastrointestinal disorders Gastrointestinal perforation	0.00% 0/72 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.85% 1/117 • Number of events 1 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	— 0/0 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.00% 0/171 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.00% 0/173 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.00% 0/167 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.
Gastrointestinal disorders Gastrooesophageal reflux	0.00% 0/72 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.85% 1/117 • Number of events 1 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	— 0/0 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.00% 0/171 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.00% 0/173 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.00% 0/167 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.
Gastrointestinal disorders Umbilical hernia	0.00% 0/72 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.85% 1/117 • Number of events 1 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	— 0/0 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.00% 0/171 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.00% 0/173 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.00% 0/167 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.
Renal and urinary disorders Calculus bladder	0.00% 0/72 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.85% 1/117 • Number of events 1 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	— 0/0 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.00% 0/171 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.00% 0/173 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.00% 0/167 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.00% 0/72 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.85% 1/117 • Number of events 1 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	— 0/0 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.58% 1/171 • Number of events 1 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.00% 0/173 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.00% 0/167 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.
Infections and infestations COVID-19	0.00% 0/72 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.00% 0/117 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	— 0/0 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.58% 1/171 • Number of events 1 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.58% 1/173 • Number of events 1 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.60% 1/167 • Number of events 1 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.
Infections and infestations Appendicitis	0.00% 0/72 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.00% 0/117 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	— 0/0 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	1.2% 2/171 • Number of events 2 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.00% 0/173 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.00% 0/167 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.
Infections and infestations COVID-19 pneumonia	0.00% 0/72 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.00% 0/117 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	— 0/0 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.00% 0/171 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.00% 0/173 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.60% 1/167 • Number of events 1 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.
Infections and infestations Viral infection	0.00% 0/72 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.00% 0/117 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	— 0/0 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.00% 0/171 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.58% 1/173 • Number of events 1 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.00% 0/167 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastrointestinal neoplasm	0.00% 0/72 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.00% 0/117 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	— 0/0 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.00% 0/171 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.00% 0/173 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.60% 1/167 • Number of events 1 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.00% 0/72 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.00% 0/117 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	— 0/0 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.00% 0/171 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.00% 0/173 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.60% 1/167 • Number of events 1 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of the tongue	0.00% 0/72 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.00% 0/117 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	— 0/0 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.00% 0/171 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.58% 1/173 • Number of events 1 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.00% 0/167 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.
Psychiatric disorders Alcohol withdrawal syndrome	0.00% 0/72 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.00% 0/117 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	— 0/0 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.58% 1/171 • Number of events 1 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.00% 0/173 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.00% 0/167 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.
Nervous system disorders Transient ischaemic attack	0.00% 0/72 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.00% 0/117 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	— 0/0 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.58% 1/171 • Number of events 1 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.00% 0/173 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.60% 1/167 • Number of events 1 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.
Nervous system disorders Dizziness	0.00% 0/72 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.00% 0/117 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	— 0/0 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.00% 0/171 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.58% 1/173 • Number of events 1 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.00% 0/167 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.
Nervous system disorders Parkinsonism	0.00% 0/72 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.00% 0/117 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	— 0/0 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.00% 0/171 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.58% 1/173 • Number of events 1 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.00% 0/167 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.
Nervous system disorders Vertebral artery occlusion	0.00% 0/72 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.00% 0/117 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	— 0/0 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.58% 1/171 • Number of events 1 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.00% 0/173 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.00% 0/167 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.
Nervous system disorders Visual field defect	0.00% 0/72 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.00% 0/117 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	— 0/0 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.58% 1/171 • Number of events 1 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.00% 0/173 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.00% 0/167 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.
Eye disorders Optic ischaemic neuropathy	0.00% 0/72 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.00% 0/117 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	— 0/0 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.00% 0/171 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.58% 1/173 • Number of events 2 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.00% 0/167 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.
Cardiac disorders Myocardial infarction	0.00% 0/72 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.00% 0/117 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	— 0/0 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.58% 1/171 • Number of events 1 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.00% 0/173 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.00% 0/167 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.
Gastrointestinal disorders Abdominal hernia obstructive	0.00% 0/72 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.00% 0/117 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	— 0/0 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.58% 1/171 • Number of events 1 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.00% 0/173 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.00% 0/167 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.
Musculoskeletal and connective tissue disorders Spondylolisthesis	0.00% 0/72 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.00% 0/117 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	— 0/0 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.58% 1/171 • Number of events 1 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.00% 0/173 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.00% 0/167 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.
General disorders Chest pain	0.00% 0/72 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.00% 0/117 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	— 0/0 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.58% 1/171 • Number of events 1 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.00% 0/173 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.00% 0/167 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.
Injury, poisoning and procedural complications Fall	0.00% 0/72 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.00% 0/117 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	— 0/0 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.58% 1/171 • Number of events 1 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.00% 0/173 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.00% 0/167 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.
Injury, poisoning and procedural complications Femur fracture	0.00% 0/72 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.00% 0/117 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	— 0/0 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.00% 0/171 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.58% 1/173 • Number of events 1 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.00% 0/167 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.
Injury, poisoning and procedural complications Hip fracture	0.00% 0/72 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.00% 0/117 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	— 0/0 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.58% 1/171 • Number of events 1 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.00% 0/173 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.00% 0/167 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.
Surgical and medical procedures Mitral valve replacement	0.00% 0/72 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.00% 0/117 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	— 0/0 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.00% 0/171 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.58% 1/173 • Number of events 1 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.00% 0/167 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.

Other adverse events

Measure	K0706, Low Dose (Part 2) n=72 participants at risk K0706: low dose, orally, once-daily	K0706, High Dose (Part 2) n=117 participants at risk K0706: high dose, orally, once-daily	Placebo (Part 2) Prior placebo transitioned to K0706 high dose	K0706, Low Dose (Part 1) n=171 participants at risk K0706: low dose, orally, once-daily	K0706, High Dose (Part 1) n=173 participants at risk K0706: high dose, orally, once-daily	Placebo (Part 1) n=167 participants at risk placebo: placebo, orally, once-daily
Infections and infestations Urinary tract infection	1.4% 1/72 • Number of events 1 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	6.0% 7/117 • Number of events 9 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	— 0/0 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	5.3% 9/171 • Number of events 10 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	9.2% 16/173 • Number of events 20 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	7.8% 13/167 • Number of events 17 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.
Psychiatric disorders Anxiety	1.4% 1/72 • Number of events 1 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	2.6% 3/117 • Number of events 3 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	— 0/0 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	2.9% 5/171 • Number of events 8 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	5.2% 9/173 • Number of events 9 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	3.6% 6/167 • Number of events 7 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.
Infections and infestations Nasopharyngitis	5.6% 4/72 • Number of events 6 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	2.6% 3/117 • Number of events 3 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	— 0/0 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	2.9% 5/171 • Number of events 7 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	3.5% 6/173 • Number of events 7 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	7.2% 12/167 • Number of events 13 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.
Nervous system disorders Headache	2.8% 2/72 • Number of events 2 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	3.4% 4/117 • Number of events 4 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	— 0/0 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	6.4% 11/171 • Number of events 13 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	7.5% 13/173 • Number of events 15 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	6.0% 10/167 • Number of events 12 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.
Nervous system disorders Tremor	2.8% 2/72 • Number of events 2 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	4.3% 5/117 • Number of events 5 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	— 0/0 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	3.5% 6/171 • Number of events 6 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	8.1% 14/173 • Number of events 14 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	1.8% 3/167 • Number of events 4 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.
Gastrointestinal disorders Nausea	2.8% 2/72 • Number of events 2 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	2.6% 3/117 • Number of events 3 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	— 0/0 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	10.5% 18/171 • Number of events 22 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	10.4% 18/173 • Number of events 22 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	6.0% 10/167 • Number of events 10 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.
Gastrointestinal disorders Diarrhoea	2.8% 2/72 • Number of events 2 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	5.1% 6/117 • Number of events 7 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	— 0/0 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	10.5% 18/171 • Number of events 18 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	11.6% 20/173 • Number of events 30 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	4.2% 7/167 • Number of events 9 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.
Skin and subcutaneous tissue disorders Rash	1.4% 1/72 • Number of events 1 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	6.8% 8/117 • Number of events 10 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	— 0/0 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	13.5% 23/171 • Number of events 28 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	17.3% 30/173 • Number of events 34 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	3.6% 6/167 • Number of events 6 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/72 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	6.8% 8/117 • Number of events 9 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	— 0/0 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	5.3% 9/171 • Number of events 13 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	10.4% 18/173 • Number of events 19 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.60% 1/167 • Number of events 1 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/72 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	1.7% 2/117 • Number of events 2 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	— 0/0 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	5.8% 10/171 • Number of events 11 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	8.1% 14/173 • Number of events 17 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	1.2% 2/167 • Number of events 2 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.
Musculoskeletal and connective tissue disorders Back pain	2.8% 2/72 • Number of events 7 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	5.1% 6/117 • Number of events 6 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	— 0/0 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	8.2% 14/171 • Number of events 16 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	2.9% 5/173 • Number of events 7 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	5.4% 9/167 • Number of events 9 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.
General disorders Fatigue	0.00% 0/72 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	6.8% 8/117 • Number of events 8 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	— 0/0 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	2.9% 5/171 • Number of events 11 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	9.8% 17/173 • Number of events 20 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	4.8% 8/167 • Number of events 8 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.
Infections and infestations Covid-19	0.00% 0/72 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	5.1% 6/117 • Number of events 6 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	— 0/0 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	9.9% 17/171 • Number of events 17 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	4.0% 7/173 • Number of events 7 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	8.4% 14/167 • Number of events 14 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/72 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.85% 1/117 • Number of events 1 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	— 0/0 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	2.3% 4/171 • Number of events 4 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	5.8% 10/173 • Number of events 10 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.00% 0/167 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.
Nervous system disorders Dizziness	2.8% 2/72 • Number of events 3 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	2.6% 3/117 • Number of events 5 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	— 0/0 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	2.3% 4/171 • Number of events 4 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	5.8% 10/173 • Number of events 12 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	4.8% 8/167 • Number of events 12 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.
Gastrointestinal disorders Constipation	1.4% 1/72 • Number of events 1 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	2.6% 3/117 • Number of events 3 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	— 0/0 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.58% 1/171 • Number of events 1 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	5.8% 10/173 • Number of events 12 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	4.8% 8/167 • Number of events 8 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.
General disorders Pyrexia	0.00% 0/72 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	3.4% 4/117 • Number of events 4 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	— 0/0 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	4.1% 7/171 • Number of events 7 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	6.9% 12/173 • Number of events 14 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	3.0% 5/167 • Number of events 5 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.
Gastrointestinal disorders Abdominal pain upper	1.4% 1/72 • Number of events 1 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	3.4% 4/117 • Number of events 4 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	— 0/0 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	2.9% 5/171 • Number of events 6 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	4.6% 8/173 • Number of events 11 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	1.2% 2/167 • Number of events 4 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.
General disorders Asthenia	0.00% 0/72 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	5.1% 6/117 • Number of events 6 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	— 0/0 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.58% 1/171 • Number of events 1 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	4.0% 7/173 • Number of events 7 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.	0.60% 1/167 • Number of events 1 • Any AE/SAE that occurs until the follow-up visit, 30 days post Week 76 (the end of treatment visit), or 30 days post the last dose of study drug for subjects with early discontinuation, should be reported and included in the safety analysis of the study. Any AE/SAE occurring past this date will be reported only if it is considered related to study drug by the Investigator. Part 2 is an optional long-term extension study; patients who had previously received placebo were transitioned to high-dose K0706 in the part 2 study.

Additional Information

Head, Clinical Development

Sun Pharma Advanced Research Company Limited

Phone: 912266455645

Email: clinical.trials@sparcmail.com

Results disclosure agreements

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